Sample records for active parental consent

  1. Bias in Student Survey Findings from Active Parental Consent Procedures

    ERIC Educational Resources Information Center

    Shaw, Thérèse; Cross, Donna; Thomas, Laura T.; Zubrick, Stephen R.

    2015-01-01

    Increasingly, researchers are required to obtain active (explicit) parental consent prior to surveying children and adolescents in schools. This study assessed the potential bias present in a sample of actively consented students, and in the estimates of associations between variables obtained from this sample. Students (n = 3496) from 36…

  2. Active parental consent in school-based research. An examination of ethical and methodological issues.

    PubMed

    Esbensen, F A; Deschenes, E P; Vogel, R E; West, J; Arboit, K; Harris, L

    1996-12-01

    To date, most school-based research has used passive parental consent. However, the Family Privacy Protection Act of 1995 aims to change these requirements. The proposed legislation requires written parental consent if minors are to be asked "sensitive" questions as part of any program or activity funded in whole or in part by the federal government. This act is representative of a growing trend toward restricting research involving minors. Whether or not this act is passed by Congress, two lines of concern are highlighted by this legislation. The first deals with ethical issues surrounding consent procedures. For instance, are parental rights compromised when active consent is not mandated? A second line of inquiry pertains to the effect of active consent procedures on response rates and sample bias. In this article, the authors discuss ethical issues surrounding passive and active consent procedures and then report response rates from two projects in which active consent procedures were implemented.

  3. Active Parent Consent for Health Surveys with Urban Middle School Students: Processes and Outcomes

    ERIC Educational Resources Information Center

    Secor-Turner, Molly; Sieving, Renee; Widome, Rachel; Plowman, Shari; Vanden Berk, Eric

    2010-01-01

    Background: To achieve high participation rates and a representative sample, active parent consent procedures require a significant investment of study resources. The purpose of this article is to describe processes and outcomes of utilizing active parent consent procedures with sixth-grade students from urban, ethnically diverse, economically…

  4. How Does Active Parental Consent Influence the Findings of Drug-Use Surveys in Schools?

    ERIC Educational Resources Information Center

    White, Victoria M.; Hill, David J.; Effendi, Yuksel

    2004-01-01

    This study examines the impact of passive and active parental consent procedures on the type of adolescents participating in a school-based survey examining substance use. Schools recruited from a random sample of metropolitan schools were assigned to passive or active parental consent condition. Results showed that participation rates in active…

  5. 34 CFR 300.300 - Parental consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 2 2013-07-01 2013-07-01 false Parental consent. 300.300 Section 300.300 Education... Placements Parental Consent § 300.300 Parental consent. (a) Parental consent for initial evaluation. (1)(i... child with a disability under § 300.8 must, after providing notice consistent with §§ 300.503 and 300...

  6. 34 CFR 300.300 - Parental consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 2 2011-07-01 2010-07-01 true Parental consent. 300.300 Section 300.300 Education... Placements Parental Consent § 300.300 Parental consent. (a) Parental consent for initial evaluation. (1)(i... child with a disability under § 300.8 must, after providing notice consistent with §§ 300.503 and 300...

  7. 34 CFR 300.300 - Parental consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 2 2012-07-01 2012-07-01 false Parental consent. 300.300 Section 300.300 Education... Placements Parental Consent § 300.300 Parental consent. (a) Parental consent for initial evaluation. (1)(i... child with a disability under § 300.8 must, after providing notice consistent with §§ 300.503 and 300...

  8. 34 CFR 300.300 - Parental consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 2 2014-07-01 2013-07-01 true Parental consent. 300.300 Section 300.300 Education... Placements Parental Consent § 300.300 Parental consent. (a) Parental consent for initial evaluation. (1)(i... child with a disability under § 300.8 must, after providing notice consistent with §§ 300.503 and 300...

  9. Evaluating Active Parental Consent Procedures for School Programming: Addressing the Sensitive Topic of Suicide Prevention.

    PubMed

    Totura, Christine M Wienke; Kutash, Krista; Labouliere, Christa D; Karver, Marc S

    2017-02-01

    Suicide is the second leading cause of death for adolescents. Whereas school-based prevention programs are effective, obtaining active consent for youth participation in public health programming concerning sensitive topics is challenging. We explored several active consent procedures for improving participation rates. Five active consent methods (in-person, students taking forms home, mailing, mailing preceded by primers, mailing followed by reminder calls) were compared against passive consent procedures to evaluate recruitment success, as determined by participation (proportion who responded yes) and response (proportion who returned any response) rates. Participation acceptance rates ranged from 38 to 100% depending on consent method implemented. Compared with passive consent, active consent procedures were more variable in response and participation rates. In-person methods provided higher rates than less interpersonal methods, such as mailing or students taking consents home. Mailed primers before or reminder calls after consent forms were mailed increased response but not participation rates. Students taking consents home resulted in the lowest rates. Although passive consent produces the highest student participation, these methods are not always appropriate for programs addressing sensitive topics in schools. In-person active consent procedures may be the best option when prioritizing balance between parental awareness and successful student recruitment. © 2017, American School Health Association.

  10. The Effects of Requiring Parental Consent for Research on Adolescents' Risk Behaviors: A Meta-analysis.

    PubMed

    Liu, Chao; Cox, Ronald B; Washburn, Isaac J; Croff, Julie M; Crethar, Hugh C

    2017-07-01

    Requiring parental consent may result in sampling biases that confound scientific conclusions and stifle the representation of children most at risk for adverse outcomes. This study aims to investigate whether active parental consent, compared with passive parental consent, creates a bias in response rate, demographic makeup, and adverse outcomes in adolescent samples. A meta-analysis was performed on peer-reviewed articles and unpublished dissertations from 1975 to 2016 in five computerized databases ERIC, PsycINFO, MEDLINE, PubMed and ProQuest. Quantitative studies were retained if they included the following keywords: active consent (or informed consent or parental consent), passive consent (or waiver of consent), risk behavior, adolescen*. Fifteen studies were identified with a total number of 104,074 children. Results showed (1) response rates were significantly lower for studies using active consent procedure than those using passive consent procedure (Z = 3.05, p = .002); (2) more females, younger participants, and less African-Americans were included in studies using active consent procedures than studies using passive procedures (Z = -2.73, p = .006; Z = -12.06, p < .00001; Z = 2.19, p = .03, respectively); (3) studies with passive consent procedures showed higher rates of self-reported substance use than studies using active consent procedures (Z = 3.07, p = .002). Requiring active parental consent can lead to a systematic bias in the sample where the population under study is misrepresented. Institutional review board committees should collaborate with researchers to find solutions that protect minors without silencing the voice of high-risk youth in the literature. Copyright © 2017 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  11. Opt-Out Parental Consent in Online Surveys: Ethical Considerations.

    PubMed

    Harris, Jane; Porcellato, Lorna

    2018-07-01

    This article aims to foster discussion and debate around seeking parental consent from young people recruited online. The growth of social media, particularly for young people, has led to increased interest in young people's online activities as both a research topic and recruitment setting. In a health-related study, which sought to recruit young people aged 13 to 18 years old from YouTuber fan communities to an online survey, the question arose of how parental consent could be sought from young people below 16 when no link existed between researcher and parents/guardians. A practical strategy is proposed which combines novel communication methods for participant information, opt-out online consent and age verification to address this issue. Strengths and limitations of these approaches are discussed.

  12. Children, biobanks and the scope of parental consent

    PubMed Central

    Hens, Kristien; Cassiman, Jean-Jacques; Nys, Herman; Dierickx, Kris

    2011-01-01

    The use of stored tissue samples from children for genetic research raises specific ethical questions that are not all analogous to those raised when adult participants are concerned. These include issues with regard to consent, as it is typically a parent who consents to the use of samples from children. In this paper, we discuss the scope of parental consent. This scope has a temporal dimension and one related to the content of consent. It is not questioned that the temporal scope of parental consent is limited and that young adults have the right to decide on the fate of their samples when they reach the age of maturity. With regard to the content of consent, the question remains whether parents are allowed to give full broad consent to any possible future research on the samples of their children. We argue that they should not be allowed to do so, based on two premises. First, it is generally acknowledged that children have a right to express their own values and that they should be given the opportunity to develop their own autonomy as they grow older. Second, research and science are not completely value-free and some types of research may be more sensitive than other types. Children should be given the opportunity to express their values also in this respect. PMID:21386873

  13. 16 CFR 312.5 - Parental consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... available technology, to ensure that the person providing consent is the child's parent. (2) Existing... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... children, including consent to any material change in the collection, use, or disclosure practices to which...

  14. Parental views on informed consent for expanded newborn screening.

    PubMed

    Moody, Louise; Choudhry, Kubra

    2013-09-01

    An increasing array of rare inherited conditions can be detected as part of the universal newborn screening programme. The introduction and evaluation of these service developments require consideration of the ethical issues involved and appropriate mechanisms for informing parents and gaining consent if required. Exploration of parental views is needed to inform the debate and specifically consider whether more flexible protocols are needed to fit with the public perception of new developments in this context. This study has been undertaken to explore perceptions and attitudes of parents and future parents to an expanded newborn screening programme in the United Kingdom and the necessary information provision and consent processes. A mixed methods study involving focus groups (n = 29) and a web-survey (n = 142) undertaken with parents and future parents. Parents want guaranteed information provision with clear decision-making powers and an awareness of the choices available to them. The difference between existing screening provision and expanded screening was not considered to be significant enough by participants to warrant formal written, informed consent for expanded screening. It is argued that the ethical review processes need to be more flexible towards the provision of information and consent processes for service developments in newborn screening. © 2011 John Wiley & Sons Ltd.

  15. 78 FR 56183 - Children's Online Privacy Protection Rule Proposed Parental Consent Method; Imperium, LLC...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-12

    ... Proposed Parental Consent Method; Imperium, LLC Application for Approval of Parental Consent Method AGENCY... Trade Commission requests public comment concerning the proposed parental consent method submitted by... Parental Consent Method, Project No. P-135419'' on your comment, and file your comment online at https...

  16. Counseling Minors Without Parental Consent.

    ERIC Educational Resources Information Center

    Croxton, Tom A.; And Others

    1988-01-01

    Examines from legal and psychological perspectives counseling services that are provided to minors without parental knowledge or consent. Explores current mental health agency policies and practices, and makes recommendations regarding the counseling needs and rights of minors. (SKC)

  17. Obtaining active parental consent for school-based research: a guide for researchers.

    PubMed

    Wolfenden, Luke; Kypri, Kypros; Freund, Megan; Hodder, Rebecca

    2009-06-01

    Schools increasingly require researchers to obtain active parental consent for students to participate in health research. We sought to identify effective strategies for the recruitment of child research participants through schools. A search of Medline, PsycINFO, Educational Resources Information Center, ProQuest 5000 and the Cochrane Library electronic databases was conducted for the period 1988 to 2008. The review found evidence that the following strategies may be effective in enhancing participation rates: 1) promotion of the research to school principals, teachers, parents and students; 2) dissemination of study information using methods allowing direct contact with parents (i.e. telephone or face-to-face); 3) provision of incentives to teachers, students and at a class level; 4) making reminder contacts; and 5) having a member of the research team co-ordinate and closely monitor the recruitment process. Application of these strategies should reduce the risk of non-response and other biases that result from selective non-participation. Further randomised controlled trials of these and other strategies are required to strengthen the evidence base.

  18. Parental comprehension following informed consent for pediatric cataract surgery.

    PubMed

    Erraguntla, Vasudha; De la Huerta, Irina; Vohra, Sunita; Abdolell, Mohamed; Levin, Alex V

    2012-04-01

    To investigate the effectiveness of information transfer by the pediatric cataract surgeon to the parents or guardians of children during the informed-consent process. Prospective observational case series. Parents of 31 children undergoing cataract surgery. Parents were enrolled from the clinical practice of 1 pediatric cataract surgeon. Using a checklist developed in consultation with other pediatric cataract surgeons, the surgeon discussed the nature of the disease, the course without surgical intervention, the surgical procedure, the risks and benefits, and the postoperative care. Immediately after the discussion, parents were invited to complete a questionnaire assessing information recall. Analysis of variance and the t test were used to determine associations between questionnaire scores and demographic variables. The surgeon subsequently called parents and discussed again the issues that they had not remembered correctly, as identified by the questionnaire responses. The study and data accumulation were carried out with the approval of the Research Ethics Board at The Hospital for Sick Children, Toronto, Ont. Informed consent for the research was obtained from the parents or legal guardians of the children enrolled in the study. The study adhered to the tenets of the Declaration of Helsinki. Of 31 parents, 18 (58%) overestimated their understanding of the informed-consent discussion. Parents scored well on questions about the nature of the disease and the postoperative follow-up but scored lower on questions regarding surgical risks and outcomes. Parents identified several barriers to understanding, including the large amount of information, stress, and preoccupation with the child. No association was noted between the level of understanding and demographic factors. Parents may overestimate their understanding of informed-consent discussions. Some parents may be overly optimistic about risks and outcomes. The surgeon's follow-up communication with parents

  19. Parental perspectives on consent for participation in large-scale, non-biological data repositories.

    PubMed

    Manhas, Kiran Pohar; Page, Stacey; Dodd, Shawn X; Letourneau, Nicole; Ambrose, Aleta; Cui, Xinjie; Tough, Suzanne C

    2016-01-01

    Data sharing presents several challenges to the informed consent process. Unique challenges emerge when sharing pediatric or pregnancy-related data. Here, parent preferences for sharing non-biological data are examined. Groups (n = 4 groups, 18 participants) and individual interviews (n = 19 participants) were conducted with participants from two provincial, longitudinal pregnancy cohorts (AOB and APrON). Qualitative content analysis was applied to transcripts of semi-structured interviews. Participants were supportive of a broad, one-time consent model or a tiered consent model. These preferences were grounded in the perceived obligations for reciprocity and accuracy. Parents want reciprocity among participants, repositories and researchers regarding respect and trust. Furthermore, parents' worry about the interrelationships between the validity of the consent processes and secondary data use. Though parent participants agree that their research data should be made available for secondary use, they believe their consent is still required. Given their understanding that obtaining and informed consent can be challenging in the case of secondary use, parents agreed that a broad, one-time consent model was acceptable, reducing the logistical burden while maintaining respect for their contribution. This broad model also maintained participant trust in the research and secondary use of their data. The broad, one-time model also reflected parents' perspectives surrounding child involvement in the consent process. The majority of parents felt decision made during childhood were the parents responsibility and should remain in parental purview until the child reaches the age of majority.

  20. Fertility and Parental Consent for Minors to Receive Contraceptives

    PubMed Central

    Zavodny, Madeline

    2004-01-01

    Objectives. I examined the effect of imposing a requirement for parental consent before minors can receive medical contraceptives. Methods. Birth and abortions among teens, relative to adults, in a suburban Illinois county that imposed a parental consent requirement in 1998 were compared with births and abortions in nearby counties during the period 1997–2000. Results. The relative proportion of births to women under age 19 years in the county rose significantly compared with nearby counties, whereas the relative proportion of abortions to women under age 20 years declined insignificantly, with a relative increase in the proportion of pregnancies (births and abortions) to young women in the county. Conclusions. Imposing a parental consent requirement for contraceptives, but not abortions, appears to raise the frequency of pregnancies and births among young women. PMID:15284042

  1. Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters.

    PubMed

    Hoberman, Alejandro; Shaikh, Nader; Bhatnagar, Sonika; Haralam, Mary Ann; Kearney, Diana H; Colborn, D Kathleen; Kienholz, Michelle L; Wang, Li; Bunker, Clareann H; Keren, Ron; Carpenter, Myra A; Greenfield, Saul P; Pohl, Hans G; Mathews, Ranjiv; Moxey-Mims, Marva; Chesney, Russell W

    2013-06-01

    A child's health, positive perceptions of the research team and consent process, and altruistic motives play significant roles in the decision-making process for parents who consent for their child to enroll in clinical research. This study identified that nonconsenting parents were better educated, had private insurance, showed lower levels of altruism, and less understanding of study design. To determine the factors associated with parental consent for their child's participation in a randomized, placebo-controlled trial. Cross-sectional survey conducted from July 2008 to May 2011. The survey was an ancillary study to the Randomized Intervention for Children with VesicoUreteral Reflux Study. Seven children's hospitals participating in a randomized trial evaluating management of children with vesicoureteral reflux. Parents asked to provide consent for their child's participation in the randomized trial were invited to complete an anonymous online survey about factors influencing their decision. A total of 120 of the 271 (44%) invited completed the survey; 58 of 125 (46%) who had provided consent and 62 of 144 (43%) who had declined consent completed the survey. A 60-question survey examining child, parent, and study characteristics; parental perception of the study; understanding of the design; external influences; and decision-making process. RESULTS Having graduated from college and private health insurance were associated with a lower likelihood of providing consent. Parents who perceived the trial as having a low degree of risk, resulting in greater benefit to their child and other children, causing little interference with standard care, or exhibiting potential for enhanced care, or who perceived the researcher as professional were significantly more likely to consent to participate. Higher levels of understanding of the randomization process, blinding, and right to withdraw were significantly positively associated with consent to participate. CONCLUSIONS AND

  2. 78 FR 77026 - Children's Online Privacy Protection Rule Proposed Parental Consent Method; iVeriFly, Inc...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-20

    ... Proposed Parental Consent Method; iVeriFly, Inc., Application for Approval of Parental Consent Method... Federal Trade Commission requests public comment concerning the proposed parental consent method submitted... Application for Parental Consent Method, Project No. P-135420'' on your comment, and file your comment online...

  3. Parental consent for abortion: impact of the Massachusetts law.

    PubMed Central

    Cartoof, V G; Klerman, L V

    1986-01-01

    This study assessed the impact of Massachusetts' parental consent law, which requires unmarried women under age 18 to obtain parental or judicial consent before having an abortion. Data were analyzed on monthly totals of abortions and births to Massachusetts minors prior to and following the April 1981 implementation of the law. Findings indicate that half as many minors obtained abortions in the state during the 20 months after the law went into effect as had done so previously. More than 1,800 minors residing in Massachusetts traveled to five surrounding states during these 20 months to avoid the statute's mandates. This group accounts for the reduction in in-state abortions. A small number of minors (50 to 100) bore children rather than aborting during 1982, perhaps because of the law. Findings suggest that this state's parental consent law had little effect on adolescent's pregnancy-resolution behavior. PMID:3953915

  4. 78 FR 51677 - Children's Online Privacy Protection Rule Proposed Parental Consent Method; AssertID, Inc...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-21

    ...-AB20 Children's Online Privacy Protection Rule Proposed Parental Consent Method; AssertID, Inc. Application for Approval of Parental Consent Method AGENCY: Federal Trade Commission (FTC or Commission... concerning the proposed parental consent method submitted by AssertID, Inc. (``AssertID'') under the...

  5. How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study

    PubMed Central

    Woolfall, Kerry; Frith, Lucy; Gamble, Carrol; Gilbert, Ruth; Mok, Quen; Young, Bridget

    2015-01-01

    Objective Alternatives to prospective informed consent to enable children with life-threatening conditions to be entered into trials of emergency treatments are needed. Across Europe, a process called deferred consent has been developed as an alternative. Little is known about the views and experiences of those with first-hand experience of this controversial consent process. To inform how consent is sought for future paediatric critical care trials, we explored the views and experiences of parents and practitioners involved in the CATheter infections in CHildren (CATCH) trial, which allowed for deferred consent in certain circumstances. Design Mixed method survey, interview and focus group study. Participants 275 parents completed a questionnaire; 20 families participated in an interview (18 mothers, 5 fathers). 17 CATCH practitioners participated in one of four focus groups (10 nurses, 3 doctors and 4 clinical trial unit staff). Setting 12 UK children's hospitals. Results Some parents were momentarily shocked or angered to discover that their child had or could have been entered into CATCH without their prior consent. Although these feelings resolved after the reasons why consent needed to be deferred were explained and that the CATCH interventions were already used in clinical care. Prior to seeking deferred consent for the first few times, CATCH practitioners were apprehensive, although their feelings abated with experience of talking to parents about CATCH. Parents reported that their decisions about their child's participation in the trial had been voluntary. However, mistiming the deferred consent discussion had caused distress for some. Practitioners and parents supported the use of deferred consent in CATCH and in future trials of interventions already used in clinical care. Conclusions Our study provides evidence to support the use of deferred consent in paediatric emergency medicine; it also indicates the crucial importance of practitioner communication

  6. Pilot evaluation of parental and professional views regarding consent in neonatal medicine by telephone interviews and questionnaires

    PubMed Central

    2017-01-01

    Objective The objectives of the study were to determine (1) parental and professional views regarding the type of consent required for common neonatal interventions and (2) whether there has been a change in professional understanding regarding the requirements of consent since the last UK survey in 2003. Design Cohort study of (1) parents of babies admitted to a single-centre tertiary neonatal unit and (2) healthcare professionals. Methods The views of 8 parents of former neonatal patients and 69 neonatal professionals were sought using online and telephone survey methodology regarding 20 neonatal interventions and whether implied consent, explicit verbal consent or explicit written consent should be obtained. Results Agreement, defined as both parental and professional consensus on the type of consent required, was present in 12/20 of the interventions. Comparison between professional views in 2003 demonstrated a change regarding type of consent for 50% of interventions with a shift towards obtaining explicit written consent certain treatments. Conclusions The study indicates areas of consensus that exist between parents and professionals regarding consent for common neonatal interventions and a change in professional views regarding consent since the last UK survey in 2003. These data might help inform the development of national guidance for how professionals should obtain consent in neonatology. PMID:29637148

  7. Improving the readability and processability of a pediatric informed consent document: effects on parents' understanding.

    PubMed

    Tait, Alan R; Voepel-Lewis, Terri; Malviya, Shobha; Philipson, Sandra J

    2005-04-01

    To examine whether a consent document modified to conform with the federal guidelines for readability and processability would result in greater parental understanding compared with a standard form. Randomized clinical study. The preoperative waiting area of a larger tertiary care children's hospital. A total of 305 parents of children scheduled for minor elective surgical procedures. Parents were randomized to receive information about a clinical study in 1 of 4 ways: (1) standard consent form alone, (2) standard consent form with verbal disclosure, (3) modified form alone (standard form modified to meet the federal guidelines for readability and processability), and (4) modified form with verbal disclosure. Parents were interviewed to determine their understanding of 11 elements of consent, including study purpose, protocol, risks, benefits to child (direct), benefit to others (indirect), freedom to withdraw, alternatives, duration of study, voluntariness, confidentiality, and whom to contact. Their responses were scored by 2 independent assessors. Understanding of the protocol, study duration, risks, and direct benefits, together with overall understanding, was greater among parents who received the modified form (P<.001). Additionally, parents reported that the modified form had greater clarity (P = .009) and improved layout compared with the standard form (P<.001). When parents were shown both forms, 81.2% preferred the modified version. Results suggest that a consent form written according to federal guidelines for readability and processability can improve parent understanding and thus will be important in enhancing the informed consent process.

  8. A semi-qualitative study of attitudes to vaccinating adolescents against human papillomavirus without parental consent.

    PubMed

    Brabin, Loretta; Roberts, Stephen A; Kitchener, Henry C

    2007-02-09

    The first vaccine to prevent human papillomavirus (HPV) and cervical cancer has been licensed, and in future, vaccination may be routinely offered to 10-14 year old girls. HPV is a sexually transmitted virus and some parents may refuse consent for vaccination. Under-16s in the UK have a right to confidential sexual health care without parental consent. We investigated parents' views on making available HPV vaccination to adolescent minors at sexual health clinics without parental consent. This was a semi-qualitative analysis of views of parents of 11-12 year old school children collected as part of a population-based survey of parental attitudes to HPV vaccination in Manchester. Parents were firstly asked if they agreed that a well-informed child should be able to request vaccination at a sexual health clinic without parental consent, and secondly, to provide a reason for this answer. Ethical perspectives on adolescent autonomy provided the framework for descriptive analysis. 307 parents answered the question, and of these, 244 (80%) explained their views. Parents with views consistent with support for adolescent autonomy (n = 99) wanted to encourage responsible behaviour, protect children from ill-informed or bigoted parents, and respected confidentiality and individual rights. In contrast, 97 parents insisted on being involved in decision-making. They emphasised adult responsibility for a child's health and guidance, erosion of parental rights, and respect for cultural and moral values. Other parents (n = 48) wanted clearer legal definitions governing parental rights and responsibilities or hoped for joint decision-making. Parents resistant to adolescent autonomy would be less likely to consent to future HPV vaccination, (67%) than parents supporting this principle (89%; p < 0.001). In the UK, the principle of adolescent autonomy is recognised and logically should include the right to HPV vaccination, but this may concern parents who would otherwise approve

  9. Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial.

    PubMed

    Natale, Joanne E; Lebet, Ruth; Joseph, Jill G; Ulysse, Christine; Ascenzi, Judith; Wypij, David; Curley, Martha A Q

    2017-05-01

    To evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child's participation in a multisite pediatric critical care clinical trial. We performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation. Multivariable logistic regression modeling estimated associations between patient race and ethnicity and parental refusal of study consent. Among the 3438 children meeting enrollment criteria and approached for consent, 2954 had documented race/ethnicity of non-Hispanic White (White), non-Hispanic Black (Black), or Hispanic of any race. Inability to approach for consent was more common for parents of Black (19.5%) compared with White (11.7%) or Hispanic children (13.2%). Among those offered consent, parents of Black (29.5%) and Hispanic children (25.9%) more frequently refused consent than parents of White children (18.2%, P < .0167 for each). Compared with parents of White children, parents of Black (OR 2.15, 95% CI 1.56-2.95, P < .001) and Hispanic (OR 1.44, 95% CI 1.10-1.88, P = .01) children were more likely to refuse consent. Parents of children offered participation in the intervention arm were more likely to refuse consent than parents in the control arm (OR 2.15, 95% CI 1.37-3.36, P < .001). Parents of Black and Hispanic children were less likely to be approached for, and more frequently declined consent for, their child's participation in a multisite critical care clinical trial. Ameliorating this racial disparity may improve the validity and generalizability of study findings. ClinicalTrials.gov: NCT00814099. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Parental consent for abortion and the judicial bypass option in Arkansas: effects and correlates.

    PubMed

    Joyce, Ted

    2010-09-01

    In 2005, Arkansas changed its parental notification requirement for minors seeking an abortion to a parental consent law, under which a minor can obtain an abortion without consent after obtaining a judicial waiver. Using state health department data on 7,463 abortions among 15-19-year-olds over the period 2001-2007, an analysis of abortion and second-trimester abortion rates among Arkansas minors relative to rates among older teenagers evaluated the influence of the 2005 change in the law. Linear and logistic regression analyses estimated the changes in rates among different age-groups, and assessed the likelihood of minors' using the bypass procedure or having a second-trimester abortion. No association was found between the change in the law and either the abortion rate or the second-trimester abortion rate among minors in the state. Ten percent of all abortions among minors were obtained through the judicial bypass procedure, and minors aged 15 or younger who had an abortion were less likely than those aged 17 to get a waiver (odds ratio, 0.2). Minors who used the bypass option were less likely than those who obtained parental consent to have a second-trimester abortion (0.5), and they terminated the pregnancy 1.1 weeks earlier, on average, than did minors who had gotten such consent. States that convert a parental notification statute to a parental consent statute are unlikely to experience a decrease in abortions among minors. Copyright © 2010 by the Guttmacher Institute.

  11. Evaluating Active Parental Consent Procedures for School Programming: Addressing the Sensitive Topic of Suicide Prevention

    ERIC Educational Resources Information Center

    Totura, Christine M. Wienke; Kutash, Krista; Labouliere, Christa D.; Karver, Marc S.

    2017-01-01

    Background: Suicide is the second leading cause of death for adolescents. Whereas school-based prevention programs are effective, obtaining active consent for youth participation in public health programming concerning sensitive topics is challenging. We explored several active consent procedures for improving participation rates. Methods: Five…

  12. Does parental consent for birth control affect underage pregnancy rates? The case of Texas.

    PubMed

    Girma, Sourafel; Paton, David

    2013-12-01

    Previous work based on conjectural responses of minors predicted that the 2003 Texas requirement for parental consent for state-funded birth control to minors would lead to a large increase in underage pregnancies. We use state- and county-level data to test this prediction. The latter allow us to compare the impact of parental consent in counties with and without state-funded family planning clinics. We control for characteristics systematically correlated with the presence of state-funded clinics by combining difference-in-difference estimation with propensity score-weighted regressions. The evidence suggests that the parental consent mandate led to a large decrease in attendance at family planning clinics among teens but did not lead to an increase in underage pregnancies.

  13. Parental Consent for Abortion and the Judicial Bypass Option in Arkansas: Effects and Correlates

    PubMed Central

    Joyce, Ted

    2010-01-01

    CONTEXT In 2005, Arkansas changed its parental notification requirement for minors seeking an abortion to a parental consent law, under which a minor can obtain an abortion without consent after obtaining a judicial waiver. METHODS Using state Department of Health data on 7,463 abortions among 15–19-year-olds over the period 2001–2007, an analysis of abortion and second-trimester abortion rates among Arkansas minors relative to rates among older teenagers evaluated the influence of the 2005 change in the law. Linear and logistic regression analyses estimated the changes in rates among different age-groups, and assessed the likelihood of minors’ using the bypass procedure or having a second-trimester abortion. RESULTS No association was found between the change in the law and either the abortion rate or the second-trimester abortion rate among minors in the state. Ten percent of all abortions among minors were obtained through the judicial bypass procedure, and minors aged 15 or younger who had an abortion were less likely than those aged 17 to get a waiver (odds ratio, 0.2). Minors who used the bypass option were less likely than those who obtained parental consent to have a second-trimester abortion (0.5), and they terminated the pregnancy 1.1 weeks earlier, on average, than did minors who had gotten such consent. CONCLUSIONS States that convert a parental notification statute to a parental consent statute are unlikely to experience a decrease in abortions among minors. PMID:20887286

  14. Why parents and children consent to become involved in medical student teaching.

    PubMed

    Pinnock, Ralph; Weller, Jennifer; Shulruf, Boaz; Jones, Rhys; Reed, Peter; Mizutani, Satomi

    2011-04-01

    Clinical experience in paediatrics is essential for medical undergraduates. This is the first study, of which we are aware, to examine why children of different ages admitted acutely to hospital and their parents agree to become involved in medical student teaching. We wanted to establish whether they considered that they needed to give consent before seeing medical students, whether this was routinely sought and what influenced their decisions. Data were collected using questionnaires and semi-structured interviews of parents and children. Questionnaires were completed by 105 parents of children less than 6 years old, and 34 children between 10 years and 15 years old and their parents. Interviews were conducted with 32 children between the ages of 6 and 10 years and their parents. Most parents and children consider that they have a responsibility to teaching but must always be asked for consent. They were motivated by altruism, but fear of emotional distress or pain can lead them to refuse. Younger children may not be able to give reasons for not wanting to see a medical student but sometimes have firm views, which must be respected. Having seen a medical student previously did influence children's or parents' opinions. Most children who have seen a medical student were prepared to see students again. Medical students can be reassured that parents and children admitted acutely to a children's hospital have a positive attitude to student involvement and are prepared to help them learn clinical skills, but consent must always be obtained and the child's perspective must always be considered. © 2011 The Authors. Journal of Paediatrics and Child Health © 2011 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

  15. How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India.

    PubMed

    Rajaraman, Divya; Jesuraj, Nelson; Geiter, Lawrence; Bennett, Sean; Grewal, Harleen Ms; Vaz, Mario

    2011-02-15

    A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation. In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process. In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location. The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease.

  16. A qualitative study to assess school nurses' views on vaccinating 12-13 year old school girls against human papillomavirus without parental consent.

    PubMed

    Stretch, Rebecca; McCann, Rosemary; Roberts, Stephen A; Elton, Peter; Baxter, David; Brabin, Loretta

    2009-07-21

    In the UK, parental consent for the routine vaccination of 12-13 year olds schoolgirls against human papillomavirus (HPV) is recommended, although legally girls may be able to consent themselves. As part of a vaccine study conducted ahead of the National HPV Vaccine Programme we sought the views of school nurses on vaccinating girls who did not have parental consent. HPV vaccination was offered to all 12 year old girls attending schools in two Primary Care Trusts in Greater Manchester. At the end of the study semi-structured, tape-recorded interviews were conducted with school nurses who had delivered the vaccine (Cervarix). The interview template was based on concepts derived from the Theory of Planned Behaviour. Transcripts were analysed thematically in order to understand school nurses' intentions to implement vaccination based on an assessment of Gillick competency. School nurses knew how to assess the competency of under-16s but were still unwilling to vaccinate if parents had refused permission. If parents had not returned the consent form, school nurses were willing to contact parents, and also to negotiate with parents who had refused consent. They seemed unaware that parental involvement required the child's consent to avoid breaking confidentiality. Nurses' attitudes were influenced by the young appearance and age of the school year group rather than an individual's level of maturity. They were also confused about the legal guidelines governing consent. School nurses acknowledged the child's right to vaccination and strongly supported prevention of HPV infection but ultimately believed that it was the parents' right to give consent. Most were themselves parents and shared other parents' concerns about the vaccine's novelty and unknown long-term side effects. Rather than vaccinate without parental consent, school nurses would defer vaccination. Health providers have a duty of care to girls for whom no parental consent for HPV vaccination has been given

  17. Parental Refusal to Consent for Evaluation: A Legal Analysis with Implications for School Psychologists

    ERIC Educational Resources Information Center

    Etscheidt, Susan; Clopton, Kerri; Haselhuhn, Charlotte

    2012-01-01

    The decision to begin the process for special education eligibility has complexities impacting children, parents, teachers, and schools. The Individuals with Disabilities Education Improvement Act (IDEA) eligibility provisions specify the need to obtain consent prior to evaluation and options when consent cannot be obtained. School psychologists…

  18. Parents, adolescents, and consent for research participation.

    PubMed

    Iltis, Ana S

    2013-06-01

    Decisions concerning children in the health care setting have engendered significant controversy and sparked ethics policies and statements, legal action, and guidelines regarding who ought to make decisions involving children and how such decisions ought to be made. Traditionally, parents have been the default decision-makers for children not only with regard to health care but with regard to other matters, such as religious practice and education. In recent decades, there has been a steady trend away from the view that parents are in authority over their children and toward the view that children are rights-bearers who should be granted greater authority over themselves. The mature minor doctrine refers to the decision to grant mature minors the authority to make decisions traditionally reserved for their parents. This essay (1) documents the trend towards expanding the understanding of some minors as "mature" and hence as having the right and authority to give informed consent, (2) examines the reasons for which some commentators have a special interest in expanding the mature minor doctrine to the research setting and allowing minors to enroll in research without parental permission, and (3) defends the view that the mature minor doctrine, regardless of its application to clinical health care decisions, ought to be set aside in the research setting in favor of greater parental involvement.

  19. The impact of parental consent on the HIV testing of minors.

    PubMed

    Meehan, T M; Hansen, H; Klein, W C

    1997-08-01

    This investigation assessed change in use of human immunodeficiency virus (HIV) testing by minors after removal of the parental consent requirement in Connecticut. HIV counseling and testing records for 13- to 17-year-olds who accessed publicly funded testing sites were analyzed. The number of visits increased by 44% from the 12-month period before the statutory change (n = 656) to the 12-month period thereafter (n = 965). The number of HIV tests increased twofold. Visits and tests of high-risk minors tripled. Minors should have the right to consent to HIV testing.

  20. Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process.

    PubMed

    Allmark, P; Mason, S

    2006-08-01

    To assess whether continuous consent, a process in which information is given to research participants at different stages in a trial, and clinician training in that process were effective when used by clinicians while gaining consent to the Total Body Hypothermia (TOBY) trial. The TOBY trial is a randomised controlled trial (RCT) investigating the use of whole-body cooling for neonates with evidence of perinatal asphyxia. Obtaining valid informed consent for the TOBY trial is difficult, but is a good test of the effectiveness of continuous consent. Semistructured interviews were conducted with 30 sets of parents who consented to the TOBY trial and with 10 clinicians who sought it by the continuous consent process. Analysis was focused on the validity of parental consent based on the consent components of competence, information, understanding and voluntariness. No marked problems with consent validity at the point of signature were observed in 19 of 27 (70%) couples. Problems were found mainly to lie with the competence and understanding of the parents: mothers, particularly, had problems with competence in the early stages of consent. Problems in understanding were primarily to do with side effects. Problems in both competence and understanding were observed to reduce markedly, particularly for mothers, in the post-signature phase, when further discussion took place. Randomisation was generally understood but unpopular. Information was not always given by clinicians in stages during the short period available before parents gave consent. Most clinicians, however, were able to give follow-up information. Consent validity was found to compare favourably with similar trials examined in the Euricon study. Adopting the elements of the continuous consent process and clinician training in RCTs should be considered by researchers, particularly when they have concerns about the quality of consent they are likely to obtain by using a conventional process.

  1. A qualitative study to assess school nurses' views on vaccinating 12–13 year old school girls against human papillomavirus without parental consent

    PubMed Central

    Stretch, Rebecca; McCann, Rosemary; Roberts, Stephen A; Elton, Peter; Baxter, David; Brabin, Loretta

    2009-01-01

    Background In the UK, parental consent for the routine vaccination of 12–13 year olds schoolgirls against human papillomavirus (HPV) is recommended, although legally girls may be able to consent themselves. As part of a vaccine study conducted ahead of the National HPV Vaccine Programme we sought the views of school nurses on vaccinating girls who did not have parental consent. Methods HPV vaccination was offered to all 12 year old girls attending schools in two Primary Care Trusts in Greater Manchester. At the end of the study semi-structured, tape-recorded interviews were conducted with school nurses who had delivered the vaccine (Cervarix™). The interview template was based on concepts derived from the Theory of Planned Behaviour. Transcripts were analysed thematically in order to understand school nurses' intentions to implement vaccination based on an assessment of Gillick competency. Results School nurses knew how to assess the competency of under-16s but were still unwilling to vaccinate if parents had refused permission. If parents had not returned the consent form, school nurses were willing to contact parents, and also to negotiate with parents who had refused consent. They seemed unaware that parental involvement required the child's consent to avoid breaking confidentiality. Nurses' attitudes were influenced by the young appearance and age of the school year group rather than an individual's level of maturity. They were also confused about the legal guidelines governing consent. School nurses acknowledged the child's right to vaccination and strongly supported prevention of HPV infection but ultimately believed that it was the parents' right to give consent. Most were themselves parents and shared other parents' concerns about the vaccine's novelty and unknown long-term side effects. Rather than vaccinate without parental consent, school nurses would defer vaccination. Conclusion Health providers have a duty of care to girls for whom no parental

  2. Obtaining waivers of parental consent: A strategy endorsed by gay, bisexual, and queer adolescent males for health prevention research.

    PubMed

    Flores, Dalmacio; McKinney, Ross; Arscott, Joyell; Barroso, Julie

    Requiring parental consent in studies with sexual minority youth (SMY) can sometimes be problematic as participants may have yet to disclose their sexual orientation, may not feel comfortable asking parents' permission, and may promote a self-selection bias. We discuss rationale for waiving parental consent, strategies to secure waivers from review boards, and present participants' feedback on research without parents' permission. We share our institutional review board proposal in which we made a case that excluding SMY from research violates ethical research principles, does not recognize their autonomy, and limits collection of sexuality data. Standard consent policies may inadvertently exclude youth who are at high risk for negative health outcomes or may potentially put them at risk because of forced disclosure of sexual orientation. Securing a waiver addresses these concerns and allows for rich data, which is critical for providers to have a deeper understanding of their unique sexual health needs. To properly safeguard and encourage research informed by SMY, parental consent waivers may be necessary. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. The impact of parental consent on the HIV testing of minors.

    PubMed Central

    Meehan, T M; Hansen, H; Klein, W C

    1997-01-01

    OBJECTIVES: This investigation assessed change in use of human immunodeficiency virus (HIV) testing by minors after removal of the parental consent requirement in Connecticut. METHODS: HIV counseling and testing records for 13- to 17-year-olds who accessed publicly funded testing sites were analyzed. RESULTS: The number of visits increased by 44% from the 12-month period before the statutory change (n = 656) to the 12-month period thereafter (n = 965). The number of HIV tests increased twofold. Visits and tests of high-risk minors tripled. CONCLUSIONS: Minors should have the right to consent to HIV testing. PMID:9279271

  4. Care and Consent.

    ERIC Educational Resources Information Center

    Gottesman, Roberta

    1981-01-01

    Discusses the legal ramifications of informed consent for medical treatment of schoolchildren, including the problems posed by parents unwilling to give adequate medical protection to their children because of religious or other reasons. Covers the types of medical care that minors can receive without parental consent. (WD)

  5. Constitutional Law: Abortion, Parental and Spousal Consent Requirements, Right to Privacy

    ERIC Educational Resources Information Center

    Long, Sharon L.; Ravenscraft, Patricia

    1976-01-01

    The constitutionality of the Missouri abortion statute was challenged by two physicians and Planned Parenthood of Central Missouri in the Danforth case. The Supreme Court reversed a district court decision in part, ruling that parental and spousal consent requirements are unconstitutional. For journal availability see HE 508 875. (LBH)

  6. What constitutes consent when parents and daughters have different views about having the HPV vaccine: qualitative interviews with stakeholders.

    PubMed

    Wood, Fiona; Morris, Lucy; Davies, Myfanwy; Elwyn, Glyn

    2011-08-01

    The UK Human Papillomavirus (HPV) vaccine programme commenced in the autumn of 2008 for year 8 (age 12-13 years) schoolgirls. We examine whether the vaccine should be given when there is a difference of opinion between daughters and parents or guardians. Qualitative study using semi-structured interviews. A sample of 25 stakeholders: 14 professionals involved in the development of the HPV vaccination programme and 11 professionals involved in its implementation. Overriding the parents' wishes was perceived as problematic and could damage the relationship between school and parents. A number of practical problems were raised in relation to establishing whether parents were genuinely against their daughter receiving the vaccine. Although many respondents recognised that the Gillick guidelines were relevant in establishing whether a girl could provide consent herself, they still felt that there were significant problems in establishing whether girls could be assessed as Gillick competent. In some areas school nurses had been advised not to give the vaccine in the absence of parental consent. None of the respondents suggested that a girl should be vaccinated against her consent even if her parents wanted her to have the vaccine. While the Gillick guidelines provide a legal framework to help professionals make judgements about adolescents consenting to medical treatment, in practice there appears to be variable and confused interpretation of this guidance. Improved legal structures, management procedures and professional advice are needed to support those who are assessing competence and establishing consent to vaccinate adolescents in a school setting.

  7. When Can the Child Speak for Herself? The Limits of Parental Consent in Data Protection Law for Health Research.

    PubMed

    Taylor, Mark J; Dove, Edward S; Laurie, Graeme; Townend, David

    2017-11-13

    Draft regulatory guidance suggests that if the processing of a child's personal data begins with the consent of a parent, then there is a need to find and defend an enduring consent through the child's growing capacity and on to their maturity. We consider the implications for health research of the UK Information Commissioner's Office's (ICO) suggestion that the relevant test for maturity is the Gillick test, originally developed in the context of medical treatment. Noting the significance of the welfare principle to this test, we examine the implications for the responsibilities of a parent to act as proxy for their child. We argue, contrary to draft ICO guidance, that a data controller might legitimately continue to rely upon parental consent as a legal basis for processing after a child is old enough to provide her own consent. Nevertheless, we conclude that data controllers should develop strategies to seek fresh consent from children as soon as practicable after the data controller has reason to believe they are mature enough to consent independently. Techniques for effective communication, recommended to address challenges associated with Big Data analytics, might have a role here in addressing the dynamic relationship between data subject and processing. Ultimately, we suggest that fair and lawful processing of a child's data will be dependent upon data controllers taking seriously the truism that consent is ongoing, rather than a one-time event: the core associated responsibility is to continue to communicate with a data subject regarding the processing of personal data. © The Author 2017. Published by Oxford University Press.

  8. Constitutional Law: Abortion, Parental Consent, Minors' Right to Due Process, Equal Protection and Privacy

    ERIC Educational Resources Information Center

    Child, Barbara

    1975-01-01

    In State v. Koome, the Washington Supreme Court has striken that state's statute regarding parental consent for a minor's abortion. Implications of the finding for a minor's right to due process, equal protection, and privacy are discussed. (LBH)

  9. Are Parents of Preschool Children Inclined to Give Consent for Participation in Nutritional Clinical Trials?

    PubMed

    Nimbalkar, Somashekhar Marutirao; Patel, Dipen Vasudev; Phatak, Ajay Gajanan

    2016-01-01

    Micronutrient deficiencies can lead to anemia, growth restriction, and poor motor and cognitive development. A clinical trial was planned to assess the impact of nutritional supplementation on cognitive measures in preschool children. Conducting clinical trials in children is difficult due to underlying laws, hesitation of the research community, and difficult enrollment. We carried out a questionnaire-based feasibility survey to assess the interest of parents towards participation in such a nutrition-based study. After approval from the Institutional Human Research Ethics Committee, the principals of four kindergarten schools at Vallabh Vidyanagar, Anand, Gujarat, India consented to participate. Children at the participating schools were distributed a consent form and pre-tested questionnaire, to be taken home for parents to sign, fill and return. Out of a total of 1049 consent forms and questionnaires distributed, 602 (57.39%) signed and filled forms were returned. Despite fair awareness regarding the need of research, parents' willingness to involve their children in a 6 month duration research study, not requiring invasive measures like blood pricks, was 180 (29.9%). Nearly half (250, 41.5%) did not respond and more than a quarter (172, 28.6%) declined participation on behalf of their children. The interest level of a pre-school child's parents for participation of the child in a nutrition intervention study evaluating cognitive measures like memory is low. Understanding the study population's motivating and inhibiting factors leading to decreased participation in clinical trials is necessary to facilitate the creation of a pertinent evidence base.

  10. Protecting adolescents' right to seek treatment for sexually transmitted diseases without parental consent: the Arizona experience with Senate Bill 1309.

    PubMed

    Goodwin, Kimberly D; Taylor, Melanie M; Brown, Erin C Fuse; Winscott, Michelle; Scanlon, Megan; Hodge, James G; Mickey, Tom; England, Bob

    2012-01-01

    In 2010, Senate Bill 1309 included language to repeal an existing Arizona law that enables minors younger than 18 years of age to seek diagnosis and treatment of sexually transmitted diseases (STDs) without parental consent. Numerous implications were identified that would have stemmed from parental consent provisions originally proffered in Senate Bill 1309. These implications included diminished access to essential health services among minors, exacerbated existing health disparities, increased health-care spending costs, and thwarted efforts to curb the spread of STDs. Lastly, minors would have been deprived of existing privacy protections concerning their STD-related medical information. This case study describes how collaborative advocacy efforts resulted in the successful amendment of Senate Bill 1309 to avert the negative sexual and reproductive health outcomes among adolescents stemming from the potential repeal of their existing legal right to seek STD treatment without parental consent.

  11. Differential recall of consent information and parental decisions about enrolling children in research studies.

    PubMed

    Boccia, Maria L; Campbell, Frances A; Goldman, Barbara D; Skinner, Martie

    2009-01-01

    In the present simulation research, the authors examined the relations between the type of information that low-income parents (N = 116) recalled from informed-consent materials and their hypothetical decision to enroll a child in a clinical study. The authors gave parents or guardians of Head Start children information about a medical protocol involving high risk and significant potential benefit to child participants. Differential recall of the various categories of information (procedures, benefits, risks and costs, rights, and other) showed that relative to all consent information conveyed to them, participants recalled most about procedures and least about their child's rights as a study participant. Relative to their own recall, they also recounted most about procedures, slightly more about benefits than risks, and least about research rights. The pattern of recall differed among those who agreed to enroll and those who declined. The ratio of recalled risks to benefits predicted enrollment decisions.

  12. Protecting Adolescents' Right to Seek Treatment for Sexually Transmitted Diseases without Parental Consent: The Arizona Experience with Senate Bill 1309

    PubMed Central

    Goodwin, Kimberly D.; Taylor, Melanie M.; Brown, Erin C. Fuse; Winscott, Michelle; Scanlon, Megan; Hodge, James G.; Mickey, Tom; England, Bob

    2012-01-01

    In 2010, Senate Bill 1309 included language to repeal an existing Arizona law that enables minors younger than 18 years of age to seek diagnosis and treatment of sexually transmitted diseases (STDs) without parental consent. Numerous implications were identified that would have stemmed from parental consent provisions originally proffered in Senate Bill 1309. These implications included diminished access to essential health services among minors, exacerbated existing health disparities, increased health-care spending costs, and thwarted efforts to curb the spread of STDs. Lastly, minors would have been deprived of existing privacy protections concerning their STD-related medical information. This case study describes how collaborative advocacy efforts resulted in the successful amendment of Senate Bill 1309 to avert the negative sexual and reproductive health outcomes among adolescents stemming from the potential repeal of their existing legal right to seek STD treatment without parental consent. PMID:22547855

  13. Stability of parental understanding of random assignment in childhood leukemia trials: an empirical examination of informed consent.

    PubMed

    Greenley, Rachel Neff; Drotar, Dennis; Zyzanski, Stephen J; Kodish, Eric

    2006-02-20

    To examine stability versus change in parental understanding of random assignment in randomized clinical trials (RCTs) for pediatric leukemia and to identify factors associated with changes in understanding. Eighty-four parents of children diagnosed with acute lymphoblastic leukemia or acute myeloid leukemia who were enrolled onto a pediatric leukemia RCT at one of six US children's hospitals participated. Parents were interviewed twice, once within 48 hours after the Informed Consent Conference (ICC; time 1 [T1]) and again 6 months later (time 2 [T2]). Interviews focused on parental understanding of key components of the RCT, including random assignment. Interviews were audiotaped, transcribed, and later analyzed. Changes in understanding of random assignment occurred in 19% of parents, with 17% of parents deteriorating in understanding from T1 to T2. Forty-nine percent of parents failed to understand random assignment at both times. Factors associated with understanding at both times included majority ethnicity, high socioeconomic status, parental reading of consent document, and presence of a nurse during the ICC. Physician discussion of specific components of the RCT was also associated with understanding at both times. Female caregivers and parents of low socioeconomic status were overrepresented among those who showed decay in understanding from T1 to T2. Parents showed little gain in understanding over time. Factors that predicted understanding at diagnosis as well as sustained understanding over time may be important intervention targets. Attention to both modifiable and nonmodifiable barriers is important for clinical practice.

  14. 16 CFR 312.5 - Parental consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

  15. 16 CFR 312.5 - Parental consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

  16. 16 CFR 312.5 - Parental consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

  17. 16 CFR 312.5 - Parental consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

  18. Consent Form Return Rates for Third-Grade Urban Elementary Students

    ERIC Educational Resources Information Center

    Ji, Peter; Flay, Brian R.; Phil, D.; DuBois, David L.; Brechling, Vanessa; Day, Joseph; Cantillon, Dan

    2006-01-01

    Objective: To maximize active parent consent form return rates for third-grade minority, urban students enrolled in predominantly low-income elementary schools in Chicago, Ill. Methods: Research staff used a class incentive and class visits to retrieve consent forms from students. Results: Of the 811 third-grade students, 98% returned a form and …

  19. Parental and youth understanding of the informed consent process for pediatric endoscopy.

    PubMed

    Jubbal, Kevin; Chun, Stanford; Chang, Jeremy; Zhang, Sherry; Terrones, Laura; Huang, Jeannie S

    2015-06-01

    Informed consent (IC) is an essential communication between patient/representative and physician that acknowledges patient autonomy; assent is the equivalent process performed between youth and physician. For clinical procedures involving youth, only the IC process between guardian/parent and physician is required to be performed. Nevertheless, experts recommend that youth undergo assent whenever possible. In the present study, we explored both parental and youth understanding of required IC elements in IC discussions before pediatric endoscopy. Following signing of IC documents on the day of endoscopy at a tertiary care academic medical center, youth and their parents underwent structured interviews to assess comprehension of key elements of the IC process. A total of 88 children and adolescents and their parents were evaluated. Two youth and 12 parents demonstrated comprehensive understanding of key IC elements for pediatric endoscopy. Suboptimal youth understanding was demonstrated for nature of the procedure (25% with adequate understanding) and related risks (17%), and alternatives (14%) to the procedure. Suboptimal parental understanding was demonstrated for procedure alternatives (24%). Youth overall understanding of IC varied by age, whereas parental global understanding of IC varied by physician. Understanding of IC performed for pediatric endoscopy could be improved in both parents and youth. Our findings suggest that interventions targeting parents, youth, and physicians may be helpful. Further study is needed to determine whether our findings are representative of IC understanding at other pediatric endoscopy centers.

  20. Factors influencing parental consent in a hypothetical pediatric vaccine trial in a developing country setting: a questionnaire study.

    PubMed

    Serce, Ozge; Gonen, Ismail; Bakir, Mustafa

    2015-01-01

    Clinical vaccine trials have been lacking in the pediatric population due to lower consent rate of the parents. We assessed characteristics of the parents, and motives and barriers underlying the decision process. The results of the questionnaire were evaluated by multivariate analysis. Parents who opted in were younger and more often employed than the parents who opted out. The most important motives were receiving detailed information about trial and benefits to human health. The qualified education of medical community and public about the rationale and benefits of trials is essential for opt-in.

  1. Voluntary Informed Consent in Paediatric Oncology Research.

    PubMed

    Dekking, Sara A S; Van Der Graaf, Rieke; Van Delden, Johannes J M

    2016-07-01

    In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. © 2015 John Wiley & Sons Ltd.

  2. A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol.

    PubMed

    Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

    2011-01-04

    The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Australian New Zealand Clinical Trials Registry ACTRN12610000332022.

  3. Consents or waivers of responsibility? Parents' information in NICU.

    PubMed

    Bellieni, Carlo V; Coradeschi, Caterina; Curcio, Maria R; Grande, Elisa; Buonocore, Giuseppe

    2018-05-14

    Informing the patient is a base of modern medicine; nonetheless, a great discrepancy exists between hospitals on the way this information should be administered. This is particularly important when the patient are babies: the information should be given to their parents who should approve or disapprove the treatment. Aim of this study is to assess the adequacy of the information administered to the parents of babies admitted into the Neonatal Intensive Care Units. We analyzed the consent forms of center-north Italy NICUs. To this aim, we assessed if the forms had acceptable length and other features; we then asked some volunteers to simulate an information process and to score the forms for their easiness, comprehensibility and explicability to others. Twenty-one NICUs accepted to participate. Only 7 out of 21 had an adequate information form; the other 14 could be described as "waiver of responsibility " (WOR), because they were too prolix and contained too many hypothetical procedures. The overall level of easiness, comprehensibility and explicability to others was suboptimal, being lower in those forms we defined WOR. The results are far to be optimal. More care should be devoted to the process of informing parents at the admission into the NICU: an information overload should be avoided and information should be tailored on the baby's state. Further analysis should be devoted to whether the use of WOR is routine in other countries.

  4. [Informed consent and parental refusal for medical treatment in childhood. The threshold of medical and social tolerance. Part II].

    PubMed

    Guadarrama-Orozco, Jessica H; Garduño Espinosa, Juan; Vargas López, Guillermo; Viesca Treviño, Carlos

    Medical care in pediatric patients is conditional to parental consent. Parents decide the time and type of treatment they want their children to receive when they are ill. The physician should request parental consent before carrying out the most appropriate therapy. When parents refuse the treatment offered, the physician should seek alternative therapies that may be better accepted by parents and find the most beneficial treatment for children and their families. If physicians and parents are unable to agree on the best therapeutic methods, then the physician becomes involved in an ethical conflict related to the best interests of the child and parental choices. From the above posture, the following questions arise: What should the physician do when faced with this situation? Should the physician use legal measures to force parents to accept treatment? Under what conditions is it justified to force parents and when should the decision be tolerated? What is the role of the Hospital Bioethics Committee concerning this issue? This second part focuses on proposing four practical criteria to be used by the physician and Hospital Bioethics Committee when all alternative therapies and conciliatory options have been exhausted with parents and they continue to refuse treatment. The physician then has to make a decision because the child is placed at risk of harm. This decision focuses on whether there is danger to the minor arising from the decisions of parents and if such harm is avoidable. Copyright © 2015 Hospital Infantil de México Federico Gómez. Publicado por Masson Doyma México S.A. All rights reserved.

