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Sample records for industry informed consent

  1. Informed Consent

    MedlinePlus

    ... saved articles window. My Saved Articles » My ACS » Informed Consent Download Printable Version [PDF] » ( En español ) Learn about informed consent, a process you go through before getting a ...

  2. Informed Consent

    PubMed Central

    Manion, F.; Hsieh, K.; Harris, M.

    2015-01-01

    Summary Background Despite efforts to provide standard definitions of terms such as “medical record”, “computer-based patient record”, “electronic medical record” and “electronic health record”, the terms are still used interchangeably. Initiatives like data and information governance, research biorepositories, and learning health systems require availability and reuse of data, as well as common understandings of the scope for specific purposes. Lacking widely shared definitions, utilization of the afore-mentioned terms in research informed consent documents calls to question whether all participants in the research process — patients, information technology and regulatory staff, and the investigative team — fully understand what data and information they are asking to obtain and agreeing to share. Objectives This descriptive study explored the terminology used in research informed consent documents when describing patient data and information, asking the question “Does the use of the term “medical record” in the context of a research informed consent document accurately represent the scope of the data involved?” Methods Informed consent document templates found on 17 Institutional Review Board (IRB) websites with Clinical and Translational Science Awards (CTSA) were searched for terms that appeared to be describing the data resources to be accessed. The National Library of Medicine’s (NLM) Terminology Services was searched for definitions provided by key standards groups that deposit terminologies with the NLM. Discussion The results suggest research consent documents are using outdated terms to describe patient information, health care terminology systems need to consider the context of research for use cases, and that there is significant work to be done to assure the HIPAA Omnibus Rule is applied to contemporary activities such as biorepositories and learning health systems. Conclusions “Medical record”, a term used extensively

  3. Informed consent.

    PubMed

    Steevenson, Grania

    2006-08-01

    Disclosure of information prior to consent is a very complex area of medical ethics. On the surface it would seem to be quite clear cut, but on closer inspection the scope for 'grey areas' is vast. In practice, however, it could be argued that the number of cases that result in complaint or litigation is comparatively small. However, this does not mean that wrong decisions or unethical scenarios do not occur. It would seem that in clinical practice these ethical grey areas concerning patients' full knowledge of their condition or treatment are quite common. One of the barometers for how much disclosure should be given prior to consent could be the feedback obtained from the patients. Are they asking relevant questions pertinent to their condition and do they show a good understanding of the options available? This should be seen as a positive trait and should be welcomed by the healthcare professionals. Ultimately it gives patients greater autonomy and the healthcare professional can expand and build on the patient's knowledge as well as allay fears perhaps based on wrongly held information. Greater communication with the patient would help the healthcare professional pitch their explanations at the right level. Every case and scenario is different and unique and deserves to be treated as such. Studies have shown that most patients can understand their medical condition and treatment provided communication has been thorough (Gillon 1996). It is in the patients' best interests to feel comfortable with the level of disclosure offered to them. It can only foster greater trust and respect between them and the healthcare profession which has to be mutually beneficial to both parties. PMID:16939165

  4. Informed consent - adults

    MedlinePlus

    ... state). What Should Occur During the Informed Consent Process? When asking for your informed consent, your doctor ... What is Your Role in the Informed Consent Process? You are an important member of your health ...

  5. [Informed consent].

    PubMed

    Rodríguez, C R; González Parra, E; Martínez Castelao, A

    2008-01-01

    - Basic law 41/2002 on patient autonomy regulates the rights and obligations of patients, users and professionals, as well as those of public and private health care centers and services. This regulation refers to patient autonomy, the right to information and essential clinical documentation. - This law establishes the minimum requirements for the information the patient should receive and the decision making in which the patient should take part. Diagnostic tests are performed and therapeutic decisions are taken in the ACKD unit in which patient information is an essential and mandatory requirement according to this law. PMID:19018748

  6. Guideline 2: Informed Consent.

    ERIC Educational Resources Information Center

    American Journal on Mental Retardation, 2000

    2000-01-01

    The second in seven sets of guidelines based on the consensus of experts in the treatment of psychiatric and behavioral problems in mental retardation (MR) focuses on informed consent. Guidelines cover underlying concepts, usual components, informed consent as a process, information to include, what to provide, when to obtain informed consent, and…

  7. 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

  8. Informed consent: II.

    PubMed

    Miller, L J

    1980-11-21

    In the second article of his four-part series on informed consent, the author discusses defenses a physician may employ against informed consent claims. Seven situations are described where failure to disclose risks might be justified by lack of materiality, standards of medical practice, or lack of proximate cause of the injury. Miller cites cases in which these arguments were recognized by the courts, but cautions against generalization of their applicability to other cases. PMID:7431561

  9. From Informed Consent to Negotiated Consent.

    ERIC Educational Resources Information Center

    Moody, Harry R.

    1988-01-01

    Considers informed consent standard inadequate for insuring autonomy in long term care. Argues for complex standard of "negotiated consent." Illuminates philosophical argument by qualitative data from interviews with physicians, nurses, and social workers in nursing homes, which demonstrated continuum of interventions ranging from advocacy and…

  10. Can Broad Consent be Informed Consent?

    PubMed

    Sheehan, Mark

    2011-11-01

    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

  11. Issues for informed consent.

    PubMed

    Pindyck, J P; Barber, B; Miller, L J; Lammers, S E; Merton, V; Hubbard, J B; Mauer, A M; Taswell, H F; Surgenor, D M

    1983-01-01

    Informed consent from a cytapheresis donor is the culmination of a complex decision making process during which the blood collecting agency presents sufficient information to enable the donor to make a free choice whether or not to donate. The institution bears the responsibility for providing all information relevant to the donor's decision, whether favorable or unfavorable. At no other stage of its contact with the donor can a collecting agency discharge its public trust more meaningfully. Thus, informed consent is not only the greatest altruistic expression from the unrelated volunteer donor, or the expression of deepest commitment to the family for the related donor, it is also the fullest expression of the value which the institute places on the autonomy of the donor. The foundation upon which the concept of informed consent rests has been laid by law, medicine, government, ethics, and religion. Although the procedures accompanying the informed consent process appear bureaucratic, they should be viewed as the components of a remarkable, dynamic process. The consent of a donor to undergo cytapheresis is an eloquent statement of the value he or she places on the importance of another human being's life. PMID:6546055

  12. Informed Consent in California

    PubMed Central

    Fine, Arthur

    1977-01-01

    Informed consent is a legal obligation due from a physician to his patient, an obligation which may not be met by the physician's skillful treatment of his patient. It may only be met by the treating physician obtaining from his patient knowing authorization for carrying out the intended medical procedure. The physician is required to disclose whatever would be material to his patient's decision, including the nature and purpose of the procedure, and the risks and alternatives. The disclosures should be made by the physician to his patient, and not through use of consent forms which are not particular to individual patients. To minimize any subsequent claim by the patient that there was a lack of adequate disclosures, the physician should record in the patient's chart the circumstances of the patient's consent, and should not rely on the patient's unreliable ability to recall those circumstances. PMID:898948

  13. Risk communication and informed consent in the medical tourism industry: A thematic content analysis of canadian broker websites

    PubMed Central

    2011-01-01

    Background Medical tourism, thought of as patients seeking non-emergency medical care outside of their home countries, is a growing industry worldwide. Canadians are amongst those engaging in medical tourism, and many are helped in the process of accessing care abroad by medical tourism brokers - agents who specialize in making international medical care arrangements for patients. As a key source of information for these patients, brokers are likely to play an important role in communicating the risks and benefits of undergoing surgery or other procedures abroad to their clientele. This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures. The purpose of this article is to examine the language, information, and online marketing of Canadian medical tourism brokers' websites in light of such ethical concerns. Methods An exhaustive online search using multiple search engines and keywords was performed to compile a comprehensive directory of English-language Canadian medical tourism brokerage websites. These websites were examined using thematic content analysis, which included identifying informational themes, generating frequency counts of these themes, and comparing trends in these counts to the established literature. Results Seventeen websites were identified for inclusion in this study. It was found that Canadian medical tourism broker websites varied widely in scope, content, professionalism and depth of information. Three themes emerged from the thematic content analysis: training and accreditation, risk communication, and business dimensions. Third party accreditation bodies of debatable regulatory value were regularly mentioned on the reviewed websites, and discussion of surgical risk was absent on 47% of the websites reviewed, with limited discussion of risk on the remaining ones. Terminology describing brokers' roles was somewhat inconsistent across

  14. 42 CFR 441.257 - Informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 4 2011-10-01 2011-10-01 false Informed consent. 441.257 Section 441.257 Public... Sterilizations § 441.257 Informed consent. (a) Informing the individual. For purposes of this subpart, an individual has given informed consent only if— (1) The person who obtained consent for the...

  15. 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... Sterilizations § 441.257 Informed consent. (a) Informing the individual. For purposes of this subpart, an individual has given informed consent only if— (1) The person who obtained consent for the...

  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... Sterilizations § 441.257 Informed consent. (a) Informing the individual. For purposes of this subpart, an individual has given informed consent only if— (1) The person who obtained consent for the...

  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 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

  19. Informed consent for antipsychotic medication.

    PubMed Central

    Schachter, D.; Kleinman, I.; Williams, J. I.

    1999-01-01

    OBJECTIVE: To determine family physicians' attitudes and practices regarding documentation of informed consent for antipsychotic medication. DESIGN: Pilot cross-sectional study. SETTING: Teaching and non-teaching hospitals in Toronto, Ont. PARTICIPANTS: Thirty family physicians were selected in equal numbers from teaching and non-teaching hospitals with no more than five physicians from a given hospital. Participants were treating at least 10 patients with antipsychotic medication. Participants' mean age was 44.3 years; 83% were men. MAIN OUTCOME MEASURES: Documentation of consent and of disclosure of consent for antipsychotic medication in patients' charts. RESULTS: Documentation was found in only 13% of charts. Whether it was there or not did not correlate with information disclosed, score on an attitude scale, or demographics. Physicians who found documentation time-consuming were less likely to document. Most physicians disclosed reasons for antipsychotic medication, but less than half described tardive dyskinesia, a potentially irreversible movement disorder that affects about 25% of patients on long-term treatment. CONCLUSIONS: The low rate of documentation observed in this sample was consistent with reports of similar samples and might indicate that family physicians are unaware of recommendations for documentation or simply do not have time to keep abreast of current recommendations. Many physicians thought signed consent forms unnecessary for psychotic patients, and even more believed seeking consent for antipsychotic medications would increase patient anxiety. PMID:10386214

  20. 42 CFR 441.257 - Informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Sterilizations § 441.257 Informed consent. (a) Informing the individual. For purposes of this subpart, an individual has given informed consent only if— (1) The person who obtained consent for the sterilization... procedure at any time before the sterilization without affecting the right to future care or treatment...

  1. Placebo Effects and Informed Consent.

    PubMed

    Alfano, Mark

    2015-01-01

    The concepts of placebos and placebo effects refer to extremely diverse phenomena. I recommend dissolving the concepts of placebos and placebo effects into loosely related groups of specific mechanisms, including (potentially among others) expectation-fulfillment, classical conditioning, and attentional-somatic feedback loops. If this approach is on the right track, it has three main implications for the ethics of informed consent. First, because of the expectation-fulfillment mechanism, the process of informing cannot be considered independently from the potential effects of treatment. Obtaining informed consent influences the effects of treatment. This provides support for the authorized concealment and authorized deception paradigms, and perhaps even for outright deceptive placebo use. Second, doctors may easily fail to consider the potential benefits of conditioning, leading them to misjudge the trade-off between beneficence and autonomy. Third, how attentional-somatic feedback loops play out depends not only on the content of the informing process but also on its framing. This suggests a role for libertarian paternalism in clinical practice. PMID:26479091

  2. [The origin of informed consent].

    PubMed

    Mallardi, V

    2005-10-01

    The principle of informed consent, aimed at the lawfulness of health assistance, tends to reflect the concept of autonomy and of decisional autodetermination of the person requiring and requesting medical and/or surgical interventions. This legal formula, over the last few years, has gained not only considerable space but also importance in the doctrinal elaboration and approaches, as well as juridical interpretations, thereby influencing the everyday activities of the medical profession. Informed consent is still the object of continuous explorations, not only asfar as concerns the already confirmed theoretical profile but, instead, the ambiguous practical and consequential aspect. Analysing how the concept and role of consensus was born and developed with the more adequate and reasonable excursions to make it valid and obtain it, it is impossible not to take into consideration, on the one hand, the very ancient philosophical origins and, on the other, the fact that it was conditioned by religion with the moral aspects and the accelerated deontological evolution with pathways parallel to the needs and the progress offered by new forms of treatment and novel biotechnological applications. The principle of consent is a relatively new condition. In fact, already in the times of not only the Egyptian civilisation, but also the Greek and Roman, documents have been found which show how the doctor's intervention had, in some way, first to be approved by the patient. Plato (law IV) had already foreseen the problems, the procedures and the modes of information which are, in synthesis, at the root of the principles of the present formula of informed consent and correlated the practice of the information and consensus with the quality and social position of the patient. The only guarantee that the patient might have, derived from a fundamental principle of medicine of all times: "in disease, focus on two aims, to improve and not to cause damage". A figure can be recognised

  3. 28 CFR 512.16 - Informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Informed consent. 512.16 Section 512.16... RESEARCH Research § 512.16 Informed consent. (a) Before commencing a research project requiring participation by staff or inmates, the researcher shall give each participant a written informed...

  4. 28 CFR 512.16 - Informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Informed consent. 512.16 Section 512.16... RESEARCH Research § 512.16 Informed consent. (a) Before commencing a research project requiring participation by staff or inmates, the researcher shall give each participant a written informed...

  5. 28 CFR 512.16 - Informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Informed consent. 512.16 Section 512.16... RESEARCH Research § 512.16 Informed consent. (a) Before commencing a research project requiring participation by staff or inmates, the researcher shall give each participant a written informed...

  6. Infants, Children, and Informed Consent*

    PubMed Central

    Campbell, A. G. M.

    1974-01-01

    Obtaining informed consent for non-therapeutic experimentation on infants and children has ethical and legal implications that cause great controversy. There is some danger that worthy research will be inhibited if current ethical codes are interpreted too strictly, yet infants, children, and other vulnerable groups clearly must be protected from exploitation as research subjects. It is suggested that permission from parents coupled with integrity of the investigator will remain the child's best protection, but several additional protective mechanisms are available and should be used. Some guidelines for non-therapeutic research are suggested which should not only provide adequate protection for infants and young children involved in research projects, but allow investigators reasonable freedom to prosecute worthy research vital to continued improvements in child care. PMID:4413853

  7. 21 CFR 50.25 - Elements of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 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...

  8. 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...

  9. 21 CFR 50.25 - Elements of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 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...

  10. 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...

  11. 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...

  12. Informed patient consent: a historical perspective.

    PubMed

    Dowd, S B; Wilson, B

    1995-01-01

    This article reviews the concept of informed patient consent by examining two long-term studies in which adequate consent was not obtained from study participants: the radiation experiments sponsored by the U.S. government beginning in the 1940s and the Tuskegee Syphilis Experiment conducted from 1932 to 1972. The article discusses how these experiments represent a violation of informed consent guidelines and research ethics. It also explores the ethical implications of the experiments to radiologic technologists today and discusses the technologist's role in obtaining patient consent in research and clinical practice settings. PMID:8570838

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. Informed consent for upper gastrointestinal endoscopy.

    PubMed

    Plumeri, P A

    1994-07-01

    The process of informed consent is an ethical, legal, and medical necessity for endoscopists before performing upper endoscopy. The basics of informed consent include the nature, benefits, risks, and alternatives of the procedure being performed. A simple, straightforward application of the process is essential to appropriate care by endoscopists in everyday clinical practice. PMID:8069471

  18. 28 CFR 512.16 - Informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Informed consent. 512.16 Section 512.16 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE GENERAL MANAGEMENT AND ADMINISTRATION RESEARCH Research § 512.16 Informed consent. (a) Before commencing a research project requiring participation by staff or inmates, the...

  19. 28 CFR 512.16 - Informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Informed consent. 512.16 Section 512.16 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE GENERAL MANAGEMENT AND ADMINISTRATION RESEARCH Research § 512.16 Informed consent. (a) Before commencing a research project...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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)...

  7. Informed consent for videoconsultations in Canada.

    PubMed

    Chouinard, Isabelle; Scott, Richard E

    2009-01-01

    We performed a qualitative study of the practice of informed consent for videoconsultation in Canada. Fourteen cases were examined: the 13 provinces and territories, and the Federal jurisdiction representing aboriginal groups. Twenty-seven interviews were conducted with key informants (14 telehealth experts, 13 legal experts). The telehealth experts were people with direct experience of telehealth practice. The majority of the telehealth experts agreed that videoconsultations had not been integrated into the health-care system. An interesting finding of the study was that the integration status of videoconsultations was not indicative of informed consent practices. Telehealth providers favoured express written consent, or risk management practices, although there was a desire to move towards implied consent models for videoconsultations. The study also showed that the legal ramifications of the electronic transmission of non-recorded, real-time, personal health information had not been explored. This represents an important factor in guiding future consent for videoconsultations in Canada. PMID:19471027

  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. 49 CFR 11.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 1 2012-10-01 2012-10-01 false Documentation of informed consent. 11.117 Section... Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent... following: (1) A written consent document that embodies the elements of informed consent required by §...

  10. 7 CFR 1c.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 1 2013-01-01 2013-01-01 false Documentation of informed consent. 1c.117 Section 1c... Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent... following: (1) A written consent document that embodies the elements of informed consent required by §...

  11. 49 CFR 11.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 1 2011-10-01 2011-10-01 false Documentation of informed consent. 11.117 Section... Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent... following: (1) A written consent document that embodies the elements of informed consent required by §...

  12. 7 CFR 1c.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 1 2012-01-01 2012-01-01 false Documentation of informed consent. 1c.117 Section 1c... Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent... following: (1) A written consent document that embodies the elements of informed consent required by §...

  13. 49 CFR 11.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 1 2013-10-01 2013-10-01 false Documentation of informed consent. 11.117 Section... Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent... following: (1) A written consent document that embodies the elements of informed consent required by §...

  14. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false Documentation of informed consent. 46.117 Section... informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be...) A written consent document that embodies the elements of informed consent required by § 46.116....

  15. 49 CFR 11.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 1 2014-10-01 2014-10-01 false Documentation of informed consent. 11.117 Section... Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent... following: (1) A written consent document that embodies the elements of informed consent required by §...

  16. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 1 2011-10-01 2011-10-01 false Documentation of informed consent. 46.117 Section... informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be...) A written consent document that embodies the elements of informed consent required by § 46.116....

  17. 7 CFR 1c.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 1 2011-01-01 2011-01-01 false Documentation of informed consent. 1c.117 Section 1c... Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent... following: (1) A written consent document that embodies the elements of informed consent required by §...

  18. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 1 2012-10-01 2012-10-01 false Documentation of informed consent. 46.117 Section... informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be...) A written consent document that embodies the elements of informed consent required by § 46.116....

  19. 7 CFR 1c.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 1 2014-01-01 2014-01-01 false Documentation of informed consent. 1c.117 Section 1c... Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent... following: (1) A written consent document that embodies the elements of informed consent required by §...

  20. 49 CFR 11.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Documentation of informed consent. 11.117 Section... Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent... following: (1) A written consent document that embodies the elements of informed consent required by §...

  1. Informed consent practices of Chinese nurse researchers.

    PubMed

    Olsen, Douglas P; Honghong Wang; Pang, Samantha

    2010-03-01

    Nursing research in China is at an early stage of development and little is known about the practices of Chinese nurse researchers. This interview study carried out at a university in central China explores the informed consent practices of Chinese nurse researchers and the cultural considerations of using a western technique. Nine semistructured interviews were conducted in English with assistance and simultaneous translation from a Chinese nurse with research experience. The interviews were analyzed by one western and two Chinese researchers and major themes were identified. All participants endorsed informed consent as ethically required. Differences were noted between some of the informed consent practices typically recommended in the USA and those identified in this study, such as: recruitment using local and government officials, recruiting directly from medical records without special permission, family consultation in consent and consent control, and not revealing randomization to intervention groups receiving different treatments. PMID:20185442

  2. Informed Consent for Reconstructive Pelvic Surgery.

    PubMed

    Alam, Pakeeza; Iglesia, Cheryl B

    2016-03-01

    Informed consent is the process in which a patient makes a decision about a surgical procedure or medical intervention after adequate information is relayed by the physician and understood by the patient. This process is critical for reconstructive pelvic surgeries, particularly with the advent of vaginal mesh procedures. In this article, we review the principles of informed consent, the pros and cons of different approaches in reconstructive pelvic surgery, the current legal issues surrounding mesh use for vaginal surgery, and tips on how to incorporate this information when consenting patients for pelvic floor surgery. PMID:26880513

  3. 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. PMID:26686529

  4. Informed consent: moral necessity or illusion?

    PubMed

    Doyal, L

    2001-09-01

    There is a professional and legal consensus about the clinical duty to obtain informed consent from patients before treating them. This duty is a reflection of wider cultural values about the moral importance of respect for individual autonomy. Recent research has raised practical problems about obtaining informed consent. Some patients have cognitive and emotional problems with understanding clinical information and do not apparently wish to participate in making decisions about their treatment. This paper argues that such research does not undermine their potential to provide informed consent. Rather, sufficient resources are required to create better communication skills among clinicians and more effective educational materials for patients. Finally, cognitive and emotional inequality among patients is maintained to be a reflection of wider social and economic inequalities. Researchers who take the right to informed consent seriously should also address these. PMID:11533435

  5. The changing face of informed consent.

    PubMed

    Main, B G; Adair, S R L

    2015-10-01

    All healthcare professionals are required to gain a patient's consent before proceeding with examination, investigation or treatment. Gone are the days when consent was about protecting the professional. Following a recent landmark Supreme Court case, 'informed' consent is now embedded in UK law. Patients have the right to high-quality information that allows them to be involved in making decisions about their care. Dentists have a duty of care to provide this information and guide their patients through the process. This paper reviews key ethical, legal, and professional guidance available to dentists about informed consent and concludes by discussing how shared decision-making is a model of healthcare delivery with much to offer dentist and patient alike. PMID:26450244

  6. 21 CFR 50.27 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Documentation of informed consent. 50.27 Section... PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.27 Documentation of informed consent. (a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written...

  7. 21 CFR 50.27 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Documentation of informed consent. 50.27 Section... PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.27 Documentation of informed consent. (a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written...

  8. 21 CFR 50.27 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Documentation of informed consent. 50.27 Section... PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.27 Documentation of informed consent. (a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written...

  9. 21 CFR 50.27 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Documentation of informed consent. 50.27 Section... PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.27 Documentation of informed consent. (a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written...

  10. Informed Consent and Cluster-Randomized Trials

    PubMed Central

    Dawson, Angus

    2012-01-01

    We argue that cluster-randomized trials are an important methodology, essential to the evaluation of many public health interventions. However, in the case of at least some cluster-randomized trials, it is not possible, or is incompatible with the aims of the study, to obtain individual informed consent. This should not necessarily be seen as an impediment to ethical approval, providing that sufficient justification is given for this omission. We further argue that it should be the institutional review board’s task to evaluate whether the protocol is sufficiently justified to proceed without consent and that this is preferable to any reliance on community consent or other means of proxy consent. PMID:22390511

  11. Written Informed Consent: Closing the Door to Clinical Research. and Another Look at Informed Consent.

    ERIC Educational Resources Information Center

    Noble, Mary Anne; Oberst, Marilyn T.

    1985-01-01

    Two viewpoints on written informed consent are presented: Written informed consent should not be required unless research goes beyond the bounds of normal practice and poses danger or discomfort to the patient; and the principles of autonomy and individual rights must be applied at least as stringently to research as to practice. (CT)

  12. Informed Consent in Social Work Ethics Education: Guiding Student Education with an Informed Consent Template

    ERIC Educational Resources Information Center

    Burkemper, Ellen M.

    2004-01-01

    This article proposes the use of an informed consent template for educating social work students. The elements of informed consent, derived primarily from the National Association of Social Workers' "Code of Ethics", are operationalized in the template. The suggestion is that instructors will use the template for classroom instruction and require…

  13. 45 CFR 690.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 3 2011-10-01 2011-10-01 false Documentation of informed consent. 690.117 Section... PROTECTION OF HUMAN SUBJECTS § 690.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent...

  14. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 1 2012-07-01 2012-07-01 false Documentation of informed consent. 97.117 Section 97...) § 97.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  15. 38 CFR 16.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... PROTECTION OF HUMAN SUBJECTS § 16.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form... elements of informed consent required by § 16.116. This form may be read to the subject or the...

  16. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Documentation of informed consent. 26... Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1117 Documentation of informed consent. (a) Informed consent must be documented by the use of a written consent form approved by the IRB and signed...

  17. 22 CFR 225.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Documentation of informed consent. 225.117....117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  18. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Documentation of informed consent. 26... EPA § 26.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB...

  19. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Documentation of informed consent. 26... EPA § 26.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB...

  20. 16 CFR 1028.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Documentation of informed consent. 1028.117... SUBJECTS § 1028.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB...

  1. 22 CFR 225.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Documentation of informed consent. 225.117....117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  2. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 1 2013-07-01 2013-07-01 false Documentation of informed consent. 97.117 Section 97...) § 97.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  3. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Documentation of informed consent. 26... Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1117 Documentation of informed consent. (a) Informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  4. 28 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Documentation of informed consent. 46.117....117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  5. 15 CFR 27.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 15 Commerce and Foreign Trade 1 2014-01-01 2014-01-01 false Documentation of informed consent. 27... SUBJECTS § 27.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB...

  6. 16 CFR 1028.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Documentation of informed consent. 1028.117... SUBJECTS § 1028.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB...

  7. 45 CFR 690.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 3 2012-10-01 2012-10-01 false Documentation of informed consent. 690.117 Section... PROTECTION OF HUMAN SUBJECTS § 690.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent...

  8. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Documentation of informed consent. 26... Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1117 Documentation of informed consent. (a) Informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  9. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Documentation of informed consent. 26... EPA § 26.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB...

  10. 16 CFR 1028.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Documentation of informed consent. 1028.117... SUBJECTS § 1028.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB...

  11. 45 CFR 690.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 3 2014-10-01 2014-10-01 false Documentation of informed consent. 690.117 Section... PROTECTION OF HUMAN SUBJECTS § 690.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent...

  12. 22 CFR 225.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 22 Foreign Relations 1 2013-04-01 2013-04-01 false Documentation of informed consent. 225.117....117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  13. 38 CFR 16.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... PROTECTION OF HUMAN SUBJECTS § 16.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form... elements of informed consent required by § 16.116. This form may be read to the subject or the...

  14. 22 CFR 225.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Documentation of informed consent. 225.117....117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  15. 28 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Documentation of informed consent. 46.117....117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  16. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 1 2014-07-01 2014-07-01 false Documentation of informed consent. 97.117 Section 97...) § 97.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  17. 15 CFR 27.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 15 Commerce and Foreign Trade 1 2012-01-01 2012-01-01 false Documentation of informed consent. 27... SUBJECTS § 27.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB...

  18. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Documentation of informed consent. 26... Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1117 Documentation of informed consent. (a) Informed consent must be documented by the use of a written consent form approved by the IRB and signed...

  19. 45 CFR 690.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 3 2013-10-01 2013-10-01 false Documentation of informed consent. 690.117 Section... PROTECTION OF HUMAN SUBJECTS § 690.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent...

  20. 28 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Documentation of informed consent. 46.117....117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  1. 15 CFR 27.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 15 Commerce and Foreign Trade 1 2011-01-01 2011-01-01 false Documentation of informed consent. 27... SUBJECTS § 27.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB...

  2. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false Documentation of informed consent. 97.117 Section 97...) § 97.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  3. 38 CFR 16.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... PROTECTION OF HUMAN SUBJECTS § 16.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form... elements of informed consent required by § 16.116. This form may be read to the subject or the...

  4. 16 CFR 1028.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Documentation of informed consent. 1028.117... SUBJECTS § 1028.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB...

  5. 15 CFR 27.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 15 Commerce and Foreign Trade 1 2013-01-01 2013-01-01 false Documentation of informed consent. 27... SUBJECTS § 27.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB...

  6. 28 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Documentation of informed consent. 46.117....117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  7. 38 CFR 16.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... PROTECTION OF HUMAN SUBJECTS § 16.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form... elements of informed consent required by § 16.116. This form may be read to the subject or the...

  8. 28 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Documentation of informed consent. 46.117....117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  9. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Documentation of informed consent. 26... EPA § 26.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB...

  10. Understood consent versus informed consent: a new paradigm for obtaining consent for pediatric research studies.

    PubMed

    Isles, Alan F

    2013-01-01

    All too often the informed consent process is viewed by members of research teams as a challenge of getting a parent or young person's signature on a form. Informed consent is, however, much more than a signed form. Rather, it is a process, often iterative, in which the parent or young person is given sufficient information about a study in order that they can make a truly informed decision about participation. Substantial effort is required in producing appropriately formatted and readable documents using plain language at about Grade 6 or 12-year old reading level. Achieving truly understood consent involves the researcher spending significant one-on-one time with the parent or young person explaining in simple language what is proposed and then using so-called repeat-back techniques to test the understanding of the participants. This is critically important if the research involves randomization to different treatments or use of a placebo arm and, in particular if the research involves more than minimal risk. PMID:24400284

  11. Informed Consent: How Much Awareness Is There?

    PubMed Central

    Purcaru, Daniel; Preda, Adrian; Popa, Daniela; Moga, Marius Alexandru; Rogozea, Liliana

    2014-01-01

    Improving the informed consent process in clinical research is of constant concern to regulatory authorities in the field and presents a challenge for both the specialists and patients involved. Informed consent is a process that should adequately match the complexity of clinical research. In analyzing the behaviour of 68 patients during the informed consent process related to the clinical research performed at Neomed Clinical Center in Brasov, we found that many patients do not ask any questions (35.3%). From those who do, part of the questions (20,6%) referred to general aspects (addressed the form but not the gist) of the clinical trial, some (72,8%) referred to specific aspects of the clinical trial they will attend and others (6,6%) unrelated to the clinical trial. These results suggest a lack of interest, awareness, and understanding of the information presented in the informed consent form. The possible underlying causes of this attitude and its bureaucratic, ethic, and legal implications are discussed. PMID:25329168

  12. 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

  13. Learning Ethics through Everyday Problems: Informed Consent

    ERIC Educational Resources Information Center

    Verdu, Fernando; Frances, Francesc; Castello, Ana

    2012-01-01

    The teaching of bioethics and its importance in clinical relationships is to a certain extent complicated when we address students of medicine, young people who are more used to dealing with and solving strictly clinical problems. Informed Consent is one of the aspects of professional practice that is generally and widely accepted in Western…

  14. Informed Consent and the "Medical Student Psychiatrist."

    ERIC Educational Resources Information Center

    Cohen, Daniel L.; And Others

    1990-01-01

    Responses to a 1986 questionnaire by 91 departments of clinical psychiatry in U.S. medical schools revealed that a substantial proportion (29.3 percent) were not fully compliant with established guidelines requiring informed consent from patients before allowing students to participate in their psychiatric assessment and care. (Author/DB)

  15. Limning the Semantic Frontier of Informed Consent.

    PubMed

    Washington, Harriet A

    2016-09-01

    It is the researcher's responsibility to provide accurate, complete, and unbiased verbal and written information yet, as this essay discusses, challenges to meaningful research consent abound in the communication between researcher and subject. This discussion of these challenges is far from exhaustive, but it will flag some of the potholes that researchers must anticipate on the sometimes rocky road to eliciting meaningful consent. These include, but are not limited to, inadequate scientific literacy, poorly written consent forms, and even the deployment of scientific terms and seductive acronyms like CURE and MIRACL. Studies with acronyms, for example, enroll five times as many patients as those without, are more likely to be published by prestigious journals, and have higher Jadad methodologic quality scores although they are no more likely to conclude with positive findings. Other barriers to researcher-subject communication include: widely differing beliefs and customs, semiotics, socioeconomic status, iatrophobia, and dramatically different histories of treatment in the medical-research arena. PMID:27587444

  16. 21 CFR 50.20 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false General requirements for informed consent. 50.20... PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.20 General requirements for informed... informed consent of the subject or the subject's legally authorized representative. An investigator...