  5. Consent to autopsy for neonates.

    PubMed

    McHaffie, H E; Fowlie, P W; Hume, R; Laing, I A; Lloyd, D J; Lyon, A J

    2001-07-01

    To determine parents' views on autopsy after treatment withdrawal. Face to face interviews with 59 sets of bereaved parents (108 individual parents) for whose 62 babies there had been discussion of treatment withdrawal. All except one couple were asked for permission for postmortem examination; 38% refused. The main reasons for declining were concerns about disfigurement, a wish to have the child left in peace, and a feeling that an autopsy was unnecessary because the parents had no unanswered questions. The diagnosis, the age of the child, and the approach of the consultant appeared to influence consent rates. Of those who agreed to autopsies, 92% were given the results by the neonatologist concerned. Whether or not they had agreed to the procedure, at 13 months no parent expressed regrets about their decision. Autopsy rates in the East of Scotland stand at 62%. Parents' perceptions are an important element in consent to postmortem examination.

  6. Active choice but not too active: Public perspectives on biobank consent models

    PubMed Central

    Simon, Christian M.; L’Heureux, Jamie; Murray, Jeffrey C.; Winokur, Patricia; Weiner, George; Newbury, Elizabeth; Shinkunas, Laura; Zimmerman, Bridget

    2013-01-01

    Purpose Despite important recent work, US public attitudes toward specific biobank consent models are not well understood. Public opinion data can help shape efforts to develop ethically sound and publicly trusted mechanisms for informing and consenting prospective biobank donors. The purpose of this study was to explore public perspectives toward a range of consent models currently being used or considered for use among comprehensive US biobanks. Methods The study used an exploratory mixed-methods design, using focus groups and telephone surveys. Eligible participants were English-speaking residents in the catchment area of a comprehensive biobank being developed at the University of Iowa. Results Forty-eight participants in seven focus groups and 751 survey participants were recruited. Biobanks were unfamiliar to almost all study participants but were seen as valuable resources. Most focus group (63%) and survey (67%) participants preferred a prospective opt-in over an opt-out consent approach. Broad, research-unspecific consent was preferred over categorical and study-specific consent models for purposes of approving future research use. Conclusion Many individuals may want to make an active and informed choice at the point of being approached for biobank participation but are prepared to consent broadly to future research use and to forego additional choices as a result. PMID:21555942

  7. Informed consent in paediatric critical care research--a South African perspective.

    PubMed

    Morrow, Brenda M; Argent, Andrew C; Kling, Sharon

    2015-09-09

    Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources. Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is usually required for child research participation, but obtaining consent may be challenging in paediatric critical care research. Local regulations may also impede important research if overly restrictive. By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in the context of paediatric critical care research in South Africa. Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement for child research participation in South Africa. However, parents of critically ill or injured children might be incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic misconceptions and sociocultural and language issues are also barriers to obtaining valid consent. Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies or devices. We propose that parents or legal guardians of critically ill or injured children should only be approached to consent for their child's participation in clinical research when it is ethically justifiable and in the best interests of both

  8. Legal protection of informed consent of minors.

    PubMed

    Osuna, Eduardo

    2010-06-01

    One of the pillars of healthcare provision is respect for the autonomy of the patient's wishes, which is given substance by the process of obtaining informed consent. Minors deserve special protection, entitled to basic rights and increasingly autonomous as they develop. In certain situations, minors are deemed matures and able to consent to treatment without the involvement of a parent or guardian. The assessment of competence would be based on the child's functional ability, not on age or outcome of the decision. This manuscript includes a brief analysis of legal perspectives on informed consent of minors, and minors' capacities to make medical decisions. Remaining questions of how to evaluate capacity and balance parental and minor autonomy are explored. Considerations on informed consent in different situations as refusing treatment and termination of pregnancy by female children are analyzed.

  9. Adolescents and consent to treatment.

    PubMed

    Dickens, B M; Cook, R J

    2005-05-01

    Adolescents, defined by WHO as 10 to 19 years old, can give independent consent for reproductive health services if their capacities for understanding have sufficiently evolved. The international Convention on the Rights of the Child, almost universally ratified, limits parental powers, and duties, by adolescents' "evolving capacities" for self-determination. Legal systems may recognize "mature minors" as enjoying adult rights of medical consent, even when consent to sexual relations does not absolve partners of criminal liability; their consent does not make the adolescents offenders. There is usually no chronological "age of consent" for medical care, but a condition of consent, meaning capacity for understanding. Like adults, mature minors enjoy confidentiality and the right to treatment according to their wishes rather than their best interests. Minors incapable of self-determination may grant or deny assent to treatment for which guardians provide consent. Emancipated minors' self-determination may also be recognized, for instance on marriage or default of adults' guardianship.

  10. 34 CFR 303.401 - Definitions of consent, native language, and personally identifiable information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 2 2011-07-01 2010-07-01 true Definitions of consent, native language, and personally... Definitions of consent, native language, and personally identifiable information. As used in this subpart— (a... which consent is sought, in the parent's native language or other mode of communication; (2) The parent...

  11. Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk.

    PubMed

    Rogers, C G; Tyson, J E; Kennedy, K A; Broyles, R S; Hickman, J F

    1998-04-01

    The objective of this study was to assess a modified consent procedure allowed under federal regulations and developed for studies, particularly clinical trials, that are judged by the Institutional Review Board to reduce or have no effect on patient risk. This was a randomized trial of a conventional consent procedure that required parental signature to give consent (opting in) after a comprehensive disclosure of the rights of participants in research versus a modified consent procedure that required parental signature to refuse consent (opting out) after specific disclosures appropriate when risk is not increased. Consent was sought for a trial of primary follow-up care for disadvantaged infants at high risk, a trial judged by our Institutional Review Board to increase access to care for both groups. A blinded assessor interviewed mothers within 24 hours of the consent decision. Among the 44 mothers interviewed, the modified consent group scored higher than the conventional consent group in recall and understanding of study purpose and methods (47% vs 30%; p < 0.02). Other comparisons provided no evidence that the modified consent procedure was less desirable. Virtually all mothers reported satisfaction. The modified approach may improve communication and facilitate studies judged by the Institutional Review Board to be risk-neutral or risk-reducing. Further evaluation of a modified consent procedure for such studies is warranted.

  12. Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department.

    PubMed

    Spencer, Sandra P; Stoner, Michael J; Kelleher, Kelly; Cohen, Daniel M

    2015-08-01

    Informed consent is an ethical process for ensuring patient autonomy. Multimedia presentations (MMPs) often aid the informed consent process for research studies. Thus, it follows that MMPs would improve informed consent in clinical settings. The aim of this study was to determine if an MMP for the informed consent process for ketamine sedation improves parental satisfaction and comprehension as compared with standard practice. This 2-phase study compared 2 methods of informed consent for ketamine sedation of pediatric patients. Phase 1 was a randomized, prospective study that compared the standard verbal consent to an MMP. Phase 2 implemented the MMP into daily work flow to validate the previous year's results. Parents completed a survey evaluating their satisfaction of the informed consent process and assessing their knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction with the informed consent process and knowledge of ketamine sedation. One hundred eighty-four families from a free-standing, urban, tertiary pediatric emergency department with over 85,000 annual visits were enrolled. Different demographics were not associated with a preference for the MMP or improved scores on the content quiz. Intervention families were more likely "to feel involved in the decision to use ketamine" and to understand that "they had the right to refuse the ketamine" as compared with control families. The intervention group scored significantly higher overall on the content section than the control group. Implementation and intervention families responded similarly to all survey sections. Multimedia presentation improves parental understanding of ketamine sedation, whereas parental satisfaction with the informed consent process remains unchanged. Use of MMP in the emergency department for informed consent shows potential for both patients and providers.

  13. Informing the Uninformed: Optimizing the Consent Message Using a Fractional Factorial Design

    PubMed Central

    Tait, Alan R.; Voepel-Lewis, Terri; Nair, Vijayan N.; Narisetty, Naveen N.; Fagerlin, Angela

    2013-01-01

    Objective Research information should be presented in a manner that promotes understanding. However, many parents and research subjects have difficulty understanding and making informed decisions. This study was designed to examine the effect of different communication strategies on parental understanding of research information. Participants 640 parents of children scheduled for elective surgery Design Observational study using a fractional factorial design Setting Large tertiary care children's hospital Interventions Parents were randomized to receive information about a hypothetical pain trial presented in one of 16 consent documents containing different combinations of 5 selected communication strategies (i.e., length, readability, processability [formatting], graphical display, and supplemental verbal disclosure). Main outcome measures Parents were interviewed to determine their understanding of the study elements (e.g., protocol, alternatives etc.) and their gist (main point) and verbatim (actual) understanding of the risks and benefits. Results Main effects for understanding were found for processability, readability, message length, use of graphics, and verbal discussion. Consent documents with high processability, 8th grade reading level, and graphics resulted in significantly greater gist and verbatim understanding compared with forms without these attributes (mean difference, 95% CI = 0.57, 0.26–0.88, correct responses out of 7 and 0.54, 0.20–0.88 correct responses out of 4 for gist and verbatim, respectively). Conclusions Results identified several communication strategy combinations that improved parents' understanding of research information. Adoption of these active strategies by investigators, clinicians, IRBs, and study sponsors represents a simple, practical, and inexpensive means to optimize the consent message and enhance parental, participant, and patient understanding. PMID:23700028

  14. Would Parents Consent to a Comparative Effectiveness Trial of Oral Doxycycline Versus Intravenous Ceftriaxone for the Treatment of Children with Lyme Meningitis?

    PubMed

    Garro, Aris; Koster, Michael; LaRue, Molly; Hipolito, Evelyn; Congdon, Elizabeth; Burnett, Kathleen; Cullen, Nicole; Nigrovic, Lise E

    2018-05-01

    Children with Lyme meningitis are often treated with intravenous ceftriaxone, although oral doxycycline may be effective. Parents were surveyed after observing a video describing a hypothetical Lyme meningitis treatment trial. Eighty-four of 102 (82%) would consent to their child participating. Parents would accept 2 additional days of symptoms (noninferiority margin) with doxycycline even if ceftriaxone hastened symptom resolution.

  15. 25 CFR 43.14 - Consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... AFFAIRS, DEPARTMENT OF THE INTERIOR EDUCATION MAINTENANCE AND CONTROL OF STUDENT RECORDS IN BUREAU SCHOOLS... students, without the written consent of the parents or of an eligible student, to any party other than the... schools or school systems at which a student is interested in enrolling. The student or parent must be...

  16. Counterproductive Effects of Parental Consent in Research Involving LGBTTIQ Youth: International Research Ethics and a Study of a Transgender and Two-Spirit Community in Canada

    ERIC Educational Resources Information Center

    Taylor, Catherine G.

    2008-01-01

    This article offers an evidence-based argument for exempting the majority of LGBTTIQ youth from parental consent requirements in research studies. The argument is grounded in international research ethics principles and social science research studies of risks to the well-being of LGBTTIQ youth. A schema derived from consent concepts used in…

  17. The accompanying adult: authority to give consent in the UK.

    PubMed

    Lal, Seema Madhur Lata; Parekh, Susan; Mason, Carol; Roberts, Graham

    2007-05-01

    Children may be accompanied by various people when attending for dental treatment. Before treatment is started, there is a legal requirement that the operator obtain informed consent for the proposed procedure. In the case of minors, the person authorized to give consent (parental responsibility) is usually a parent. To ascertain if accompanying persons of children attending the Department of Paediatric Dentistry at the Eastman Dental Hospital, London were empowered to give consent for the child's dental treatment. A total of 250 accompanying persons of children attending were selected, over a 6-month period. A questionnaire was used to establish whether the accompanying person(s) were authorized to give consent. The study showed that 12% of accompanying persons had no legal authority to give consent for the child's dental treatment. Clinicians need to be aware of the status of persons accompanying children to ensure valid consent is obtained.

  18. Consent to treatment by minors attending accident and emergency departments: guidelines.

    PubMed Central

    Williams, L; Harris, A; Thompson, M; Brayshaw, A

    1997-01-01

    The absolute right to refuse medical treatment, even if the reasons are irrational, is confined to competent adults. Children under 16 years can give legal consent to treatment in the absence of consent from those with parental responsibility. Children under 18 years do not, however, have an absolute right to consent, or refuse to consent, to treatment. The views of children assume increasing importance with age and maturity. Accident and emergency medical and nursing staff may face difficult decisions when children, or those with parental responsibility, refuse to consent to medical treatment. This paper presents guidelines designed to guide the decision making process in immediately or potentially life threatening conditions and in non-life-threatening conditions. Images Figure 1 Figure 2 p289-a PMID:9315927

  19. Consent Procedures and Participation Rates in School-Based Intervention and Prevention Research: Using a Multi-Component, Partnership-Based Approach to Recruit Participants

    PubMed Central

    Leff, Stephen S.; Franko, Debra L.; Weinstein, Elana; Beakley, Kelly; Power, Thomas J.

    2009-01-01

    Evaluations of school-based interventions and prevention programs typically require parental consent for students to participate. In school-based efforts, program evaluators may have limited access to parents and considerable effort is required to obtain signed consent. This issue is particularly salient when conducting research in under-resourced, urban schools, where parent involvement in the school setting may be somewhat limited. The aims of this article were to (a) examine the published school-based prevention and intervention literature to assess the state of the field in terms of consent procedures and participation rates; and (b) describe two examples of health promotion studies that used multi-component, partnership-based strategies in urban schools to encourage communication among children, their parents, and researchers. The purpose of the case studies was to generate hypotheses to advance the science related to school-based participant recruitment for research studies. Of nearly 500 studies reviewed, only 11.5% reported both consent procedures and participation rates. Studies using active consent procedures had a mean participation rate of 65.5% (range: 11–100%). This article highlights the need for researchers to report consent procedures and participation rates and describes partnership-based strategies used to enroll students into two urban, school-based health promotion studies. PMID:19834586

  20. Written Parental Consent and the Use of Incentives in a Youth Smoking Prevention Trial: A Case Study from Project SPLASH

    ERIC Educational Resources Information Center

    Leakey, Tricia; Lunde, Kevin B.; Koga, Karin; Glanz, Karen

    2004-01-01

    More Institutional Review Boards (IRBs) are requiring written parental consent in school health intervention trials. Because this requirement presents a formidable challenge in conducting large-scale research, it is vital for investigators to share effective strategies learned from completed trials. Investigators for the recently completed Project…

  1. ‘The Words Will Pass with the Blowing Wind’: Staff and Parent Views of the Deferred Consent Process, with Prior Assent, Used in an Emergency Fluids Trial in Two African Hospitals

    PubMed Central

    Molyneux, Sassy; Njue, Maureen; Boga, Mwanamvua; Akello, Lilian; Olupot-Olupot, Peter; Engoru, Charles; Kiguli, Sarah; Maitland, Kathryn

    2013-01-01

    Objective To document and explore the views and experiences of key stakeholders regarding the consent procedures of an emergency research clinical trial examining immediate fluid resuscitation strategies, and to discuss the implications for similar trials in future. Methods A social science sub-study of the FEAST (Fluid Expansion As Supportive Therapy) trial. Interviews were held with trial team members (n = 30), health workers (n = 15) and parents (n = 51) from two purposively selected hospitals in Soroti, Uganda, and Kilifi, Kenya. Findings Overall, deferred consent with prior assent was seen by staff and parents as having the potential to protect the interests of both patients and researchers, and to avoid delays in starting treatment. An important challenge is that the validity of verbal assent is undermined when inadequate initial information is poorly understood. This concern needs to be balanced against the possibility that full prior consent on admission potentially causes harm through introducing delays. Full prior consent also potentially imposes worries on parents that clinicians are uncertain about how to proceed and that clinicians want to absolve themselves of any responsibility for the child’s outcome (some parents’ interpretation of the need for signed consent). Voluntariness is clearly compromised for both verbal assent and full prior consent in a context of such vulnerability and stress. Further challenges in obtaining verbal assent were: what to do in the absence of the household decision-maker (often the father); and how medical staff handle parents not giving a clear agreement or refusal. Conclusion While the challenges identified are faced in all research in low-income settings, they are magnified for emergency trials by the urgency of decision making and treatment needs. Consent options will need to be tailored to particular studies and settings, and might best be informed by consultation with staff members and community

  2. On the Ottoman consent documents for medical interventions and the modern concept of informed consent.

    PubMed

    Kara, Mahmut A; Aksoy, Sahin

    2006-09-01

    Information for patients prior to medical intervention is one of the principles of modern medical practice. In this study, we looked at an earlier practice of this principle. Ottoman judges had record books called sicil. One of the categories in sicils was the consent documents called riza senedi, which was a patient-physician contract approved by the courts. These contracts were especially for the protection of physicians from punishment if the patient dies. It is not clear whether patients were informed properly or not. Consent for minors was obtained from parents. However, a situation where an adult does not have the capacity to consent, was not clear in these documents. Any sign of free withdrawal of consent was not found in these records. Due to the legal system of Ottoman State, these contracts were related to Islamic law rather than modern civil law. We aim, in this paper, to present a legal practice, which is possible to consider as an early example of the informed consent practice.

  3. 34 CFR 303.404 - Parent consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... obtained before— (1) Conducting the initial evaluation and assessment of a child under § 303.322; and (2... the child will not be able to receive the evaluation and assessment or services unless consent is... of the Act (34 CFR 300.571) and 34 CFR part 99 (Family Educational Rights and Privacy), both of which...

  4. Commentary on "Waiting in Araf". Informed consent: issues and regulations.

    PubMed

    Catlin, A

    1998-01-01

    Children have the right to safety and appropriate consideration of their physical, emotional, and psychological needs in regards to treatment or research decisions. Parents have an equal right to be honored in their parenthood and respected for what they would want as the best thing for their child as a member of the family. When children are mature enough, they should be offered the opportunity of assenting or dissenting to research participation. Until such time, parents may make what they feel to be the best decisions. If a nurse feels that these principles are being violated, he or she should attempt to seek further clarification. In order to obtain information about an ongoing research project, it would be appropriate to contact the IRB or a member of the hospital ethics committee. In most cases, a satisfactory explanation will be found. In the rare case that patient's rights are truly being violated, the American Nurses Association Code of Ethics requires that nurses report incompetent, unethical, or illegal practices (ANA, 1994). Nurses who "whistle-blow" may or may not be protected against retaliation. Some states in the U.S. have developed laws that prohibit the discharge of an employee who reports unethical practices. One might expect that in some countries a nurse might not only endanger her position for such reporting but endanger his or her life as well. Ulusoy reports on research done on children without knowledge or consent of parents. Although this case took place long ago, it is certain that there are still countries in which informed consent is undeveloped and such practices continue. Nurses in developed countries with established consent policies can be hopeful that such activity is no longer seen here. As international collaboration in nursing research grows, nurses in developed nations can work to provide educational opportunities regarding the consent process for colleagues across the globe.

  5. Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia.

    PubMed

    Mboizi, Robert B; Afolabi, Muhammed O; Okoye, Michael; Kampmann, Beate; Roca, Anna; Idoko, Olubukola T

    2017-09-02

    Communicating essential research information to low literacy research participants in Africa is highly challenging, since this population is vulnerable to poor comprehension of consent information. Several supportive materials have been developed to aid participant comprehension in these settings. Within the framework of a pneumococcal vaccine trial in The Gambia, we evaluated the recall and decay of consent information during the trial which used an audio-visual tool called 'Speaking Book', to foster comprehension among parents of participating infants. The Speaking Book was developed in the 2 most widely spoken local languages. Four-hundred and 9 parents of trial infants gave consent to participate in this nested study and were included in the baseline assessment of their knowledge about trial participation. An additional assessment was conducted approximately 90 d later, following completion of the clinical trial protocol. All parents received a Speaking Book at the start of the trial. Trial knowledge was already high at the baseline assessment with no differences related to socio-economic status or education. Knowledge of key trial information was retained at the completion of the study follow-up. The Speaking Book (SB) was well received by the study participants. We hypothesize that the SB may have contributed to the retention of information over the trial follow-up. Further studies evaluating the impact of this innovative tool are thus warranted.

  6. Parent influences on preschoolers' objectively assessed physical activity.

    PubMed

    Oliver, Melody; Schofield, Grant M; Schluter, Philip J

    2010-07-01

    The purposes of this study were to examine the relationship between accelerometer-derived physical activity (PA) in preschoolers and their parents, and to investigate other potential child and parental associates of child PA. Families of children aged 2-5 yrs were recruited in Auckland, New Zealand, from October 2006 to July 2007. Consenting children and parents had their height, weight, and waist circumference measured and were asked to wear accelerometers over 7 consecutive days, measuring PA in 15s epochs. Accelerometer data were gathered from 78 children, 62 mothers and 20 fathers over a median of 6.5-7 days, and converted to estimated daily PA rates for each individual using negative binomial generalised estimating equation (GEE) modelling. Potential associates of children's daily PA rates were then assessed using normal GEE models with exchangeable correlation structures. After taking account of all factors in the final multivariable model, parental PA rates (coefficient 0.09, 95% CI 0.03, 0.16, P=0.01) and child age (coefficient 0.11, 95% CI 0.01, 0.21, P=0.03) were the only factors significantly associated with child PA rates. Younger children may stand to benefit from PA intervention, and encouraging parental involvement in preschool PA interventions may be useful for increasing PA levels in young children. More work in this field is needed to corroborate these findings, improve generalisability, and determine causality. Copyright 2009 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  7. 34 CFR 300.9 - Consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... SERVICES, DEPARTMENT OF EDUCATION ASSISTANCE TO STATES FOR THE EDUCATION OF CHILDREN WITH DISABILITIES... parent revokes consent in writing for their child's receipt of special education services after the child is initially provided special education and related services, the public agency is not required to...

  8. [Informed consent consultation as a part of patient safety in pediatric traumatology].

    PubMed

    Kraus, R; Heberer, J

    2013-10-01

    In pediatric traumatology as in any other surgical specialty, every treatment measure has to be protected by an adequate clarification. A legally effective clarification has to cover various aspects, such as diagnosis, treatment, risk and safety clarification and leads to an informed consent consultation. The contents of this informed consent discussion must be documented. The nature and extent of clarification, among other things depend on the urgency of the procedure and in an emergency it can be dispensed with in pediatric traumatology. In the case of minors the conversation must be conducted basically in the presence of both parents as they alone are legally entitled to give approval. General treatment proxies are not allowed. If it is not possible to talk to both parents the physician is allowed to trust that the parent present represents the will of the absent parent. Intervention cannot be carried out against the will of adolescents capable of self-determination even with the consent of the parents. The application of these rules is illustrated by means of practical examples.

  9. 34 CFR 300.9 - Consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... SERVICES, DEPARTMENT OF EDUCATION ASSISTANCE TO STATES FOR THE EDUCATION OF CHILDREN WITH DISABILITIES... parent revokes consent in writing for their child's receipt of special education services after the child... amend the child's education records to remove any references to the child's receipt of special education...

  10. Success of University Student Volunteers in Obtaining Consent for Reviewing Private Health Information for Emergency Research.

    PubMed

    Kramer, Adam I; Stephenson, Elizabeth; Betel, Adam; Crudden, Johanna; Boutis, Kathy

    2017-01-01

    This study aimed to determine the success of university student volunteers in obtaining consent from parents to allow review of their child's personal health information (PHI) for emergency research screening. This study also aimed to examine the variables associated with successful consent. This was a prospective cross-sectional study conducted at a pediatric emergency department (ED). University students, who functioned as delegates of the health information custodian, approached parents for consent. Of 2,506 parents, 1,852 (73.9%) provided consent to allow review of their child's PHI for research screening. Variables associated with successful consent were high (≥12 months) versus low (<12 months) volunteer experience (OR = 2.0), research related (vs. unrelated) to the child's chief complaint (OR = 2.0), child treated regularly by specialists at the study institution (OR = 1.7), and ED presentation mid-week vs. weekend (OR = 1.7) and morning vs. evening presentation (OR = 1.4). When approached by a university student volunteer, about 25% of parents declined to have their child's PHI reviewed for research screening. This model of obtaining consent may put some emergency research at risk for selection bias. Variables that increase the odds of successful consent can be considered in program design to improve the effectiveness of this model.

  11. Informed consent recall and comprehension in orthodontics: traditional vs improved readability and processability methods.

    PubMed

    Kang, Edith Y; Fields, Henry W; Kiyak, Asuman; Beck, F Michael; Firestone, Allen R

    2009-10-01

    Low general and health literacy in the United States means informed consent documents are not well understood by most adults. Methods to improve recall and comprehension of informed consent have not been tested in orthodontics. The purposes of this study were to evaluate (1) recall and comprehension among patients and parents by using the American Association of Orthodontists' (AAO) informed consent form and new forms incorporating improved readability and processability; (2) the association between reading ability, anxiety, and sociodemographic variables and recall and comprehension; and (3) how various domains (treatment, risk, and responsibility) of information are affected by the forms. Three treatment groups (30 patient-parent pairs in each) received an orthodontic case presentation and either the AAO form, an improved readability form (MIC), or an improved readability and processability (pairing audio and visual cues) form (MIC + SS). Structured interviews were transcribed and coded to evaluate recall and comprehension. Significant relationships among patient-related variables and recall and comprehension explained little of the variance. The MIC + SS form significantly improved patient recall and parent recall and comprehension. Recall was better than comprehension, and parents performed better than patients. The MIC + SS form significantly improved patient treatment comprehension and risk recall and parent treatment recall and comprehension. Patients and parents both overestimated their understanding of the materials. Improving the readability of consent materials made little difference, but combining improved readability and processability benefited both patients' recall and parents' recall and comprehension compared with the AAO form.

  12. Telemedicine Provides Non-Inferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

    PubMed Central

    Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

    2016-01-01

    Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face

  13. A randomized controlled trial of an electronic informed consent process.

    PubMed

    Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

    2014-12-01

    A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

  14. A Randomized Controlled Trial of an Electronic Informed Consent Process

    PubMed Central

    Rothwell, Erin; Wong, Bob; Rose, Nancy C.; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A.; Botkin, Jeffrey R.

    2018-01-01

    A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. PMID:25747685

  15. The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research.

    PubMed

    Megone, Christopher; Wilman, Eleanor; Oliver, Sandy; Duley, Lelia; Gyte, Gill; Wright, Judy

    2016-09-09

    Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials? In a systematic search, we identified 30 studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature. Between them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment. In addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental 'consent' to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental 'consent' in a perinatal context, parents are authorising infant participation, not giving 'proxy consent'. Finally, there are reasons for giving weight to both parental 'consent' and the infant's best interests in

  16. Factors affecting consent in pediatric critical care research.

    PubMed

    Menon, Kusum; Ward, Roxanne E; Gaboury, Isabelle; Thomas, Margot; Joffe, Ari; Burns, Karen; Cook, Deborah

    2012-01-01

    Consent for research is a difficult and unpredictable process in pediatric critical care populations. The objectives of this study were to describe consent rates in pediatric critical care research and their association with patient, legal guardian, consent process, and study design-related factors. A prospective, cohort study was conducted from 2009 to 2010 in six tertiary care pediatric intensive care units (PICU) in Canada with legal guardians of patients who were approached for consent for any ongoing PICU research study. Data were recorded on details of the consent process for all consent encounters. We recorded 271 consent encounters. The overall consent rate was 80.1% (217/271). We observed higher consent rates when the research assistant was introduced by a member of the clinical team prior to approaching the family (89.7 vs. 77.7%; P = 0.04). Legal guardians of cardiac surgery patients were less likely to provide consent than those of all other patients (75.3 vs. 86.0%; P = 0.03). There was no difference in consent rates between therapeutic (117/145, 80.7%) versus non-therapeutic studies (100/126, 79.4%; P = 0.88). This study provides future researchers with consent data for determination of recruitment rates, sample sizes, budget estimations, and study timelines. Future pediatric critical care studies should consider incorporating the lower consent rates in cardiac surgery patients and routine introduction of the research assistant to the family by a member of the patient's care team into their study designs. The potential influence of parental factors on consent rates in pediatric critical care studies requires further research.

  17. Parent and child physical activity and sedentary time: do active parents foster active children?

    PubMed

    Jago, Russell; Fox, Kenneth R; Page, Angie S; Brockman, Rowan; Thompson, Janice L

    2010-04-15

    Physical activity has many positive effects on children's health while TV viewing has been associated with adverse health outcomes. Many children do not meet physical activity recommendations and exceed TV viewing guidelines. Parents are likely to be an important influence on their children's behaviour. There is an absence of information about the associations between parents' and children's physical activity and TV viewing. Year 6 children and their parent were recruited from 40 primary schools. Results are presented for the 340 parent-child dyads with accelerometer data that met a > or = 3 day inclusion criteria and the 431 parent-child dyads with complete self-reported TV viewing. Over 80% of the dyads with valid TV viewing data included mothers and their child. Mean minutes of moderate to vigorous physical activity (MVPA), minutes of sedentary time per day and counts per minute were assessed by accelerometer. Self-reported hours of TV viewing were coded into 3 groups (< 2 hours per day, 2-4 hours per day and >4 hours per day. Linear and multi-nominal regression models were run by child gender to examine parent-child associations. In linear regression models there was an association for the overall sedentary time of girls and their parents (t = 2.04. p = .020) but there was no association between girls' and parents' physical activity. There were no associations between parents' and boys' sedentary or physical activity time. For girls, the risk of watching more than 4 hours of TV per day, (reference = 2 hours of TV per day), was 3.67 times higher if the girl's parent watched 2-4 hours of TV per day (p = 0.037). For boys, the risk of watching more than 4 hours of TV per day, was 10.47 times higher if the boy's parent watched more than 4 hours of TV per day (p = 0.038). There are associations in the sedentary time of parents and daughters. Higher parental TV viewing was associated with an increased risk of high levels of TV viewing for both boys and girls. There

  18. But is this really the ‘parent’ or ‘guardian’? Practical strategies for consent to child research in South Africa

    PubMed Central

    Slack, C M; Strode, A E

    2018-01-01

    Research ethics committees (RECs) in South Africa may require consent from a parent or legal guardian for child research. In instances where an REC determines that parental or guardianship consent is required, how far should researchers go to establish if the accompanying adult is in fact the parent or guardian? Should researchers accept disclosures at face value, probe assertions that are made, or even call for supporting documentation? In this article we set out the facts research staff should possess, propose key questions they could ask, and recommend practical steps for uncertain cases. We recognise that a parental/guardianship consent strategy may not be appropriate in all instances, but do not debate that issue in this article. This article is confined to practical advice for researchers wishing to implement a parental or guardianship consent approach. PMID:29887973

  19. Sterilizing the mentally-handicapped: who can give consent?

    PubMed

    1980-01-26

    Due to the vulnerable position of the mentally handicapped individual, the question of whether the state or any other interested 3rd party should intervene in procreative rights even with consent will depend to a great extent on the ability and autonomy of the individual to make the decision. There are 3 elements to consent: 1) it must be voluntary; 2) it requires that the individual has sufficient information to make a decision; and 3) it is imperative that the person providing the consent have the mental competence to appreciate exactly what is being consented to and the implication of the consent. Consent can be either personal consent or it may be "3rd party" consent. The 3rd party consent is used when an individual is incapable of providing personal consent. It is crucially important that those mentally handicapped individuals who are capable of making a decision do make such a decision when they agree to undergo sterilization. There is nothing inherent in mental handicap that prevents an individual from providing competent consent to a sterilization. The situation when someone other than the individual to be sterilized consents to the procedure poses more problems. Some glaring problems that arise when 3rd party consent on behalf of full-time residents in state institutions is allowed are the following: 1) state coercion behind such decisions is too easily concealed; 2) persuasion can be brought to bear on parents who already bear the stigma of a mentally handicapped child; and 3) administrative convenience may too easily be substituted for the benefit to the individual.

  20. Key factors in children's competence to consent to clinical research.

    PubMed

    Hein, Irma M; Troost, Pieter W; Lindeboom, Robert; Benninga, Marc A; Zwaan, C Michel; van Goudoever, Johannes B; Lindauer, Ramón J L

    2015-10-24

    Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors including the developmental stage, the influence of parents and peers, and life experience. We examined potential determining factors for children's competence to consent to clinical research and to what extent they explain the variation in competence judgments. From January 1, 2012 through January 1, 2014, pediatric patients aged 6 to 18 years, eligible for clinical research studies were enrolled prospectively at various in- and outpatient pediatric departments. Children's competence to consent was assessed by MacArthur Competence Assessment Tool for Clinical Research. Potential determining child variables included age, gender, intelligence, disease experience, ethnicity and socio-economic status (SES). We used logistic regression analysis and change in explained variance in competence judgments to quantify the contribution of a child variable to the total explained variance. Contextual factors included risk and complexity of the decision to participate, parental competence judgment and the child's or parents decision to participate. Out of 209 eligible patients, 161 were included (mean age, 10.6 years, 47.2 % male). Age, SES, intelligence, ethnicity, complexity, parental competence judgment and trial participation were univariately associated with competence (P < 0.05). Total explained variance in competence judgments was 71.5 %. Only age and intelligence significantly and independently explained the variance in competence judgments, explaining 56.6 % and 12.7 % of the total variance respectively. SES, male gender, disease experience and ethnicity each explained less than 1 % of the variance in competence judgments. Contextual factors together explained an extra 2

  1. Orthodontic informed consent considering information load and serial position effect.

    PubMed

    Pawlak, Caroline E; Fields, Henry W; Beck, F Michael; Firestone, Allen R

    2015-03-01

    Previous research has demonstrated that current methods of informed consent are relatively ineffective as shown by poor recall and comprehension by adolescent patients and their parents. The purpose of this study was to determine whether adding a short videotape presentation reiterating the issues related to informed consent to a modified informed consent document that emphasizes a limited number of core and patient-specific custom "chunks" at the beginning of an informed consent presentation improved the recall and comprehension of the risks, benefits, and alternatives of orthodontic treatment. A second objective was to evaluate the current related data for recommendable practices. Seventy patient-parent pairs were randomly divided into 2 groups. The intervention group (group A) patients and parents together reviewed a customized slide show and a short videotape presentation describing the key risks of orthodontic treatment. Group B followed the same protocol without viewing the videotape. All patients and parents were interviewed independently by research assistants using an established measurement tool with open-ended questions. Interviews were transcribed and scored for the appropriateness of responses using a previously established codebook. Lastly, the patients and parents were given 2 reading literacy tests, 1 related to health and 1 with general content followed by the self-administered demographic and psychological state questionnaires. There were no significant differences between the groups for sociodemographic variables. There were no significant differences between the groups for overall recall and comprehension; recall and comprehension for the domains of treatment, risk, and responsibility; and recall and comprehension for core, general, and custom items. The positional effects were limited in impact. When compared with previous studies, these data further demonstrate the benefit of improved readability and audiovisual supplementation with the

  2. 34 CFR 300.300 - Parental consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... the parent of the child; (ii) The rights of the parents of the child have been terminated in... REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION ASSISTANCE TO STATES FOR THE EDUCATION OF CHILDREN WITH...) The public agency proposing to conduct an initial evaluation to determine if a child qualifies as a...

  3. Social mobilisation, consent and acceptability: a review of human papillomavirus vaccination procedures in low and middle-income countries.

    PubMed

    Kabakama, Severin; Gallagher, Katherine E; Howard, Natasha; Mounier-Jack, Sandra; Burchett, Helen E D; Griffiths, Ulla K; Feletto, Marta; LaMontagne, D Scott; Watson-Jones, Deborah

    2016-08-19

    Social mobilisation during new vaccine introductions encourages acceptance, uptake and adherence to multi-dose schedules. Effective communication is considered especially important for human papillomavirus (HPV) vaccine, which targets girls of an often-novel age group. This study synthesised experiences and lessons learnt around social mobilisation, consent, and acceptability during 55 HPV vaccine demonstration projects and 8 national programmes in 37 low and middle-income countries (LMICs) between January 2007 and January 2015. A qualitative study design included: (i) a systematic review, in which 1,301 abstracts from five databases were screened and 41 publications included; (ii) soliciting 124 unpublished documents from governments and partner institutions; and (iii) conducting 27 key informant interviews. Data were extracted and analysed thematically. Additionally, first-dose coverage rates were categorised as above 90 %, 90-70 %, and below 70 %, and cross-tabulated with mobilisation timing, message content, materials and methods of delivery, and consent procedures. All but one delivery experience achieved over 70 % first-dose coverage; 60 % achieved over 90 %. Key informants emphasized the benefits of starting social mobilisation early and actively addressing rumours as they emerged. Interactive communication with parents appeared to achieve higher first-dose coverage than non-interactive messaging. Written parental consent (i.e., opt-in), though frequently used, resulted in lower reported coverage than implied consent (i.e., opt-out). Protection against cervical cancer was the primary reason for vaccine acceptability, whereas fear of adverse effects, exposure to rumours, lack of project/programme awareness, and schoolgirl absenteeism were major reasons for non-vaccination. Despite some challenges in obtaining parental consent and addressing rumours, experiences indicated effective social mobilisation and high HPV vaccine acceptability in LMICs. Social

  4. Hope and persuasion by physicians during informed consent.

    PubMed

    Miller, Victoria A; Cousino, Melissa; Leek, Angela C; Kodish, Eric D

    2014-10-10

    To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure. Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire. The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower. Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain. © 2014 by American Society of Clinical Oncology.

  5. Hope and Persuasion by Physicians During Informed Consent

    PubMed Central

    Miller, Victoria A.; Cousino, Melissa; Leek, Angela C.; Kodish, Eric D.

    2014-01-01

    Purpose To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure. Patients and Methods Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire. Results The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower. Conclusion Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain. PMID:25199753

  6. A cognitive approach for design of a multimedia informed consent video and website in pediatric research.

    PubMed

    Antal, Holly; Bunnell, H Timothy; McCahan, Suzanne M; Pennington, Chris; Wysocki, Tim; Blake, Kathryn V

    2017-02-01

    Poor participant comprehension of research procedures following the conventional face-to-face consent process for biomedical research is common. We describe the development of a multimedia informed consent video and website that incorporates cognitive strategies to enhance comprehension of study related material directed to parents and adolescents. A multidisciplinary team was assembled for development of the video and website that included human subjects professionals; psychologist researchers; institutional video and web developers; bioinformaticians and programmers; and parent and adolescent stakeholders. Five learning strategies that included Sensory-Modality view, Coherence, Signaling, Redundancy, and Personalization were integrated into a 15-min video and website material that describes a clinical research trial. A diverse team collaborated extensively over 15months to design and build a multimedia platform for obtaining parental permission and adolescent assent for participant in as asthma clinical trial. Examples of the learning principles included, having a narrator describe what was being viewed on the video (sensory-modality); eliminating unnecessary text and graphics (coherence); having the initial portion of the video explain the sections of the video to be viewed (signaling); avoiding simultaneous presentation of text and graphics (redundancy); and having a consistent narrator throughout the video (personalization). Existing conventional and multimedia processes for obtaining research informed consent have not actively incorporated basic principles of human cognition and learning in the design and implementation of these processes. The present paper illustrates how this can be achieved, setting the stage for rigorous evaluation of potential benefits such as improved comprehension, satisfaction with the consent process, and completion of research objectives. New consent strategies that have an integrated cognitive approach need to be developed and

  7. 34 CFR 303.401 - Definitions of consent, native language, and personally identifiable information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... which consent is sought, in the parent's native language or other mode of communication; (2) The parent... proficiency, means the language or mode of communication normally used by the parent of a child eligible under... child's parent, or other family member; (2) The address of the child; (3) A personal identifier, such as...

  8. A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy.

    PubMed

    Friedlander, Joel A; Loeben, Greg S; Finnegan, Patricia K; Puma, Anita E; Zhang, Xuemei; de Zoeten, Edwin F; Piccoli, David A; Mamula, Petar

    2011-04-01

    To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy. The Consent-20 instrument was developed and piloted on 47 subjects. Subsequently, parents of 101 children undergoing first-time, diagnostic upper endoscopy performed under moderate IV sedation were prospectively and consecutively, blinded, randomised and enrolled into two groups that received either standard form-based informed consent or standard form-based informed consent plus a commercial (Emmi Solutions, Inc, Chicago, Il), sixth grade level, interactive learning module (electronic assisted consent). Anonymously and electronically, the subjects' anxiety (State Trait Anxiety Inventory), satisfaction (Modified Group Health Association of America), number of questions asked, and attainment of informed consent were assessed (Consent-20). Statistics were calculated using t test, paired t test, and Mann Whitney tests. The ability to achieve informed consent, as measured by the new instrument, was 10% in the control form-based consent group and 33% in the electronic assisted consent group (p<0.0001). Electronically assisting form-based informed consent did not alter secondary outcome measures of subject satisfaction, anxiety or number of questions asked in a paediatric endoscopy unit. This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy. It also shows that even when necessary information was repeated electronically in a comprehensive and standardised video, informed consent as measured by our instrument was incompletely achieved. The supplemental information did, however, significantly improve understanding in a manner that did not negatively impact workflow, subject anxiety or subject satisfaction. Additional study of informed consent is required.

  9. The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research.

    PubMed

    Wilman, E; Megone, C; Oliver, S; Duley, L; Gyte, G; Wright, J M

    2015-11-04

    Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet approaching parents at this difficult time raises challenges for the obtaining of valid informed consent to such research. This study asked: what light does the empirical literature cast on an ethically defensible approach to the obtaining of informed consent in perinatal clinical trials? A systematic search identified 49 studies. Analysis began by applying philosophical frameworks which were then refined in light of the concepts emerging from empirical studies to present a coherent picture of a broad literature. Between them, studies addressed the attitudes of both parents and clinicians concerning consent in neonatal trials; the validity of the consent process in the neonatal research context; and different possible methods of obtaining consent. Despite a variety of opinions among parents and clinicians there is a strongly and widely held view that it is important that parents do give or decline consent for neonatal participation in trials. However, none of the range of existing consent processes reviewed by the research is satisfactory. A significant gap is evaluation of the widespread practice of emergency 'assent', in which parents assent or refuse their baby's participation as best they can during the emergency and later give full consent to ongoing participation and follow-up. Emergency assent has not been evaluated for its acceptability, how such a process would deal with bad outcomes such as neonatal death between assent and consent, or the extent to which late parental refusal might bias results. This review of a large number of empirical papers, while not making fundamental changes, has refined and developed the conceptual framework from philosophy for examining informed consent in this context.

  10. 12 CFR 980.6 - Finance Board consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Finance Board consent. 980.6 Section 980.6 Banks and Banking FEDERAL HOUSING FINANCE BOARD NEW FEDERAL HOME LOAN BANK ACTIVITIES NEW BUSINESS ACTIVITIES § 980.6 Finance Board consent. The Finance Board may at any time provide consent for a Bank to undertake a particular new business activity and...

  11. Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research.

    PubMed

    Hein, Irma M; De Vries, Martine C; Troost, Pieter W; Meynen, Gerben; Van Goudoever, Johannes B; Lindauer, Ramón J L

    2015-11-09

    For many decades, the debate on children's competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children's competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children's competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives. Although assessment of children's competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad. Previous research outcomes showed that children's medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents

  12. [Informed consent and parental refusal to medical treatment in childhood. The threshold of medical and social tolerance. Part I].

    PubMed

    Guadarrama-Orozco, Jessica H; Garduño Espinosa, Juan; Vargas López, Guillermo; Viesca Treviño, Carlos

    Informed consent is a right of all individuals and no one can force anyone to receive treatment against their wishes. The right to accept or refuse treatment persists in individuals who are incompetent from a legal point of view; this is exercised on their behalf by a third party. Children are considered incompetent to make medical decisions about their own health and their parents or legal guardians are empowered to make those decisions. However, parental authority is not absolute and there are situations where their decisions are not the best, sometimes leading to jeopardizing the well-being and even the lives of their children, forcing the state to intervene on behalf of the best interests of the child. This is the reason why it is necessary to ask the following questions: is it really the child's best interest that moves us to legally intervene when a parent refuses to accept the proposed medical treatment or is the damage done to make this decision? What kind of parental decisions are those that should not be tolerated? After a review of the theme, we conclude that if the decision of the parents regarding a medical decision is considered to be made with maleficence that is harmful to the child, it is justified that the State intervenes. Finally, we exposed four criteria that can be used in making decisions in complex cases where parents refuse treatment for their children. Copyright © 2015. Publicado por Masson Doyma México S.A.

  13. 12 CFR 980.6 - Finance Board consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 7 2011-01-01 2011-01-01 false Finance Board consent. 980.6 Section 980.6 Banks and Banking FEDERAL HOUSING FINANCE BOARD NEW FEDERAL HOME LOAN BANK ACTIVITIES NEW BUSINESS ACTIVITIES § 980.6 Finance Board consent. The Finance Board may at any time provide consent for a Bank to...

  14. Community perspectives on research consent involving vulnerable children in Western Kenya.

    PubMed

    Vreeman, Rachel; Kamaara, Eunice; Kamanda, Allan; Ayuku, David; Nyandiko, Winstone; Atwoli, Lukoye; Ayaya, Samuel; Gisore, Peter; Scanlon, Michael; Braitstein, Paula

    2012-10-01

    Involving vulnerable pediatric populations in international research requires culturally appropriate ethical protections. We sought to use mabaraza, traditional East African community assemblies, to understand how a community in western Kenya viewed participation of children in health research and informed consent and assent processes. Results from 108 participants revealed generally positive attitudes towards involving vulnerable children in research, largely because they assumed children would directly benefit. Consent from parents or guardians was understood as necessary for participation while gaining child assent was not. They felt other caregivers, community leaders, and even community assemblies could participate in the consent process. Community members believed research involving orphans and street children could benefit these vulnerable populations, but would require special processes for consent.

  15. Parental decision making around perinatal autopsy: a qualitative investigation.

    PubMed

    Meaney, Sarah; Gallagher, Stephen; Lutomski, Jennifer E; O'Donoghue, Keelin

    2015-12-01

    Decades of decline in uptake rates of perinatal autopsies has limited investigation into the causes and risk factors for stillbirth. This study aimed to qualitatively explore perinatal autopsy decision-making processes in parents who experienced antepartum and intrapartum stillbirths. A qualitative semi-structured interview format was utilized. The line of questioning centred on how parents came to decide on consenting or declining to have a perinatal autopsy undertaken. Interpretative phenomenological analysis was employed as the analytic strategy. Purposive sampling was used to recruit 10 parents who either consented or declined autopsy from a large tertiary maternity hospital in Cork Ireland, where there were 30 stillbirths in 2011. Findings revealed four superordinate themes influencing parents' decision-making which varied with type of stillbirth experienced. Those parents who experienced antepartum stillbirths were more likely to consent; thus, knowing that the child was stillborn prior to delivery rather than on the day of delivery was associated with consent. In fact, these parents had more time for meaning-making; those consenting wanted to rule out self-blame and were fearful about future pregnancies. Parents who declined autopsy wanted to protect their infant from further harm. Interestingly, parents' knowledge and understanding of the autopsy itself were acquired primarily from public discourse. Parents' decision-making regarding autopsy is profoundly affected by their emotional response to stillbirth; clinicians and other health professionals may play a key role, especially if they can address parental concerns regarding the invasiveness of the autopsy procedure. © 2014 John Wiley & Sons Ltd.

  16. Can Broad Consent be Informed Consent?

    PubMed Central

    Sheehan, Mark

    2011-01-01

    In biobanks, a broader model of consent is often used and justified by a range of different strategies that make reference to the potential benefits brought by the research it will facilitate combined with the low level of risk involved (provided adequate measures are in place to protect privacy and confidentiality) or a questioning of the centrality of the notion of informed consent. Against this, it has been suggested that the lack of specific information about particular uses of the samples means that such consent cannot be fully autonomous and so is unethical. My answer to the title question is a definite ‘yes’. Broad consent can be informed consent and is justified by appeal to the principle of respect for autonomy. Indeed, I will suggest that the distinction between the various kinds of consent is not a distinction between kinds of consent but between the kinds of choice a person makes. When an individual makes a choice (of any kind) it is important that they do so according to the standards of informed consent and consistent with the choice that they are making. PMID:22102849

  17. Emerging issues in paediatric health research consent forms in Canada: working towards best practices.

    PubMed

    Dove, Edward S; Avard, Denise; Black, Lee; Knoppers, Bartha M

    2013-01-30

    Obtaining a research participant's voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008-2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child's assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child's psychological and social perspective; (3) whether a child's ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child's perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed. The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study. The analysis provides valuable insight and evidence into

  18. Emerging issues in paediatric health research consent forms in Canada: working towards best practices

    PubMed Central

    2013-01-01

    Background Obtaining a research participant’s voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Methods Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008–2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child’s assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child’s psychological and social perspective; (3) whether a child’s ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child’s perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed. Results The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study. Conclusions The

  19. Community Perspectives on Research Consent Involving Vulnerable Children in Western Kenya

    PubMed Central

    Vreeman, Rachel; Kamaara, Eunice; Kamanda, Allan; Ayuku, David; Nyandiko, Winstone; Atwoli, Lukoye; Ayaya, Samuel; Gisore, Peter; Scanlon, Michael; Braitstein, Paula

    2013-01-01

    Involving vulnerable pediatric populations in international research requires culturally appropriate ethical protections. We sought to use mabaraza, traditional East African community assemblies, to understand how a community in western Kenya viewed participation of children in health research and informed consent and assent processes. Results from 108 participants revealed generally positive attitudes towards involving vulnerable children in research, largely because they assumed children would directly benefit. Consent from parents or guardians was understood as necessary for participation while gaining child assent was not. They felt other caregivers, community leaders, and even community assemblies could participate in the consent process. Community members believed research involving orphans and street children could benefit these vulnerable populations, but would require special processes for consent. PMID:23086047

  20. 12 CFR 1272.6 - FHFA consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 9 2013-01-01 2013-01-01 false FHFA consent. 1272.6 Section 1272.6 Banks and Banking FEDERAL HOUSING FINANCE AGENCY FEDERAL HOME LOAN BANKS NEW BUSINESS ACTIVITIES § 1272.6 FHFA consent. The FHFA may at any time provide consent for a Bank to undertake a particular new business...

  1. 12 CFR 1272.6 - FHFA consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 10 2014-01-01 2014-01-01 false FHFA consent. 1272.6 Section 1272.6 Banks and Banking FEDERAL HOUSING FINANCE AGENCY FEDERAL HOME LOAN BANKS NEW BUSINESS ACTIVITIES § 1272.6 FHFA consent. The FHFA may at any time provide consent for a Bank to undertake a particular new business...

  2. 12 CFR 1272.6 - FHFA consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 9 2012-01-01 2012-01-01 false FHFA consent. 1272.6 Section 1272.6 Banks and Banking FEDERAL HOUSING FINANCE AGENCY FEDERAL HOME LOAN BANKS NEW BUSINESS ACTIVITIES § 1272.6 FHFA consent. The FHFA may at any time provide consent for a Bank to undertake a particular new business...

  3. Parents’ Activity-Related Parenting Practices Predict Girls’ Physical Activity

    PubMed Central

    DAVISON, KIRSTEN KRAHNSTOEVER; CUTTING, TANJA M.; BIRCH, LEANN L.

    2008-01-01

    Purpose Using a sample of 180 9-yr-old girls and their parents, this study examined (a) parents’ activity-related parenting strategies and similarities and differences in such strategies for mothers and fathers, and (b) links between activity-related parenting strategies and girls’ physical activity patterns. Methods Measures of girls’ physical activity included the Children’s Physical Activity scale, participation in organized sports, and physical fitness. We developed a questionnaire to assess ways in which parents promote physical activity among their children. Results Exploratory and confirmatory factor analyses identified two factors for each parent including logistic support of girls’ activity (i.e., enrolling girls in sports and driving them to events) and parents’ explicit modeling (i.e., the extent to which parents used their own behavior to encourage their daughters to be active). Mothers reported significantly higher levels of logistic support than fathers, whereas fathers reported higher levels of explicit modeling than mothers. Although mothers and fathers tended to report different methods of support, both methods were associated with higher physical activity among girls. Finally, girls reported significantly higher levels of physical activity when at least one parent reported high levels of overall support in comparison to no parents; no significant differences were identified for support from one versus two parents. Conclusion Results from this study indicate the positive contribution that parents can have on activity practices of their young daughters. PMID:12972881

  4. Autism, intellectual disability, and a challenge to our understanding of proxy consent.

    PubMed

    Graber, Abraham

    2017-06-01

    This paper focuses on a hypothetical case that represents an intervention request familiar to those who work with individuals with intellectual disability. Stacy has autism and moderate intellectual disability. Her parents have requested treatment for her hand flapping. Stacy is not competent to make her own treatment decisions; proxy consent is required. There are three primary justifications for proxy consent: the right to an open future, substituted judgment, and the best interest standard. The right to an open future justifies proxy consent on the assumption of future autonomy whereas substituted judgment justifies proxy consent via reference to past autonomy. Neither applies. Stacy has not been, nor will she be, competent to make her own treatment decisions. The best interest standard justifies proxy consent on the grounds of beneficence. It is unlikely that hand flapping harms Stacy. None of the three primary means of justifying proxy consent apply to Stacy's case.

  5. Child consent and the law: an insight and discussion into the law relating to consent and competence.

    PubMed

    Parekh, S A

    2007-01-01

    The law governing consent for children is not very clear. A child can consent to treatment but usually in practice is unable to refuse it. Even if both the child and parents refuse treatment, courts are reluctant to accept this, particularly if it is in the best interest of the child. In order to consent to treatment, a child must be competent enough to do so, and this competence is judged usually by a doctor. Children can even consent to contraceptives and abortion if 'competent' to do so. This concept perfectly lacks moral, ethical and emotional competence, and judgement of competence is carried out usually purely scientifically by pure science-orientated objective professionals like doctors. A broad discussion about the issues of children refusing treatment is conducted from the legal, ethical and philosophical point of view. Life-saving treatment and various other cases are also discussed. There is no right answer to the question. A more holistic approach is needed, and not only doctors but also sociologists, care specialists and even clergymen should be asked to judge competence in a multidisciplinary environment, particularly for contraceptives and abortion. This multidisciplinary working can be extended to other areas in medical law as well particularly in light of changes in medicine. Experience in life should be valued in a decision-making environment for judging competence. The law in relation to child consent is unclear and requires changes in order to clarify what is perceived as the child's best interest.

  6. Actividades Para Padres: A Parent Handbook (Activities for Parents: A Parent Handbook).

    ERIC Educational Resources Information Center

    Coca, Benjamin

    Thirty Mora, New Mexico parents attended a 13-session parent involvement workshop (The Mora Adventure) designed to help parents foster successful school experiences through non-school activities with their children. A parent involvement model was used as the basis of the workshop in which the parents developed more effective communication skills;…

  7. Impact and acceptability of self-consent procedures for the school-based human papillomavirus vaccine: a mixed-methods study protocol

    PubMed Central

    Audrey, Suzanne; Ferrie, Joanne; Evans, Karen; Bell, Michael; Yates, Julie; Roderick, Marion; MacLeod, John; Hickman, Matthew

    2018-01-01

    Introduction The human papillomavirus (HPV) vaccine, administered in early adolescence, can substantially reduce cervical cancer incidence and mortality. However, lack of written parental consent is a key reason why some young women do not receive the vaccine. The national legal framework allows girls to be vaccinated without parental consent provided they are deemed Gillick competent, but there is some reticence about vaccinating without written parental consent. Self-consent procedures are being implemented in Bristol and South Gloucestershire. This study will examine the implementation, acceptability and impact of these new procedures. Methods and analysis Statistical analyses of routine data from Public Health England and the Child Health Information System will test if there has been an increase in HPV vaccination uptake in two ways: (a) Is there an increase when comparing before and after the change in our intervention sites? and (b) Does the percentage change in our intervention sites differ from comparison sites (similar to our intervention sites in terms of initial HPV uptake, ethnicity and deprivation levels) in England where no such intervention took place and how? For the process evaluation, we will develop a logic model and use questionnaires, observations and audio-recorded interviews with young women, school nurses, school staff and parents to examine the context, implementation of self-consent and response to the new procedures. Ethics and dissemination The University of Bristol Faculty of Health Sciences Research Ethics Committee and the National Health Service Health Research Authority provided approvals for the study. We will produce a report with recommendations about self-consent procedures in conjunction with key stakeholders. At least two papers will be written for publication in peer-reviewed journals and for conference presentations. A summary of results will be shared with participating immunisation nurses, school staff, young people and

  8. Informed Consent to Treatment in Psychiatry

    PubMed Central

    Neilson, Grainne; Chaimowitz, Gary

    2015-01-01

    Summary Patients have a right to be informed and actively involved in their health care. Fundamental to a person’s dignity and autonomy is the right to make decisions about their psychiatric treatment, including their right to refuse unwanted treatments, providing that the refusal is a capable one. It is important that psychiatrists have an awareness of the ethical underpinnings of consent and the legislated requirements related to consent, including precedent cases. Consent may change over time and for different conditions and circumstances. Consent must be an ongoing process.