  17. 21 CFR 50.20 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false General requirements for informed consent. 50.20... PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.20 General requirements for informed... informed consent of the subject or the subject's legally authorized representative. An investigator...

  18. 21 CFR 50.20 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false General requirements for informed consent. 50.20... PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.20 General requirements for informed... informed consent of the subject or the subject's legally authorized representative. An investigator...

  19. Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents

    PubMed Central

    Munung, Nchangwi Syntia; Marshall, Patricia; Campbell, Megan; Littler, Katherine; Masiye, Francis; Ouwe-Missi-Oukem-Boyer, Odile; Seeley, Janet; Stein, D J; Tindana, Paulina; de Vries, Jantina

    2016-01-01

    Background The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium. Methods A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of test results. Results Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results. Conclusion H3Africa research makes use of three consent models—specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa. PMID:26644426

  20. Informed consent in medical practice. With particular reference to neurology.

    PubMed

    Faden, A I; Faden, R R

    1978-11-01

    Informed consent is a significant ethical as well as medicolegal issue. Both aspects are summarized in this article, which focuses on the major unresolved problems raised by legal and moral analyses of informed consent. The discussion stresses the effects of the doctrine of informed consent on medical practice, with particular reference to problems encountered in the neurological health field. PMID:718477

  1. 7 CFR 1c.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 1 2012-01-01 2012-01-01 false General requirements for informed consent. 1c.116... General requirements for informed consent. Except as provided elsewhere in this policy, no investigator... obtained the legally effective informed consent of the subject or the subject's legally...

  2. 10 CFR 745.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false General requirements for informed consent. 745.116 Section... informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as... effective informed consent of the subject or the subject's legally authorized representative....

  3. 32 CFR 219.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 2 2012-07-01 2012-07-01 false General requirements for informed consent. 219... informed consent of the subject or the subject's legally authorized representative. An investigator shall... language understandable to the subject or the representative. No informed consent, whether oral or...

  4. 40 CFR 26.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Supported by EPA § 26.116 General requirements for informed consent. Except as provided elsewhere in this... the investigator has obtained the legally effective informed consent of the subject or the subject's... representative. No informed consent, whether oral or written, may include any exculpatory language through...

  5. 15 CFR 27.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... OF HUMAN SUBJECTS § 27.116 General requirements for informed consent. Except as provided elsewhere in... unless the investigator has obtained the legally effective informed consent of the subject or the subject... subject or the representative. No informed consent, whether oral or written, may include any...

  6. 16 CFR 1028.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Documentation of informed consent. 1028.117 Section 1028.117 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be...

  7. 49 CFR 11.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 1 2012-10-01 2012-10-01 false General requirements for informed consent. 11.116....116 General requirements for informed consent. Except as provided elsewhere in this policy, no... has obtained the legally effective informed consent of the subject or the subject's legally...

  8. 15 CFR 27.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... OF HUMAN SUBJECTS § 27.116 General requirements for informed consent. Except as provided elsewhere in... unless the investigator has obtained the legally effective informed consent of the subject or the subject... subject or the representative. No informed consent, whether oral or written, may include any...

  9. 21 CFR 50.27 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Documentation of informed consent. 50.27 Section 50.27 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.27 Documentation of informed consent. (a) Except as provided in §...

  10. 45 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 1 2012-10-01 2012-10-01 false General requirements for informed consent. 46.116... for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human... effective informed consent of the subject or the subject's legally authorized representative....

  11. 40 CFR 26.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Supported by EPA § 26.116 General requirements for informed consent. Except as provided elsewhere in this... the investigator has obtained the legally effective informed consent of the subject or the subject's... representative. No informed consent, whether oral or written, may include any exculpatory language through...

  12. 32 CFR 219.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 2 2014-07-01 2014-07-01 false Documentation of informed consent. 219.117... (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of...

  13. 16 CFR 1028.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false General requirements for informed consent... HUMAN SUBJECTS § 1028.116 General requirements for informed consent. Except as provided elsewhere in... unless the investigator has obtained the legally effective informed consent of the subject or the...

  14. 10 CFR 745.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false General requirements for informed consent. 745.116 Section... informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as... effective informed consent of the subject or the subject's legally authorized representative....

  15. 7 CFR 1c.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 1 2014-01-01 2014-01-01 false General requirements for informed consent. 1c.116... General requirements for informed consent. Except as provided elsewhere in this policy, no investigator... obtained the legally effective informed consent of the subject or the subject's legally...

  16. 21 CFR 50.20 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false General requirements for informed consent. 50.20 Section 50.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.20 General requirements for informed consent. Except as provided in...

  17. 34 CFR 97.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 1 2013-07-01 2013-07-01 false General requirements for informed consent. 97.116... Subjects) § 97.116 General requirements for informed consent. Except as provided elsewhere in this policy... investigator has obtained the legally effective informed consent of the subject or the subject's...

  18. 28 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false General requirements for informed consent... SUBJECTS § 46.116 General requirements for informed consent. Except as provided elsewhere in this policy... investigator has obtained the legally effective informed consent of the subject or the subject's...

  19. 34 CFR 97.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 1 2014-07-01 2014-07-01 false General requirements for informed consent. 97.116... Subjects) § 97.116 General requirements for informed consent. Except as provided elsewhere in this policy... investigator has obtained the legally effective informed consent of the subject or the subject's...

  20. 40 CFR 26.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Supported by EPA § 26.116 General requirements for informed consent. Except as provided elsewhere in this... the investigator has obtained the legally effective informed consent of the subject or the subject's... representative. No informed consent, whether oral or written, may include any exculpatory language through...

  1. 40 CFR 26.1116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... informed consent. No investigator may involve a human being as a subject in research covered by this subpart unless the investigator has obtained the legally effective informed consent of the subject. An.... No informed consent, whether oral or written, may include any exculpatory language through which...

  2. 22 CFR 225.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 22 Foreign Relations 1 2013-04-01 2013-04-01 false General requirements for informed consent. 225... SUBJECTS § 225.116 General requirements for informed consent. Except as provided elsewhere in this policy... investigator has obtained the legally effective informed consent of the subject or the subject's...

  3. 7 CFR 1c.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 1 2013-01-01 2013-01-01 false General requirements for informed consent. 1c.116... General requirements for informed consent. Except as provided elsewhere in this policy, no investigator... obtained the legally effective informed consent of the subject or the subject's legally...

  4. 28 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false General requirements for informed consent... SUBJECTS § 46.116 General requirements for informed consent. Except as provided elsewhere in this policy... investigator has obtained the legally effective informed consent of the subject or the subject's...

  5. 34 CFR 97.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 1 2012-07-01 2012-07-01 false General requirements for informed consent. 97.116... Subjects) § 97.116 General requirements for informed consent. Except as provided elsewhere in this policy... investigator has obtained the legally effective informed consent of the subject or the subject's...

  6. 49 CFR 11.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 1 2014-10-01 2014-10-01 false General requirements for informed consent. 11.116....116 General requirements for informed consent. Except as provided elsewhere in this policy, no... has obtained the legally effective informed consent of the subject or the subject's legally...

  7. 38 CFR 16.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... informed consent. 16.116 Section 16.116 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.116 General requirements for informed consent. Except as... covered by this policy unless the investigator has obtained the legally effective informed consent of...

  8. 15 CFR 27.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... OF HUMAN SUBJECTS § 27.116 General requirements for informed consent. Except as provided elsewhere in... unless the investigator has obtained the legally effective informed consent of the subject or the subject... subject or the representative. No informed consent, whether oral or written, may include any...

  9. 40 CFR 26.1116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... informed consent. No investigator may involve a human being as a subject in research covered by this subpart unless the investigator has obtained the legally effective informed consent of the subject. An.... No informed consent, whether oral or written, may include any exculpatory language through which...

  10. 45 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false General requirements for informed consent. 46.116... for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human... effective informed consent of the subject or the subject's legally authorized representative....

  11. 32 CFR 219.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 2 2014-07-01 2014-07-01 false General requirements for informed consent. 219... informed consent of the subject or the subject's legally authorized representative. An investigator shall... language understandable to the subject or the representative. No informed consent, whether oral or...

  12. 32 CFR 219.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 2 2012-07-01 2012-07-01 false Documentation of informed consent. 219.117... (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of...

  13. 28 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false General requirements for informed consent... SUBJECTS § 46.116 General requirements for informed consent. Except as provided elsewhere in this policy... investigator has obtained the legally effective informed consent of the subject or the subject's...

  14. 16 CFR 1028.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false General requirements for informed consent... HUMAN SUBJECTS § 1028.116 General requirements for informed consent. Except as provided elsewhere in... unless the investigator has obtained the legally effective informed consent of the subject or the...

  15. 22 CFR 225.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false General requirements for informed consent. 225... SUBJECTS § 225.116 General requirements for informed consent. Except as provided elsewhere in this policy... investigator has obtained the legally effective informed consent of the subject or the subject's...

  16. 22 CFR 225.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 1 2014-04-01 2014-04-01 false General requirements for informed consent. 225... SUBJECTS § 225.116 General requirements for informed consent. Except as provided elsewhere in this policy... investigator has obtained the legally effective informed consent of the subject or the subject's...

  17. 38 CFR 16.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... informed consent. 16.116 Section 16.116 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.116 General requirements for informed consent. Except as... covered by this policy unless the investigator has obtained the legally effective informed consent of...

  18. 32 CFR 219.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 2 2011-07-01 2011-07-01 false Documentation of informed consent. 219.117... (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of...

  19. 32 CFR 219.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 2 2013-07-01 2013-07-01 false General requirements for informed consent. 219... informed consent of the subject or the subject's legally authorized representative. An investigator shall... language understandable to the subject or the representative. No informed consent, whether oral or...

  20. 49 CFR 11.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 1 2013-10-01 2013-10-01 false General requirements for informed consent. 11.116....116 General requirements for informed consent. Except as provided elsewhere in this policy, no... has obtained the legally effective informed consent of the subject or the subject's legally...

  1. 40 CFR 26.1116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... informed consent. No investigator may involve a human being as a subject in research covered by this subpart unless the investigator has obtained the legally effective informed consent of the subject or the... subject or the representative. No informed consent, whether oral or written, may include any...

  2. 38 CFR 16.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... informed consent. 16.116 Section 16.116 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.116 General requirements for informed consent. Except as... covered by this policy unless the investigator has obtained the legally effective informed consent of...

  3. 32 CFR 219.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 2 2013-07-01 2013-07-01 false Documentation of informed consent. 219.117... (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of...

  4. Helping patients to give informed consent.

    PubMed

    Dorrity, Austin; Mee, Steve; Buckley, Alison; Corless, Louise

    This is the second article in a seven-part series demonstrating the value of analysing patient narratives in nursing and nurse education. Part 1 reviewed the evidence regarding the use of narrative and focused on unintended communication. This article draws on a story exploring consent and capacity, and demonstrates the lessons that can be learnt for all fields of nursing. We hope your reflections on the narratives will help to inform your professional practice and provide evidence for revalidation. PMID:27145672

  5. Vulnerable Subjects: Why Does Informed Consent Matter?

    PubMed

    Goodwin, Michele

    2016-09-01

    This special issue of the Journal Law, Medicine & Ethics takes up the concern of informed consent, particularly in times of controversy. The dominant moral dilemmas that frame traditional bioethical concerns address medical experimentation on vulnerable subjects; physicians assisting their patients in suicide or euthanasia; scarce resource allocation and medical futility; human trials to develop drugs; organ and tissue donation; cloning; xenotransplantation; abortion; human enhancement; mandatory vaccination; and much more. The term "bioethics" provides a lens, language, and guideposts to the study of medical ethics. It is worth noting, however, that medical experimentation is neither new nor exclusive to one country. Authors in this issue address thorny subjects that span borders and patients: from matters dealing with children and vaccination to the language and perception of consent. PMID:27587443

  6. 42 CFR 50.204 - Informed consent requirement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent... informed consent for a sterilization procedure must offer to answer any questions the individual to be... individual is free to withhold or withdraw consent to the procedure any time before the sterilization...

  7. Informed-Consent Issues with Adolescent Health Behavior Research

    ERIC Educational Resources Information Center

    Olds, R. Scott

    2003-01-01

    Objective: To identify the informed-consent issues when conducting adolescent health behavior research. Methods: A literature review was conducted across diverse academic fields about the informed-consent issues that were relevant to adolescent health behavior research. Results: Issues included defining consent, assent and permission, minimal…

  8. 10 CFR 745.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Documentation of informed consent. 745.117 Section 745.117 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.117 Documentation of informed consent. (a... research would be the consent document and the principal risk would be potential harm resulting from...

  9. 10 CFR 745.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Documentation of informed consent. 745.117 Section 745.117 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.117 Documentation of informed consent. (a... research would be the consent document and the principal risk would be potential harm resulting from...

  10. 10 CFR 745.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Documentation of informed consent. 745.117 Section 745.117 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.117 Documentation of informed consent. (a... research would be the consent document and the principal risk would be potential harm resulting from...

  11. 10 CFR 745.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Documentation of informed consent. 745.117 Section 745.117 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.117 Documentation of informed consent. (a... research would be the consent document and the principal risk would be potential harm resulting from...

  12. 10 CFR 745.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Documentation of informed consent. 745.117 Section 745.117 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.117 Documentation of informed consent. (a... research would be the consent document and the principal risk would be potential harm resulting from...

  13. [Scientific drug safety information for patients' consent].

    PubMed

    Suzuki-Nishimura, Tamiko

    2011-01-01

    One of the important roles of pharmacists is to continue their contributions to new drug discovery and development. However, it seems to be very difficult to obtain patient satisfaction with new drugs. Because new medicines have both benefit and risk, there should be many systems to maximize the safety and efficacy of the drugs. In clinical trials, the rights, safety and welfare of human subjects under the investigator's care must be protected. Good Clinical Practice is a harmonized ICH-guideline, and the safety information of an investigational product is explained to patients who voluntarily enter the clinical trials. Since safety information about investigational products is still limited, subjects are informed about the results of animal experiments and those of finished clinical trials. The sponsor of clinical trials should be responsible for the on-going safety evaluation of the investigational products. When additional safety information is collected in the clinical trials, the written informed consent form should be appropriately revised. During the review process, quality, safety and efficacy of new drugs are evaluated and judged based on the scientific risk-benefit balance. The safety information collected in clinical trials is reflected in the decision-making process written in the review reports. All-case investigation should be also performed until data from a certain number of patients has been accumulated in order to collect early safety and efficacy data. Important messages written in review reports for drug safety and patient consent are explained. Risk communication will improve the application of patients' consent for new drugs. PMID:21628970

  14. Ethical issues in informed consent with substance abusers.

    PubMed

    McCrady, B S; Bux, D A

    1999-04-01

    Alcohol and drug abusers present issues that complicate the informed consent process. The present study examined the practices of federally funded clinical investigators in obtaining informed consent from alcohol and drug abusers. Ninety-one (51%) researchers completed a 27-item survey on informed consent issues. The majority of investigators (57%) recruited participants susceptible to coercion; most used procedures to minimize coercion. Two thirds of researchers used objective means to determine competence to give consent and comprehension of consent forms. Virtually all investigators had policies to deal with suicidality, homicidality, or reports of child abuse; less than 1/2 informed participants of these limits to confidentiality. Almost 50% of investigators had dealt with intoxicated or suicidal participants; 12% had encountered homicidal participants; and 23% had encountered child abuse or neglect. Half of the sample used collateral data sources; about 1/2 of these obtained written informed consent from collaterals. Guidelines for informed consent with substance abusers are suggested. PMID:10224728

  15. Informed consent: Enforcing pharmaceutical companies' obligations abroad.

    PubMed

    Lee, Stacey B

    2010-01-01

    The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement by an international tribunal or through one universally adopted code of ethics. This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the "right to health." This article concludes that by building on the federal appellate court's ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections. PMID:20930251

  16. Informed Consent-Uninformed Participants: Shortcomings of Online Social Science Consent Forms and Recommendations for Improvement.

    PubMed

    Perrault, Evan K; Nazione, Samantha A

    2016-07-01

    As informed consent forms continue to lengthen, are these lengthening forms helping to create better informed participants? The aim of this research was to determine whether the length of consent forms affected reading frequency and comprehension, and to provide recommendations on how to improve consent forms in the social sciences so they are more likely to be read. A quasi-experiment was conducted using actual consent forms at two liberal arts schools, one requiring a long form (463 words, n = 73) and one requiring a shorter form (236 words, n = 57). Participants exposed to the shorter form reported fully reading, or at least skimming the form more frequently than those exposed to the longer form. Those exposed to the shorter form also comprehended more of the form's information. The majority of participants indicated consent forms need to be shortened if researchers want future participants to be more likely to read these forms' contents. Additional recommendations are discussed. PMID:27329533

  17. Disclosing Information in Interview Introductions: Methodological Consequences of Informed Consent.

    ERIC Educational Resources Information Center

    Sobal, Jeff

    1982-01-01

    Varying amounts of information about the interview, interviewer and research can be provided to potential respondents during the interview introduction. Two studies in a large eastern center city may be interpreted as supporting greater disclosure to ensure informed consent by the respondent, thus improving the public image of survey research.…

  18. [Informed consent in aesthetic plastic surgery].

    PubMed

    Fenger, H

    2006-02-01

    The informed consent plays a very decisive part in aesthetic plastic surgery. As there is often no medical indication in plastic surgery, the patient has to be informed about all the facts of an operation, especially about the possible risks. The legal requests for therapeutic and economic clarification gain in importance. The jurisdiction in Germany demands a merciless clarification for the patient. The patient needs to be clarified about all facts early enough so that he has a sufficient amount of time to weigh-up the pros und cons of the operation and if necessary to take advice from someone else. The sufficient documentation is very important at the sight of the extensive burden of proof at the expense of the physician. PMID:16538575

  19. Consent for audio-video recording of informed consent process in rural South India

    PubMed Central

    Chauhan, Ramesh Chand; Purty, Anil J.; Singh, Neelima

    2015-01-01

    Introduction and Objectives: In recent times, audio-video (A-V) recording of consent process for all the study subjects entering a clinical trial has been made mandatory. A-V recording of informed consent process is a big challenge due to confidentiality and the sociocultural environment in India. It is important to find out the acceptability for A-V recording of the consent process and reasons for refusal, if any to address this new challenge. Materials and Methods: A descriptive survey was done among 150 residents of a rural community of South India. Acceptability for A-V recording of consent process was assessed among those who had given the informed written consent for participation in the study. An attempt to find the factors determining the refusal was also made. Results: More than one-third (34%) of the study subjects refused to give consent for A-V recording of consent process. Not interested in recording or don’t like to be recorded (39%) were the most common reasons to refuse for A-V recording of consent process. The refusal was higher among female and younger age-group adult subjects. Socioeconomic status was not found to be significantly associated with refusal to consent for A-V recording. Conclusion: Refusal for A-V recording of consent process is high in the South Indian rural population. Before any major clinical trial, particularly a field trial, an assessment of consent for A-V recording would be helpful in recruitment of study subjects. PMID:26229752

  20. Intensive care patients' evaluations of the informed consent process.

    PubMed

    Clark, Paul Alexander

    2007-01-01

    This study examines the informed consent process from the perspective of intensive care patients. Using the largest single-method database of patient-derived information in the United States, we systematically outlined and tested several key factors that influence patient evaluations of the intensive care unit (ICU) informed consent process. Measures of information, understanding, and decision-making involvement were found to predict overall patient satisfaction and patient loyalty intentions. Specific actions supportive of ICU informed consent, such as giving patients information on advance directives, patient's rights, and organ donation, resulted in significantly higher patient evaluation scores with large effect sizes. This research suggests that the effectiveness of the informed consent process in the ICU from the patient's perspective can be measured and evaluated and that ICU patients place a high value on the elements of the informed consent process. PMID:17704678

  1. Who is the patient? Disclosure of information and consent in anesthesia and intensive care (informed consent).

    PubMed

    Korusić, Andelko; Merc, Vlasta; Duzel, Viktor; Tudorić-Djeno, Ivana; Zidak, Davorka; Brundula, Ana; Sojcić, Natasa; Milanović, Rudolf; Barić, Ada; Beslić, Gabrijela

    2013-09-01

    Physicians have always strived to uphold all the ethical postulates of the medical profession in all aspects of the practice, however with the vast advances in science and technology, numerous ethical dilemmas regarding all aspects of life and ultimately death have emerged. Medical decisions however, are no longer in the sole jurisdiction of traditional Hippocratic medicine but are now deliberated and delivered by the patient and they are comprised of a number of additional determining aspects such as psychological, social, legal, religious, esthetic, administrative etc., which all together represent the complete best interest of the patient. This is the basic goal of the "Informed Consent". The widening of legal boundaries regarding professional liability may consequentially lead to a "defensive medicine" and a deterioration in the quality of healthcare. In the Republic of Croatia there a four types of liability and the hyperproduction of laws which regulate healthcare geometrically increase the hazards to which physicians are exposed to on a daily basis. When evaluating the Croatian informed consent for anesthesia, we can come to the conclusion that it is completely impractical and as such entirely unnecessary. Anesthesiologists should concentrate on an informed consent which would in brief explain all the necessary information a "reasonable" anesthesiologist would disclose to a "reasonable" patient so that a patient could undertake a diagnostic or therapeutic procedure unburdened and with complete confidence in the physicians who are involved in the treatment of the respective patient. PMID:24308256

  2. [Information sheet and informed consent in biomedical research with samples].

    PubMed

    Gil Membrado, Cristina

    2012-01-01

    This paper examines from a practical perspective, the content of the information sheet to the participant in a clinical trial in which pharmacogenetic studies are conducted and/or pharmacogenomics, and scope of informed consent. The text is accompanied by a guide of questions to assess the fit of a participant information sheet on the regulation of clinical trials, biological samples and protection of personal data. PMID:23115824

  3. Participant Informed Consent in Cluster Randomized Trials: Review

    PubMed Central

    Giraudeau, Bruno; Caille, Agnès; Le Gouge, Amélie; Ravaud, Philippe

    2012-01-01

    Background The Nuremberg code defines the general ethical framework of medical research with participant consent as its cornerstone. In cluster randomized trials (CRT), obtaining participant informed consent raises logistic and methodologic concerns. First, with randomization of large clusters such as geographical areas, obtaining individual informed consent may be impossible. Second, participants in randomized clusters cannot avoid certain interventions, which implies that participant informed consent refers only to data collection, not administration of an intervention. Third, complete participant information may be a source of selection bias, which then raises methodological concerns. We assessed whether participant informed consent was required in such trials, which type of consent was required, and whether the trial was at risk of selection bias because of the very nature of participant information. Methods and Findings We systematically reviewed all reports of CRT published in MEDLINE in 2008 and surveyed corresponding authors regarding the nature of the informed consent and the process of participant inclusion. We identified 173 reports and obtained an answer from 113 authors (65.3%). In total, 23.7% of the reports lacked information on ethics committee approval or participant consent, 53.1% of authors declared that participant consent was for data collection only and 58.5% that the group allocation was not specified for participants. The process of recruitment (chronology of participant recruitment with regard to cluster randomization) was rarely reported, and we estimated that only 56.6% of the trials were free of potential selection bias. Conclusions For CRTs, the reporting of ethics committee approval and participant informed consent is less than optimal. Reports should describe whether participants consented for administration of an intervention and/or data collection. Finally, the process of participant recruitment should be fully described (namely

  4. Informed consent: corner stone in ethical medical and dental practice.

    PubMed

    Kakar, Heena; Gambhir, Ramandeep Singh; Singh, Simarpreet; Kaur, Amarinder; Nanda, Tarun

    2014-01-01

    Progress in health care technologies has enabled patients to be better informed about all aspects of health care. Patients' informed consent is a legal regulation and a moral principle which represents patients' rights to take part in the clinical decisions concerning their treatment. With increasing awareness among the patients, the concept of informed consent is also evolving in developing countries like India. It is important for the medical and dental practitioners to have a written and signed informed consent from their patients before performing any invasive or irreversible procedures. Informed consent is also needed when providing medical care to children, foreign patients, and incorporating images of the patients while conducting medical and dental research. The present review addresses some of the vital issues regarding informed consent when providing medical and dental care with current review of the literature. PMID:24791241

  5. 7 CFR 1c.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 1 2011-01-01 2011-01-01 false General requirements for informed consent. 1c.116 Section 1c.116 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject...

  6. 38 CFR 16.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2011-07-01 2011-07-01 false General requirements for informed consent. 16.116 Section 16.116 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.116 General requirements for informed consent. Except as provided elsewhere in this policy,...

  7. 10 CFR 745.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false General requirements for informed consent. 745.116 Section 745.116 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by...

  8. Critical evaluation of research articles in relation to informed consent.

    PubMed

    Biswas, B; Ahmad, R

    2006-12-01

    The concept of research bioethics arose and developed over the last three decades mainly in response to moral crisis created by rapidly advancing medical science and technology. Accordingly, reinterpretation of some fundamental principles of ethics is needed. At the heart of the ethical principle of respect for person, lies the informed consent process. Nuremberg Code, Helsinki Declaration of World Medical Association (WMA), Council for International Organizations of Medical Sciences (CIOMS) Guidelines etc. demonstrated the importance of informed consent in biomedical research involving human subjects. This article was planned to evaluate the reflection of informed consent in the published research articles. Fifty-two articles published in national and international journals were studied among which informed consent was found to be taken only in 21(40.4%) occasions and the same was not taken in 31(59.6%) occasions. Study showed that out of 38 articles published in national journals, informed consent was taken from only in 12(31.6%) situations, while out of 14 articles published in international journals, informed consent was taken in 9(64.3%) situations. Out of 36 observational studies, informed consent (both written and verbal) was taken from only 27.8% cases, whereas out of 16 interventional experiments, informed consent was taken in 68.8% situations. PMID:17867274

  9. 15 CFR 27.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false General requirements for informed consent. 27.116 Section 27.116 Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION OF HUMAN SUBJECTS § 27.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve...

  10. 22 CFR 225.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false General requirements for informed consent. 225.116 Section 225.116 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF HUMAN SUBJECTS § 225.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as...

  11. 45 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false General requirements for informed consent. 46.116 Section 46.116 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.116 General requirements for informed consent. Except...

  12. 7 CFR 1c.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false General requirements for informed consent. 1c.116 Section 1c.116 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject...

  13. 21 CFR 50.20 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false General requirements for informed consent. 50.20 Section 50.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... language understandable to the subject or the representative. No informed consent, whether oral or...

  14. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false Documentation of informed consent. 46.117 Section 46.117 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.117 Documentation of informed consent. (a) Except as provided...

  15. 10 CFR 745.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false General requirements for informed consent. 745.116 Section 745.116 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by...

  16. 45 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false General requirements for informed consent. 46.116 Section 46.116 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.116 General requirements for informed consent. Except...

  17. Counseling Programs' Informed Consent Practices: A Survey of Student Preferences

    ERIC Educational Resources Information Center

    Pease-Carter, Cheyenne; Minton, Casey A. Barrio

    2012-01-01

    This study examined 115 master's-level counseling students' preferences for content, timing, and method of programmatic informed consent. Students rated the majority of items as moderately or extremely important to receive, and they indicated a desire for the informed consent to be facilitated through a combination of both oral and written methods…

  18. 16 CFR 1028.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false General requirements for informed consent. 1028.116 Section 1028.116 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve...

  19. Contemporary interpretation of informed consent: autonomy and paternalism.

    PubMed

    Robertson, Louise

    2016-06-01

    The Supreme Court's decision in the Montgomery case has questioned what is meant by 'informed consent'. Clinicians must establish who is a reasonable patient and exactly what they want to know. Obtaining informed consent requires a relationship to be built between patient and clinician and must respect patient autonomy. PMID:27269752

  20. Consent, Informal Organization and Job Rewards: A Mixed Methods Analysis

    ERIC Educational Resources Information Center

    Laubach, Marty

    2005-01-01

    This study uses a mixed methods approach to workplace dynamics. Ethnographic observations show that the consent deal underlies an informal stratification that divides the workplace into an "informal periphery," a "conventional core" and an "administrative clan." The "consent deal" is defined as an exchange of autonomy, voice and schedule…

  1. 14 CFR 1230.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Documentation of informed consent. 1230.117 Section 1230.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  2. 14 CFR 1230.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Documentation of informed consent. 1230.117 Section 1230.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  3. 14 CFR 1230.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Documentation of informed consent. 1230.117 Section 1230.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  4. 14 CFR 1230.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Documentation of informed consent. 1230.117 Section 1230.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  5. 32 CFR 219.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 2 2010-07-01 2010-07-01 false Documentation of informed consent. 219.117... (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.117 Documentation of informed consent. (a... breach of confidentiality. Each subject will be asked whether the subject wants documentation linking...

  6. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Documentation of informed consent. 97.117 Section 97...) § 97.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section... wants documentation linking the subject with the research, and the subject's wishes will govern; or...

  7. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Documentation of informed consent. 26... EPA § 26.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this... wants documentation linking the subject with the research, and the subject's wishes will govern; or...

  8. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF... Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1117 Documentation of informed consent....