  9. Ethical considerations in investigating youth alcohol norms and behaviours: a case for mature minor consent.

    PubMed

    Hildebrand, J; Maycock, B; Comfort, J; Burns, S; Adams, E; Howat, P

    2015-12-01

    Mature minor consent only became available in Australia in 2007. There is neither an explicitly defined protocol, nor a clear definition evident in the literature relating to use of the mature minor concept in health research. Due to difficulties in defining fixed age ranges to varying levels of maturity and vulnerability, there is a lack of clarity surrounding when it might be reasonable and ethical to apply for or grant a waiver for parental consent. This paper describes the challenges faced and solutions created when gaining approval for use of mature minor consent in a respondent-driven sampling (RDS) study to explore the social norms and alcohol consumption among 14-17-year-old adolescents (n = 1012) in the community. The University's Human Research Ethics Committee granted mature minor consent for this study, and the techniques applied enabled recruitment of adolescents from community-based settings through use of RDS to achieve the required sample. This paper has relevance for research that requires a waiver for parental consent; it presents a case study for assessing mature minors and makes recommendations on how ethical guidelines can be improved to assist human research ethics application processes.

  10. Parental attitudes and information needs in an adolescent HPV vaccination programme

    PubMed Central

    Stretch, R; Roberts, S A; McCann, R; Baxter, D; Chambers, G; Kitchener, H; Brabin, L

    2008-01-01

    We sent a questionnaire to 38% (1084) of 2817 parents whose daughters had been offered human papillomavirus vaccination and who had agreed to participate. Of these, 60% (651) returned a questionnaire. Responses suggested that fact sheets and parent information evenings confirmed, rather than changed, consent decisions. The views of active refusers on safety and efficacy may be difficult to change, lowering vaccine coverage. PMID:18985038

  11. Consent Agreement and Consent Order

    EPA Pesticide Factsheets

    Contains legal consent agreement and consent order for the assessment of a civil penality pursuant to Section 14(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), BioLab Inc., Conyers, GA, September 14, 1998.

  12. The Minor's Right to Consent to Medical Treatment: A Corollary of the Constitutional Right of Privacy

    ERIC Educational Resources Information Center

    Raitt, G. Emmett, Jr.

    1975-01-01

    Argues that the existing rules governing a physician's liability for treating a child without parental consent merit reconsideration because the minor possesses a fundamental constitutional right, stemming from the right of privacy, to consent to medical care. Proposes guidelines for the development of a legislative program implementing these…

  13. Minors' rights to consent to treatment: navigating the complexity of State laws.

    PubMed

    Vukadinovich, David M

    2004-01-01

    State laws recognize that a competent adult patient has the right to consent to or refuse medical treatment. While the law is clear with regard to the right of competent adults, state statutes are more complicated when the patient is a minor. While the law should, and does, attempt to balance the rights and obligations of parents and guardians against the access and privacy rights of minors, complicated state statutory schemes often fail to simultaneously address those contrasting goals in a consistent and uniform manner. The result is a confusing set of seemingly arbitrary and sometimes conflicting provisions that require the detailed attention of healthcare providers to ensure legal compliance. With the aim of helping healthcare practitioners meet their legal obligations, this Article examines state laws governing minor's consent rights byfocusing on the instances in which a minor's parent, guardian, or other authorized adult is permitted to consent to treatment on behalf of a minor and the instances in which a minor is authorized to act independent of adult intervention.

  14. Optimization of informed consent for umbilical cord blood banking.

    PubMed

    Sugarman, Jeremy; Kurtzberg, Joanne; Box, Tamara L; Horner, Ronnie D

    2002-12-01

    The purpose of this project was to evaluate the informed consent process for donation to a public umbilical cord blood bank. Telephone interviews were conducted with 170 women who had given consent to donate their newborn infants' umbilical cord blood. Of the 170 women who were contacted, 96.8% of the women reported that all their questions had been answered. Nevertheless, approximately one third of the respondents did not consider themselves to be in research, and almost one quarter of the respondents did not know how to contact the umbilical cord blood bank if they or their infant became seriously ill. Further, a substantial proportion of the respondents did not understand the full range of alternatives to donation and incorrectly endorsed potential benefits. Informed consent could be optimized by (1) having those personnel who obtain consent emphasize that banking involves research and to explain the true benefits of donation, (2) ensuring that parents know how and when to contact the umbilical cord blood bank after donation, and (3) using phone surveys to continue assessments and to monitor changes in the process.

  15. Involving parents from the start: Formative evaluation for a large RCT with Botswana Junior Secondary School students

    PubMed Central

    Miller, Kim S.; Chirwa-Motswere, Catherine; Winskell, Kate; Stallcup, Elizabeth

    2016-01-01

    While HIV prevention research conducted among adolescent populations may encounter parental resistance, the active engagement of parents from inception to trial completion may alleviate opposition. In preparation for implementing a large randomized controlled trial (RCT) examining the efficacy of a behavioural intervention targeting adolescent sexual risk behaviours, a formative evaluation was undertaken to assess parental reactions to the proposed trial. Six focus groups were conducted with parents of adolescents (aged 13–17) from rural, peri-urban, and urban Botswana junior secondary schools. Focus groups explored comprehension and acceptability among parents of the forthcoming trial including HSV-2 testing, the return of results to the adolescent (not the parent), trial information materials and the parental consent process. Parents welcomed the study and understood and accepted its moral and ethical considerations. Their reactions regarding return of HSV-2 results only to adolescents (not the parent) were mixed. Parents understood the consent process and most agreed to consent, while indicating their desire to remain informed and involved throughout the RCT. The FGDs provided valuable information and insights that helped strengthen the study. As a result of parents’ feedback, counselling procedures were strengthened and direct linkages to local services and care were made. Informational materials were revised to increase clarity, and materials and procedures were developed to encourage and support parental involvement and parent-child dialogue. Ultimately, parental feedback led to a decision by the Government of Botswana to allow parents to access their child’s HSV-2 test results. PMID:27002354

  16. Engaging Urban Parents of Early Adolescents in Parenting Interventions: Home Visits vs. Group Sessions.

    PubMed

    Finigan-Carr, Nadine M; Copeland-Linder, Nikeea; Haynie, Denise L; Cheng, Tina L

    2014-01-01

    Interventions targeting parents of young children have shown effectiveness, but research is lacking about best practices for engaging parents of early adolescents. Low levels of enrollment and attendance in parenting interventions present major problems for researchers and clinicians. Effective and efficient ways to engage and collaborate with parents to strengthen parenting practices and to promote healthy development of early adolescents are needed. This exploratory mixed methods study examined the feasibility of three methods of engaging parents in positive parenting activities. Participants were parents of youth ages 11-13 enrolled in three urban, public middle schools in neighborhoods characterized by high rates of community violence. Families ( N = 144) were randomized into one of three interventions: six home sessions, two home sessions followed by four group sessions, or six group sessions. The majority of parents were single, non-Hispanic, African American mothers. Urban parents of middle school students were more likely to participate in home visits than in group sessions; offering a combination did not increase participation in the group sessions. As only 34% of those who consented participated in the intervention, qualitative data were examined to explain the reasons for non-participation.

  17. Engaging Urban Parents of Early Adolescents in Parenting Interventions: Home Visits vs. Group Sessions

    PubMed Central

    Finigan-Carr, Nadine M.; Copeland-Linder, Nikeea; Haynie, Denise L.; Cheng, Tina L.

    2016-01-01

    Interventions targeting parents of young children have shown effectiveness, but research is lacking about best practices for engaging parents of early adolescents. Low levels of enrollment and attendance in parenting interventions present major problems for researchers and clinicians. Effective and efficient ways to engage and collaborate with parents to strengthen parenting practices and to promote healthy development of early adolescents are needed. This exploratory mixed methods study examined the feasibility of three methods of engaging parents in positive parenting activities. Participants were parents of youth ages 11–13 enrolled in three urban, public middle schools in neighborhoods characterized by high rates of community violence. Families (N = 144) were randomized into one of three interventions: six home sessions, two home sessions followed by four group sessions, or six group sessions. The majority of parents were single, non-Hispanic, African American mothers. Urban parents of middle school students were more likely to participate in home visits than in group sessions; offering a combination did not increase participation in the group sessions. As only 34% of those who consented participated in the intervention, qualitative data were examined to explain the reasons for non-participation. PMID:27122960

  18. Predicting Child Physical Activity and Screen Time: Parental Support for Physical Activity and General Parenting Styles

    PubMed Central

    Crain, A. Lauren; Senso, Meghan M.; Levy, Rona L.; Sherwood, Nancy E.

    2014-01-01

    Objective: To examine relationships between parenting styles and practices and child moderate-to-vigorous physical activity (MVPA) and screen time. Methods: Participants were children (6.9 ± 1.8 years) with a body mass index in the 70–95th percentile and their parents (421 dyads). Parent-completed questionnaires assessed parental support for child physical activity (PA), parenting styles and child screen time. Children wore accelerometers to assess MVPA. Results: Parenting style did not predict MVPA, but support for PA did (positive association). The association between support and MVPA, moreover, varied as a function of permissive parenting. For parents high in permissiveness, the association was positive (greater support was related to greater MVPA and therefore protective). For parents low in permissiveness, the association was neutral; support did not matter. Authoritarian and permissive parenting styles were both associated with greater screen time. Conclusions: Parenting practices and styles should be considered jointly, offering implications for tailored interventions. PMID:24812256

  19. Involving parents from the start: formative evaluation for a large randomised controlled trial with Botswana Junior Secondary School students.

    PubMed

    Vig, Jessica; Miller, Kim S; Chirwa-Motswere, Catherine; Winskell, Kate; Stallcup, Elizabeth

    2016-01-01

    While HIV prevention research conducted among adolescent populations may encounter parental resistance, the active engagement of parents from inception to trial completion may alleviate opposition. In preparation for implementing a large randomised controlled trial (RCT) examining the efficacy of a behavioural intervention targeting adolescent sexual risk behaviours, a formative evaluation was undertaken to assess parental reactions to the proposed trial. Six focus groups were conducted with parents of adolescents (aged 13-17) from rural, peri-urban and urban junior secondary schools in Botswana. Focus groups explored comprehension and acceptability among parents of the forthcoming trial including HSV-2 testing, the return of results to the adolescent (not the parent), trial information materials and the parental consent process. Parents welcomed the study and understood and accepted its moral and ethical considerations. Their reactions regarding return of HSV-2 results only to adolescents (not the parent) were mixed. Parents understood the consent process and most agreed to consent, while indicating their desire to remain informed and involved throughout the RCT. The focus group discussions (FGDs) provided valuable information and insights that helped strengthen the study. As a result of parents' feedback, counselling procedures were strengthened and direct linkages to local services and care were made. Informational materials were revised to increase clarity, and materials and procedures were developed to encourage and support parental involvement and parent-child dialogue. Ultimately, parental feedback led to a decision by the Government of Botswana to allow parents to access their child's HSV-2 test results.

  20. Assessing the quality of informed consent in a resource-limited setting: a cross-sectional study.

    PubMed

    Kiguba, Ronald; Kutyabami, Paul; Kiwuwa, Stephen; Katabira, Elly; Sewankambo, Nelson K

    2012-08-21

    The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant. Of the 600 participants interviewed, two thirds (64.2%, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9%, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7%, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7%, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95% CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care.

  1. Predictors of adolescents' consent to use health records for research and results from data collection in a Swedish twin cohort.

    PubMed

    Ullemar, Vilhelmina; Lundholm, Cecilia; Örtqvist, Anne K; Gumpert, Clara Hellner; Anckarsäter, Henrik; Lundström, Sebastian; Almqvist, Catarina

    2015-06-01

    Non-random selection into a study population due to differences between consenters and non-consenters may introduce participation bias. Past investigations of factors predicting consent to collection of medical health records for research imply that age, sex, health status, and education are of importance for participation, but disagree on the direction of effects. Very little is known about influences on consent from adolescents. Two cohorts of Swedish 15-year-old twins (total n = 4,611) previously invited to the Child and Adolescent Twin Study in Sweden (CATSS) responded to a questionnaire with information on sex, individual's health, height, weight, and parental factors. The questionnaire included a question for consent to collection of medical health records. Predictors for consent were analyzed using logistic regression. Additionally, regional differences in the collection of health records of consenters were evaluated. Males were significantly less likely to consent compared to females (OR 0.74, 95% CI 0.64-0.85). The twin siblings' decision to consent was strongly associated with consent (OR 10.9, 95% CI 8.76-13.5), and individuals whose parents had responded to the original CATSS study were more likely to consent to record collection at age 15 (OR 2.2, 95% CI 1.81-2.75). Results of the subsequent collection of consenters' medical health records varied between geographical regions of Sweden. We identified several predictors for adolescents' consent to collection of their medical health records. Further selection was introduced through the subsequent record collection. Whether this will induce participation bias in future studies depends on the research questions' relationship to the identified predictors.

  2. Ethical Considerations for the Participation of Children of Minor Parents in Clinical Trials.

    PubMed

    Ott, Mary A; Crawley, Francis P; Sáez-Llorens, Xavier; Owusu-Agyei, Seth; Neubauer, David; Dubin, Gary; Poplazarova, Tatjana; Begg, Norman; Rosenthal, Susan L

    2018-06-01

    Children of minor parents are under-represented in clinical trials. This is largely because of the ethical, legal, and regulatory complexities in the enrolment, consent, and appropriate access of children of minor parents to clinical research. Using a case-based approach, we examine appropriate access of children of minor parents in an international vaccine trial. We first consider the scientific justification for inclusion of children of minor parents in a vaccine trial. Laws and regulations governing consent generally do not address the issue of minor parents. In their absence, local community and cultural contexts may influence consent processes. Rights of the minor parent include dignity in their role as a parent and respect for their decision-making capacity in that role. Rights of the child include the right to have decisions made in their best interest and the right to the highest attainable standard of health. Children of minor parents may have vulnerabilities related to the age of their parent, such as increased rates of poverty, that have implications for consent. Neuroscience research suggests that, by age 12-14 years, minors have adult-level capacity to make research decisions in situations with low emotion and low distraction. We conclude with a set of recommendations based on these findings to facilitate appropriate access and equity related to the participation of children of minor parents in clinical research.

  3. Predicting child physical activity and screen time: parental support for physical activity and general parenting styles.

    PubMed

    Langer, Shelby L; Crain, A Lauren; Senso, Meghan M; Levy, Rona L; Sherwood, Nancy E

    2014-07-01

    To examine relationships between parenting styles and practices and child moderate-to-vigorous physical activity (MVPA) and screen time. Participants were children (6.9 ± 1.8 years) with a body mass index in the 70-95th percentile and their parents (421 dyads). Parent-completed questionnaires assessed parental support for child physical activity (PA), parenting styles and child screen time. Children wore accelerometers to assess MVPA. Parenting style did not predict MVPA, but support for PA did (positive association). The association between support and MVPA, moreover, varied as a function of permissive parenting. For parents high in permissiveness, the association was positive (greater support was related to greater MVPA and therefore protective). For parents low in permissiveness, the association was neutral; support did not matter. Authoritarian and permissive parenting styles were both associated with greater screen time. Parenting practices and styles should be considered jointly, offering implications for tailored interventions. © The Author 2014. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  4. A survey on surgeons' perceived quality of the informed consent process in a Swiss paediatric surgery unit.

    PubMed

    Guinand, Julie; Gapany, Christophe; Simon, Jeanne-Pascale; Wasserfallen, Jean-Blaise; Joseph, Jean-Marc

    2015-01-01

    To evaluate the levels of satisfaction and opinions on the usefulness of the informed consent form currently in use in our Paediatric Surgery Department. Qualitative study carried out via interviews of senior paediatric surgeons, based on a questionnaire built up from reference criteria in the literature and public health law. Physicians with between 2 and 35 years experience of paediatric surgery, with a participation rate of 92 %, agreed on the definition of an informed consent form, were satisfied with the form in use and did not wish to modify its structure. The study revealed that signing the form was viewed as mandatory, but meant different things to different participants, who diverged over whom that signature protected. Finally, all respondents were in agreement over what information was necessary for parents of children requiring surgery. Paediatric surgeons seemed to be satisfied with the informed consent form in use. Most of them did not identify that the first aim of the informed consent form is to give the patient adequate information to allow him to base his consent, which is a legal obligation, the protection of physicians by the formalisation and proof of the informed consent being secondary. Few surgeons brought up the fact that the foremost stakeholder in paediatric surgery are the children themselves and that their opinions are not always sought. In the future, moving from informed consent process to shared decision-making, a more active bidirectional exchange may be strongly considered. Involving children in such vital decisions should become the norm while keeping in mind their level of maturity.

  5. Is Consent Based on Trust Morally Inferior to Consent Based on Information?

    PubMed

    Kongsholm, Nana Cecilie Halmsted; Kappel, Klemens

    2017-07-01

    Informed consent is considered by many to be a moral imperative in medical research. However, it is increasingly acknowledged that in many actual instances of consent to participation in medical research, participants do not employ the provided information in their decision to consent, but rather consent based on the trust they hold in the researcher or research enterprise. In this article we explore whether trust-based consent is morally inferior to information-based consent. We analyse the moral values essential to valid consent - autonomy, voluntariness, non-manipulation, and non-exploitation - and assess whether these values are less protected and promoted by consent based on trust than they are by consent based on information. We find that this is not the case, and thus conclude that trust-based consent if not morally inferior to information-based consent. © 2017 John Wiley & Sons Ltd.

  6. Parenting styles, parenting practices, and physical activity in 10- to 11-year olds.

    PubMed

    Jago, Russell; Davison, Kirsten K; Brockman, Rowan; Page, Angie S; Thompson, Janice L; Fox, Kenneth R

    2011-01-01

    The objective of this study was to determine whether parenting styles and practices are associated with children's physical activity. Cross-sectional survey of seven hundred ninety-two 10- to 11-year-old UK children in Bristol (UK) in 2008-2009 was conducted. Accelerometer-assessed physical activity and mean minutes of moderate-to-vigorous physical activity (mean MVPA) and mean counts per minute (mean CPM) were obtained. Maternal parenting style and physical activity parenting practices were self-reported. In regression analyses, permissive parenting was associated with higher mean MVPA among girls (+6.0 min/day, p<0.001) and greater mean CPM (+98.9 accelerometer counts/min, p=0.014) among boys when compared to children with authoritative parents. Maternal logistic support was associated with mean CPM for girls (+36.2 counts/min, p=0.001), while paternal logistic support was associated with boys' mean MVPA (+4.0 min/day, p=0.049) and mean CPM (+55.7 counts/min, p=0.014). Maternal permissive parenting was associated with higher levels of physical activity than authoritative parenting, but associations differed by child gender and type of physical activity. Maternal logistic support was associated with girls' physical activity, while paternal logistic support was associated with boys' physical activity. Health professionals could encourage parents to increase logistic support for their children's physical activity. Copyright © 2010 Elsevier Inc. All rights reserved.

  7. Informed consent in psychotherapy.

    PubMed

    Beahrs, J O; Gutheil, T G

    2001-01-01

    The authors sought a rational approach to implementing informed consent within the practice of psychotherapy. The history of informed consent in psychotherapy was reviewed to define a common synthesis that maximizes the potential benefits and minimizes the potential hazards. The benefits of informed consent in psychotherapy include fostering a positive treatment outcome through enhancing patient autonomy, responsibility, and self-therapeutic activity; lessening the risks of regressive effects and therapist liability; and helping the practice of psychotherapy extend beyond particular parochialisms by providing checks and balances on therapist judgments. The hazards include the unpredictability of interactional outcomes and the possibilities of replacing positive expectancy with negative suggestion, replacing a therapeutic alliance with a legalistic stance, and misimplying that patients are passive recipients. Practical implementation of informed consent in psychotherapy must balance such tensions in service of optimal treatment. As a guiding principle, the authors recommend that psychotherapists convey to a prospective patient information that is material to the particular patient's decision. The level of detail needed in informed consent discussions varies directly with the cost and risks of the proposed treatment, the presence of viable alternatives and their relative grounding in scientific data and professional acceptance, and the presence of significant controversy. Unresolved is the question of how to address problematic or controversial psychotherapeutic trends that temporarily enjoy wide professional support.

  8. Dutch children and parents' views on active and non-active video gaming.

    PubMed

    De Vet, Emely; Simons, Monique; Wesselman, Maarten

    2014-06-01

    Active video games that require whole body movement to play the game may be an innovative health promotion tool to substitute sedentary pastime with more active time and may therefore contribute to children's health. To inform strategies aimed at reducing sedentary behavior by replacing non-active by active gaming, opinions about active and non-active video games are explored among 8- to 12-year-old children and their parents. Six qualitative, semi-structured focus groups were held with 8- to 12-year-old children (n = 46) and four with their parents (n = 19) at three different primary schools in The Netherlands. The focus groups with children discussed game preferences, gaming context and perceived game-related parenting. The focus groups with parents addressed considerations in purchasing video games, perceived positive and negative consequences of gaming, and game-related parenting. Both children and their parents were very positive about active video games and preferred active games over non-active games. Active video games were considered more social than non-active video games, and active games were played more often together with friends and family than non-active video games. Parenting practices did not differ for active and non-active video games, although some parents were less strict regarding active games. Two conditions for practical implementation were met: children enjoyed active video games, and parents were willing to buy active video games. Active video games were preferred to non-active video games, illustrating that using active video games is a promising health promotion tool to reduce sedentary pastime in youth.

  9. Parenting styles, parenting practices, and physical activity in 10- to 11-year olds

    PubMed Central

    Jago, Russell; Davison, Kirsten K.; Brockman, Rowan; Page, Angie S.; Thompson, Janice L.; Fox, Kenneth R.

    2011-01-01

    Objective The objective of this study was to determine whether parenting styles and practices are associated with children's physical activity. Methods Cross-sectional survey of seven hundred ninety-two 10- to 11-year-old UK children in Bristol (UK) in 2008–2009 was conducted. Accelerometer-assessed physical activity and mean minutes of moderate-to-vigorous physical activity (mean MVPA) and mean counts per minute (mean CPM) were obtained. Maternal parenting style and physical activity parenting practices were self-reported. Results In regression analyses, permissive parenting was associated with higher mean MVPA among girls (+ 6.0 min/day, p < 0.001) and greater mean CPM (+ 98.9 accelerometer counts/min, p = 0.014) among boys when compared to children with authoritative parents. Maternal logistic support was associated with mean CPM for girls (+ 36.2 counts/min, p = 0.001), while paternal logistic support was associated with boys' mean MVPA (+ 4.0 min/day, p = 0.049) and mean CPM (+ 55.7 counts/min, p = 0.014). Conclusions Maternal permissive parenting was associated with higher levels of physical activity than authoritative parenting, but associations differed by child gender and type of physical activity. Maternal logistic support was associated with girls' physical activity, while paternal logistic support was associated with boys' physical activity. Health professionals could encourage parents to increase logistic support for their children's physical activity. PMID:21070805

  10. Under-age girls and contraception: the parent's right to be informed.

    PubMed

    Brahams, Diana

    1983-08-06

    A British barrister considers the issue of whether the giving of advice or the prescribing of contraceptives to girls younger than 16 without parental consent constitutes criminal conduct by the physician. Brahams examines relevant criminal and family law, common law, recent court decisions, and Department of Health and Human Services policy concerning the minor's right to consent, parental interests, and physician responsibilities.

  11. Informed consent and the readability of the written consent form.

    PubMed

    Sivanadarajah, N; El-Daly, I; Mamarelis, G; Sohail, M Z; Bates, P

    2017-11-01

    Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised consent forms (both in summary and detailed formats) endorsed by the British Orthopaedic Association (BOA) were retrieved from orthoconsent.com and assessed for readability. This involved using an online tool to calculate the validated Flesch reading ease score (FRES). This was compared with the FRES for the National Health Service (NHS) Consent Form 1. Data were analysed and interpreted according to the FRES grading table. Results The FRES for Consent Form 1 was 55.6, relating to the literacy expected of an A level student. The mean FRES for the BOA summary consent forms (n=27) was 63.6 (95% confidence interval [CI]: 61.2-66.0) while for the detailed consent forms (n=32), it was 68.9 (95% CI: 67.7-70.0). All BOA detailed forms scored >60, correlating to the literacy expected of a 13-15-year-old. The detailed forms had a higher FRES than the summary forms (p<0.001). Conclusions This study demonstrates that the BOA endorsed standardised consent forms are much easier to read and understand than the NHS Consent Form 1, with the detailed BOA forms being the easiest to read. Despite this, owing to varying literacy levels, a significant proportion of patients may struggle to give informed consent based on the written information provided to them.

  12. Measles high school vaccination program, 2014-2015: online survey of parents in NSW, Australia.

    PubMed

    Nicholl, Sonya; Seale, Holly; Campbell-Lloyd, Sue

    2018-06-14

    In 2014, a high school-based measles supplementary immunisation activity (SIA) took place in New South Wales (NSW), Australia, in response to a large number of adolescents being identified as undervaccinated or unvaccinated against measles. The program focused on areas of NSW where previous measles outbreaks had occurred and where large numbers of undervaccinated adolescents lived. More than 11 000 students were vaccinated in 2014, and the program continued in 2015, when more than 4000 students in Years 11 and 12 were vaccinated. Parents of students vaccinated during the program were surveyed to determine their level of satisfaction with the program. An online link to the anonymous survey with instructions was sent in a text message between August 2015 and May 2016 to parents of students who had consented or been vaccinated during the 2014 and 2015 measles, mumps and rubella (MMR) supplementary immunisation activities (SIAs). Responses were received from parents in all Local Health Districts (LHDs), and response rates ranged from <1% to 21% across different districts with 59% of the total number of complete responses from three LHDs. Overall, parents were satisfied with the MMR program, its resources and how it was implemented. Suggestions were received to improve consent processes, increase student involvement and increase school staff accountability. More than half of the parents reported difficulty finding their child's previous vaccination record. Improving vaccination record access and management was highlighted as an area of improvement in the program. Although response rates were low, the survey has generated important ideas that may help to further improve implementation of school vaccination programs, including allowing electronic consent, increasing student engagement, improving access to previous vaccination records and increasing school staff accountability.

  13. Evaluation of a prototype interactive consent program for pediatric clinical trials: a pilot study

    PubMed Central

    Voepel-Lewis, Terri; McGonegal, Maureen; Levine, Robert

    2011-01-01

    Standard written methods of presenting research information may be difficult for many parents and children to understand. This pilot study was designed to examine the use of a novel prototype interactive consent program for describing a hypothetical pediatric asthma trial to parents and children. Parents and children were interviewed to examine their baseline understanding of key elements of a clinical trial, eg, randomization, placebo, and blinding. Subjects then reviewed age-appropriate versions of an interactive computer program describing an asthma trial, and their understanding of key research concepts was again tested along with their understanding of the details of the trial. Parents and children also completed surveys to examine their perceptions and satisfaction with the program. Both parents and children demonstrated improved understanding of key research concepts following administration of the consent program. For example, the percentage of parents and children who could correctly define the terms clinical trials and placebo improved from 60% to 80%, and 80% to 100% among parents and 25% to 50% and 0% to 50% among children, respectively, following review of the interactive programs. Parents and children's overall understanding of the details of the asthma trial were 14.2±0.84 and 9.25±4.9 (0–15 scale, where 15 is complete understanding), respectively. Results also suggest that the interactive programs were easy to use and facilitated understanding of the clinical trial among parents and children. Interactive media may offer an effective means of presenting understandable information to parents and children regarding participation in clinical trials. Further work to examine this novel approach appears warranted. PMID:21803924

  14. Assessing children’s competence to consent in research by a standardized tool: a validity study

    PubMed Central

    2012-01-01

    Background Currently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children’s competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents. Methods/design In this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130–190 subjects, providing a minimum of 10–15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s). It is anticipated that 160 participants will be recruited over 2 years to complete enrollment. Discussion A validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In this study we will establish

  15. The places parents go: understanding the breadth, scope, and experiences of activity spaces for parents.

    PubMed

    Wolf, Jennifer Price; Freisthler, Bridget; Kepple, Nancy Jo; Chávez, Raúl

    2017-04-01

    Neighborhood environments are related to parenting behaviors, which in turn have a life-long effect on children's health and well-being. Activity spaces, which measure individual routine patterns of movement, may be helpful in assessing how physical and social environments shape parenting. In this study we use qualitative data and GIS mapping from 4 California cities to examine parental activity spaces. Parents described a number of factors that shape their activity spaces including caregiving status, the age of their children, and income. Parental activity spaces also varied between times (weekends vs. weekdays) and places (adult-only vs. child-specific places). Knowing how to best capture and study parental activity spaces could identify mechanisms by which environmental factors influence parenting behaviors and child health.

  16. Practical Communication Guidance to Improve Phase I Informed Consent Conversations and Decision-Making in Pediatric Oncology

    PubMed Central

    Johnson, Liza-Marie; Leek, Angela C.; Drotar, Dennis; Noll, Robert B.; Rheingold, Susan R.; Kodish, Eric D.; Baker, Justin N.

    2015-01-01

    Background It can be difficult to explain pediatric Phase I oncology trials to families of children with refractory cancer. Parents may misunderstand the information presented to them, and physicians may assume that certain topics are covered in the informed consent document and need not be discussed. Communication models can help to ensure effective discussions. Methods Suggestions for improving the informed consent process were first solicited from Phase I study clinicians via questionnaire. Eight parents who had enrolled their child on a Phase I pediatric oncology trial were recruited for an advisory group designed to assess the clinicians’ suggestions and make additional recommendations for improving informed consent for pediatric Phase I trials. Results A Phase I Communication Model was designed to incorporate the suggestions of clinicians and families. It focuses on education of parents/families about Phase I trials at specific time points during a child’s illness, but specifically at the point of relapse. We also present an informative Phase I fact sheet that can be distributed to families. Conclusions Families who will be offered information about a Phase I clinical trial can first receive a standardized fact sheet explaining the general purpose of these early-phase clinical trials. Parental understanding may be further enhanced when oncologists address key themes, beginning at diagnosis and continuing through important decision points during the child’s illness. This model should be prospectively evaluated. PMID:25873253

  17. Randomization to Standard and Concise Informed Consent Forms: Development of Evidence-Based Consent Practices

    PubMed Central

    Enama, Mary E.; Hu, Zonghui; Gordon, Ingelise; Costner, Pamela; Ledgerwood, Julie E.; Grady, Christine

    2012-01-01

    Background Consent to participate in research is an important component of the conduct of ethical clinical trials. Current consent practices are largely policy-driven. This study was conducted to assess comprehension of study information and satisfaction with the consent form between subjects randomized to concise or to standard informed consent forms as one approach to developing evidence-based consent practices. Methods Participants (N=111) who enrolled into two Phase I investigational influenza vaccine protocols (VRC 306 and VRC 307) at the NIH Clinical Center were randomized to one of two IRB-approved consents; either a standard or concise form. Concise consents had an average of 63% fewer words. All other aspects of the consent process were the same. Questionnaires about the study and the consent process were completed at enrollment and at the last visit in both studies. Results Subjects using concise consent forms scored as well as those using standard length consents in measures of comprehension (7 versus 7, p=0.79 and 20 versus 21, p=0.13), however, the trend was for the concise consent group to report feeling better informed. Both groups thought the length and detail of the consent form was appropriate. Conclusions Randomization of study subjects to different length IRB-approved consents forms as one method for developing evidence-based consent practices, resulted in no differences in study comprehension or satisfaction with the consent form. A concise consent form may be used ethically in the context of a consent process conducted by well-trained staff with opportunities for discussion and education throughout the study. PMID:22542645

  18. Beyond informed consent.

    PubMed Central

    Bhutta, Zulfiqar A.

    2004-01-01

    Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. The emphasis in most externally sponsored research projects in developing countries is on laborious documentation of several mechanical aspects of the research process rather than on assuring true comprehension and voluntary participation. The onus for the oversight of this process is often left to overworked and ill-equipped local ethics review committees. Current guidelines and processes for obtaining informed consent should be reviewed with the specific aim of developing culturally appropriate methods of sharing information about the research project and obtaining and documenting consent that is truly informed. Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings. PMID:15643799

  19. "Consent is Good, Joyous, Sexy": A banner campaign to market consent to college students.

    PubMed

    Thomas, Kristie A; Sorenson, Susan B; Joshi, Manisha

    2016-01-01

    This study assessed the recall of, reaction to, and understanding of a brief campus banner campaign promoting consent in sexual relationships, and determined whether campaign exposure was associated with subsequent engagement in activities related to sexual assault education, awareness, and prevention. A stratified random sample of 1,200 undergraduates was recruited during fall of 2010; 628 (52.3%) participated. To account for history and maturation, an experimental research design was employed with an online survey. Direct and indirect campaign exposure was associated with increased action. Students expressed primarily positive reactions to and appeared to understand the consent message. The campaign appealed to and was associated with increased activity among a wide range of students with one exception: a negative effect was observed for business students. Colorful banners with pithy, upbeat messages hold promise for engaging undergraduates in conversations and proactive activities related to sexual assault prevention.

  20. Parental attitudes towards and perceptions of their children's participation in clinical research: a developing-country perspective.

    PubMed

    Nabulsi, Mona; Khalil, Yvette; Makhoul, Jihad

    2011-07-01

    Paediatric clinical research faces unique challenges that compromise optimal recruitment of children into clinical trials. A main barrier to enrolment of children is parental misconceptions about the research process. In developing countries, there is a knowledge gap regarding parental perceptions of and attitudes towards their children's participation in clinical trials. To explore such perceptions and attitudes in Lebanese parents. 33 in-depth interviews were conducted with parents with and without previous research experience. Interviews were tape-recorded, transcribed in colloquial Arabic, and later subjected to thematic analysis. Benefit/risk ratio assessment was a major determinant of parental consent. Fear of adverse events or painful procedures in research was a recurring theme in most interviews. Whereas perception of direct benefit to the child, trust in the physician or institution, financial gains or having a positive previous experience in research facilitated consent, a complex informed consent form and misunderstanding of the term 'randomisation' hindered parental approval of participation. Lebanese parents have perceptions of and attitudes towards children's participation in clinical trials that are similar to those reported from the industrialised world. Improving communication with parents and building trust between researchers and parents is important for successful recruitment. Investigators planning to conduct paediatric trials in developing countries need to simplify consent forms and devise new ways to explain randomisation.

  1. Correlates of children and parents being physically active together.

    PubMed

    Lee, Sarah M; Nihiser, Allison; Strouse, Darcy; Das, Barnali; Michael, Shannon; Huhman, Marian

    2010-11-01

    Co-physical activity (between parents and children), as an outcome variable, and its correlates have not been examined previously. The purpose of this study was to investigate correlates of co-physical activity among a nationally representative sample of 9- to 13-year-old children and their parents. Data were from the 2004 Youth Media Campaign Longitudinal Survey, a national survey of 5177 child-parent dyads. Parents of 9- to 13-year-old children were asked to report co-physical activity. Parents and children responded to a series of sociodemographic, behavioral, and psychosocial measures. Co-physical activity was treated as a dichotomous variable (ie, some or none). Logistic regression was used to assess associations of correlates directly and possible interactions between correlates. More than three-quarters of parents reported co-physical activity at least 1 day in the prior week. Age, race/ethnicity, sports team participation, eating meals together, parental confidence to influence the child's organized activity, and the child's perception of parental support were significantly associated with co-physical activity. The majority of respondents reported participating in co-physical activity, and multiple sociodemographic, behavioral, and psychosocial correlates were significantly associated with co-physical activity. This study provides insight for physical activity interventions that might involve parents.

  2. What Can Parents Do? A Review of State Laws Regarding Decision Making for Adolescent Drug Abuse and Mental Health Treatment

    PubMed Central

    Kerwin, MaryLouise E.; Kirby, Kimberly C.; Speziali, Dominic; Duggan, Morgan; Mellitz, Cynthia; Versek, Brian; McNamara, Ashley

    2013-01-01

    This study examined US state laws regarding parental and adolescent decision-making for substance use and mental health inpatient and outpatient treatment. State statues for requiring parental consent favored mental health over drug abuse treatment and inpatient over outpatient modalities. Parental consent was sufficient in 53%–61% of the states for inpatient treatment, but only for 39% – 46% of the states for outpatient treatment. State laws favored the rights of minors to access drug treatment without parental consent, and to do so at a younger age than for mental health treatment. Implications for how these laws may impact parents seeking help for their children are discussed. PMID:25870511

  3. Ethical Issues Regarding Informed Consent for Minors for Space Tourism

    NASA Astrophysics Data System (ADS)

    Marsh, Melvin S.

    2010-01-01

    This paper describes the difficulty with informed consent and debates whether or not whether adults should be able to ethically, morally, and legally consent for their children during the high-risk activity of space tourism. The experimental nature of space vehicles combined with the high likelihood of medical complications and the destination places space tourism legally in the category of "adventure activities," which include adventure travel to exotic locations as well as adventure sports, such as mountain climbing, rafting, etc. which carry a high risk of danger (http://rescommunis.wordpress.com/2008/02/14/interview-tracey-l-knutson-adventure-sports-defense-attorney-on-space-tourism-risk-and-informed-consente/). However, unlike other adventure sports, adults currently cannot consent for their minor children. Other topics also receive attention, such as a "mature minors" clause, radiation exposure of potential future children, and other difficulties preventing adults from legally consenting to space travel.

  4. Organ Donation in Switzerland - An Analysis of Factors Associated with Consent Rate

    PubMed Central

    Keel, Isabelle; Immer, Franz F.; Jüni, Peter

    2014-01-01

    Background and Aim Switzerland has a low post mortem organ donation rate. Here we examine variables that are associated with the consent of the deceased’s next of kin (NOK) for organ donation, which is a prerequisite for donation in Switzerland. Methods and Analysis During one year, we registered information from NOK of all deceased patients in Swiss intensive care units, who were approached for consent to organ donation. We collected data on patient demographics, characteristics of NOK, factors related to the request process and to the clinical setting. We analyzed the association of collected predictors with consent rate using univariable logistic regression models; predictors with p-values <0.2 were selected for a multivariable logistic regression. Results Of 266 NOK approached for consent, consent was given in 137 (51.5%) cases. In multivariable analysis, we found associations of consent rates with Swiss nationality (OR 3.09, 95% CI: 1.46–6.54) and German language area (OR 0.31, 95% CI: 0.14–0.73). Consent rates tended to be higher if a parent was present during the request (OR 1.76, 95% CI: 0.93–3.33) and if the request was done before brain death was formally declared (OR 1.87, 95% CI: 0.90–3.87). Conclusion Establishing an atmosphere of trust between the medical staff putting forward a request and the NOK, allowing sufficient time for the NOK to consider donation, and respecting personal values and cultural differences, could be of importance for increasing donation rates. Additional measures are needed to address the pronounced differences in consent rates between language regions. PMID:25208215

  5. Informed consent, parental permission, and assent in pediatric practice. Committee on Bioethics.

    PubMed

    1998-01-01

    The statement on informed consent, parental permission, and patient assent has a long and extraordinary history. The first draft of this document, prepared by William G. Bartholome, MD, was presented to the original American Academy of Pediatrics (AAP) Committee on Bioethics in 1985. Bill put his soul into the manuscript and has watched over it carefully ever since. Now, a decade later, those who have worked on its continued development and urged its adoption as Academy policy applaud its publication. No one is more gratified than its primary author and champion. Those who have had the privilege to know Dr. Bartholome share his sense of accomplishment, but cannot help but experience a cruel sense of irony. Just as the work Bill considers his most important contribution has become available for public appreciation, Dr. Bartholome suffers from a serious illness that threatens his life. Bill always wanted "the experience, perspective, and power of children" to be taken most seriously. Through the years of the statement's revisions and re-presentation within the Academy, Bill "had faith in the power of the text and the ideas it contained, ... that its time would come." The statement embodies Bill Bartholome's dedication to children. Throughout his career, he worked to make medicine and medical research safer and more friendly for children. The AAP and its Committee on Bioethics, on behalf of all our colleagues, extend heartfelt thanks to Dr. William G. Bartholome for helping us more fully appreciate that children are in the process of becoming, in his words, "intelligent, observant, capable, and responsible persons" who deserve our utmost respect.

  6. Minor Consent and Delivery of Adolescent Vaccines

    PubMed Central

    Ford, Carol A.; Skiles, Martha P.; English, Abigail; Cai, Jianwen; Agans, Robert P.; Stokley, Shannon; Markowitz, Lauri; Koumans, Emilia H.

    2016-01-01

    Purpose To explore whether, and to what extent, minor consent influences adolescent vaccine delivery in the United States. Methods A telephone survey was completed by 263 professionals with responsibilities for adolescent health care and/or vaccination in 43 states. Measures included perceived frequency of unaccompanied minor visits and perceived likelihood of vaccine delivery to unaccompanied minors in hypothetical scenarios that varied by adolescent age, vaccine type, visit type, and clinical setting. Results Among the 76 respondents most familiar with private primary care clinics, 47.1% reported perceptions that 17-year-old patients often present without a parent/legal guardian. Among the 104 respondents most familiar with public primary care clinics, 56.7% reported that 17-year-old patients often present alone. In response to hypothetical scenarios, approximately 30% of respondents familiar with private clinics and 50% of respondents familiar with public clinics reported perceptions that unaccompanied 17-year-old adolescents would not receive influenza, Tdap, or human papillomavirus vaccines during routine check-ups because they could not provide consent. Perceived likelihood of unaccompanied minors receiving vaccines when seen for confidential services in primary care, sexually transmitted disease, and Title X/family planning clinics varied significantly by vaccine type and clinical setting. On average, respondents reported that they would support minors having the ability to self-consent for vaccines at age 14. Conclusions The inability of minors to consent for vaccines is likely one barrier to vaccination. Interventions to increase adolescent vaccination should consider strategies that increase the ability of unaccompanied minors, particularly older minors, to receive vaccines within the context of legal, ethical, and professional guidelines. PMID:24074605

  7. Participation of Adolescent Girls in a Study of Sexual Behaviors: Balancing Autonomy and Parental Involvement

    PubMed Central

    Short, Mary B.; Wiemann, Constance; Rosenthal, Susan L.

    2009-01-01

    Study Objective The process of research with adolescents should balance parental involvement and adolescent autonomy. The attendance of parents and peers at research study visits of girls participating in a 6-month study of topical microbicide acceptability is described, as well as the participants’ conversations with their parents. Methods Girls, 14 through 21 years, were recruited from previous studies (3%), advertisements (14%), clinics (17%), and recommendations by friends (66%) to participate. Girls under 18 years were required to have parental consent, but parents could provide verbal phone consent as long as a signed consent form was returned before participation. Results The 208 participants were 41% African-American, 30% Hispanic, and 29% Caucasian. Girls averaged 18 years of age, and 95 (46%) were under 18. Seventeen percent of parents attended the first visit; all but one was with a daughter of less than 18 years. The mothers of older adolescents were less likely to attend the appointment with them. More Caucasian than African-American girls came with a mother. Parental attendance decreased at follow-up visits. Thirty-seven percent of girls brought a peer to the first visit; there were no age or race/ethnic differences. There was no relationship between attending with a parent or peer and talking to a parent about the study. Some adolescents obtained parental consent to participate in the study while keeping their sexual behaviors private. Conclusions Parental attendance at study visits may not be marker of parental involvement with the study. Creative ways for balancing concerns about confidentiality, promotion of autonomy, and adult involvement should be considered. PMID:19345916

  8. Activity-related parenting practices: development of the Parenting Related to Activity Measure (PRAM) and links with mothers' eating psychopathology and compulsive exercise beliefs.

    PubMed

    Haycraft, Emma; Powell, Faye; Meyer, Caroline

    2015-01-01

    This is a two-study paper that developed a measure to assess parenting practices related to children's physical activity and explored maternal predictors of such parenting practices. Study 1: A self-report measure of parents' activity-related practices (the Parenting Related to Activity Measure) was developed, and a principal component analysis was carried out using data from 233 mothers of 4.5- to 9-year-old children. The results supported a six-factor model and yielded the following subscales: Responsibility/monitoring; Activity regulation; Control of active behaviours; Overweight concern; Rewarding parenting; and Pressure to exercise. Study 2: Mothers (N = 170) completed the Parenting Related to Activity Measure, alongside measures of eating psychopathology and compulsive exercise, to identify predictors of activity-related parenting practices. Mothers' eating psychopathology and exercise beliefs predicted activity parenting practices with their sons and daughters, but different predictors were seen for mothers of daughters versus sons. Mothers' eating and exercise attitudes are important predictors of their activity-related parenting practices, particularly with girls. Identifying early interactions around activity/exercise could be important in preventing the development of problematic beliefs about exercise, which are often a key symptom of eating disorders. Copyright © 2014 John Wiley & Sons, Ltd and Eating Disorders Association. Copyright © 2014 John Wiley & Sons, Ltd and Eating Disorders Association.

  9. Parents' Networking Strategies: Participation of Formal and Informal Parent Groups in School Activities and Decisions

    ERIC Educational Resources Information Center

    Wanat, Carolyn L.

    2010-01-01

    This case study examined parent groups' involvement in school activities and their participation in decision making. Research questions included the following: (1) What is the nature of parent groups in schools? (2) What activities and issues gain parent groups' attention and participation? (3) How do parent groups communicate concerns about…

  10. The Influence of Partner Status and Sexual Behavior on College Women's Consent Communication and Feelings.

    PubMed

    Marcantonio, Tiffany; Jozkowski, Kristen N; Wiersma-Mosley, Jackie

    2018-05-09

    Sexual consent has permeated mainstream discourse as a mechanism used to decrease rates of sexual assault and increase sex-positive communication. Women's external consent behaviors are frequently examined; however, research exploring their internal consent and feelings associated with sexual activity are understudied. The purpose of this study was to understand how partner status and sexual behavior at most recent sexual activity influence women's external/internal consent and feelings during sexual activity. Three-hundred and ninety women completed a survey on consent, partner status, and most recent sexual behavior. Internal and external consent differed by partner status for women who engaged in vaginal-penile sex, but not genital and oral sex. Feelings associated with the sexual act were different within each behavior group and partner status. Women with a serious dating partner reported stronger feelings related to sexual activity, higher internal consent feelings, and increased use of non-verbal external consent cues. Partner status appears to influence factors of interest for vaginal-penile sex, but not genital and oral sex. Findings from this study can inform prevention efforts to increase sex-positive communication around consent.

  11. Examining a conceptual model of parental nurturance, parenting practices and physical activity among 5-6 year olds.

    PubMed

    Sebire, Simon J; Jago, Russell; Wood, Lesley; Thompson, Janice L; Zahra, Jezmond; Lawlor, Deborah A

    2016-01-01

    Parenting is an often-studied correlate of children's physical activity, however there is little research examining the associations between parenting styles, practices and the physical activity of younger children. This study aimed to investigate whether physical activity-based parenting practices mediate the association between parenting styles and 5-6 year-old children's objectively-assessed physical activity. 770 parents self-reported parenting style (nurturance and control) and physical activity-based parenting practices (logistic and modeling support). Their 5-6 year old child wore an accelerometer for five days to measure moderate-to-vigorous physical activity (MVPA). Linear regression was used to examine direct and indirect (mediation) associations. Data were collected in the United Kingdom in 2012/13 and analyzed in 2014. Parent nurturance was positively associated with provision of modeling (adjusted unstandardized coefficient, β = 0.11; 95% CI = 0.02, 0.21) and logistic support (β = 0.14; 0.07, 0.21). Modeling support was associated with greater child MVPA (β = 2.41; 0.23, 4.60) and a small indirect path from parent nurturance to child's MVPA was identified (β = 0.27; 0.04, 0.70). Physical activity-based parenting practices are more strongly associated with 5-6 year old children's MVPA than parenting styles. Further research examining conceptual models of parenting is needed to understand in more depth the possible antecedents to adaptive parenting practices beyond parenting styles. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  12. Parental Support Exceeds Parenting Style for Promoting Active Play in Preschool Children

    ERIC Educational Resources Information Center

    Schary, David P.; Cardinal, Bradley J.; Loprinzi, Paul D.

    2012-01-01

    Emerging evidence suggests that parenting style may directly or indirectly influence school-aged children's activity behaviour. Given that relatively fewer studies have been conducted among preschool-aged children, this study's primary purpose was to examine the direct relationships between parental support and parenting style on preschool…

  13. Adolescents' physical activity is associated with previous and current physical activity practice by their parents.

    PubMed

    Christofaro, Diego Giulliano Destro; Andersen, Lars Bo; Andrade, Selma Maffei de; Barros, Mauro Virgílio Gomes de; Saraiva, Bruna Thamyres Ciccotti; Fernandes, Rômulo Araújo; Ritti-Dias, Raphael Mendes

    The purpose of this study was to determine whether parents' current and previous physical activity practice is associated with adolescents' physical activity. The sample was composed of 1231 adolescents (14-17 years), and 1202 mothers and 871 fathers were interviewed. Weight and height of the adolescents were measured. Self-reported parents' weight and height were obtained. The current and previous physical activity levels (Baecke's questionnaire) of parents (during childhood and adolescence) and adolescents' physical activity levels were obtained using a questionnaire. The magnitude of the associations between parent and adolescent physical activity levels was determined by binary logistic regression (adjusted by sex, age, and socioeconomic level of adolescents and education level of parents). The current physical activity practice by parents was associated with adolescents' physical activity (p<0.001). The physical activities reported by parents in their childhood and adolescence were also associated with higher physical activity levels among adolescents. Adolescents whose parents were both physically active in the past and present were six times (OR=6.67 [CI=1.94-22.79]) more likely to be physically active compared to adolescents with no parents who were physically active in the past. The current and previous physical activities of parents were associated with higher levels of physical activity in adolescents, even after controlling for confounding factors. Copyright © 2017 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

  14. Blood Transfusion in Children: The Refusal of Jehovah's Witness Parents'.

    PubMed

    Conti, Adelaide; Capasso, Emanuele; Casella, Claudia; Fedeli, Piergiorgio; Salzano, Francesco Antonio; Policino, Fabio; Terracciano, Lucia; Delbon, Paola

    2018-01-01

    In Italy, both parents have parental responsibility; as a general principle they have the power to give or withhold consent to medical procedures on their children, including consent for blood transfusion; however these rights are not absolute and exist only to promote the welfare of children. The Authors discuss ethical and legal framework for Jehovah's Witness parents' refusal of blood transfusion in Italy. They searched national judgments concerning Jehovah's Witness parents' refusal of blood transfusion - and related comments - in national legal databases and national legal journals, and literature on medical literature databases. In the case of Jehovah's Witness parents' refusal of blood transfusion for their child, Italian Courts adopt measures that prevents the parents from exercise their parental responsibility not in the child's best interest. In the event that refusal by the parents, outside of emergency situations, exposes the child's health to serious risk, health workers must proceed by notifying the competent authority, according also to the Italian Code of Medical Ethics. When the patient is a minor, the child's best interest always come first.

  15. Parental Attitudes and Young People's Online Sexual Activities

    ERIC Educational Resources Information Center

    Sorbring, Emma; Hallberg, Jonas; Bohlin, Margareta; Skoog, Therése

    2015-01-01

    Parental attitudes towards young people's sexuality in traditional (i.e. non-online media) settings have been associated with young people's sexual activities. In this study, we explored the association between key parent and youth characteristics and parental attitudes towards young people's online sexual activities. We also examined the…

  16. The Effect of Parental Involvement on Children's Physical Activity.

    PubMed

    Rebold, Michael J; Lepp, Andrew; Kobak, Mallory S; McDaniel, John; Barkley, Jacob E

    2016-03-01

    To assess the amount, intensity, enjoyment, and preference of children's physical activity in a controlled gymnasium setting under 3 experimental, social conditions: alone, with a parent watching, and with a parent participating. Children (n = 10 girls, 10 boys), 3-6 years old, along with 1 parent (n = 17 mothers, 3 fathers) per child participated in each social condition on separate days for 30 minutes in which they could choose from a variety of physical and/or sedentary activities. A greater number of accelerometer counts (P ≤ .02) were accumulated during the parent participating (109,523 ± 32,155 counts) condition than the alone (67,938 ± 37,857 counts) and parent watching (85,624 ± 44,985 counts) conditions. Counts during parent watching were also greater (P = .01) than alone. More time (P ≤ .008) was allocated to sedentary activities during the alone (16.2 ± 9.6 minutes) condition than parent watching (9.6 ± 9.3 minutes) and parent participating (3.8 ± 5.1 minutes). Children liked (P ≤ .02) the parent participating (9.9 ± 0.45 cm) condition more than alone (8.0 ± 2.72 cm) and parent watching (8.7 ± 1.52 cm). A greater (P < .001) proportion of children identified the parent participating (80%) as their preferred condition over either the parent watching (10%) or alone (10%) conditions. Parental participation during physical activity (or at minimum direct supervision) may be an important component in the development of physical activity environments intended to maximize physical activity behavior in children. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. The ethics of neonatal research: An ethicist's and a parents' perspective.

    PubMed

    Janvier, Annie; Farlow, Barbara

    2015-12-01

    The ethics of neonatal research are complex because vulnerable new parents are asked to provide consent on behalf of their fragile baby. Whereas clinical neonatal care has evolved to value personalized and shared decision-making, the goal of research ethics is still to standardize the informed consent process and make it as complete and thorough as possible. Ethicists, lawyers and physicians have shaped the field of research ethics and consent for research. The goal of detailed informed consent is to protect participants from harm, but procedures were developed without input from the principal stakeholders: ex-neonatal intensive care unit parents/patients. Empirical investigations examining patient and parental perspectives on research and research ethics are lacking. Rigorous investigations are needed to determine how parents of sick neonates want their families to be protected, knowing that a lack of research is also harmful. Large randomized controlled multicenter trials will always be needed to improve neonatal outcomes. These trials are costly and time-consuming. Currently, the way in which research is funded and regulated and the way in which academic merit is recognized lead to inefficiency and a waste of precious resources. Following a review of the history of research ethics, this article examines and discusses the ethics of research in neonatology. In addition, challenges and opportunities are identified and ideas for future investigations are proposed. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. Informed Consent in Dentistry.

    PubMed

    Reid, Kevin I

    2017-03-01

    A review of literature regarding informed consent in dentistry reveals a paucity of information and minimal scholarship devoted to this subject. But this begs the question about informed consent somehow being different for dentistry than for medicine or other healthcare delivery. My account draws distinctions where appropriate but is rooted in the premise that informed consent is an ethical construct applicable to vulnerable people as patients independent of what type of treatment or body part being considered. This paper highlights the crucial importance of the process of informed consent and refusal in dentistry, underscoring its important place in oral healthcare. This paper will not address the unique circumstances involving consent in those without capacity or focus on informed consent in the research setting; our focus will be on those patients with full decisionmaking capacity in the clinical setting. I will emphasize the importance of disclosure of treatment options and highlight the benefits of shared-decision-making in the informed consent process.

  19. Information Parents Must Know about Online Privacy.

    ERIC Educational Resources Information Center

    Markell, Ginny

    2000-01-01

    Presents four tips to help parents monitor whether website operators are complying with the 1988 Children's Online Privacy Protection Act: look for privacy policies on children's websites; determine if they ask for parental consent to collect personal information; regularly monitor information being sent to children; and determine if web operators…

  20. Best practice guidelines on informed consent for weight loss surgery patients.

    PubMed

    Sabin, James; Fanelli, Robert; Flaherty, Helen; Istfan, Nawfal; Mariner, Wendy; Barnes, Janet Nally; Pratt, Janey S A; Rossi, Laura; Samour, Patricia

    2005-02-01

    To provide evidence-based guidelines on informed consent and the education that underlies it for legally competent, severely obese weight loss surgery (WLS) patients. We conducted a systematic review of the scientific literature published on MEDLINE between 1984 and 2004. Three articles focused on informed consent for WLS; none was based on empirical studies. We summarized each paper and assigned evidence categories according to a grading system derived from established evidence-based models. We also relied on informed consent and educational materials from six WLS programs in Massachusetts. All evidence is Category D. Recommendations were based on a review of the available literature, informed consent materials from WLS programs, and expert opinion. This Task Group found that the informed consent process contributes to long-term outcome in multiple ways but is governed by limited legal requirements. We focused our report on the legal and ethical issues related to informed consent, i.e., disclosure vs. comprehension. Recommendations centered on the importance of assessing patient comprehension of informed consent materials, the content of those materials, and the use of active teaching/learning techniques to promote understanding. Although demonstrated comprehension is not a legal requirement for informed consent in Massachusetts or other states, the members of this Task Group found that the best interests of WLS patients, providers, and facilities are served when clinicians engage patients in active learning and collaborative decision making.

  1. Patient perceptions and recall of consent for regional anaesthesia compared with consent for surgery.

    PubMed

    Zarnegar, Roxaneh; Brown, Matthew R D; Henley, Matthew; Tidman, Victoria; Pathmanathan, Ahilan

    2015-11-01

    In Britain, consent for surgery is documented using a Department of Health form signed by the surgeon and the patient. In contrast, anaesthetic procedures have no formalised consent process. Evidence on the process of consent for regional anaesthesia, and patient perceptions of this, is scarce outside obstetric practice. We aimed to determine patient recall and perceptions of consent for interscalene brachial plexus block and compared this to surgical consent for shoulder arthroplasty. Prospective observational survey. A specialist musculoskeletal centre, UK. Forty-six patients (female:male 30:16, mean age 61 years) undergoing shoulder arthroplasty with interscalene brachial plexus block. Recall and understanding of consent for regional anaesthesia and surgery was examined using a semi-structured questionnaire 1-2 days after arthroplasty. Surgical consent forms and discussions recorded by the anaesthetist were examined in participants' medical notes to compare against the level of recall. Analysis to determine statistical significance was conducted using McNemar's test. Recall of surgical risks was overall significantly better than recall of brachial plexus block risks. Compared to their recollections of surgical risk, patients remembered fewer specific risks for brachial plexus block (p < 0.001). There were more patients unable to recall any risks when questioned about brachial plexus block than about their surgery (p < 0.05). One-third of patients did not regard the consent discussion about regional anaesthesia as important as consent for surgery and over one-quarter had not recognised the preoperative discussion about the brachial plexus block as a consent process similar to that conducted for surgery. Fundamental misunderstandings about the consent process are prevalent. Future work in this area should seek to investigate how documentation of the consent process and patients' understanding of consent for regional anaesthesia can be improved. © The Royal

  2. Parental Influence on Physical Activity of Children with Disabilities

    ERIC Educational Resources Information Center

    Siebert, Erin A.; Hamm, Jessica; Yun, Joonkoo

    2017-01-01

    The purpose of this study was to identify parental influences on physical activity behaviours of children with disabilities. One hundred and forty-eight parents of children with disabilities responded to a survey about factors related to parent and child physical activity, parental support and belief in their child's abilities regarding physical…

  3. Parent Knowledge and Attitudes About School-Based Hepatitis B Immunization Programs.

    ERIC Educational Resources Information Center

    Middleman, Amy B.; Guajardo, Andrea D.; Sunwoo, Edward; Sansaricq, Kim M.

    2002-01-01

    Surveyed parents of students in the Houston Independent School District to determine preferences regarding immunization clinic site and preferred consent procedures for a Hepatitis B immunization program. Results indicated a significant lack of parent knowledge regarding the Hepatitis B virus. Demographic variables influenced parents' knowledge…

  4. Consenting options for posthumous organ donation: presumed consent and incentives are not favored

    PubMed Central

    2012-01-01

    Background Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries. Methods We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable) the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive. Results Mean(SD) age was 32(9) year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p < 0.001), donor-only informed consent (5[3,7], p < 0.001), and presumed consent (7[3,10], p < 0.001). The addition of a financial or medical incentive, respectively, reduced ranking of mandated choice to 7[4,9], p < 0.001, and 5[3,8], p < 0.001; for donor-or-surrogate informed consent to 7[5,9], p < 0.001, and 5[3,7], p = 0.004; and for donor-only informed consent to 8[6,10], p < 0.001, and 5[3,7], p = 0.56. Distribution of ranking score of perception of norm and preference were similar except for no-organ donation (11[7,11] vs. 11[6,11], respectively, p = 0.002). Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p < 0.001), more preferred mandated choice with financial incentive option (6[3,8] vs. 8[4,9], p < 0.001), and

  5. Parental acceptance of pediatric behavior management techniques: a comparative study.

    PubMed

    Elango, I; Baweja, D K; Shivaprakash, P K

    2012-01-01

    To evaluate and compare the attitude toward behavior techniques among parents of healthy and special children in Indian subpopulation. Parents of healthy (Group A) and special children (Group B) watched videotape vignette of 10 behavior management techniques (BMTs) in groups and rated them using Visual Analog Scale (VAS). Group B parents were subgrouped as: Group B 1 (34 parents of medically compromised children), Group B 2 (34 parents of physically compromised children), and Group B 3 (34 parents of children with neuropathological disorders). Both Group A and Group B subjects judged all techniques as "acceptable." Group B parents were less accepting to techniques than Group A parents, except live modeling. Contingent escape and live modeling were the first ranked techniques in Group A and Group B parents, respectively. Voice control (VC) and hand-over-mouth exercise (HOM) were the least accepted techniques in both groups. Parents with low income and less education were more receptive to the techniques studied. A total of 25.49% of parents in each group did not consent to the use of HOM. Factors such as having a disabled child, low income, and less education influenced parental acceptability. HOM should be used with great caution and clinicians should approach the issue of informed consent on an individual basis.

  6. Informed Consent in Pediatric Otolaryngology: What Risks and Benefits Do Parents Recall?

    PubMed

    Pianosi, Kiersten; Gorodzinsky, Ayala Y; Chorney, Jill MacLaren; Corsten, Gerard; Johnson, Liane B; Hong, Paul

    2016-08-01

    To evaluate parental recall of surgical risks and benefits in pediatric otolaryngology and to assess for factors that may influence recall. Prospective cohort study. Academic pediatric otolaryngology clinic. Eighty-four parents of children <6 years of age who underwent consultation for adeno/tonsillectomy and/or tympanostomy tube insertion were prospectively enrolled. Consultation visits were video recorded and the benefits and risks of surgery documented. Two weeks following the consultation, parents were contacted for assessment of recall of information discussed during the consultation. Overall, parents recalled only one-third of the risks of surgery mentioned by the surgeons. Parents were significantly more likely to recall the benefits of surgery as opposed to the risks (P < .001). Nine parents (10.7%) reported that no benefits were discussed during the consultation, and 10 (11.9%) reported no mention of any risks. Inconsistencies were present in which risks and benefits were mentioned by the providers. Parents who decided to proceed with surgery (58.3%) were significantly less likely to recall the surgical risks than those who did not (P < .001). The specific surgeon involved, the number of caregivers present, parental education level, and prior surgical history did not influence recall. Parental recall of benefits and risks associated with common pediatric otolaryngology procedures was poor. This information is important because a low rate of recall may influence parents' perspectives of the procedure and could alter their decision-making processes or expectations. Methods to improve parental recall should be further studied. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

  7. 78 FR 36642 - Proposed Information Collection (Statement of Dependency of Parent(s)) Activity: Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ... (Statement of Dependency of Parent(s)) Activity: Comment Request AGENCY: Veterans Benefits Administration... claimant's parents' dependency. DATES: Written comments and recommendations on the proposed collection of... use of other forms of information technology. Title: Statement of Dependency of Parent(s), VA Form 21...

  8. 75 FR 61251 - Proposed Information Collection (Statement of Dependency of Parent(s)) Activity: Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-04

    ... (Statement of Dependency of Parent(s)) Activity: Comment Request AGENCY: Veterans Benefits Administration... claimant's parents' dependency. DATES: Written comments and recommendations on the proposed collection of... use of other forms of information technology. Title: Statement of Dependency of Parent(s), VA Form 21...

  9. "Consent Is Good, Joyous, Sexy": A Banner Campaign to Market Consent to College Students

    ERIC Educational Resources Information Center

    Thomas, Kristie A.; Sorenson, Susan B.; Joshi, Manisha

    2016-01-01

    Objective: This study assessed the recall of, reaction to, and understanding of a brief campus banner campaign promoting consent in sexual relationships, and determined whether campaign exposure was associated with subsequent engagement in activities related to sexual assault education, awareness, and prevention. Participants: A stratified random…

  10. Girls' Physically Active Play and Parental Behavior.

    ERIC Educational Resources Information Center

    Tauber, Margaret A.

    Sex differences in children's physical activity levels, and associations between girls' activity level, childrearing characteristics and parent-child play behavior were investigated in a quasi-naturalistic situation. As part of a longitudinal project, 144 third grade children were videotaped in a 1-hour play session with one of their parents. A…

  11. Informed consent: what does it mean?

    PubMed Central

    Kirby, M D

    1983-01-01

    The editorial in the September 1982 issue of this journal and many articles before and since have addressed the problem of informed consent. Is it possible? Is it a useful concept? Is there anything new to be said about it? In this article the basic rationale of the rule (patient autonomy) is explained and the extent of the rule explored. Various exceptions have been offered by the law and an attempt is made to catalogue the chief of these. A number of specially vulnerable groups are then identified, the most important, and vexed, being children. How can informed consent be secured in the case of young patients? Finally, a few problems are mentioned in an attempt to get this subject back to reality. The appeal to the principle primum non nocere may be medical paternalism in disguise. Informed consent is the competing principle that reminds us of the primacy of human autonomy. A pointer is given to the future: even the use of sound recordings to explain medical procedures and to activate informed consent so that it may become a reality and not just a lawyer's myth, should be considered. PMID:6876100

  12. Examining a conceptual model of parental nurturance, parenting practices and physical activity among 5–6 year olds

    PubMed Central

    Sebire, Simon J.; Jago, Russell; Wood, Lesley; Thompson, Janice L.; Zahra, Jezmond; Lawlor, Deborah A.

    2016-01-01

    Rationale Parenting is an often-studied correlate of children's physical activity, however there is little research examining the associations between parenting styles, practices and the physical activity of younger children. Objective This study aimed to investigate whether physical activity-based parenting practices mediate the association between parenting styles and 5–6 year-old children's objectively-assessed physical activity. Methods 770 parents self-reported parenting style (nurturance and control) and physical activity-based parenting practices (logistic and modeling support). Their 5–6 year old child wore an accelerometer for five days to measure moderate-to-vigorous physical activity (MVPA). Linear regression was used to examine direct and indirect (mediation) associations. Data were collected in the United Kingdom in 2012/13 and analyzed in 2014. Results Parent nurturance was positively associated with provision of modeling (adjusted unstandardized coefficient, β = 0.11; 95% CI = 0.02, 0.21) and logistic support (β = 0.14; 0.07, 0.21). Modeling support was associated with greater child MVPA (β = 2.41; 0.23, 4.60) and a small indirect path from parent nurturance to child's MVPA was identified (β = 0.27; 0.04, 0.70). Conclusions Physical activity-based parenting practices are more strongly associated with 5–6 year old children's MVPA than parenting styles. Further research examining conceptual models of parenting is needed to understand in more depth the possible antecedents to adaptive parenting practices beyond parenting styles. PMID:26647364

  13. Dibasic Esters; Final Enforceable Consent Agreement and Testing Consent Order

    EPA Pesticide Factsheets

    Under section 4 of the Toxic Substances Control Act (TSCA), EPA has issued a testing consent order (Order) that incorporates an enforceable consent agreement (ECA) with the Aceto Corporation, E.I. du Pont de Nemours and Company, and Solutia Inc.

  14. Improving informed consent: Stakeholder views.

    PubMed

    Anderson, Emily E; Newman, Susan B; Matthews, Alicia K

    2017-01-01

    Innovation will be required to improve the informed consent process in research. We aimed to obtain input from key stakeholders-research participants and those responsible for obtaining informed consent-to inform potential development of a multimedia informed consent "app." This descriptive study used a mixed-methods approach. Five 90-minute focus groups were conducted with volunteer samples of former research participants and researchers/research staff responsible for obtaining informed consent. Participants also completed a brief survey that measured background information and knowledge and attitudes regarding research and the use of technology. Established qualitative methods were used to conduct the focus groups and data analysis. We conducted five focus groups with 41 total participants: three groups with former research participants (total n = 22), and two groups with researchers and research coordinators (total n = 19). Overall, individuals who had previously participated in research had positive views regarding their experiences. However, further discussion elicited that the informed consent process often did not meet its intended objectives. Findings from both groups are presented according to three primary themes: content of consent forms, experience of the informed consent process, and the potential of technology to improve the informed consent process. A fourth theme, need for lay input on informed consent, emerged from the researcher groups. Our findings add to previous research that suggests that the use of interactive technology has the potential to improve the process of informed consent. However, our focus-group findings provide additional insight that technology cannot replace the human connection that is central to the informed consent process. More research that incorporates the views of key stakeholders is needed to ensure that multimedia consent processes do not repeat the mistakes of paper-based consent forms.

  15. Assessment of children's capacity to consent for research: a descriptive qualitative study of researchers' practices.

    PubMed

    Gibson, Barbara E; Stasiulis, Elaine; Gutfreund, Shawna; McDonald, Maria; Dade, Lauren

    2011-08-01

    In Canadian jurisdictions without specific legislation pertaining to research consent, the onus is placed on researchers to determine whether a child is capable of independently consenting to participate in a research study. Little, however, is known about how child health researchers are approaching consent and capacity assessment in practice. The aim of this study was to explore and describe researchers' current practices. The study used a qualitative descriptive design consisting of 14 face-to-face interviews with child health researchers and research assistants in Southern Ontario. Transcribed interviews were analysed for common themes. Procedures for assessing capacity varied considerably from the use of age cutoffs to in-depth engagement with each child. Three key issues emerged from the accounts: (1) requirements that consent be provided by a single person thwarted researchers' abilities to support family decision-making; (2) little practical distinction was made between assessing if a child was capable, versus determining if study information had been adequately explained by the researcher; and (3) participants' perceived that review boards' requirements may conflict with what they considered ethical consent practices. The results suggest that researchers' consent and capacity knowledge and skills vary considerably. Perceived discrepancies between ethical practice and ethics boards' requirements suggest the need for dialogue, education and possibly ethics board reforms. Furthermore we propose, where appropriate, a 'family decision-making' model that allows parents and their children to consent together, thereby shifting the focus from separate assent and consent procedures to approaches that appropriately engage the child and family.

  16. Parental mediation, online activities, and cyberbullying.

    PubMed

    Mesch, Gustavo S

    2009-08-01

    Cyberbullying, the use of information and communication technologies to intentionally harm others, has become an important area of research. Studies have begun to investigate the extent of cyberbullying and its victims' personality characteristics. Less is known about the effect of specific online activities and the role of parental mediation on the likelihood of being bullied. This study attempts to fill this gap in the literature conducting a secondary analysis of a representative sample of the U.S. youth population, the Teens and Parents survey conducted by the Pew and American Life Project (n = 935). The results indicate that the risk of youth being bullied is higher for adolescents who have an active profile on social networking sites and participate in chat rooms but not in playing games online. Gender differences emerge in risk factors. A few parental mediation techniques are protective, but most are not. The results indicate the need for more parental participation to reduce risks to youth arising from Internet use for interpersonal communication.

  17. Establishing and adhering to sexual consent: the association between reading magazines and college students' sexual consent negotiation.

    PubMed

    Hust, Stacey J T; Marett, Emily Garrigues; Ren, Chunbo; Adams, Paula M; Willoughby, Jessica F; Lei, Ming; Ran, Weina; Norman, Cassie

    2014-01-01

    Content analyses have cataloged the sexual scripts present in magazines largely because of their perceived value to readers and their potential role as sex educators. Although it is generally agreed that magazines have the potential to influence sexual attitudes and behavioral intentions, the effects of this medium are not as frequently researched as are other forms of media. The current study tested whether exposure to magazines was associated with intentions related to sexual consent negotiation. A survey of 313 college students indicated that exposure to men's magazines was significantly associated with lower intentions to seek sexual consent and lower intentions to adhere to decisions about sexual consent. In contrast, exposure to women's magazines was significantly associated with greater intentions to refuse unwanted sexual activity. Overall, the findings of this study further reinforce the critical need for responsible and realistic portrayals of sex in entertainment media, specifically magazines.

  18. Parental Activity as a Determinant of Activity Level and Patterns of Activity in Obese Children.

    ERIC Educational Resources Information Center

    Kalakanis, Lisa E.; Goldfield, Gary S.; Paluch, Rocco A.; Epstein, Leonard H.

    2001-01-01

    Investigated the level and pattern of moderate-to-vigorous physical activity (MVPA) in obese children, examining predictors of their activity. Children and their parents wore accelerometers for several days and provided demographic data. Parental activity levels significantly and independently predicted and improved the prediction of children's…

  19. An Observational Study of Children's Involvement in Informed Consent for Exome Sequencing Research.

    PubMed

    Miller, Victoria A; Werner-Lin, Allison; Walser, Sarah A; Biswas, Sawona; Bernhardt, Barbara A

    2017-02-01

    The goal of this study was to examine children's involvement in consent sessions for exome sequencing research and associations of involvement with provider and parent communication. Participants included 44 children (8-17 years) from five cohorts who were offered participation in an exome sequencing study. The consent sessions were audiotaped, transcribed, and coded. Providers attempted to facilitate the child's involvement in the majority (73%) of sessions, and most (75%) children also verbally participated. Provider facilitation was strongly associated with likelihood of child participation. These findings underscore that strategies such as asking for children's opinions and soliciting their questions show respect for children and may increase the likelihood that they are engaged and involved in decisions about research participation.

  20. Parental Perceptions of Physical Activity Benefits for Youth With Developmental Disabilities.

    PubMed

    Pitchford, E Andrew; Siebert, Erin; Hamm, Jessica; Yun, Joonkoo

    2016-01-01

    Physical activity promotion is of need for youth with developmental disabilities. Parental perceptions of physical activity benefits may influence youth behaviors. This study investigated the relationship between parental beliefs on the importance of physical activity and physical activity levels among youth with disabilities. Parents and caregivers of 113 youth with disabilities reported on the perceived benefits of physical activity, the child's physical activity level, and demographic information. Linear regression analyses to examine the relative association between parental perceived benefits and child physical activity (R² = 0.19) indicated that physical activity level was predicted by parental beliefs and child gender. Health promotion for youth with disabilities should consider educating parents and caregivers of physical activity benefits, in addition to creating more opportunities.

  1. Moon Watch: A Parental-Involvement Homework Activity.

    ERIC Educational Resources Information Center

    Rillero, Peter; Gonzalez-Jensen, Margarita; Moy, Tracy

    2000-01-01

    Presents the goals, philosophy, and methods of the SPLASH (Student-Parent Laboratories Achieving Science at Home) program. Describes an at-home, parental-involvement activity called Moon Watch in which students and their parents observe how the phases of the moon and the moon's position in the sky change over a two-week period. (WRM)

  2. Improving informed consent: Stakeholder views

    PubMed Central

    Anderson, Emily E.; Newman, Susan B.; Matthews, Alicia K.

    2017-01-01

    Purpose Innovation will be required to improve the informed consent process in research. We aimed to obtain input from key stakeholders—research participants and those responsible for obtaining informed consent—to inform potential development of a multimedia informed consent “app.” Methods This descriptive study used a mixed-methods approach. Five 90-minute focus groups were conducted with volunteer samples of former research participants and researchers/research staff responsible for obtaining informed consent. Participants also completed a brief survey that measured background information and knowledge and attitudes regarding research and the use of technology. Established qualitative methods were used to conduct the focus groups and data analysis. Results We conducted five focus groups with 41 total participants: three groups with former research participants (total n = 22), and two groups with researchers and research coordinators (total n = 19). Overall, individuals who had previously participated in research had positive views regarding their experiences. However, further discussion elicited that the informed consent process often did not meet its intended objectives. Findings from both groups are presented according to three primary themes: content of consent forms, experience of the informed consent process, and the potential of technology to improve the informed consent process. A fourth theme, need for lay input on informed consent, emerged from the researcher groups. Conclusions Our findings add to previous research that suggests that the use of interactive technology has the potential to improve the process of informed consent. However, our focus-group findings provide additional insight that technology cannot replace the human connection that is central to the informed consent process. More research that incorporates the views of key stakeholders is needed to ensure that multimedia consent processes do not repeat the mistakes of paper

  3. Childhood immunization: when physicians and parents disagree.

    PubMed

    Gilmour, Joan; Harrison, Christine; Asadi, Leyla; Cohen, Michael H; Vohra, Sunita

    2011-11-01

    Persistent fears about the safety and efficacy of vaccines, and whether immunization programs are still needed, have led a significant minority of parents to refuse vaccination. Are parents within their rights when refusing to consent to vaccination? How ought physicians respond? Focusing on routine childhood immunization, we consider the ethical, legal, and clinical issues raised by 3 aspects of parental vaccine refusal: (1) physician counseling; (2) parental decision-making; and (3) continuing the physician-patient relationship despite disagreement. We also suggest initiatives that could increase confidence in immunization programs.

  4. A qualitative study of experience of parents of adolescents who received ECT.

    PubMed

    Grover, Sandeep; Varadharajan, Natarajan; Avasthi, Ajit

    2017-12-01

    To evaluate the experience of parents of adolescents who received ECT for severe mental illness. Using qualitative methods, 6 parents of 5 adolescents were interviewed by using a self-designed semi-structured interview after the completion of ECT course. The clinicians involved in the ECT procedure, i.e., seeking informed consent and administration of ECT were not aware about the study. All the interviews were recorded and the content was analysed and themes were generated. Parents of all the 5 adolescents expressed that their children were considered for ECT only after the patient had not responded to medication and were unmanageable. Prior to ECT the treating doctors did explain to them about the ECT procedure, they were given information booklet and they were not coerced to consent for ECT. Some of the parents reported that they had dilemma prior to giving consent and were scared prior to the first ECT. However, as the clinical condition of their children improved, they felt that ECT was a good treatment. Majority of the parents felt that ECT was delayed for their children. When asked about restriction in use of ECT in children and adolescents, the parents expressed that it is important for law makers to understand the distress of the parents,when their children are acutely ill. They expressed that decision of administration of ECT must be left to the family and the treating clinicians. Parents of adolescents considered for ECT are generally satisfied with the treatment procedure. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. Young people's views about consenting to data linkage: findings from the PEARL qualitative study.

    PubMed

    Audrey, Suzanne; Brown, Lindsey; Campbell, Rona; Boyd, Andy; Macleod, John

    2016-03-21

    Electronic administrative data exist in several domains which, if linked, are potentially useful for research. However, benefits from data linkage should be considered alongside risks such as the threat to privacy. Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study. The Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. Qualitative research was incorporated in the PEARL study to examine participants' views about data linkage and inform approaches to information sharing. This paper focusses on issues of consent. Digitally recorded interviews were conducted with 55 participants aged 17-19 years. Terms and processes relating to consent, anonymization and data linkage were explained to interviewees. Scenarios were used to prompt consideration of linking different sources of data, and whether consent should be requested. Interview recordings were fully transcribed. Thematic analysis was undertaken using the Framework approach. Participant views on data linkage appeared to be most influenced by: considerations around the social sensitivity of the research question, and; the possibility of tangible health benefits in the public interest. Some participants appeared unsure about the effectiveness of anonymization, or did not always view effective anonymization as making consent unnecessary. This was related to notions of ownership of personal information and etiquette around asking permission for secondary use. Despite different consent procedures being explained, participants tended to equate consent with 'opt-in' consent through which participants are 'asked' if their data can be used for a specific study. Participants raising similar concerns came to differing conclusions about whether consent was needed. Views changed when presented with different scenarios, and were sometimes inconsistent. Findings

  6. Parental education and physical activity in pre-school children.

    PubMed

    Vale, S; Ricardo, N; Soares-Miranda, L; Santos, R; Moreira, C; Mota, J

    2014-05-01

    The purpose of this study was to objectively assess pre-school children's total physical activity (TPA) patterns and compliance with guidelines and to examine differences relative to parental education. The sample consisted on 509 healthy pre-school children, aged 3-6 years recruited from kindergartens located in the metropolitan area of Porto, Portugal. The PA was assessed for 7 consecutive days by accelerometry. For TPA, we followed the guidelines of the National Association for Sport and Physical Education (NASPE) (children who spent at least >120  min per day in active play). For TPA, we calculated the proportion of children who spent at least >120  min per day in active play and moderate-to-vigorous physical activity (MVPA), we calculated the proportion of children who spent at least >60  min per day in active play. Parental education was analysed according to the Portuguese education system. Children with parents in the highest education level were less active than children from low and middle education level (P ≤ 0.001) in all patterns of PA (week and weekend). Regarding TPA during the week we found that the majority of children from low and middle parental education meet the NASPE guidelines. On the other hand, more than half the children from high parental education did not meet these recommendations (P ≤ 0.001) and MVPA recommendations (P ≤ 0.05). In both recommendations, children from low parental education were twice more likely to meet the recommendations compared with children belonging to high parental education. Parent education was negatively associated with children's daily physical activity patterns and compliance with guidelines. © 2013 John Wiley & Sons Ltd.

  7. National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis.

    PubMed

    Mendelson, Scott J; Courtney, D Mark; Gordon, Elisa J; Thomas, Leena F; Holl, Jane L; Prabhakaran, Shyam

    2018-03-01

    No standard approach to obtaining informed consent for stroke thrombolysis with tPA (tissue-type plasminogen activator) currently exists. We aimed to assess current nationwide practice patterns of obtaining informed consent for tPA. An online survey was developed and distributed by e-mail to clinicians involved in acute stroke care. Multivariable logistic regression analyses were performed to determine independent factors contributing to always obtaining informed consent for tPA. Among 268 respondents, 36.7% reported always obtaining informed consent and 51.8% reported the informed consent process caused treatment delays. Being an emergency medicine physician (odds ratio, 5.8; 95% confidence interval, 2.9-11.5) and practicing at a nonacademic medical center (odds ratio, 2.1; 95% confidence interval, 1.0-4.3) were independently associated with always requiring informed consent. The most commonly cited cause of delay was waiting for a patient's family to reach consensus about treatment. Most clinicians always or often require informed consent for stroke thrombolysis. Future research should focus on standardizing content and delivery of tPA information to reduce delays. © 2018 American Heart Association, Inc.

  8. Supporting Head Start Parents: Impact of a Text Message Intervention on Parent-Child Activity Engagement

    ERIC Educational Resources Information Center

    Hurwitz, Lisa B.; Lauricella, Alexis R.; Hanson, Ann; Raden, Anthony; Wartella, Ellen

    2015-01-01

    Head Start emphasises parent engagement as a critical strategy in promoting children's long-term learning. Parents can support children's positive development by engaging them in stimulating activities. The following study assessed whether a service that delivered parenting tips via text message could prompt parents of children enrolled in Head…

  9. Informed consent: Part II.

    PubMed

    Murphy, E K

    1988-05-01

    Although the legal responsibility to inform and obtain the patient's consent lies with the surgeon, the agency may have a duty to ensure that the patient's consent has been obtained. Agency liability is limited to those cases in which the agency knew (or should have known) that informed consent was not obtained. It is still unclear whether agencies have an affirmative duty to ensure that consent has been obtained. If this duty does exist, it appears that a policy requiring documentation in the medical record of the patient's consent meets this requirement. It is clear that whatever the extent of the agency's duty, it does not include the duty to give the patient information or assess his or her level of understanding. Court opinions discourage anyone but the physician from doing so. A nurse's legal responsibility is limited to following agency policy. Courts have not recognized any independent nurse duty beyond that which accrues to them as employees of the agency. Perioperative nurses often provide the final checkpoint that consent has been obtained and documented before the procedure begins. This unique position raises additional legal concerns if the agency's policy is not followed or if the premedicated patient arrives without proper consent documentation in the record. Perioperative nursing concerns will be discussed next month in Part III.

  10. 75 FR 77958 - Agency Information Collection (Statement of Dependency of Parent(s)) Activity Under OMB Review

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-14

    ... (Statement of Dependency of Parent(s)) Activity Under OMB Review AGENCY: Veterans Benefits Administration...: Statement of Dependency of Parent(s), VA Form 21-509. OMB Control Number: 2900-0089. Type of Review... VA Form 21-509 to report income and dependency information. Surviving parents of deceased veterans...

  11. Conceptualizing physical activity parenting practices using expert informed concept mapping analysis.

    PubMed

    Mâsse, Louise C; O'Connor, Teresia M; Tu, Andrew W; Hughes, Sheryl O; Beauchamp, Mark R; Baranowski, Tom

    2017-06-14

    Parents are widely recognized as playing a central role in the development of child behaviors such as physical activity. As there is little agreement as to the dimensions of physical activity-related parenting practices that should be measured or how they should be operationalized, this study engaged experts to develop an integrated conceptual framework for assessing parenting practices that influence multiple aspects of 5 to 12 year old children's participation in physical activity. The ultimate goal of this study is to inform the development of an item bank (repository of calibrated items) aimed at measuring physical activity parenting practices. Twenty four experts from 6 countries (Australia, Canada, England, Scotland, the Netherlands, & United States (US)) sorted 77 physical activity parenting practice concepts identified from our previously published synthesis of the literature (74 measures) and survey of Canadian and US parents. Concept Mapping software was used to conduct the multi-dimensional scaling (MDS) analysis and a cluster analysis of the MDS solution of the Expert's sorting which was qualitatively reviewed and commented on by the Experts. The conceptual framework includes 12 constructs which are presented using three main domains of parenting practices (neglect/control, autonomy support, and structure). The neglect/control domain includes two constructs: permissive and pressuring parenting practices. The autonomy supportive domain includes four constructs: encouragement, guided choice, involvement in child physical activities, and praises/rewards for their child's physical activity. Finally, the structure domain includes six constructs: co-participation, expectations, facilitation, modeling, monitoring, and restricting physical activity for safety or academic concerns. The concept mapping analysis provided a useful process to engage experts in re-conceptualizing physical activity parenting practices and identified key constructs to include in

  12. An evaluation of "informed consent" with volunteer prisoner subjects.

    PubMed

    Marini, J L; Sheard, M H; Bridges, C I

    1976-11-01

    "Informed consent" sets a goal for investigators experimenting with human subjects, but little is known about how to achieve or evaluate it in an experiment. In a 3-year, double-blind study with incarcerated men, we attempted to provide a "free and informed consent" and evaluated our efforts with an unannounced questionnaire administered to subjects after they completed the experiment. At that time, approximately two-thirds had sufficient information for an informed consent, but only one-third was well informed about all key aspects of the experiment and one-third was insufficiently informed to give an informed consent. We found that institution- or study-based coercion was minimal in our experiment. From our evaluation of the questionnaire and experience at the study institution, we conclude that an experiment with human subjects should be designed to include an ongoing evaluation of informed consent, and active attempts should be made to avoid or minimize coercive inducements. Experiments with significant risk, which require a long duration and/or large sample size relative to the institution's population, should probably not be performed on prisoner subjects. The experimenter should be independent of the penal institution's power structure. Presenting and explaining a consent form to volunteers on one occasion is probably an in adequate procedure for obtaining and maintaining an informed consent.

  13. Playtime Is Science: Implementing a Parent/Child Activity Program.

    ERIC Educational Resources Information Center

    Sprung, Barbara; And Others

    A program of science activities for children in the early childhood years and their parents is offered. The three different formats of the Playtime Is Science program are adaptable to a variety of settings and schedules. The Parent/Child Activity Program includes one parents-only session in which participants learn that routine chores involve…

  14. Informed consent for genetic research.

    PubMed

    Hamvas, Aaron; Madden, Katherine K; Nogee, Lawrence M; Trusgnich, Michelle A; Wegner, Daniel J; Heins, Hillary B; Cole, F Sessions

    2004-06-01

    Rapid technological advances in genetic research and public concern about genetic discrimination have led to anticipatory safeguards in the informed consent process in the absence of legal examples of proven discrimination. Despite federal and state regulations to restrict access to personal health information, including genetic information, institutional review boards have required the addition of language to informed consent documents that warns about the risks of discrimination with participation in genetic research. To determine the reasons that families refused consent for their infant's participation in a study evaluating a genetic cause of respiratory distress syndrome. Survey conducted between February 1, 2002, and March 31, 2003. Academic, tertiary free-standing children's hospital. A convenience sample of 465 families were approached for consent. The 135 families who refused consent were surveyed. Reasons for refusal. Of the nonconsenting families, 79% spontaneously and specifically identified institutionally required language in our consent form concerning the risk of denial of access to health insurance and employment as the primary reason for refusal; 97% indicated that their fears resulted directly from language in our consent form. Only 20% of families who refused consent cited inadequate time to consider the study. The institutionally required description of risk of genetic discrimination due solely to participation in genetic research was the primary reason for refusal to consent in this cohort. Information about federally and institutionally mandated protections for confidentiality of participants in genetic research should be included in the informed consent document to balance the description of hypothetical risks and more accurately inform subjects.

  15. Parental catastrophizing about child's pain and its relationship with activity restriction: the mediating role of parental distress.

    PubMed

    Caes, L; Vervoort, T; Eccleston, C; Vandenhende, M; Goubert, L

    2011-01-01

    Recent research has demonstrated that parental behaviors have an important impact upon child and adolescent pain outcomes. At present, however, we do not know which parents engage in particular behaviors and why. In 2 studies, the impact of parental catastrophizing about their child's pain upon parental tendency to stop their child's pain-inducing activity was investigated. Further, the mediating role of parental distress was explored. In study 1, a sample of schoolchildren (n=62; M=12.48 years; SD=1.72) took part in a cold-pressor task. In study 2, a clinical sample of adolescents with chronic pain (n=36; M=15.68 years; SD=1.85) performed a 2-min walking task designed as a pain-inducing activity. In both studies, the accompanying parent was asked to watch their child performing the pain task. Findings revealed, for both studies, that parents with a high level of catastrophic thinking about their child's pain experienced more distress and a greater behavioral tendency of wanting to stop their child's pain-inducing activity. Further, parental feelings of distress mediated the relationship between parental catastrophic thinking and parents' tendency to restrict their child's activity. The findings are discussed in light of an affective-motivational conceptualization of pain and pain behavior. Parental catastrophizing was associated with parental tendency to restrict their child's engagement in a painful test, and this relationship was mediated by parental distress. Copyright © 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  16. Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?

    PubMed Central

    Steinsbekk, Kristin Solum; Kåre Myskja, Bjørn; Solberg, Berge

    2013-01-01

    In the endeavour of biobank research there is dispute concerning what type of consent and which form of donor–biobank relationship meet high ethical standards. Up until now, a ‘broad consent' model has been used in many present-day biobank projects. However it has been, by some scholars, deemed as a pragmatic, and not an acceptable ethical solution. Calls for change have been made on the basis of avoidance of paternalism, intentions to fulfil the principle of autonomy, wish for increased user participation, a questioning of the role of experts and ideas advocating reduction of top–down governance. Recently, an approach termed ‘dynamic consent' has been proposed to meet such challenges. Dynamic consent uses modern communication strategies to inform, involve, offer choices and last but not the least obtain consent for every research projects based on biobank resources. At first glance dynamic consent seems appealing, and we have identified six claims of superiority of this model; claims pertaining to autonomy, information, increased engagement, control, social robustness and reciprocity. However, after closer examination, there seems to be several weaknesses with a dynamic consent approach; among others the risk of inviting people into the therapeutic misconception as well as individualizing the ethical review of research projects. When comparing the two models, broad consent still holds and can be deemed a good ethical solution for longitudinal biobank research. Nevertheless, there is potential for improvement in the broad model, and criticism can be met by adapting some of the modern communication strategies proposed in the dynamic consent approach. PMID:23299918

  17. 78 FR 61002 - Agency Information Collection (Statement of Dependency of Parent(s)) Activity Under OMB Review

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-02

    ... (Statement of Dependency of Parent(s)) Activity Under OMB Review AGENCY: Veterans Benefits Administration... INFORMATION: Title: Statement of Dependency of Parent(s), VA Form 21-509. OMB Control Number: 2900-0089. Type...) for support complete VA Form 21-509 to report income and dependency information. Surviving parents of...

  18. Parental Factors in Children’s Active Transport to School

    PubMed Central

    Henne, Heather M.; Tandon, Pooja S.; Frank, Larry D.; Saelens, Brian E.

    2014-01-01

    Objective Identify non-distance factors related to children’s active transport (AT) to school, including parental, home, and environment characteristics. Understanding the factors related to children’s AT to school, beyond distance to school, could inform interventions to increase AT and children’s overall physical activity. Study Design Participants were in the Neighborhood Impact on Kids Study, a longitudinal, observational cohort study of children aged 6 - 11 and their parents in King County, WA and San Diego County, CA between 2007-2009. Parents reported frequency and mode of child transport to school, perceived neighborhood, home and family environments, parental travel behaviors, and sociodemographics. Methods Children living less than a 20 minute walk to school were in this analysis. Children classified as active transporters (walked/bicycled to or from school at least once per week) were compared with those not using AT as often. Results Children using AT were older and had parents who reported themselves using active transport. Having a family rule that restricts the child to stay within sight of the parent or home and more parent working hours was related to lower odds of a child using AT. Conclusions Children’s AT to school is associated with parental AT to work and other locations. Interventions should be considered that enable whole family AT, ameliorate safety concerns and decrease the need for parental supervision, such as walking school buses. PMID:24999161

  19. Engaging parents to increase youth physical activity a systematic review.

    PubMed

    O'Connor, Teresia M; Jago, Russell; Baranowski, Tom

    2009-08-01

    Parents are often involved in interventions to engage youth in physical activity, but it is not clear which methods for involving parents are effective. A systematic review was conducted of interventions with physical activity and parental components among healthy youth to identify how best to involve parents in physical activity interventions for children. Identified intervention studies were reviewed in 2008 for study design, description of family components, and physical activity outcomes. The quality of reporting was assessed using the CONSORT checklist for reporting on trials of nonpharmacologic treatments. The literature search identified 1227 articles, 35 of which met review criteria. Five of the 14 RCTs met > or =70% of CONSORT checklist items. Five general procedures for involving parents were identified: (1) face-to-face educational programs or parent training, (2) family participatory exercise programs, (3) telephone communication, (4) organized activities, and (5) educational materials sent home. Lack of uniformity in reporting trials, multiple pilot studies, and varied measurements of physical activity outcomes prohibited systematic conclusions. Interventions with educational or training programs during family visits or via telephone communication with parents appear to offer some promise. There is little evidence for effectiveness of family involvement methods in programs for promoting physical activity in children, because of the heterogeneity of study design, study quality, and outcome measures used. There is a need to build an evidence base of more-predictive models of child physical activity that include parent and child mediating variables and procedures that can effect changes in these variables for future family-based physical activity interventions.

  20. Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy

    PubMed Central

    Borello, Alessandro; Passera, Roberto; Surace, Alessandra; Marola, Silvia; Buccelli, Claudio; Niola, Massimo; Di Lorenzo, Pierpaolo; Amato, Maurizio; Di Domenico, Lorenza; Solej, Mario; Martino, Valter

    2016-01-01

    Abstract Background Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. Methods This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed. Results Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension. Conclusions Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding. PMID:28352847

  1. Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy.

    PubMed

    Borello, Alessandro; Ferrarese, Alessia; Passera, Roberto; Surace, Alessandra; Marola, Silvia; Buccelli, Claudio; Niola, Massimo; Di Lorenzo, Pierpaolo; Amato, Maurizio; Di Domenico, Lorenza; Solej, Mario; Martino, Valter

    2016-01-01

    Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed. Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension. Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding.

  2. CTEPP STANDARD OPERATING PROCEDURE FOR OBTAINING INFORMED CONSENT (SOP-1.13)

    EPA Science Inventory

    The CTEPP informed consent procedures are described in the SOP. After an eligible subject provides verbal consent, staff schedule a visit to meet with the subject in person to explain study activities and answer questions about the study. During the visit, staff demonstrate how...

  3. Preoperative parental information and parents' presence at induction of anaesthesia.

    PubMed

    Astuto, M; Rosano, G; Rizzo, G; Disma, N; Raciti, L; Sciuto, O

    2006-06-01

    Preoperative preparation of paediatric patients and their environment in order to prevent anxiety is an important issue in paediatric anaesthesia. Anxiety in paediatric patients may lead to immediate negative postoperative responses. When a child undergoes surgery, information about the child's anaesthesia must be provided to parents who are responsible for making informed choices about healthcare on their child's behalf. A combination of written, pictorial, and verbal information would improve the process of informed consent. The issue of parental presence during induction of anaesthesia has been a controversial topic for many years. Potential benefits from parental presence at induction include reducing or avoiding the fear and anxiety that might occur in both the child and its parents, reducing the need for preoperative sedatives, and improving the child's compliance even if other studies showed no effects on the anxiety and satisfaction level. The presence of other figures such as clowns in the operating room, together with one of the child's parents, is an effective intervention for managing child and parent anxiety during the preoperative period.

  4. Parental Perceptions of Physical Activity Benefits for Youth with Developmental Disabilities

    ERIC Educational Resources Information Center

    Pitchford, E. Andrew; Siebert, Erin; Hamm, Jessica; Yun, Joonkoo

    2016-01-01

    Physical activity promotion is of need for youth with developmental disabilities. Parental perceptions of physical activity benefits may influence youth behaviors. This study investigated the relationship between parental beliefs on the importance of physical activity and physical activity levels among youth with disabilities. Parents and…

  5. Review of parental activation interventions for parents of children with special health care needs.

    PubMed

    Mirza, M; Krischer, A; Stolley, M; Magaña, S; Martin, M

    2018-05-01

    A large number of U.S. children are identified as having special health care needs (CSHCN). Despite parents' central role in managing their child's needs, many parents report difficulties in navigating service systems, finding information about their child's condition, and accessing health care and community resources. Therefore, there is a need for interventions that "activate" parents of children with special health care needs to increase their knowledge, skills, and confidence in managing, coordinating, and advocating for their child's needs. This study sought to review the existing literature and examine the effects of parent support interventions that focus on parental activation either in part or whole, on child, parent, or family outcomes. Specific aims included (a) summarizing the nature and content of interventions; (b) describing changes in relevant outcomes; (c) identifying limitations and making recommendations for future research. Following electronic databases were searched: MEDLINE, EMBASE, PsycINFO via ProQuest, PubMed, Cumulative Index to Nursing and Allied Health via EBSCO, Education Resources Information Center (ERIC) via ProQuest, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register), and Google Scholar. Twenty-two studies were selected, data were extracted, and quality was assessed using standardized procedures. Five intervention categories were identified: parent-to-parent supports, psycho-educational groups, content-specific groups, community health worker model, and self-management-based interventions. Although most studies showed positive effects of the intervention, evidence was inconsistent for parental outcomes such as self-efficacy, confidence, strain, depression, and perceived social support. Evidence was more consistent in showing improvement in parent coping and in use of community-based services and resources. There is a need to boost active

  6. Effects of financial incentives on the intention to consent to organ donation: a questionnaire survey.

    PubMed

    Mayrhofer-Reinhartshuber, D; Fitzgerald, A; Benetka, G; Fitzgerald, R

    2006-11-01

    Shortage of donor organs is a serious problem for transplantation medicine. One controversial suggestion to increase the number of organ donors is financial incentives for consent. The aim of this study was to test whether different forms and amounts of financial incentives were apt to increase the consent to organ donation. Data were collected via questionnaires in urban and rural regions of Austria and randomly assigned to settings with three different amounts of financial incentives. The questionnaire was designed by using the theory of planned behaviour of Ajzen. Parents 69 mothers and 35 fathers; ages 25 to 65 years were evaluated for intention to consent to organ donation, perceived social norm, and positive/ negative aspects of organ donation without and with various financial incentives. The intention to consent to organ donation dropped highly significantly (Z = -7.556 P = .000) from the basic condition (M = 1.13; confidence interval [CIs] 0.78 to 1.51) to the condition with financial incentives (M = -1.58; CI, 1.96 to -1.15). No influence of the amount of financial incentive was observed. Highly significant differences were measured between both conditions for the social norm (Z = -5.638; P < .000) and the attitude toward organ donation (Z = -1.962; P < .05; Z = -2.104; P < .035). Financial incentives led to decreased consents and elicited strong rejections and negative reactions of the participants. Taking money for consent to organ donation seems to be a strict taboo for most people in Austrian society.

  7. Learning Activities Parents Can Do with Their Children.

    ERIC Educational Resources Information Center

    Arizona State Dept. of Education, Phoenix.

    Learning activities parents can do with their children are described. Descriptions of activities are organized according to three age ranges: kindergarten through 3rd grade, 4th through 6th grade, and 7th through 12th grade. Initial discussion concerns pointers for parents of kindergartners; 41 things schools expect children to do before they…

  8. Parental physical activity, safety perceptions and children’s independent mobility

    PubMed Central

    2013-01-01

    Background Parents are likely to be a basic influence on their children's behavior. There is an absence of information about the associations between parents' physical activity and perception of neighborhood environment with children’s independent mobility. The purpose of this study is to examine the contribution of parental physical activity and perception of neighborhood safety to children’s independent mobility. Methods In this cross-sectional study of 354 pupils and their parents, independent mobility, perceptions of neighborhood safety and physical activity were evaluated by questionnaire. Categorical principal components analyses were used to determine the underlying dimensions of both independent mobility and perceptions of neighborhood safety items. Results The strongest predictor of independent mobility was the parental perception of sidewalk and street safety (ß = 0.132). Parent’s physical activity was also a significant predictor. The final model accounted for 13.0% of the variance. Conclusions Parental perception of neighborhood safety and parents’ self reported physical activity might be associated with children’s independent mobility. Further research in this topic is needed to explore this possible association. PMID:23767778

  9. Parental Support of Children's Physical Activity in Hong Kong

    ERIC Educational Resources Information Center

    Leung, Ka-Man; Chung, Pak-Kwong; Kim, Seungmo

    2017-01-01

    This study (a) presented a structural model for examining how parents' perceptions of their children's competence, exercise benefits, exercise barriers and neighbourhood safety influenced parental support and their children's physical activity (PA) and (b) examined the mediating effect of parental support on children's PA. Parents of 478 children…

  10. Focusing on flu: Parent perspectives on school-located immunization programs for influenza vaccine.

    PubMed

    Middleman, Amy B; Short, Mary B; Doak, Jean S

    2012-10-01

    School-located immunization programs (SLIP) will only be successful if parents consent to their children's participation. It is critical to understand parent perspectives regarding the factors that make them more or less likely to provide that consent. Organizations creating SLIPs will be able to capitalize on the aspects of SLIPs that parents appreciate, and address and correct issues that may give rise to parent concerns. This study involved five focus groups among the parents of school students in a large, urban school district. Findings highlight the broad range of concepts important to parents when considering participation in a SLIP. The safety and trust issues regarding vaccines in general that are so important to parents are also important to parents when considering participation in a SLIP. Effective communication strategies that include assurances regarding tracking of information and the competence and experience of immunizers will be helpful when addressing parents regarding SLIPs. In addition, parents were very cognizant of and positive regarding the public health benefits associated with SLIPs. Further study among larger populations of parents will further refine these ideas and aid in the development of successful influenza vaccine SLIPs that directly address and communicate with parents about the issues most important to them.

  11. Designing a physical activity parenting course: Parental views on recruitment, content and delivery

    PubMed Central

    2012-01-01

    Background Many children do not engage in sufficient levels of physical activity (PA) and spend too much time screen-viewing (SV). High levels of SV (e.g. watching TV, playing video games and surfing the internet) and low levels of PA have been associated with adverse health outcomes. Parenting courses may hold promise as an intervention medium to change children’s PA and SV. The current study was formative work conducted to design a new parenting programme to increase children’s PA and reduce their SV. Specifically, we focussed on interest in a course, desired content and delivery style, barriers and facilitators to participation and opinions on control group provision. Methods In-depth telephone interviews were conducted with thirty two parents (29 female) of 6–8 year olds. Data were analysed thematically. An anonymous online survey was also completed by 750 parents of 6–8 year old children and descriptive statistics calculated. Results Interview participants were interested in a parenting course because they wanted general parenting advice and ideas to help their children be physically active. Parents indicated that they would benefit from knowing how to quantify their child’s PA and SV levels. Parents wanted practical ideas of alternatives to SV. Most parents would be unable to attend unless childcare was provided. Schools were perceived to be a trusted source of information about parenting courses and the optimal recruitment location. In terms of delivery style, the majority of parents stated they would prefer a group-based approach that provided opportunities for peer learning and support with professional input. Survey participants reported the timing of classes and the provision of childcare were essential factors that would affect participation. In terms of designing an intervention, the most preferred control group option was the opportunity to attend the same course at a later date. Conclusions Parents are interested in PA/SV parenting

  12. Designing a physical activity parenting course: parental views on recruitment, content and delivery.

    PubMed

    Jago, Russell; Steeds, Joanna K; Bentley, Georgina F; Sebire, Simon J; Lucas, Patricia J; Fox, Kenneth R; Stewart-Brown, Sarah; Turner, Katrina M

    2012-07-05

    Many children do not engage in sufficient levels of physical activity (PA) and spend too much time screen-viewing (SV). High levels of SV (e.g. watching TV, playing video games and surfing the internet) and low levels of PA have been associated with adverse health outcomes. Parenting courses may hold promise as an intervention medium to change children's PA and SV. The current study was formative work conducted to design a new parenting programme to increase children's PA and reduce their SV. Specifically, we focussed on interest in a course, desired content and delivery style, barriers and facilitators to participation and opinions on control group provision. In-depth telephone interviews were conducted with thirty two parents (29 female) of 6-8 year olds. Data were analysed thematically. An anonymous online survey was also completed by 750 parents of 6-8 year old children and descriptive statistics calculated. Interview participants were interested in a parenting course because they wanted general parenting advice and ideas to help their children be physically active. Parents indicated that they would benefit from knowing how to quantify their child's PA and SV levels. Parents wanted practical ideas of alternatives to SV. Most parents would be unable to attend unless childcare was provided. Schools were perceived to be a trusted source of information about parenting courses and the optimal recruitment location. In terms of delivery style, the majority of parents stated they would prefer a group-based approach that provided opportunities for peer learning and support with professional input. Survey participants reported the timing of classes and the provision of childcare were essential factors that would affect participation. In terms of designing an intervention, the most preferred control group option was the opportunity to attend the same course at a later date. Parents are interested in PA/SV parenting courses but the provision of child care is essential

  13. Assessing physician-parent communication during emergency medical procedures in children: an observational study in a low-literacy Latino patient population.

    PubMed

    Dahl, Aaron; Sinha, Madhumita; Rosenberg, David I; Tran, Melissa; Valdez, André

    2015-05-01

    Effective physician-patient communication is critical to the clinical decision-making process. We studied parental recall of information provided during an informed consent discussion process before performance of emergency medical procedures in a pediatric emergency department of an inner-city hospital with a large bilingual population. Fifty-five parent/child dyads undergoing emergency medical procedures were surveyed prospectively in English/Spanish postprocedure for recall of informed consent information. Exact logistic regression was used to predict the ability to name a risk, benefit, and alternative to the procedure based on a parent's language, education, and acculturation. Among English-speaking parents, there tended to be higher proportions that could name a risk, benefit, or alternative. Our regression models showed overall that the parents with more than a high school education tended to have nearly 5 times higher odds of being able to name a risk. A gap in communication may exist between physicians and patients (or parents of patients) during the consent-taking process, and this gap may be impacted by socio-demographic factors such as language and education level.

  14. Malawian parents' perceptions of physical activity and child development: a qualitative study.

    PubMed

    Pulakka, A; Ashorn, P; Gondwe, A; Phiri, N; Ashorn, U

    2015-11-01

    In scientific studies, physical activity is measured by the amount of bodily movement, but lay perceptions of physical activity might be different. Parental influence is important for the development of children's physical activity behaviour, and parental perceptions of facilitators of physical activity are context specific. We aimed to investigate how parents of young Malawian children conceptualize physical activity in childhood, situate it in child development and understand its facilitators. We used convenience sampling to identify parents of young children from different socio-economic backgrounds and age groups in semi-rural area of Malawi. We conducted in-depth interviews with 16 parents, a focus group discussion with six parents and key informant interviews with two nurses in Malawi. Six of the participants were fathers. We analysed the data with conventional qualitative content analysis by inductive approach. The parents emphasized practical skills, education and proper behaviour as goals for their children. They viewed activity as encompassing both mental and physical qualities and they perceived it as a positive attribute of children. The parents discussed skills acquisition, social competence, health and bodily movement as signs for being active. As facilitators of physical activity the parents mentioned balanced diet, good health and stimulation. The main concerns of the parents in regard to facilitators of physical activity and good child development were the availability of food and the child being healthy. Malawian parents' concept of children's physical activity is more comprehensive than scientific definition and includes aspects of both physical and mental activity. © 2014 John Wiley & Sons Ltd.

  15. Cross-cultural validation of the parent-patient activation measure in low income Spanish- and English-speaking parents.

    PubMed

    DeCamp, Lisa Ross; Leifheit, Kathryn; Shah, Harita; Valenzuela-Araujo, Doris; Sloand, Elizabeth; Polk, Sarah; Cheng, Tina L

    2016-12-01

    (1) To measure healthcare activation among low-income parents by language (English/Spanish); and (2) to assess the psychometrics of the Parent-Patient Activation Measure (P-PAM) in the study population. We surveyed parents/guardians of publicly-insured children who were established patients at a pediatrics clinic for ≥6months. Surveys included the Parent-Patient Activation Measure (P-PAM), a 13-item measure adapted from the well-validated Patient Activation Measure (PAM). Of 316 surveys, 68% were completed in Spanish. Mean activation score in the English-language survey group was 79.1 (SD 16.2); mean score in the Spanish-language group was 70.7 (SD 17.9) (p<0.001). Scale reliability was high (English α=0.90; Spanish α=0.93). The P-PAM had acceptable test-retest reliability, but no previously reported PAM factor structure fit the study data adequately for either language. Healthcare activation among low-income parents was greater for parents surveyed in English compared with those surveyed in Spanish. The P-PAM has acceptable reliability and validity in English and Spanish, but a different factor structure than the PAM. Activation as measured by the P-PAM may not have the same associations with or impact on health/healthcare outcomes in pediatrics compared with adults owing to possible measure differences between the P-PAM and PAM. Published by Elsevier Ireland Ltd.

  16. Parental knowledge of adolescent activities: links with parental attachment style and adolescent substance use.

    PubMed

    Jones, Jason D; Ehrlich, Katherine B; Lejuez, C W; Cassidy, Jude

    2015-04-01

    Parents' knowledge of their adolescents' whereabouts and activities is a robust predictor of adolescent risk behavior, including the use of drugs and alcohol. Surprisingly few studies have attempted to identify parental characteristics that are associated with the degree of parental knowledge. The present study is the first to examine how parental attachment style relates to mother, father, and adolescent reports of parental knowledge. Further, we used structural equation modeling to test the associations among parents' attachment styles, reports of parental knowledge, and adolescents' alcohol and marijuana use. Participants included 203 adolescents (M age = 14.02, SD = .91) living in 2-parent households and their parent(s). As predicted, mothers' and fathers' insecure attachment styles were negatively associated with self-reported and adolescent-reported parental knowledge, and all 3 reports of parental knowledge were negatively related to adolescent substance use. Mothers' and fathers' attachment styles were unrelated to adolescent substance use. However, evidence emerged for indirect effects of parental attachment style on adolescent substance use through reports of parental knowledge. Implications for prevention efforts and the importance of multiple reporters within the family are discussed. (c) 2015 APA, all rights reserved).

  17. Challenges to obtaining parental permission for child participation in a school-based waterpipe tobacco smoking prevention intervention in Qatar.

    PubMed

    Nakkash, Rima T; Al Mulla, Ahmad; Torossian, Lena; Karhily, Roubina; Shuayb, Lama; Mahfoud, Ziyad R; Janahi, Ibrahim; Al Ansari, Al Anoud; Afifi, Rema A

    2014-09-30

    Involving children in research studies requires obtaining parental permission. A school-based intervention to delay/prevent waterpipe use for 7th and 8th graders in Qatar was developed, and parental permission requested. Fifty three percent (2308/4314) of the parents returned permission forms; of those 19.5% of the total (840/4314) granted permission. This paper describes the challenges to obtaining parental permission. No research to date has described such challenges in the Arab world. A random sample of 40 schools in Doha, Qatar was selected for inclusion in the original intervention. Permission forms were distributed to parents for approval of their child's participation. The permission forms requested that parents indicate their reasons for non-permission if they declined. These were categorized into themes. In order to understand reasons for non-permission, interviews with parents were conducted. Phone numbers of parents were requested from the school administration; 12 of the 40 schools (30%) agreed to provide the contact information. A random sample of 28 parents from 12 schools was interviewed to reach data saturation. Thematic analysis was used to analyze their responses. Reasons for non-permission documented in both the forms and interviews included: poor timing; lack of interest; the child not wanting to participate; and the child living in a smoke-free environment. Interviews provided information on important topics to include in the consent forms, parents' decision-making processes regarding their child's participation, and considerations for communicating with parents. Many parents also indicated that this was the first time they had been asked to give an informed consent for their child's participation in a study. Results indicate that more attention needs to be given to the informed parental consent process. Researchers should consider enhancing both the methods of communicating information as well the specific information provided. Before

  18. 42 CFR 441.257 - Informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... individual has given informed consent only if— (1) The person who obtained consent for the sterilization..., provided a copy of the consent form and provided orally all of the following information or advice to the individual to be sterilized: (i) Advice that the individual is free to withhold or withdraw consent to the...

  19. 42 CFR 441.257 - Informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... individual has given informed consent only if— (1) The person who obtained consent for the sterilization..., provided a copy of the consent form and provided orally all of the following information or advice to the individual to be sterilized: (i) Advice that the individual is free to withhold or withdraw consent to the...