  9. Consent.

    PubMed

    Rowe, A H

    1994-06-01

    Before a dental practitioner examines a patient he or she must obtain the patient's consent to do so, and before undertaking any form of complex or expensive treatment the patient's consent must be in writing. Failure to do this could leave the practitioner open to prosecution for assault, and liable for damages in a civil court. PMID:7875347

  10. Experiences with Obtaining Informed Consent for Genomic Sequencing

    PubMed Central

    Bernhardt, Barbara A.; Roche, Myra I.; Perry, Denise L.; Scollon, Sarah R.; Tomlinson, Ashley N.; Skinner, Debra

    2016-01-01

    Despite the increased utilization of genome and exome sequencing, little is known about the actual content and process of informed consent for sequencing. We addressed this by interviewing 29 genetic counselors and research coordinators experienced in obtaining informed consent for sequencing in research and clinical settings. Interviews focused on the process and content of informed consent; patients/participants’ common questions, concerns and misperceptions; and challenges to obtaining informed consent. Content analysis of transcribed interviews revealed that the main challenges to obtaining consent related to the broad scope and uncertainty of results, and patient/ participants’ unrealistic expectations about the likely number and utility of results. Interviewees modified their approach to sessions according to contextual issues surrounding the indication for testing, type of patient, and timing of testing. With experience, most interviewees structured sessions to place less emphasis on standard elements in the consent form and technological aspects of sequencing. They instead focused on addressing misperceptions and helping patients/participants develop realistic expectations about the types and implications of possible results, including secondary findings. These findings suggest that informed consent sessions should focus on key issues that may be misunderstood by patients/participants. Future research should address the extent to which various stakeholders agree on key elements of informed consent. PMID:26198374

  11. Informed consent in the (mis)information age.

    PubMed

    Nelson, Erin L

    2004-01-01

    Recent studies suggest that large numbers of health-care consumers are turning to the Internet as a source of health information. This article considers the potential impact of on-line health information on women's health-care decisions, and the role of physicians relating to their patients' use of the Internet as an information source. In particular, the article examines the effect of on-line health information on the informed consent process. Physicians' disclosure obligations (their legal duty to provide information to patients) and the law of informed consent are briefly described. The article then considers the Internet as a source of health information, and instances and types of misinformation. Finally, the article suggests steps physicians may take to help their patients benefit from Internet health information and to become critical consumers who do not fall victim to inaccurate or misleading information. The article concludes by suggesting that physicians make a practice of asking their patients about alternate sources of information they may have accessed, in order to help ensure that patients' health-care decisions are based on current, accurate, and complete information. PMID:14715125

  12. Informed consent is not routinely documented for procedures using allografts.

    PubMed

    Porter, Scott E; Stull, Douglass; Kneisl, Jeffrey S; Frick, Steven L

    2004-06-01

    Patients who receive musculoskeletal allografts may have severe postoperative infections develop. Media reports have heightened public awareness of the risk of allograft use. Explaining these risks to patients preoperatively has become more important as attention to informed consent issues has increased. This study retrospectively investigated the patterns of informed consent for allograft bone used during elective orthopaedic procedures at a major teaching hospital. Forty-seven (32%) of 148 patients had preoperative discussions of allograft risks and benefits documented with a signed preoperative consent. In nearly 70% of the cases in which structural allograft was used, preoperative consent was documented. Only 8% of cases in which nonstructural, highly processed allograft was used had documented preoperative consent. Forty-eight (32%) of 148 patients were treated with allograft and autograft. Consent was obtained for the harvesting and use of autograft from 90% of these patients. In none of these patients was consent obtained for the allograft used. Although risks of disease transmission vary widely with the degree of allograft processing and the source of its procurement, informed consent for any allograft use should be a routine part of preoperative discussions of risks and benefits in elective orthopaedic surgeries. PMID:15232464

  13. 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.

  14. Informed Consent in Decision-Making in Pediatric Practice.

    PubMed

    Katz, Aviva L; Webb, Sally A

    2016-08-01

    Informed consent should be seen as an essential part of health care practice; parental permission and childhood assent is an active process that engages patients, both adults and children, in their health care. Pediatric practice is unique in that developmental maturation allows, over time, for increasing inclusion of the child's and adolescent's opinion in medical decision-making in clinical practice and research. This technical report, which accompanies the policy statement "Informed Consent in Decision-Making in Pediatric Practice" was written to provide a broader background on the nature of informed consent, surrogate decision-making in pediatric practice, information on child and adolescent decision-making, and special issues in adolescent informed consent, assent, and refusal. It is anticipated that this information will help provide support for the recommendations included in the policy statement. PMID:27456510

  15. Surgeons' Silence: A History of Informed Consent in Orthopaedics

    PubMed Central

    Jones, Kevin B

    2007-01-01

    The moment of decision to proceed with surgical intervention is charged with some of the deepest uncertainties in medicine, but has long been cloaked under the confidence asserted by the traditionally custodial surgeon. This paper reviews the history and ethical basis for informed surgical consent. Beginning with theoretical foundations and the changing ethics of medical decision making since the ancient Greeks, it then reviews how the stage was set for informed consent by technological breakthroughs that made surgical interventions tolerable and acceptably safe. Finally, the legal generation of the doctrine of informed consent is reviewed and the current state of disclosure, shared decision-making, and uncertainty explored. PMID:17907443

  16. Shared decision making and informed consent for hysterectomy.

    PubMed

    Ogburn, Tony

    2014-03-01

    This article provides an overview of the components of the informed consent process for surgery including the components specific to hysterectomy. Shared decision making and informed consent for hysterectomy rely on a mutual understanding by the patient and surgeon of the goals, risks, benefits, and alternatives as well as the choice of hysterectomy technique. The importance of a patient-centered approach is emphasized with an explanation of several communication methods and resources for decision aids that will help to ensure that patients have a good understanding of the items listed above and are able to provide informed consent. PMID:24145363

  17. The Difficulties of Informed Consent in Stem Cell Transplant.

    PubMed

    Cook, Rachel J; Runaas, Lyndsey N

    2016-02-01

    Informed consent is the process by which a competent patient is provided with a sufficient amount of relevant information to make an educated decision about a procedure. The process of informed consent is designed to prioritize patients' autonomy. Stem cell transplant (SCT) is a complicated process with many possible results and requirements for on-going decision-making depending on outcomes and complications. While understanding basic theories of decision science will help the physician provide improved information at the time of consent, experiential learning by the patients as they proceed through SCT may have the strongest influence in continued patient decision-making that may or may not align with their initial informed consent. PMID:26837771

  18. Informed consent in dental malpractice claims. A retrospective study.

    PubMed

    Lopez-Nicolas, Manuel; Falcón, Maria; Perez-Carceles, Maria Dolores; Osuna, Eduardo; Luna, Aurelio

    2007-06-01

    With the introduction of informed consent in dental practice in Spain during the last ten years activity has been focused on avoiding complaints rather than on giving adequate information to the patient. However, in the eyes of many professionals the document by which patients accept the cost or estimated charge of treatment is the equivalent of informed consent. Although Spanish law permits verbal consent in some cases (low risk therapeutic activities), some dentists interpret this law in a very broad way. The aim of this paper was to study the fulfilment of informed consent in relation to professional malpractice claims presented to the College of Dentists of the province of Murcia, south east Spain (regional professional association) during the last twelve years (n=52). Evaluation of the complaints pointed to adequate professional behaviour in 14 cases and malpractice in 38 cases (in 29 of which the treatment applied was technically correct but with inadequate information provided during the process, while nine cases represented technical errors). The written document of informed consent was absent in 40 cases, although the verbal information supplied was considered adequate in 14 cases. When the document of informed consent was present (12 cases) it was considered unsuitable, although adequately complemented by oral information. PMID:17695737

  19. Informed consent for research participation in frail older persons.

    PubMed

    Barron, Jeremy S; Duffey, Patricia L; Byrd, Linda Jo; Campbell, Robin; Ferrucci, Luigi

    2004-02-01

    Informed consent has been the most scrutinized and controversial aspect of clinical research ethics. Institutional review boards (IRBs), government regulatory agencies, and the threat of litigation have all contributed to increasingly detailed consent documents that hope to ensure that subjects are not misled or coerced. Unfortunately, the growing regulatory burden on researchers has not succeeded in protecting subjects, but has rather made the consent process less effective and has discouraged research on vulnerable populations. As a matter of fact, investigators and ethicists continue to identify failures of the consenting process, particularly concerning participation in research of older individuals. The challenges involved in ensuring appropriate consent from the elderly include physical frailty, reduced autonomy and privacy, and impaired decision-making capacity due to dementia, delirium, or other neuropsychiatric illnesses. Ageism among investigators also contributes to failure of informed consent. The evaluation and continuing re-evaluation of an individual's decision-making capacity is critical but difficult. In the most extreme cases, the older adult's ability to participate in the consent process is clearly impaired. However, in many instances, the decision-making capacity is only partially impaired but declines during the course of a research project. Implementing methods of effective communication may enable many frail elderly individuals to make informed decisions. Special challenges are posed by research on end-of-life care, which typically involves frail, older subjects who are uniquely vulnerable, and research is conducted in institutional settings where subtle violations of autonomy are routine. Clearly, the frail elderly represent a vulnerable population that deserves special attention when developing and evaluating an informed consent process. Two important ethical conflicts should be kept in mind. First, although vulnerable older patients must

  20. Informed Consent at Gunpoint: When Psychiatry Affects Gun Ownership.

    PubMed

    Candilis, Philip J; Khurana, Gagandeep; Leong, Gregory B; Weinstock, Robert

    2015-06-01

    As states take more steps to connect patients' gun ownership to their mental health, psychiatrists are being asked to provide mental health information after clinical interviews as well as after confiscation. This move into the patient-physician relationship raises new questions about how psychiatrists should obtain informed consent when interviews may result in reports to legal authorities. Consent warnings are already practiced more in the breach than in the observance and informed consent is imperfect at its best. In communities torn by controversies surrounding gun control, vehement political views will further influence these established themes to result in unprecedented pressures on patient confidentiality. This analysis draws on new movements in ethical theory and behavioral medicine that go beyond balancing principles to question the use of psychiatry in firearm reporting, and support a vigorous practice of informed consent to protect both individuals and the communities they live in. PMID:25640524

  1. 42 CFR 50.204 - Informed consent requirement.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent... available alternative methods of family planning and birth control; (3) Advice that the...

  2. 42 CFR 50.204 - Informed consent requirement.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent... available alternative methods of family planning and birth control; (3) Advice that the...

  3. 42 CFR 50.204 - Informed consent requirement.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent... available alternative methods of family planning and birth control; (3) Advice that the...

  4. 42 CFR 50.204 - Informed consent requirement.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent... available alternative methods of family planning and birth control; (3) Advice that the...

  5. 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. PMID:25351375

  6. 14 CFR § 1230.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false Documentation of informed consent. § 1230.117 Section § 1230.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS (Eff. until 2-14-14) § 1230.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this...

  7. [Informed consent and neuromodulation techniques for psychiatric purposes: an introduction].

    PubMed

    Mandarelli, Gabriele; Moscati, Filippo Maria; Venturini, Paola; Ferracuti, Stefano

    2013-01-01

    The aim of this review was to investigate informed consent-related issues concerning vagus nerve stimulation and deep brain stimulation in the treatment of psychiatric disorders. We searched the principal medical databases for studies concerning informed consent, as well as ethical and deontological issues in psychosurgery. Data were critically analysed. We also provided guidelines for the evaluation of accuracy of the informed consent in such treatments. Despite major deontological and ethical implications, there is substantial lack of information pertaining informed consent decision-making in psychiatric patients with an indication for psychosurgery. In clinical research studies, deep brain stimulation and vagus nerve stimulation have been mainly used in drug-resistant major depressive disorder, Tourette syndrome and obsessive-compulsive disorder. Existing data on efficacy and tolerability, as well as those studies indicating the risk for incapacity in drug-resistant severe mental disorders, suggest the need to achieve a better understanding of the capacity to consent to psychosurgery in patients affected by mental disorders. Informed consent decision-making in clinical trials of deep brain stimulation and vagus nerve stimulation in psychiatric patients is largely unknown and deserves further investigation. PMID:24056827

  8. Adherence to informed consent standards in Shiraz hospitals: matrons’ perspective

    PubMed Central

    Mohsenian Sisakht, Alireza; Karamzade Ziarati, Najme; Kouchak, Farideh; Askarian, Mehrdad

    2015-01-01

    Background: Informed consent is an important part of the patients’ rights and hospitals are assigned to obtain informed consent before any diagnostic or therapeutic procedures. Obtaining an informed consent enables patients to accept or reject their care or treatments and prevent future contentions among patients and medical staff. Methods: This survey was carried out during 2011-2. We assessed adherence of 33 Shiraz hospitals (governmental and non-governmental) to informed consent standards defined by Joint Commission International (JCI) Accreditation, USA. The questionnaire was designed using the Delphi method and then filled out by hospital matrons. We calculated valid percent frequency for each part of the questionnaire and compared these frequencies in governmental and non-governmental hospitals using analytical statistics. Results: Considering 63% of the hospitals that filled out the questionnaire, no statistically significant difference was observed between the governmental and non-governmental hospitals in adherence to informed consent standards. Conclusion: This study shows a relatively acceptable adherence to standards about informed consent in Shiraz hospitals but the implementation seems not to be as satisfactory. PMID:25584348

  9. Informed consent for research in Borderline Personality Disorder

    PubMed Central

    Dew, Rachel E

    2007-01-01

    Background Previous research on informed consent for research in psychiatric patients has centered on disorders that affect comprehension and appreciation of risks. Little has been written about consent to research in those subjects with Borderline Personality Disorder, a prevalent and disabling condition. Discussion Despite apparently intact cognition and comprehension of risks, a borderline subject may deliberately choose self-harm in order to fulfill abnormal psychological needs, or due to suicidality. Alternatively, such a subject may refuse enrollment due to transference or the desire to harm him or herself. Such phenomena could be precipitated or prevented by the interpersonal dynamics of the informed consent encounter. Summary Caution should be exercised in obtaining informed consent for research from subjects with Borderline Personality Disorder. A literature review and recommendations for future research are discussed. PMID:17493277

  10. Informed consent: a crucial step in cancer patient education.

    PubMed

    Rimer, Barbara; Jones, Wendy L; Keintz, Martha K; Catalano, Robert B; Engstrom, Paul F

    1984-01-01

    Informed consent is an issue of major importance for cancer patients and for the practitioners who treat them. Recently, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research emphasized the educational goals of the consent process. Nevertheless, past research confirms that these goals are difficult to attain. In this paper, we present an overview of informed consent and describe a study of informed consent to cancer treatment conducted at the Fox Chase Cancer Center in which the consultation between the patient and physician (and/or other health professional) was observed and patients were interviewed. On the average, patients recalled less than 40% of what they were told. Patients who were told more items recalled more; however, they recalled a smaller proportion of what they were told. Several implications for health education are drawn from the study results. PMID:11658652

  11. [Informed consent for genetic information management in Colombian law].

    PubMed

    Gómez Córdoba, Ana Isabel

    2011-01-01

    Deciphering the human genome has allowed the development of new health care ways which have been generically referred to as genomic medicine. However, this new knowledge is not devoid of risks related to the access and use of genetic information, involving not only the individual, but also the biological family, ethnic group and community to which he/she belong to. This affects both individual and collective rights, which must be protected by law. This manuscript reviews the Colombian law, specifically in terms of the access and use of genetic information for diagnostic and treatment purposes, focusing on the informed consent process. The concept of genetic information, the risks and benefits associated with genetic data management and the description and critical analysis of the present Colombian regulations were thus reviewed. As a conclusion, the juridical framework of Colombia shows deficiencies regarding the protection of both individual and collective rights linked to the access and use of genetic information. PMID:22984754

  12. Informed Consent, Gatekeepers and Go-Betweens: Negotiating Consent in Child- and Youth-Orientated Institutions

    ERIC Educational Resources Information Center

    Heath, Sue; Charles, Vikki; Crow, Graham; Wiles, Rose

    2007-01-01

    Gaining informed consent from research participants is widely regarded as central to ethical research practice. This article reports on research which sought to identify contemporary practice in this area amongst researchers working in fields where research participants are often constructed as vulnerable within the research process, and where…

  13. Different Aspects of Informed Consent in Aesthetic Surgeries

    PubMed Central

    Nejadsarvari, Nasrin; Ebrahimi, Ali

    2014-01-01

    Providing an informed consent has an important role in promotion of medical treatments and reduction of judiciary litigations in this process. Today with cultural changes and wide propagation that is usually charming, the request for aesthetic surgery has an increasing trend. These problems with complexity of cosmetic surgeries lead to deeper differences of information between plastic surgeons and patients, so the discussion on giving information to a patient is of great importance. Regarding the elective choice of aesthetic surgeries, there is a need on providing a standard informed consent form. There are some problems on advertisements of aesthetic surgeries by non-plastic surgeons, taking insufficient or incorrect information to the patients affecting the patients’ autonomy. In fact, correct operative information should be share with the patients. Probable complications and alternative procedures should be presented to the patient to choose an operative option freely and without any charming. Obtaining a written informed consent can protect researchers and their sponsor institutions from any litigation. Patients with psychiatric problems can not benefit from aesthetic surgery and also they have no competency for giving any informed consent. So psychiatric problems can even worsen the surgical interventions. In this article, fundamentals of plastic surgery to provide an informed consent were reviewed and the legal and ethical considerations were evaluated. PMID:25489529

  14. Informed consent and some of its problems in Pakistan.

    PubMed

    Khan, Robyna Irshad

    2008-02-01

    Informed consent has become an essential element of human subject research. Certain components are essential for a well-understood informed consent. There are problems in procurement of a comprehensive and meaningful consent in the Pakistani research settings. The inefficient healthcare systems, low literacy rate with masses having no concept of individual rights, higher social status enjoyed by physicians inhibiting the patients from questioning them, and unwillingness to hear bad news are some of these factors. Establishing Bioethics education at all levels, encouraging the involvement of families in decision making, using improvisation in procurement of consent are suggested solutions. There needs to be a consideration for both beneficence and autonomy with emphasis on balancing and doing equal justice to both. PMID:18333527

  15. Audio-video recording of informed consent process: Boon or bane.

    PubMed

    Kulkarni, Niranjan G; Dalal, Jeroze J; Kulkarni, Tejashree N

    2014-01-01

    The Drugs Technical Advisory Board has recommended inclusion of audio-video (AV) recording of the informed consent process while conducting clinical trials in India. It is included as draft rule in the gazette of India notification dated 7(th) June 2013. This will soon become a law. There are many anticipated advantages of AV recording like reliability, transparency, and improvement in quality of conduct of informed consent process. However, at the same time the industry will need to address challenges in infrastructure, maintaining confidentiality, cost implication, and so on. AV recording will help reassure the government and community about standards maintained by the industry/institute while conducting informed consent process, thereby increasing society's faith in clinical research. PMID:24551580

  16. Audio-video recording of informed consent process: Boon or bane

    PubMed Central

    Kulkarni, Niranjan G.; Dalal, Jeroze J.; Kulkarni, Tejashree N.

    2014-01-01

    The Drugs Technical Advisory Board has recommended inclusion of audio-video (AV) recording of the informed consent process while conducting clinical trials in India. It is included as draft rule in the gazette of India notification dated 7th June 2013. This will soon become a law. There are many anticipated advantages of AV recording like reliability, transparency, and improvement in quality of conduct of informed consent process. However, at the same time the industry will need to address challenges in infrastructure, maintaining confidentiality, cost implication, and so on. AV recording will help reassure the government and community about standards maintained by the industry/institute while conducting informed consent process, thereby increasing society's faith in clinical research. PMID:24551580

  17. Improving the informed consent process in international collaborative rare disease research: effective consent for effective research.

    PubMed

    Gainotti, Sabina; Turner, Cathy; Woods, Simon; Kole, Anna; McCormack, Pauline; Lochmüller, Hanns; Riess, Olaf; Straub, Volker; Posada, Manuel; Taruscio, Domenica; Mascalzoni, Deborah

    2016-08-01

    The increased international sharing of data in research consortia and the introduction of new technologies for sequencing challenge the informed consent (IC) process, adding complexities that require coordination between research centres worldwide. Rare disease consortia present special challenges since available data and samples may be very limited. Thus, it is especially relevant to ensure the best use of available resources but at the same time protect patients' right to integrity. To achieve this aim, there is an ethical duty to plan in advance the best possible consent procedure in order to address possible ethical and legal hurdles that could hamper research in the future. Therefore, it is especially important to identify key core elements (CEs) to be addressed in the IC documents for international collaborative research in two different situations: (1) new research collections (biobanks and registries) for which information documents can be created according to current guidelines and (2) established collections obtained without IC or with a previous consent that does not cover all CEs. We propose here a strategy to deal with consent in these situations. The principles have been applied and are in current practice within the RD-Connect consortia - a global research infrastructure funded by the European Commission Seventh Framework program but forward looking in terms of issues addressed. However, the principles established, the lessons learned and the implications for future research are of direct relevance to all internationally collaborative rare-disease projects. PMID:26860059

  18. Improving the informed consent process in international collaborative rare disease research: effective consent for effective research

    PubMed Central

    Gainotti, Sabina; Turner, Cathy; Woods, Simon; Kole, Anna; McCormack, Pauline; Lochmüller, Hanns; Riess, Olaf; Straub, Volker; Posada, Manuel; Taruscio, Domenica; Mascalzoni, Deborah

    2016-01-01

    The increased international sharing of data in research consortia and the introduction of new technologies for sequencing challenge the informed consent (IC) process, adding complexities that require coordination between research centres worldwide. Rare disease consortia present special challenges since available data and samples may be very limited. Thus, it is especially relevant to ensure the best use of available resources but at the same time protect patients' right to integrity. To achieve this aim, there is an ethical duty to plan in advance the best possible consent procedure in order to address possible ethical and legal hurdles that could hamper research in the future. Therefore, it is especially important to identify key core elements (CEs) to be addressed in the IC documents for international collaborative research in two different situations: (1) new research collections (biobanks and registries) for which information documents can be created according to current guidelines and (2) established collections obtained without IC or with a previous consent that does not cover all CEs. We propose here a strategy to deal with consent in these situations. The principles have been applied and are in current practice within the RD-Connect consortia – a global research infrastructure funded by the European Commission Seventh Framework program but forward looking in terms of issues addressed. However, the principles established, the lessons learned and the implications for future research are of direct relevance to all internationally collaborative rare-disease projects. PMID:26860059

  19. Rethinking Informed Consent in Research on Heroin-Assisted Treatment.

    PubMed

    Uusitalo, Susanne; Broers, Barbara

    2015-09-01

    Can heroin addicts give consent to research on trials in which heroin is prescribed to them? Analyses of addicts and informed consent have been objects of debate in several articles. Informed consent requires the agent not only to be competent but also to give consent voluntarily. This has been questioned because of alleged features of heroin addiction. Until recently the discussion has focused on heroin addicts' desires for heroin, whether these are irresistible and thus pose a problem for giving consent. Still, in light of empirical evidence, there seems to be a consensus more or less that the problem is not whether the addicts can resist their desire for heroin. A recent article concentrates specifically on heroin addicts' false assumptions of options and voluntariness. We argue that the prevailing framing of the options in this discussion in terms of heroin and access to it is problematic. The way in which the options are typically laid out suggests an assumption that participation in the research is allegedly based on the addicts' views on using the drug. We argue that this way of presenting the options is, first, a mismatch to the studies carried out and, second, symptomatic of potential misconceptions about heroin addiction and addicts. Furthermore, we also suggest that the account of voluntariness needs to be realistic in order for subjects to be able to give consent voluntarily in actual situations, and for medical research to carry out studies on improving outcomes in addiction treatment in an ethical way. PMID:25425507

  20. How informed is informed consent? The BHAT experience.

    PubMed

    Howard, J M; DeMets, D

    1981-12-01

    In the Beta-blocker Heart Attack Trial (BHAT) a number of strategies were implemented to increase the probability of informed voluntary consent among survivors of an acute myocardial infarction. To evaluate the subjects' comprehension of the study, a bioethicist conducted in-depth home interviews with a random sample of 64 participants from 11 geographic areas. The great majority of respondents proved to be well informed about the study design, its scientific logic, and possible risks of the experimental drug. However, five subjects (8% of the sample) appeared to believe they were involved in a therapeutic program rather than a research project. The analysis of predictor variables indicates that education, race, and age were associated with the degree of respondent awareness of fundamental aspects of the trial. PMID:6120794

  1. [From informed to shared: the developing process of consent].

    PubMed

    Casari, E F; Massimo, L M E

    2002-06-01

    Based on the respect of the four well known ethical principles "autonomy, non-maleficence, beneficence and justice", of clinical cognitive psychology, social psychology and bioethics, and in the light of moral values, we wish to comment the clinical problems involving informed consent for diagnostic procedures, treatment and research in pediatrics. Studies of the issues in attitudes and shared consent in the clinical management involving children, their parents and the therapeutic team are still limited. Our suggestion is to manage the process of informed consent as a negotiated "shared consent" originated from the cognitive social representation theory, and taking into consideration the evolutive characteristics of the cognitive processes in children and adolescents, the ego defence mechanisms, the coping behaviour activated in the relationship among the pediatric patient, his/her family and the physicians. Many parents told us that the informed consent process is helpful though often confusing. Satisfaction was not related to ethnicity or education level. They found discussions more helpful than the consent documents. The more difficult process concerned their understanding of the concept of randomisation and the request of their consent to this procedure. The model we suggest has also the aim to give adequate and honest informations to children and adolescents through a continuous dialogue with the physician, until this become a routine part of their life in hospital care, to avoid confusion, to satisfy any request and curiosity, to be honest and helpful with any answer. We strongly believe that medical students, and in particular pediatricians, must be trained on "communication" and that they need to acquire, in addition to their medical capability, a good knowledge on this topic, including ethics and relational aspects. In our opinion, pediatricians must become expert also in the following topics: "Problem-related Learning", "The Family System Health Model

  2. Informed Consent in School Health Research: Why, How, and Making It Easy.

    ERIC Educational Resources Information Center

    Ross, James G.; Sundberg, Elizabeth C.; Flint, Katherine H.

    1999-01-01

    Obligation to obtain informed consent for student participation in health-related research creates complex legal, ethical, and administrative responsibilities. This paper traces the historical impetus behind informed consent, identifies key elements comprising informed consent, reviews types of consent procedures used in schools, and suggests ways…

  3. Informed or Misinformed Consent? Abortion Policy in the United States.

    PubMed

    Daniels, Cynthia R; Ferguson, Janna; Howard, Grace; Roberti, Amanda

    2016-04-01

    Since 2010, the United States has witnessed a dramatic expansion of state-based restrictions on abortion. The most common of these are informed consent statutes, which require that a woman seeking an abortion receive a state-authored informational packet before the abortion procedure can be performed. These laws, in addition to requiring the provision of information about alternatives to and risks of abortion, all also require details of embryological and fetal development. This article presents the findings of a comprehensive study of state-authored informed consent materials regarding embryological and fetal development. To conduct this study, we recruited a panel of experts in human anatomy to assess the accuracy of these materials in the context of the constitutional standard established inPlanned Parenthood of Southeastern Pennsylvania et al. v. Robert P. Casey et al.(505 U.S. 833 (1992)): that such information must be "truthful" and "nonmisleading." We find that nearly one-third of the informed consent information is medically inaccurate, that inaccurate information is concentrated primarily in the earlier weeks of pregnancy and is clustered around particular body systems. We discuss the implications of our findings for the question of the constitutionality of informed consent laws as they have been implemented in practice. PMID:26732319

  4. INFORMED CONSENT: THE MEDICAL AND LEGAL CHALLENGE OF OUR TIME

    PubMed Central

    Séllos Simões, Luiz Carlos

    2015-01-01

    Objective: To assess the real importance of obtaining informed consent, through an appropriate form, and its role in the outcome from civil liability claims. Methods: The wordings of the current Brazilian law and jurisprudence were compared with rulings from the State Court of the State of Rio de Janeiro, in 269 civil liability claims against healthcare professionals and hospitals. Results: Favorable and unfavorable outcomes (i.e. acquittals and convictions) were compared, and possible variations in the verdicts were discussed in relation to whether informed consent forms had been filled out or not. Conclusions: Obtaining informed consent, by means of appropriate forms, is still not a widespread practice in the Brazilian healthcare or judicial systems. It is recommended that this practice be adopted in the manner described in this paper, since this is prescribed in Brazilian law. PMID:27022541

  5. Legal briefing: informed consent in the clinical context.

    PubMed

    Pope, Thaddeus Mason; Hexum, Melinda

    2014-01-01

    This issue's "Legal Briefing" column covers recent legal developments involving informed consent.1 We covered this topic in previous articles in The Journal of Clinical Ethics.2 But an updated discussion is warranted. First, informed consent remains a central and critically important issue in clinical ethics. Second, there have been numerous significant legal changes over the past year. We categorize recent legal developments into the following 13 categories: (1) Medical Malpractice Liability, (2) Medical Malpractice Liability in Wisconsin, (3) Medical Malpractice Liability in Novel Situations, (4) Enforcement by Criminal Prosecutors, (5) Enforcement by State Medical Boards, (6) Enforcement through Anti-Discrimination Laws, (7) Statutorily Mandated Disclosures Related to End-of-Life Counseling, (8) Statutorily Mandated Disclosures Related to Aid in Dying, (9) Statutorily Mandated Disclosures Related to Abortion, (10) Statutorily Mandated Disclosures Related to Telemedicine, (11) Statutorily Mandated Disclosures Related to Other Interventions, (12) Statutorily Mandated Gag and Censorship Laws, (13) Informed Consent in the Research Context. PMID:24972066

  6. 38 CFR 16.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2010-07-01 2010-07-01 false Documentation of informed... PROTECTION OF HUMAN SUBJECTS § 16.117 Documentation of informed consent. (a) Except as provided in paragraph... asked whether the subject wants documentation linking the subject with the research, and the...

  7. 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

  8. Hypothetical contractarianism and the disclosure requirement problem in informed consent.

    PubMed

    Cust, Kenneth F T

    1991-01-01

    Two of the more deeply problematic issues surrounding the doctrine of informed consent are providing a justification for the practice of informed consent and providing an account of the nature and amount of information that must be disclosed in order for informed consent to take place. This paper is concerned with the latter problem, the problem of disclosure requirements, but it deals with this problem in a novel way; it approaches the problem by asking what fully informed and fully rational agents would agree to under certain hypothetical conditions. In general terms I juxtapose the hypothetical contractarianism found in Rawls' A Theory of Justice with that found in Gauthier's Morals By Agreement and ask what their respective hypothetical contractors would agree to with respect to choosing a particular standard of disclosure to govern the practice of informed consent. In more specific terms a contrast is made between what a Rawlsian agent behind a veil of ignorance would choose as compared to what, in Gauthier's terms, an ideal actor making an Archimedean choice would choose. The idea of an Archimedean point, and the subsequent choice made from that point, although technically identified by Rawls, originated with Archimedes of Syracuse. PMID:11651182

  9. 77 FR 29983 - Federal Acquisition Regulation; Information Collection; Subcontract Consent

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-21

    ...Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning subcontract consent. This OMB Clearance expires August 31, 2012. Public comments are particularly invited on: Whether this collection of......

  10. Teaching the Process of Obtaining Informed Consent to Medical Students.

    ERIC Educational Resources Information Center

    Johnson, Shirley M.; And Others

    1992-01-01

    A unit on informed consent for first-year osteopathy students consists of pre- and posttests, a lecture, readings, small-group discussion, a model videotaped interview, and students' videotaped interviews with a simulated patient. Students were most successful in establishing patient rapport and discussion, least successful in conflict resolution…

  11. 45 CFR 690.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 3 2014-10-01 2014-10-01 false General requirements for informed consent. 690.116 Section 690.116 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE...) The research or demonstration project is to be conducted by or subject to the approval of state...

  12. 45 CFR 690.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 3 2012-10-01 2012-10-01 false General requirements for informed consent. 690.116 Section 690.116 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE...) The research or demonstration project is to be conducted by or subject to the approval of state...

  13. 45 CFR 690.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 3 2013-10-01 2013-10-01 false General requirements for informed consent. 690.116 Section 690.116 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE...) The research or demonstration project is to be conducted by or subject to the approval of state...

  14. 40 CFR 26.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false General requirements for informed consent. 26.116 Section 26.116 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.116 General requirements...

  15. 40 CFR 26.1116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false General requirements for informed consent. 26.1116 Section 26.1116 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of...

  16. 28 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights,...

  17. Informed Consent in Decision-Making in Pediatric Practice.

    PubMed

    2016-08-01

    Informed consent should be seen as an essential part of health care practice; parental permission and childhood assent is an active process that engages patients, both adults and children, in health care. Pediatric practice is unique in that developmental maturation allows, over time, for increasing inclusion of the child's and adolescent's opinion in medical decision-making in clinical practice and research. PMID:27456514

  18. Informed Consent in Educational Settings and the Novice Researcher

    ERIC Educational Resources Information Center

    Sanderson, Lara

    2010-01-01

    Research ethics are of fundamental importance to any research. They define and shape the research process from the very beginning as they are the code on which academics rely on as guiding practice in the field (Hopf, 2004). Informed consent is an interesting concept as it is interwoven with other ethical issues that include power, privacy and…

  19. Confidentiality and Informed Consent: School Counsellors' Perceptions of Ethical Practices

    ERIC Educational Resources Information Center

    Lehr, Ron; Lehr, Andria; Sumarah, John

    2007-01-01

    This article presents the findings of in-depth interviews with school counsellors in Nova Scotia on issues related to confidentiality and informed consent. Of the 224 school counsellors in the province, 43 counsellors, representing all school boards, agreed to a 45-minute semi-structured telephone interview focusing on their current practices…

  20. Informed consent in Croatia. A work in progress.

    PubMed

    Vučemilo, Luka; Borovečki, Ana

    2014-07-01

    As Croatia makes the transition from one political system and type of economy to another, there are inevitable social and political changes that have a profound affect on the healthcare system. This article charts some of the progress of change with respect to patients' rights and informed consent. PMID:24865264

  1. 14 CFR 1230.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false General requirements for informed consent. 1230.116 Section 1230.116 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION..., to the extent the physician is permitted to do so under applicable federal, state, or local...

  2. 14 CFR 1230.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false General requirements for informed consent. 1230.116 Section 1230.116 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION..., to the extent the physician is permitted to do so under applicable federal, state, or local...

  3. 16 CFR 1028.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false General requirements for informed consent. 1028.116 Section 1028.116 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF... the subject; (5) A statement that significant new findings developed during the course of the...

  4. Use of altered informed consent in pragmatic clinical research

    PubMed Central

    McKinney, Ross E.; Beskow, Laura M.; Ford, Daniel E.; Lantos, John D.; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J.; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin

    2015-01-01

    There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to IRBs as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients’ rights and interests. PMID:26374677

  5. Understanding informed consent for participation in international health research.

    PubMed

    Jegede, Ayodele S

    2009-08-01

    To participate in health research, there is a need for well-administered informed consent. Understanding of informed consent, especially in international health research, is influenced by the participants' understanding of information and the meaning attached to the information communicated to them regarding the purpose and procedure of the research. Incorrect information and the power differential between researcher and participants may lead to participants becoming victims of harmful research procedures. Meningitis epidemics in Kano in early 1996 led to a response from drug companies, especially Pfizer, as well as humanitarian workers from Médecins Sans Frontiers, which resulted in an unethical trial. Pfizer's drug trial during the epidemics has left a lasting controversy, which has yet to be resolved. This paper examines the key issues surrounding the controversy, discusses the context of informed decision-making, the ethical issues and implications of the incident, and concludes with some recommendations. Relevant texts, journals, Internet materials, newspaper articles and documentary materials on the conduct of the Pfizer's Trovan trial have been consulted. Four types of action (act intuitively, act rationally, act ignorantly, and act contextually - based on information provided) are identified as possible options for decision making. Participants most likely acted in ignorance due to poor understanding of the information contained in the verbal informed consent administered, thereby raising ethical issues. It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences. PMID:18637943

  6. Informed consent in theory and practice: legal and medical perspectives on the informed consent doctrine and a proposed reconceptualization.

    PubMed

    Sprung, C L; Winick, B J

    1989-12-01

    The theoretical, legal, and medical doctrines of informed consent are analyzed. The elements of informed consent include disclosure of information, competency, understanding, voluntariness, and decision-making. The doctrine is ground in deference to individual autonomy and recognition that the exercise of self-determination in matters of health is a liberty interest honored by our history and traditions. The exceptions to informed consent including emergency, incompetency, therapeutic privilege, and waiver are especially important in critically ill patients and reflect a balancing of autonomy values and society's interest in the promotion of health. Legal decisions inevitably are based on atypical physician-patient encounters and focus on a particular problem or procedure rather than on overall medical care. In addition, they often reflect an artificial view of the doctor-patient relationship. Medical decision-making is a complex, evolving pursuit of a diagnosis and proper treatment regimen. Moreover, patients are not always interested in the role assigned to them by law. A reconceptualization of informed consent doctrines utilizing sliding scale standards based on variables pertinent to each individual patient is suggested. PMID:2686937

  7. Donation of eggs in assisted reproduction and informed consent.

    PubMed

    Uroz, Victoria; Guerra, Lucia

    2009-09-01

    In Spain, there exists an increasing amount of advertising for the donation of eggs for assisted reproduction. This study attempts to assess: (1) scientific evidence available about adverse effects of egg donation; (2) characteristics of the information given in the informed consent to donors; and (3) the legality of this advertising. The main results are: (1) Many severe problems are associated with induction of ovulation, as ovarian hyperstimulation (reported frequencies from 5.9 to 15%), thromboembolism, hepatic failure and increased risk of ovarian, breast, endometrial and colon cancer. (2) Informed consent for egg donors is very incomplete, according to the Spanish law 41/2002 on Patient's Information. (3) Current advertising to promote egg donation does not respect, among others, law 14/2006 about Assisted Human Reproduction, as it includes reference to economic compensation or benefits but no information about the risks. Deontological and judicial disciplinary procedures should be initiated to protect donors' rights. PMID:20157970

  8. Informed Consent in the Changing Landscape of Research.

    PubMed

    Hammer, Marilyn J

    2016-09-01

    The history of informed consent dates back as early as the 16th century (Selek, 2010). The current tenets of informed consent pertaining to the ethical conduct of research on human participants predominately stems from the 1947 Nuremberg Code (National Institutes of Health, 2016), which was created following the Nuremberg trials at the end of World War II. The unethical conduct of research on human participants during the Holocaust, coupled with experiments (e.g., the Tuskegee syphilis study), prompted a more formalized structure for ensuring the well-being and autonomy of human participants in research studies. The World Medical Association (2013) created the Declaration of Geneva in 1948 (Fischer, 2006), followed by the Declaration of Helsinki in 1964, to apply ethical principles to medical research involving human participants (Fischer, 2006; Rickham, 1964). A decade later, on July 12, 1974, the National Research Act was signed into law (U.S. Department of Health and Human Services [HHS], 1979). Through this act, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed and charged with developing guidelines for the conduct of biomedical and behavioral research. The guidelines were established in the Belmont Report (HHS, 1979; U.S. Department of Health, Education, and Welfare, 1979), which continues to be periodically updated. The Belmont Report describes the general principles of respect for persons, beneficence, and justice, and it outlines the process of obtaining informed consent to ensure that these principles are followed (HHS, 1979). In 1998, an informed consent checklist was instituted (HHS, 1998). Although clearly outlined, defined, and described in consent forms, it is beneficial to revisit how informed participants are when they enter research studies, particularly for patients undergoing treatment for cancer. This article will provide an overview of several areas for consideration. 
. PMID

  9. [Patterns of information and informed consent procedures. Study of the Ethical Commission of the ANMCO].

    PubMed

    Zuppiroli, Alfredo; Bobbio, Marco; Geraci, Enrico; Martelloni, Massimo; Spinsanti, Sandro; Vergassola, Rossano; Violini, Roberto

    2002-01-01

    A survey on patterns of information and informed consent procedures during daily clinical practice has been performed by the Ethical Commission of ANMCO. A structured questionnaire (38 questions) was sent to the 653 cardiological units of the National Health Service in Italy. Four hundred and eighty (73.5%) were received. The following variables were considered to evaluate differences in the answers from the various cardiological units: geographical site, presence or absence of an in-patient department, a cath-lab, and of cardiac surgery facilities. Independent predictors of returning questionnaires were: geographical site (Northern Italy vs Central and Southern) and the presence of a cath-lab. Informed consent forms were provided in 53% of instances, while in 40% a free comment about the topic of informed consent was sent. Statistically significant differences in the answers were found about physicians' and nurses' role, ways of information, qualitative and quantitative risk estimates, other persons' role, models of consent forms and procedures of obtaining consent. Free comments and informed consent forms did not allow a statistical analysis. However, they still provided sufficient material to identify specific patterns of how cardiologists deal with the informed consent process. The distinction between the two phases of information and consent was rarely clear. Information or educational material was often mixed with consent forms. While some still showed a paternalistic approach, or else considered informed consent as a formal act, others demonstrated a deep understanding of the significance of the concept of informed consent. A widespread need of guidelines and standard patterns resulted. PMID:11899574

  10. 76 FR 256 - Informed Consent Elements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    ... responsibility of investigators (74 FR 68750 at 68752). Clinical research (as opposed to clinical practice) is... specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National...

  11. Aspects of vulnerable patients and informed consent in clinical trials

    PubMed Central

    Kuthning, Maria; Hundt, Ferdinand

    2013-01-01

    Scope: To discuss the rationale behind informed consent in clinical trials focusing on vulnerable patients from a European and German viewpoint. Methods: Scientific literature search via PubMed, Medline, Google. Results: Voluntary informed consent is the cornerstone of policies regulating clinical trials. To enroll a patient into a clinical trial without having obtained written and signed consent is to be considered as a serious issue in the conduct of a clinical trial. Development of ethical guidance for physicians started before Christ Era with the Hippocratic Oath. Main function of consent, as articulated in all guidelines developed for clinical research, is to facilitate an individual’s freedom of choice, respect autonomy, and thus to ensure welfare of the participants in clinical trials. Minors are unable to provide legally binding informed consent, this issue is addressed through a combination of parental permission and minor’s assent. Illiteracy is a critical problem that affects all corners of our earth; it has no boundaries and exists among every race and ethnicity, age group, and economic class. New strategies to improve communication with patients including the use of videotapes or animated cartoon illustrations could be taught. Finally the time with the potential participant seems to be the best way to improve understanding. Conclusion: Discovery of life saving and life enhancing new treatments requires partnership that is based on good communication and trust between patients and researchers, sponsors, ethics committees, authorities, lawyers and politicians so that vulnerable patients can benefit from the results of well controlled clinical trials. PMID:23346043

  12. Informed consent and the limits of confidentiality.

    PubMed

    Haggerty, L A; Hawkins, J

    2000-06-01

    Investigators encounter many legal and ethical issues when they conduct research on partner abuse. Balancing abused women's rights to privacy with legally mandated reporting requirements involves considerable thought and planning. Failure to protect participants may result in escalation of abuse as well as loss of children to protective services. Various perspectives on maintaining participant privacy while conforming to legal mandates to report child abuse, homicidality, and suicidality are discussed. The role of confidentiality certificates in providing legal immunity for researchers and the method of obtaining the certificates are presented. In addition, the authors describe the strategies for participant protection that are implemented in a federally funded study of abuse, women's self-care, and pregnancy outcomes. The decision to clearly and specifically inform abused women of the limits of confidentiality allows participants to make informed decisions about disclosures, but may result in diminished recruitment. PMID:10826257

  13. Legal and Ethical Aspects of Informed Consent: A Nursing Research Perspective.

    ERIC Educational Resources Information Center

    Cassidy, Virginia R.; Oddi, Lorys F.

    1986-01-01

    Issues related to the doctrine of informed consent for research on human subjects are discussed as they concern the conduct of nursing research. They include the subject's capacity to consent, disclosure of information, and freedom to decide. (MSE)

  14. Legal issues affecting confidentiality and informed consent in reproductive health.

    PubMed

    Rockett, L R

    2000-01-01

    The law governing confidentiality and informed consent has acquired unique characteristics in the area of reproductive health, as a consequence of both the establishment of a constitutional right to privacy in reproductive health matters and the reaction of those politically and morally opposed to the exercise of that right. The primary issues have involved: 1) the right of minors to receive reproductive health services without parental consent, which remains a political battleground; 2) laws requiring physicians to provide information to pregnant patients that is intended, not to inform them of the risks and benefits of the procedure, but to discourage them from obtaining abortions; 3) coerced and prohibited sterilizations; 4) court-ordered contraception and procedures to protect the fetus; and 5) restrictions on counseling about abortion, contraception, sterilization, and other reproductive health services authorized by state conscience or noncompliance clauses that shield such restrictions from the usual ethical, medical, and legal rules governing informed consent. The last area is of profound significance to the ability of women to make informed decisions about their reproductive health options. In the current economic environment, which fuels mergers and acquisitions involving sectarian and nonsectarian institutions, women are increasingly being put at risk as a result of such restrictions. PMID:11070641

  15. Theory and practice of informed consent in the Czech Republic

    PubMed Central

    Krizova, Eva; Simek, Jiri

    2007-01-01

    The large‐scale change of Czech society since 1989 has involved the democratic transformation of the health system. To empower the patient was one important goal of the healthcare reform launched immediately after the Velvet Revolution. The process has been enhanced by the accession of the Czech Republic to the European Union and the adoption of important European conventions regulating the area. The concept of informed consent and a culture of negotiation are being inserted into a traditionally paternalistic culture. Our article describes the current situation on the issue of the communication of information on state of health and treatment, and on the question of the participation of the patient in decisions on treatment. We present empirical results of a public opinion survey on this issue. The results show a still prevailing submissive attitude towards the physicians, despite the fact that the concept of informed consent has become more and more publicly familiar (42% of respondents gave the completely correct answer regarding informed consent). The impact of age, education and sex on answers to the questionnaire was analysed. Men, younger and more educated respondents were more likely to show the autonomous attitude, whereas women, older and less educated people tended to show the traditional submissive attitude. Further, our article raises the question of the cultural and historical background within which the current ethically and legally binding norms (products of western democracies, in fact) are interpreted. The question is how far cultural modifications are tolerable in the practical implementation of universal ethical constructs (informed consent). PMID:17470503

  16. Patient and parent understanding of informed consent in orthodontics.

    PubMed

    Mortensen, Micah G; Kiyak, H Asuman; Omnell, Lena

    2003-11-01

    In both medical and dental settings, researchers have found that patients do not adequately comprehend the information given during informed consent discussions, especially the less educated, low-income patients. Because of the importance of patient compliance with orthodontic treatment regimens, this study examined patient and parent understanding of the child's Phase I orthodontic treatment in a public dental clinic with ethnically diverse, low-income patients. Interviews were conducted with 29 children (ages 6-12) and their parents or guardians at the orthodontic case presentation appointment. The orthodontist explained the reasons for treatment, the orthodontic procedures to be used, the risks, the alternatives, and patient and parent responsibilities during treatment; the session was audiotaped. Interviews were conducted immediately after this discussion and the results compared with the orthodontists' presentations. In general, both children and parents recalled significantly fewer reasons for treatment (1.10, 1.66, and 2.34 items, respectively), procedures (1.55, 1.59, and 2.45, respectively), risks associated with treatment (0.66, 1.48, and 4.66, respectively), and responsibilities of the child during treatment (2.21, 2.07, and 3.38, respectively) than what the orthodontist had told them. They were also less likely to recall the reasons, procedures, and risks that were most frequently cited by the orthodontist. These findings raise concerns about the effectiveness of current informed consent techniques with public health populations, especially the low recall rates within 30 minutes of the case presentations. Low recall of risks by children and their parents, particularly for critical risks such as relapse, caries, and periodontal problems, raises concerns about treatment compliance, success, and more importantly, the effectiveness of the informed consent process itself. Future research should focus on methods to improve the informed consent process among

  17. 21 CFR 50.24 - Exception from informed consent requirements for emergency research.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Exception from informed consent requirements for... AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.24 Exception from informed consent requirements for emergency research. (a) The IRB responsible for the...

  18. 21 CFR 50.24 - Exception from informed consent requirements for emergency research.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Exception from informed consent requirements for... AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.24 Exception from informed consent requirements for emergency research. (a) The IRB responsible for the...

  19. 21 CFR 50.24 - Exception from informed consent requirements for emergency research.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Exception from informed consent requirements for emergency research. 50.24 Section 50.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.24 Exception from informed consent...

  20. Informed consent and its implications in family practice.

    PubMed

    Mangold, W J

    1975-04-01

    The doctrine of informed consent has had its practical introduction to medical malpractice litigation in the past five years. Its definition has not changed since the days when its definitive application was only a fond dream of the malpractice plaintiffs attorneys. However, with neh new methods of presenting this theory to the courts, and with the newly emerging practice fo having rulings on matters of law substituted by judges for prevailing standards of medical practice, the implications for family physicians have become tremendous. Hopefullum by understanding the principles involved in its application in the pertinent landmark cases, family physicians will be better able to abid the pitfalls engendered by the doctrine of informed consent. PMID:1127387

  1. Informed consent for HPV vaccination: a relational approach.

    PubMed

    Gottvall, Maria; Tydén, Tanja; Larsson, Margareta; Stenhammar, Christina; Höglund, Anna T

    2015-03-01

    The aim of this study was to explore the relational aspects of the consent process for HPV vaccination as experienced by school nurses, based on the assumption that individuals have interests related to persons close to them, which is not necessarily to be apprehended as a restriction of autonomy; rather as a voluntary and emotionally preferred involvement of their close ones. Thirty Swedish school nurses were interviewed in five focus groups, before the school based vaccination program had started in Sweden. The empirical results were discussed in light of theories on relational autonomy. The school nurses were convinced that parental consent was needed for HPV vaccination of 11-year-old girls, but problems identified were the difficulty to judge when a young person is to be regarded as autonomous and what to do when children and parents do not agree on the decision. A solution suggested was that obtaining informed consent in school nursing is to be seen as a deliberative process, including the child, the parents and the nurse. The nurses described how they were willing strive for a dialogue with the parents and negotiate with them in the consent process. Seeing autonomy as relational might allow for a more dialogical approach towards how consent is obtained in school based vaccination programs. Through such an approach, conflicts of interests can be made visible and become possible to deal with in a negotiating dialogue. If the school nurses do not focus exclusively on accepting the individual parent's choice, but strive to engage in a process of communication and deliberation, the autonomy of the child might increase and power inequalities might be reduced. PMID:23275146

  2. Informed Consent, Body Property, and Self-Sovereignty.

    PubMed

    Rao, Radhika

    2016-09-01

    Recent cases involving biosamples taken from indigenous tribes and newborn babies reveal the emptiness of informed consent. This venerable doctrine often functions as a charade, a collective fiction which thinly masks the uncomfortable fact that the subjects of human research are not actually afforded full information regarding the types of research that may be contemplated, nor do they provide meaningful consent. But if informed consent fails to provide adequate protection to the donors of biological materials, why not turn to principles of property law? Property is power, yet current law permits everyone except for those who donate biological materials to possess property rights. The reluctance to invoke property probably stems from fears of resurrecting slavery and the commodification of human beings. But ironically, avoidance of property transforms the subjects of human research into objects that can be owned only by others, resulting in new forms of oppression and exploitation. Human research subjects are autonomous individuals who should not only possess the power to contribute their biological materials, but also the right to help control the course of research, and to share in the resulting benefits or profits. Conferring body property might enable research subjects to regain power and a measure of self-sovereignty. PMID:27587448

  3. Towards better-informed consent: Research with livestock-keepers and informal traders in East Africa.

    PubMed

    Cooper, Tarni Louisa; Kirino, Yumi; Alonso, Silvia; Lindahl, Johanna; Grace, Delia

    2016-06-01

    With the rise of the One Health paradigm, ethicists have called for new research approaches, considering the interdependent relationships of humans, animals, and their environment. These relationships can be particularly complex within resource-poor, smallholder livestock systems, necessitating a rigorous informed-consent process. Little has been published on informed consent beyond human-subject research. This paper outlines two studies on informed consent, for research identifying diseases of animal and human importance, within smallholder livestock value chains. Firstly, a randomized independent-group study compared three communication tools (written, cartoons, and photographs) for informing 22 Tanzanian livestock-keepers before seeking their consent. A significant difference in comprehension and engagement in the informed-consent process was found between tools, and cartoons had the highest (i.e. best combined comprehension and engagement) scores. Most (21 out of 22) farmers answered half or more the questions correctly, but none were able to answer all questions. Comprehension testing allowed identification of common misunderstandings, such as immediate benefits the farmers would receive and the process to be used for relaying research results. Dialogue stimulated by cartoons and photographs allowed researchers to determine and respond to participants' varied relationships with their livestock. The second study assessed preferred methods for indicating consent among informal-sector milk vendors in Nairobi, Kenya. Of consenting participants, 61% (140/230) indicated consent verbally, 39% (90/230) signed consent and none chose thumbprint. There was a significant enumerator-effect on both overall consent and the methods chosen. Several of these findings echo those published in human-medical research. Additionally, highlighted here is the importance of facilitating dialogue during the informed-consent process in One Health research, for a more nuanced understanding

  4. Informed consent in direct-to-consumer personal genome testing: the outline of a model between specific and generic consent.

    PubMed

    Bunnik, Eline M; Janssens, A Cecile J W; Schermer, Maartje H N

    2014-09-01

    Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that current practices of information provision are insufficient and that there is a place--and a need--for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. PMID:23137034

  5. Informed consent to breech birth in New Zealand.

    PubMed

    Powell, Rhonda; Walker, Shawn; Barrett, Alison

    2015-07-24

    The authors note significant room for improvement in facilitating informed consent in the management of breech presentation. New Zealand maternity care providers, including midwives, general practitioners and specialist obstetricians, have legal duties to provide full and unbiased information about risks and benefits of all relevant treatment options. In the case of breech presentation, such options include the interventions of external cephalic version or planned caesarean section, as well as the option to decline intervention and proceed with a planned vaginal breech birth. Information should be presented in a balanced and accessible way and not limited to the provider's personal preferences. Women have legal rights to make an informed choice, to give or refuse consent, to a second opinion and to co-operation among providers. The right of competent persons to refuse medical treatment, including the right to refuse caesarean section, is well established. Clinical policies therefore should include appropriate and non-coercive care for women who choose to birth their breech-presenting baby vaginally, compliance with such policies should be the norm, and consideration should be given to any institutional reforms or educational priorities needed to achieve this. PMID:26367363

  6. 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...

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 2 2010-07-01 2010-07-01 false 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...

  8. Distinctions in Disclosure: Mandated Informed Consent in Abortion and ART.

    PubMed

    Daar, Judith

    2015-01-01

    Enactment of mandated pre-procedure disclosures in abortion and assisted reproductive technology (ART) services has swelled in recent years. Calls to equally regard these mandates as neutral tools in furtherance of patient protection fail to acknowledge key substantive and structural differences in these reproduction-affecting mandates. While ART mandates permit physicians to use their medical judgment to protect presumptively vulnerable egg donors and gestational carriers, abortion disclosures impart scientifically suspect messaging aimed at dissuading women from pursuing pregnancy termination. These and other distinctions counsel in favor of regarding and analyzing abortion and ART mandated disclosures as separate and distinguishable informed consent tools. PMID:26242946

  9. Cross-cultural perspectives on research participation and informed consent.

    PubMed

    Barata, Paula C; Gucciardi, Enza; Ahmad, Farah; Stewart, Donna E

    2006-01-01

    This study examined Portuguese Canadian and Caribbean Canadian immigrants' perceptions of health research and informed consent procedures. Six focus groups (three in each cultural group) involving 42 participants and two individual interviews were conducted. The focus groups began with a general question about health research. This was followed by three short role-plays between the moderator and the assistant. The role-plays involved a fictional health research study in which a patient is approached for recruitment, is read a consent form, and is asked to sign. The role-plays stopped at key moments at which time focus group participants were asked questions about their understanding and their perceptions. Focus group transcripts were coded in QSR NUDIST software using open coding and then compared across cultural groups. Six overriding themes emerged: two were common in both the Portuguese and Caribbean transcripts, one emphasized the importance of trust and mistrust, and the other highlighted the need and desire for more information about health research. However, these themes were expressed somewhat differently in the two groups. In addition, there were four overriding themes that were specific to only one cultural group. In the Portuguese groups, there was an overwhelming positive regard for the research process and an emphasis on verbal as opposed to written information. The Caribbean participants qualified their participation in research studies and repeatedly raised images of invasive research. PMID:16039028

  10. Managing the "known unknowns": theranostic cancer nanomedicine and informed consent.

    PubMed

    Jotterand, Fabrice; Alexander, Archie A

    2011-01-01

    The potential clinical applications and the economic benefits of theranostics represent a tremendous incentive to push research and development forward. However, we should also carefully examine the possible downsides. In this chapter, we address the issue of how theranostics might challenge our current concept of informed consent, especially the disclosure of information concerning diagnosis and treatment options to human subjects. We argue that our lack of data concerning long-term effects and risks of nanoparticles on human health and the environment could undermine the process when it comes to weighing the risks against the benefits. Our lack of an agreed upon framework for risk management in nanomedicine may require us to adopt an "upstream" approach that emphasizes communication and transparency among all relevant stakeholders to help them make informed choices that enable safety or progress. PMID:21424464

  11. [About medical accidents and their medicolegal implications. Information and consent].

    PubMed

    El Banna, S; Beauthier, F; Beauthier, J P

    2013-01-01

    Medical practice today is not simple because of various factors impinging on the doctor-patient relationship. The concept of consent arises from the ethical principle of patient autonomy and basic human rights. It is also the rule of law (Civil Code article 16-3) that guarantees the patient's right and freedom to decide what should or should not happen to his/her body and to gather information before undergoing a test/procedure/surgery. No one else has the right to coerce the patient to act in a particular way. The authors after a reflexion about medical accidents and their medicolegal implications, discuss the means to display in order to provide to the patients the adequate information about their disease and proposed treatment, therefore protecting the medical practitioner from the consequences of insufficient or ill information. PMID:24505867

  12. Putting the 'informed' into 'consent': a matter of plain language.

    PubMed

    Green, J B; Duncan, R E; Barnes, G L; Oberklaid, F

    2003-12-01

    Health professionals frequently write at the same level for lay readers as they write for peers. In relation to health research and ethical requirements to provide written explanation of studies, this can complicate the notion of informed consent. Plain language information statements need to be clearly understood by research subjects if the ethics process for research approval is to fulfil its objective. Many delays in gaining ethics approval for child-related research are caused by substandard plain language statements (PLS). We describe specific issues for information statements for research with children, young people and their parents/guardians, particularly in consideration of the literacy capabilities of the general population. We highlight the usefulness of everyday language when explaining research and science in writing to families, and present some guidelines for writing PLS that have emerged from the introduction of a plain language service by an Ethics in Human Research Committee. PMID:14629504

  13. Informed consent procedure for clinical trials in emergency settings: the Polish perspective.

    PubMed

    Iwanowski, Piotr S

    2007-09-01

    Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients' to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of Helsinki, Good Clinical Practice guideline, Additional Protocol to the European Bioethical Convention concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow waivers from participants' consent or deferred consent for emergency research, the regulations of most European Community countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting regulations on a waiver from a participant's consent in emergency research exist and the regulations on surrogate consent of temporarily incompetent adults are too restrictive and authorise only the guardianship courts to consent, which is not or hardly feasible in practice. European Community regulations need to be amended to allow for implementation of the deferred consent or waivers from consent for emergency research in order to enable ethical research of emergency conditions that should become a large part of important public health priorities. PMID:18210227

  14. Role of the informed consent, from mesotherapy to opioid therapy.

    PubMed

    Mammucari, M; Lazzari, M; Maggiori, E; Gafforio, P; Tufaro, G; Baffini, S; Maggiori, S; Palombo, E; de Meo, B; Sabato, A F

    2014-01-01

    Informed consent is part of a process of communication useful to obtain an agreement (conscious, voluntary and free) between doctors and patients. Mesotherapy is based on the introduction of drugs by intradermal route in order to obtain a dose-sparing effect with respect to deeper administration. Opioids are the most appropriate therapy for patients who do not respond to other therapies. Proper communication between doctor and patient, including an explanation of the potential benefits, limitations and risks (even mild), is recommended both in clinical practice and research. Active participation of the patient has the advantage of better control of adverse events, both of mesotherapy and opioid-based therapy. This information-education process returns to the fundamental concept of "first do no harm" and set a "therapeutic partnership" with patients. PMID:24615182

  15. [Informed consent and experimental treatments: the case of mesotherapy].

    PubMed

    Mammucari, Massimo; Gatti, Antonio; Maggiori, Enrica; Vergari, Benedetto; Gafforio, Paolo; Tufaro, Giuseppe; Maggiori, Sergio

    2013-05-01

    Mesotherapy is a minimally invasive technique based on the introduction of pharmacologically active compounds in the surface layer of the skin. The intradermal route has been known for many years and it has the aim of reducing the dose and slowing the diffusion into the underlying tissues. Mesotherapy requires a clinical diagnosis and informed consent. Patient should be well informed about potential benefits, limitations, and risks (even mild). The process of doctor-patient interaction in mesotherapy is an example of compliance with the basic concept: "first do no harm" and, at the same time, the advantage for the patient to conclude a "therapeutic alliance". We propose a draft form to facilitate the decision-making process. PMID:23748687

  16. Informed consent among nursing students participating in biomedical research.

    PubMed

    Nambiar, Anupama; Christopher, D J; Mammen, Joy; David, Thambu; Kang, Gagandeep; David, Shirley

    2012-01-01

    For consent in biomedical research, it is essential that research participants understand the need for research, the study protocol, the risk and benefits of participation, the freedom to participate or decline and the right to leave the study at any time. A structured questionnaire was used to assess understanding and knowledge among nursing trainees participating in a cohort study investigating exposure and latent tuberculosis at a tertiary care hospital. Data were collected for 138 participants. While 97% were aware of their enrollment into a research protocol, only 78% could state that it was a study on tuberculosis. Approximately two-thirds were aware of plans for blood collection, but not all of them knew the timings or number of samples. The majority (59%) participants had consulted others before making the decision to participate, and only 73% felt that their participation was completely voluntary. Even among healthcare trainees, emphasis needs to be placed on testing both the knowledge and understanding of participants to ensure the principle and practice of truly informed consent. PMID:22864079

  17. The politics of information: informed consent in abortion and end-of-life decision making.

    PubMed

    Suter, Sonia M

    2013-01-01

    The politics of reproduction dominate the political landscape now more than ever. One area of controversy has been informed consent statutes for abortion, which have been praised by the pro-life movement but derided by the pro-choice movement. More recently, legislatures have begun to enact informed consent statutes with respect to end-of-life decision making, an area almost as politically controversial as abortion. Like many abortion disclosure laws, some of these have been entitled "Right to Know" statutes. Yet, the supporters and opponents of each set of statutes tend not to be the same, aligning to a large extent based on their place in the culture wars over life and death. In this Article, I strive not only to show the remarkably similar critiques each side marshals but also to use these concerns to think in more nuanced ways about the goals of informed consent and whether the disclosure mandates achieve those goals. I first argue in favor of the aspirational goals of informed consent as a process that allows patients to participate in their medical decision making. While conceding the inherently political nature of abortion and end-of-life care, I also contend that the significance of decisions regarding those matters warrants, at least in theory, legislative efforts to ensure that patients have the opportunity to engage in deliberative and informed decision making. In describing and responding to the similar critiques of both sets of laws--the political bias of the statutes; the efforts to persuade, especially with non-medical information; the potential vulnerability of the targeted audience; and the interference with physician discretion--I uncover and challenge some of the presumptions about informed consent inherent in those critiques. Although information that persuades or influences is not per se problematic, I argue that disclosure of information that is inaccurate, untrue, or emotionally inflammatory harms informed consent. Even well-crafted informed

  18. The writing of informed consent in accessible language: difficulties.

    PubMed

    Fernandes, Nurimar C

    2015-06-01

    In order to assess the adequacy of informed consent terminology of research projects developed at the Clementino Fraga Filho University Hospital (Federal University of Rio de Janeiro) , we conducted a review study on the terminology found in 55 projects (2008-20013) . Such projects belonged to different medical specialties and were all registered in the hospital's Ethics in Research Committee. Patients had difficulty in understanding the meanings of 76 medical terms and expressions; only 12 of them could be replaced. On the other hand, the present study reached the conclusion that, in most cases, the writing with scientific terms is essential in items such as justification/objectives and procedures, being insurmountable obstacles to the participants of this research and patients' understanding. PMID:26291263

  19. SIDCER informed consent form: principles and a developmental guideline.

    PubMed

    Koonrungsesomboon, Nut; Laothavorn, Junjira; Chokevivat, Vichai; Hirayama, Kenji; Karbwang, Juntra

    2016-01-01

    The quality of informed consent forms (ICFs) remains an issue in clinical research. The lengthy and complicated ICFs currently being used lower research participants' ability to read and understand the information provided therein. In collaboration with the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), we have developed the SIDCER ICF, which could be of value in improving the quality of the ICFs. The three principles underlying the SIDCER ICF were: (i) an ICF contains all the required regulatory elements; (ii) an ICF provides only such information as is relevant for the subject's decision-making; and (iii) an ICF presents information in a simple format that conveys relevant information to the target population. The SIDCER ICF template, with its instructions, was then structured to assist an investigator in developing an enhanced ICF according to the three principles. The applicability of the SIDCER ICF was tested using a phase I study protocol, and a variety of experts with a special interest in ethics and clinical research were invited to evaluate the comprehensiveness of the three-page ICF for the phase I study. The SIDCER ICF template was refined and finalised in accordance with the results and comments from the experts. PMID:27009426

  20. When is informed consent required in cluster randomized trials in health research?

    PubMed Central

    2011-01-01

    This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice? We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it

  1. 78 FR 59943 - Submission for OMB Review; 30-Day Comment Request; Interactive Informed Consent for Pediatric...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-30

    ... children's understanding of information about a hypothetical clinical trial presented using either a...; Interactive Informed Consent for Pediatric Clinical Trials SUMMARY: In compliance with the requirement of... information on the proposed project contact: Victoria Pemberton, Clinical Trials Specialist, NHLBI,...