  20. Leisure time activities, parental monitoring and drunkenness in adolescents.

    PubMed

    Tomcikova, Zuzana; Veselska, Zuzana; Madarasova Geckova, Andrea; van Dijk, Jitse P; Reijneveld, Sijmen A

    2013-01-01

    The aim of this cross-sectional study was to explore the association between adolescent drunkenness and participation in risky leisure time activities and parental monitoring. A sample of 3,694 Slovak elementary school students (mean age 14.5 years; 49.0% males) was assessed for drunkenness in the previous month, participation in risky leisure activities and parental monitoring. Participation in risky leisure time activities increased the probability of drunkenness among adolescents, while parental monitoring decreased it. The effect did not change after adding the mother's and father's monitoring into the models. Our results imply that adolescents involved in going out with friends, having parties with friends and/or visiting sporting events every day or several times a week are at a higher risk of drunkenness, as are those less monitored by their parents. These less monitored adolescents and their parents should become a target group in prevention. Copyright © 2012 S. Karger AG, Basel.

  1. 12 CFR 347.119 - Specific consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... processing procedure. (d) Specific consent. Direct or indirect investments in or activities of foreign... control such organization as a result of a foreign investment; or (ii) A bank would be establishing a... foreign country. (1) Applicable law or practice in the foreign country where the foreign organization or...

  2. Parent-child interactions and objectively measured child physical activity: a cross-sectional study

    PubMed Central

    2010-01-01

    Background Parents influence their children's behaviors directly through specific parenting practices and indirectly through their parenting style. Some practices such as logistical and emotional support have been shown to be positively associated with child physical activity (PA) levels, while for others (e.g. monitoring) the relationship is not clear. The objectives of this study were to determine the relationship between parent's PA-related practices, general parenting style, and children's PA level. Methods During the spring of 2007 a diverse group of 99 parent-child dyads (29% White, 49% Black, 22% Hispanic; 89% mothers) living in low-income rural areas of the US participated in a cross-sectional study. Using validated questionnaires, parents self-reported their parenting style (authoritative, authoritarian, permissive, and uninvolved) and activity-related parenting practices. Height and weight were measured for each dyad and parents reported demographic information. Child PA was measured objectively through accelerometers and expressed as absolute counts and minutes engaged in intensity-specific activity. Results Seventy-six children had valid accelerometer data. Children engaged in 113.4 ± 37.0 min. of moderate-vigorous physical activity (MVPA) per day. Children of permissive parents accumulated more minutes of MVPA than those of uninvolved parents (127.5 vs. 97.1, p < 0.05), while parents who provided above average levels of support had children who participated in more minutes of MVPA (114.2 vs. 98.3, p = 0.03). While controlling for known covariates, an uninvolved parenting style was the only parenting behavior associated with child physical activity. Parenting style moderated the association between two parenting practices - reinforcement and monitoring - and child physical activity. Specifically, post-hoc analyses revealed that for the permissive parenting style group, higher levels of parental reinforcement or monitoring were associated with higher

  3. Parent-child interactions and objectively measured child physical activity: a cross-sectional study.

    PubMed

    Hennessy, Erin; Hughes, Sheryl O; Goldberg, Jeanne P; Hyatt, Raymond R; Economos, Christina D

    2010-10-07

    Parents influence their children's behaviors directly through specific parenting practices and indirectly through their parenting style. Some practices such as logistical and emotional support have been shown to be positively associated with child physical activity (PA) levels, while for others (e.g. monitoring) the relationship is not clear. The objectives of this study were to determine the relationship between parent's PA-related practices, general parenting style, and children's PA level. During the spring of 2007 a diverse group of 99 parent-child dyads (29% White, 49% Black, 22% Hispanic; 89% mothers) living in low-income rural areas of the US participated in a cross-sectional study. Using validated questionnaires, parents self-reported their parenting style (authoritative, authoritarian, permissive, and uninvolved) and activity-related parenting practices. Height and weight were measured for each dyad and parents reported demographic information. Child PA was measured objectively through accelerometers and expressed as absolute counts and minutes engaged in intensity-specific activity. Seventy-six children had valid accelerometer data. Children engaged in 113.4 ± 37.0 min. of moderate-vigorous physical activity (MVPA) per day. Children of permissive parents accumulated more minutes of MVPA than those of uninvolved parents (127.5 vs. 97.1, p < 0.05), while parents who provided above average levels of support had children who participated in more minutes of MVPA (114.2 vs. 98.3, p = 0.03). While controlling for known covariates, an uninvolved parenting style was the only parenting behavior associated with child physical activity. Parenting style moderated the association between two parenting practices - reinforcement and monitoring - and child physical activity. Specifically, post-hoc analyses revealed that for the permissive parenting style group, higher levels of parental reinforcement or monitoring were associated with higher levels of child physical

  4. Should consent be required for organ procurement?

    PubMed

    Zambrano, Alexander

    2018-06-08

    Must we obtain a patient's consent before posthumously removing her organs? According to the consent requirement, in order to permissibly remove organs from a deceased person, it is necessary that her prior consent be obtained. If the consent requirement is true, then this seems to rule out policies that do not seek and obtain a patient's prior consent to organ donation, while at the same time vindicating policies that do seek and obtain patient consent. In this paper, however, I argue that once we recognize the difference between consent, on the one hand, and wishing or desiring, on the other, we will see that obtaining consent before organ removal is neither necessary nor sufficient to respect patient autonomy in organ procurement. © 2018 John Wiley & Sons Ltd.

  5. Parental Knowledge of Adolescent Activities: Links with Parental Attachment Style and Adolescent Substance Use

    PubMed Central

    Jones, Jason D.; Ehrlich, Katherine B.; Lejuez, C. W.; Cassidy, Jude

    2015-01-01

    Parents’ knowledge of their adolescents’ whereabouts and activities is a robust predictor of adolescent risk behavior, including the use of drugs and alcohol. Surprisingly few studies have attempted to identify parental characteristics that are associated with the degree of parental knowledge. The present study is the first to examine how parental attachment style relates to mother, father, and adolescent reports of parental knowledge. Further, we used structural equation modeling to test the associations among parents’ attachment styles, reports of parental knowledge, and adolescents’ alcohol and marijuana use. Participants included 203 adolescents (mean age = 14.02, SD = .91) living in two-parent households and their parent(s). As predicted, mothers’ and fathers’ insecure attachment styles were negatively associated with self-reported and adolescent-reported parental knowledge, and all three reports of parental knowledge were negatively related to adolescent substance use. Mothers’ and fathers’ attachment styles were unrelated to adolescent substance use. However, evidence emerged for indirect effects of parental attachment style on adolescent substance use through reports of parental knowledge. Implications for prevention efforts and the importance of multiple reporters within the family are discussed. PMID:25730406

  6. Informed consent and nudging.

    PubMed

    Simkulet, William

    2018-06-19

    In order to avoid patient abuse, under normal situations before performing a medical intervention on a patient, a physician must obtain informed consent from that patient, where to give genuine informed consent a patient must be competent, understand her condition, her options and their expected risks and benefits, and must expressly consent to one of those options. However, many patients refrain from the option that their physician believes to be best, and many physicians worry that their patients make irrational healthcare decisions, hindering their ability to provide efficient healthcare for their patients. Some philosophers have proposed a solution to this problem: they advocate that physicians nudge their patients to steer them towards their physician's preferred option. A nudge is any influence designed to predictably alter a person's behavior without limiting their options or giving them reasons to act. Proponents of nudging contend that nudges are consistent with obtaining informed consent. Here I argue that nudging is incompatible with genuine informed consent, as it violates a physician's obligation to tell their patients the truth, the whole truth, and nothing but the truth during adequate disclosure. © 2018 John Wiley & Sons Ltd.

  7. Fun and Learning for Parents and Children: An Activities Handbook.

    ERIC Educational Resources Information Center

    Trans-Management Systems, Inc.

    Based on the assumption that the more parents enjoy playing with their children, the more children will learn from their parents, this booklet is a collection of fun activities for parents to do with their preschool children. The booklet is organized according to location for the activity, whether in a particular room in the house or outdoors.…

  8. 32 CFR 634.8 - Implied consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Driving Privileges § 634.8 Implied consent. (a) Implied consent... their consent to evidential tests for alcohol or other drug content of their blood, breath, or urine...

  9. Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study.

    PubMed

    Abay, Serebe; Addissie, Adamu; Davey, Gail; Farsides, Bobbie; Addissie, Thomas

    2016-01-01

    Informed consent is a key component of bio-medical research involving human participants. However, obtaining informed consent is challenging in low literacy and resource limited settings. Rapid Ethical Assessment (REA) can be used to contextualize and simplify consent information within a given study community. The current study aimed to explore the effects of social, cultural, and religious factors during informed consent process on a proposed HPV-serotype prevalence study. A qualitative community-based REA was conducted in Adigudom and Mynebri Kebeles, Northern Ethiopia, from July to August 2013. Data were collected by a multi-disciplinary team using open ended questions concerning informed consent components in relation to the parent study. The team conducted one-to-one In-Depth Interviews (IDI) and Focus Group Discussions (FGDs) with key informants and community members to collect data based on the themes of the study. Tape recorded data were transcribed in Tigrigna and then translated into English. Data were categorized and thematically analyzed using open coding and content analysis based on pre-defined themes. The REA study revealed a number of socio-cultural issues relevant to the proposed study. Low community awareness about health research, participant rights and cervical cancer were documented. Giving a vaginal sample for testing was considered to be highly embarrassing, whereas giving a blood sample made participants worry that they might be given a result without the possibility of treatment. Verbal consent was preferred to written consent for the proposed study. This rapid ethical assessment disclosed important socio-cultural issues which might act as barriers to informed decision making. The findings were important for contextual modification of the Information Sheet, and to guide the best consent process for the proposed study. Both are likely to have enabled participants to understand the informed consent better and consequently to comply with the

  10. Environmental and cultural correlates of physical activity parenting practices among Latino parents with preschool-aged children

    USDA-ARS?s Scientific Manuscript database

    Parents can influence their children's physical activity (PA) through parenting practices (PP). Correlates of PA-PP have not been investigated. This study therefore aimed to examine the independent contributions of (1) socio-demographic, (2) cultural, (3) parent perceived-environmental, and (4) obje...

  11. Nudging, informed consent and bullshit.

    PubMed

    Simkulet, William

    2017-11-18

    Some philosophers have argued that during the process of obtaining informed consent, physicians should try to nudge their patients towards consenting to the option the physician believes best, where a nudge is any influence that is expected to predictably alter a person's behaviour without (substantively) restricting her options. Some proponents of nudging even argue that it is a necessary and unavoidable part of securing informed consent. Here I argue that nudging is incompatible with obtaining informed consent. I assume informed consent requires that a physician tells her patient the truth about her options and argue that nudging is incompatible with truth-telling. Instead, nudging satisfies Harry Frankfurt's account of bullshit. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  12. An Examination of Parents' Preferred School Counselor Professional Activities

    ERIC Educational Resources Information Center

    Wilder, Christopher R.

    2010-01-01

    The purpose of this study was to examine parent preferences for school counselor professional activities. The primary focus of research was to determine if any relationship exists between (1) parents' demographic factors--gender, age, socioeconomic status, ethnicity--and their preferences for school counselors' professional activities; (2)…

  13. A qualitative study of participants' views on re-consent in a longitudinal biobank.

    PubMed

    Dixon-Woods, Mary; Kocman, David; Brewster, Liz; Willars, Janet; Laurie, Graeme; Tarrant, Carolyn

    2017-03-23

    Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or "biobanks" over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank. We conducted a qualitative study involving interviews with 24 people who were participating in a longitudinal biobank. Their views were elicited using a semi-structured interview schedule and scenarios based on a hypothetical biobank. Data analysis was based on the constant comparative method. What participants identified as requiring new consent was not a straightforward matter predictable by algorithms about the scope of the consent, but instead was contingent. They assessed whether proposed new research implied a fundamental alteration in the underlying character of the biobank and whether specific projects were within the scope of the original consent. What mattered most to them was that the cooperative bargain into which they had entered was maintained in good faith. They saw re-consent as one important safeguard in this bargain. In determining what required re-consent, they deployed two logics. First, they used a logic of boundaries, where they sought to detect any possible rupture with their existing framework of cooperation. Second, they used a logic of risk, where they assessed proposed research for any potential threats for them personally or the research endeavour. When they judged that a need for re-consent had been activated, participants saw the process as way of re-actualising and renewing the cooperative bargain. Participants' perceptions of research as a process of mutual co-operation between volunteer and researcher were fundamental to their views on consent. Consenting arrangements for biobanks should respect the cooperative values that are important to participants, recognise the two

  14. Testing an online, dynamic consent portal for large population biobank research.

    PubMed

    Thiel, Daniel B; Platt, Jodyn; Platt, Tevah; King, Susan B; Fisher, Nicole; Shelton, Robert; Kardia, Sharon L R

    2015-01-01

    Michigan's BioTrust for Health, a public health research biobank comprised of residual dried bloodspot (DBS) cards from newborn screening contains over 4 million samples collected without written consent. Participant-centric initiatives are IT tools that hold great promise to address the consent challenges in biobank research. Working with Private Access Inc., a pioneer in patient-centric web solutions, we created and pilot tested a dynamic informed consent simulation, paired with an educational website, focusing on consent for research utilizing DBSs in Michigan's BioTrust for Health. Out of 187 pilot testers recruited in 2 groups, 137 completed the consent simulation and exit survey. Over 50% indicated their willingness to set up an account if the simulation went live and to recommend it to others. Participants raised concerns about the process of identity verification and appeared to have little experience with sharing health information online. Applying online, dynamic approaches to address the consent challenges raised by biobanks with legacy sample collections should be explored, given the positive reaction to our pilot test and the strong preference for active consent. Balancing security and privacy with accessibility and ease of use will continue to be a challenge. © 2014 S. Karger AG, Basel.

  15. Effective Group Work for Elementary School-Age Children Whose Parents Are Divorcing.

    ERIC Educational Resources Information Center

    DeLucia-Waack, Janice; Gerrity, Deborah

    2001-01-01

    Parental divorce is the issue of most concern for elementary school children. This article describes interventions for children-of-divorce groups for elementary school children. Suggests guidelines related to goal setting; securing agency and parental consent; leadership planning; recruitment, screening, and selection of members; group member…

  16. 25 CFR 43.16 - Copy to be provided to parents or eligible students.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Copy to be provided to parents or eligible students. 43... AND CONTROL OF STUDENT RECORDS IN BUREAU SCHOOLS § 43.16 Copy to be provided to parents or eligible students. Where the consent of a parent or eligible student is required under this part for the release of...

  17. Informed consent in surgical trials.

    PubMed

    Etchells, E

    1999-12-01

    All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of information, and voluntariness. Capacity is the ability to understand information relevant to making a decision and to appreciate the reasonably foreseeable consequences of a decision or lack of decision. To protect vulnerable persons, an incapable person should not be enrolled in most clinical trials. The only exception is if the study can only be conducted on incapable persons. If the willing research participant is incapable, consent must be obtained from others through a process called substitute (or proxy) consent. Disclosure refers to the provision of relevant information to the patient and its comprehension by the patient. Most surgical trials carry more than minimal risks, so the requirement for careful disclosure of these risks to potential participants is generally stringent. Voluntariness refers to the freedom of a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver can be justified only if the delay required to obtain consent would prevent the research from occurring and only after prior consultation with from the "community" of potential research participants.

  18. Rites of consent: negotiating research participation in diverse cultures.

    PubMed

    Barrett, Robert J; Parker, Damon B

    2003-04-01

    The significance of informed consent in research involving humans has been a topic of active debate in the last decade. Much of this debate, we submit, is predicated on an ideology of individualism. We draw on our experiences as anthropologists working in Western and non Western (Iban) health care settings to present ethnographic data derived from diverse scenes in which consent is gained. Employing classical anthropological ritual theory, we subject these observational data to comparative analysis. Our article argues that the individualist assumptions underlying current bioethics guidelines do not have universal applicability, even in Western research settings. This is based on the recognition that the social world is constitutive of personhood in diverse forms, just one of which is individualistic. We submit that greater attention must be paid to the social relations the researcher inevitably engages in when conducting research involving other people, be this in the context of conventional medical research or anthropological field work. We propose, firstly, that the consenting process continues throughout the life of any research project, long after the signature has been secured, and secondly, that both group and individual dimensions of consent, and the sequence in which these dimensions are addressed, should be carefully considered in all cases where consent is sought.

  19. Influence of parental alcohol-related attitudes, behavior and parenting styles on alcohol use in late and very late adolescence.

    PubMed

    Stafström, Martin

    2014-01-01

    Parents influence adolescent drinking behavior, but to what extent does this association diminish with age, however? The cross-sectional data was drawn from the Scania drug use survey 2007, consisting of 4,828 secondary education students in the 9th and 11th grade. The age- and gender-adjusted findings indicate that having parents who are consenting to alcohol use (OR 1.4), having been provided with alcohol by one's parents (OR 1.8), having parents with an authoritarian (OR 1.5) or neglectful (OR 2.1) parenting style, and having parents who both have a university degree (OR 1.3) were factors significantly associated with monthly heavy episodic drinking. These findings lead to the conclusion that parenting styles as well as parental attitudes and behaviors are important throughout the high school years. Thus, prevention targeting parents should emphasize both these domains. © 2014 S. Karger AG, Basel.

  20. Self-efficacy and physical activity in adolescent and parent dyads.

    PubMed

    Rutkowski, Elaine M; Connelly, Cynthia D

    2012-01-01

    The study examined the relationships between self-efficacy and physical activity in adolescent and parent dyads. A cross-sectional, correlational design was used to explore the relationships among levels of parent physical activity, parent-adolescent self-efficacy, and adolescent physical activity. Descriptive and multivariate regression analyses were conducted in a purposive sample of 94 adolescent/parent dyads. Regression results indicated the overall model significantly predicted adolescent physical activity (R(2) = .20, R(2)(adj) = .14, F[5, 70]= 3.28, p= .01). Only one of the five predictor variables significantly contributed to the model. Higher levels of adolescent self-efficacy was positively related to greater levels of adolescent physical activity (β= .29, p= .01). Practitioners are encouraged to examine the level of self-efficacy and physical activity in families in an effort to develop strategies that impact these areas and ultimately to mediate obesity-related challenges in families seeking care. © 2011, Wiley Periodicals, Inc.

  1. 49 CFR 1503.423 - Consent orders.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Assessment of Civil Penalties by TSA § 1503.423 Consent orders. (a) Issuance. At any time before the issuance..., may agree to dispose of the case by the issuance of a consent order by TSA. (b) Contents. A consent...

  2. Open consent, biobanking and data protection law: can open consent be 'informed' under the forthcoming data protection regulation?

    PubMed

    Hallinan, Dara; Friedewald, Michael

    2015-01-01

    This article focuses on whether a certain form of consent used by biobanks--open consent--is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent--in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context--exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of 'data'. The authors argue that these assumptions are difficult to apply to genetic data

  3. Implementation of a national school-based Human Papillomavirus (HPV) vaccine campaign in Fiji: knowledge, vaccine acceptability and information needs of parents.

    PubMed

    La Vincente, S F; Mielnik, D; Jenkins, K; Bingwor, F; Volavola, L; Marshall, H; Druavesi, P; Russell, F M; Lokuge, K; Mulholland, E K

    2015-12-18

    In 2008 Fiji implemented a nationwide Human Papillomavirus (HPV) vaccine campaign targeting all girls aged 9-12 years through the existing school-based immunisation program. Parents of vaccine-eligible girls were asked to provide written consent for vaccination. The purpose of this study was to describe parents' knowledge, experiences and satisfaction with the campaign, the extent to which information needs for vaccine decision-making were met, and what factors were associated with vaccine consent. Following vaccine introduction, a cross-sectional telephone survey was conducted with parents of vaccine-eligible girls from randomly selected schools, stratified by educational district. Factors related to vaccine consent were explored using Generalised Estimating Equations. There were 560 vaccine-eligible girls attending the participating 19 schools at the time of the campaign. Among these, 313 parents could be contacted, with 293 agreeing to participate (93.6%). Almost 80% of participants reported having consented to HPV vaccination (230/293, 78.5%). Reported knowledge of cervical cancer and HPV prior to the campaign was very low. Most respondents reported that they were satisfied with their access to information to make an informed decision about HPV vaccination (196/293, 66.9%). and this was very strongly associated with provision of consent. Despite their young age, the vaccine-eligible girls were often involved in the discussion and decision-making. Most consenting parents were satisfied with the campaign and their decision to vaccinate, with almost 90% indicating they would consent to future HPV vaccination. However, negative media reports about the vaccine campaign created confusion and concern. Local health staff were cited as a trusted source of information to guide decision-making. Just over half of the participants who withheld consent cited vaccine safety fears as the primary reason (23/44, 52.3%). This is the first reported experience of HPV introduction

  4. Consenting to counter-normative sexual acts: differential effects of consent on anger and disgust as a function of transgressor or consenter.

    PubMed

    Russell, Pascale Sophie; Piazza, Jared

    2015-01-01

    Anger and disgust may have distinct roles in sexual morality; here, we tested hypotheses regarding the distinct foci, appraisals, and motivations of anger and disgust within the context of sexual offenses. We conducted four experiments in which we manipulated whether mutual consent (Studies 1-3) or desire (Study 4) was present or absent within a counter-normative sexual act. We found that anger is focused on the injustice of non-consensual sexual acts, and the transgressor of the injustice (Studies 1 and 3). Furthermore, the sexual nature of the act was not critical for the elicitation of anger--as anger also responded to unjust acts of violence (Study 3). By contrast, we hypothesised and found that disgust is focused on whether or not a person voluntarily engaged in, desired or consented to a counter-normative sexual act (Studies 2-4). Appraisals of abnormality and degradation were the primary appraisals of disgust, and the sexual nature of the act was a critical elicitor of disgust (Study 3). A final study ruled out victimisation as the mechanism of the effect of consent on disgust and indicated that the consenter's sexual desire was the mechanism (Study 4). Our results reveal that anger and disgust have differential roles in consent-related sexual offenses due to the distinct appraisals and foci of these emotions.

  5. [Schizophrenia and informed consent to research].

    PubMed

    Fovet, T; Amad, A; Thomas, P; Jardri, R

    2015-10-01

    Informed consent to research remains a complex issue, while sometimes staying difficult to obtain, even in the general population. This problem may be maximized with patients suffering from schizophrenia. This paper summarizes available data in the literature about informed consent for research involving patients suffering from schizophrenia. Medline and Google Scholar searches were conducted using the following MESH terms: schizophrenia, informed consent and research. Studies using dedicated standardized scales (e.g. MacCAT-CR) revealed a decrease in the capacity to consent of patients with schizophrenia when compared with healthy individuals. Keeping in mind that schizophrenia is an heterogeneous disorder, patients with the lowest insight as well as those with the most severe cognitive symptoms appeared more impaired in their capacity to consent. Such a poor capacity to understand and consent to trials was shown linked with alterations in decision-making. For these specific patients, interventions may be set up to increase their capacity to consent. Various strategies were proposed: enhanced consent forms, extended discussion, test/feedback method or multimedia interventions. Among them, interventions relying on communication and the growing field of information technologies (e.g. web-based tools) seem promising. Finally, associations grouping families and patients (like the French Association UNAFAM) may facilitate the involvement of patients in research programs with safer conditions. Patients suffering from schizophrenia appear able to consent to research programs when suitable interventions are proposed. Further studies are now needed to optimize and individualize such interventions. Copyright © 2014 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

  6. Associations between general parenting styles and specific food-related parenting practices and children's food consumption.

    PubMed

    Vereecken, Carine; Legiest, Erwin; De Bourdeaudhuij, Ilse; Maes, Lea

    2009-01-01

    Explore the impact of general parenting style and specific food-related parenting practices on children's dietary habits. Cross-sectional study of sixth graders and their parents. Data were gathered (in 2003) in 69 of 100 randomly selected elementary schools in Belgium. All sixth graders (N = 1957) were invited to participate; 82.4% of their parents gave consent and completed questionnaires, resulting in 1614 parent-child pairs. Children's consumption of breakfast, fruit, vegetables, soft drinks, and sweets was assessed by self-administered food frequency questionnaires. Parents completed questionnaires on sociodemographic characteristics, general parenting styles (authoritarian, authoritative, indulgent, or neglecting) and specific food-related parenting practices (pressure, reward, encouragement through negotiation, catering on children's demands, permissiveness, avoiding negative modeling, and praise). Logistic regression analyses were performed, with general parenting style and specific food-related parenting practices as predictors and dietary habits as dependent variables, controlling for sociodemographic characteristics and children's weight status. General parenting style did not show any significant impact on dietary habits. In contrast, the food-related parenting practice "encouragement through negotiation" showed a significant positive impact, whereas "pressure," "catering on demand," and "permissiveness" were practices with an unhealthy impact. Nutrition education programs that guide parents in firm but not coercive food parenting skills are likely to have a positive impact upon children's dietary habits.

  7. 20 CFR 401.100 - Disclosure of records with the written consent of the subject of the record.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ADMINISTRATION PRIVACY AND DISCLOSURE OF OFFICIAL RECORDS AND INFORMATION Disclosure of Official Records and.... Except as permitted by the Privacy Act and the regulations in this part, or when required by the FOIA, we... record is to be disclosed. (d) A parent or guardian of a minor is not authorized to give written consent...

  8. 20 CFR 401.100 - Disclosure of records with the written consent of the subject of the record.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION PRIVACY AND DISCLOSURE OF OFFICIAL RECORDS AND INFORMATION Disclosure of Official Records and.... Except as permitted by the Privacy Act and the regulations in this part, or when required by the FOIA, we... record is to be disclosed. (d) A parent or guardian of a minor is not authorized to give written consent...

  9. Self-reported parenting style is associated with children's inflammation and immune activation.

    PubMed

    Byrne, Michelle L; Badcock, Paul B; Simmons, Julian G; Whittle, Sarah; Pettitt, Adam; Olsson, Craig A; Mundy, Lisa K; Patton, George C; Allen, Nicholas B

    2017-04-01

    Family environments and parenting have been associated with inflammation and immune activation in children and adolescents; however, it remains unclear which specific aspects of parenting drive this association. In this study, we cross-sectionally examined the association between 5 discrete parenting styles and inflammation and immune activation in late childhood. Data were drawn from 102 families (55 with female children, mean age 9.50 years, SD = 0.34) participating in the Imaging Brain Development in the Childhood to Adolescence Transition Study. Children provided saliva samples from which inflammation (C-reactive protein) and immune competence/activation (secretory immunoglobulin A) were measured. Parents completed the Alabama Parenting Questionnaire, which measures 5 aspects of parenting style-positive parental involvement, positive disciplinary techniques, consistency in disciplinary techniques, corporal punishment, and monitoring and supervision. Results showed that higher scores on the poor parental monitoring scale were associated with higher levels of both inflammation and immune activation in children. This study highlights parental monitoring and supervision as a specific aspect of parenting behavior that may be important for children's physical and mental health. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  10. Activities with Parents on the Computer: An Ecological Framework

    ERIC Educational Resources Information Center

    Paiva, João C.; Morais, Carla; Moreira, Luciano

    2017-01-01

    This paper proposes an ecological framework "Activities with Parents on the Computer" (APC) to bridge home and school contexts by involving parents and students in digital media based assignments. An exploratory case-study was conducted based on ten parent-child dyads that engaged in an APC at home. Attitudes were assessed through a…

  11. [Deferred consent for inclusion of patients unable to give their consent in studies in the field of emergency medicine].

    PubMed

    Kompanje, E J O; Jansen, T C; Le Noble, J L M L; de Geus, H R; Bakker, J

    2008-09-20

    Respect for individual autonomy, expressed in the concept of informed consent, is a basic principle in research with humans. Many patients in intensive care are unable to give consent because of mental incapacity, and this can be further complicated in emergency research, in which the treatment or experiment needs to be initiated without delay. In those situations consent can be deferred. Randomization is done without prior consent, followed by patients' or relatives' consent at a later stage. Butwhat should one do with the data if the patient dies at an early stage after randomization before consent could be obtained? Should the data be used or not? Should the relatives be asked for consent for using the data? The Dutch Central Committee on Research involving Human Subjects (CCMO) states that asking for consent after the patient has died makes no sense, because with the death of the patient the research has ended. Relatives do not have the authority to give consent for the use of medical data after the patient has died. Data can be used anonymously in the final analysis of the trial. We propose a flowchart for this procedure.

  12. Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study.

    PubMed

    Williams, Barbara F; French, John K; White, Harvey D

    2003-03-15

    Anxiety, fear, pain, and treatment with morphine might compromise the ability of patients to comprehend information about, and give informed consent for, participation in clinical trials. We aimed to assess whether patients with acute myocardial infarction could understand written and verbal information and whether they were competent to give autonomous informed consent to participate in a clinical trial. We prospectively studied 399 patients with acute myocardial infarction in 16 hospitals in New Zealand and Australia who were eligible for participation in the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. We assessed readability of patient information sheets, patients' educational status, their views of the consent process, comprehension of verbal and written information, and competence to give consent. The patient information sheet needed a year 13 (age 18) educational level for comprehension, although only 75 of 345 patients (22%) had been educated beyond secondary school. Only 63 of 346 (18%) read the patient information sheet before giving or refusing consent to participate. Patients who gave consent were more likely to report good or partial comprehension of the information provided than were those who refused consent (272 [89%] vs 14 [70%], respectively; p=0.009). In an assessment of competence to make an autonomous decision, 75 of 145 (52%) were ranked at the lowest grade and 26 (18%) were not competent to consent. Although the consent process for HERO-2 met regulatory requirements for clinical trials, it was inappropriate for the needs of most patients. The patients' comprehension of the information provided and their competence to autonomously give consent was less than optimum.

  13. Satisfying the needs of Japanese cancer patients: a comparative study of detailed and standard informed consent documents.

    PubMed

    Sato, Keiko; Watanabe, Toru; Katsumata, Noriyuki; Sato, Tosiya; Ohashi, Yasuo

    2014-02-01

    Simplified informed consent forms have been successful in improving patient satisfaction and decreasing patient anxiety. However, unsolved problems remain about whether these documents improve comprehension and satisfaction of patients with standard literacy skills. s To investigate whether a detailed consent form explaining the key elements of informed consent, in comparison to a standard consent form, would increase the comprehension and satisfaction of adult cancer patients. Patients who were eligible for the National Surgical Adjuvant Study of Breast Cancer (protocol 01(N-SAS/BC-01)) were randomly selected to receive one of the following four versions: detailed document with graphics, detailed document without graphics, standard document with graphics, and standard document without graphics. The forms were written in plain language from the patients' point of view. A total of 85 patients were administered questionnaires via interview to assess levels of comprehension, satisfaction, and anxiety. Patients demonstrated a strong understanding of information regarding treatment and research. Patient comprehension did not differ significantly between the detailed document arms and the standard document arms. Patient satisfaction level increased according to the amount of information presented in the consent form; most patients preferred the detailed document with graphics. Anxiety and accrual rates in the parent study were not affected by informed consent procedures. Findings were limited to adults who had standard literacy skills and may not be generalizable to a population with lower literacy. Informed consent can be a significant experience for a population with standard literacy skills, as long as the document is easily comprehensible. Such information should be provided in a format that corresponds with patient needs, education levels, and preferences.

  14. Clustering of diet- and activity-related parenting practices: cross-sectional findings of the INPACT study

    PubMed Central

    2013-01-01

    Background Various diet- and activity-related parenting practices are positive determinants of child dietary and activity behaviour, including home availability, parental modelling and parental policies. There is evidence that parenting practices cluster within the dietary domain and within the activity domain. This study explores whether diet- and activity-related parenting practices cluster across the dietary and activity domain. Also examined is whether the clusters are related to child and parental background characteristics. Finally, to indicate the relevance of the clusters in influencing child dietary and activity behaviour, we examined whether clusters of parenting practices are related to these behaviours. Methods Data were used from 1480 parent–child dyads participating in the Dutch IVO Nutrition and Physical Activity Child cohorT (INPACT). Parents of children aged 8–11 years completed questionnaires at home assessing their diet- and activity-related parenting practices, child and parental background characteristics, and child dietary and activity behaviours. Principal component analysis (PCA) was used to identify clusters of parenting practices. Backward regression analysis was used to examine the relationship between child and parental background characteristics with cluster scores, and partial correlations to examine associations between cluster scores and child dietary and activity behaviours. Results PCA revealed five clusters of parenting practices: 1) high visibility and accessibility of screens and unhealthy food, 2) diet- and activity-related rules, 3) low availability of unhealthy food, 4) diet- and activity-related positive modelling, and 5) positive modelling on sports and fruit. Low parental education was associated with unhealthy cluster 1, while high(er) education was associated with healthy clusters 2, 3 and 5. Separate clusters were related to both child dietary and activity behaviour in the hypothesized directions: healthy clusters

  15. Communicating with parents about vaccination: a framework for health professionals.

    PubMed

    Leask, Julie; Kinnersley, Paul; Jackson, Cath; Cheater, Francine; Bedford, Helen; Rowles, Greg

    2012-09-21

    A critical factor shaping parental attitudes to vaccination is the parent's interactions with health professionals. An effective interaction can address the concerns of vaccine supportive parents and motivate a hesitant parent towards vaccine acceptance. Poor communication can contribute to rejection of vaccinations or dissatisfaction with care. We sought to provide a framework for health professionals when communicating with parents about vaccination. Literature review to identify a spectrum of parent attitudes or 'positions' on childhood vaccination with estimates of the proportion of each group based on population studies. Development of a framework related to each parental position with determination of key indicators, goals and strategies based on communication science, motivational interviewing and valid consent principles. Five distinct parental groups were identified: the 'unquestioning acceptor' (30-40%), the 'cautious acceptor' (25-35%); the 'hesitant' (20-30%); the 'late or selective vaccinator' (2-27%); and the 'refuser' of all vaccines (<2%). The goals of the encounter with each group will vary, depending on the parents' readiness to vaccinate. In all encounters, health professionals should build rapport, accept questions and concerns, and facilitate valid consent. For the hesitant, late or selective vaccinators, or refusers, strategies should include use of a guiding style and eliciting the parent's own motivations to vaccinate while, avoiding excessive persuasion and adversarial debates. It may be necessary to book another appointment or offer attendance at a specialised adverse events clinic. Good information resources should also be used. Health professionals have a central role in maintaining public trust in vaccination, including addressing parents' concerns. These recommendations are tailored to specific parental positions on vaccination and provide a structured approach to assist professionals. They advocate respectful interactions that aim to

  16. Parental Intentions to Enroll Children in a Voluntary Expanded Newborn Screening Program

    PubMed Central

    Paquin, Ryan S.; Peay, Holly L.; Gehtland, Lisa M.; Lewis, Megan A.; Bailey, Donald B.

    2016-01-01

    Background and Objectives Nearly all babies in the United States are tested at birth for rare, serious, and treatable disorders through mandatory state newborn screening (NBS). Recently, there have been calls for an expanded, voluntary model to facilitate early diagnosis and treatment of a wider range of disorders. We applied the reasoned action framework to examine parental intentions to participate in voluntary expanded screening. Methods We recruited a national cohort of recent and expectant parents living in the U.S. who completed a self-administered online survey (N = 1,001). Using a mixed-level fractional factorial experiment, we studied parental participation intentions and preferences for timing of consent, cost, consent format, and testing options. Results We conducted a hierarchical regression analysis assessing parental intentions to participate in voluntary expanded NBS. Attitudes, perceived normative influence, and perceived behavioral control explained substantial variance in intention, with perceived normative influence emerging as the strongest predictor. We found no evidence that the manipulated program features altered mean levels of intention, but timing of parental permission, cost, and permission format moderated the relative importance of reasoned action constructs on intention. Conclusion Program design features may impact the psychological mechanisms underlying parental decision making for voluntary expanded screening. These results have important implications for parent education, outreach, and informed parental permission procedures. PMID:27526258

  17. College students and sexual consent: unique insights.

    PubMed

    Jozkowski, Kristen N; Peterson, Zoë D

    2013-01-01

    Sexual assault continues to be a salient health concern, especially among college women. Because assault is often defined in terms of consent, prevention efforts hinge on promoting the definition and the obtainment of consent as a mechanism to reduce assault. Despite the focus on consent promotion, research specifically examining consent in general and among college students specifically is limited. College students (n = 185) were recruited to participate in an open-ended survey in which they were asked to report how they indicated consent and interpreted their partners' consent to engage in a range of sexual behaviors. Content analysis was utilized to qualitatively analyze responses. In the current study, data were assessed for emerging themes across all items. In examining participants' responses, four distinct themes emerged: (a) endorsement of the traditional sexual script; (b) women are responsible for performing oral sex; (c) men's consent to sex can be aggressive; and (d) men utilize deception to obtain consent to sex. Findings suggest that men are conceptualized as sexual initiators and women as sexual gatekeepers, and that men's sexual pleasure is primary whereas women's experience of pleasure is secondary. Findings articulate the need for more pointed research aimed at assessing sexual consent among college students.

  18. [Effects of active parenting today based on goal attainment theory on parenting stress, parenting behavior, and parenting satisfaction in mothers of school-age children].

    PubMed

    Park, Kyung Im; Oh, Sangeun

    2012-10-01

    The purpose of this study was to verify effects of the Active Parenting Today (APT) program based on King's Goal Attainment Theory on parenting stress, parenting behavior, and parenting satisfaction in mothers of school-age children. This was a quasi-experimental study with a non-equivalent control group pre-post test design. Participants were 39 mothers of school-age children (19 in the experiment group and 20 in the control group) who were registered at two community children centers in G city. The experimental group received the APT program (2 hours/session/week) and telephone counseling (2 times/week) for 8 weeks. Data were analyzed using χ²-test, t-test, Fisher exact probability test, and ANCOVA with the SPSS/Win15.0 program. Parenting stress was significantly lower in the experimental group than in the control group. Positive parenting behavior and parenting satisfaction were significantly higher in the experimental group than in the control group. However, negative parenting behavior was not significantly different between the two groups. The results of this study indicate that the APT program based on King's Goal Attainment Theory is useful in reducing parenting stress, creating positive parenting behavior change, and promoting parenting satisfaction in mothers of school-age children.

  19. 21 CFR 50.25 - Elements of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Elements of informed consent. 50.25 Section 50.25... OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to...

  20. 21 CFR 50.25 - Elements of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Elements of informed consent. 50.25 Section 50.25... OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to...

  1. 21 CFR 50.25 - Elements of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Elements of informed consent. 50.25 Section 50.25... OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to...

  2. 22 CFR 128.11 - Consent agreements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 22 Foreign Relations 1 2013-04-01 2013-04-01 false Consent agreements. 128.11 Section 128.11... § 128.11 Consent agreements. (a) The Directorate of Defense Trade Controls and the respondent may, by agreement, submit to the Administrative Law Judge a proposal for the issuance of a consent order. The...

  3. 22 CFR 128.11 - Consent agreements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Consent agreements. 128.11 Section 128.11... § 128.11 Consent agreements. (a) The Directorate of Defense Trade Controls and the respondent may, by agreement, submit to the Administrative Law Judge a proposal for the issuance of a consent order. The...

  4. 22 CFR 128.11 - Consent agreements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Consent agreements. 128.11 Section 128.11... § 128.11 Consent agreements. (a) The Directorate of Defense Trade Controls and the respondent may, by agreement, submit to the Administrative Law Judge a proposal for the issuance of a consent order. The...

  5. 7 CFR 1.420 - Consent recommendation.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Consent recommendation. 1.420 Section 1.420... Conservation and Shortage Relief Act of 1990 (16 U.S.C. 620 et seq.) § 1.420 Consent recommendation. Any time before the Judge files the decision, the parties of record may enter a consent recommendation. Such...

  6. 7 CFR 1.420 - Consent recommendation.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 1 2011-01-01 2011-01-01 false Consent recommendation. 1.420 Section 1.420... Conservation and Shortage Relief Act of 1990 (16 U.S.C. 620 et seq.) § 1.420 Consent recommendation. Any time before the Judge files the decision, the parties of record may enter a consent recommendation. Such...

  7. Physical activity parenting: A systematic review of questionnaires and their associations with child activity levels

    USDA-ARS?s Scientific Manuscript database

    Insufficient physical activity (PA) is considered a critical contributor to childhood overweight. Parents are a key in influencing their child's PA through various mechanisms of PA parenting, including support, restriction of PA, and facilitation of enrollment in PA classes or activities. However, s...

  8. Intervention Research with Youths at Elevated Risk for Suicide: Meeting the Ethical and Regulatory Challenges of Informed Consent and Assent

    ERIC Educational Resources Information Center

    King, Cheryl A.; Kramer, Anne C.

    2008-01-01

    Intervention research with youths at elevated risk for suicidal behavior and suicide--a vulnerable and high risk population--presents investigators with numerous ethical challenges. This report specifically addresses those challenges involving the informed consent and assent process with parents/guardians and youths. The challenges are delineated…

  9. Enhancing informed consent for research and treatment.

    PubMed

    Dunn, L B; Jeste, D V

    2001-06-01

    Increased scrutiny of informed consent calls for further research into decision making by patients who may be at risk for impairments. We review interventions designed to improve patient understanding of informed consent. A number of studies, within as well as outside psychiatry, have evaluated the effectiveness of specific interventions, as well as possible "predictors" of understanding of consent, such as subject characteristics, psychiatric symptoms, and cognitive impairment. Deficits in patients' understanding of informed consent may be partially related to poorly conceived, written, or organized informed consent materials; these deficits may be remediable with educational interventions. We find that effective interventions include corrected feedback, multiple learning trials, and more organized or simplified consent forms. Educational levels of patients generally correlate with levels of understanding. Even among individuals with psychiatric illness or cognitive impairment, deficits in understanding can be remedied with certain educational interventions. A variety of interventions can enhance understanding of informed consent.

  10. USign--a security enhanced electronic consent model.

    PubMed

    Li, Yanyan; Xie, Mengjun; Bian, Jiang

    2014-01-01

    Electronic consent becomes increasingly popular in the healthcare sector given the many benefits it provides. However, security concerns, e.g., how to verify the identity of a person who is remotely accessing the electronic consent system in a secure and user-friendly manner, also arise along with the popularity of electronic consent. Unfortunately, existing electronic consent systems do not pay sufficient attention to those issues. They mainly rely on conventional password based authentication to verify the identity of an electronic consent user, which is far from being sufficient given that identity theft threat is real and significant in reality. In this paper, we present a security enhanced electronic consent model called USign. USign enhances the identity protection and authentication for electronic consent systems by leveraging handwritten signatures everyone is familiar with and mobile computing technologies that are becoming ubiquitous. We developed a prototype of USign and conducted preliminary evaluation on accuracy and usability of signature verification. Our experimental results show the feasibility of the proposed model.

  11. Physical Activity Parenting Measurement and Research: Challenges, Explanations, and Solutions

    PubMed Central

    Mâsse, Louise C.; Timperio, Anna; Frenn, Marilyn D.; Saunders, Julie; Mendoza, Jason A.; Gobbi, Erica; Hanson, Phillip; Trost, Stewart G.

    2013-01-01

    Abstract Physical activity (PA) parenting research has proliferated over the past decade, with findings verifying the influential role that parents play in children's emerging PA behaviors. This knowledge, however, has not translated into effective family-based PA interventions. During a preconference workshop to the 2012 International Society for Behavioral Nutrition and Physical Activity annual meeting, a PA parenting workgroup met to: (1) Discuss challenges in PA parenting research that may limit its translation, (2) identify explanations or reasons for such challenges, and (3) recommend strategies for future research. Challenges discussed by the workgroup included a proliferation of disconnected and inconsistently measured constructs, a limited understanding of the dimensions of PA parenting, and a narrow conceptualization of hypothesized moderators of the relationship between PA parenting and child PA. Potential reasons for such challenges emphasized by the group included a disinclination to employ theory when developing measures and examining predictors and outcomes of PA parenting as well as a lack of agreed-upon measurement standards. Suggested solutions focused on the need to link PA parenting research with general parenting research, define and adopt rigorous standards of measurement, and identify new methods to assess PA parenting. As an initial step toward implementing these recommendations, the workgroup developed a conceptual model that: (1) Integrates parenting dimensions from the general parenting literature into the conceptualization of PA parenting, (2) draws on behavioral and developmental theory, and (3) emphasizes areas which have been neglected to date including precursors to PA parenting and effect modifiers. PMID:23944918

  12. Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials.

    PubMed

    Gillies, Katie; Elwyn, Glyn; Cook, Jonathan

    2014-07-30

    Informed consent of trial participants is both an ethical and a legal requirement. When facing a decision about trial participation, potential participants are provided with information about the trial and have the opportunity to have any questions answered before their degree of 'informed-ness' is assessed, usually subjectively, and before they are asked to sign a consent form. Currently, standardised methods for assessing informed consent have tended to be focused on aspects of understanding and associated outcomes, rather than on the process of consent and the steps associated with decision-making. Potential trial participants who were approached regarding participation in one of three randomised controlled trials were asked to complete a short questionnaire to measure their deliberation about trial participation. A total of 136 participants completed the 10-item questionnaire (DelibeRATE) before they made an explicit decision about trial participation (defined as signing the clinical trial consent form). Overall DelibeRATE scores were compared and investigated for differences between trial consenters and refusers. No differences in overall DelibeRATE scores were identified. In addition, there was no significant difference between overall score and the decision to participate, or not, in the parent trial. To our knowledge, this is the first study to prospectively measure the deliberation stage of the informed consent decision-making process of potential trial participants across different conditions and clinical areas. Although there were no differences detected in overall scores or scores of trial consenters and refusers, we did identify some interesting findings. These findings should be taken into consideration by those designing trials and others interested in developing and implementing measures of potential trial participants decision making during the informed consent process for research. International Standard Randomised Controlled Trial Number (ISRCTN

  13. Ethics, informed consent, and assisted reproduction.

    PubMed

    Macklin, R

    1995-09-01

    Informed consent to treatment is an ethical requirement often misunderstood or not fully appreciated by physicians. The purpose of obtaining informed consent is to ensure that patients know what doctors propose to do and freely grant their permission. Although the purpose of informed consent and the standards by which it is to be employed are the same in all areas of medical practice, special problems arise in assisted reproduction. Voluntary, informed consent is an instance of a reproductive right that should be recognized by the international medical community, and not limited to Western and European countries.

  14. Parental perceived built environment measures and active play in Washington DC metropolitan children.

    PubMed

    Roberts, Jennifer D; Knight, Brandon; Ray, Rashawn; Saelens, Brian E

    2016-06-01

    Previous research identified associations between perceived built environment and adult physical activity; however, fewer studies have explored associations in children. The Built Environment and Active Play (BEAP) Study examined relationships between children's active play and parental perceptions of home neighborhood built environments within the Washington, DC metropolitan area (DMV). With this cross-sectional study, a questionnaire was administered in 2014 to parents of children (7-12 years old) residing in the DMV. Data were collected on children's active play, home built environment parental perceptions, and demographics. Active play response data were dichotomized by whether the child did or did not meet the 60-min/day Physical Activity Guidelines for Americans (PAGAs) recommendation. Perceived home neighborhood built environment data were also dichotomized. Chi-square tests determined differences in parental perceived built environment measures between active and non-active child groups. Logistic regression assessed the association of parental perceived built environment variables with active play while adjusting for demographic variables. The BEAP Study population (n = 144) included a uniquely diverse population of children with 23.7% African Americans and 10.4% Asian Americans. A statistically significant greater proportion of active children's parents agreed with the importance of neighborhood esthetics, active play areas, walkability and safety as compared to the parents of non-active children. Fully adjusted logistic regression models demonstrated that some parental perceived built environment measures (e.g. access to play equipment) were predictors of their children meeting the 60-min/day PAGA recommendation. Our findings support the important role of home neighborhood built environment perceptions on childhood active play.

  15. Using informed consent to save trust.

    PubMed

    Eyal, Nir

    2014-07-01

    Increasingly, bioethicists defend informed consent as a safeguard for trust in caretakers and medical institutions.This paper discusses an ‘ideal type’ of that move. What I call the trust-promotion argument for informed consent states:1. Social trust, especially trust in caretakers and medical institutions, is necessary so that, for example,people seek medical advice, comply with it, and participate in medical research.2. Therefore, it is usually wrong to jeopardise that trust.3. Coercion, deception, manipulation and other violations of standard informed consent requirements seriously jeopardise that trust.4. Thus, standard informed consent requirements are justified.This article describes the initial promise of this argument, then identifies challenges to it. As I show, the value of trust fails to account for some common sense intuitions about informed consent. We should revise the argument, common sense morality, or both.

  16. Parental perceptions of barriers to active commuting to school in Spanish children and adolescents.

    PubMed

    Huertas-Delgado, Francisco Javier; Herrador-Colmenero, Manuel; Villa-González, Emilio; Aranda-Balboa, María Jesús; Cáceres, María Victoria; Mandic, Sandra; Chillón, Palma

    2017-06-01

    : Understanding parental barriers is crucial to promote active commuting to school since the parental perceptions influence how young people commute. This study examined parental barriers to active commuting to school among Spanish children and adolescents, and their association with their gender and the usual mode of commuting. Parents of children ( n = 628) and parents of adolescents ( n = 151) from Granada (Spain) completed a paper-based questionnaire about perceived parental barriers to active commuting to school and mode of commuting. Data were analyzed using the Chi-square test. Among Spanish parents, the most common barriers reported by parents of children were traffic volume and dangerous intersections, whereas the most frequent barriers reported by parents of adolescents were distance to school and dangerous intersections. Compared to parents of children, a greater proportion of parents of adolescents reported distance to school and crime and smaller proportion reported traffic volume as barriers to active commuting to school. Among parents of children, crime was a more commonly reported as a barrier by parents of girls. Although some barriers reported by parents of passive commuters were similar for children and adolescents (such as distance to school and absence of a policeman at crosswalks), other barriers were specific to parents of children. The main parental barriers to active commuting in children were traffic volume and dangerous intersections whereas for adolescents were distance and dangerous intersections. Among Spanish parents, parental barriers to active commuting are influenced by children's age, gender and mode of commuting to school. © The Author 2017. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

  17. Balancing the quality of consent.

    PubMed Central

    Hansson, M O

    1998-01-01

    The rule that one must obtain informed consent is well established in medical ethics and an intrinsic part of clinical practice and of research in biomedicine. However, there is a tendency that the rule today is being applied too rigidly and with too little sensitivity to the values that are at stake in connection with different kinds of research protocols. It is here argued that the quality of consent needs to be balanced against variables such as degree of confidentiality and importance of values at stake, in order to be ethically acceptable. Appropriate information and consent procedures should be adjusted accordingly. Three levels are suggested, ranging from extensively informed consent with both written and oral information, through informed refusal with only a limited amount of information given to, at the other end of the scale, just making relevant information available. PMID:9650113

  18. Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico

    PubMed Central

    Verástegui, Emma L

    2006-01-01

    Background A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important. Methods To gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale. Results Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8TH Grade. Conclusion The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the

  19. Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico.

    PubMed

    Verástegui, Emma L

    2006-12-13

    A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important. To gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale. Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8th grade. The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may

  20. Bidirectional associations between activity-related parenting practices, and child physical activity, sedentary screen-based behavior and body mass index: a longitudinal analysis.

    PubMed

    Sleddens, Ester F C; Gubbels, Jessica S; Kremers, Stef P J; van der Plas, Eline; Thijs, Carel

    2017-07-06

    It has been generally assumed that activity-related parenting practices influence children's activity behavior and weight status. However, vice versa parents may also change their parenting behaviors in response to their perceptions of their child's activity behavior and weight status. This study examined the bidirectional relationships between activity-related parenting practices, and physical activity, sedentary screen-based behavior, and body mass index (BMI) between children's age of 5 and 7 years. Three scales of the Activity-related Parenting Questionnaire (i.e. 'restriction of sedentary behavior', 'stimulation of physical activity', and 'monitoring of physical activity') were completed by 1694 parents of the Dutch KOALA Birth Cohort Study at the child's age of around 5 and again around age 7. Physical activity, sedentary screen-based behavior and BMI were measured at both ages as well. Linear regression models were used to estimate the bidirectional associations between each parenting practice and the child's physical activity levels, sedentary screen-based behavior and BMI z-scores. Several parenting practices at age 5 predicted child physical activity, sedentary screen-based behavior, and BMI z-scores at age 7. Restriction of sedentary behavior positively predicted child BMI and sedentary screen-based behavior, whereas this practice negatively predicted child physical activity. In addition, stimulation of physical activity at age 5 was significantly associated with higher levels of child physical activity at age 7. The following child factors at age 5 predicted parenting practices at age 7: Child physical activity positively predicted parental stimulation of physical activity and monitoring activities. Sedentary screen-based behavior was associated with lower parental stimulation to be active. Findings generally revealed that parents and children mutually influence each other's behavior. A reinforcing feedback loop was present between parental stimulation

  1. Environmental and cultural correlates of physical activity parenting practices among Latino parents with preschool-aged children: Ninos Activos

    USDA-ARS?s Scientific Manuscript database

    Latino children are at high risk of becoming obese. Physical activity (PA) can help prevent obesity. Parents can influence children's PA through parenting practices. This study aimed to examine the independent contributions of (1) sociodemographic, (2) cultural, (3) parent perceived environmental, a...

  2. Shared scientific thinking in everyday parent-child activity

    NASA Astrophysics Data System (ADS)

    Crowley, Kevin; Callanan, Maureen A.; Jipson, Jennifer L.; Galco, Jodi; Topping, Karen; Shrager, Jeff

    2001-11-01

    Current accounts of the development of scientific reasoning focus on individual children's ability to coordinate the collection and evaluation of evidence with the creation of theories to explain the evidence. This observational study of parent-child interactions in a children's museum demonstrated that parents shape and support children's scientific thinking in everyday, nonobligatory activity. When children engaged an exhibit with parents, their exploration of evidence was observed to be longer, broader, and more focused on relevant comparisons than children who engaged the exhibit without their parents. Parents were observed to talk to children about how to select and encode appropriate evidence and how to make direct comparisons between the most informative kinds of evidence. Parents also sometimes assumed the role of explainer by casting children's experience in causal terms, connecting the experience to prior knowledge, or introducing abstract principles. We discuss these findings with respect to two dimensions of children's scientific thinking: developments in evidence collection and developments in theory construction.

  3. Informed consent, parental permission, and assent in pediatric practice. Committee on Bioethics, American Academy of Pediatrics.

    PubMed

    1995-02-01

    The statement on informed consent, parental permission, and patient assent has a long and extraordinary history. The first draft of this document, prepared by William G. Bartholome, MD, was presented to the original American Academy of Pediatrics (AAP) Committee on Bioethics in 1985. Bill put his soul into the manuscript and has watched over it carefully ever since. Now, a decade later, those who have worked on its continued development and urged its adoption as Academy policy applaud its publication. No one is more gratified than its primary author and champion. Those who have had the privilege to know Dr Bartholome share his sense of accomplishment, but cannot help but experience a cruel sense of irony. Just as the work Bill considers his most important contribution has become available for public appreciation, Dr Bartholome suffers from a serious illness that threatens his life. Bill always wanted "the experience, perspective, and power of children" to be taken most seriously. Through the years of the statement's revisions and re-presentation within the Academy, Bill "had faith in the power of the text and the ideas it contained, ... that its time would come." The statement embodies Bill Bartholome's dedication to children. Throughout his career, he worked to make medicine and medical research safer and more friendly for children. The AAP and its Committee on Bioethics, on behalf of all our colleagues, extend heartful thanks to Dr William G. Bartholome for helping us more fully appreciate that children are in the process of becoming, in his words, "intelligent, observant, capable, and responsible persons" who deserve our utmost respect.

  4. Understanding affluent adolescent adjustment: The interplay of parental perfectionism, perceived parental pressure, and organized activity involvement.