  2. 78 FR 27243 - Proposed Collection; 60-Day Comment Request: Interactive Informed Consent for Pediatric Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ... parents' and children's understanding of information about a hypothetical clinical trial presented using... Informed Consent for Pediatric Clinical Trials SUMMARY: In compliance with the requirement of Section 3506... information on the proposed project, contact: Ms. Victoria Pemberton, Clinical Trials Specialist,...

  3. 21 CFR 50.24 - Exception from informed consent requirements for emergency research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... emergency research. 50.24 Section 50.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Exception from informed consent requirements for emergency research. (a) The IRB responsible for the review... investigation without requiring that informed consent of all research subjects be obtained if the IRB (with...

  4. 21 CFR 50.24 - Exception from informed consent requirements for emergency research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... emergency research. 50.24 Section 50.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Exception from informed consent requirements for emergency research. (a) The IRB responsible for the review... investigation without requiring that informed consent of all research subjects be obtained if the IRB (with...

  5. 34 CFR 99.30 - Under what conditions is prior consent required to disclose information?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 1 2013-07-01 2013-07-01 false Under what conditions is prior consent required to disclose information? 99.30 Section 99.30 Education Office of the Secretary, Department of Education FAMILY... Information From Education Records? § 99.30 Under what conditions is prior consent required to...

  6. 34 CFR 99.30 - Under what conditions is prior consent required to disclose information?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 1 2012-07-01 2012-07-01 false Under what conditions is prior consent required to disclose information? 99.30 Section 99.30 Education Office of the Secretary, Department of Education FAMILY... Information From Education Records? § 99.30 Under what conditions is prior consent required to...

  7. 34 CFR 99.30 - Under what conditions is prior consent required to disclose information?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false Under what conditions is prior consent required to disclose information? 99.30 Section 99.30 Education Office of the Secretary, Department of Education FAMILY... Information From Education Records? § 99.30 Under what conditions is prior consent required to...

  8. 34 CFR 99.30 - Under what conditions is prior consent required to disclose information?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Under what conditions is prior consent required to disclose information? 99.30 Section 99.30 Education Office of the Secretary, Department of Education FAMILY... Information From Education Records? § 99.30 Under what conditions is prior consent required to...

  9. Random Assignment and Informed Consent: A Case Study of Multiple Perspectives

    ERIC Educational Resources Information Center

    Walker, Robert; Hoggart, Lesley; Hamilton, Gayle

    2008-01-01

    Although random assignment is generally the preferred methodology in impact evaluations, it raises numerous ethical concerns, some of which are addressed by securing participants' informed consent. However, there has been little investigation of how consent is obtained in social experiments and the amount of information that can be conveyed--and…

  10. Ethical Considerations in Assessing the Competency of Older Adults: A Provision of Informed Consent.

    ERIC Educational Resources Information Center

    Orel, Nancy A.

    1998-01-01

    Obtaining informed consent for older adults can be problematic if there is a question of the person's competency. This article discusses the current literature and research concerning competency as it relates to an elderly person's ability to provide informed consent. Criteria and instruments that are utilized to determine competency are…

  11. Negotiating Informed Consent with Children in School-Based Research: A Critical Review

    ERIC Educational Resources Information Center

    Gallagher, Michael; Haywood, Sarah L.; Jones, Manon W.; Milne, Sue

    2010-01-01

    The methods literature on research with children recognises the challenges of negotiating informed consent with this group. Special "child-friendly" techniques are advocated to overcome these challenges. We argue that, upon closer inspection, research with children foregrounds more fundamental problems with informed consent that are not easily…

  12. Informed Consent for Intrusive Behavioral Treatments: Behavioral Treatment and Review System.

    ERIC Educational Resources Information Center

    Irvin, Larry K.; Singer, George S.

    Informed consent is required from a child's parent or guardian before use of some types of behavior modification for severe behavior problems, such as tantrums, self-abuse, aggression, stealing, destruction of property, etc. Behavior modification procedures that produce physical or psychological discomfort or pain require informed consent because…

  13. 10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Pt. 850, App. A Appendix A to Part 850—Chronic Beryllium Disease Prevention Program Informed Consent Form I, _______ have carefully read...

  14. Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations

    PubMed Central

    Gupta, Umesh Chandra; Kharawala, Saifuddin

    2012-01-01

    Obtaining informed consent in psychiatry clinical research involving subjects with diminished mental abilities and impaired consent capacity has been a challenge for researchers, posing many ethical concerns and procedural hurdles due to participants’ cognitive deficits and impaired ability to judge reality. Regulations seem inadequate and provide limited guidance, not sufficient to address all the ethical issues inherent in different situations related to obtaining consent from decisionally impaired persons. Researchers are struggling to find a balance between risk-benefit ratio, research advancement, and autonomy of study subjects. Inspired to improve the consent process in psychiatry clinical research, many studies have been conducted focusing on various informed consent-related ethical concerns, with the aim of developing appropriate strategies and optimizing the informed consent procedure in psychiatry clinical research, overcoming the ethical concerns. This article critically reviews the various ethical issues and consent challenges, their underlying reasons, and investigates the appropriate strategies and practices needed to be adopted while obtaining informed consent from subjects with impaired consent capacity, participating in psychiatry clinical research. PMID:22347696

  15. Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project—study protocol for a nationwide prospective cohort study

    PubMed Central

    Kortram, Kirsten; Spoon, Emerentia Q W; Ismail, Sohal Y; d'Ancona, Frank C H; Christiaans, Maarten H L; van Heurn, L W Ernest; Hofker, H Sijbrand; Hoksbergen, Arjan W J; Homan van der Heide, Jaap J; Idu, Mirza M; Looman, Caspar W N; Nurmohamed, S Azam; Ringers, Jan; Toorop, Raechel J; van de Wetering, Jacqueline; Ijzermans, Jan N M; Dor, Frank J M F

    2016-01-01

    Introduction Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence. Methods and analysis The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof. Ethics and dissemination Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the

  16. Refusing the information paradigm: informed consent, medical research, and patient participation.

    PubMed

    Felt, Ulrike; Bister, Milena D; Strassnig, Michael; Wagner, Ursula

    2009-01-01

    This article challenges the assumption that patient autonomy can best be assured by providing proper information through formalized procedures such as informed consent. We suggest that to understand and consider laypeople's ways of knowing and decision making, one has to move beyond the information paradigm and take into account a much broader context. Concretely, we investigate informed consent in connection with donating skin tissue remaining from medically indicated surgery. We use interviews with patients and observation protocols to analyse patients' perceptions and ways of making sense of informed consent beyond its bioethical ideal. Patients situate themselves in a larger system of solidarity, enroll in an overall positive image of science as a linear process of innovation oriented towards output, and simultaneously take a pragmatic stance towards hospital routines as a necessary passage point towards receiving good treatment. Because informed consent is one of the central articulations between the biomedical system and society, we conclude by reflecting on the consequences of our findings on a socio-political level. PMID:19103717

  17. Electroconvulsive therapy, the placebo effect and informed consent.

    PubMed

    Blease, Charlotte Rosalind

    2013-03-01

    Major depressive disorder is not only the most widespread mental disorder in the world, it is a disorder on the rise. In cases of particularly severe forms of depression, when all other treatment options have failed, the use of electroconvulsive therapy (ECT) is a recommended treatment option for patients. ECT has been in use in psychiatric practice for over 70 years and is now undergoing something of a restricted renaissance following a sharp decline in its use in the 1970s. Despite its success in treating severe depression there is continued debate as to the effectiveness of ECT: in some studies, it is argued that ECT is marginally more effective than sham ECT. In addition, there is still no clear explanation of how ECT works; among the range of hypotheses proposed it is claimed that ECT may work by harnessing placebo effects. In light of the uncertainties over the mechanism of action of ECT and given the risk of serious side effects that ECT may produce, I contend that the process of informed consent must include comprehensive accounts of these uncertainties. I examine the possible consequences of providing adequate information to potential ECT patients, including the consideration that ECT may still prove to be effective even if physicians are open about the possibility of it working as a placebo. I conclude that if we value patient autonomy as well as the professional reputation of medical practitioners, a fuller description of ECT must be provided to patients and their carers. PMID:23038801

  18. The adequacy of informed consent forms in genetic research in Oman: a pilot study.

    PubMed

    Al-Riyami, Asya; Jaju, Deepali; Jaju, Sanjay; Silverman, Henry J

    2011-08-01

    Genetic research presents ethical challenges to the achievement of valid informed consent, especially in developing countries with areas of low literacy. During the last several years, a number of genetic research proposals involving Omani nationals were submitted to the Department of Research and Studies, Ministry of Health, Oman. The objective of this paper is to report on the results of an internal quality assurance initiative to determine the extent of the information being provided in genetic research informed consent forms. In order to achieve this, we developed checklists to assess the inclusion of basic elements of informed consent as well as elements related to the collection and future storage of biological samples. Three of the authors independently evaluated and reached consensus on seven informed consent forms that were available for review. Of the seven consent forms, four had less than half of the basic elements of informed consent. None contained any information regarding whether genetic information relevant to health would be disclosed, whether participants may share in commercial products, the extent of confidentiality protections, and the inclusion of additional consent forms for future storage and use of tissue samples. Information regarding genetic risks and withdrawal of samples were rarely mentioned (1/7), whereas limits on future use of samples were mentioned in 3 of 7 consent forms. Ultimately, consent forms are not likely to address key issues regarding genetic research that have been recommended by research ethics guidelines. We recommend enhanced educational efforts to increase awareness, on the part of researchers, of information that should be included in consent forms. PMID:21266001

  19. Informed Consent for Interventional Radiology Procedures: A Survey Detailing Current European Practice

    SciTech Connect

    O'Dwyer, H.M.; Lyon, S.M.; Fotheringham, T.; Lee, M.J.

    2003-09-15

    Purpose: Official recommendations for obtaining informed consent for interventional radiology procedures are that the patient gives their consent to the operator more than 24 hr prior to the procedure. This has significant implications for interventional radiology practice. The purpose of this study was to identify the proportion of European interventional radiologists who conform to these guidelines. Methods: A questionnaire was designed consisting of 12 questions on current working practice and opinions regarding informed consent. These questions related to where, when and by whom consent was obtained from the patient. Questions also related to the use of formal consent forms and written patient information leaflets. Respondents were asked whether they felt patients received adequate explanation regarding indications for intervention,the procedure, alternative treatment options and complications. The questionnaire was distributed to 786 European interventional radiologists who were members of interventional societies. The anonymous replies were then entered into a database and analyzed. Results: Two hundred and fifty-four (32.3%) questionnaires were returned. Institutions were classified as academic (56.7%),non-academic (40.5%) or private (2.8%). Depending on the procedure,in a significant proportion of patients consent was obtained in the outpatient department (22%), on the ward (65%) and in the radiology day case ward (25%), but in over half (56%) of patients consent or re-consent was obtained in the interventional suite. Fifty percent of respondents indicated that they obtain consent more than 24 hr before some procedures, in 42.9% consent is obtained on the morning of the procedure and 48.8% indicated that in some patients consent is obtained immediately before the procedure. We found that junior medical staff obtained consent in 58% of cases. Eighty-two percent of respondents do not use specific consent forms and 61% have patient information leaflets. The

  20. Improving the Process of Informed Consent for PCI: Patient Outcomes from the ePRISM Study

    PubMed Central

    Spertus, John A.; Bach, Richard; Bethea, Charles; Chhatriwalla, Adnan; Curtis, Jeptha P.; Gialde, Elizabeth; Guerrero, Mayra; Gosch, Kensey; Jones, Philip; Kugelmass, Aaron; Leonard, Bradley M.; McNulty, Edward J.; Shelton, Marc; Ting, Henry H.; Decker, Carole

    2014-01-01

    Background While the process of informed consent is designed to transfer knowledge of the risks and benefits of treatment and to engage patients in shared medical decision-making, this is poorly done in routine clinical care. We assessed the impact of a novel informed consent form for percutaneous coronary intervention (PCI) that is more simply written, includes images of the procedure and embeds individualized estimates of outcomes on multiple domains of successful informed consent and shared decision-making. Methods We interviewed 590 PCI patients receiving traditional consent documents and 527 patients receiving novel ePRISM consents at 9 US centers and compared patients' perceptions, knowledge transfer and engagement in medical decision-making. Heterogeneity across sites was assessed and adjusted for using hierarchical models. Results Site-adjusted analyses revealed more frequent review (72% for ePRISM vs. 45% for original consents) and better understanding of the ePRISM consents (odds ratios (ORs)=1.8–3.0, depending upon the outcome) with marked heterogeneity across sites (median relative difference (MRD) in the ORs of ePRISM's effect = 2–3.2). Patients receiving ePRISM consents better understood the purposes and risks of the procedure (ORs=1.9–3.9, MRDs=1.1–6.2), engaged more in shared decision-making (proportional OR=2.1 [95%CI=1.02–4.4], MRD=2.2) and discussed stent options with their physicians (58% vs. 31%; site-adjusted odds ratio=2.7 [95% CI=1.2, 6.3], MRD=2.6) more often. Conclusions A personalized consent document improved the process of informed consent and shared decision-making. Marked heterogeneity across hospitals highlights that consent documents are but one aspect of engaging patients in understanding and participating in treatment. PMID:25641532

  1. Health literacy predicts participant understanding of orally-presented informed consent information

    PubMed Central

    Ownby, Raymond L; Acevedo, Amarilis; Goodman, Kenneth; Caballero, Joshua; Waldrop-Valverde, Drenna

    2016-01-01

    Informed consent for participation in studies with human subjects is a critically important aspect of clinical research, but research has shown that many potential subjects do not understand information relevant to their participation. A better understanding of factors related to participant understanding of study-related information is thus important. As part of a study to develop a new measure of health literacy, participants viewed a 50 second video in their preferred language (Spanish or English) of a clinician presenting informed consent information. They then responded to six questions about it. In progressively more complicated regression models, we evaluated the relation of demographic variables, general cognitive ability, and health literacy to participants’ recall of the information. In a model that only included demographic variables, Spanish language, black race and older age were associated with poorer performance. In a model that included the effects of general cognitive ability and health literacy as well as demographics, education and health literacy were related to performance. Informed consent interventions that take potential research subjects’ levels of health literacy into account may result in better understanding of research-related information that can inform their decision to participate. PMID:26767117

  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. 77 FR 63833 - Equifax Information Services LLC; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... Equifax Information Services LLC; Analysis of Proposed Consent Order To Aid Public Comment AGENCY: Federal... methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the.... The following Analysis to Aid Public Comment describes the terms of the consent agreement, and...

  4. Informed Consent for Research in a Nursing Home: Processes and Issues.

    ERIC Educational Resources Information Center

    Cohen-Mansfield, Jiska; And Others

    1988-01-01

    Examined difficulty of obtaining valid informed consent from participants in research with older persons. Of 470 nursing home residents asked to participate in nonrisk study, 406 agreed. High consent rate was attributed to perception of research significance, presentation format, and absence of risk or pain. (Author/NB)

  5. The Effects of Enhanced Informed Consent in a Pro-Life Pregnancy Counseling Center.

    ERIC Educational Resources Information Center

    Mardirosian, Kathryn; And Others

    1990-01-01

    Investigated effects of enhanced informed consent condition on attitudes of female clients (n=60) toward a counselor, counseling situation, and decision making in a pro-life pregnancy center. Results suggest enhanced consent did not lead to increased or decreased decisions to abort nor to differential attitudes toward counselor or setting.…

  6. A jurisdictional review of the legislation governing informed consent by chiropractors across Canada.

    PubMed

    Boucher, Pierre B; Brousseau, Danica; Chahine, Sarah

    2016-03-01

    The objective of this jurisdictional review is to provide summary information pertaining to the regulation of chiropractors in Canadian provinces and territories on the topic of informed consent. Our review shows that two provinces have legislated for all healthcare professions: Ontario and Prince Edward Island. Two chiropractic regulatory bodies (New Brunswick and, Newfoundland and Labrador) have adopted the Canadian Chiropractic Association Code of Conduct. All chiropractic regulatory bodies of the other provinces and Yukon have adopted their own specific dispositions regarding informed consent. Chiropractors in Prince Edward Island, Saskatchewan and Québec must obtain informed consent in writing. PMID:27069269

  7. Communal discourse as a supplement to informed consent for genetic research.

    PubMed

    Foster, M W; Eisenbraun, A J; Carter, T H

    1997-11-01

    Genetic technologies present unique problems for the practice of informed consent. They provide information that may affect a study participant's family or kindred, which may be identifiable as an ethnic or locally isolated population. That information may be used to construct adverse perceptions of such identifiable populations, including non-participants who may not have been informed of or consented to the analyses. To address collective implications of genetic research, we describe a process that can supplement individual consent. Our approach engages pre-existing social units in discourses about proposed research. Communal discourses can influence individuals' decisions to participate in research studies. PMID:9354789

  8. A jurisdictional review of the legislation governing informed consent by chiropractors across Canada

    PubMed Central

    Boucher, Pierre B.; Brousseau, Danica; Chahine, Sarah

    2016-01-01

    The objective of this jurisdictional review is to provide summary information pertaining to the regulation of chiropractors in Canadian provinces and territories on the topic of informed consent. Our review shows that two provinces have legislated for all healthcare professions: Ontario and Prince Edward Island. Two chiropractic regulatory bodies (New Brunswick and, Newfoundland and Labrador) have adopted the Canadian Chiropractic Association Code of Conduct. All chiropractic regulatory bodies of the other provinces and Yukon have adopted their own specific dispositions regarding informed consent. Chiropractors in Prince Edward Island, Saskatchewan and Québec must obtain informed consent in writing. PMID:27069269

  9. Social Annotation Valence: The Impact on Online Informed Consent Beliefs and Behavior

    PubMed Central

    Shaer, Orit; Okerlund, Johanna; Westendorf, Lauren; Ball, Madeleine; Nov, Oded

    2016-01-01

    Background Social media, mobile and wearable technology, and connected devices have significantly expanded the opportunities for conducting biomedical research online. Electronic consent to collecting such data, however, poses new challenges when contrasted to traditional consent processes. It reduces the participant-researcher dialogue but provides an opportunity for the consent deliberation process to move from solitary to social settings. In this research, we propose that social annotations, embedded in the consent form, can help prospective participants deliberate on the research and the organization behind it in ways that traditional consent forms cannot. Furthermore, we examine the role of the comments’ valence on prospective participants’ beliefs and behavior. Objective This study focuses specifically on the influence of annotations’ valence on participants’ perceptions and behaviors surrounding online consent for biomedical research. We hope to shed light on how social annotation can be incorporated into digitally mediated consent forms responsibly and effectively. Methods In this controlled between-subjects experiment, participants were presented with an online consent form for a personal genomics study that contained social annotations embedded in its margins. Individuals were randomly assigned to view the consent form with positive-, negative-, or mixed-valence comments beside the text of the consent form. We compared participants’ perceptions of being informed and having understood the material, their trust in the organization seeking the consent, and their actual consent across conditions. Results We find that comment valence has a marginally significant main effect on participants’ perception of being informed (F2=2.40, P=.07); specifically, participants in the positive condition (mean 4.17, SD 0.94) felt less informed than those in the mixed condition (mean 4.50, SD 0.69, P=.09). Comment valence also had a marginal main effect on the

  10. Architecture of a consent management suite and integration into IHE-based regional health information networks

    PubMed Central

    2011-01-01

    Background The University Hospital Heidelberg is implementing a Regional Health Information Network (RHIN) in the Rhine-Neckar-Region in order to establish a shared-care environment, which is based on established Health IT standards and in particular Integrating the Healthcare Enterprise (IHE). Similar to all other Electronic Health Record (EHR) and Personal Health Record (PHR) approaches the chosen Personal Electronic Health Record (PEHR) architecture relies on the patient's consent in order to share documents and medical data with other care delivery organizations, with the additional requirement that the German legislation explicitly demands a patients' opt-in and does not allow opt-out solutions. This creates two issues: firstly the current IHE consent profile does not address this approach properly and secondly none of the employed intra- and inter-institutional information systems, like almost all systems on the market, offers consent management solutions at all. Hence, the objective of our work is to develop and introduce an extensible architecture for creating, managing and querying patient consents in an IHE-based environment. Methods Based on the features offered by the IHE profile Basic Patient Privacy Consent (BPPC) and literature, the functionalities and components to meet the requirements of a centralized opt-in consent management solution compliant with German legislation have been analyzed. Two services have been developed and integrated into the Heidelberg PEHR. Results The standard-based Consent Management Suite consists of two services. The Consent Management Service is able to receive and store consent documents. It can receive queries concerning a dedicated patient consent, process it and return an answer. It represents a centralized policy enforcement point. The Consent Creator Service allows patients to create their consents electronically. Interfaces to a Master Patient Index (MPI) and a provider index allow to dynamically generate XACML

  11. A tiered-layered-staged model for informed consent in personal genome testing.

    PubMed

    Bunnik, Eline M; Janssens, A Cecile J W; Schermer, Maartje H N

    2013-06-01

    In recent years, developments in genomics technologies have led to the rise of commercial personal genome testing (PGT): broad genome-wide testing for multiple diseases simultaneously. While some commercial providers require physicians to order a personal genome test, others can be accessed directly. All providers advertise directly to consumers and offer genetic risk information about dozens of diseases in one single purchase. The quantity and the complexity of risk information pose challenges to adequate pre-test and post-test information provision and informed consent. There are currently no guidelines for what should constitute informed consent in PGT or how adequate informed consent can be achieved. In this paper, we propose a tiered-layered-staged model for informed consent. First, the proposed model is tiered as it offers choices between categories of diseases that are associated with distinct ethical, personal or societal issues. Second, the model distinguishes layers of information with a first layer offering minimal, indispensable information that is material to all consumers, and additional layers offering more detailed information made available upon request. Finally, the model stages informed consent as a process by feeding information to consumers in each subsequent stage of the process of undergoing a test, and by accommodating renewed consent for test result updates, resulting from the ongoing development of the science underlying PGT. A tiered-layered-staged model for informed consent with a focus on the consumer perspective can help overcome the ethical problems of information provision and informed consent in direct-to-consumer PGT. PMID:23169494

  12. Ethical issues of informed consent: mothers' experiences enrolling their children in bone marrow transplantation research.

    PubMed

    Stevens, Patricia E; Pletsch, Pamela K

    2002-04-01

    Twelve mothers whose children had undergone bone marrow transplantation were interviewed about their experiences giving informed consent. They were asked to describe how they were introduced to bone marrow transplantation as a course of action to treat their gravely ill children, what their understanding of the protocol was, and the process by which they gave their consent. Their stories reveal complex ethical issues that may surface in the course of informed consent for research involving children. Findings suggest that mothers perceive life-and-death circumstances when a child is offered bone marrow transplantation, altering the voluntary nature of the research enterprise. The emotional trauma of the diagnosis decreases a mother's ability to absorb and understand vital information, and the emergent nature of the children's condition and the urgency to begin treatment further compromise informed consent by constricting the time and resources mothers may need to make a decision. Once a protocol is underway, mothers often experience regrets and self-recriminations about their decision to consent. Recommendations are offered that expand upon the current cognitive/rational approach to informed consent and take into account emotional experiences and the importance of building relationships to ensure informed consent over the life of a clinical trial. PMID:11984094

  13. Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer.

    PubMed

    Simes, R J; Tattersall, M H; Coates, A S; Raghavan, D; Solomon, H J; Smartt, H

    1986-10-25

    Methods of obtaining informed consent have evolved differently in Western countries without substantive information on the impact of these different practices on the patients. A randomised study was performed to compare two commonly adopted methods of seeking consent to randomised treatment: an individual approach at the discretion of each doctor and a uniform policy of total disclosure of all relevant information. The impact of both consent procedures on the patient's understanding and anxiety levels and on the doctor-patient relationship was assessed by means of a questionnaire given soon after the consent interview. Fifty seven patients were assigned at random to two groups: to 29 patients an individual approach to seeking consent was adopted and to 28 patients all relevant information was given. Seven patients refused consent to randomised treatment, with slightly more refusals by patients in the total disclosure group (5 v 2, p = 0.25). The main effects of total disclosure of all information compared with an individual approach to seeking consent were: a better understanding of treatment and side effects and of research aspects of the treatments; less willingness to agree to randomised treatment; and increased anxiety. No significant differences were found in patients' perceptions of the doctor-patient relationship. A repeat questionnaire given three to four weeks later no longer showed significant differences between the two groups. PMID:3094776

  14. Informed decision making and abortion: crisis pregnancy centers, informed consent, and the first amendment.

    PubMed

    Ahmed, Aziza

    2015-01-01

    Shifting laws and regulations increasingly displace the centrality of women's health concerns in the provision of abortion services. This is exemplified by the growing presence of deceptive Crisis Pregnancy Centers alongside new informed consent laws designed to dissuade women from seeking abortions. Litigation on informed consent is further complicated in the clinical context due to the increased mobilization of facts - such as the gestational age or sonogram of the fetus - delivered with the intent to dissuade women from accessing abortion. In other words, factual information utilized for ideological purpose. To preserve a woman's autonomy and decision-making capacity, there must be a concerted effort on the part of legislators and courts to place a woman's health at the center of abortion law and policy. PMID:25846038

  15. Informed consent revisited: a doctrine in the service of cancer care.

    PubMed

    Schachter, Madeleine; Fins, Joseph J

    2008-10-01

    Informed consent traditionally has been viewed as a safeguard for the protection of patients' decisional autonomy. While informed consent is a critical means for the protection of the patient's dominion over the integrity of his body, exclusive consideration of the doctrine as a safeguard for patients eclipses the doctrine's significant benefits for the therapeutic endeavor. Undertaking a thorough informed consent process helps the physician avoid the unilateral burdens of paternalism; furthers compliance with the doctor's legal obligations, ethical duties, and clinical responsibilities; and, as importantly, enhances the collaborative treatment enterprise. When informed consent is viewed narrowly and solely as a protective device for patients' rights, the physician may be less likely to engage the patient in ongoing discussions. Important opportunities may be missed to elicit additional clinical information, assess psychosocial concerns, and reiterate the commitment to collaboration and patient autonomy. PMID:18849321

  16. Informed consent: towards improved lay-friendliness of patient information sheets.

    PubMed

    Pilegaard, Morten; Ravn, Hanne Berg

    2013-01-01

    Regional research ethics committee (REC) members have voiced a need for the linguistic improvement of informed consent documents to ensure duly informed consent and to ease committee deliberation. We have little knowledge of what elements of language use hamper comprehension, or of the extent of medical researchers' appreciation of this problem and their willingness to accept intervention. This qualitative, explorative study proposes an intervention design and tests its feasibility and acceptability. Semi-structured interviews with potential REC applicants informed a linguistic intervention benchmarked against existing guidelines, mandated locally and nationally, and then evaluated quantitatively in a semi-controlled set-up and qualitatively via questionnaires. Potential applicants professed the psychological acceptability of linguistic intervention. The intervention comprised a downloadable Microsoft Word template outlining information structure, a detailed guideline offering advice for each move and self-selected linguistic screening. It was used by 14 applicants and had a measurable effect on REC deliberation time and approval rates. The intervention instruments overall made it easier for applicants to produce informed consent documents meeting prescribed ethical standards concerning lay-friendliness. In conclusion, it was found that linguistic intervention is relevant, feasible and psychologically acceptable to REC applicants; it aids their text production process and seems to enhance the lay-friendliness of these texts. PMID:25233558

  17. Biobank research and ethics: the problem of informed consent in Polish biobanks

    PubMed Central

    Pawlikowski, Jakub; Sak, Jarosław; Marczewski, Krzysztof

    2011-01-01

    Introduction The dynamic development of biobanks causes some ethical, social, and legal problems. The most discussed problems are obtaining informed consent, especially for future research, from minors and from deceased people. The aim of this article is to present the current standards held by Polish biobanks concerning obtaining a participant's informed consent in some aspects. Material and methods Survey was carried out by anonymous questionnaire among 59 institutions which deal with the collecting and storage of human cells and tissues in the year 2008. Twenty four filled-in copies of the questionnaires were sent back (return=41%). Results Almost every institution (92%) obtains written consent, but a third of the surveyed institutions (29%) do not obtain consent for the future use of the samples. The majority of the respondents (83%) support the idea of using biological materials for research purposes of a donor who died if he did not leave any written objection to such practices and 46% of respondents stated that biobanks should obtain the consent from the already mature donor who gave their samples as a child. Conclusions The practice and rules for obtaining informed consent for the scientific research require improvement. The possibility to use the human materials in the future, conditions for getting access to the data, the possibility of their withdrawal from the database and using the materials and data after the death of the donor should be clearly determined when the informed consent to collect the material is obtained. PMID:22291838

  18. Reporting ethics committee approval and informed consent: Review of an Ayurvedic journal

    PubMed Central

    Bolshete, Pravin M.

    2015-01-01

    Introduction: Reporting of ethical approval and informed consent in clinical research articles involving human subjects is necessary as per the International Committee of Medical Journal Editors (ICMJE). Aim: To assess the reporting of ethics committee approval and informed consent in clinical research articles published in AYU journal. Materials and Methods: This was a retrospective analysis of published articles in AYU from 2012 to 2014. All original articles (clinical research) were included. Data was collected to note – Ethics Committee approval and written informed consent (assent from children when applicable). Descriptive statistics was used to report the findings. Results: A total of 104 articles were included in this analysis. Of these, 38 articles included children. Ethics committee approval was reported in 53 (51.0%) articles and consent was also reported in 51 (49.0%) articles. Thirty-eight (36.5%) articles reported both ethics committee approval and consent, whereas 38 (36.5%) articles did not report both. Only five articles reported consent from guardian or parent whereas none of the articles were reported assent. Conclusion: Findings from this study demonstrate that Ayurvedic clinical research articles lack in reporting ethics committee approval and written informed consent.

  19. 22 CFR 225.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... representative, but in any event, the investigator shall give either the subject or the representative adequate... investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That the only... documentation requirement is waived, the IRB may require the investigator to provide subjects with a...

  20. 7 CFR 1c.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... any event, the investigator shall give either the subject or the representative adequate opportunity... investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That the only... documentation requirement is waived, the IRB may require the investigator to provide subjects with a...

  1. 15 CFR 27.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... representative, but in any event, the investigator shall give either the subject or the representative adequate... investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That the only... documentation requirement is waived, the IRB may require the investigator to provide subjects with a...

  2. 45 CFR 690.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 690.117 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION...: (1) That the only record linking the subject and the research would be the consent document and the... asked whether the subject wants documentation linking the subject with the research, and the...

  3. Patients' consent preferences for research uses of information in electronic medical records: interview and survey data

    PubMed Central

    Willison, Donald J; Keshavjee, Karim; Nair, Kalpana; Goldsmith, Charlie; Holbrook, Anne M

    2003-01-01

    Objectives To assess patients' preferred method of consent for the use of information from electronic medical records for research. Design Interviews and a structured survey of patients in practices with electronic medical records. Setting Family practices in southern Ontario, Canada. Participants 123 patients: 17 were interviewed and 106 completed a survey. Main outcome measures Patients' opinions and concerns on use of information from their medical records for research and their preferences for method of consent. Results Most interviewees were willing to allow the use of their information for research purposes, although the majority preferred that consent was sought first. The seeking of consent was considered an important element of respect for the individual. Most interviewees made little distinction between identifiable and anonymised data. Research sponsored by private insurance firms generated the greatest concern, and research sponsored by foundation the least. Sponsorship by drug companies evoked negative responses during interview and positive responses in the survey. Conclusions Patients are willing to allow information from their medical records to be used for research, but most prefer to be asked for consent either verbally or in writing. What is already known on this topicLegislation is being introduced worldwide to restrict the circumstances under which personal information may be used for secondary purposes without consentLittle empirical information exists about patients' concerns over privacy and preferences for consent for use of such information for researchWhat this study addsPatients are willing to allow personal information to be used for research purposes but want to be actively consulted firstPatients make little distinction between identifiable and non-identifiable informationMost patients prefer a time limit for their consent PMID:12586673

  4. Evaluating the Readibility of Informed Consent Forms Available Before Anaesthesia: A Comparative Study

    PubMed Central

    Boztaş, Nilay; Özbilgin, Şule; Öçmen, Elvan; Altuntaş, Gözde; Özkardeşler, Sevda; Hancı, Volkan; Günerli, Ali

    2014-01-01

    Objective Informed consent forms that are used prior to administering anaesthesia inform patients before any proposed surgical procedure or treatment. They should provide patients with sufficient information about the operation and treatment. Readibility refers to whether it is easy or hard for a reader to read and understand an available text, and this is evaluated via various formulas. The aim of this study was to evaluate the readability of different informed consent forms commonly used in the anaesthesiology departments of different hospitals in our country using different readability formulas. Methods After obtaining ethics committee approval, the readability of different consent forms used in the anaesthesiology departments of university hospitals (n=15), Ministry of Health (MOH) education and research hospitals (n=15), and public hospitals (n=15) was analysed. Each consent form was displayed electronically in “Microsoft Word” and the number of words contained was counted automatically. The first 100 words on the first page of the forms were evaluated using the Gunning Fog, Flesch-Kincaid and Ateşman readability formulations. The rate of medical terms detected within these 100 words was determined as a percentage (%). Results Different consent forms obtained from 45 anaesthesia departments were assessed using various readability formulas. According to the Gunning Fog index, the readability of the consent forms obtained from MOH education and research and public hospitals was relatively low. The Flesch-Kincaid index measured very low levels of readability in all institutions. The Ateşman index displayed very low readability levels for the consent forms used in university hospitals, and low levels in other institutions. Conclusion We conclude that the readability of the anaesthesia informed consent forms is low. The level of education in our country should be considered in the preparation of anaesthesia consent forms. We believe that physicians should pay

  5. Improving informed consent with minority participants: results from researcher and community surveys.

    PubMed

    Quinn, Sandra Crouse; Garza, Mary A; Butler, James; Fryer, Craig S; Casper, Erica T; Thomas, Stephen B; Barnard, David; Kim, Kevin H

    2012-12-01

    Strengthening the informed consent process is one avenue for improving recruitment of minorities into research. This study examines that process from two different perspectives, that of researchers and that of African American and Latino community members. Through the use of two separate surveys, we compared strategies used by researchers with the preferences and attitudes of community members during the informed consent process. Our data suggest that researchers can improve the informed consent process by incorporating methods preferred by the community members along with methods shown in the literature for increasing comprehension. With this approach, the informed consent process may increase both participants' comprehension of the material and overall satisfaction, fostering greater trust in research and openness to future research opportunities. PMID:23324203

  6. Knowledge and awareness of informed consent among orthodontists and patients: A pilot study

    PubMed Central

    Alagesan, Anitha; Vaswani, Vina; Vaswani, Ravi; Kulkarni, Uma

    2015-01-01

    Aim: Despite fixed professional opinion of what might constitute optimal treatment, patients must be informed of the various treatment options available in orthodontics to manage their clinical problem. The purpose of this study was to compare and evaluate the knowledge and awareness among practicing orthodontists and patients with regard to informed consent in clinical practice and research. Materials and Methods: Twenty-five orthodontists and 25 patients were enrolled in a questionnaire study which was descriptive and cross-sectional in the nature. The questionnaire focused on the following aspects; contents of informed consent, at what age and who can give consent. Results: The study showed a majority of orthodontists (79.14%) were aware of knowledge regarding informed consent when compared to patients(35.14%). Conclusion: The overall result showed the huge gap that exists between orthodontists and patients and thus making it categorical for patients to be more involved in the decision-making process. PMID:26604580

  7. Informed consent: what does it mean and how is it achieved?

    PubMed

    2016-05-01

    Informed consent is an essential part of any contract and, in veterinary practice, it is vital that the client understands the range of treatment options, estimated costs and the significance and risks of any procedure that a veterinary surgeon may carry out. But what does informed consent actually mean, and how is this achieved in day-to-day practice? Georgina Mills reports from a panel discussion of this topic, held during the BSAVA congress last month. PMID:27154930

  8. Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia

    PubMed Central

    Vučemilo, Luka; Borovečki, Ana

    2015-01-01

    Background High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. Methods 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. Results The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10–19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Conclusions Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation. PMID:26376183

  9. 14 CFR § 1230.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false General requirements for informed consent. § 1230.116 Section § 1230.116 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS (Eff. until 2-14-14) § 1230.116 General requirements for informed consent. Except as provided elsewhere in this...

  10. Personalized disclosure by information-on-demand: attending to patients' needs in the informed consent process.

    PubMed

    Siegal, Gil; Bonnie, Richard J; Appelbaum, Paul S

    2012-01-01

    Obtaining informed consent has typically become a stylized ritual of presenting and signing a form, in which physicians are acting defensively and patients lack control over the content and flow of information. This leaves patients at risk both for being under-informed relative to their decisional needs and of receiving more information than they need or desire. By personalizing the process of seeking and receiving information and allowing patients to specify their desire for information in a prospective manner, we aim to shift genuine control over the informational process to patients. A new paradigm of Information on Demand, such as we suggest, would also enhance legal certainty, achieve greater congruence between the information patients want and the information they receive, and promote more meaningful patient-physician interactions, a desirable outcome that has been difficult to achieve by other means. PMID:22789051

  11. Efficacy of a separate informed consent for anesthesia services: A prospective study from the Caribbean

    PubMed Central

    Rampersad, Kavi; Chen, Deryk; Hariharan, Seetharaman

    2016-01-01

    Background and Aims: This study aimed to determine whether a separate written consent form improved the efficacy of the informed consent process for anesthesia in adult patients undergoing elective surgery at a tertiary care teaching hospital. Material and Methods: We randomized patients into two groups prospectively. The first group (Group A) signed the hospital's standard Consent for Operation form only while the second group (Group B) signed a separate Consent for Anesthesia form additionally. Patients were interviewed postoperatively with an eight-item questionnaire with responses in a 5-point Likert scale. A composite adequacy of consent index was generated from the responses and analyzed. Results: Two hundred patients (100 in each group) were studied. All patients indicated that the anesthesiologist(s) had their permission to proceed with their anesthesia care. The mean adequacy of consent index score in Group B was higher than that of Group A (30.6 ± 4.6 [standard deviation (SD)] vs. 27.9 ± 5.2 [SD]) (P < 0.001). The separate written consent had a positive impact on the patients’ understanding of the nature and purpose of the intended anesthesia procedures (P = 0.04), satisfaction with the adequacy of information provided about common side effects (P < 0.001) and rare but serious complications (P = 0.008). Conclusions: A separate written consent for anesthesia improved the efficacy of the informed consent process with respect to better information about the nature and purpose of anesthesia, common side effects, and rare but serious complications. PMID:27006535

  12. Informed consent for blood transfusion: what do medicine residents tell? What do patients understand?

    PubMed

    Friedman, Mark; Arja, Wajih; Batra, Rashmi; Daniel, Sugganth; Hoehn, Daniela; Paniz, Alberto Mondolfi; Selegean, Sorin; Slova, Denisa; Srivastava, Swati; Vergara, Norge

    2012-10-01

    Blood transfusion is a common intervention in the hospital setting, and its benefits may not be clear but it has associated risks. Despite this, transfusion consent may not be obtained satisfactorily. We assessed transfusion consent effectiveness by comparing information given by residents with information understood by patients who receive transfusions. Medicine department residents who obtained consent were surveyed via telephone in conjunction with bedside surveys of adult inpatients who received transfusions. A total of 43 patient and 34 resident surveys were completed. Deficiencies in the transfusion consent process were noted. Discussed transfusion benefits (such as wound healing) were not always true benefits whereas some important risks (such as transfusion-related acute lung injury) were infrequently conferred. Risks were more often reported as "not discussed" than benefits. Only a few participants were aware of the hospital's Transfusion Health Guide, which provides information on transfusion benefits, risks, and alternatives. PMID:23010711

  13. The Importance of Purpose: Moving beyond Consent in the Societal Use of Personal Health Information

    PubMed Central

    Grande, David; Mitra, Nandita; Shah, Anand; Wan, Fei; Asch, David A.

    2015-01-01

    Background Adoption of electronic health record systems has increased the availability of patient-level electronic health information. Objective Examine public support for secondary uses of electronic health information under different consent arrangements. Design National experimental survey to examine perceptions of uses of electronic health information when varying along three dimensions: patient consent (obtained vs. not obtained), use (research vs. marketing), and framing of the findings (abstract description without results vs. specific results). Setting Nationally representative survey. Participants 3,064 African American, Hispanic, and non-Hispanic White individuals representing a response rate of 65%. Measurements Appropriateness of health information use described in vignettes on a 1-10 scale (1=not at all appropriate; 10=very appropriate). Results Mean ratings ranged from a low of 3.81 for a marketing use when consent was not obtained and specific results were presented to a high of 7.06 for a research use when consent was obtained and specific results were presented. Participants rated scenarios where consent was obtained as more appropriate compared to when consent was not obtained (+1.01; 95% CI 0.69, 1.34, P<0.001). Participants rated scenarios where the use was marketing as less appropriate compared to when the use was research (−2.03; 95% CI −2.27, −1.78, P<0.001). Unconsented research uses were seen as more appropriate than consented marketing uses (5.65 vs. 4.52; difference = 1.13; 95% CI 0.87, 1.39).. Limitations Participants rated hypothetical scenarios and results could be vulnerable to non-response bias despite the high response rate. Conclusions Although approaches to health information sharing emphasize consent, public opinion also emphasizes purpose suggesting a need to focus more attention on the social value of information use. Primary Funding Source National Human Genome Research Institute PMID:25506854

  14. "Not Tied Up Neatly with a Bow": Professionals' Challenging Cases in Informed Consent for Genomic Sequencing.

    PubMed

    Tomlinson, Ashley N; Skinner, Debra; Perry, Denise L; Scollon, Sarah R; Roche, Myra I; Bernhardt, Barbara A

    2016-02-01

    As the use of genomic technology has expanded in research and clinical settings, issues surrounding informed consent for genome and exome sequencing have surfaced. Despite the importance of informed consent, little is known about the specific challenges that professionals encounter when consenting patients or research participants for genomic sequencing. We interviewed 29 genetic counselors and research coordinators with considerable experience obtaining informed consent for genomic sequencing to understand their experiences and perspectives. As part of this interview, 24 interviewees discussed an informed consent case they found particularly memorable or challenging. We analyzed these case examples to determine the primary issue or challenge represented by each case. Challenges fell into two domains: participant understanding, and facilitating decisions about testing or research participation. Challenges related to participant understanding included varying levels of general and genomic literacy, difficulty managing participant expectations, and contextual factors that impeded participant understanding. Challenges related to facilitating decision-making included complicated family dynamics such as disagreement or coercion, situations in which it was unclear whether sequencing research would be a good use of participant time or resources, and situations in which the professional experienced disagreement or discomfort with participant decisions. The issues highlighted in these case examples are instructive in preparing genetics professionals to obtain informed consent for genomic sequencing. PMID:25911622

  15. Comprehensibility of Translated Informed Consent Documents Used in Clinical Research in Psychiatry

    PubMed Central

    Jhanwar, Venu Gopal; Bishnoi, Ram Jeevan

    2010-01-01

    Background: Informed consent forms are required in all clinical trials which are approved by an independent Ethics Committee before practical use in the trials. However, how much the average subject actually understands of the information contained in these informed consent forms is uncertain. Aim: In a cross sectional study, the translated informed consent forms used in psychiatric clinical trials were assessed with respect to their ease of readability. Materials and Methods: We analyzed 30 informed consent forms translated from English to Hindi used in multinational and multicentre psychiatric clinical trials sponsored by different sponsors. We examined consent forms for readability scores and factors that might relate to readability. Results: The mean readability score for the informed consent forms, determined by the Flesch-Kincaid Grade Level Index (FKGL) was grade levels of 13.66. The ease of readability assessed by the Flesch Reading Ease Score (FRES) was 46.08 suggesting significant complexity of the texts. These values carry even more significance when the average years of schooling for India as a whole are 6.2 years. Conclusion: Our results show that the most informed consent forms were too complex to understand by an average adult subject. We suggest reducing this complexity and increasing the ease of readability so those average subjects receive the intended information as exactly as it could be. This can be achieved by few simple measures like improving the deficiencies in translation processes, encouraging the investigators to participate while preparing these forms, and enhanced understanding of the site specific requirements, namely culture, language (dialect), general literacy rate, etc. PMID:21799552

  16. Ethical considerations for informed consent in infertility research: The use of electronic health records

    PubMed Central

    Wells, Kristen J.; Gordon, Janna R.; Su, H. Irene; Plosker, Shayne; Quinn, Gwendolyn P.

    2015-01-01

    The growing use of electronic health records (EHRs) in healthcare provides rich opportunities for biomedical research. Using EHRs, massive quantities of patient data can be extracted for research without the need to recruit patients, schedule study visits, or rely on self-reporting. However, this innovation poses significant concerns about patient privacy and confidentiality of data. Patients receiving infertility treatment may be particularly vulnerable to data breaches, as their EHRs often include sensitive health information about themselves, their partner, and their offspring. Helping patients with infertility to make informed decisions about sharing data is crucial, yet little is known about best practices for obtaining informed consent to use EHR data for research. This commentary reviews possible options for obtaining informed consent for EHR use among patients seeking fertility services. In addition, this commentary summarizes the limited research available on patient preferences for informed consent practices. PMID:27066591

  17. Theoretical Model of Critical issues in Informed Consent in HIV Vaccine Trials

    PubMed Central

    Lewis, Cindi A.; Dewhurst, Stephen; McMahon, James M.; Bunce, Catherine A.; Keefer, Michael C.; Alio, Amina P.

    2014-01-01

    The informed consent (IC) process for HIV vaccine trials poses unique challenges and would benefit from improvements to its historically-based structure and format. Here, we propose a theoretical framework that provides a basis for systematically evaluating and addressing these challenges. The proposed framework follows a linear pathway, starting with the precondition of voluntariness, three main variables of valid decision-making (competency, provision of information and understanding) and then the consequential outcome of either refusal or consent to participate. The existing literature reveals that culturally appropriate provision of information and resultant understanding by the vaccine trial participant are among the most significant factors influencing the authenticity of valid decision-making, though they may be overridden by other considerations, such as individual altruism, mistrust and HIV-related stigma. Community collaborations to foster bidirectional transmission of information and more culturally tailored consenting materials therefore represent a key opportunity to enhance the informed consent process. By providing a visual synopsis of the issues most critical to IC effectiveness in a categorical and relational manner, the framework provided here presents HIV vaccine researchers a tool by which the informed consent process can be more systematically evaluated and consequently improved. PMID:24865892

  18. Applying a sociolinguistic model to the analysis of informed consent documents.

    PubMed

    Granero-Molina, José; Fernández-Sola, Cayetano; Aguilera-Manrique, Gabriel

    2009-11-01

    Information on the risks and benefits related to surgical procedures is essential for patients in order to obtain their informed consent. Some disciplines, such as sociolinguistics, offer insights that are helpful for patient-professional communication in both written and oral consent. Communication difficulties become more acute when patients make decisions through an informed consent document because they may sign this with a lack of understanding and information, and consequently feel deprived of their freedom to make their choice about different treatments or surgery. This article discusses findings from documentary analysis using the sociolinguistic SPEAKING model, which was applied to the general and specific informed consent documents required for laparoscopic surgery of the bile duct at Torrecárdenas Hospital, Almería, Spain. The objective of this procedure was to identify flaws when information was provided, together with its readability, its voluntary basis, and patients' consent. The results suggest potential linguistic communication difficulties, different languages being used, cultural clashes, asymmetry of communication between professionals and patients, assignment of rights on the part of patients, and overprotection of professionals and institutions. PMID:19889919

  19. Broadening research consent in the era of genome-informed medicine.

    PubMed

    Kronenthal, Courtney; Delaney, Susan K; Christman, Michael F

    2012-04-01

    Genetic variant associations and advances in research technologies are generating an unprecedented volume of genomic data. Whole-genome sequencing will introduce even greater depth to current data sets and will propel medical research and development. Yet as one area of biomedical research evolves, another stagnates: informed consent. As presently employed, informed consent is not entirely attuned to the era of whole-genome sequencing. The greatest value of genomic data lays in its accessibility over time; the current model of informed consent restricts the use of data and does not readily accommodate prospective basic and clinical research, a priori research, or opportunities to act upon incidental findings. It also disengages the research participant from the discovery process, discouraging the provision of research results that may have clinical value to that individual. A revisited informed consent approach-the Informed Cohort Oversight Board (ICOB)-has been proven successful at consenting individuals to a model which facilitates the simultaneous construction of longitudinal data with the return of results to participants as scientific knowledge and technology allows. The opportunity to sequence once and consult often is cost-effective, encourages scientific innovation, and provides the opportunity to quickly translate genomics into better clinical care. PMID:22422050

  20. “Ready-to-Recruit” or “Ready-to-Consent” Populations?: Informed Consent and the Limits of Subject Autonomy

    PubMed Central

    Fisher, Jill A.

    2011-01-01

    This paper queries the pharmaceutical industry’s concept of “ready-to-recruit” populations by examining its recruitment strategies for clinical trials and the types of human subjects who participate in these drug studies. The argument is that the pharmaceutical industry has profited from a system comprised of what can more aptly be characterized as ready-to-consent populations, meaning populations who do not have better alternatives than participation in clinical trials. Further, through qualitative research, this paper aims to highlight some of the limitations of current U.S. federal regulation and to show how these limits signal problems that are not normally discussed in the medical ethics literature about research on human subjects. It does this by examining the impotence of informed consent – both as a concept and as a practice – in light of recruitment strategies and the structural reasons motivating individuals to participate in clinical trials. PMID:21359125

  1. Patients may not recall disclosure of risk of death: implications for informed consent.

    PubMed

    Wade, T C

    1990-07-01

    This study examined the issue of rational decision-making involved in the 'patient need' standard of informed consent. A majority of elective cholecystectomy patients (90% of 144) correctly identified their risk of death on a multiple choice questionnaire after preoperative counselling, but before surgery. However, many of those patients who answered correctly (54%) reported that they were not informed about the risk of death when questioned again after discharge. An attempt to discriminate patients who reported being informed from those who did not using measures of preoperative pain, emotional distress and medication was not successful. Faced with an inability to obtain informed consent from some patients, coupled with legal liability for failing to do so, surgeons are advised to obtain consent in writing, to provide comprehensive, multi-media counselling, and to be particularly conscientious with confused patients and those with complications. PMID:2398803

  2. Nurses' roles in informed consent in a hierarchical and communal context.

    PubMed

    Susilo, Astrid P; Van Dalen, Jan; Scherpbier, Albert; Tanto, Sugiharto; Yuhanti, Patricia; Ekawati, Nora

    2013-06-01

    Although the main responsibility for informed consent of medical procedures rests with doctors, nurses' roles are also important, especially as patient advocates. Nurses' preparation for this role in settings with a hierarchical and communal culture has received little attention. We explored the views of hospital managers and nurses regarding the roles of nurses in informed consent and factors influencing these roles. We conducted a qualitative study in a private, multispecialty hospital in Indonesia. Semi-structured interviews were conducted with seven managers. Two rounds of focus group discussions with nurses (n = 27) were conducted. Constant comparative approach was used in the analysis. Nurses can act as manager, witness, information giver, and advocate in the informed consent process. These roles are influenced by nurses' preparedness, hospital culture and policy, patients' understanding, family involvement, and cost-related issues. In preparation for these tasks, nurses should acquire communication skills, clinical knowledge, and legal and ethical knowledge. PMID:23378543

  3. Informed consent to psychotherapy: protecting the dignity and respecting the autonomy of patients.

    PubMed

    Fisher, Celia B; Oransky, Matthew

    2008-05-01

    Well-implemented informed consent procedures demonstrate psychotherapists' respect for clients' right to self-determination and can initiate meaningful contributions to treatment through enhancing mutual trust, building rapport, and facilitating a sense of ownership. This article details key components of informed consent to psychotherapy by placing them within real-world psychotherapy scenarios. We provide information on client-therapist discussions of the nature and course of therapy, fees and payment policies, the involvement of third parties, confidentiality policies, and new and untested treatments. In addition, this article addresses informed consent procedures for individuals with impaired cognitive capacities and under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations. PMID:18381749

  4. 10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a...

  5. 10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a...

  6. 10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a...

  7. 10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a...

  8. 10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a...

  9. [Informed consent in cardiology. The Committee on Informed Consent of the Commission on Professional Matters of the Sociedad Española de Cardiología].

    PubMed

    de los Reyes López, M; Iñíguez Romo, A; Goicolea de Oro, A; Funes López, B; Castro Beiras, A

    1998-10-01

    In the last thirty years, the clinical relationship between physicians and patients has been rather modified. There are several factors that have contributed to this change: a) New ways to execute medical practises, specially referred to the development of new techniques; b) Cultural changes in our western society, mainly in the mediterranean area, where there has been progress in the recognition of patients' autonomy to decide about their own lives, health and their own bodies; c) The increasing number of lawsuits, complaints and judgements about the problems that clinical information involves, particularly the informed consent in clinical practise. We consider it necessary to make an extensive and deep discussion from all of the areas in Medicine and Law, to analyze the different ethical and legal parts of the informed consent. For that reason the Spanish Society of Cardiology offers their members a basic document in order to reflect about these facts, developing arguments, justifications and supports. This document has also considered models, conditions to their applicability according to Spanish law, and the experience we have had. Finally, there is a list of diagnostic procedures and interventional practises in cardiology that might be preceded by a written informed consent document. We considered them by the name of Spanish Society of Cardiology recommendations. PMID:9834627

  10. Contemporary issues concerning informed consent in Japan based on a review of court decisions and characteristics of Japanese culture

    PubMed Central

    2014-01-01

    Background Since Japan adopted the concept of informed consent from the West, its inappropriate acquisition from patients in the Japanese clinical setting has continued, due in part to cultural aspects. Here, we discuss the current status of and contemporary issues surrounding informed consent in Japan, and how these are influenced by Japanese culture. Discussion Current legal norms towards informed consent and information disclosure are obscure in Japan. For instance, physicians in Japan do not have a legal duty to inform patients of a cancer diagnosis. To gain a better understanding of these issues, we present five court decisions related to informed consent and information disclosure. We then discuss Japanese culture through reviews of published opinions and commentaries regarding how culture affects decision making and obtaining informed consent. We focus on two contemporary problems involving informed consent and relevant issues in clinical settings: the misuse of informed consent and persistence in obtaining consent. For the former issue, the phrase "informed consent" is often used to express an opportunity to disclose medical conditions and recommended treatment choices. The casual use of the expression "informed consent" likely reflects deep-rooted cultural influences. For the latter issue, physicians may try to obtain a signature by doing whatever it takes, lacking a deep understanding of important ethical principles, such as protecting human dignity, serving the patient’s best interest, and doing no harm in decision-making for patients. There is clearly a misunderstanding of the concept of informed consent and a lack of complete understanding of ethical principles among Japanese healthcare professionals. Although similar in some respects to informed consent as it originated in the United States, our review makes it clear that informed consent in Japan has clear distinguishing features. Summary Japanese healthcare professionals should aim to understand

  11. Motivating donors to genetic research? Anthropological reasons to rethink the role of informed consent.

    PubMed

    Hoeyer, Klaus; Lynöe, Niels

    2006-01-01

    In this article we explore the contribution from social anthropology to the medical ethical debates about the use of informed consent in research, based on blood samples and other forms of tissue. The article springs from a project exploring donors' motivation for providing blood and healthcare data for genetic research to be executed by a Swedish start-up genomics company. This article is not confined to empirical findings, however, as we suggest that anthropology provides reason to reassess the theoretical understanding of autonomy as generally defined by Beauchamp and Childress. Careful consideration of the trust expressed by donors through the act of donation, furthermore, suggests that there is reason to redirect the ethical scrutiny from informed consent to issues concerning institutional arrangements and social responsibility. In particular, we suggest that an anthropological approach could facilitate a reconsideration of the political implications of using informed consent as a regulatory practice in tissue-based research. PMID:16645794

  12. Sub-orbital commercial Human space flight and informed consent in the United States

    NASA Astrophysics Data System (ADS)

    Carminati, Maria-Vittoria « Giugi »; Griffith, Doug; Campbell, Mark R.

    2013-12-01

    Commercial space flight is expected to rapidly develop in the near future. This will begin with sub-orbital missions and then progress to orbital flights. In the United States, technical informed consent of space flight participants is required by the commercial space flight operator for regulatory purposes. Additionally, though not required by U.S. regulation, the aerospace medicine professional involved in the medical screening of both space flight participants and crewmembers will be asked to assist operators in obtaining medical informed consent for liability purposes. The various US federal and state regulations regarding informed consent for sub-orbital commercial space flight are evolving and are unfamiliar to most aerospace medical professionals and are reviewed and discussed.

  13. Informed consent: law, clinical reality, and the role of the family physician.

    PubMed

    Cotsonas, C E

    1992-01-01

    Informed consent is typically seen as most relevant to surgical and other invasive specialties. Although family physicians perform fewer high-risk procedures, they are nonetheless extensively involved in the informed consent process because of the comprehensive and continuing nature of the family physician-patient relationship. Family physicians have a particularly important role in helping their patients to understand what diagnostic or therapeutic alternatives are available. Family physicians have an independent role in the informed consent process, as well as a collaborative role in the context of consultation and referral. Legal rules that require disclosure of alternatives to the patient by the treating physician are examined in the context of the family physician's role as a coordinator of patient care. Practical suggestions regarding discussion of alternatives, extent of disclosure, coordination with consulting physicians, and encouragement of patients' participation in discussions are offered. PMID:1575073

  14. USING FORMATIVE RESEARCH TO DEVELOP A CONTEXT-SPECIFIC APPROACH TO INFORMED CONSENT FOR CLINICAL TRIALS

    PubMed Central

    Corneli, Amy L.; Bentley, Margaret E.; Sorenson, James R.; Henderson, Gail E.; van der Horst, Charles; Moses, Agnes; Nkhoma, Jacqueline; Tenthani, Lyson; Ahmed, Yusuf; Heilig, Charles M.; Jamieson, Denise J.

    2009-01-01

    Participant understanding is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturally appropriate and innovative approaches. To increase the effectiveness of the consent process for a clinical trial in Malawi on interventions to prevent mother-to-child transmission of HIV during breastfeeding, formative research was conducted to explore the community’s understanding of medical research as well as how to explain research through local terms and meanings. Contextual analogies and other approaches were identified to explain consent information. Guided by theory, strategies for developing culturally appropriate interventions, and recommendations from the literature, we demonstrate how the formative data were used to develop culturally appropriate counseling cards specifically for the trial in Malawi. With appropriate contextual modifications, the steps outlined here could be applied in other clinical trials conducted elsewhere, as well as in other types of research. PMID:19385837

  15. Understanding of Essential Elements Required in Informed Consent Form among Researchers and Institutional Review Board Members.

    PubMed

    Koonrungsesomboon, Nut; Laothavorn, Junjira; Karbwang, Juntra

    2015-06-01

    The process of informed consent remains a constant challenge in clinical research. The aim of the present study was to evaluate the understanding of researchers and members of Institutional Review Boards (IRBs) regarding the essential elements of an Informed Consent Form (ICF) as required by internationally recognized regulations. Using eight case studies to illustrate basic ethical elements, the study involved 107 participants, mainly from the Asia Pacific and African regions. The results showed that most of the participants had general knowledge regarding the essential elements required in an ICF. However, the issues of confidentiality of data and payment for study participation proved to be problematic for some participants, accounting for 35% and 28% of all incorrect answers respectively. This suggests that participants' understanding of the underlying concepts of the required ICF elements is limited. Ethical training of researchers and IRB members, particularly in the Asia Pacific and African regions, concerning valid informed consent is still needed. PMID:26161029

  16. Understanding of Essential Elements Required in Informed Consent Form among Researchers and Institutional Review Board Members

    PubMed Central

    Koonrungsesomboon, Nut; Laothavorn, Junjira; Karbwang, Juntra

    2015-01-01

    The process of informed consent remains a constant challenge in clinical research. The aim of the present study was to evaluate the understanding of researchers and members of Institutional Review Boards (IRBs) regarding the essential elements of an Informed Consent Form (ICF) as required by internationally recognized regulations. Using eight case studies to illustrate basic ethical elements, the study involved 107 participants, mainly from the Asia Pacific and African regions. The results showed that most of the participants had general knowledge regarding the essential elements required in an ICF. However, the issues of confidentiality of data and payment for study participation proved to be problematic for some participants, accounting for 35% and 28% of all incorrect answers respectively. This suggests that participants’ understanding of the underlying concepts of the required ICF elements is limited. Ethical training of researchers and IRB members, particularly in the Asia Pacific and African regions, concerning valid informed consent is still needed. PMID:26161029

  17. 34 CFR 99.30 - Under what conditions is prior consent required to disclose information?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 1 2014-07-01 2014-07-01 false Under what conditions is prior consent required to disclose information? 99.30 Section 99.30 Education Office of the Secretary, Department of Education FAMILY EDUCATIONAL RIGHTS AND PRIVACY May an Educational Agency or Institution Disclose Personally Identifiable Information From Education Records?...