    PubMed

    Randall, Edin T; Bohnert, Amy M; Travers, Lea V

    2015-06-01

    This cross-sectional study examined relations between affluent adolescent adjustment and culturally salient factors within parent-child relationship and extracurricular domain. Bootstrapping techniques evaluated mediated effects among parental perfectionism, perceived parental pressure, intensity of organized activity (OA) involvement, and adolescent adjustment (i.e., depressive and anxiety symptoms, life satisfaction) within a sample of 10th graders and their parents (n = 88 parent-child pairs) from four high schools in affluent communities. Findings indicated that adolescents with more perfectionistic parents perceived more parental pressure and experienced poorer adjustment. Results also demonstrated that affluent adolescents who perceived more parental pressure were more intensely involved in OAs, but that higher OA intensity was linked to better adjustment. Findings highlight the importance of considering parental perfectionism when understanding adolescent behaviors and psychological outcomes, confirm the negative direct effects of parental pressure on adjustment, and corroborate prior research dispelling that highly intense OA involvement is linked to adolescent maladjustment. Copyright © 2015 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

  5. Spillovers of health education at school on parents' physical activity.

    PubMed

    Berniell, Lucila; de la Mata, Dolores; Valdés, Nieves

    2013-09-01

    This paper exploits state health education (HED) reforms as quasi-natural experiments to estimate the causal impact of HED received by children on their parents' physical activity. We use data from the Panel Study of Income Dynamics for the period 1999-2005 merged with data on state HED reforms from the National Association of State Boards of Education Health Policy Database and the 2000 and 2006 School Health Policies and Programs Study. To identify the spillover effects of HED requirements on parents' behavior, we use several methodologies (triple differences, changes in changes, and difference in differences) in which we allow for different types of treatments. We find a positive effect of HED reforms at the elementary school on the probability of parents doing light physical activity. Introducing major changes in HED increases the probability of fathers engaging in physical activity by between 6.3 and 13.7 percentage points, whereas on average, this probability for mothers does not seem to be affected. We analyze several heterogeneous impacts of the HED reforms to unveil the mechanisms behind these spillovers. We find evidence consistent with hypotheses such as gender specialization of parents in childcare activities or information sharing between children and parents. Copyright © 2013 John Wiley & Sons, Ltd.

  6. Readability of Invasive Procedure Consent Forms.

    PubMed

    Eltorai, Adam E M; Naqvi, Syed S; Ghanian, Soha; Eberson, Craig P; Weiss, Arnold-Peter C; Born, Christopher T; Daniels, Alan H

    2015-12-01

    Informed consent is a pillar of ethical medicine which requires patients to fully comprehend relevant issues including the risks, benefits, and alternatives of an intervention. Given the average reading skill of US adults is at the 8th grade level, the American Medical Association (AMA) and the National Institutes of Health (NIH) recommend patient information materials should not exceed a 6th grade reading level. We hypothesized that text provided in invasive procedure consent forms would exceed recommended readability guidelines for medical information. To test this hypothesis, we gathered procedure consent forms from all surgical inpatient hospitals in the state of Rhode Island. For each consent form, readability analysis was measured with the following measures: Flesch Reading Ease Formula, Flesch-Kincaid Grade Level, Fog Scale, SMOG Index, Coleman-Liau Index, Automated Readability Index, and Linsear Write Formula. These readability scores were used to calculate a composite Text Readability Consensus Grade Level. Invasive procedure consent forms were found to be written at an average of 15th grade level (i.e., third year of college), which is significantly higher than the average US adult reading level of 8th grade (p < 0.0001) and the AMA/NIH recommended readability guidelines for patient materials of 6th grade (p < 0.0001). Invasive procedure consent forms have readability levels which makes comprehension difficult or impossible for many patients. Efforts to improve the readability of procedural consent forms should improve patient understanding regarding their healthcare decisions. © 2015 Wiley Periodicals, Inc.

  7. Parents’ views on child physical activity and their implications for physical activity parenting interventions: a qualitative study

    PubMed Central

    2012-01-01

    Background Establishing healthy physical activity (PA) behaviours in early childhood is important for future PA behaviours. Parents play a central role in young children’s PA. However, there is currently little research on parenting interventions to increase child PA. This study was formative work to inform the content of a pilot randomised-controlled trial. Methods In-depth telephone interviews were carried out with 32 parents of 6 to 8 year old children residing in two areas that varied in their socio-economic characteristics, in Bristol, UK. Data were analysed thematically using a framework approach. Results Most parents described their child as being active or very active and indicated that they did not perceive a need for an increase in their child’s PA. Parents used a variety of visual cues to make this judgement, the most common being that they perceived their child as having lots of energy or that they did not view them as overweight. Parents reported environmental factors such as monetary cost, time constraints, lack of activity provision and poor weather as the main barriers to their child’s PA. Parental support and child’s enjoyment of PA appeared to be important facilitators to children participating in PA. Conclusion Improving parents’ knowledge of the PA recommendations for children, and increasing their awareness of the benefits of PA beyond weight status may be an important first step for a parenting PA intervention. Although parents commonly perceive environmental factors as the main barriers to their child’s PA, parental concern about low levels of child PA, their capacity to support behaviour change, child motivation, self confidence and independence may be key areas to address within an intervention to increase child PA. Effective methods of helping parents address the latter have been developed in the context of generic parenting programmes. PMID:23167910

  8. Handbook of Family Activities for Parents of Learning Disabled Children.

    ERIC Educational Resources Information Center

    Nicholson, Georgia

    Intended for parents, the handbook describes characteristics of learning disabled (LD) children and offers activities that the child can perform in the home to build skill proficiency. It is explained that the activities are designed to relieve the parent and child of constant awareness of the disability, to avoid use of special materials and…

  9. Informed consent comprehension in African research settings.

    PubMed

    Afolabi, Muhammed O; Okebe, Joseph U; McGrath, Nuala; Larson, Heidi J; Bojang, Kalifa; Chandramohan, Daniel

    2014-06-01

    Previous reviews on participants' comprehension of informed consent information have focused on developed countries. Experience has shown that ethical standards developed on Western values may not be appropriate for African settings where research concepts are unfamiliar. We undertook this review to describe how informed consent comprehension is defined and measured in African research settings. We conducted a comprehensive search involving five electronic databases: Medline, Embase, Global Health, EthxWeb and Bioethics Literature Database (BELIT). We also examined African Index Medicus and Google Scholar for relevant publications on informed consent comprehension in clinical studies conducted in sub-Saharan Africa. 29 studies satisfied the inclusion criteria; meta-analysis was possible in 21 studies. We further conducted a direct comparison of participants' comprehension on domains of informed consent in all eligible studies. Comprehension of key concepts of informed consent varies considerably from country to country and depends on the nature and complexity of the study. Meta-analysis showed that 47% of a total of 1633 participants across four studies demonstrated comprehension about randomisation (95% CI 13.9-80.9%). Similarly, 48% of 3946 participants in six studies had understanding about placebo (95% CI 19.0-77.5%), while only 30% of 753 participants in five studies understood the concept of therapeutic misconception (95% CI 4.6-66.7%). Measurement tools for informed consent comprehension were developed with little or no validation. Assessment of comprehension was carried out at variable times after disclosure of study information. No uniform definition of informed consent comprehension exists to form the basis for development of an appropriate tool to measure comprehension in African participants. Comprehension of key concepts of informed consent is poor among study participants across Africa. There is a vital need to develop a uniform definition for

  10. What is presumed when we presume consent?

    PubMed Central

    Pierscionek, Barbara K

    2008-01-01

    Background The organ donor shortfall in the UK has prompted calls to introduce legislation to allow for presumed consent: if there is no explicit objection to donation of an organ, consent should be presumed. The current debate has not taken in account accepted meanings of presumption in law and science and the consequences for rights of ownership that would arise should presumed consent become law. In addition, arguments revolve around the rights of the competent autonomous adult but do not always consider the more serious implications for children or the disabled. Discussion Any action or decision made on a presumption is accepted in law and science as one based on judgement of a provisional situation. It should therefore allow the possibility of reversing the action or decision. Presumed consent to organ donation will not permit such reversal. Placing prime importance on the functionality of body organs and their capacity to sustain life rather than on explicit consent of the individual will lead to further debate about rights of ownership and potentially to questions about financial incentives and to whom benefits should accrue. Factors that influence donor rates are not fully understood and attitudes of the public to presumed consent require further investigation. Presuming consent will also necessitate considering how such a measure would be applied in situations involving children and mentally incompetent adults. Summary The presumption of consent to organ donation cannot be understood in the same way as is presumption when applied to science or law. Consideration should be given to the consequences of presuming consent and to the questions of ownership and organ monetary value as these questions are likely to arise should presumed consent be permitted. In addition, the implications of presumed consent on children and adults who are unable to object to organ donation, requires serious contemplation if these most vulnerable members of society are to be

  11. Health Literacy among Parents of Pediatric Patients

    PubMed Central

    Tran, T. Paul; Robinson, Laura M.; Keebler, John R.; Walker, Richard A.; Wadman, Michael C.

    2008-01-01

    Background Health literacy is an important predictor of healthcare outcomes, but research on this topic has largely been absent from the emergency medicine literature. Objective We measured the prevalence of health literacy in parents or guardians of pediatric patients seen in the emergency department (ED). Methods This was an observational study conducted in a Midwestern urban, university-based, tertiary, Level 1 trauma center ED with 33,000 visits/year. Using convenience sampling during a three-month period, English-speaking parents or guardians of pediatric patients (< 19 yrs.) were asked to complete the short version of the Test of Functional Health Literacy for Adults (s-TOFHLA). Parents/guardians were excluded if they had uncorrected visual impairment, required an interpreter, had altered mental status, or if the patients they accompanied were the subjects of a medical or trauma activation. Results Of the 188 parents or guardians approached, six did not consent or withdrew, one was excluded, leaving 181 (96.3%) in the study. Of these, 19 (10.5%) had either “marginal” or “inadequate” health literacy, while 162 (89.5%, 95% CI: 84.1%, 93.6%) had “adequate” health literacy. Conclusion A large majority (89.5%) of English-speaking parents or guardians of pediatric patients evaluated in the ED have adequate health literacy. This data may prompt ED professionals to adjust their communication styles in the evaluation of children. Future multi-center studies are needed to confirm the findings in this pilot study. PMID:19561727

  12. Parental refusal of life-saving treatments for adolescents: Chinese familism in medical decision-making re-visited.

    PubMed

    Hui, Edwin

    2008-06-01

    This paper reports two cases in Hong Kong involving two native Chinese adolescent cancer patients (APs) who were denied their rights to consent to necessary treatments refused by their parents, resulting in serious harm. We argue that the dynamics of the 'AP-physician-family-relationship' and the dominant role Chinese families play in medical decision-making (MDM) are best understood in terms of the tendency to hierarchy and parental authoritarianism in traditional Confucianism. This ethic has been confirmed and endorsed by various Chinese writers from Mainland China and Hong Kong. Rather than giving an unqualified endorsement to this ethic, based more on cultural sentimentalism than rational moral reasoning, we warn that a strong familism in MDM, which deprives 'weak' family members of rights, represents the less desirable elements of this tradition, against which healthcare professionals working in this cultural milieu need to safeguard. Specifically for APs, we suggest that parental authority and family integrity should be re-interpreted in terms of parental responsibility and the enhancement of children's interests respectively, as done in the West. This implies that when parents refuse to consent to necessary treatment and deny their adolescent children's right to consent, doctors, as the only remaining advocates of the APs' interest, have the duty to inform the state, which can override parental refusal to enable the doctors to fulfill their professional and moral obligations. In so doing the state exercises its 'parens patriae' power to defend the defenseless in society and the integrity of the medical profession.

  13. Dynamic axes of informed consent in Japan.

    PubMed

    Specker Sullivan, Laura

    2017-02-01

    Scholarship in cross-cultural bioethics routinely frames Japanese informed consent in contrast to informed consent in North America. This contrastive analysis foregrounds cancer diagnosis disclosure and physician paternalism as unique aspects of Japanese informed consent that deviate from American practices. Drawing on in-depth interviews with 15 Japanese medical professionals obtained during fieldwork in Japan from 2013 to 15, this article complicates the informed consent discourse beyond East-West comparisons premised on Anglo-American ethical frameworks. It expands professional perspectives to include nurses, medical social workers, clinical psychologists, and ethicists and it addresses informed consent for a broad range of conditions in addition to cancer. The results suggest that division of affective labor is an under-theorized dimension of informed consent that is perceived as at odds with principled demands for universal informed consent. These practical tensions are conceptualized as cultural differences, with Japan identified in terms of omakase as practical and supportive and the United States identified in terms of jiko kettei as principled and self-determining. These results have implications for the methodology of cross-cultural bioethics as well as for theories and practices of informed consent in both Japan and the United States. I conclude that responsible cross-cultural work in bioethics must begin from the ground up, incorporating all relevant stakeholder perspectives, attitudes, and experiences. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. The limits of parental responsibility regarding medical treatment decisions.

    PubMed

    Woolley, Sarah L

    2011-11-01

    Parental responsibility (PR) was a concept introduced by the Children Act (CA) 1989 which aimed to replace the outdated notion of parental rights and duties which regarded children as parental possessions. Section 3(1) CA 1989 defines PR as 'all the rights, duties, powers, responsibilities and authority which by law a parent of a child has in relation to the child'. In exercising PR, individuals may make medical treatment decisions on children's behalf. Medical decision-making is one area of law where both children and the state can intercede and limit parental decision-making. Competent children can consent to treatment and the state can interfere if parental decisions are not seemingly in the child's 'best interests'. This article examines the concept, and limitations, of PR in relation to medical treatment decision-making.

  15. RELATIONSHIP BETWEEN PARENTS' MOTIVATION FOR PHYSICAL ACTIVITY AND THEIR BELIEFS, AND SUPPORT OF THEIR CHILDREN'S PHYSICAL ACTIVITY: A CLUSTER ANALYSIS.

    PubMed

    Naisseh, Matilda; Martinent, Guillaume; Ferrand, Claude; Hautier, Christophe

    2015-08-01

    Previous studies have neglected the multivariate nature of motivation. The purpose of the current study was to first identify motivational profiles of parents' own physical activity. Second, the study examined if such profiles differ in the way in which parents perceive their children's competence in physical activity and the importance and support given to their children's physical activity. 711 physically active parents (57% mothers; M age = 39.7 yr.; children 6-11 years old) completed the Situational Motivation Scale, the Parents' Perceptions of Physical Activity Importance and their Children's Ability Questionnaire, and the Parental Support for Physical Activity Scale. Cluster analyses indicated four motivational profiles: Highly self-determined, Moderately self-determined, Non-self-determined, and Externally motivated profiles. Parents' beliefs and support toward their children's physical activity significantly differed across these profiles. It is the first study using Self-Determination Theory that provides evidence for the interpersonal outcomes of motivation.

  16. Parental Perceptions on Childrens' Out-of-School Physical Activity and Family-Based Physical Activity

    ERIC Educational Resources Information Center

    Noonan, Robert J.; Boddy, Lynne M.; Fairclough, Stuart J.; Knowles, Zoe R.

    2017-01-01

    This study explored parents' physical activity (PA) knowledge and perceptions of children's out-of-school PA to formatively contribute to a family-based intervention design. Eleven telephone interviews were conducted with parents of children aged 10-11 years. Child and parent data were triangulated and family case studies were written. Most…

  17. Autism beyond pediatrics: why bioethicists ought to rethink consent in light of chronicity and genetic identity.

    PubMed

    Perry, Alexandra

    2012-06-01

    Autism is a chronic neurodevelopmental disorder that presents unique challenges to bioethicists. In particular, bioethicists ought to reconsider pediatric consent in light of disparity between beliefs that are held about the disorder by parents and adults with autism. The neurodiverse community ought to be given some consideration in this debate, and, as such, there may be a role for autistic narratives in clarifying this problem. © 2011 Blackwell Publishing Ltd.

  18. 42 CFR 50.205 - Consent form requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.205 Consent form... person who obtains the consent; and (4) The physician who will perform the sterilization procedure. (c... performing the sterilization must certify by signing the consent form, that: (i) Shortly before the...

  19. Where no consent = death.

    PubMed

    1977-01-01

    Men must be made to understand the value of family planning - particularly in societies where men hold the power of decision in the family. Dr. Kotha Pannikar, chairman of the Kedah Family Planning Association (FPA) in Malaysia, illustrated this point in discussion which followed the Consultation of Medical and Communication Fieldworkers conference in Kuala Lumpur in August, with a story about 1 of her own patients. When the girl, who had a rheumatic heart, was 16, Dr. Pannikar advised the parents that she needed cardiac surgery if she were to be a healthy wife and mother. But the parents lived some distance from Dr. Pannikar's surgery and did not heed the advice. The girl was married to a carpenter from a traditional Chinese family, in which "the man is lord and master." Her new home had no piped water, and in additional to normal domestic tasks she had to carry water from a source 1 1/2 miles agay. In the 7th month of her 1st pregnancy, she went into cardiac failure. After the 3rd pregnancy and a 3rd cardiac failure, Dr. Pannikar tried to arrange a sterilization "but we could not get consent - her husband refused to turn up at the hospital." When the girl was admitted to hospital 6 months into her 4th pregnancy, Dr. Pannikar got hold of her patient's mother-in-law. "I told her if she wanted a servant in the house, it was easy to get one. But no servant would look after her grandchildren the way their mother would. I told her if she wanted to save the girl's life she had better speak to her son." During the 4th delivery, the girl went into cardiac arrest and spent 2 weeks in intensive care. The mother-in-law prevailed upon her son to at least consent, and the girl was sterilized before she left hospital. But "it was a very near thing," Dr. Pannikar recalls "and it wouldn't have happened if the husband had felt he was responsible in parenthood." The Kedah FPA makes special efforts to reach men. Dr. Pannikar herself talks to men's organizations like the Lions and

  20. 75 FR 29782 - Notice of Proposed Consent Decree and Proposed Order on Consent Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-27

    ... DEPARTMENT OF JUSTICE Notice of Proposed Consent Decree and Proposed Order on Consent Under the Clean Water Act Notice is hereby given that, on May 18, 2010, a proposed Consent Decree in United States... 301(a) and 504(a) of the Clean Water Act, 33 U.S.C. 1311(a) & 1364(a), in connection with un-permitted...

  1. Readability of Invasive Procedure Consent Forms

    PubMed Central

    Eltorai, Adam E. M.; Naqvi, Syed S.; Ghanian, Soha; Eberson, Craig P.; Weiss, Arnold‐Peter C.; Born, Christopher T.

    2015-01-01

    Abstract Background Informed consent is a pillar of ethical medicine which requires patients to fully comprehend relevant issues including the risks, benefits, and alternatives of an intervention. Given the average reading skill of US adults is at the 8th grade level, the American Medical Association (AMA) and the National Institutes of Health (NIH) recommend patient information materials should not exceed a 6th grade reading level. We hypothesized that text provided in invasive procedure consent forms would exceed recommended readability guidelines for medical information. Materials and methods To test this hypothesis, we gathered procedure consent forms from all surgical inpatient hospitals in the state of Rhode Island. For each consent form, readability analysis was measured with the following measures: Flesch Reading Ease Formula, Flesch–Kincaid Grade Level, Fog Scale, SMOG Index, Coleman–Liau Index, Automated Readability Index, and Linsear Write Formula. These readability scores were used to calculate a composite Text Readability Consensus Grade Level. Results Invasive procedure consent forms were found to be written at an average of 15th grade level (i.e., third year of college), which is significantly higher than the average US adult reading level of 8th grade (p < 0.0001) and the AMA/NIH recommended readability guidelines for patient materials of 6th grade (p < 0.0001). Conclusion Invasive procedure consent forms have readability levels which makes comprehension difficult or impossible for many patients. Efforts to improve the readability of procedural consent forms should improve patient understanding regarding their healthcare decisions. PMID:26678039

  2. Informed Consent for Electroconvulsive Therapy--Finding Balance.

    PubMed

    Mankad, Mehul

    2015-09-01

    Informed consent underpins all medical decisions, including the decision to undergo electroconvulsive therapy (ECT). Written informed consent remains the standard before the initiation of ECT and requires the inclusion of several components to be considered valid. Prospective patients must be aware of risks and benefits of ECT as well as risks and benefits of alternate, and potentially less effective, interventions. Patients must also possess adequate decision-making capacity to make an informed choice about treatment. Consent for ECT may present unique issues, such as the interplay between potential cognitive adverse effects and informed consent. Options to address this concern include thorough explanation of this topic before the initiation of ECT, continued reassessment of consent during ECT, or some combination of approaches.

  3. Cross-sectional and longitudinal associations between parenting style and adolescent girls' physical activity.

    PubMed

    Saunders, Julie; Hume, Clare; Timperio, Anna; Salmon, Jo

    2012-12-03

    Understanding the influences on physical activity is crucial, particularly among important target groups such as adolescent girls. This study describes cross-sectional and longitudinal associations between parenting style and girls' participation in organized sport, walking/cycling trips and objectively assessed moderate to vigorous physical activity (MVPA). Data were collected from adolescent girls (n=222) and their parents in 2004 and again in 2006. Parents self-reported their demographic characteristics and parenting style. Girls self-reported their organized sport participation and weekly walking/cycling trips, while MVPA was assessed using accelerometers. Linear regression and interaction analyses were performed. Interactions between socio-demographic factors and parenting style with organized sport, walking/cycling trips and MVPA are presented. There were cross-sectional associations between authoritative (B=-0.45, p=0.042) and indulgent (B=-0.56, p=0.002) parenting and the number of walking/cycling trips, and authoritarian (B=0.27, p=0.033) parenting and frequency of organized sport. Significant interactions included those between: family status, authoritative parenting and daily (p=0.048) and week day (p=0.013) MVPA; education, indulgent parenting and MVPA on weekend days (p=0.006); and, employment, authoritarian parenting and duration and frequency of organized sport (p=0.004), highlighting the complexity of these relationships. Longitudinal analyses revealed significant decreases in organized sport and MVPA, significant increases in walking/cycling trips and no significant associations between parenting and physical activity. Parenting styles appear to influence walking and cycling trips among adolescent girls, though not physical activity within other domains. Socio-demographic characteristics interact with the relationships between parenting and physical activity. While these findings can inform the development of family-based interventions to improve

  4. PALS: Parent Activities for Learning Basic Skills.

    ERIC Educational Resources Information Center

    South Carolina State Dept. of Education, Columbia.

    Developed for K-3 teachers to send home with their students, this collection of learning activities and games is offered to help reinforce students' language arts and mathematics skills and to enhance parental involvement. Suggestions to the teacher include sending home only those pages containing activities for skills currently being studied and…

  5. Money for consent--psychological consideration.

    PubMed

    Mayrhofer-Reinhartshuber, David; Fitzgerald, Annelies; Fitzgerald, Robert D

    2005-01-01

    Regarding the increasing gap between demand and supply of donor organs the question is increasingly discussed, if families of organ donors should receive a financial incentive for consenting to organ donation. However, little attention has been paid to the psychological consequences of such incentives. We discuss the question of financial incentives for families of presumed organ donors in the light of relevant psychological theories. Overview of the psychological literature. Only well established theories were included. We summarise, that financial benefits for consent to organ donoation could affect adversely the public opinion toward organ donation and the whole process of transplantation and thus could counterproductively influence the consent rates.

  6. Communicating with parents about vaccination: a framework for health professionals

    PubMed Central

    2012-01-01

    Background A critical factor shaping parental attitudes to vaccination is the parent’s interactions with health professionals. An effective interaction can address the concerns of vaccine supportive parents and motivate a hesitant parent towards vaccine acceptance. Poor communication can contribute to rejection of vaccinations or dissatisfaction with care. We sought to provide a framework for health professionals when communicating with parents about vaccination. Methods Literature review to identify a spectrum of parent attitudes or ‘positions’ on childhood vaccination with estimates of the proportion of each group based on population studies. Development of a framework related to each parental position with determination of key indicators, goals and strategies based on communication science, motivational interviewing and valid consent principles. Results Five distinct parental groups were identified: the ‘unquestioning acceptor’ (30–40%), the ‘cautious acceptor’ (25–35%); the ‘hesitant’ (20–30%); the ‘late or selective vaccinator’ (2–27%); and the ‘refuser’ of all vaccines (<2%). The goals of the encounter with each group will vary, depending on the parents’ readiness to vaccinate. In all encounters, health professionals should build rapport, accept questions and concerns, and facilitate valid consent. For the hesitant, late or selective vaccinators, or refusers, strategies should include use of a guiding style and eliciting the parent’s own motivations to vaccinate while, avoiding excessive persuasion and adversarial debates. It may be necessary to book another appointment or offer attendance at a specialised adverse events clinic. Good information resources should also be used. Conclusions Health professionals have a central role in maintaining public trust in vaccination, including addressing parents’ concerns. These recommendations are tailored to specific parental positions on vaccination and provide a structured

  7. 42 CFR 50.204 - Informed consent requirement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent...

  8. 42 CFR 50.204 - Informed consent requirement.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent...

  9. 42 CFR 50.204 - Informed consent requirement.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent...

  10. 42 CFR 50.204 - Informed consent requirement.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent...

  11. 42 CFR 50.204 - Informed consent requirement.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent...

  12. Conceptualizing physical activity parenting practices using expert informed concept mapping analysis

    USDA-ARS?s Scientific Manuscript database

    Parents are widely recognized as playing a central role in the development of child behaviors such as physical activity. As there is little agreement as to the dimensions of physical activity-related parenting practices that should be measured or how they should be operationalized, this study engage...

  13. Parents' Perceptions of Physical Activity for Their Children with Visual Impairments

    ERIC Educational Resources Information Center

    Perkins, Kara; Columna, Luis; Lieberman, Lauren; Bailey, JoEllen

    2013-01-01

    Introduction: Ongoing communication with parents and the acknowledgment of their preferences and expectations are crucial to promote the participation of physical activity by children with visual impairments. Purpose: The study presented here explored parents' perceptions of physical activity for their children with visual impairments and explored…

  14. Social Physique Anxiety and Intention to Be Physically Active: A Self-Determination Theory Approach

    ERIC Educational Resources Information Center

    Sicilia, Álvaro; Sáenz-Alvarez, Piedad; González-Cutre, David; Ferriz, Roberto

    2016-01-01

    Purpose: Based on self-determination theory, the purpose of this study was to analyze the relationship between social physique anxiety and intention to be physically active, while taking into account the mediating effects of the basic psychological needs and behavioral regulations in exercise. Method: Having obtained parents' prior consent, 390…

  15. Parental consent requirements and privacy rights of minors: the contraceptive controversy.

    PubMed

    1975-03-01

    That the adult zone of privacy recognized by the Supreme Court during the past decade embraces access to contraceptives is suggested. 2 further questions are examined: 1) whether the right of children to have access to contraceptives is fundamental and 2) whether countervailing interests of parents and state should outweigh whatever interest the child has in obtaining contraceptives. More fundamentally, 3 complex issues relative to an analysis of minors' rights to obtain contraceptives are discussed: 1) the scope of the constitutional right of adults to obtain contraceptives remains uncertain; 2) courts have not yet articulated the special factors that determine how existing frameworks for analyzing the rights of adults are to be applied to minors; and 3) the question of minors' access to contraceptive involves a particularly complex mixture of the interests of minors, parents, and the state.

  16. Predictors of body mass index in female parents whose children participate in a competitive, creative, problem-solving program.

    PubMed

    Moustaid-Moussa, Naima; Costello, Carol A; Greer, Betty P; Spence, Marsha; Fitzhugh, Eugene; Muenchen, Robert; Kalupahana, Nishan S

    2012-01-01

    Recent findings from our research indicate that children participating in a creative afterschool program exhibit overall healthier lifestyle practices compared to the average US pediatric population. This observation led us to investigate the prevalence of overweight/obesity and lifestyle practices of their parents. To determine the strongest predictors of weight status for female parents whose children were participating in such creative afterschool program. Surveyed subjects were parents of children who competed in the 2008 and 2009 Destination ImagiNation(®) Global Finals in Knoxville, Tennessee. A total of 4,608 children participated in data collection, with parental consent. For the combined 2 years, 1,118 parents, 87% of whom were females (n=1,032) completed online questionnaires, which were based on the Behavioral Risk Factor Surveillance System and included self-reported height, weight, dietary intake, physical activity, and socioeconomic status. The majority of this population was white, and less than 5% were African American or Hispanic. We report here results obtained for the female parents. Only 45.2% of these female parents were overweight/obese, compared to a national average of 64.1% reported by the National Health Nutrition Examination Surveys for 2007-2008. Furthermore, this population was significantly more physically active compared to national average. Most parents (76%) had completed a college degree and reported high incomes. Parents with the lowest income were the most obese in this population. Finally, we found a significant association between parent and child weight status. These studies demonstrate that female parents of children who have healthy lifestyles were physically active, which likely accounts for the parents' lower overweight/obesity rates. In addition to physical activity, income and percentage of calories from fat were all predictors of weight status.

  17. Feasibility trial evaluation of a physical activity and screen-viewing course for parents of 6 to 8 year-old children: Teamplay

    PubMed Central

    2013-01-01

    Background Many children spend too much time screen-viewing (watching TV, surfing the internet and playing video games) and do not meet physical activity (PA) guidelines. Parents are important influences on children’s PA and screen-viewing (SV). There is a shortage of parent-focused interventions to change children’s PA and SV. Methods Teamplay was a two arm individualized randomized controlled feasibility trial. Participants were parents of 6–8 year old children. Intervention participants were invited to attend an eight week parenting program with each session lasting 2 hours. Children and parents wore an accelerometer for seven days and minutes of moderate-to-vigorous intensity PA (MVPA) were derived. Parents were also asked to report the average number of hours per day that both they and the target child spent watching TV. Measures were assessed at baseline (time 0) at the end of the intervention (week 8) and 2 months after the intervention had ended (week 16). Results There were 75 participants who provided consent and were randomized but 27 participants withdrew post-randomization. Children in the intervention group engaged in 2.6 fewer minutes of weekday MVPA at Time 1 but engaged in 11 more minutes of weekend MVPA. At Time 1 the intervention parents engaged in 9 more minutes of weekday MVPA and 13 more minutes of weekend MVPA. The proportion of children in the intervention group watching ≥ 2 hours per day of TV on weekend days decreased after the intervention (time 0 = 76%, time 1 = 39%, time 2 = 50%), while the control group proportion increased slightly (79%, 86% and 87%). Parental weekday TV watching decreased in both groups. In post-study interviews many mothers reported problems associated with wearing the accelerometers. In terms of a future full-scale trial, a sample of between 80 and 340 families would be needed to detect a mean difference of 10-minutes of weekend MVPA. Conclusions Teamplay is a promising parenting program

  18. Agreement between parent and child report on parental practices regarding dietary, physical activity and sedentary behaviours: the ENERGY cross-sectional survey.

    PubMed

    Rebholz, Cornelia E; Chinapaw, Mai J M; van Stralen, Maartje M; Bere, Elling; Bringolf, Bettina; De Bourdeaudhuij, Ilse; Jan, Nataša; Kovacs, Eva; Maes, Lea; Manios, Yannis; Moreno, Luis; Singh, Amika S; Brug, Johannes; te Velde, Saskia J

    2014-09-05

    Parents and their parenting practices play an important role in shaping their children's environment and energy-balance related behaviours (EBRBs). Measurement of parenting practices can be parent- or child-informed, however not much is known about agreement between parent and child perspectives. This study aimed to assess agreement between parent and child reports on parental practices regarding EBRBs across different countries in Europe and to identify correlates of agreement. Within the ENERGY-project, a cross-sectional survey was conducted among 10-12 year old children and their parents in eight European countries. Both children and parents filled in a questionnaire on 14 parental practices regarding five different EBRBs (i.e. soft drink, fruit juice and breakfast consumption, sports activity and watching TV) and socio-demographic characteristics. Children's anthropometric measurements were taken at school. We calculated percentages of agreement between children and their parents and weighted kappa statistics (for ordinal variables) per practice and country and assessed factors associated with agreement using multilevel linear regression. Reports of 6425 children and their parents were available for analysis. Overall mean agreement between parent and child reports was 43% and varied little among countries. The lowest agreement was found for questions assessing joint parent-child activities, such as sports (27%; Kappa (κ) = 0.14) or watching TV (30%; κ = 0.17), and for parental allowance of the child to have soft drinks (32%; κ = 0.24) or fruit juices (32%; κ = 0.19), or to watch TV (27%; κ = 0.17). Having breakfast products available at home or having a TV in the child's bedroom were the only practices with moderate to good agreement (>60%; κ = 0.06 and 0.77, respectively). In general, agreement was lower for boys, younger children, younger parents, parents with less than 14 years of education, single parents, parents with a higher self-reported body

  19. [Issues related to consent to healthcare decisions in children and adolescents].

    PubMed

    Bailly, D

    2010-02-01

    The process of consent to healthcare decisions in children and adolescents often set physicians difficult problems. From what age is a child able to understand the information given to him or her about illness and treatment? Is an ill child indeed in the capacity to give his or her voluntary consent to treatment? How to define and to assess the capacity of an ill child to take part in treatment decisions? More than the age of the child, it is his or her level of cognitive, emotional and social development and its interactions with illness that will determine his or her degree of involvement in the decision-making process. There is a moral and ethical need to respect the rights and autonomy of every individual, regardless of age. This does not mean viewing children and adolescents as rational and autonomous decision-makers. This implies that we must promote their developmentally appropriate participation in shared decision-making with parents and physicians. Therefore, instead of asking, "should children and adolescents be granted absolute autonomy in decision making?" we ought to ask, "should we treat children and adolescents like people?" Copyright (c) 2010 Elsevier Masson SAS. All rights reserved.

  20. Parenting Outcomes of Single Active Duty Postpartum Women

    DTIC Science & Technology

    1998-04-15

    Single active duty mothers face many of the same stressors as civilian single parents, including role strain, child care issues, and lack of...discretionary time. Child care is a difficult issue for single parents who need care that is flexible, convenient, and available at a reasonable cost...Deployments, work related travel, shift work, and relocations pose additional and unique problems for child care arrangements for military (Wahl & Randall

  1. 42 CFR 441.258 - Consent form requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Consent form requirements. 441.258 Section 441.258... informed consent as set forth on the consent form; and (iii) To the best of his or her knowledge and belief...) To the best of his or her knowledge and belief, the individual appeared mentally competent and...

  2. Validation of parent-reported physical activity and sedentary time by accelerometry in young children.

    PubMed

    Sarker, Hrishov; Anderson, Laura N; Borkhoff, Cornelia M; Abreo, Kathleen; Tremblay, Mark S; Lebovic, Gerald; Maguire, Jonathon L; Parkin, Patricia C; Birken, Catherine S

    2015-11-30

    It is unknown if young children's parent-reported physical activity and sedentary time are correlated with direct measures. The study objectives were to compare parent-reported physical and sedentary activity versus directly measured accelerometer data in early childhood. From 2013 to 2014, 117 healthy children less than 6 years of age were recruited to wear Actical accelerometers for 7 days. Accelerometer data and questionnaires were available on 87 children (74%). Average daily physical activity was defined as the sum of activity ≥100 counts per minute, and sedentary time as the sum of activity <100 counts per minute during waking hours. Parents reported daily physical activity (unstructured free play in and out of school, and organized activities) and selected sedentary behaviors (screen time, stroller time, time in motor vehicle). Spearman correlation coefficients and Bland-Altman plots were used to assess the validity of parent-reported measures compared to accelerometer data. Total physical activity was significantly greater when measured by accelerometer than parent-report; the median difference was 131 min/day (p < 0.001). Parent-reported child physical activity was weak to moderately correlated with directly measured total physical activity (r = 0.39, 95% CI 0.19, 0.56). The correlations between types of physical activity (unstructured free play in and outside of school/daycare, and organized structured activity) and accelerometer were r = 0.30 (95% CI 0.09, 0.49); r = 0.42 (95% CI 0.23, 0.58); r = 0.26 (95% CI 0.05, 0.46), respectively. There was no correlation between parent-reported and accelerometer-measured total sedentary time in children (r = 0.10, 95% CI -0.12, 0.33). When the results were stratified by age group (<18, 18-47, and 48-70 months of age) no statistically significant correlations were observed and some inverse associations were observed. The correlation between parent-report of young children's physical activity and accelerometer

  3. A cross-sectional study of the relationship between parents' and children's physical activity.

    PubMed

    Stearns, Jodie A; Rhodes, Ryan; Ball, Geoff D C; Boule, Normand; Veugelers, Paul J; Cutumisu, Nicoleta; Spence, John C

    2016-10-28

    Though parents' physical activity (PA) is thought to be a predictor of children's PA, findings have been mixed. The purpose of this study was to examine the relationship between pedometer-measured steps/day of parents' and their children and potential moderators of this relationship. We also assessed the parent-child PA relationship as measured by questionnaires. Six-hundred and twelve 7-8 year olds and one of their parents wore Steps Count (SC)-T2 pedometers for four consecutive days. Parents reported their PA from the last seven days and their child's usual PA. Hierarchical linear regressions were used to assess the parent-child PA relationships, controlling for covariates. Gender (parent, child), gender homogeneity, weight status (parent, child), weight status homogeneity, and socioeconomic status (SES) variables (parent education, household income, area-level SES) were tested as potential moderators of this relationship. Partial r's were used as an estimate of effect size. Parents' steps was significantly related to children's steps (r partial  = .24). For every 1,000 step increase in parents' steps, the children took 260 additional steps. None of the tested interactions were found to moderate this relationship. Using questionnaires, a relatively smaller parent-child PA relationship was found (r partial  = .14). Physically active parents tend to have physically active children. Interventions designed to get children moving more throughout the day could benefit from including a parent component. Future research should explore the mechanisms by which parents influence their children, and other parent attributes and styles as potential moderators.

  4. Pizzas, Pennies and Pumpkin Seeds: Mathematical Activities for Parents and Children.

    ERIC Educational Resources Information Center

    Apelman, Maja; King, Julie

    Children have many natural opportunities to learn about the basic aspects of quantity. This booklet is addressed to parents who want to support their children's mathematical growth. The activities presented suggest many ways in which parents and children can use mathematics in their environment. The activities are organized around common…

  5. Improving the Proficiency of Research Consent Administrators

    PubMed Central

    Larson, Elaine L.; Lally, Rachel; Foe, Gabriella; Joaquin, Gabriela; Meyer, Dodi D.; Cohn, Elizabeth G.

    2015-01-01

    Abstract Objective: To describe the development and testing of a module to improve consent administrators’ skills when obtaining research consent from culturally and linguistically diverse and low literacy populations. Design: Development and psychometric testing of video module including community vignettes. Methods: Following initial content, face, and construct validity testing by experts, a field trial was conducted with pre‐ and postknowledge tests and satisfaction surveys completed by 112 consent administrators. Results: Mean score out of a possible 10 on pretest was 8.6 (±standard deviation [SD], 1.55) and on posttest was 9.1 (±SD, 1.2; paired t‐test 95% confidence interval of difference: –0.18 to –0.88; two‐tailed p = 0.003). The average years of experience with obtaining consent was 6.42 years (range: 0–35), but years of experience was not significantly associated with either pre‐ or posttest scores (p = 0.82 and 0.44, respectively). Most user evaluations were positive, although suggestions for improvements were made. Conclusion: Although pretest scores were relatively high, training needs of research consent administrators for consenting diverse and low literacy populations may be unmet. We urge that institutional review boards, researchers, policymakers, educators, and bioethicists address the training needs of research consent administrators and we offer this training module as one potential resource and adjunct to such training. PMID:25676061

  6. Improving the Proficiency of Research Consent Administrators.

    PubMed

    Larson, Elaine L; Lally, Rachel; Foe, Gabriella; Joaquin, Gabriela; Meyer, Dodi D; Cohn, Elizabeth G

    2015-08-01

    To describe the development and testing of a module to improve consent administrators' skills when obtaining research consent from culturally and linguistically diverse and low literacy populations. Development and psychometric testing of video module including community vignettes. Following initial content, face, and construct validity testing by experts, a field trial was conducted with pre- and postknowledge tests and satisfaction surveys completed by 112 consent administrators. Mean score out of a possible 10 on pretest was 8.6 (±standard deviation [SD], 1.55) and on posttest was 9.1 (±SD, 1.2; paired t-test 95% confidence interval of difference: -0.18 to -0.88; two-tailed p = 0.003). The average years of experience with obtaining consent was 6.42 years (range: 0-35), but years of experience was not significantly associated with either pre- or posttest scores (p = 0.82 and 0.44, respectively). Most user evaluations were positive, although suggestions for improvements were made. Although pretest scores were relatively high, training needs of research consent administrators for consenting diverse and low literacy populations may be unmet. We urge that institutional review boards, researchers, policymakers, educators, and bioethicists address the training needs of research consent administrators and we offer this training module as one potential resource and adjunct to such training. © 2015 Wiley Periodicals, Inc.

  7. Promoting Parent and Child Physical Activity Together: Elicitation of Potential Intervention Targets and Preferences.

    PubMed

    Rhodes, Ryan E; Lim, Clarise

    2018-02-01

    Promoting physical activities that involve both parents and their children would be very useful to the improved health and well-being of families, yet coactivity interventions have been particularly unsuccessful in past research. The purpose of this study was to elicit the salient parental beliefs about coactivity framed through theory of planned behavior in order to inform future intervention content. A representative sample of Canadian parents ( N = 483) with children aged 6 to 14 years completed belief elicitation measures of theory of planned behavior, as well as coactivity and program preferences. Analyses included content theming by physical activity belief and preference through tallies of the percentages of parents endorsing each belief. Exploratory analyses of differences in endorsed themes were conducted by parent (mother, father), age of child (6-10 years, 11-14 years), and sex of the child. The results showed that behavioral beliefs about health, interpersonal and educational/learning opportunities and control beliefs about lack of time, various incompatible parent/child factors, parental health, and bad weather were dominant themes. Most of these themes did not vary in endorsement by parent and child characteristics. By contrast, preferences for various activities varied by parent and child characteristics, yet parents overwhelmingly desired the activities to be outdoors, close to home, after work, and originally delivered from community health professionals via Internet or face-to face means. Overall, the findings provide several considerations for specific targets to improve future physical activity intervention approaches among parents and their children.

  8. Cross-sectional and longitudinal associations between parenting style and adolescent girls’ physical activity

    PubMed Central

    2012-01-01

    Background Understanding the influences on physical activity is crucial, particularly among important target groups such as adolescent girls. This study describes cross-sectional and longitudinal associations between parenting style and girls’ participation in organized sport, walking/cycling trips and objectively assessed moderate to vigorous physical activity (MVPA). Methods Data were collected from adolescent girls (n=222) and their parents in 2004 and again in 2006. Parents self-reported their demographic characteristics and parenting style. Girls self-reported their organized sport participation and weekly walking/cycling trips, while MVPA was assessed using accelerometers. Linear regression and interaction analyses were performed. Interactions between socio-demographic factors and parenting style with organized sport, walking/cycling trips and MVPA are presented. Results There were cross-sectional associations between authoritative (B=−0.45, p=0.042) and indulgent (B=−0.56, p=0.002) parenting and the number of walking/cycling trips, and authoritarian (B=0.27, p=0.033) parenting and frequency of organized sport. Significant interactions included those between: family status, authoritative parenting and daily (p=0.048) and week day (p=0.013) MVPA; education, indulgent parenting and MVPA on weekend days (p=0.006); and, employment, authoritarian parenting and duration and frequency of organized sport (p=0.004), highlighting the complexity of these relationships. Longitudinal analyses revealed significant decreases in organized sport and MVPA, significant increases in walking/cycling trips and no significant associations between parenting and physical activity. Conclusion Parenting styles appear to influence walking and cycling trips among adolescent girls, though not physical activity within other domains. Socio-demographic characteristics interact with the relationships between parenting and physical activity. While these findings can inform the

  9. Physical activity in adolescents: analysis of the social influence of parents and friends.

    PubMed

    Cheng, Luanna Alexandra; Mendonça, Gerfeson; Farias Júnior, José Cazuza de

    2014-01-01

    To analyze the association between physical activity and social support from parents and friends on the physical activity level among adolescents. Data from 2,361 adolescents (56.6% females; mean age 16.4; SD = 1.2), from public and private high schools were analyzed. The physical activity level of the adolescents, parents, and friends were measured through a questionnaire. Parents' and friends' support and self-efficacy were measured using two previously tested scales. Data analysis was performed using the structural equation modeling in IBM® SPSS® Amos™ 20.0. Physical activity of friends was directly associated with physical activity level of adolescents. Physical activity of the father was associated with that of their sons, and the physical activity of mother was associated with that of their daughters. An indirect association was identified between the physical activity of parents and friends with physical activity level of the adolescents, mediated by social support. Social support was directly associated with physical activity in adolescents of both genders and indirectly mediated by self-efficacy. Parents and friends have a social influence on adolescents' level of physical activity through the mechanism of behavior modeling or through social support, mediated by self-efficacy. Copyright © 2013 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

  10. Parents as passengers during pediatric transport.

    PubMed

    Lewis, M M; Holditch-Davis, D; Brunssen, S

    1997-01-01

    The transport environment presents a unique setting in which the feasibility, advantages, and disadvantages of passengers accompanying a patient must be assessed carefully. The purpose of this study was to describe the current practice of including parents as passengers during pediatric interfacility transport. One-hundred-eighty-eight critical care transport programs in the United States responded to a voluntary mail survey, providing information about current policies, practices, and crew perceptions of the advantages and disadvantages of carrying parents as passengers. Extra seating for passengers was available in 96% of ambulances, 86% of fixed-wing aircraft, and 54% of helicopters used for pediatric transport. Parents traveled as passengers in all types of vehicles; most frequently in ambulances and fixed-wing aircraft. Twenty percent of helicopter programs allowed parent passengers on more than half of their pediatric transports in this vehicle. Advantages of parent passengers included emotional benefit for the parent and child, availability of parents for history and consent, good public relations, and having the parent present if the child dies. Disadvantages included potential parent anxiety, crew distraction, and space limitations. This study reflects the widely diverse policies, practices, and opinions relevant to this topic and confirms a need for further study.

  11. Predictors of body mass index in female parents whose children participate in a competitive, creative, problem-solving program

    PubMed Central

    Moustaid-Moussa, Naima; Costello, Carol A.; Greer, Betty P.; Spence, Marsha; Fitzhugh, Eugene; Muenchen, Robert; Kalupahana, Nishan S.

    2012-01-01

    Background Recent findings from our research indicate that children participating in a creative afterschool program exhibit overall healthier lifestyle practices compared to the average US pediatric population. This observation led us to investigate the prevalence of overweight/obesity and lifestyle practices of their parents. Objective To determine the strongest predictors of weight status for female parents whose children were participating in such creative afterschool program. Design Surveyed subjects were parents of children who competed in the 2008 and 2009 Destination ImagiNation® Global Finals in Knoxville, Tennessee. A total of 4,608 children participated in data collection, with parental consent. For the combined 2 years, 1,118 parents, 87% of whom were females (n=1,032) completed online questionnaires, which were based on the Behavioral Risk Factor Surveillance System and included self-reported height, weight, dietary intake, physical activity, and socioeconomic status. The majority of this population was white, and less than 5% were African American or Hispanic. Results We report here results obtained for the female parents. Only 45.2% of these female parents were overweight/obese, compared to a national average of 64.1% reported by the National Health Nutrition Examination Surveys for 2007—2008. Furthermore, this population was significantly more physically active compared to national average. Most parents (76%) had completed a college degree and reported high incomes. Parents with the lowest income were the most obese in this population. Finally, we found a significant association between parent and child weight status. Conclusions These studies demonstrate that female parents of children who have healthy lifestyles were physically active, which likely accounts for the parents’ lower overweight/obesity rates. In addition to physical activity, income and percentage of calories from fat were all predictors of weight status. PMID:22912600

  12. Interactive multimedia consent for biobanking: a randomized trial.

    PubMed

    Simon, Christian M; Klein, David W; Schartz, Helen A

    2016-01-01

    The potential of interactive multimedia to improve biobank informed consent has yet to be investigated. The aim of this study was to test the separate effectiveness of interactivity and multimedia at improving participant understanding and confidence in understanding of informed consent compared with a standard, face-to-face (F2F) biobank consent process. A 2 (face-to-face versus multimedia) × 2 (standard versus enhanced interactivity) experimental design was used with 200 patients randomly assigned to receive informed consent. All patients received the same information provided in the biobank's nine-page consent document. Interactivity (F(1,196) = 7.56, P = 0.007, partial η(2) = 0.037) and media (F(1,196) = 4.27, P = 0.04, partial η(2) = 0.021) independently improved participants' understanding of the biobank consent. Interactivity (F(1,196) = 6.793, P = 0.01, partial η(2) = 0.033), but not media (F(1,196) = 0.455, not significant), resulted in increased participant confidence in their understanding of the biobank's consent materials. Patients took more time to complete the multimedia condition (mean = 18.2 min) than the face-to-face condition (mean = 12.6 min). This study demonstrated that interactivity and multimedia each can be effective at promoting an individual's understanding and confidence in their understanding of a biobank consent, albeit with additional time investment. Researchers should not assume that multimedia is inherently interactive, but rather should separate the two constructs when studying electronic consent.

  13. Interactive multimedia consent for biobanking: A randomized trial

    PubMed Central

    Simon, Christian M.; Klein, David W.; Schartz, Helen A.

    2015-01-01

    Purpose Interactive multimedia’s potential to improve biobank informed consent has yet to be investigated. The aim of this study was to test the separate effectiveness of interactivity and multimedia at improving participant understanding and confidence of understanding of informed consent, compared to a standard, face-to-face (F2F) biobank consent process. Methods A 2 (F2F versus multimedia) × 2 (standard versus enhanced interactivity) experimental design was used with 200 patients randomly assigned to receive informed consent. All patients received the same information provided in the Biobank’s 9-page consent document. Results Interactivity (F(1,196)=7.56, p=0.007, partial η2=0.037) and Media (F(1,196)=4.27, p=0.04, partial η2=0.021) independently improved participants’ understanding of the Biobank consent. Interactivity (F(1,196) = 6.793, p = 0.01, partial η2=0.033), but not Media (F(1,196) = 0.455, n.s.), resulted in increased participant confidence in their understanding of the Biobank’s consent. Patients took more time to complete the multimedia (M=18.2 min.) than the F2F (M=12.6 min.) conditions. Conclusion This study demonstrated that interactivity and multimedia each can be effective at promoting individuals’ understanding and confidence in understanding of a biobank consent, albeit with additional time investment. Researchers should not assume that multimedia is inherently interactive, but rather separate the two constructs when studying electronic consent. PMID:25834945

  14. Association between Hypothesized Parental Influences and Preschool Children's Physical Activity Behavior

    ERIC Educational Resources Information Center

    Loprinzi, Paul D.; Schary, David P.; Beets, Michael W.; Leary, Janie; Cardinal, Bradley J.

    2013-01-01

    Background: To date, most research investigating the influence of parents on children"s physical activity behavior has been conducted among school-aged children. As a result, we have a limited understanding of the mechanisms through which parents can influence their young children's physical activity behavior. The purpose of this study was to…

  15. Parental Involvement in a School-Based Child Physical Activity and Nutrition Program in Southeastern United States: A Qualitative Analysis of Parenting Capacities.

    PubMed

    Ickes, Scott; Mahoney, Emily; Roberts, Alison; Dolan, Carrie

    2016-03-01

    Parent involvement varies widely in school-based programs designed to promote physical activity and healthy nutrition, yet the underlying factors that may limit parent's participation and support of learned behaviors at home are not well understood. We conducted a qualitative study that consisted of one focus group (n = 5) and 52 in-depth interviews among parents whose children participated in a school-based physical activity and nutrition (PAN) promotion program in Williamsburg, Virginia, United States. We sought to identify factors that enabled or constrained parent's support of and involvement in children's programs and to understand the underlying factors that contribute to family success in making dietary and physical activity changes at home. Parents identified their physical and mental health, self-confidence, time, and decision making as underlying "capacities" in the family health pattern. When strengthened, these capacities encourage healthful family behavior and support of school-based PAN programs. Families that succeeded in adopting lessons learned from school-based PAN programs identified four primary strategies for success: shared goals, meal planning, modeling of good behaviors, and collective activities. Interventions that aim to improve child nutrition and physical activity and the broader family health environment should consider underlying capacities of parents and the importance of joint goals and activities. © 2016 Society for Public Health Education.

  16. Communicating with parents of premature infants: who is the informant?

    PubMed

    Kowalski, W J; Leef, K H; Mackley, A; Spear, M L; Paul, D A

    2006-01-01

    To determine what sources of information are most helpful for neonatal intensive care unit (NICU) parents, who provides NICU parents with the information, and also what expectations parents have regarding obtaining information. A 19-item questionnaire was given to the parents of infants 32 weeks or younger prior to discharge from the NICU. Out of the 101 parents who consented, almost all of the parents (96%) felt that 'the medical team gave them the information they needed about their baby' and that the 'neonatologist did a good job of communicating' with them (91%). However, the nurse was chosen as 'the person who spent the most time explaining the baby's condition, 'the best source of information,' and the person who told them 'about important changes in their baby's condition' (P<0.01). Although the neonatologist's role in parent education is satisfactory, the parents identified the nurses as the primary source of information.

  17. Family Ecological Predictors of Physical Activity Parenting in Low-Income Families

    ERIC Educational Resources Information Center

    Lampard, Amy M.; Jurkowski, Janine M.; Lawson, Hal A.; Davison, Kirsten K.

    2013-01-01

    Physical activity (PA) parenting, or strategies parents use to promote PA in children, has been associated with increased PA in children of all ages, including preschool-aged children. However, little is known about the circumstances under which parents adopt such behaviors. This study examined family ecological factors associated with PA…

  18. The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol.

    PubMed

    Perrenoud, Beatrice; Velonaki, Venetia-Sofia; Bodenmann, Patrick; Ramelet, Anne-Sylvie

    2015-10-01

    on the improvement of the print material, the process (e.g. the communication of the appropriate information) or both. Davis et al. conducted a randomized controlled trial to compare two polio vaccine pamphlets written at a sixth grade level - an international standardized pamphlet and an easy-to-read pamphlet - for the comprehension and preference among parents. Although the parents in the intervention group (N=304) achieved significantly higher comprehension than the control group (N=306) (65% vs 60%, p<0.005), the authors concluded that simplifying written material increases appeal but not the comprehension to an adequate level without use of instructional graphics. Similarly, Lorenzen et al. found that a reader friendly informed consent document to surgical procedures was more commonly read by the health care users as compared to the original consent document; however, no difference was found in terms of the participants' capacity to describe the procedure in their own words. Kang et al. evaluated recall and comprehension of orthodontic informed consent among pairs of children and their parents (N=90) applying three different informed consent procedures. According to this study, a combination of improving the readability of consent materials and the informed consent process (audio and visual cues) led to better recall for the patients and better recall and comprehension for their parents compared to an improved readability form or the usual informed consent form. Smith et al. used a randomized controlled trial to compare a decision aid (booklet and DVD) specifically designed for adults with low literacy skills (N=357) with a standard information booklet (N=173) on screening for bowel cancer. They found that the proportion of participants making an informed choice was 22% higher in the intervention group than in the control group (34% vs 12%, P<0.001). Matsuyama et al. (ABSTRACT TRUNCATED)

  19. Attraction to Physical Activity in Urban Schoolchildren: Parental Socialization and Gender Influences.

    ERIC Educational Resources Information Center

    Brustad, Robert J.

    1996-01-01

    This study examined the contribution of parent socialization and gender to urban elementary students' (N=107) interest in physical activity. Questionnaires indicated significant relationships between parental socialization processes and children's perceived physical competence and attraction to physical activity. (SM)

  20. Informed consent for MRI and fMRI research: Analysis of a sample of Canadian consent documents

    PubMed Central

    2011-01-01

    Background Research ethics and the measures deployed to ensure ethical oversight of research (e.g., informed consent forms, ethics review) are vested with extremely important ethical and practical goals. Accordingly, these measures need to function effectively in real-world research and to follow high level standards. Methods We examined approved consent forms for Magnetic Resonance Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) studies approved by Canadian research ethics boards (REBs). Results We found evidence of variability in consent forms in matters of physical and psychological risk reporting. Approaches used to tackle the emerging issue of incidental findings exposed extensive variability between and within research sites. Conclusion The causes of variability in approved consent forms and studies need to be better understood. However, mounting evidence of administrative and practical hurdles within current ethics governance systems combined with potential sub-optimal provision of information to and protection of research subjects support other calls for more scrutiny of research ethics practices and applicable revisions. PMID:21235768

  1. Beliefs about Physical Activity among Children Who Are Visually Impaired and Their Parents

    ERIC Educational Resources Information Center

    Stuart, Moira E.; Lieberman, Lauren; Hand, Karen E.

    2006-01-01

    This survey of 25 visually impaired children aged 10-12 and their parents investigated the value the parents placed on their children's physical activity and the barriers to physical activity that the children faced. The results revealed that as vision loss increased, parents' expectations for their children's ability to be physically active…

  2. Obtaining consent to oral and maxillofacial surgery.

    PubMed

    Poswillo, D

    1989-09-01

    The question of whether or not a patient has consented to treatment has recently become significant to all who practise oral and maxillofacial surgery. It is often linked to professional negligence when the outcome differs from the patient's perception or expectation of the operation. Consent may be oral or written, applies to referred patients and all those with physical and mental handicap and religious restrictions. Examples of procedure in discussing consent assist the surgeon to inform without creating fear. Knowledge of the benefits of informed consent and current legal opinion assist the oral and maxillofacial surgeon to avoid the pitfalls of failure to inform.