  18. 32 CFR 806b.47 - Rules for releasing Privacy Act information without consent of the subject.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Rules for releasing Privacy Act information...) DEPARTMENT OF THE AIR FORCE ADMINISTRATION PRIVACY ACT PROGRAM Disclosing Records to Third Parties § 806b.47 Rules for releasing Privacy Act information without consent of the subject. The Privacy Act...

  19. The Necessity of Professional Disclosure and Informed Consent for Rehabilitation Counselors

    ERIC Educational Resources Information Center

    Carlisle, Jeffrey; Neulicht, Ann T.

    2010-01-01

    Within the rehabilitation counseling arena, professional disclosure and informed consent are critical concepts for the rehabilitation counselor to understand. Once understood, they become key components of a rehabilitation counselor's daily practice. Counselors need to provide sufficient prior information about their evaluation and services to…

  20. Agency and communication challenges in discussions of informed consent in pediatric cancer research.

    PubMed

    Young, Amanda J; Kim, Loel; Shu Li; Baker, Justin N; Schmidt, Michael; Camp, Jonathan W; Barfield, Raymond C

    2010-05-01

    In this article we examine the discourse of four focus groups we conducted at a pediatric research hospital in which we queried teenage patients, parents, nurses, and physicians about their perceptions of the informed consent process in research. Autonomy, as the goal of informed consent, is a murky concept, with some ethicists questioning the possibility that it can ever be attained. We argue that it might be more productive to consider agency, which we define as language and action that are constructed, negotiated, and maintained through effective communication. Our goal was to understand how individuals rhetorically constructed agency in discussions of informed consent experiences. After transcribing and coding the focus group interviews, we identified six aspects of agency in participants' discourse: (a) defining roles, (b) seeking information, (c) providing information, (d) supporting others, (e) making decisions, and (f) claiming agency for self. Examining these aspects of agency indicated that efforts to improve the informed consent process must address: (a) status differentials, (b) role definitions, (c) information flow, and (d) relationships. PMID:20154295

  1. Informed Consent: An Ethical Issue in Conducting Research with Male Partner Violent Offenders

    PubMed Central

    Crane, Cory A.; Hawes, Samuel W.; Mandel, Dolores; Easton, Caroline J.

    2014-01-01

    Ethical codes help guide the methods of research that involve samples gathered from “at-risk” populations. The current paper reviews general as well as specific ethical principles related to gathering informed consent from partner violent offenders mandated to outpatient treatment, a group that may be at increased risk of unintentional coercion in behavioral sciences research due to court-mandates that require outpatient treatment without the ethical protections imbued upon prison populations. Recommendations are advanced to improve the process of informed consent within this special population and data supporting the utility of the recommendations in a sample 70 partner violent offenders are provided. Data demonstrate that participants were capable of comprehending all essential elements of consent. PMID:25892900

  2. Ethical issues in implementation research: a discussion of the problems in achieving informed consent

    PubMed Central

    Hutton, Jane L; Eccles, Martin P; Grimshaw, Jeremy M

    2008-01-01

    Background Improved quality of care is a policy objective of health care systems around the world. Implementation research is the scientific study of methods to promote the systematic uptake of clinical research findings into routine clinical practice, and hence to reduce inappropriate care. It includes the study of influences on healthcare professionals' behaviour and methods to enable them to use research findings more effectively. Cluster randomized trials represent the optimal design for evaluating the effectiveness of implementation strategies. Various codes of medical ethics, such as the Nuremberg Code and the Declaration of Helsinki inform medical research, but their relevance to cluster randomised trials in implementation research is unclear. This paper discusses the applicability of various ethical codes to obtaining consent in cluster trials in implementation research. Discussion The appropriate application of biomedical codes to implementation research is not obvious. Discussion of the nature and practice of informed consent in implementation research cluster trials must consider the levels at which consent can be sought, and for what purpose it can be sought. The level at which an intervention is delivered can render the idea of patient level consent meaningless. Careful consideration of the ownership of information, and rights of access to and exploitation of data is required. For health care professionals and organizations, there is a balance between clinical freedom and responsibility to participate in research. Summary While ethical justification for clinical trials relies heavily on individual consent, for implementation research aspects of distributive justice, economics, and political philosophy underlie the debate. Societies may need to trade off decisions on the choice between individualized consent and valid implementation research. We suggest that social sciences codes could usefully inform the consideration of implementation research by

  3. 77 FR 12590 - Winchester Industries; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ...The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order--embodied in the consent agreement--that would settle these...

  4. Confidentiality, Informed Consent, and Ethical Considerations in Reviewing the Client's Psychotherapy Records

    ERIC Educational Resources Information Center

    Blunt, David R.

    2006-01-01

    Ethical dilemmas that break the confidentiality of the client eventually test the psychologist's boundaries such that not taking action may place the patient in a position where they suffer, hurt themselves, or others. The effectiveness in obtaining a valid informed consent might depend upon the therapists training, experience, and sound judgment…

  5. Breast Implant Informed Consent Should Include the Risk of Anaplastic Large Cell Lymphoma.

    PubMed

    Clemens, Mark W; Miranda, Roberto N; Butler, Charles E

    2016-04-01

    Breast implant-associated anaplastic large cell lymphoma (ALCL) is a rare T-cell lymphoma arising around breast implants. Public awareness has increased following a safety communication warning of the association of breast implant-associated ALCL by the U.S. Food and Drug Administration in 2011. Difficulty with determining an accurate assessment of risk, including diagnosis, or standardized treatment regimen has led surgeons to commonly omit preoperative discussion of this rare and frequently misunderstood cancer. Risk disclosure is a form of respect for patient autonomy, and informed consent has positive practical and moral consequences for the practice of plastic surgery. A model of breast implant-associated ALCL informed consent implementation and health care provider education are reviewed with 1-year process follow-up at a tertiary cancer center. Breast implant-associated ALCL should be included during preoperative counseling on the risks of breast implantation when obtaining informed consent. Pertinent aspects of decision-making include disease awareness, presenting symptoms, and resources for concerned patients. Education of health care professionals and provision of patient-focused materials ensures effectiveness of the informed consent process. PMID:27018666

  6. IMPROVING THE RISK-BENEFIT RELATIONSHIP AND INFORMED CONSENT FOR PATIENTS TREATED WITH HYDROXYCHLOROQUINE

    PubMed Central

    Flach, Allan J.

    2007-01-01

    Purpose To determine the prevalence of high-risk factors for hydroxychloroquine (HCQ) retinopathy and compliance with the American Academy of Ophthalmology (AAO) screening guidelines at the San Francisco Veterans Affairs Medical Center (VASF) and to develop an approach to improve the risk-benefit relationship and informed consent during HCQ treatment. Methods All medical records of patients receiving HCQ were reviewed, with special attention to high-risk factors for retinopathy. The results were used to develop a method of enhancing the risk-benefit relationship and improving informed consent at the VASF. Results Of the 109 patients taking HCQ at the VASF, 87% had at least one high-risk factor for retinal toxicity and 47% had two or more risk factors. Thirty-four percent had no evidence of an eye examination having been performed. An approach has been developed to improve the risk-benefit and informed consent for patients using HCQ at the VASF. Conclusions A significant number of veterans taking HCQ may be at an increased risk for retinal toxicity. More than one-third of these patients may not be managed as recommended by the AAO. Methods to minimize these risks and improve informed consent are outlined. PMID:18427609

  7. 46 CFR Exhibit No. 2 to Subpart S... - Respondent's Consent Form for Informal Adjudication

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... the Settlement Officer to determine the above-numbered claim in accordance with subpart S (46 CFR 502... 46 Shipping 9 2010-10-01 2010-10-01 false Respondent's Consent Form for Informal Adjudication No. Exhibit No. 2 to Subpart S of Part 502 Shipping FEDERAL MARITIME COMMISSION GENERAL AND...

  8. REALIZATION OF INFORMED CONSENT AS ONE OF PATIENT’S RIGHTS: CURRENT SITUATION IN AZERBAIJAN

    PubMed Central

    Rustamova, F. A.; Mammadov, V. G.; Munir, K. M.

    2016-01-01

    Azerbaijan is a country in which the law is based on democratic principles. The mentioned principles underlie the national health care law. Democratic values, such as respect for human rights and freedoms, human dignity, as well as universal bioethical principles that are widely implemented in the national law, create conditions for the implementation of the patient’s rights. The basic law governing the doctor-patient relationship, Law on Protection of Health of Population in Azerbaijan, reflects the basic patients’ rights and obligations of doctors and medical institutions. Informed consent, which is a key component of patient rights, is also reflected, however, to date, a significant drawback of the Azerbaijan medical legislation is described in the article in this field. For example, at the moment there is no single standardized informed consent form in the country’s different medical institutions. Due to the absence of any legally approved standards for informed consent forms, public and private health care institutions individually develop such forms, which sometimes can differ significantly. At the moment, one of the important directions in the field of healthcare is its improvement in accordance with international standards. The research made it possible to make conclusions about the necessary measures to improve and unify the informed consent form. The authors also analyzed the main provisions of the medical law of Azerbaijan and identified the main trends of its further development. PMID:27434222

  9. 10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION... my lungs and breathing / / Chest X-ray / / Spirometry (a breathing test) / / Blood test called...

  10. 10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION... my lungs and breathing / / Chest X-ray / / Spirometry (a breathing test) / / Blood test called...

  11. 10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION... my lungs and breathing / / Chest X-ray / / Spirometry (a breathing test) / / Blood test called...

  12. 10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION... my lungs and breathing / / Chest X-ray / / Spirometry (a breathing test) / / Blood test called...

  13. Realizing Informed Consent in Times of Controversy: Lessons from the SUPPORT Study.

    PubMed

    Morse, Robert J; Wilson, Robin Fretwell

    2016-09-01

    This Essay examines the elegantly simple idea that consent to medical treatment or participation in human research must be "informed" to be valid. It does so by using as a case study the controversial clinical research trial known as the Surfactant, Positive Pressure, and Oxygenation Randomized Trial ("SUPPORT"). The Essay begins by charting, through case law and the adoption of the common rule, the evolution of duties to secure fully informed consent in both research and treatment. The Essay then utilizes the SUPPORT study, which sought to pinpoint the level of saturated oxygen that should be provided to extremely low birth weight infants to demonstrate modern complexities and shortcomings of the duty to secure informed consent. This Essay shows how the duty is measured by foreseeability of risks and benefits in human research and why federal regulators believed the trade-offs in risk and benefits from differing oxygen levels administered in the support study were foreseeable. It then explores the contours of the duty to secure informed consent when applied to researchers who also serve as treating physicians, highlighting how common law duties differ in jurisdictions that apply the professional standard and those that apply the patient-centered material risk standard. This Essay provides new insight into what the law must do to make real the notion that [e]very human being of adult years and sound mind has a right to determine what shall be done with his body." PMID:27587446

  14. 46 CFR Exhibit No. 2 to Subpart S... - Respondent's Consent Form for Informal Adjudication

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... the Settlement Officer to determine the above-numbered claim in accordance with subpart S (46 CFR 502... 46 Shipping 9 2011-10-01 2011-10-01 false Respondent's Consent Form for Informal Adjudication No. Exhibit No. 2 to Subpart S of Part 502 Shipping FEDERAL MARITIME COMMISSION GENERAL AND...

  15. Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative.

    PubMed

    Lentz, Jennifer; Kennett, Michele; Perlmutter, Jane; Forrest, Annemarie

    2016-07-01

    Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Broad consensus among sponsors, research staff, study participants, and advocates indicate that the current process could be improved to enhance participants' understanding of study-related information and meet the needs of individuals. The Clinical Trials Transformation Initiative (CTTI) convened a project to identify problems in the current process and to formulate recommendations for improvement. A literature review, expert interviews, and multi-stakeholder meeting were conducted to identify barriers and develop solutions for a more effective informed consent process. Four key topics were the foundation of the recommendations: 1) defining an effective informed consent process, 2) training research staff, 3) improving the informed consent document, and 4) exploring the use of electronic consent. The ideal informed consent process involves an ongoing, interactive conversation between the participant and knowledgeable, responsive research staff who were trained in best practices. The informed consent process should be supported by a tiered informed consent document that provides critically relevant information to aid in the decision to participate in a study. Adoption of the CTTI informed consent recommendations should lead to a more participant-centric informed consent process. Participant involvement better meets the needs of participants and benefits the clinical trial enterprise by promoting a research culture that encourages informed participation in clinical studies. PMID:27327780

  16. Informed consent for abdominal aortic aneurysm repair: Assessing variations in surgeon opinion through a national survey

    PubMed Central

    Dardik, Alan; Bradley, Elizabeth H.; Gusberg, Richard J.; Fraenkel, Liana

    2009-01-01

    Objective Informed consent discussions for elective abdominal aortic aneurysm (AAA) repair should reflect appropriate risks of the open or endovascular repair (EVAR), but few guidelines exist describing what surgeons should discuss. This study examines expert opinion regarding what constitutes informed consent. Methods Design We conducted an anonymous, web-based, national survey of vascular surgeons. Associations between surgeon characteristics and opinions regarding informed consent were measured using bivariate statistics; multivariable logistic regression was performed to estimate effects adjusted for covariates. Setting Academic and private practice surgeons were surveyed. Subjects United States members of the International Society for Vascular Surgery membership. Main Outcome Measure. Surgeons' self-reported opinions regarding the content of informed consent for AAA repair. Results A total of 199 surgeons completed the survey (response rate 51%). More than 90% of respondents reported that it was essential to discuss mortality risk for both procedures. However, only 60% and 30% of respondents reported that it was essential to discuss the risk of myocardial infarction and stroke, respectively. Opinions varied by procedure regarding the risks of impotence (32% vs 62%; EVAR vs open repair), reintervention (78% vs 17%), and rupture during long-term follow-up (57% vs 17%). Younger and private practice surgeons were more likely to discuss complications compared with older surgeons and those in academic practice. Surgeons who perform predominantly EVAR were more likely to quote higher mortality rates for open repair (odds ration [OR] = 3.1, 95% confidence interval [CI] = 1.4-6.4) and lower reintervention rates for EVAR (OR = 0.3, 95% CI = 0.1-0.7) compared with other surgeons. Conclusions This is the first study of the practice of informed consent for AAA repair. The only risk that the vast majority of surgeons agreed should be included in informed consent for AAA

  17. Brief Report: Staged-informed Consent in the Cohort Multiple Randomized Controlled Trial Design.

    PubMed

    Young-Afat, Danny A; Verkooijen, Helena A M; van Gils, Carla H; van der Velden, Joanne M; Burbach, Johannes P; Elias, Sjoerd G; van Delden, Jonannes J; Relton, Clare; van Vulpen, Marco; van der Graaf, Rieke

    2016-05-01

    The "cohort multiple randomized controlled trial," a new design for pragmatic trials, embeds multiple trials within a cohort. The cohort multiple RCT is an attractive alternative to conventional RCTs in fields where recruitment is slow, multiple new (competing) interventions for the same condition have to be tested, new interventions are highly preferred by patients and doctors, and the risk of disappointment bias, cross-over, and contamination is considerable. To prevent these unwanted effects, the cohort multiple RCT provides information on randomization to the intervention group/arm only, and only after randomization (i.e., prerandomization). To some, especially in a clinical setting, this is not ethically acceptable. In this article, we argue that prerandomization in the cohort multiple randomized controlled trial (cmRCT) can be avoided by adopting a staged-informed consent procedure. In the first stage, at entry into the cohort, all potential participants are asked for their informed consent to participate in a cohort study and broad consent to be either randomly selected to be approached for experimental interventions or to serve as control without further notice during participation in the cohort. In a second stage, at the initiation of an RCT within the cohort, informed consent to receive the intervention is then only sought in those randomly selected for the intervention arm. At the third stage, after completion of each RCT, all cohort participants receive aggregate disclosure of trial results. This staged-informed consent procedure avoids prerandomization in cmRCT and aims to keep participants actively engaged in the research process. PMID:27035689

  18. [ETHICAL ASPECTS OF INFORMED CONSENT IN REFRACTIVE SURGERY].

    PubMed

    Van Cauwenberge, F; Rakic, J-M; Rorive, G

    2016-03-01

    With the introduction of the use of Laser assisted surgery, refractive eye surgery knows a very large success. Surgery of well being, it requires that an extensive information is delivered to the patient concerning the benefit and possible side-effects of the available treatments. This information process may reduce the frequency of negligence claims relating to Laser eye surgery. PMID:27311245

  19. Between personal and relational privacy: understanding the work of informed consent in cancer genetics in Brazil.

    PubMed

    Goldim, José Roberto; Gibbon, Sahra

    2015-07-01

    Drawing from perspectives of both bioethics and anthropology, this article explores how the boundaries between personal and relational privacy are negotiated by patients and practitioners in the context of an emerging domain of cancer genetics in Brazil. It reflects on the place of informed consent in the history of bioethics in North America in contrast to the development of bioethics in Brazil and the particular social cultural context in which consent is sought in Brazilian public health care. Making use of empirical research with families and individuals receiving genetic counselling related to increased genetic risk for cancer, in genetic clinics in southern Brazil, it examines how informed consent is linked to the necessary movement between personal and relational privacy. The paper illustrates the value of a particular tool known as a 'sociogram' to examine the complex interpersonal dynamics that arise in negotiating informed consent at the interface between the family and the individual in Brazil. The paper, therefore, points to the scope of further interdisciplinary exchanges between anthropology and bioethics, confronting the new challenges that arise in the context of medical genetics in developing country. PMID:25998783

  20. Informed Consent in Genome-Scale Research: What Do Prospective Participants Think?

    PubMed Central

    Trinidad, Susan Brown; Fullerton, Stephanie M.; Bares, Julie M.; Jarvik, Gail P.; Larson, Eric B.; Burke, Wylie

    2012-01-01

    Background To promote effective genome-scale research, genomic and clinical data for large population samples must be collected, stored, and shared. Methods We conducted focus groups with 45 members of a Seattle-based integrated healthcare delivery system to learn about their views and expectations for informed consent in genome-scale studies. Results Participants viewed information about study purpose, aims, and how and by whom study data could be used to be at least as important as information about risks and possible harms. They generally supported a tiered consent approach for specific issues, including research purpose, data sharing, and access to individual research results. Participants expressed a continuum of opinions with respect to the acceptability of broad consent, ranging from completely acceptable to completely unacceptable. Older participants were more likely to view the consent process in relational – rather than contractual – terms, compared with younger participants. The majority of participants endorsed seeking study subjects’ permission regarding material changes in study purpose and data sharing. Conclusions Although this study sample was limited in terms of racial and socioeconomic diversity, our results suggest a strong positive interest in genomic research on the part of at least some prospective participants and indicate a need for increased public engagement, as well as strategies for ongoing communication with study participants. PMID:23493836

  1. Thomas G. Orr Memorial Lecture. Surgical informed consent: what it is and is not.

    PubMed

    Edwards, W S; Yahne, C

    1987-12-01

    A more systematic approach to addressing the crucial issue of informed consent is needed in medical education. Surgeons cannot afford gaps in their medical education regarding the communication process with patients. We found that many surgical residents and faculty understand the mechanics of the informed consent process quite well and could perform well under the artificial circumstances of our video interview. Whether they would do as well if a real patient was considering nonoperative therapy, or was a ne'er-do-well, or an alcoholic is not known. Two main causes of interference with the process have been identified: conflicting messages which surgeons get from within the profession, from the courts, and from within themselves and lack of time for dialogue with patients, and poor timing of the consent process. Areas that were uncovered that need further investigation include the barrier created by some surgeons' internal, often unrecognized, biases about surgery being the only satisfactory mode of treatment for some illnesses and some surgeons' belief that longevity should be the goal of all therapy, without considering that for some patients, maintenance of certain quality lifestyles is more important than a longer life. We hope that surgeons can learn to look at the informed consent process as a wonderful opportunity to communicate their personal concern for the patient as a person, not just a sick gallbladder to remove, and that this process can become the channel through which the wounded relationship of the patient and the physician can be healed. PMID:3425796

  2. Using an informed consent in mammography screening: a randomized trial.

    PubMed

    Baena-Cañada, José M; Rosado-Varela, Petra; Expósito-Álvarez, Inmaculada; González-Guerrero, Macarena; Nieto-Vera, Juan; Benítez-Rodríguez, Encarnación

    2015-12-01

    Spanish women do not make an informed choice regarding breast cancer screening (BCS). Our aim was to evaluate the impact of receiving information regarding real BCS benefits and risks on knowledge, attitude, decision, feelings, and worries about cancer. Randomized controlled clinical trial of 355 women aged between 45 and 67 years, 177 and 178 assigned to the intervention group (IG) and control group (CG), respectively. After breast screening, women received either Nordic Cochrane Centre information on BCS or standard information. The primary outcome (knowledge) was determined from questionnaire administered at baseline and after a month. Answers were scored from 0 to 10 and scores of 5 or more indicated that women were well informed (had "good knowledge"). Questionnaires regarding attitudes, future screening intentions, and psychosocial impact were also administered. The Chi-squared and Student's t-tests were used to compare qualitative and quantitative variables, respectively. Good knowledge was acquired by 32 (18.10%) IG women and 15 (8.40%) CG women (P = 0.008). Mean scores from first to second interview increased from 2.97 (SD 1.16) to 3.43 (SD 1.39) in the CG and from and from 2.96 (SD 1.23) to 3.95 (SD 1.78) (P = 0.002) in the IG. No differences were found in the secondary endpoints. Women receiving information based on the Nordic Cochrane Centre document were better informed. This means of providing information is not very efficacious, nor does it modify attitude, decision, feelings, or worries about cancer. PMID:26377150

  3. Usual Care and Informed Consent in Clinical Trials of Oxygen Management in Extremely Premature Infants

    PubMed Central

    Cortés-Puch, Irene; Wesley, Robert A.; Carome, Michael A.; Danner, Robert L.; Wolfe, Sidney M.; Natanson, Charles

    2016-01-01

    Objective The adequacy of informed consent in the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) has been questioned. SUPPORT investigators and publishing editors, heads of government study funding agencies, and many ethicists have argued that informed consent was adequate because the two oxygen saturation target ranges studied fell within a range commonly recommended in guidelines. We sought to determine whether each oxygen target as studied in SUPPORT and four similar randomized controlled trials (RCTs) was consistent with usual care. Design/Participants/Setting PubMed, EMBASE, Web of Science, and Scopus were searched for English articles back to 1990 providing information on usual care oxygen management in extremely premature infants. Data were extracted on intended and achieved oxygen saturation levels as determined by pulse oximetry. Twenty-two SUPPORT consent forms were examined for statements about oxygen interventions. Results While the high oxygen saturation target range (91 to 95%) was consistent with usual care, the low range (85 to 89%) was not used outside of the SUPPORT trial according to surveys and clinical studies of usual care. During usual care, similar lower limits (< 88%) were universally paired with higher upper limits (≥ 92%) and providers skewed achieved oxygen saturations toward the upper-end of these intended ranges. Blinded targeting of a low narrow range resulted in significantly lower achieved oxygen saturations and a doubling of time spent below the lower limit of the intended range compared to usual care practices. The SUPPORT consent forms suggested that the low oxygen saturation arm was a widely practiced subset of usual care. Conclusions SUPPORT does not exemplify comparative effectiveness research studying practices or therapies in common use. Descriptions of major differences between the interventions studied and commonly practiced usual care, as well as potential risks associated with these

  4. Informed consent--suggested procedures for informed consent for unrelated haematopoietic stem cell donors at various stages of recruitment, donor evaluation, and donor workup.

    PubMed

    Rosenmayr, A; Hartwell, L; Egeland, T

    2003-04-01

    The Ethics Working Group of the World Marrow Donor Association (WMDA) was established to address the increasing and complex number of ethical issues surrounding unrelated haematopoietic stem cell donation where the selected donor and recipient reside in different countries. This paper considers the topic of informed donor consent, but recognises that the recommendations contained within the paper may be subject to cultural variances in interpretation, and to adjustment to meet the legal requirements of individual countries. Nevertheless, the extent of international cooperation establishes sufficient common denominators for the recommendations to be widely adhered to in the interests of best practice. PMID:12692618

  5. Simple genetics language as source of miscommunication between genetics researchers and potential research participants in informed consent documents.

    PubMed

    Morgenstern, Justin; Hegele, Robert A; Nisker, Jeff

    2015-08-01

    Informed consent is based on communication, requiring language to convey meanings and ensure understandings. The purpose of this study was to investigate the use of language in informed consent documents used in the genetics research funded by Canadian Institutes of Health Research and Genome Canada. Consent documents were requested from the principal investigators in a recent round of funding. A qualitative content analysis was performed, supported by NVivo7™. Potential barriers to informed consent were identified, including language that was vague and variable, words with both technical and common meanings, novel phrases without clear meaning, a lack of definitions, and common concepts that assume new definitions in genetics research. However, we noted that difficulties in comprehension were often obscured because the words used were generally simple and familiar. We conclude that language gaps between researcher and potential research participants may unintentionally impair comprehension and ultimately impair informed consent in genomics research. PMID:24751688

  6. Informed consent, biobank research, and locality: perceptions of breast cancer patients in three European countries.

    PubMed

    Petersen, Imme; Desmedt, Christine; Harris, Adrian; Buffa, Francesca; Kollek, Regine

    2014-07-01

    Comparative studies are missing that explore how socio-cultural and institutional circumstances influence patient comprehension and expectations regarding informed consent for current and future research on their tissue and data. This study compares how breast cancer patients in three European countries (the United Kingdom, Belgium, and Germany) who have consented to participate in tumor banking assess the given consent and the accompanying local contextual factors influencing it. Our survey demonstrates that only 59% of the patients in the British survey, but about 90% in the German and Belgian surveys, correctly recalled tissue and data donation for study purposes. Of those who remembered the study participation status correctly, about 90% had altruistic motives. At the same time, approximately half of the survey participants, or even 70% of the Belgians, expected personal benefit from research participation and information on cancer risk within the family. About half of the interviewees, but only 27% of the British participants, definitively wanted to be asked for re-consent for future research. Of the local contextual factors under study, participants' appraisals of medical science and data protection were particularly pertinent. More culturally and contextually sensitive comparative research is needed to better understand patient attitudes toward research participation and tissue donation in the context of biobank research. PMID:25746784

  7. A consumer perspective on informed consent and third-party issues.

    PubMed

    Terry, S F; Terry, P F

    2001-01-01

    Our two children were diagnosed with a rare genetic disorder, which led us to establish a research foundation. This led to in-depth consideration of issues surrounding informed consent from a consumer perspective. Third-party issues arose as central to the formulation of ethical policy in the establishment of a blood and tissue bank and an epidemiologic study. We suggest that a number of myths--privacy is possible, samples can be stripped of identifiers, humans are subjects, voluntary informed consent is attainable, genetics is about the individual only, genetic information is different than other medical information, research is altruistic, the public will learn truths about genetic research via media, and research is culturally competent--make it difficult to resolve the issues intrinsic to informed consent. A number of important elements could make policy decisions less complicated. These include conducting culturally competent research; conveying noncoercive hope, not hype; contacting the voluntary informant only; asking the informant to extend contact to other family members; requiring a comprehensive informed consent process for all contacted; and engaging in state-of-the-art data protections. There is a need for a "Genomic Hippocratic Oath," creating an ethical basis for research similar to the one vowed by health care professionals. Establishing ethical policies as a result of the collaboration of policy makers, researchers, and consumers will allow research to progress ethically at a rapid rate. If regulations are oppressive, they will thwart research; if they are too lenient, participants will not receive protections needed to participate safely. PMID:11803770

  8. 14 CFR 1230.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... information that is given to the subject or the representative shall be in language understandable to the... language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the...

  9. 77 FR 56644 - Federal Acquisition Regulation; Information Collection; Subcontract Consent

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-13

    ... FR 29983, on May 21, 2012. One respondent submitted comments. Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of... require and the much higher numbers that might be required for a very complex disclosure by a...

  10. Specimen collection for induced pluripotent stem cell research: harmonizing the approach to informed consent.

    PubMed

    Lowenthal, Justin; Lipnick, Scott; Rao, Mahendra; Hull, Sara Chandros

    2012-05-01

    Induced pluripotent stem cells (iPSCs) have elicited excitement in both the scientific and ethics communities for their potential to advance basic and translational research. They have been hailed as an alternative to derivation from embryos that provides a virtually unlimited source of pluripotent stem cells for research and therapeutic applications. However, research with iPSCs is ethically complex, uniquely encompassing the concerns associated with genomics, immortalized cell lines, transplantation, human reproduction, and biobanking. Prospective donation of tissue specimens for iPSC research thus requires an approach to informed consent that is constructed for this context. Even in the nascent stages of this field, approaches to informed consent have been variable in ways that threaten the simultaneous goals of protecting donors and safeguarding future research and translation, and investigators are seeking guidance. We address this need by providing concrete recommendations for informed consent that balance the perspectives of a variety of stakeholders. Our work combines analysis of consent form language collected from investigators worldwide with a conceptual balancing of normative ethical concerns, policy precedents, and scientific realities. Our framework asks people to consent prospectively to a broad umbrella of foreseeable research, including future therapeutic applications, with recontact possible in limited circumstances. We argue that the long-term goals of regenerative medicine, interest in sharing iPSC lines, and uncertain landscape of future research all would be served by a framework of ongoing communication with donors. Our approach balances the goals of iPSC and regenerative medicine researchers with the interests of individual research participants. PMID:23197820

  11. Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing

    PubMed Central

    Afolabi, Muhammed Olanrewaju; Bojang, Kalifa; D’Alessandro, Umberto; Imoukhuede, Egeruan Babatunde; Ravinetto, Raffaella M; Larson, Heidi Jane; McGrath, Nuala; Chandramohan, Daniel

    2014-01-01

    Background International guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information. Objectives This study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia. Methods We developed the informed consent document of the malaria treatment trial into a multimedia tool integrating video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the multimedia tool were assessed using quantitative and qualitative methods. In two separate visits, the participants’ comprehension of the study information was measured by using a validated digitised audio questionnaire. Results The majority of participants (70%) reported that the multimedia tool was clear and easy to understand. Participants had high scores on the domains of adverse events/risk, voluntary participation, study procedures while lowest scores were recorded on the question items on randomisation. The differences in mean scores for participants’ ‘recall’ and ‘understanding’ between first and second visits were statistically significant (F (1,41)=25.38, p<0.00001 and (F (1, 41) = 31.61, p<0.00001 respectively. Conclusions Our locally developed multimedia tool was acceptable and easy to administer among low literacy participants in The Gambia. It also proved to be effective in delivering and sustaining comprehension of study information across a diverse group of participants. Additional research is needed to compare the tool to the traditional consent interview, both in The Gambia and in other sub-Saharan settings. PMID:25133065

  12. The role of the clinical trial nurse in the informed consent process.

    PubMed

    Cantini, Franca; Ells, Carolyn

    2007-06-01

    The purpose of this descriptive study was to elicit information about the current practice of clinical trial nurses in the informed consent process. A 50-item self-administered anonymous questionnaire was completed by a sample of 95 nurses from hospitals affiliated with McGill University in Montreal, Quebec, Canada, who were members of a clinical trial research team whose principal investigator was a physician and whose research participants were competent adults. The nurses were all members of the provincial nurses' association. Clinical trial nurses were found to have an important role in the informed consent process and to experience conflict of interest and other ethical dilemmas as members of clinical trial research teams. There is a need to develop specific practical and ethical guidelines for nurses involved with clinical trial research and to develop educational programs for nurses working in clinical research. PMID:17679589

  13. How to achieve informed consent for research from Spanish-speaking individuals with low literacy: a qualitative report.