  3. Political Activism of Palestinian Youth: Exploring Individual, Parental, and Ecological Factors

    ERIC Educational Resources Information Center

    Spellings, Carolyn R.; Barber, Brian K.; Olsen, Joseph A.

    2012-01-01

    The growing literature on youth and political conflict has not included an adequate focus on youth activism. To address this deficit, this study used youth- and parent-reported data (N = 6,718) from the 1994-1995 Palestinian Family Study to test an ecological model of family influence (parents' activism, expectations for their adolescents'…

  4. Enhancing HIV Vaccine Trial Consent Preparedness Among Street Drug Users

    PubMed Central

    Fisher, Celia B.

    2011-01-01

    This research used open-ended and true-false questions to assess the preparedness of 96 ethnically diverse, economically and socially marginalized adult street drug users to consent to participate in HIV vaccine trials (HVT). Specific areas of consent vulnerability included misconceptions about: (1) the recuperative value and risk of vaccines in general; (2) the presence of the HIV virus within the vaccine and the possibility of contracting or transmitting HIV as a consequence of participation; (3) inclusion criteria and experimental blinds; and (4) distrust in the medical and research establishments. A brief HVT lesson administered to 30 participants was effective in correcting specific HVT knowledge misperceptions and increasing certain, but not all areas of HVT trust. Assessment of post-lesson responses to ethics-relevant questions provides information on respondents' attitudes toward AIDS safe behavior, research risks and benefits, monetary compensation, and willingness to participate. Implications for enhancing informed consent for HVT involving active drug users are discussed. PMID:20569151

  5. The objective measurement of physical activity and sedentary behaviour in 2-3 year olds and their parents: a cross-sectional feasibility study in the bi-ethnic Born in Bradford cohort.

    PubMed

    Costa, Silvia; Barber, Sally E; Cameron, Noël; Clemes, Stacy A

    2015-11-11

    The reported lower physical activity (PA) levels of British South Asians (SA) are suggested as a key influence in their increased risk of non-communicable diseases compared to their White British peers. Differences in objectively measured PA and sedentary behaviour (SB) between these ethnic groups have been observed during childhood (ages: 8-10 years). However, no information exists on objectively measured PA/SB in younger children, or how early in life differences in these behaviours emerge. Assessing PA/SB in the Born in Bradford (BIB) cohort study provides an opportunity to address such gaps in the literature, but previous studies have found recruiting and retaining SA participants challenging, and the feasibility of using accelerometers with SA children and parents is unknown. This study investigated the feasibility of recruiting and objectively measuring the habitual PA/SB of 2-3 year old SA and White British children and parents from the BIB study. Families were informed about the study during routine BIB assessments. Consenting families were visited at home for anthropometry measurements, interviews, material delivery and collection. Participants (child and parents) were instructed to wear the ActiGraph GT3X+ for 8 days. Descriptive statistics were computed, and ethnic differences tested (Chi-square) for recruitment uptake and compliance. 160 families (30 % SA) provided contact details, and 97 (22 % SA) agreed to enter the study. White British families showed lower refusal and higher intake into the study than SA (p = 0.006). Of 89 children issued with an accelerometer, 34 % complied with the 8-day protocol (significantly less SA; p = 0.015) and 75 % provided enough days (≥ 3) to assess habitual PA/SB (no ethnic differences). Parental rates of compliance with the protocol did not differ between ethnicities. Issues experienced with the protocol and accelerometer use, and successful implementation strategies/procedures are presented. Although greater efforts

  6. Informed consent and moral integrity.

    PubMed Central

    Gillett, G R

    1989-01-01

    Informed consent is required for any medical procedure although the situations in which it is given are beset by uncertainties and indeterminacies. These make medicolegal scrutiny of such situations very difficult. Although some people find the decision in the Sidaway case incomprehensible because of its continuing regard for a 'professional practice standard' in informed consent, I will argue that an important fact in many cases is the moral integrity of the doctor concerned and the pattern of his practice. This may provide the only morally principled and legally accessible evidence enabling a correct decision to be made in a difficult case. Although the epistemological significance of a professional practice standard is thereby defended the 'prudent patient standard' for what counts as consent is left intact. PMID:2795625

  7. Factors Influencing the Effects of Parental Marital Status on Adolescent Sexual Activity.

    ERIC Educational Resources Information Center

    Renninger, Gretchen; Chambliss, Catherine

    Many studies have been done pertaining to the effects of parental divorce on children. Recently, studies have shown that parental marital status has an effect on adolescents' sexual activity. Specifically, children of divorced parents have been found to be younger at first coitus than children of married parents. This study attempted to replicate…

  8. Consent process for US-based family reference DNA samples.

    PubMed

    Katsanis, Sara H; Snyder, Lindsey; Arnholt, Kelly; Mundorff, Amy Z

    2018-01-01

    DNA collection from family members of the missing is a tenet for missing persons' and mass fatality investigations. Procedures for consenting family members are disparate, depending on the context supporting the reason for sample collection. While guidelines and best practices have been developed for handling mass fatalities and for identification of the missing, these guidelines do not address standard consent practices for living family members of potential victims. We examined the relevant U.S. laws, international guidelines and best practices, sampled consent forms currently used for DNA collection of family members, and drafted model language for a consent form to communicate the required and recommended information. We modeled the consent form on biobank consenting practices and tested the consent language among students and the general population for constructive feedback and readability. We also asked respondents to consider the options for DNA collection and either hypothetically agree or disagree. The model language presented here highlights information important to relay in consent processes and can serve as a foundation for future consent practices in mass fatalities and missing persons' investigations. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. Risk perception and decision processes underlying informed consent to research participation.

    PubMed

    Reynolds, William W; Nelson, Robert M

    2007-11-01

    According to the rational choice model, informed consent should consist of a systematic, step-by-step evaluation of all information pertinent to the treatment or research participation decision. Research shows that people frequently deviate from this normative model, however, employing decision-making shortcuts, or heuristics. In this paper we report findings from a qualitative study of 32 adolescents and (their) 31 parents who were recruited from two Northeastern US hospitals and asked to consider the risks of and make hypothetical decisions about research participation. The purpose of this study was to increase our understanding of how diabetic and at-risk adolescents (i.e., those who are obese and/or have a family history of diabetes) and their parents perceive risks and make decisions about research participation. Using data collected from adolescents and parents, we identify heuristic decision processes in which participant perceptions of risk magnitude, which are formed quickly and intuitively and appear to be based on affective responses to information, are far more prominent and central to the participation decision than are perceptions of probability. We discuss participants' use of decision-making heuristics in the context of recent research on affect and decision processes, and we consider the implications of these findings for researchers.

  10. Parental social support and the physical activity-related behaviors of youth: a review.

    PubMed

    Beets, Michael W; Cardinal, Bradley J; Alderman, Brandon L

    2010-10-01

    Social support from parents serves as one of the primary influences of youth physical activity-related behaviors. A systematic review was conducted on the relationship of parental social support to the physical activity-related behaviors of youth. Four categories of social support were identified, falling under two distinct mechanisms-tangible and intangible. Tangible social support is divided into two categories: instrumental-purchasing equipment/payment of fees and transportation-and conditional-doing activity with and watching/supervision. Intangible social support is divided into the two categories of motivational- encouragement and praise-and informational-discussing benefits of. The majority of studies demonstrated positive associations among selected measures of parental tangible and intangible social support and youth activity. Overall, parental social support demonstrated positive effects. Many studies, however, combine social support categories and/or respondents into composite measures, making it difficult to disentangle the specific effects of parents and the type of support provided.

  11. Parental consent for bone marrow transplantation in the case of genetic disorders.

    PubMed

    Prows, C A; McCain, G C

    1997-01-01

    To describe the responses of mothers and fathers who were offered bone marrow transplantation (BMT) for their children with genetic disorders. Qualitative. Private hospital rooms/offices. Six mothers and 4 fathers of children with genetic disorders. The basic social-psychological problem confronting the parents was the conflicting alternatives of life versus death for their children. It was certain that these children would die from their genetic disorders but without having to endure the pain and suffering of a BMT. The BMT would be difficult, possibly resulting in death, but with a chance of survival. Parents believed that BMT was the only chance of survival for their children, leaving them no choice except to pursue the BMT treatment.

  12. Responsibility for children's physical activity: parental, child, and teacher perspectives.

    PubMed

    Cox, Michele; Schofield, Grant; Kolt, Gregory S

    2010-01-01

    Some large-scale child physical activity campaigns have focused on the concept of responsibility, however, there are no measures which establish a link between responsible behavior and physical activity levels. To provide the basis of information required for the development of relevant measurement tools, this study examined the meaning of personal, parental, and third party responsibility for children's physical activity. Eight focus groups, comprising children aged 11-12 yrs, their parents, and teachers from two upper primary schools in Auckland, New Zealand, were conducted. Children (four groups; n=32), their parents (two groups; n=13), and teachers (two groups; n=15) were separated by socio-economic status, and children also by gender. The transcripts from the focus group interviews were then analysed using thematic induction methodology. Across the groups, participants commonly identified a number of behaviors that they felt were indicative of personal, parental, and third party responsibility for children's physical activity. These behaviors formed natural groups with common themes (e.g., self-management, safety), which in most cases were not impacted on by socio-economic status or gender. Responsibility was therefore found to be a concept that could be related to children's physical activity. It was suggested that these behaviors could be used as a starting point in understanding the relationship between responsibility and physical activity, and to assist with the development of measurement tools assessing the relationship between responsibility and levels of physical activity in the future. In turn, this may lead to the development of more targeted messages for large-scale physical activity campaigns. Copyright (c) 2009 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  13. Emergency research without consent under Polish law.

    PubMed

    Rózyńska, Joanna; Czarkowski, Marek

    2007-09-01

    Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject's life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning

  14. Standard Versus Simplified Consent Materials for Biobank Participation: Differences in Patient Knowledge and Trial Accrual.

    PubMed

    Garrett, Sarah B; Murphy, Marie; Wiley, James; Dohan, Daniel

    2017-12-01

    Replacing standard consent materials with simplified materials is a promising intervention to improve patient comprehension, but there is little evidence on its real-world implementation. We employed a sequential two-arm design to compare the effect of standard versus simplified consent materials on potential donors' understanding of biobank processes and their accrual to an active biobanking program. Participants were female patients of a California breast health clinic. Subjects from the simplified arm answered more items correctly ( p = .064), reported "don't know" for fewer items ( p = .077), and consented to donate to the biobank at higher rates ( p = .025) than those from the standard arm. Replacing an extant consent form with a simplified version is feasible and may benefit patient comprehension and study accrual.

  15. Jehovah's Witness and consent for blood transfusion in a child: The Indian scenario.

    PubMed

    Gopakumar, K G; Priyakumari, T; Nair, Manjusha; Kusumakumary, P

    2018-01-01

    In India, the clinical guidelines and laws governing consent for blood transfusion in a minor are meager and vague. In an elective situation, whether the parents can make a decision for the child on his/her behalf or whether the doctor has the right to make the decision in the best interests of the child is not clear. We present the case scenario of a child belonging to Jehovah's Witness denomination diagnosed with Burkitt lymphoma. His parents were in a dilemma whether to opt for blood transfusion or not. In the absence of laws and guidelines in this context, and considering the complications that he developed during the treatment period, it was very challenging for us to manage the situation both medically and medico-legally. This situation highlights the need for framing consensus guidelines/laws regarding elective blood transfusion in a minor to make health-care delivery, smooth, transparent and flawless.

  16. Parent Stress and the Active Child

    ERIC Educational Resources Information Center

    Erickson, Karen; Prom, Megan

    2006-01-01

    The purpose of the current study was to look at whether a child's activity level was correlated with the level of stress a mother experiences. Parents can describe their children as having distinct and recognizable patterns of behavior as young as in infancy (Paaren, Hewitt, Lemery, Bihun & Goldsmith, 2000). Even at birth, some children are much…

  17. 28 CFR 549.52 - Informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

  18. 28 CFR 549.52 - Informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

  19. 28 CFR 549.52 - Informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

  20. 28 CFR 549.52 - Informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

  1. 28 CFR 549.52 - Informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

  2. Locations of Joint Physical Activity in Parent-Child Pairs Based on Accelerometer and GPS Monitoring

    PubMed Central

    Dunton, Genevieve Fridlund; Liao, Yue; Almanza, Estela; Jerrett, Micheal; Spruijt-Metz, Donna; Pentz, Mary Ann

    2012-01-01

    Background Parental factors may play an important role in influencing children’s physical activity levels. Purpose This cross-sectional study sought to describe the locations of joint physical activity among parents and children. Methods Parent-child pairs (N = 291) wore an Actigraph GT2M accelerometer and GlobalSat BT-335 Global Positioning Systems (GPS) device over the same 7-day period. Children were ages 8–14 years. Joint behavior was defined by a linear separation distance of less than 50m between parent and child. Land use classifications were assigned to GPS data points. Results Joint physical activity was spread across residential locations (35%), and commercial venues (24%), and open spaces/parks (20%). Obese children and parents performed less joint physical activity in open spaces/parks than under/normal weight children and parents (p’s < .01). Conclusions Understanding where joint parent-child physical activity naturally occurs may inform location-based interventions to promote these behaviors. PMID:23011914

  3. Gender differences in heterosexual college students' conceptualizations and indicators of sexual consent: implications for contemporary sexual assault prevention education.

    PubMed

    Jozkowski, Kristen N; Peterson, Zoë D; Sanders, Stephanie A; Dennis, Barbara; Reece, Michael

    2014-01-01

    Because sexual assault is often defined in terms of nonconsent, many prevention efforts focus on promoting the clear communication of consent as a mechanism to reduce assault. Yet little research has specifically examined how sexual consent is being conceptualized by heterosexual college students. In this study, 185 Midwestern U.S. college students provided responses to open-ended questions addressing how they define, communicate, and interpret sexual consent and nonconsent. The study aimed to assess how college students define and communicate consent, with particular attention to gender differences in consent. Results indicated no gender differences in defining consent. However, there were significant differences in how men and women indicated their own consent and nonconsent, with women reporting more verbal strategies than men and men reporting more nonverbal strategies than women, and in how they interpreted their partner's consent and nonconsent, with men relying more on nonverbal indicators of consent than women. Such gender differences may help to explain some misunderstandings or misinterpretations of consent or agreement to engage in sexual activity, which could partially contribute to the occurrence of acquaintance rape; thus, a better understanding of consent has important implications for developing sexual assault prevention initiatives.

  4. Consent and refusal in dementia research: conceptual and practical considerations.

    PubMed

    Cohen-Mansfield, J

    2003-01-01

    This article discusses types of consent refusals, rates of refusal, factors that affect consent, and methods to increase rates of consent in elderly research participants and in those with dementia in particular. Refusals can be categorized according to several types: complete refusal, refusal that is time-contingent, partial refusal, and contingent agreement. Rates of consent vary greatly across studies of persons with dementia. This variation can also be affected by different methodologies of calculating rates, in addition to differences in content of studies, populations, and procedures. To warrant consent, a study must first be scientifically sound, with a high likelihood of advancing knowledge, and must provide maximal protection to participants. Consent rates are affected by the following factors: levels of anticipated risks and benefits of the study, relationships among the different caregivers involved in the care of the potential subject, the ability of the researcher to properly identify and locate the person who needs to provide consent, characteristics and attitudes of the person providing consent, and the method of obtaining consent, including timing, location, method of presentation, and type of consent requested. An understanding of these issues can assist the researcher in tailoring research procedures so as to maximize rates of consent. It also raises ethical issues that warrant further discussion concerning the process of obtaining consent from and for persons with dementia.

  5. Changing associations of Australian parents' physical activity with their children's sport participation: 1985 to 2004.

    PubMed

    Dollman, James

    2010-12-01

    The socio-ecological milieu of children's physical activity is changing, perhaps causing perturbations within the causal 'web' that explains physical activity behaviours. It is unclear if the relative importance of parental role modelling is changing. Accordingly, this study examined associations of child-perceived parent physical activity and children's sport participation in 1985 and 2004. In 1985 (179 girls, 211 boys) and 2004 (210 girls, 218 boys), Australian schoolchildren (9-15 years) in the same eight schools were surveyed on sport participation and perceptions of parents' physical activity. In the 1985 sample, girls with active fathers played more sport. In 2004, boys and girls with active fathers or active mothers reported higher sport participation. In 1985, there were no differences in sport participation between those with both, either or neither parent active. In 2004, sport participation was highest among boys and girls with both parents active. These results underscore the current role of parents as socialising agents for physical activity. Intervention design should be founded on the most recent evidence of children's physical activity correlates. © 2010 The Authors. ANZJPH © 2010 Public Health Association of Australia.

  6. Is the Intergenerational Transmission of High Cultural Activities Biased by the Retrospective Measurement of Parental High Cultural Activities?

    ERIC Educational Resources Information Center

    de Vries, Jannes; de Graaf, Paul M.

    2008-01-01

    In this article we study the bias caused by the conventional retrospective measurement of parental high cultural activities in the effects of parental high cultural activities and educational attainment on son's or daughter's high cultural activities. Multi-informant data show that there is both random measurement error and correlated error in the…

  7. Description of a Mobile-based Electronic Informed Consent System Development.

    PubMed

    Hwang, Min-A; Kwak, In Ja

    2015-01-01

    Seoul National University Hospital constructed and implemented a computer-based informed consent system in December 2011. As of 2013, 30% of the informed consents were still filled out manually on paper. Patients and medical staff continuously suggested the implementation of a system for electronic informed consent using portable devices. Therefore, a mobile-based system for electronic informed consent was developed in 2013 to prevent the issues that arise with computer-based systems and paper informed consent. The rate of filling out electronic informed consent increased from 69% to 95% following the implementation of the mobile-based electronic informed consent. This construction of a mobile-based electronic informed consent system would be a good reference point for the development of a mobile-based Electronic Medical Record and for various mobile system environments in medical institutions.

  8. Barriers Affecting Physical Activity in Rural Communities: Perceptions of Parents and Children

    ERIC Educational Resources Information Center

    McWhinney, Sharon; McDonald, Andrea; Dawkins-Moultin, Lenna; Outley, Corliss; McKyer, E. Lisako; Thomas, Audrene

    2011-01-01

    A comprehensive understanding of the barriers inhibiting physical activity among children is critical in the fight against childhood obesity. This qualitative interview study examined parents' and children's perceptions of the barriers to physical activity in rural communities of low socioeconomic status. Parents and children concurred that the…

  9. Physical Activity of Parents of Children with Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Haegele, Justin A.; Lee, Jihyun; Chang, Seung Ho

    2017-01-01

    A preliminary study was conducted to investigate the physical activity status of parents of children with autism spectrum disorder (ASD) and related demographic characteristics. Thirty-four parents completed the IPAQ-S and demographic survey. Mean metabolic equivalent-minutes per week (MET-min/week) across participants was 3,371. Significant…

  10. Autonomy, consent and responsibility. Part II. Informed consent in medical care and in the law.

    PubMed

    Mellado, J M

    Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

  11. Parental and Adolescent Perceptions of Neighborhood Safety Related to Adolescents’ Physical Activity in Their Neighborhood

    PubMed Central

    Esteban-Cornejo, Irene; Carlson, Jordan A.; Conway, Terry L.; Cain, Kelli L.; Saelens, Brian E.; Frank, Lawrence D.; Glanz, Karen; Roman, Caterina G.; Sallis, James F.

    2017-01-01

    Purpose The purpose of this study was to examine the association between adolescent and parental perceptions of neighborhood safety and adolescents’ physical activity in multiple locations and to investigate the moderating effect of sex within this association. Method This cross-sectional study was conducted with 928 adolescents aged 12 to 16 years old and 1 of their parents. Adolescents and parents reported their perceptions of neighborhood safety (traffic safety, pedestrian safety, crime safety, and stranger danger safety). Adolescents reported how often they were physically active in multiple locations (physical activity in the neighborhood, in parks, and for active transport). Mixed-effects linear regression models were used to investigate these associations while controlling for demographics and the Walkability Index. Results Parent-perceived crime safety was positively associated with adolescents’ physical activity in parks (B = .094, p = .024). Parent-perceived traffic safety was positively associated with adolescents’ reported physical activity in the neighborhood (B = .186, p = .014). Adolescents’ physical activity for active transport was positively associated with parent-perceived traffic safety (B = .179, p = .001), stranger danger safety (B = .110, p = .013), and crime safety (B = .077, p = .035). There were 2 interactions by sex on the relation between adolescent traffic safety perception and parent pedestrian safety perception in the neighborhood and adolescents’ physical activity in parks (i.e., statistically significant only for boys). Conclusions Parents’ perceptions of traffic, stranger danger, and crime safety were all related to adolescents’ active transportation. Multiple safety concerns may be motivating parents to restrict adolescent mobility by walking and bicycling. PMID:27030158

  12. Delegating Informed Consent.

    PubMed

    Koch, Valerie Gutmann

    2017-11-01

    Ten years ago, Megan Shinal sought the care of neurosurgeon Steven Toms for the surgical treatment of a recurrent nonmalignant tumor in the pituitary region of her brain. In their twenty-minute meeting, Shinal did not make a final decision about which surgical approach she wished to pursue. Subsequently, she spoke with Tom's physician assistant once by phone and once in person, when she signed the consent form, which did not appear to designate which surgical approach she had chosen. During the operation-a total resection-Toms perforated Shinal's carotid artery, resulting in hemorrhage, stroke, brain injury, and partial blindness. The jury found that Toms had fulfilled his informed-consent obligations prior to performing the resection; however, in June 2017, the Supreme Court of Pennsylvania overturned the decision, relying on the Pennsylvania Medical Care Availability and Reduction of Error Act. The court found that the language of the act is unambiguous in its requirement that "a physician's duty to provide information to a patient sufficient to obtain her informed consent is non-delegable." Presumably, this rule of nondelegation applies beyond the surgical theater to other major treatment decisions. And it is unclear whether it applies to other professionals in a subordinate position to the treating physician, such as residents and fellows. © 2017 The Hastings Center.

  13. Active Parenting Now: Program Kit.

    ERIC Educational Resources Information Center

    Popkin, Michael H.

    Based largely on the theories of Alfred Adler and Rudolf Dreikurs, this parent education curriculum is a video-based interactive learning experience that teaches a comprehensive model of parenting to parents of children ages 5 to 12 years. The kit provides parents with the skills needed to help their children develop courage, responsibility, and…

  14. 42 CFR 441.257 - Informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 4 2013-10-01 2013-10-01 false Informed consent. 441.257 Section 441.257 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations § 441.257 Informed consent. (a) Informing...

  15. 42 CFR 441.257 - Informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 4 2014-10-01 2014-10-01 false Informed consent. 441.257 Section 441.257 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations § 441.257 Informed consent. (a) Informing...

  16. 42 CFR 441.257 - Informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 4 2012-10-01 2012-10-01 false Informed consent. 441.257 Section 441.257 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations § 441.257 Informed consent. (a) Informing...

  17. 21 CFR 640.61 - Informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The written...

  18. 21 CFR 640.61 - Informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The written...

  19. 21 CFR 640.61 - Informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The written...

  20. 21 CFR 640.61 - Informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The written...

  1. 21 CFR 640.61 - Informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The written...

  2. THE PARAMETERS OF INFORMED CONSENT

    PubMed Central

    Raab, Edward L

    2004-01-01

    ABSTRACT Purpose To describe the components of a proper informed consent; which risks must be disclosed and which need not; additional safeguards for incapacitated persons, minors, and research subjects; and where the law will imply consent that is not otherwise obtained. Methods Summarization of current law obtained from legal treatises, reports of recent cases, and personal experience as a reviewer and expert. Results Lack of informed consent can reinforce a claim of medical malpractice or serve as an alternative point of attack when the case is otherwise weak. Special requirements must be met when patients are the subjects of clinical research. Conclusion Demonstration of a well-conducted process, not merely of a paper, not only protects the physician from exposure to liability, but increases the patient’s autonomy in decisions concerning health and encourages compliance with treatment. PMID:15747761

  3. Family ecological predictors of physical activity parenting in low-income families.

    PubMed

    Lampard, Amy M; Jurkowski, Janine M; Lawson, Hal A; Davison, Kirsten K

    2013-01-01

    Physical activity (PA) parenting, or strategies parents use to promote PA in children, has been associated with increased PA in children of all ages, including preschool-aged children. However, little is known about the circumstances under which parents adopt such behaviors. This study examined family ecological factors associated with PA parenting. Low-income parents (N = 145) of preschool-aged children (aged 2 to 5 years) were recruited from five Head Start centers in upstate New York. Guided by the family ecological model (FEM), parents completed surveys assessing PA parenting and relevant family and community factors. Hierarchical regression analysis identified independent predictors of PA parenting. Parent depressive symptoms, life pressures that interfere with PA and perceived empowerment to access PA resources were associated with PA parenting. Community factors, including neighborhood play safety and social capital, were not independently associated with PA parenting in the multivariate model. Together, family ecological factors accounted for a large proportion of the variance in PA parenting (R (2) = .37). Findings highlight the need to look beyond cognitive predictors of PA parenting in low-income families and to examine the impact of their broader life circumstances including indicators of stress.

  4. The role of consent in medical research: breaking or building walls? A call for legislative reform.

    PubMed

    Dangata, Yohanna Yanshiyi

    2011-12-01

    Research has been integral to the practice of medicine for almost as long as the discipline has existed. Until fairly recently research used to be conducted on human subjects without mandatory requirement for their consent. However, over time medical research became associated with significant cruelty resulting in an outcry for regulation of research actives. This resulted in significant legislation in place for monitoring. Today it is mandatory to obtain consent from subjects before embarking on medical research, and indeed treatment. Its significant regulatory role notwithstanding, the issue of consent at times becomes a hindrance to research. This paper examines the issue of consent in relation to medical research in the context of present legislation. It lays out the background to medical research with respect to purpose, scope, standard protocol and related issues; it then addresses the issue of consent in various scenarios, highlighting problems and the need for legislative reform. It is maintained that while regulatory measures have brought a lot of sanity to medical research and the medical profession, some measures are building walls inhibitory to research activities. Research being integral to the development and growth of healthcare delivery, there is need for reformation of current medical law for balance between patient protectionism and progress in medical research for effective patient care.

  5. Effect of Nature-Activities Education Program on the Multiple Intelligence Level of Children in the Age Group of 8 to 12 Years

    ERIC Educational Resources Information Center

    Ceylan, Merve

    2018-01-01

    Research population consists of 15 children who attended a 5 week (3 days a week) nature-activities course with the consent of their parents during the summer term of 2016-2017 academic year. Participants were selected from children who had never taken part in a nature activity before. Measurement tool of this study was "Development of…

  6. 29 CFR 6.43 - Consent findings and order.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Consent findings and order. 6.43 Section 6.43 Labor Office... Interest Proceedings § 6.43 Consent findings and order. (a) At any time prior to the receipt of evidence or... Administrative Law Judge, the parties may enter into consent findings and an order disposing of the proceeding in...

  7. 29 CFR 6.18 - Consent findings and order.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Consent findings and order. 6.18 Section 6.18 Labor Office... Contracts Subject to the Service Contract Act) § 6.18 Consent findings and order. (a) At any time prior to... of the decision of the Administrative Law Judge, the parties may enter into consent findings and an...

  8. 29 CFR 6.32 - Consent findings and order.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Consent findings and order. 6.32 Section 6.32 Labor Office... Consent findings and order. (a) At any time prior to the receipt of evidence or, at the discretion of the... enter into consent findings and an order disposing of the proceeding in whole or in part. (b) Any...

  9. Parental Youth Assets and Sexual Activity: Differences by Race/Ethnicity

    ERIC Educational Resources Information Center

    Tolma, Eleni L.; Oman, Roy F.; Vesely, Sara K.; Aspy, Cheryl B.; Beebe, Laura; Fluhr, Janene

    2011-01-01

    Objectives: To examine how the relationship between parental-related youth assets and youth sexual activity differed by race/ethnicity. Methods: A random sample of 976 youth and their parents living in a Midwestern city participated in the study. Multivariate logistic regression analyses were conducted for 3 major ethnic groups controlling for the…

  10. [The informed consent in international clinical trials including developing countries].

    PubMed

    Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

    2008-01-01

    The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

  11. Associations between Parental and Friend Social Support and Children's Physical Activity and Time Spent outside Playing.

    PubMed

    Loucaides, Constantinos A; Tsangaridou, Niki

    2017-01-01

    The purpose of this study was to examine the structural validity of a parent and a child questionnaire that assessed parental and friends' influences on children's physical activity and investigate the associations between the derived factors, physical activity, and time spent outside. Children ( N = 154, mean age = 11.7) and 144 of their parents completed questionnaires assessing parental and friends' influences on children's physical activity. Children wore a pedometer for six days. Exploratory factor analyses revealed four factors for the parental and five for the child's questionnaire that explained 66.71% and 63.85% of the variance, respectively. Five factors were significantly associated with physical activity and five significantly associated with time spent outside. Higher correlations were revealed between "general friend support," "friends' activity norms," and physical activity ( r = 0.343 and 0.333 resp., p < 0.001) and between "general friend support" and time spent outside ( r = 0.460, p < 0.001). Obtaining information relating to parental and friends' influences on physical activity from both parents and children may provide a more complete picture of influences. Parents and friends seem to influence children's physical activity behavior and time spent outside, but friends' influences may have a stronger impact on children's behaviors.

  12. Associations between Parental and Friend Social Support and Children's Physical Activity and Time Spent outside Playing

    PubMed Central

    Tsangaridou, Niki

    2017-01-01

    The purpose of this study was to examine the structural validity of a parent and a child questionnaire that assessed parental and friends' influences on children's physical activity and investigate the associations between the derived factors, physical activity, and time spent outside. Children (N = 154, mean age = 11.7) and 144 of their parents completed questionnaires assessing parental and friends' influences on children's physical activity. Children wore a pedometer for six days. Exploratory factor analyses revealed four factors for the parental and five for the child's questionnaire that explained 66.71% and 63.85% of the variance, respectively. Five factors were significantly associated with physical activity and five significantly associated with time spent outside. Higher correlations were revealed between “general friend support,” “friends' activity norms,” and physical activity (r = 0.343 and 0.333 resp., p < 0.001) and between “general friend support” and time spent outside (r = 0.460, p < 0.001). Obtaining information relating to parental and friends' influences on physical activity from both parents and children may provide a more complete picture of influences. Parents and friends seem to influence children's physical activity behavior and time spent outside, but friends' influences may have a stronger impact on children's behaviors. PMID:28348605

  13. Hyper-parenting is negatively associated with physical activity among 7-12year olds.

    PubMed

    Janssen, Ian

    2015-04-01

    To explore associations between helicopter, little emperor, tiger mom, and concerted cultivation hyper-parenting styles with child physical activity. 724 North American parents of 7-12 year olds completed a survey (May, 2014) that assessed their engagement in the hyper-parenting styles and the frequency that their child played outdoors, walked/bicycled, and played organized sports. Z-scores were generated for each hyper-parenting style and four groups were created: low (<-1 SD), below average (-1 to -0.49 SD), average (-0.50 to 0.50 SD), above average (0.51 to 0.1.0 SD), and high (>1 SD). Outdoor play, active transportation, and organized sport did not differ across helicopter parenting groups. Children in the low little emperor group had higher (P<0.005) outdoor play and active transportation scores than children in the average, above average, and high groups (exception: high group for outdoor play). Children in the low tiger mom and concerted cultivation groups had higher (P<0.005) outdoor play, active transportation, and organized sport scores than children in the average, above average, and high groups (exceptions: average and high tiger mom groups for organized sport). Little emperor, tiger mom, and concerted cultivation parenting styles were associated with lower physical activity among 7-12 year olds. Copyright © 2015. Published by Elsevier Inc.

  14. Changes in Children's Behavior and Costs for Service Use Associated with Parents' Response to Treatment for Dysthymia

    ERIC Educational Resources Information Center

    Byrne, Carolyn; Browne, Gina; Roberts, Jacqueline; Mills, Michael; Bell, Barbara; Gafni, Amiram; Jamieson, Ellen; Webb, Michelle

    2006-01-01

    Objective: This study examined differences in children's behavior and expenditures for health and social services used when their parents with dysthymia did or did not respond to antidepressant therapy. Method: Children ages 4 to 16 years of consenting parents enrolled in a treatment trial for dysthymia who did and did not respond to treatment…

  15. Parent perspectives on information about late effects of childhood cancer treatment and their role in initial treatment decision making.

    PubMed

    Greenzang, Katie A; Dauti, Angela; Mack, Jennifer W

    2018-06-01

    Though most childhood cancer survivors experience late effects of treatment, we know little about parent preferences for late effects information during therapy, or how parents weigh late effects when making treatment decisions. Our objective was to explore how parents of children with cancer consider late effects in initial treatment decision making and during active cancer treatment. Semistructured interviews were conducted with 12 parents of children with cancer who were actively receiving treatment at Dana-Farber/Boston Children's Cancer and Blood Disorders Center. Interviews were audio-recorded, transcribed verbatim, and qualitatively analyzed using thematic analysis. Ten of 12 parents reported that they had to decide between two or more treatment options for their child's cancer. Of those, 50% (5/10) considered late effects to be an important factor in their decision making. Most parents wanted early and detailed information about their child's risk of late effects to make treatment decisions and to feel prepared for the future. However, a few parents felt too overwhelmed to focus on late effects at diagnosis. While many recalled extensive late effects information in informed consent discussions, some parents felt these issues were minimally addressed. Parents desire detailed information about late effects to make informed treatment decisions and prepare for the future. Despite the role of late effects in treatment decision making, some parents feel that late effects are either inadequately addressed or too overwhelming to process at diagnosis. Parents may benefit from early assessment of their information needs and a return to these issues over time. © 2018 Wiley Periodicals, Inc.

  16. How modifiable factors influence parental decision-making about organ donation.

    PubMed

    Luberda, Kamila; Cleaver, Karen

    2017-11-07

    A global shortage of organs from children and adults available for transplantation is compounded by the failure of next of kin to consent for organs to be donated after death. Non-modifiable and modifiable factors influence decision-making in this area. Modifiable factors are of interest when examining families' decision-making about the donation of organs from their deceased child. A scoping review was undertaken to determine how modifiable factors influence parental decision-making about organ donation. Thematic analysis identified two themes: interactions with healthcare professionals and pre-disposition to organ donation. Satisfaction with experiences of hospital care, the information provided and the way it was communicated, as well as interactions pertaining to emotional support were all found to be modifiable factors that influenced decision making. Likewise, a predisposition to organ donation and knowing the deceased's wishes were associated with the consent decision. Nurses working in critical care environments need to be able to support parents during this difficult time. This article aims to raise awareness of modifiable factors that influence parental decision-making, highlighting their relevance for children's nursing practice. ©2017 RCN Publishing Company Ltd. All rights reserved. Not to be copied, transmitted or recorded in any way, in whole or part, without prior permission of the publishers.

  17. Testing an alternate informed consent process.

    PubMed

    Yates, Bernice C; Dodendorf, Diane; Lane, Judy; LaFramboise, Louise; Pozehl, Bunny; Duncan, Kathleen; Knodel, Kendra

    2009-01-01

    One of the main problems in conducting clinical trials is low participation rate due to potential participants' misunderstanding of the rationale for the clinical trial or perceptions of loss of control over treatment decisions. The objective of this study was to test an alternate informed consent process in cardiac rehabilitation participants that involved the use of a multimedia flip chart to describe a future randomized clinical trial and then asked, hypothetically, if they would participate in the future trial. An attractive and inviting visual presentation of the study was created in the form of a 23-page flip chart that included 24 color photographs displaying information about the purpose of the study, similarities and differences between the two treatment groups, and the data collection process. We tested the flip chart in 35 cardiac rehabilitation participants. Participants were asked if they would participate in this future study on two occasions: immediately after the description of the flip chart and 24 hours later, after reading through the informed consent document. Participants were also asked their perceptions of the flip chart and consent process. Of the 35 participants surveyed, 19 (54%) indicated that they would participate in the future study. No participant changed his or her decision 24 hours later after reading the full consent form. The participation rate improved 145% over that of an earlier feasibility study where the recruitment rate was 22%. Most participants stated that the flip chart was helpful and informative and that the photographs were effective in communicating the purpose of the study. Participation rates could be enhanced in future clinical trials by using a visual presentation to explain and describe the study as part of the informed consent process. More research is needed to test alternate methods of obtaining informed consent.

  18. Le consentement libre et éclairé aux soins en psychiatrie

    PubMed Central

    Neilson, Grainne; Chaimowitz, Gary

    2015-01-01

    Résumé Le patient a le droit d’être informé sur les soins de santé qui lui sont proposés et de participer activement à la prise de décisions relativement à ces soins. Le respect de la dignité et de l’autonomie de la personne passe par le respect de son droit de prendre des décisions à propos de ses soins psychiatriques, notamment de refuser un traitement, pour autant qu’elle soit apte à prendre des décisions. Il importe que le psychiatre connaisse les fondements éthiques du consentement libre et éclairé et les exigences prévues par le droit en cette matière, y compris la jurisprudence. Le consentement n’est pas immuable, pouvant changer avec le temps, au fil de l’évolution des conditions et des circonstances. Par conséquent, le consentement doit être un processus continu.

  19. 27 CFR 26.64 - Consents of surety.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Taxpayment of Liquors and Articles in Puerto Rico Bonds § 26.64 Consents of surety. Consents of surety to changes in the...

  20. Dog Ownership, Dog Walking, and Children's and Parents' Physical Activity

    ERIC Educational Resources Information Center

    Salmon, Jo; Timperio, Anna; Chu, Binh; Veitch, Jenny

    2010-01-01

    This study aimed to determine cross-sectional associations of dog ownership, dog walking, and physical activity (PA) among children and their parents. Objective measures of PA were obtained for children ages 5-6 and 10-12 years from 19 primary schools across Melbourne, Australia. Parents self-reported their PA, dog ownership, and frequency of dog…

  1. Physical Activity and Screen-Media–Related Parenting Practices Have Different Associations with Children's Objectively Measured Physical Activity

    PubMed Central

    Chen, Tzu-An; Baranowski, Janice; Thompson, Deborah; Baranowski, Tom

    2013-01-01

    Abstract Background Children's physical activity (PA) is inversely associated with children's weight status. Parents may be an important influence on children's PA by restricting sedentary time or supporting PA. The aim of this study was to investigate the association of PA and screen-media–related [television (TV) and videogame] parenting practices with children's PA. Methods Secondary analyses of baseline data were performed from an intervention with 9- to 12-year-olds who received active or inactive videogames (n=83) to promote PA. Children's PA was assessed with 1 week of accelerometry at baseline. Parents reported their PA, TV, and videogame parenting practices and child's bedroom screen-media availability. Associations were investigated using Spearman's partial correlations and linear regressions. Results Although several TV and videogame parenting practices were significantly intercorrelated, only a few significant correlations existed between screen-media and PA parenting practices. In linear regression models, restrictive TV parenting practices were associated with greater child sedentary time (p=0.03) and less moderate-to-vigorous PA (MVPA; p=0.01). PA logistic support parenting practices were associated with greater child MVPA (p=0.03). Increased availability of screen-media equipment in the child's bedroom was associated with more sedentary time (p=0.02) and less light PA (p=0.01) and MVPA (p=0.05) in all three models. Conclusion In this cross-sectional sample, restrictive screen-media and supportive PA parenting practices had opposite associations with children's PA. Longitudinal and experimental child PA studies should assess PA and screen-media parenting separately to understand how parents influence their child's PA behaviors and whether the child's baseline PA or screen media behaviors affect the parent's use of parenting practices. Recommendations to remove screens from children's bedrooms may also affect their PA. PMID:24028564

  2. Ability to Consent to Parkinson Disease Research

    MedlinePlus

    ... Steven Karceski, MD The ability to consent to Parkinson disease research Eran Klein, MD, PhD WHAT IS THIS ... 1 on giving consent to be part of Parkinson disease (PD) research. People with PD often want to ...

  3. Extracurricular Activity and Parental Involvement Predict Positive Outcomes in Elementary School Children

    ERIC Educational Resources Information Center

    Lagace-Seguin, Daniel G.; Case, Emily

    2010-01-01

    The main goal of this study was to explore if parental involvement and extracurricular activity participation could predict well-being and academic competence in elementary school children. Seventy-two children (mean age = 10.9 years, SD = 0.85) and their parents participated. Results revealed that parental pressure and support, when paired with…

  4. The Activity Support Scale for Multiple Groups (ACTS-MG): Child-reported Physical Activity Parenting in African American and Non-Hispanic White Families.

    PubMed

    Lampard, Amy M; Nishi, Akihiro; Baskin, Monica L; Carson, Tiffany L; Davison, Kirsten K

    2016-01-01

    This study aimed to assess the psychometric properties of a child-report, multidimensional measure of physical activity (PA) parenting, the Activity Support Scale for Multiple Groups (ACTS-MG), in African American and non-Hispanic white families. The ACTS-MG was administered to children aged 5 to 12 years. A three factor model of PA parenting (Modeling of PA, Logistic Support, and Restricting Access to Screen-based Activities) was tested separately for mother's and fathers' PA parenting. The proposed three-factor structure was supported in both racial groups for mothers' PA parenting and in the African American sample for fathers' PA parenting. Factorial invariance between racial groups was demonstrated for mother's PA parenting. Building on a previous study examining the ACTS-MG parent-report, this study supports the use of the ACTS-MG child-report for mothers' PA parenting. However, further research is required to investigate the measurement of fathers' PA parenting across racial groups.

  5. Children's physical activity and parents' perception of the neighborhood environment: neighborhood impact on kids study.

    PubMed

    Tappe, Karyn A; Glanz, Karen; Sallis, James F; Zhou, Chuan; Saelens, Brian E

    2013-03-27

    Physical activity is important to children's physical health and well-being. Many factors contribute to children's physical activity, and the built environment has garnered considerable interest recently, as many young children spend much of their time in and around their immediate neighborhood. Few studies have identified correlates of children's activity in specific locations. This study examined associations between parent report of their home neighborhood environment and children's overall and location-specific physical activity. Parents and children ages 6 to 11 (n=724), living in neighborhoods identified through objective built environment factors as high or low in physical activity environments, were recruited from Seattle and San Diego metropolitan areas, 2007-2009. Parents completed a survey about their child's activity and perceptions of home neighborhood environmental attributes. Children wore an accelerometer for 7 days. Multivariate regression models explored perceived environment correlates of parent-reported child's recreational physical activity in their neighborhood, in parks, and in general, as well as accelerometry-based moderate-to-vigorous activity (MVPA) minutes. Parent-reported proximity to play areas correlated positively with both accelerometery MVPA and parent-reported total child physical activity. Lower street connectivity and higher neighborhood aesthetics correlated with higher reported child activity in the neighborhood, while reported safety from crime and walk and cycle facilities correlated positively with reported child activity in public recreation spaces. Different aspects of parent's perceptions of the neighborhood environment appear to correlate with different aspects of children's activity. However, prioritizing closer proximity to safe play areas may best improve children's physical activity and, in turn, reduce their risk of obesity and associated chronic diseases.

  6. Understanding how different recruitment strategies impact parent engagement with an iPad-based intervention to provide personalized information about adolescent vaccines.

    PubMed

    Dempsey, Amanda F; Maertens, Julie; Beaty, Brenda L; O'Leary, Sean T

    2015-05-01

    Inadequate provider time for addressing parents' questions and concerns about adolescent vaccines is a barrier to vaccine utilization. We sought to determine how different recruitment strategies impact the degree of engagement with an intervention that provided this information via an iPad placed in a clinical setting. We provided to three pediatric practices in the Denver area the "Teen VaxScene" web site that generates individually customized information for parents about adolescent vaccines. Three recruitment strategies were assessed for their impact on parental use of the intervention as follows: passive recruitment using posters to advertise a "kiosk" version of the intervention; posters plus a $10 incentive for using the kiosk; and posters plus a $10 incentive plus decoupling the iPad from the kiosks to enable "roving." We assessed the engagement with the intervention at multiple levels including log in, consent, and completion of a baseline survey and viewing individually tailored web pages. Surveys were used to assess barriers to using the intervention. During the 14-month study period, 693 people had contact with the iPad, 199 consented, and 48 completed the survey to enable creation of tailored content; and 42 used the tailored site. Five times as many parents (n = 40) consented to participation during the 2 months when the intervention was "roving" than during the 10-month "passive" recruitment period. Engagement with the tailored material was low, with most users viewing only the "table of contents" pages. Utilizers and nonutilizers of the intervention had similar demographic characteristics. Enabling the iPad to "rove" in the clinic greatly increased the proportion of parents consenting to use the intervention. However, meaningful engagement with the material was low. Further research is needed to understand the most effective and time efficient ways to provide vaccine-related educational information to parents of adolescents. Copyright © 2015 Society

  7. Do specific parenting practices and related parental self-efficacy associate with physical activity and screen time among primary schoolchildren? A cross-sectional study in Belgium

    PubMed Central

    De Lepeleere, Sara; De Bourdeaudhuij, Ilse; Cardon, Greet; Verloigne, Maïté

    2015-01-01

    Objectives To assess the association between specific parenting practices and related parental self-efficacy with children's physical activity (PA) and screen time. Parental body mass index (BMI), family socioeconomic status (SES), and child's age and gender were examined as possible influencing factors. Design Cross-sectional. Setting January 2014, Flanders (Belgium). Participants 207 parents (87.4% mothers) of children aged 6–12 years. Outcome measures Specific parenting practices, related parental self-efficacy, and children's PA and screen time. Results The majority of investigated parenting practices and related parental self-efficacy were not significantly associated with children's PA or screen time. However, children were more physically active if sports equipment was available at home (p<0.10) and if parents did not find it difficult to motivate their child to be physically active (p<0.05). Children had a lower screen time if parents limited their own gaming (p<0.01). The associations between parenting practices and related parental self-efficacy with children's PA or screen time were significant for parents with a normal BMI, for medium-high SES families and for parents of younger children. Furthermore, the association between the parenting relating factors and children's PA and screen time differed for boys and girls. Conclusions In contrast to what we expected, the findings of the current study show that only a very few specific parenting practices and related parental self-efficacy were associated with children's PA and screen time. It was expected that parental self-efficacy would play a more important role. This can be due to the fact that parental self-efficacy was already high in this group of parents. Therefore, it is possible that parents do not realise how difficult it is to perform certain parenting practices until they are faced with it in an intervention. Trial registration number EC/2012/317. PMID:26346871

  8. Relational autonomy in informed consent (RAIC) as an ethics of care approach to the concept of informed consent.

    PubMed

    Osuji, Peter I

    2018-03-01

    The perspectives of the dominant Western ethical theories, have dominated the concepts of autonomy and informed consent for many years. Recently this dominant understanding has been challenged by ethics of care which, although, also emanates from the West presents a more nuanced concept: relational autonomy, which is more faithful to our human experience. By paying particular attention to relational autonomy, particularity and Process approach to ethical deliberations in ethics of care, this paper seeks to construct a concept of informed consent from the perspective of ethics of care which is here called relational autonomy-in-informed consent (RAIC). Thus, providing a broader theoretical basis for informed consent beyond the usual theoretical perspectives that are particularly Western. Care ethics provides such a broader basis because it appeals to a global perspective that encompasses lessons from other cultures, and this will help to enrich the current ideas of bioethics principles of autonomy and informed consent. This objective will be achieved by exploring the ethics of care emphasis on relationships based on a universal experience of caring; and by contrasting its concept of autonomy as relational with the understanding of autonomy in the approaches of the dominant moral theories that reflect rational, individualistic, and rights-oriented autonomy of the American liberalism.

  9. Is parenting style related to children's healthy eating and physical activity in Latino families?

    PubMed

    Arredondo, Elva M; Elder, John P; Ayala, Guadalupe X; Campbell, Nadia; Baquero, Barbara; Duerksen, Susan

    2006-12-01

    Parenting styles influence a child's risk for obesity. The goals of this study are to evaluate the influence of (i) parenting style on children's health behaviors (physical activity and dietary intake), (ii) children's sociodemographic characteristics on parenting style and on children's health behaviors and (iii) parents' sociodemographic characteristics on their use of controlling styles to promote a healthy home environment. Survey and anthropometric data were collected from a community sample of Latino parents (n = 812) and their children in kindergarten through second grade. Parental use of positive reinforcement and monitoring was associated with children's healthy eating and exercise. Also, parents' use of appropriate disciplining styles was associated with healthier eating, while parental use of control styles was associated with unhealthy eating. The daughters of parents who used controlling styles ate more unhealthy foods than did the sons. Older, employed and more acculturated parents used less controlling styles than their counterparts. Parenting interventions targeting children's dietary intake and physical activity should encourage parents to use more positive reinforcement and monitor their children's health behaviors as these parenting styles are associated with healthier behaviors. Moreover, intervention researchers may want to encourage Latino parents to use less controlling styles with girls as this parenting style increased girls' risk for unhealthy eating.

  10. [Dentistry and healthcare legislation 3: informed consent].

    PubMed

    Brands, W G; van der Ven, J M; Eijkman, M A J

    2013-06-01

    The relationship between a dentist and his patient is based on trust. The principle of informed consent contributes to the quality of that relationship of trust. According to the professional standards for such a relationship, it is up to the dentist to make sure that the patient is well informed. Reliable information is necessary if the patient is to be in a position to give his or her consent for treatment. The Dutch Law of Agreement to Medical Treatment (WGBO) provides aframework for informed consent. Disciplinary judges establish the scope and if necessary the limits. It is clear that, among other things, not defining the risks beforehand can be the basis for a (disciplinary) complaint. Determining the requirements of informed consent calls for familiarity with the law and communication skills. Programmes in dental education ought to devote more attention to this issue.

  11. Broad Consent For Research With Biological Samples: Workshop Conclusions

    PubMed Central

    Grady, Christine; Eckstein, Lisa; Berkman, Ben; Brock, Dan; Cook-Deegan, Robert; Fullerton, Stephanie M.; Greely, Hank; Hansson, Mats G.; Hull, Sara; Kim, Scott; Lo, Bernie; Pentz, Rebecca; Rodriguez, Laura; Weil, Carol; Wilfond, Benjamin S.; Wendler, David

    2016-01-01

    Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The NIH Clinical Center’s Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the range of consent strategies, gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. The manuscript describes areas of agreement as well as areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and timely topic. PMID:26305750

  12. Informed consent for braces.

    PubMed

    Jharwal, Vikas; Trehan, Mridula; Rathore, Nidhi; Rathee, Pooja; Agarwal, Deepesh; Mathur, Nikunj

    2014-05-01

    The influence of law on the orthodontic profession has greatly increased in the last few decades. Dental law has emerged today as a full-fedged specialty dealing with a variety of areas, like professional negligence, doctor-patient contracts, consumer protection laws, ethics, general and special health legislations and practice regulatory mechanisms. This article highlights the concept of informed consent which is based on the premise that each individual has a right to make decisions concerning his health, disease and treatment. How to cite this article: Jharwal V, Trehan M, Rathore N, Rathee P, Agarwal D, Mathur N. Informed Consent for Braces. Int J Clin Pediatr Dent 2014;7(2):105-108.

  13. Pragmatic Randomized Trials Without Standard Informed Consent?: A National Survey.

    PubMed

    Nayak, Rahul K; Wendler, David; Miller, Franklin G; Kim, Scott Y H

    2015-09-01

    Significant debate surrounds the issue of whether written consent is necessary for pragmatic randomized, controlled trials (RCTs) with low risk. To assess the U.S. public's views on alternatives to written consent for low-risk pragmatic RCTs. National experimental survey (2 × 2 factorial design) examining support for written consent versus general notification or verbal consent in 2 research scenarios. Web-based survey conducted in December 2014. 2130 U.S. adults sampled from a nationally representative, probability-based online panel (response rate, 64.0%). Respondent's recommendation to an ethics review board and personal preference as a potential participant on how to obtain consent or notification in the 2 research scenarios. Most respondents in each of the 4 groups (range, 60.3% to 71.5%) recommended written informed consent, and personal preferences were generally in accord with that advice. Most (78.9%) believed that the pragmatic RCTs did not pose additional risks, but 62.5% of these respondents would still recommend written consent. In contrast, a substantial minority in all groups (28.5% to 39.7%) recommended the alternative option (general notification or verbal consent) over written consent. Framing effects could have affected respondents' attitudes, and nonrespondents may have differed in levels of trust toward research or health care institutions. Most of the public favored written informed consent over the most widely advocated alternatives for low-risk pragmatic RCTs; however, a substantial minority favored general notification or verbal consent. Time-sharing Experiments for the Social Sciences and Intramural Research Program of the National Institutes of Health Clinical Center.

  14. Informed Consent to Research in Long-Term Care Settings

    PubMed Central

    Jablonski, Rita A.; Bourbonniere, Meg; Kolanowski, Ann

    2010-01-01

    Informed consent to nursing home research is a two-tiered process that begins with obtaining the consent of a long-term care community at the institutional level and progresses to the engagement of individuals in the consent process. Drawing on a review of the literature and the authors’ research experiences and institutional review board service, this paper describes the practical implications of nurse investigators’ obligation to ensure informed consent among participants in long-term care research. Recommendations focus on applying a community consent model to long-term care research, promoting an evidence-based approach to the protection of residents with decisional impairment, and increasing investigators’ attention to ethical issues involving long-term care staff. PMID:20078005

  15. Seeking consent for research with indigenous communities: a systematic review.

    PubMed

    Fitzpatrick, Emily F M; Martiniuk, Alexandra L C; D'Antoine, Heather; Oscar, June; Carter, Maureen; Elliott, Elizabeth J

    2016-10-22

    When conducting research with Indigenous populations consent should be sought from both individual participants and the local community. We aimed to search and summarise the literature about methods for seeking consent for research with Indigenous populations. A systematic literature search was conducted for articles that describe or evaluate the process of seeking informed consent for research with Indigenous participants. Guidelines for ethical research and for seeking consent with Indigenous people are also included in our review. Of 1447 articles found 1391 were excluded (duplicates, irrelevant, not in English); 56 were relevant and included. Articles were categorised into original research that evaluated the consent process (n = 5) or publications detailing the process of seeking consent (n = 13) and guidelines for ethical research (n = 38). Guidelines were categorised into international (n = 8); national (n = 20) and state/regional/local guidelines (n = 10). In five studies based in Australia, Canada and The United States of America the consent process with Indigenous people was objectively evaluated. In 13 other studies interpreters, voice recording, videos, pictures, flipcharts and "plain language" forms were used to assist in seeking consent but these processes were not evaluated. Some Indigenous organisations provide examples of community-designed resources for seeking consent and describe methods of community engagement, but none are evaluated. International, national and local ethical guidelines stress the importance of upholding Indigenous values but fail to specify methods for engaging communities or obtaining individual consent. In the 'Grey literature' concerns about the consent process are identified but no solutions are offered. Consultation with Indigenous communities is needed to determine how consent should be sought from the community and the individual, and how to evaluate this process.

  16. Parental safety concerns--a barrier to sport and physical activity in children?

    PubMed

    Boufous, Soufiane; Finch, Caroline; Bauman, Adrian

    2004-10-01

    To examine the extent to which parents and carers perceive injury and safety risks as serious enough to prevent or discourage their children, aged 5-12 years, from participating in sports/physical activity and to identify factors that influence these perceptions. An analysis of the 2001 New South Wales Child Health Survey. More than one-quarter of parents/ carers of active children aged 5-12 years reported discouraging or preventing children from playing a particular sport (34.7% for boys and 16.6% for girls) because of injury and safety concerns. In boys, the most frequently discouraged sport was rugby league (23.2%), followed by rugby union (7.5%) and Australian rules football (2.8%). Among girls, the most frequently discouraged activities were rollerblading (2.7%), rugby league (2.3%) and soccer (2.1%). Multivariate analysis shows that factors independently associated with parents' decision to prevent/discourage their child from engaging in sport/physical activity include their child's age and gender, language spoken at home, presence of disability, and the respondent's relation to the child. Efforts need to be made to modify some sports/ activities, such as football codes, in order to minimise injury and to ensure that children continue enjoying their favourite activity well into adulthood. Guidelines designed to promote physical activity among children and young adolescents need to take into account parental concerns regarding the associated risk of injury.

  17. Abnormal Neural Activation to Faces in the Parents of Children with Autism

    PubMed Central

    Yucel, G. H.; Belger, A.; Bizzell, J.; Parlier, M.; Adolphs, R.; Piven, J.

    2015-01-01

    Parents of children with an autism spectrum disorder (ASD) show subtle deficits in aspects of social behavior and face processing, which resemble those seen in ASD, referred to as the “Broad Autism Phenotype ” (BAP). While abnormal activation in ASD has been reported in several brain structures linked to social cognition, little is known regarding patterns in the BAP. We compared autism parents with control parents with no family history of ASD using 2 well-validated face-processing tasks. Results indicated increased activation in the autism parents to faces in the amygdala (AMY) and the fusiform gyrus (FG), 2 core face-processing regions. Exploratory analyses revealed hyper-activation of lateral occipital cortex (LOC) bilaterally in autism parents with aloof personality (“BAP+”). Findings suggest that abnormalities of the AMY and FG are related to underlying genetic liability for ASD, whereas abnormalities in the LOC and right FG are more specific to behavioral features of the BAP. Results extend our knowledge of neural circuitry underlying abnormal face processing beyond those previously reported in ASD to individuals with shared genetic liability for autism and a subset of genetically related individuals with the BAP. PMID:25056573

  18. Informed Consent and Cognitive Dysfunction After Noncardiac Surgery in the Elderly.

    PubMed

    Hogan, Kirk J; Bratzke, Lisa C; Hogan, Kendra L

    2018-02-01

    Cognitive dysfunction 3 months after noncardiac surgery in the elderly satisfies informed consent thresholds of foreseeability in 10%-15% of patients, and materiality with new deficits observed in memory and executive function in patients with normal test performance beforehand. At present, the only safety step to avoid cognitive dysfunction after surgery is to forego surgery, thereby precluding the benefits of surgery with removal of pain and inflammation, and resumption of normal nutrition, physical activity, and sleep. To assure that consent for surgery is properly informed, risks of both cognitive dysfunction and alternative management strategies must be discussed with patients by the surgery team before a procedure is scheduled.

  19. Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

    PubMed

    Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

    2018-02-01

    Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

  20. Consent for pediatric anesthesia: an observational study.

    PubMed

    Lagana, Zoe; Foster, Andrew; Bibbo, Adriana; Dowling, Kate; Cyna, Allan M

    2012-08-01

    Informed consent prior to anesthesia is an important part of the pediatric pre-anesthetic consultation. This study aimed to observe and identify the number and nature of the anesthesia risks considered and communicated to parents/guardians and children during the pediatric informed consent process on the day of elective surgery. A convenience sample of anesthetists had their pre-anesthesia consultations voice recorded, prior to elective surgery, during a 4-month period at the largest tertiary referral centre for pediatric care in South Australia. A data collection form was used to note baseline demographic data, and voice recording transcripts were independently documented by two researchers and subsequently compared for accuracy regarding the number and nature of risks discussed. Of the 96 voice recordings, 91 (92%) were suitable for the analysis. The five most commonly discussed risks were as follows: nausea and vomiting (36%); sore throat (35%); allergy (29%); hypoxia (25%); and emergence delirium (19%). Twenty-seven pre-anesthetic consultations (30%) were found to have had no discussion of anesthetic risk at all while a further 23 consultations (26%) incorporated general statements inferring that anesthesia carried risks, but with no elaboration about their nature, ramifications or incidence. The median number of risks (IQR) specifically mentioned per consultation was higher, 3 (1) vs 1 (1), P < 0.05, when the consultation was performed by a trainee rather than a consultant anesthetist and when the patient had previous anesthesia experience odds ratio 0.34, 95% CI [0.13, 0.87], P = 0.025. The pediatric anesthesia risk discussion is very variable. Trainees tend to discuss more specific risks than consultants and a patient's previous experience of anesthesia was associated with a more limited discussion of anesthesia risk. © 2011 Blackwell Publishing Ltd.

  1. Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

    PubMed

    Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

    2018-03-01

    Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

  2. Non-completion and informed consent.

    PubMed

    Wertheimer, Alan

    2014-02-01

    There is a good deal of biomedical research that does not produce scientifically useful data because it fails to recruit a sufficient number of subjects. This fact is typically not disclosed to prospective subjects. In general, the guidance about consent concerns the information required to make intelligent self-interested decisions and ignores some of the information required for intelligent altruistic decisions. Bioethics has worried about the 'therapeutic misconception', but has ignored the 'completion misconception'. This article argues that, other things being equal, prospective subjects should be informed about the possibility of non-completion as part of the standard consent process if (1) it is or should be anticipatable that there is a non-trivial possibility of non-completion and (2) that information is likely to be relevant to a prospective subject's decision to consent. The article then considers several objections to the argument, including the objection that disclosing non-completion information would make recruitment even more difficult.

  3. Understanding the Public's Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey.

    PubMed

    De Vries, Raymond Gene; Tomlinson, Tom; Kim, Hyungjin Myra; Krenz, Chris; Haggerty, Diana; Ryan, Kerry A; Kim, Scott Y H

    2016-01-01

    Researchers and policymakers do not agree about the most appropriate way to get consent for the use of donations to a biobank. The most commonly used method is blanket-or broad-consent where donors allow their donation to be used for any future research approved by the biobank. This approach does not account for the fact that some donors may have moral concerns about the uses of their biospecimens. This problem can be avoided using "real-time"-or study-by-study-consent, but this policy places a significant burden on biobanks. In order to better understand the public's preferences regarding biobank consent policy, we surveyed a sample that was representative of the population of the United States. Respondents were presented with 5 biobank consent policies and were asked to indicate which policies were acceptable/unacceptable and to identify the best/worst policies. They were also given 7 research scenarios that could create moral concern (e.g. research intending to make abortions safer and more effective) and asked how likely they would be to provide broad consent knowing that their donation might be used in that research. Substantial minorities found both broad and study-by-study consent to be unacceptable and identified those two options as the worst policies. Furthermore, while the type of moral concern (e.g., regarding abortion, the commercial use of donations, or stem cell research) had no effect on policy preferences, an increase in the number of research scenarios generating moral concerns was related to an increased likelihood of finding broad consent to be the worst policy. The rejection of these ethically problematic and costly extremes is good news for biobanks. The challenge now is to design a policy that combines consent with access to information in a way that assures potential donors that their interests and moral concerns are being respected.

  4. Parent-child interactions and objectively measured child physical activity: a cross-sectional study

    USDA-ARS?s Scientific Manuscript database

    Parents influence their children's behaviors directly through specific parenting practices and indirectly through their parenting style. Some practices such as logistical and emotional support have been shown to be positively associated with child physical activity (PA) levels, while for others (e.g...

  5. Development and Pilot Testing of a Video-Assisted Informed Consent Process

    PubMed Central

    Sonne, Susan C.; Andrews, Jeannette O.; Gentilin, Stephanie M.; Oppenheimer, Stephanie; Obeid, Jihad; Brady, Kathleen; Wolf, Sharon; Davis, Randal; Magruder, Kathryn

    2013-01-01

    The informed consent process for research has come under scrutiny, as consent documents are increasingly long and difficult to understand. Innovations are needed to improve comprehension in order to make the consent process truly informed. We report on the development and pilot testing of video clips that could be used during the consent process to better explain research procedures to potential participants. Based on input from researchers and community partners, 15 videos of common research procedures/concepts were produced. The utility of the videos was then tested by embedding them in mock informed consent documents that were presented via an online electronic consent system designed for delivery via iPad. Three mock consents were developed, each containing five videos. All participants (n=61) read both a paper version and the video-assisted iPad version of the same mock consent and were randomized to which format they reviewed first. Participants were given a competency quiz that posed specific questions about the information in the consent after reviewing the first consent document to which they were exposed. Most participants (78.7%) preferred the video-assisted format compared to paper (12.9%). Nearly all (96.7%) reported that the videos improved their understanding of the procedures described in the consent document; however, comprehension of material did not significantly differ by consent format. Results suggest videos may be helpful in providing participants with information about study procedures in a way that is easy to understand. Additional testing of video consents for complex protocols and with subjects of lower literacy is warranted. PMID:23747986

  6. Consent, competency and ECT: a psychiatrist's view

    PubMed Central

    Taylor, P J

    1983-01-01

    Dr Taylor, an English psychiatrist, considers the issue of the symposium in the context of the Mental Health (Amendment) Act 1982. This, she says, gives little guidance on how judgment of a patient's competency or capability to consent to treatment should be made, although it specifies that unless compulsorily detained patients competently consent to ECT a special second medical opinion is required. Although some guidelines from the Department of Health may be offered before implementation of the Act in September 1983 all those working with psychiatric patients will have to consider the issues. After discussing her criteria for informed consent, some practical approaches for obtaining it and problems arising from these, and problems of surrogate consent, Dr Taylor concludes that there is no single or simple solution to the dilemma. She ends by asking: `Can refusal of ECT for severe depression ever be a competent decision?' PMID:6620319

  7. Chemically dependent physicians and informed consent disclosure.

    PubMed

    Ackerman, T F

    1996-01-01

    Developments in law, professional guidelines, and public attitudes support informed consent disclosure by physicians who have been treated for chemical dependency. This view is built on the apparent materiality of the risk of relapse to informed treatment decisions by patients. Several considerations undercut this position. The probability is remote that a patient will be injured by a recovering physician who suffers an undetected relapse while being properly monitored. Monitoring by impaired physicians programs provides a more sensitive and specific mechanism for detecting relapsed physicians. Moreover, compromise of the privacy and employment rights of recovering physicians by consent disclosure is not justified if programs provide rigorous monitoring that protects the welfare of patients. Finally, required consent disclosure will reduce referrals of chemically dependent physicians to impaired physicians programs, thereby increasing the danger to patients. Limiting demands for required consent disclosure necessitates effective operation of impaired physicians programs.

  8. The effect of informed consent on stress levels associated with extraction of impacted mandibular third molars.

    PubMed

    Casap, Nardy; Alterman, Michael; Sharon, Guy; Samuni, Yuval

    2008-05-01

    To evaluate the effect of informed consent on stress levels associated with removal of impacted mandibular third molars. A total of 60 patients scheduled for extraction of impacted mandibular third molars participated in this study. The patients were unaware of the study's objectives. Data from 20 patients established the baseline levels of electrodermal activity (EDA). The remaining 40 patients were randomly assigned into 2 equal groups receiving either a detailed document of informed consent, disclosing the possible risks involved with the surgery, or a simplified version. Pulse, blood pressure, and EDA were monitored before, during, and after completion of the consent document. Changes in EDA, but not in blood pressure, were measured on completion of either version of the consent document. A greater increase in EDA was associated with the detailed version of the consent document (P = .004). A similar concomitant increase (although nonsignificant) in pulse values was monitored on completion of both versions. Completion of overdisclosed document of informed consent is associated with changes in physiological parameters. The results suggest that overdetailed listing and disclosure before extraction of impacted mandibular third molars can increase patient stress.

  9. 32 CFR Appendix F to Part 57 - Parent and Student Rights

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... of a child with a disability or suspected of having a disability shall be obtained before any of the... educational placement. (iii) Change in EIS or educational placement. (2) If a parent of an infant or toddler... child 3 through 21 years, inclusive, refuses consent to initial evaluation, reevaluation, or initial...

  10. 32 CFR Appendix F to Part 57 - Parent and Student Rights

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... of a child with a disability or suspected of having a disability shall be obtained before any of the... educational placement. (iii) Change in EIS or educational placement. (2) If a parent of an infant or toddler... child 3 through 21 years, inclusive, refuses consent to initial evaluation, reevaluation, or initial...

  11. 32 CFR Appendix F to Part 57 - Parent and Student Rights

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... of a child with a disability or suspected of having a disability shall be obtained before any of the... educational placement. (iii) Change in EIS or educational placement. (2) If a parent of an infant or toddler... child 3 through 21 years, inclusive, refuses consent to initial evaluation, reevaluation, or initial...

  12. 32 CFR Appendix F to Part 57 - Parent and Student Rights

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... of a child with a disability or suspected of having a disability shall be obtained before any of the... educational placement. (iii) Change in EIS or educational placement. (2) If a parent of an infant or toddler... child 3 through 21 years, inclusive, refuses consent to initial evaluation, reevaluation, or initial...

  13. 32 CFR Appendix F to Part 57 - Parent and Student Rights

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... of a child with a disability or suspected of having a disability shall be obtained before any of the... educational placement. (iii) Change in EIS or educational placement. (2) If a parent of an infant or toddler... child 3 through 21 years, inclusive, refuses consent to initial evaluation, reevaluation, or initial...

  14. 49 CFR 383.72 - Implied consent to alcohol testing.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Implied consent to alcohol testing. 383.72 Section 383.72 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER... consent to alcohol testing. Any person who holds a CDL is considered to have consented to such testing as...

  15. Parent-offspring correlations in pedometer-assessed physical activity.

    PubMed

    Jacobi, David; Caille, Agnès; Borys, Jean-Michel; Lommez, Agnès; Couet, Charles; Charles, Marie-Aline; Oppert, Jean-Michel

    2011-01-01

    Physical activity is a major component of a healthy lifestyle in youth and adults. To identify determinants of this complex behavior is an important research objective in the process of designing interventions to promote physical activity at population level. In addition to individual determinants, there is evidence documenting familial influences on physical activity. However, the few studies that have addressed this issue with objective measures did not provide data on parent-offspring physical activity relationships throughout childhood and adolescence. The purpose of this study was to assess familial correlations in pedometer-assessed physical activity. We measured ambulatory activity in 286 French nuclear families (283 mothers, 237 fathers, and 631 children aged 8-18 years) by pedometer recordings (Yamax Digiwalker DW 450) over a week. Correlations were computed with their 95% confidence intervals (CI) for spouse pairs, siblings, mother-offspring, and father-offspring. Data were expressed as steps per day and computed both for the full recording period and separately for weekdays and weekends. The correlations were the highest between siblings (r=0.28, 95%CI: 0.17-0.38). Parent-offspring correlations were significant in mothers (r=0.21, 95%CI: 0.12-0.30), especially between mothers and daughters (r=0.24, 95%CI: 0.12-0.36 vs. r=0.18, 95%CI: 0.05-0.31 for sons), but were almost nonexistent in fathers. Correlations were generally higher on weekend days compared to weekdays. Mother-offspring correlations did not decrease with increasing age of children (r=0.17, 95%CI: 0.00-0.34 in 8-11-year-olds, r=0.20, 95%CI: 0.07-0.33 in 12-15-year-olds, and r=0.25, 95%CI: 0.07-0.39 in ≥16-year-olds). Finally, between-spouse correlations were significant only during weekend days (r=0.14, 95%CI: 0.01-0.27). Ambulatory activity correlated within families, with a possible mother effect. Mother-offspring correlations remained significant through the transition from childhood to

  16. Audio-visual presentation of information for informed consent for participation in clinical trials.

    PubMed

    Synnot, Anneliese; Ryan, Rebecca; Prictor, Megan; Fetherstonhaugh, Deirdre; Parker, Barbara

    2014-05-09

    using meta-analysis, where possible, and narrative synthesis of results. We assessed the risk of bias of individual studies and considered the impact of the quality of the overall evidence on the strength of the results. We included 16 studies involving data from 1884 participants. Nine studies included participants considering real clinical trials, and eight included participants considering hypothetical clinical trials, with one including both. All studies were conducted in high-income countries.There is still much uncertainty about the effect of audio-visual informed consent interventions on a range of patient outcomes. However, when considered across comparisons, we found low to very low quality evidence that such interventions may slightly improve knowledge or understanding of the parent trial, but may make little or no difference to rate of participation or willingness to participate. Audio-visual presentation of informed consent may improve participant satisfaction with the consent information provided. However its effect on satisfaction with other aspects of the process is not clear. There is insufficient evidence to draw conclusions about anxiety arising from audio-visual informed consent. We found conflicting, very low quality evidence about whether audio-visual interventions took more or less time to administer. No study measured researcher satisfaction with the informed consent process, nor ease of use.The evidence from real clinical trials was rated as low quality for most outcomes, and for hypothetical studies, very low. We note, however, that this was in large part due to poor study reporting, the hypothetical nature of some studies and low participant numbers, rather than inconsistent results between studies or confirmed poor trial quality. We do not believe that any studies were funded by organisations with a vested interest in the results. The value of audio-visual interventions as a tool for helping to enhance the informed consent process for people

  17. Informed Consent for Case Reports

    PubMed Central

    Levine, Stephen B.; Stagno, Susan J.

    2001-01-01

    A new international standard of editorial policy calls for written informed consent by the subject of every case report. Although this appears to be ethically appealing, the authors posit that in some situations, requesting informed consent may be unethical, can harm patients, and may erode the use of case reports as a valuable teaching method in psychiatry and psychotherapy. The authors discuss concerns regarding this new policy for mental health publication based on issues of transference, countertransference, best interest of the patient, and practicality. PMID:11402083

  18. The contribution of parent-child numeracy activities to young Chinese children's mathematical ability.

    PubMed

    Huang, Qi; Zhang, Xiao; Liu, Yingyi; Yang, Wen; Song, Zhanmei

    2017-09-01

    A growing body of recent research has shown that parent-child mathematical activities have a strong effect on children's mathematical learning. However, this research was conducted predominantly in Western societies and focused mainly on mothers' involvement in such activities. This study aimed to examine both mother-child and father-child numeracy activities in Hong Kong Chinese families and both parents' unique roles in predicting young Chinese children's mathematics ability. A sample of 104 Hong Kong Chinese children aged approximately 5 years and their mothers and fathers participated in this study. Mothers and fathers independently reported the frequency of their own numeracy activities with their children. Children were assessed individually using two measures of mathematical ability. Hierarchical regression models were used to investigate the contribution of parent-child numeracy activities to children's mathematical ability. Mothers' participation in number skill activities and fathers' participation in number game and application activities significantly predicted their children's mathematical performance even after controlling for background variables and children's language ability. This study extends previous research with a sample of Chinese kindergarten children and shows that parent-child numeracy activities are related to young children's mathematical ability. The findings highlight the important roles that mothers and fathers play in their young children's mathematical learning. © 2017 The British Psychological Society.

  19. Waiver of consent in noninterventional, observational emergency research: the PROMMTT experience.

    PubMed

    Fox, Erin E; Bulger, Eileen M; Dickerson, Aisha S; del Junco, Deborah J; Klotz, Patricia; Podbielski, Jeanette; Matijevic, Nena; Brasel, Karen J; Holcomb, John B; Schreiber, Martin A; Cotton, Bryan A; Phelan, Herb A; Cohen, Mitchell J; Myers, John G; Alarcon, Louis H; Muskat, Peter; Wade, Charles E; Rahbar, Mohammad H

    2013-07-01

    In the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study, waiver of consent was used because previous literature reported low response rates and subsequent bias. The goal of this article was to examine the rationale and tradeoffs of using waiver of consent in PROMMTT. PROMMTT enrolled trauma patients receiving at least 1 U of red blood cells within 6 hours after admission at 10 US Level 1 trauma centers. Local institutional review boards (IRBs) from all sites approved the study. Site 8 was required by their IRB to attempt consent but was allowed to retain data on patients unable to be consented. Of 121 subjects enrolled at Site 8, 55 consents were obtained (46%), and no patient or legally authorized representative refused to give consent. Of the patients, 36 (30%) died, and 6 (5%) were discharged before consent could be attempted. Consent was attempted but not possible among 24 patients (20%). Of the 10 clinical sites, 6 of the local IRBs approved collection of residual blood samples, 1 had previous approval to collect timed blood samples under a separate protocol, and 3 reported that their local IRBs would not approve collection of residual blood under a waiver of consent. Waiver of consent was used in PROMMTT because of the potential adverse impact of consent refusals; however, there were no refusals. If the IRB for Site 8 had required withdrawal of patients unable to consent and destruction of their data, a serious bias would likely have been introduced. Other tradeoffs included a reduction in sites participating in residual blood collection and a smaller than expected amount of residual blood collected among sites operating under a waiver of consent. Noninterventional emergency research studies should consider these potential tradeoffs carefully before deciding whether waiver of consent would best achieve the goals of a study.

  20. 21 CFR 1316.08 - Consent to inspection.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Consent to inspection. 1316.08 Section 1316.08 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.08 Consent to inspection. (a) An administrative...

  1. Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer

    PubMed Central

    Haase, Joan E.; Perkins, Susan M.; Haut, Paul R.; Henley, Amanda K.; Knafl, Kathleen A.; Tong, Yan

    2017-01-01

    Objectives To examine the feasibility/acceptability of a parent-delivered Active Music Engagement (AME + P) intervention for young children with cancer and their parents. Secondary aim to explore changes in AME + P child emotional distress (facial affect) and parent emotional distress (mood; traumatic stress symptoms) relative to controls. Methods A pilot two-group randomized trial was conducted with parents/children (ages 3–8 years) receiving AME + P (n  =  9) or attention control (n  =  7). Feasibility of parent delivery was assessed using a delivery checklist and child engagement; acceptability through parent interviews; preliminary outcomes at baseline, postintervention, 30 days postintervention. Results Parent delivery was feasible, as they successfully delivered AME activities, but interviews indicated parent delivery was not acceptable to parents. Emotional distress was lower for AME + P children, but parents derived no benefit. Conclusion Despite child benefit, findings do not support parent delivery of AME + P. PMID:27289068

  2. Sources of Variation in Consequences of Everyday Activity Settings on Child and Parent Functioning

    ERIC Educational Resources Information Center

    Trivette, Carol; Dunst, Carl; Hamby, Deborah

    2004-01-01

    Relationships between acculturation and enculturation, parent beliefs about child learning methods and parenting roles in children's learning, children's participation in family and community activity settings, and a variety of child, parent and family outcomes were examined in a sample of 203 parents. Information received from these parents…

  3. Is Parenting Style Related to Children's Healthy Eating and Physical Activity in Latino Families?

    ERIC Educational Resources Information Center

    Arredondo, Elva M.; Elder, John P.; Ayala, Guadalupe X.; Campbell, Nadia; Baquero, Barbara; Duerksen, Susan

    2006-01-01

    Parenting styles influence a child's risk for obesity. The goals of this study are to evaluate the influence of (i) parenting style on children's health behaviors (physical activity and dietary intake), (ii) children's sociodemographic characteristics on parenting style and on children's health behaviors and (iii) parents' sociodemographic…

  4. Postal consent for upper gastrointestinal endoscopy.

    PubMed

    Shepherd, H A; Bowman, D; Hancock, B; Anglin, J; Hewett, D

    2000-01-01

    Standards for good practice in clinical risk management issued by the Clinical Negligence Scheme for Trusts indicate that "appropriate information is provided to patients on the risks and benefits of proposed treatment, and of the alternatives available before a signature on a consent form is sought". To investigate the practicability and patient acceptability of a postal information and consent booklet for patients undergoing outpatient gastroscopy. Information about gastroscopy procedure, personalised appointment details, and a carbonised consent form were compiled into a single booklet. This was mailed to patients well in advance of their endoscopic procedure. Patient satisfaction for this new process was assessed by questionnaire. 275 patients received a patient information booklet. Of these, 150 (54.5%) returned the consent form by post when they confirmed their attendance; 141 (94%) had signed the form, and the other nine requested further information. Of the remaining 125 booklets sent out, 115 (92%) forms were brought back on the day of the investigation having been previously signed. The remaining 10 (8%) required further information before signing the form. An audit of 168 patients was used to test reaction to the booklet and the idea of filling in the form before coming to hospital; 155 patients (92. 2%) reported the information given in the booklet to be "very useful", and all reported it to be "clear and understandable". A specifically designed patient information booklet with integral consent form is accepted by patients, and improves the level of understanding prior to the investigation being carried out.

  5. Gaining informed consent for blood transfusion.

    PubMed

    Whitmore, Emma; Gerrard, Rebecca; Coffey, Kairen

    Transfusion of blood and blood products is a common procedure that has significant benefits but is also associated with serious risks. Patients needing blood transfusion require full information on these benefits and risks in order to make informed consent. This article, the first in a five-part series, discusses the process of gaining consent and resources available to support patients and health professionals in this.

  6. Motor training and physical activity among preschoolers with cerebral palsy: a survey of parents' experiences.

    PubMed

    Myrhaug, Hilde Tinderholt; Østensjø, Sigrid

    2014-05-01

    To describe motor training and physical activity among preschoolers with cerebral palsy (CP) in Norway, and assess associations between child, parent, and motor intervention characteristics, and parent-reported child benefits from interventions. Survey of 360 parents and data from the Norwegian CP follow-up program. The response rate was 34%. During the six months preceding the time of the survey, 75% of the children performed gross-motor training, 73% fine-motor training, 80% manual stretching, and 67% participated regularly in physical activities. The training was highly goal-directed, intensive, frequently incorporated in daily routines, and often with a high level of parental involvement. The use of goals was associated with higher parent-reported child benefits for all types of interventions. Moreover, the positive relationship, which was indicated between frequency of training, parent education, and parent-reported child benefits of gross-motor training, was not seen for fine-motor training. Parent-reported child benefits support goal-directed motor interventions, and the use of everyday activities to increase practice of motor skills.

  7. Do specific parenting practices and related parental self-efficacy associate with physical activity and screen time among primary schoolchildren? A cross-sectional study in Belgium.

    PubMed

    De Lepeleere, Sara; De Bourdeaudhuij, Ilse; Cardon, Greet; Verloigne, Maïté

    2015-09-07

    To assess the association between specific parenting practices and related parental self-efficacy with children's physical activity (PA) and screen time. Parental body mass index (BMI), family socioeconomic status (SES), and child's age and gender were examined as possible influencing factors. Cross-sectional. January 2014, Flanders (Belgium). 207 parents (87.4% mothers) of children aged 6-12 years. Specific parenting practices, related parental self-efficacy, and children's PA and screen time. The majority of investigated parenting practices and related parental self-efficacy were not significantly associated with children's PA or screen time. However, children were more physically active if sports equipment was available at home (p<0.10) and if parents did not find it difficult to motivate their child to be physically active (p<0.05). Children had a lower screen time if parents limited their own gaming (p<0.01). The associations between parenting practices and related parental self-efficacy with children's PA or screen time were significant for parents with a normal BMI, for medium-high SES families and for parents of younger children. Furthermore, the association between the parenting relating factors and children's PA and screen time differed for boys and girls. In contrast to what we expected, the findings of the current study show that only a very few specific parenting practices and related parental self-efficacy were associated with children's PA and screen time. It was expected that parental self-efficacy would play a more important role. This can be due to the fact that parental self-efficacy was already high in this group of parents. Therefore, it is possible that parents do not realise how difficult it is to perform certain parenting practices until they are faced with it in an intervention. EC/2012/317. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  8. Physical activity practice among children and adolescents with visual impairment--influence of parental support and perceived barriers.

    PubMed

    Greguol, Márcia; Gobbi, Erica; Carraro, Attilio

    2015-01-01

    To analyze the practice of physical activity among children and adolescents with visual impairments (VI), regarding the possible influence of parental support and perceived barriers. Twenty-two young people with VIs (10 + 2.74 years old) and one of each of their parents were evaluated. They responded to the Physical Activity Questionnaire for Older Children (PAQ-C), Baecke Questionnaire, the Parental Support Scale and a questionnaire about perceived barriers to physical activity. The independent samples t-test, pearson correlation test and chi-square test were performed. Blind young people showed lower physical activity levels. There were significant correlations both between parents' physical activity and the support offered to children and between the PAQ-C results and the importance given by young people to physical activity, but only for those aged between 8 and 10 years old. The main perceived barriers were lack of security, motivation, professional training and information about available physical activity programs. The influence of parental support seems to be an important factor in the adoption of a physically active lifestyle for young people with VI. Parents and children should have more information about the benefits and opportunities of physical activity. Implications for Rehabilitation Young people with visual impairment should be encouraged by parents to practice physical activity. More information should be provided on the benefits of physical activity to both parents and children. Professional training should be available to help support this group become more active.

  9. Organ procurement organizations Internet enrollment for organ donation: Abandoning informed consent

    PubMed Central

    Woien, Sandra; Rady, Mohamed Y; Verheijde, Joseph L; McGregor, Joan

    2006-01-01

    Background Requirements for organ donation after cardiac or imminent death have been introduced to address the transplantable organs shortage in the United States. Organ procurement organizations (OPOs) increasingly use the Internet for organ donation consent. Methods An analysis of OPO Web sites available to the public for enrollment and consent for organ donation. The Web sites and consent forms were examined for the minimal information recommended by the United States Department of Health and Human Services for informed consent. Content scores were calculated as percentages of data elements in four information categories: donor knowledge, donor consent reinforcement, donation promotion, and informed consent. Results There were 60 Web sites for organ donation enrollment serving the 52 states. The median percent (10 percentile-90 percentile) content scores of the Web sites for donor knowledge, donor consent reinforcement, and donation promotion were 33% (20–47), 79% (57–86), and 75% (50–100), respectively. The informed consent score was 0% (0–33). The content scores for donor knowledge and informed consent were significantly lower than donor consent reinforcement and donation promotion for all Web sites (P < .05). The content scores for the four categories were similar among the 11 regions of the United Network for Organ Sharing. Conclusion The Web sites and consent forms for public enrollment in organ donation do not fulfill the necessary requirements for informed consent. The Web sites predominantly provide positive reinforcement and promotional information rather than the transparent disclosure of organ donation process. Independent regulatory oversight is essential to ensure that Internet enrollment for organ donation complies with legal and ethical standards for informed consent. PMID:17187671

  10. Development and pilot testing of a video-assisted informed consent process.

    PubMed

    Sonne, Susan C; Andrews, Jeannette O; Gentilin, Stephanie M; Oppenheimer, Stephanie; Obeid, Jihad; Brady, Kathleen; Wolf, Sharon; Davis, Randal; Magruder, Kathryn

    2013-09-01

    The informed consent process for research has come under scrutiny, as consent documents are increasingly long and difficult to understand. Innovations are needed to improve comprehension in order to make the consent process truly informed. We report on the development and pilot testing of video clips that could be used during the consent process to better explain research procedures to potential participants. Based on input from researchers and community partners, 15 videos of common research procedures/concepts were produced. The utility of the videos was then tested by embedding them in mock-informed consent documents that were presented via an online electronic consent system designed for delivery via iPad. Three mock consents were developed, each containing five videos. All participants (n = 61) read both a paper version and the video-assisted iPad version of the same mock consent and were randomized to which format they reviewed first. Participants were given a competency quiz that posed specific questions about the information in the consent after reviewing the first consent document to which they were exposed. Most participants (78.7%) preferred the video-assisted format compared to paper (12.9%). Nearly all (96.7%) reported that the videos improved their understanding of the procedures described in the consent document; however, the comprehension of material did not significantly differ by consent format. Results suggest videos may be helpful in providing participants with information about study procedures in a way that is easy to understand. Additional testing of video consents for complex protocols and with subjects of lower literacy is warranted. Copyright © 2013 Elsevier Inc. All rights reserved.

  11. Accelerometry-Derived Physical Activity Correlations Between Parents and Their Fourth-Grade Child Are Specific to Time of Day and Activity Level.

    PubMed

    Strutz, Erin; Browning, Raymond; Smith, Stephanie; Lohse, Barbara; Cunningham-Sabo, Leslie

    2018-06-01

    The purpose of this study was to employ high-frequency accelerometry to explore parent-child physical activity (PA) relationships across a free-living sample. We recorded 7 days of wrist-mounted accelerometry data from 168 dyads of elementary-aged children and their parents. Using a custom MATLAB program (Natick, MA), we summed child and parent accelerations over 1 and 60 seconds, respectively, and applied published cut points to determine the amount of time spent in moderate-vigorous PA (MVPA). Bivariate and partial correlations examined parent-child relationships between percentage of time spent in MVPA. Weak to moderate positive correlations were observed before school (r = .326, P < .001), after school (r = .176, P = .023), during the evening (r = .213, P = .006), and on weekends (r = .231, P = .003). Partial correlations controlling for parent-child MVPA revealed significant relationships during the school day (r = .185, P = .017), before school (r = .315, P < .001), and on weekends (r = .266, P = .001). In addition, parents of more active children were significantly more active than parents of less active children during the evening. These data suggest that there is some association between parent-child PA, especially before school and on weekends. Future interventions aiming to increase PA among adults and children must consider patterns of MVPA specific to children and parents and target them accordingly.

  12. Can informed consent to research be adapted to risk?

    PubMed

    Bromwich, Danielle; Rid, Annette

    2015-07-01

    The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits for the individual research participant. Furthermore, current proposals do not address the concern that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorisation. In this paper, we show how the standard view of informed consent--consent as autonomous authorisation--can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  13. Parental Social Support and the Physical Activity-Related Behaviors of Youth: A Review

    ERIC Educational Resources Information Center

    Beets, Michael W.; Cardinal, Bradley J.; Alderman, Brandon L.

    2010-01-01

    Social support from parents serves as one of the primary influences of youth physical activity-related behaviors. A systematic review was conducted on the relationship of parental social support to the physical activity-related behaviors of youth. Four categories of social support were identified, falling under two distinct mechanisms--tangible…

  14. Parental leave and increased physical activity of fathers and mothers--results from the Northern Swedish Cohort.

    PubMed

    Johansson, Klara; Wennberg, Patrik; Hammarström, Anne

    2014-12-01

    Physical activity is an important public health issue. Factors shown to be associated with physical activity are parenthood and country-level gender equality, while the importance of individual gender equality (in parenthood or in general) remains to explore. In Scandinavia, where parental leave can be shared equally between mothers and fathers, parental leave is one dimension of gender equality in parenthood. The aim of this study was to investigate parental leave in relation to increased physical activity among men and women. Participants in the Northern Swedish Cohort with a child born 1993-2005 (n = 584) were investigated with questionnaires at ages 21 and 42; register data on parental leave between ages 28 and 42 were obtained from Statistics Sweden. The relationships between parental leave between ages 28 and 42 and meeting WHO guidelines for physical activity at age 42, as well as changes in physical activity between ages 21 and 42, were tested with multinomial regression, controlling for socio-economic status and birth year of the child. For women, the length of parental leave was not associated with increased physical activity or with meeting WHO guidelines at age 42. For men, parental leave was associated with increased physical activity, controlling for socio-economic status and age of the child, but not with meeting WHO guidelines for physical activity at age 42. A gender non-traditional out-take of parental leave might be associated with an increase in physical activity among men at the lower end of the physical activity spectrum, but not among women. © The Author 2014. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

  15. Parental perceptions of barriers to physical activity in children with developmental disabilities living in Trinidad and Tobago.

    PubMed

    Njelesani, Janet; Leckie, Karen; Drummond, Jennifer; Cameron, Deb

    2015-01-01

    Parents have a strong influence on their child's engagement in physical activities, especially for children with developmental disabilities, as these children are less likely to initiate physical activity. Knowledge is limited regarding parents' perceptions of this phenomenon in low- and middle-income countries (LMICs); yet many rehabilitation providers work with children with developmental disabilities and their parents in these contexts. The aim of this study was to explore the barriers perceived by parents of children with developmental disabilities to their children's engagement in physical activity. An occupational perspective was used to explore how parents speak about barriers to their child's engagement in physical activity. Interviews were conducted with nine parents in Port-of-Spain, Trinidad and Tobago. Parent's perceived barriers were categorized into four themes: family priorities, not an option in our environment, need to match the activity to the child's ability, and need for specialized supports. FINDINGS provide opportunities for future rehabilitation and community programming in LMICs. Implications for Rehabilitation Children living with a developmental disability may engage more in solitary and sedentary pursuits as a result of parents choosing activities that do not present extensive social and physical demands for their child. Therapists can play an important role in providing knowledge to parents of appropriate physical activity and the benefits of physical activity for children with developmental disabilities in order to promote children's participation. In environments where there is limited social support for families, therapists need to consider and be particularly supportive of parental priorities and schedules.

  16. Parents' contrasting views on diet versus activity of children: implications for health promotion and obesity prevention.

    PubMed

    Lopez-Dicastillo, Olga; Grande, Gunn; Callery, Peter

    2010-01-01

    To investigate parents' perceptions of, and contributions to, food and activity choices and maintenance of a healthy lifestyle in children. Ethnographically informed qualitative study using in-depth semi-structured interviews with 47 parents (32 mothers and 15 fathers) of 5-7-year-old children. Parents were concerned about children's low intake of food, the development of eating disorders and children being 'too active'. Therefore, they promoted eating and were controlling of diet because they thought that children would not eat enough for healthy development. They did not promote, or even curbed, physical activity because they considered their children were already active. Their accounts suggested lack of awareness of the dangers of over-consumption and inactivity. Parents' perceptions affected the way they raised their children and the choices that they made for them. Parents' concerns about under-consumption of food and over-activity contrast with the public health priorities to reduce intake and promote exercise. Health professionals need to take into account parents' perspectives on diet and physical activity when attempting to promote children's health and prevent obesity.

  17. Abnormal Neural Activation to Faces in the Parents of Children with Autism.

    PubMed

    Yucel, G H; Belger, A; Bizzell, J; Parlier, M; Adolphs, R; Piven, J

    2015-12-01

    Parents of children with an autism spectrum disorder (ASD) show subtle deficits in aspects of social behavior and face processing, which resemble those seen in ASD, referred to as the "Broad Autism Phenotype " (BAP). While abnormal activation in ASD has been reported in several brain structures linked to social cognition, little is known regarding patterns in the BAP. We compared autism parents with control parents with no family history of ASD using 2 well-validated face-processing tasks. Results indicated increased activation in the autism parents to faces in the amygdala (AMY) and the fusiform gyrus (FG), 2 core face-processing regions. Exploratory analyses revealed hyper-activation of lateral occipital cortex (LOC) bilaterally in autism parents with aloof personality ("BAP+"). Findings suggest that abnormalities of the AMY and FG are related to underlying genetic liability for ASD, whereas abnormalities in the LOC and right FG are more specific to behavioral features of the BAP. Results extend our knowledge of neural circuitry underlying abnormal face processing beyond those previously reported in ASD to individuals with shared genetic liability for autism and a subset of genetically related individuals with the BAP. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  18. Parental Work Demands and the Frequency of Child-Related Routine and Interactive Activities

    ERIC Educational Resources Information Center

    Roeters, Anne; Van Der Lippe, Tanja; Kluwer, Esther S.

    2009-01-01

    This study examined whether the frequency of child-related activities was associated with parents' own work demands and those of their partners. In addition to parental paid working hours, we considered the parents' organizational culture and experienced job insecurity. Moreover, we differentiated between child-related routine and interactive…

  19. Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study

    PubMed Central

    de Laat, Sonya; Schwartz, Lisa

    2016-01-01

    Introduction Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. Methods and analysis The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Design: Qualitative research study involving individual interviews and grounded theory methodology. Participants: SDMs for children enrolled into the SQUEEZE pilot trial. Sample size: Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Analysis: Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. Ethics and dissemination This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent

  20. Do parental involvement laws deter risky teen sex?

    PubMed

    Colman, Silvie; Dee, Thomas S; Joyce, Ted

    2013-09-01

    Parental involvement (PI) laws require that physicians notify or obtain consent from a parent(s) of a minor seeking an abortion before performing the procedure. Several studies suggest that PI laws curb risky sexual behavior because teens realize that they would be compelled to discuss a subsequent pregnancy with a parent. We show that prior evidence based on gonorrhea rates overlooked the frequent under-reporting of gonorrhea by race and ethnicity, and present new evidence on the effects of PI laws using more current data on the prevalence of gonorrhea and data that are novel to this literature (i.e., chlamydia rates and data disaggregated by year of age). We improve the credibility of our estimates over those in the existing literature using an event-study design in addition to standard difference-in-difference-in-differences (DDD) models. Our findings consistently suggest no association between PI laws and rates of sexually transmitted infections or measures of sexual behavior. Copyright © 2013 Elsevier B.V. All rights reserved.

  1. Informed consent: it is more than just a document.

    PubMed

    Wilhite, C Leigh

    2010-01-01

    With litigation in the forefront of the minds of most healthcare professionals today, obtaining valid, fully informed consent from patients means that no recovery should be allowed in a court of law against that provider for treating, examining, or operating on a patient without his or her informed consent when (1) the action of the provider in obtaining the consent of the patient, or person authorized to give consent, was in accordance with an accepted standard of practice and/or (2) a reasonable individual with information provided by the practitioner, under the circumstances, would have a general understanding of the procedure, the medically acceptable alternative procedures or treatments, and the substantial risks and hazards inherent in the proposed treatment or procedures, which are recognized among providers, in the same or similar community, who perform similar treatments. Most courts do not permit recovery against a provider if the patient would reasonably, under all the surrounding circumstances, have undergone such treatment or procedure as he or she had been advised by the provider. A consent that is evidenced in writing and meets requirements, if validly signed by the patient or another authorized person, raises a rebuttable presumption of a valid consent. A valid signature is the one that is given by a person who under all the surrounding circumstances is mentally and physically competent to give consent. Armed with this knowledge, the plastic surgical nurse will understand that informed consent is far more than just a document signed by the patient that becomes part of his or her medical record.

  2. 38 CFR 17.32 - Informed consent and advance care planning.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2013-07-01 2013-07-01 false Informed consent and... patient's activities, health, religious beliefs and values, and who has presented a signed written...) [62 FR 53961, Oct. 17, 1997, as amended at 70 FR 71774, Nov. 30, 2005; 71 FR 68740, Nov. 28, 2006; 72...

  3. 38 CFR 17.32 - Informed consent and advance care planning.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2014-07-01 2014-07-01 false Informed consent and... patient's activities, health, religious beliefs and values, and who has presented a signed written...) [62 FR 53961, Oct. 17, 1997, as amended at 70 FR 71774, Nov. 30, 2005; 71 FR 68740, Nov. 28, 2006; 72...

  4. 38 CFR 17.32 - Informed consent and advance care planning.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2012-07-01 2012-07-01 false Informed consent and... patient's activities, health, religious beliefs and values, and who has presented a signed written...) [62 FR 53961, Oct. 17, 1997, as amended at 70 FR 71774, Nov. 30, 2005; 71 FR 68740, Nov. 28, 2006; 72...

  5. 38 CFR 17.32 - Informed consent and advance care planning.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2010-07-01 2010-07-01 false Informed consent and... patient's activities, health, religious beliefs and values, and who has presented a signed written...) [62 FR 53961, Oct. 17, 1997, as amended at 70 FR 71774, Nov. 30, 2005; 71 FR 68740, Nov. 28, 2006; 72...

  6. 38 CFR 17.32 - Informed consent and advance care planning.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2011-07-01 2011-07-01 false Informed consent and... patient's activities, health, religious beliefs and values, and who has presented a signed written...) [62 FR 53961, Oct. 17, 1997, as amended at 70 FR 71774, Nov. 30, 2005; 71 FR 68740, Nov. 28, 2006; 72...

  7. Informed consent in high-risk renal transplant recipients.

    PubMed

    Cocchiara, G; Lo Monte, A I; Romano, G; Romano, M; Buscemi, G

    2009-06-01

    Before performing a clinical, diagnostic, and/or therapeutic action, the doctor is required to provide the patient with a bulk of information defined as informed consent. This expression was used for the first time in 1957 during a court case in California and the two words--informed and consent--are used together to underline the fact that the patient cannot give his or her true consent without first receiving correct information concerning the medical act in question. With regard to the medicolegal aspects governing organ transplants, despite the bulk of detailed work performed by health service workers involved in this surgical field with the aim of preparing adequate informed consent models, this has not yet been accompanied by the necessary legislative development. The informed consent model to be presented to the kidney transplant candidate should include a detailed description of the recipient's comorbidity and should aim at reducing the number of medicolegal actions, which have become more and more frequent in the last few years due to the ever increasing number of patients considered as suitable for transplantation. Informed consent, therefore, should not be a mere bureaucratic formality to be obtained casually, but should be carefully stipulated together with the patient by the transplant surgeon. It is, in fact, an indispensable condition for transforming a potentially illegal action, that is, the violation of an individual's psychophysical integrity, into a legal one.

  8. Good eggs? Evaluating consent forms for egg donation.

    PubMed

    Cattapan, Alana Rose

    2016-07-01

    Beyond gaps in the provision of information, the informed consent process for egg donation is complicated by conflicts of interest, payment and a lack of longitudinal data about physiological and psychological risks. Recent scholarship has suggested that egg donation programmes could improve the informed consent process by revising consent documents. At a minimum, these documents should include information about eight key criteria: the nature and objectives of treatment; the benefits, risks and inconveniences of egg donation; the privacy of donors and their anonymity (where applicable); disclosure that participation is voluntary (withdrawal); the availability of counselling; financial considerations; the possibility of an unsuccessful cycle and potential uses of the eggs retrieved. This study evaluates the incorporation of these minimum criteria in consent forms for egg donation, obtained through requests to Canadian fertility clinics. Even when clinics were considered to have met criteria simply by mentioning them, among the eight consent forms assessed, none met the minimum standards. Only half of clinics addressed privacy/anonymity concerns, financial issues and the possibility of a future cycle. Improving the quality of consent documentation to meet the minimum standards established by this study may not be an onerous task. For some, this will include re-evaluating how they include one or two elements of disclosure, and for others, this will require a substantial overhaul. Using the criteria provided by this study as the minimum standard for consent could ensure that donors have the basic information they need to make informed decisions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  9. Informed Consent Conversations and Documents: A Quantitative Comparison

    PubMed Central

    Koyfman, Shlomo A.; Reddy, Chandana A.; Hizlan, Sabahat; Leek, Angela C.; Kodish, Eric

    2015-01-01

    Background Informed consent for clinical research includes two components: informed consent documents (ICD) and informed consent conversations (ICC). Readability software has been used to help simplify the language of the ICD, but rarely employed to assess the language during the ICC, which may influence the quality of informed consent. This analysis was completed to determine if length and reading levels of transcribed ICCs are lower than their corresponding ICDs for selected clinical trials, and to assess whether investigator experience affected use of simpler language and comprehensiveness. Methods Prospective study where ICCs were audio-recorded at 6 institutions when families were offered participation in pediatric phase I oncology trials. Word count, Flesch-Kincaid Grade Level (FKGL) and Flesch Reading Ease Score (FRES) of ICCs were compared to corresponding ICDs, including the frequency that investigators addressed 8 pre-specified critical consent elements during the ICC. Results Sixty-nine unique physician/protocol pairs were identified. Overall, ICCs contained fewer words (4,677 vs. 6,364; p=0.0016), had lower FKGL (6 vs. 9.7; p=<0.0001) and higher FRES (77.8 vs. 56.7; p<0.0001) than their respective ICDs, but were more likely to omit critical consent elements, such as voluntariness (55%) and dose limiting toxicities (26%). Years of investigator experience was not correlated with reliably covering critical elements or decreased linguistic complexity. Conclusions Clinicians use more understandable language during ICCs than the corresponding ICD, but less reliably cover elements critical to fully informed consent. Focused efforts at providing communication training for clinician-investigators should be done to optimize the synergy between the ICD and conversation. PMID:26505269

  10. Informed Consent for Radiation in Interventional Radiology Procedures.

    PubMed

    Zener, Rebecca; Johnson, Peter; Wiseman, Daniele; Pandey, Sachin; Mujoomdar, Amol

    2018-02-01

    To explore the patient perception on radiation-related cancer risk from interventional radiology (IR) procedures and whether informed radiation consent is warranted. A multiple-choice survey was prospectively administered to 68 adults undergoing a body or neuro-IR procedure with ionizing radiation exposure. Subgroup analysis with chi-square or Fisher exact test was performed based on patient past IR history (P < .05). A total of 81% of patients wanted to be informed if there was a radiation-related 3% increased cancer risk over 5 years. Although 55% considered 3% a small risk, 28% wanted to further discuss the risks and alternate options, and 15% would have only proceeded if it were a life-saving procedure: 89%, 80%, and 67% of patients wanted to be informed with exposure risks of 1 in 100, 1 in 1000, and 1 in 10,000, respectively. Only 53% were aware they were going to be exposed to radiation, irrespective of past IR history (P = .15). Most patients believed radiation consent should include radiation-related cancer risks (85%). No past IR history was significantly associated with wanting consent to include cancer-related risk (100% vs 76%; P = .01) and deterministic risks (70% vs 41%; P = .04). A majority (69%) believed both the referring physician and the interventional radiologist were responsible for obtaining radiation consent, and 65% of patients wanted verbal consent followed by signed written consent, regardless of past IR history. Many patients want to discuss cancer-related radiation risks with both radiologists and physicians. Informed radiation consent should be considered for procedures with high anticipated radiation doses. Copyright © 2017. Published by Elsevier Inc.

  11. WHEN PARENTS CHOOSE GENDER: INTERSEX, CHILDREN, AND THE LAW.

    PubMed

    Newbould, Melanie

    2017-01-05

    In England and Wales, it is usually lawful for those with parental responsibility to consent to treatment on children who have not acquired legal capacity, providing that they are acting in the child's best interests. Whilst in most instances this process is unproblematic and the decisions made are non-controversial, there are troubling examples where this is more problematic. The difficulties for a family with a child who has an intersex condition will be considered to illustrate that there may be cases of medical and surgical treatment where even though both parents and doctors agree on a course of action in good faith, the treatment administered may not necessarily be in the best interests of the child. Sometimes, procedures carried out on an infant apparently in their best interests may later be a cause of regret to the child as an adult. The law in England and Wales will be examined to investigate other examples of controversial treatments of young children involving legal interventions to consider whether there are any parallels and what the implications of these might be to the intersex child. A model suggested by a Columbian legal case from 1995 is discussed. The courts ruled that infantile sex assignment surgery is lawful only following very stringent consent procedures. The possibility is considered that guidelines defining the consent procedure may afford some protection for the intersex child. © The Author 2017. Published by Oxford University Press; all rights reserved. For Permissions, please email: journals.permissions@oup.com.

  12. Informed consent process: A step further towards making it meaningful!

    PubMed Central

    Kadam, Rashmi Ashish

    2017-01-01

    Informed consent process is the cornerstone of ethics in clinical research. Obtaining informed consent from patients participating in clinical research is an important legal and ethical imperative for clinical trial researchers. Although informed consent is an important process in clinical research, its effectiveness and validity are always a concern. Issues related to understanding, comprehension, competence, and voluntariness of clinical trial participants may adversely affect the informed consent process. Communication of highly technical, complex, and specialized clinical trial information to participants with limited literacy, diverse sociocultural background, diminished autonomy, and debilitating diseases is a difficult task for clinical researchers. It is therefore essential to investigate and adopt innovative communication strategies to enhance understanding of clinical trial information among participants. This review article visits the challenges that affect the informed consent process and explores various innovative strategies to enhance the consent process. PMID:28828304

  13. Prevalence of Sufficient Physical Activity among Parents Attending a University

    ERIC Educational Resources Information Center

    Sabourin, Sharon; Irwin, Jennifer

    2008-01-01

    Objective: The benefits of regular physical activity are well documented. However, approximately half of all university students are insufficiently active, and no research to date exists on the activity behavior of university students who are also parents. Participants and Methods: Using an adapted version of the Godin Leisure Time Exercise…

  14. Parents' perception of their influence on their child's physical activity.

    PubMed

    VanDerworp, Gwendolyn Kay; Ryan, Sarah-Jane

    2016-03-01

    Childhood physical activity (PA) has declined in the western world recently. To combat child inactivity, government programs have been organized to promote PA within families. It is important for physiotherapists to understand the influence parents perceive to have on their child's PA habits in order to better encourage a positive parental influence. The purpose of this study is to explore how parents perceive their influence on their child/children's PA through an interpretative phenomenological analysis (IPA) approach. This qualitative study used a phenomenological approach with semi-structured interviews conducted with five participants. The interviews were analyzed using elements of IPA. Master themes developed with their corresponding subthemes: creating an environment of opportunity--logistics, opportunities through encouragement and PA within the family, barriers to PA--barriers created by parents and barriers created by external factors, and parent and child interactions--children communicating interest and disinterest in PA and parent's attitudes toward children's disinterest. The findings suggest that parents perceive themselves to have a greater positive influence on their children rather than negative. The barriers that parents create are not perceived to prevent their child's PA but rather restrict it. Many participants reported enjoying doing PA with their children and used PA as an opportunity for family time, indicating a dual purpose for PA. © The Author(s) 2014.

  15. Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer.

    PubMed

    Robb, Sheri L; Haase, Joan E; Perkins, Susan M; Haut, Paul R; Henley, Amanda K; Knafl, Kathleen A; Tong, Yan

    2017-03-01

    To examine the feasibility/acceptability of a parent-delivered Active Music Engagement (AME + P) intervention for young children with cancer and their parents. Secondary aim to explore changes in AME + P child emotional distress (facial affect) and parent emotional distress (mood; traumatic stress symptoms) relative to controls. A pilot two-group randomized trial was conducted with parents/children (ages 3-8 years) receiving AME + P ( n  =  9) or attention control ( n  =  7). Feasibility of parent delivery was assessed using a delivery checklist and child engagement; acceptability through parent interviews; preliminary outcomes at baseline, postintervention, 30 days postintervention. Parent delivery was feasible, as they successfully delivered AME activities, but interviews indicated parent delivery was not acceptable to parents. Emotional distress was lower for AME + P children, but parents derived no benefit. Despite child benefit, findings do not support parent delivery of AME + P. © The Author 2016. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  16. Consent, ethics and genetic biobanks: the case of the Athlome project.

    PubMed

    Thompson, Rachel; McNamee, Michael J

    2017-11-14

    This article provides a critical overview of the ethics and governance of genetic biobank research, using the Athlome Consortium as a large scale instance of collaborative sports genetic biobanking. We present a traditional model of written informed consent for the acquisition, storage, sharing and analysis of genetic data and articulate the challenges to it from new research practices such as genetic biobanking. We then articulate six possible alternative consent models: verbal consent, blanket consent, broad consent, meta consent, dynamic consent and waived consent. We argue that these models or conceptions of consent must be articulated in the context of the complexities of international legislation and non legislative national and international biobank governance frameworks and policies, those which govern research in the field of sports genetics. We discuss the tensions between individual rights and public benefits of genomic research as a critical ethical issue, particularly where benefits are less obvious, as in sports genomics. The inherent complexities of international regulation and biobanking governance are challenging in a relatively young field. We argue that there is much nuanced ethical work still to be done with regard to governance of sports genetic biobanking and the issues contained therein.

  17. Testing Consent Order For Bisphenol A Diglycidyl Ether

    EPA Pesticide Factsheets

    EPA has issued a Testing Consent Order that incorporates an Enforceable Consent Agreement (ECA) pursuant to the Toxic Substances Control Act (TSCA), with the Dow Chemical Company, Shell Oil Company, and Ciba-Geigy Corporation.

  18. Legal issues surrounding consent and capacity: the key to autonomy.

    PubMed

    Griffith, Richard; Tengnah, Cassam

    2011-12-01

    With campaigns from the RCN, Nursing Times and Patients' Association promoting dignity and choice in healthcare district nurses need to be aware of the legal principle that lie at the heart of autonomy, consent. In the first of a series of articles on the principles of patient consent Richard Griffith and Cassam Tengnah outline the elements of a valid consent and how important obtaining consent is to the propriety of a district nurse's practice.

  19. Autonomy and informed consent: a mistaken association?

    PubMed

    Kristinsson, Sigurdur

    2007-09-01

    For decades, the greater part of efforts to improve regulatory frameworks for research ethics has focused on informed consent procedures; their design, codification and regulation. Why is informed consent thought to be so important? Since the publication of the Belmont Report in 1979, the standard response has been that obtaining informed consent is a way of treating individuals as autonomous agents. Despite its political success, the philosophical validity of this Belmont view cannot be taken for granted. If the Belmont view is to be based on a conception of autonomy that generates moral justification, it will either have to be reinterpreted along Kantian lines or coupled with a something like Mill's conception of individuality. The Kantian interpretation would be a radical reinterpretation of the Belmont view, while the Millian justification is incompatible with the liberal requirement that justification for public policy should be neutral between controversial conceptions of the good. This consequence might be avoided by replacing Mill's conception of individuality with a procedural conception of autonomy, but I argue that the resulting view would in fact fail to support a non-Kantian, autonomy-based justification of informed consent. These difficulties suggest that insofar as informed consent is justified by respect for persons and considerations of autonomy, as the Belmont report maintained, the justification should be along the lines of Kantian autonomy and not individual autonomy.

  20. The changing face of informed surgical consent.

    PubMed

    Oosthuizen, J C; Burns, P; Timon, C

    2012-03-01

    To determine whether procedure-specific brochures improve patients' pre-operative knowledge, to determine the amount of information expected by patients during the consenting process, and to determine whether the recently proposed 'Request for Treatment' consenting process is viable on a large scale. A prospective, questionnaire-based study of 100 patients admitted for selected, elective surgical procedures. In total, 99 per cent of patients were satisfied with the information received in the out-patient department, regarding the proposed procedure. However, 38 per cent were unable to correctly state the nature of the surgery or specific procedure they were scheduled to undergo. Although the vast majority of patients were able to state the intended benefits to be gained from the procedure, only 54 per cent were able to list at least one potential complication, and 80 per cent indicated that they wished to be informed about all potential complications, even if these occurred in less than 1 per cent of cases. The introduction of procedure-specific brochures improved patients' pre-operative knowledge. Although the failings of current consenting practice are clear, the Request for Treatment consenting process would not appear to be a viable alternative because of the large number of patients unable to accurately recall the nature of the proposed surgery or potential complications, following consent counselling.