    PubMed

    Cortés, Dharma E; Drainoni, Mari-Lynn; Henault, Lori E; Paasche-Orlow, Michael K

    2010-01-01

    Investigators have the responsibility to ensure that prospective participants are fully informed about a research protocol prior to consenting to participate, yet many researchers face challenges when obtaining consent, since the majority of the general population has limited or no familiarity with research studies. These challenges are further magnified when obtaining consent from individuals with low literacy levels and who speak languages other than English. In this article we present findings from a qualitative study conducted with Spanish-speaking individuals with low-literacy designed to refine the Agency for Healthcare Research and Quality's Informed Consent and Authorization Toolkit for Minimal Risk Research. Findings from this study indicate that familiarity with providing informed consent and authorization for research or the experience of being a research participant appear to play key roles in an individual's ability to understand the consent and authorization process. While the text of the consent and authorization documents can be simplified using plain language principles, comprehension of several fundamental ideas such as risk and privacy need to be safeguarded with a consent process that confirms comprehension. Recommendations are provided to address the informational needs of individuals with low literacy levels and limited or no experience with research participation. PMID:20845202

  14. Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India

    PubMed Central

    Joglekar, Neelam S.; Deshpande, Swapna S.; Sahay, Seema; Ghate, Manisha V.; Bollinger, Robert C.; Mehendale, Sanjay M.

    2013-01-01

    Background Optimum comprehension of informed consent by research participants is essential yet challenging. This study explored correlates of lower comprehension of informed consent among 1334 participants of a cohort study aimed at estimating HIV incidence in Pune, India. Methods As part of the informed consent process, a structured comprehension tool was administered to study participants. Participants scoring ≥90% were categorised into the ‘optimal comprehension group’, whilst those scoring 80–89% were categorised into the ‘lower comprehension group’. Data were analysed to identify sociodemographic and behavioural correlates of lower consent comprehension. Results The mean ± SD comprehension score was 94.4 ± 5.00%. Information pertaining to study-related risks was not comprehended by 61.7% of participants. HIV-negative men (adjusted OR [AOR] = 4.36, 95% CI 1.71–11.05) or HIV-negative women (AOR = 13.54, 95% CI 6.42–28.55), illiteracy (AOR= 1.65, 95% CI 1.19–2.30), those with a history of multiple partners (AOR = 1.73, 95% CI 1.12–2.66) and those never using condoms (AOR = 1.35, 95% CI 1.01–1.82) were more likely to have lower consent comprehension. Conclusions We recommend exploration of domains of lower consent comprehension using a validated consent comprehension tool. Improved education in these specific domains would optimise consent comprehension among research participants. PMID:24029848

  15. A survey on informed consent process for epidural analgesia in labor pain in Korea

    PubMed Central

    Lee, Nan-Ju; Sim, Jiyeon; Lee, Mi Soon; Han, Sun Sook; Lee, Hwa Mi

    2010-01-01

    Background There is a legal obligation to explain the procedure and use of epidural analgesia in labor primarily due to the possibility of potential risks and associated complications. The present study details on the survey carried out to ascertain the current status of obtaining informed consent (IC) for explaining the epidural analgesia in labor. Methods The present study is based on a survey through a telephone questionnaire that covered all the hospitals in Korea where the anesthesiologists' belonged to and are registered with Korean Society of Anesthesiologists. The questionnaire included questions pertaining to administration of epidural analgesia to a parturient, information on different steps of obtaining an IC, whether patient status was evaluated, when the consent was obtained, and the reasons behind, if the consent had not being given. Results A total of 1,434 respondents took part in the survey, with a response rate of 97% (1,434/1,467). One hundred seventy-four hospitals had conducted epidural analgesia on the parturient. The overall rate of obtaining IC for epidural analgesia during labor was 85%, of which only 13% was conducted by anesthesiologists. The rate of evaluating preoperative patient status was 74%, of which 45% was conducted by anesthesiologists. Almost all of the consent was obtained prior to the procedure. Conclusions The rate of obtaining IC for epidural analgesia in labor is relatively high (85%) in Korea. However, it is necessary to discuss the content of the consent and the procedure followed for obtaining IC during the rapid progress of labor. PMID:20651996

  16. Loss of possession: concussions, informed consent, and autonomy.

    PubMed

    Robeson, Richard; King, Nancy M P

    2014-01-01

    The recent explosion of publicity about the dangers of concussion in contact sports - particularly in football - represents the unraveling of a disinformation campaign by the NFL amid growing public and professional concern about the game's long-term risks of harm. The persistence of controversy and denial reflects a cultural view of football players as serving the needs of the team, a resulting evidentiary skepticism, and resistance to rule changes as excessive or unenforceable. This article considers the cultural context of informed decision making by parents of youth football players and suggests that policy changes designed to lower (although they cannot eliminate) risks of brain injury have the potential to change both the culture of football and the way the benefits and harms of the game are regarded for its players, without loss of its essential excitement and appeal. PMID:25264091

  17. 76 FR 64945 - Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-19

    ... To Aid Public Comment AGENCY: Federal Trade Commission. ACTION: Proposed Consent Agreement. SUMMARY... deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment... Aid Public Comment describes the terms of the consent agreement, and the allegations in the...

  18. Readability of informed consent forms in clinical trials conducted in a skin research center

    PubMed Central

    Samadi, Aniseh; Asghari, Fariba

    2016-01-01

    Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch–Kincaid reading ease score, Flesch–Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23–14.09) using the Flesch–Kincaid formula and 14.64 ± 1.22 (12.67–18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11th grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials. PMID:27471590

  19. The new genetics and informed consent: differentiating choice to preserve autonomy.

    PubMed

    Bunnik, Eline M; de Jong, Antina; Nijsingh, Niels; de Wert, Guido M W R

    2013-07-01

    The advent of new genetic and genomic technologies may cause friction with the principle of respect for autonomy and demands a rethinking of traditional interpretations of the concept of informed consent. Technologies such as whole-genome sequencing and micro-array based analysis enable genome-wide testing for many heterogeneous abnormalities and predispositions simultaneously. This may challenge the feasibility of providing adequate pre-test information and achieving autonomous decision-making. At a symposium held at the 11th World Congress of Bioethics in June 2012 (Rotterdam), organized by the International Association of Bioethics, these challenges were presented for three different areas in which these so-called 'new genetics' technologies are increasingly being applied: newborn screening, prenatal screening strategies and commercial personal genome testing. In this article, we build upon the existing ethical framework for a responsible set-up of testing and screening offers and reinterpret some of its criteria in the light of the new genetics. As we will argue, the scope of a responsible testing or screening offer should align with the purpose(s) of testing and with the principle of respect for autonomy for all stakeholders involved, including (future) children. Informed consent is a prerequisite but requires a new approach. We present preliminary and general directions for an individualized or differentiated set-up of the testing offer and for the informed consent process. With this article we wish to contribute to the formation of new ideas on how to tackle the issues of autonomy and informed consent for (public) healthcare and direct-to-consumer applications of the new genetics. PMID:23718722

  20. Readability of informed consent forms in clinical trials conducted in a skin research center.

    PubMed

    Samadi, Aniseh; Asghari, Fariba

    2016-01-01

    Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch-Kincaid reading ease score, Flesch-Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23-14.09) using the Flesch-Kincaid formula and 14.64 ± 1.22 (12.67-18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11(th) grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials. PMID:27471590

  1. Informed Parent Consent for Pre-School and School-Aged Children with Disabilities. Alliance Action Information Sheets

    ERIC Educational Resources Information Center

    Technical Assistance ALLIANCE for Parent Centers, 2006

    2006-01-01

    Informed Parent Consent is one of the important parent rights in the Individuals with Disabilities Education Act (IDEA 2004). IDEA is the federal special education law. When your child receives special education services, there are times when the school must obtain your written permission before acting. More details are presented in this paper.…

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

    PubMed Central

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

    2016-01-01

    Background 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. Methodology 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. Results 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. Conclusion 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

  3. Evaluating Biomedical Enhancement Research: Assessing Risk & Benefit and Obtaining Informed Consent

    PubMed Central

    Mehlman, Maxwell J.; Berg, Jessica W.

    2013-01-01

    There are two primary human subject protections: assessing and comparing the risks and potential benefits of proposed research, and obtaining potential subjects’ informed consent. While there has been extensive discussion in the literature on these two aspects, no attention has been paid to whether the processes should be different when the objective of an experimental biomedical intervention is to improve individual performance or capacity (“enhancement research”) rather than to prevent, cure, or mitigate disease (“health-oriented research”). This essay examines how both assessment of risks and benefits, and obtaining informed consent in an enhancement experiment might differ from the approaches used in health-oriented investigations, and considers appropriate protections for subjects in enhancement research. PMID:18840248

  4. Informed Consent Examined Within the Context of Culturally Congruent Care: An Interprofessional Perspective.

    PubMed

    Marrone, Stephen R

    2016-07-01

    The process of obtaining informed consent for diverse patients poses many challenges for health care professionals as they try to balance ethical, legal, and accreditation requirements of the country within which they practice with the culture care needs of diverse consumers. Culturally competent health care organizations create a governance infrastructure that promotes equity and supports the delivery of culturally appropriate health care services that are responsive to diverse patients. The purpose of this article is to examine the concept of informed consent within the context of culturally congruent care to Saudi patients and families in an American hospital setting. The need for the provision of culturally congruent care that respects the contextual rights and dignity of patients and families while, at the same time, recognizing the legal, ethical, and moral codes of the health professions and requirements of federal, state, and regulatory agencies within the United States will be explored. PMID:25687482

  5. Addiction, Autonomy, and Informed Consent: On and Off the Garden Path.

    PubMed

    Levy, Neil

    2016-02-01

    Several ethicists have argued that research trials and treatment programs that involve the provision of drugs to addicts are prima facie unethical, because addicts can't refuse the offer of drugs and therefore can't give informed consent to participation. In response, several people have pointed out that addiction does not cause a compulsion to use drugs. However, since we know that addiction impairs autonomy, this response is inadequate. In this paper, I advance a stronger defense of the capacity of addicts to participate in the programs envisaged. I argue that it is only in certain circumstances that addicts find themselves choosing in ways that conflict with their genuine preferences. Research and treatment programs have none of the features that characterize choices in these autonomy-undermining circumstances, and there is therefore no reason to think that addicts lack the capacity to give informed consent to these programs. PMID:26668167

  6. Development of an Electronic Research Permissions Management System to Enhance Informed Consents and Capture Research Authorizations Data

    PubMed Central

    Obeid, Jihad S.; Gerken, Katherine; Madathil, Kapil Chalil; Rugg, Daniel; Alstad, Colin E.; Fryar, Katrina; Alexander, Randall; Gramopadhye, Anand K.; Moskowitz, Jay; Sanderson, Iain C.

    Informed consents are a critical and essential component of the clinical research process. Currently, most consents and research privacy authorizations are being captured on paper. In this paper we describe a novel method of capturing this information electronically. The objective is to allow easier tracking of research participants’ intent for current and future research involvement, enhance consent comprehension and facilitate the research workflow. After multidisciplinary analysis in key hospital registration areas and research participant enrollment, an open source software product was designed to capture this data through a user-friendly touch screen interface. The data may then be fed into a clinical data warehouse for use in cohort discovery or consent tracking. Despite ethical, legal and informatics challenges in clinical and research environments, we propose that this technology opens new avenues for significantly enhancing the consent process and positively impacting recruitment. PMID:24303263

  7. Optimizing informed consent in living liver donors: Evaluation of a comprehension assessment tool.

    PubMed

    Gordon, Elisa J; Mullee, Jack; Butt, Zeeshan; Kang, Joseph; Baker, Talia

    2015-10-01

    Adult-to-adult living liver donation is associated with considerable risks with no direct medical benefit to liver donors (LDs). Ensuring that potential LDs comprehend the risks of donation is essential to medically and ethically justify the procedure. We developed and prospectively evaluated the initial psychometrics of an "Evaluation of Donor Informed Consent Tool" (EDICT) designed to assess LDs' comprehension about the living donation process. EDICT includes 49 true/false/unsure items related to LD informed consent. Consecutive LDs undergoing evaluation at 1 academic medical center from October 2012 to September 2014 were eligible for participation in pretest/posttest interviews. Medical records were reviewed for postdonation complications. Twenty-seven LDs participated (96% participation rate). EDICT demonstrated good internal consistency reliability at pretest, 2 days before donating (Cronbach's α = 0.78), and posttest, 1 week after donating (α = 0.70). EDICT scores significantly increased over time (P = 0.01) and demonstrated good test-retest reliability (r = 0.68; P < 0.001). EDICT was associated with race/ethnicity (P = 0.02) and relationship to the recipient (P = 0.01; pretest), and income (P = 0.01) and insurance (P = 0.01; posttest), but not with decisional conflict, preoperative preparedness, satisfaction, or decisional regret (pretest and posttest). Donor complications did not impact postdonation EDICT scores. In conclusion, EDICT has promising measurement properties and may be useful in the evaluation of informed consent for potential LDs. PMID:25990592

  8. Knowledge and Attitude Toward Informed Consent Among Private Dental Practitioners in Bathinda City, Punjab, India

    PubMed Central

    Gupta, Vivek V.; Bhat, Nagesh; Asawa, Kailash; Tak, Mridula; Bapat, Salil; Chaturvedi, Pulkit

    2015-01-01

    Objectives A study was conducted with the purpose to assess the knowledge and attitude towards informed consent among private dental practitioners in Bathinda City, Punjab, India. Methods A cross-sectional survey was conducted among all private dental practitioners in Bathinda City. A self-administered structured questionnaire consisting of 14 items was used to assess their knowledge and attitude regarding informed consent. The response format was based on a 3-point Likert scale. One-way analysis of variance, independent sample t test, and stepwise multiple linear regression analysis were utilized for statistical analysis. Confidence level and level of significance were set at 95% and 5%, respectively. Results The mean scores for knowledge and attitude were 19.37 ± 31.82 and 9.40 ± 1.72, respectively. Analysis revealed that qualification and years of experience was statistically significant among both dependent variables (p ≤ 0.05). Conclusion An unbalanced knowledge of informed consent among the current dentists has suggested the need for awareness programs to fill the knowledge gaps and instill positive attitudes. PMID:25938015

  9. A Pilot Study of Simple Interventions to Improve Informed Consent in Clinical Research: Feasibility, Approach, and Results

    PubMed Central

    Kass, Nancy; Taylor, Holly; Ali, Joseph; Hallez, Kristina; Chaisson, Lelia

    2014-01-01

    Background Informed consent is intended to ensure that individuals understand the purpose, risks, and benefits of research studies, and then can decide, voluntarily, whether to enroll. However, research suggests that consent procedures do not always lead to adequate participant understanding and may be longer and more complex than necessary. Studies also suggest some consent interventions, including enhanced consent forms and extended discussions with patients, increase understanding, yet methodologic challenges have been raised in studying consent in actual trial settings. This study aimed to examine the feasibility of testing two consent interventions in actual studies and also to measure effectiveness of interventions in improving understanding of trials. Methods Participants enrolling in any of eight ongoing clinical trials (“collaborating studies”) were, for the purposes of this study, sequentially assigned to one of three study arms involving different informed consent procedures (one control and two intervention). Control participants received standard consent form and processes. Participants in the 1st intervention arm received a bulleted fact-sheet providing simple summaries of all study components in addition to the standard consent form. Participants in the 2nd intervention arm received the bulleted fact-sheet and standard consent materials and then also engaged with a member of the collaborating study staff in a feedback Q&A session. Following consent procedures, we administered closed and open ended questions to assess patient understanding and we assessed literacy level. Descriptive statistics, Wilcoxon-Mann-Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of patient understanding. Results 144 participants enrolled. Using regression analysis participants receiving the 2nd intervention, which included a standard consent form, bulleted fact sheet and structured question and answer

  10. [Informed consent in anaesthesiology: period of notice as a requisite of validity].

    PubMed

    Galán Gutiérrez, J C; Galán Cortés, J C

    2014-02-01

    The analysis of one of the requisites of the validity of the informed consent, the notice period, during which the patient should be provided with information, so that he/she can reflect and fully exercise his/her Kantian right of self-determination. National legislation appears to be insufficient when dealing with this issue, which is compensated for in some regional legislations. We conclude by pointing the need to provide the patient with information with sufficient notice prior to operations, so that he/she can ponder over his/her decision. PMID:23809780

  11. Informed Consent

    MedlinePlus

    ... State Legislative Action Center Leadership & Advocacy Summit 2017 Leadership & Advocacy Summit 2016 Webinars Practice Management Practice Management Practice Management CPT Coding Bulletin Articles ...

  12. Knowledge and Practices of Obtaining Informed Consent for Medical Procedures among Specialist Physicians: Questionnaire Study in 6 Croatian Hospitals

    PubMed Central

    Jukić, Marko; Kvolik, Slavica; Kardum, Goran; Kozina, Slavica; Tomić, Ana; Juraga

    2009-01-01

    Aim To assess physicians’ knowledge and practices for obtaining patients’ informed consent to medical procedures. Methods An anonymous and voluntary survey of knowledge and practices for obtaining informed consent was conducted among 470 physicians (63% response rate) working in 6 hospitals: 93 specialists in anesthesiology, 166 in internal medicine, and 211 in surgery. Results Only 54% physicians were acquainted with the fact that the procedure for obtaining consent was regulated by the law. Internists and surgeons were better informed than anesthesiologists (P = 0.024). More than a half of respondents (66%) were familiar with the fact that a law on patient rights was passed in Croatia; there were no differences among different specialties (P = 0.638). Only 38% of the physicians were fully informed about the procedure of obtaining consent. Internists and surgeons provided detailed information to the patient in 33% of the cases and anesthesiologists in 16% of the cases (P < 0.050). Internists reported spending more time on informing the patient than anesthesiologists and surgeons (P < 0.001). There were no differences in knowledge and practices for obtaining informed consent between physicians working in university and those working in community hospitals (P ≥ 0.05 for all questions). Conclusion Physicians in Croatia have no formal education on informed consent and implement the informed consent process in a rather formal manner, regardless of the type of hospital or medical specialty. Systemic approach at education and training at the national level is needed to improve the informed consent process. PMID:20017225

  13. "Case Neisser": experimental design, the beginnings of immunology, and informed consent.

    PubMed

    Benedek, Thomas G

    2014-01-01

    In 1892, Albert L. Neisser (1855-1916), the professor of dermatology and venereology at the University of Breslau (Prussia), undertook two series of clinical experiments: one to test whether serum from syphilitic patients had a prophylactic value against contracting syphilis, and the other to test whether such serum had a therapeutic value for syphilitic patients. The first experiment was based on the erroneous scientific hypothesis called "Colles's law," which posited that a fetus that was syphilitic due to the father's disease could in utero immunize its mother against syphilis. Neisser acknowledged that neither experiment achieved its goal. However, when his work was published, Neisser was criticized not for the various errors of experimental design that should have been recognizable to him, but because of his failure to obtain the consent of his non-syphilitic subjects. The political furor that followed led to the first governmental edict to require informed consent of participants in clinical research. This essay examines how Neisser's generally forgotten investigation into therapies for syphilis led to some of the first regulations about informed consent. PMID:25544327

  14. The effect of multimedia interventions on the informed consent process for cataract surgery in rural South India

    PubMed Central

    Karan, Abraar; Somasundaram, Prashanth; Michael, Haben; Shayegani, Aryan; Mayer, Hylton

    2014-01-01

    Context: The provision of ocular surgical interventions for poorer, less educated populations is increasing as a result of increased globalization and outreach. However, these populations still have trouble understanding surgical concepts and are not always fully informed decision makers. Aims: We aimed to test the effect that a multimedia addition to a traditional verbal informed consent would have on patient comprehension of relatively difficult cataract surgical concepts. Settings and Design: We conducted a randomized controlled trial with relatively uneducated patients reporting to a private surgical hospital in Chennai, India. 47 patients were placed into the intervention group and 50 patients were placed into the control group. Materials and Methods: The intervention group was presented with a scripted verbal informed consent as well as a 3-fold pamphlet and a presentation with a 3-dimensional model of the eye. The control group was only presented with a scripted verbal informed consent. The two groups were tested using an 11 item “True/False/I don’t know” quiz directly before the informed consent, directly after the informed consent, and one-day postoperatively. Statistical Analysis Used: Scores on the quiz were compared across groups and time-points using paired t-tests. Results: Patients in the both groups showed a significant improvement in scores between pre- and post-informed consent quizzes (P value on the order of 10-6) and the improvement in scores was significantly greater in the intervention group than the control group (P value on the order of 10-16). There was no significant difference observed in either group with regards to the change in scores between post-informed consent and post-operative quizzes. Conclusion: Multimedia aids in addition to a standard informed consent process are effective in improving patient comprehension even for patients with low literacy and limited knowledge of surgical interventions. PMID:24008787

  15. Attitudes Toward Risk and Informed Consent for Research on Medical Practices

    PubMed Central

    Cho, Mildred K.; Magnus, David; Constantine, Melissa; Lee, Sandra Soo-Jin; Kelley, Maureen; Alessi, Stephanie; Korngiebel, Diane; James, Cyan; Kuwana, Ellen; Gallagher, Thomas H.; Diekema, Douglas; Capron, Alexander M.; Joffe, Steven; Wilfond, Benjamin S.

    2015-01-01

    Background The U.S. Office for Human Research Protections has proposed that end points of randomized trials comparing the effectiveness of standard medical practices are risks of research that would require disclosure and written informed consent, but data are lacking on the views of potential participants. Objective To assess attitudes of U.S. adults about risks and preferences for notification and consent for research on medical practices. Design Cross-sectional survey conducted in August 2014. Setting Web-based questionnaire. Patients 1095 U.S. adults sampled from an online panel (n = 805) and an online convenience river sample (n = 290). Measurements Attitudes toward risk, informed consent, and willingness to participate in 3 research scenarios involving medical record review and randomization of usual medical practices. Results 97% of respondents agreed that health systems should evaluate standard treatments. Most wanted to be asked for permission to participate in each of 3 scenarios (range, 75.2% to 80.4%), even if it involved only medical record review, but most would accept nonwritten (oral) permission or general notification if obtaining written permission would make the research too difficult to conduct (range, 70.2% to 82.7%). Most perceived additional risk from each scenario (range, 64.0% to 81.6%). Limitation Use of hypothetical scenarios and a nonprobability sample that was not fully representative of the U.S. population. Conclusion Most respondents preferred to be asked for permission to participate in observational and randomized research evaluating usual medical practices, but they are willing to accept less elaborate approaches than written consent if research would otherwise be impracticable. These attitudes are not aligned with proposed regulatory guidance. Primary Funding Source National Center for Advancing Translational Sciences at the National Institutes of Health. PMID:25868119

  16. Informed consent in implantable BCI research: identification of research risks and recommendations for development of best practices

    NASA Astrophysics Data System (ADS)

    Klein, Eran; Ojemann, Jeffrey

    2016-08-01

    Objective. Implantable brain–computer interface (BCI) research promises improvements in human health and enhancements in quality of life. Informed consent of subjects is a central tenet of this research. Rapid advances in neuroscience, and the intimate connection between functioning of the brain and conceptions of the self, make informed consent particularly challenging in BCI research. Identification of safety and research-related risks associated with BCI devices is an important step in ensuring meaningful informed consent. Approach. This paper highlights a number of BCI research risks, including safety concerns, cognitive and communicative impairments, inappropriate subject expectations, group vulnerabilities, privacy and security, and disruptions of identity. Main results. Based on identified BCI research risks, best practices are needed for understanding and incorporating BCI-related risks into informed consent protocols. Significance. Development of best practices should be guided by processes that are: multidisciplinary, systematic and transparent, iterative, relational and exploratory.

  17. Local Media Influence on Opting-Out from an Exception from Informed Consent Trial

    PubMed Central

    Nelson, Maria J; DeIorio, Nicole M; MD, Terri Schmidt; Griffiths, Denise; Daya, Mohamud; Haywood, Liana; Zive, Dana; Newgard, Craig D

    2010-01-01

    Objectives News media are used for community education and notification in exception from informed consent clinical trials, yet their effectiveness as an added safeguard in such research remains unknown. We assessed the number of callers requesting opt-out bracelets following each local media report and described the errors and content within each media report. Methods We undertook a descriptive analysis of local media trial coverage (newspaper, television, radio, and weblog) and opt-out requests over a 41-month period at a single site participating in an exception from informed consent out-of-hospital trial. Two non-trial investigators independently assessed forty-one content-based media variables (including background, trial information, graphics, errors, publication information, assessment) using a standardized, semi-qualitative data collection tool. Major errors were considered serious misrepresentation of the trial purpose or protocol, whereas minor errors included misinformation unlikely to mislead the lay reader about the trial. We plotted the temporal relationship between opt-out bracelet requests and media reports. Descriptive information about the news sources and the trial coverage are presented. Results We collected 39 trial-related media reports (33 newspaper, 1 television, 1 radio, and 4 blogs). There were thirteen errors in 9 (23%) publications, 7 of which were major and 6 minor. Of 384 requests for 710 bracelets, 310 requests (80%) occurred within 4 days after trial media coverage. Graphical timeline representation of the data suggested a close association between media reports about the trial and requests for opt-out bracelets. Conclusions Based on results from a single site, local media coverage for an exception from informed consent clinical trial had a substantial portion of errors and appeared closely associated with opt-out requests. PMID:19682770

  18. A Rural Community's Involvement in the Design and Usability Testing of a Computer-Based Informed Consent Process for the Personalized Medicine Research Project

    PubMed Central

    Mahnke, Andrea N; Plasek, Joseph M; Hoffman, David G; Partridge, Nathan S; Foth, Wendy S; Waudby, Carol J; Rasmussen, Luke V; McManus, Valerie D; McCarty, Catherine A

    2014-01-01

    Many informed consent studies demonstrate that research subjects poorly retain and understand information in written consent documents. Previous research in multimedia consent is mixed in terms of success for improving participants’ understanding, satisfaction, and retention. This failure may be due to a lack of a community-centered design approach to building the interventions. The goal of this study was to gather information from the community to determine the best way to undertake the consent process. Community perceptions regarding different computer-based consenting approaches were evaluated, and a computer-based consent was developed and tested. A second goal was to evaluate whether participants make truly informed decisions to participate in research. Simulations of an informed consent process were videotaped to document the process. Focus groups were conducted to determine community attitudes towards a computer-based informed consent process. Hybrid focus groups were conducted to determine the most acceptable hardware device. Usability testing was conducted on a computer-based consent prototype using a touch-screen kiosk. Based on feedback, a computer-based consent was developed. Representative study participants were able to easily complete the consent, and all were able to correctly answer the comprehension check questions. Community involvement in developing a computer-based consent proved valuable for a population-based genetic study. These findings may translate to other types of informed consents, such as genetic clinical trials consents. A computer-based consent may serve to better communicate consistent, clear, accurate, and complete information regarding the risks and benefits of study participation. Additional analysis is necessary to measure the level of comprehension of the check-question answers by larger numbers of participants. The next step will involve contacting participants to measure whether understanding of what they consented to is

  19. Alternatives to project-specific consent for access to personal information for health research: Insights from a public dialogue

    PubMed Central

    Willison, Donald J; Swinton, Marilyn; Schwartz, Lisa; Abelson, Julia; Charles, Cathy; Northrup, David; Cheng, Ji; Thabane, Lehana

    2008-01-01

    Background The role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues. Methods We conducted seven day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly. Results Broad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research. Conclusion Because no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than

  20. Informed consent in research to improve the number and quality of deceased donor organs.

    PubMed

    Rey, Michael M; Ware, Lorraine B; Matthay, Michael A; Bernard, Gordon R; McGuire, Amy L; Caplan, Arthur L; Halpern, Scott D

    2011-02-01

    Improving the management of potential organ donors in the intensive care unit could meet an important public health goal by increasing the number and quality of transplantable organs. However, randomized clinical trials are needed to quantify the extent to which specific interventions might enhance organ recovery and outcomes among transplant recipients. Among several barriers to conducting such studies are the absence of guidelines for obtaining informed consent for such studies and the fact that deceased organ donors are not covered by extant federal regulations governing oversight of research with human subjects. This article explores the underexamined ethical issues that arise in the context of donor management studies and provides ethical guidelines and suggested regulatory oversight mechanisms to enable such studies to be conducted ethically. We conclude that both the respect that is traditionally accorded to the prior wishes of the dead and the possibility of postmortem harm support a role for surrogate consent of donors in such randomized controlled trials. Furthermore, although recipients will often be considered human subjects under federal regulations, several ethical arguments support waiving requirements for recipient consent in donor management randomized controlled trials. Finally, we suggest that new regulatory mechanisms, perhaps linked to existing regional and national organ donation and transplantation infrastructures, must be established to protect patients in donor management studies while limiting unnecessary barriers to the conduct of this important research. PMID:20975549

  1. “Negotiorum Gestio” in Family Medicine, Informed Consent Obtainment, and Disciplinary Responsibility

    PubMed Central

    Birkeland, Søren

    2016-01-01

    Introduction. Negotiorum gestio (NG) denotes an action where a person well intendedly acts on behalf of another without obtaining the latter's prior consent. In broad terms, NG-like actions have played a considerable role in health care provision. In some settings, health care delivery with only little or presumed patients' consent has been the rule rather than the exception. However, bioethical principles regarding patient autonomy and obtainment of the patient's informed consent (IC) before intervention are now increasingly materialized in the law of many countries. Aim. To study legal consequences of NG in family medicine and IC handling options. Methods. Case law examination. Results. A disciplinary board case is described concerning a family doctor conducting unlawful NG by not coming up to legal IC requirements. Discussion and Conclusion. The practical and legal implications of IC and possible role of novel Shared Decision-Making approaches in coming up to regulation and bioethical demands are discussed. It is concluded that a doctor may run an unnecessary legal risk when conducting NG in decision-competent patients and furthermore it is suggested that novel Shared Decision-Making approaches could help in obtaining a rightful and practicable IC. PMID:27110401

  2. The radiology informed consent form: recommendations from the European Society of Cardiology position paper.

    PubMed

    Carpeggiani, Clara; Picano, Eugenio

    2016-06-01

    Every radiological and nuclear medicine examination confers a definite long-term risk of cancer, but most patients undergoing such examinations receive no or inaccurate information about radiation dose and corresponding risk related to the dose received. Informed consent is a procedure to support (not substitute) the physician/patient dialogue and relationship, facilitating a free, informed and aware expression of the patient's will in the principle of patient autonomy. Physicians are responsible for providing patients with all the information on risks, benefits and alternatives useful to the patient to make the decision. In current radiological practice the information on the radiation dose and long-term cancer risks is difficult to find and not easy to understand. The form using plain language should spell-out the type of examination, the effective dose (mSv), the effective dose expressed in number of chest radiographs and the risk of cancer. The current practice clashes against the guidelines and the law. PMID:27269736

  3. A rural community's involvement in the design and usability testing of a computer-based informed consent process for the Personalized Medicine Research Project.

    PubMed

    Mahnke, Andrea N; Plasek, Joseph M; Hoffman, David G; Partridge, Nathan S; Foth, Wendy S; Waudby, Carol J; Rasmussen, Luke V; McManus, Valerie D; McCarty, Catherine A

    2014-01-01

    Many informed consent studies demonstrate that research subjects poorly retain and understand information in written consent documents. Previous research in multimedia consent is mixed in terms of success for improving participants' understanding, satisfaction, and retention. This failure may be due to a lack of a community-centered design approach to building the interventions. The goal of this study was to gather information from the community to determine the best way to undertake the consent process. Community perceptions regarding different computer-based consenting approaches were evaluated, and a computer-based consent was developed and tested. A second goal was to evaluate whether participants make truly informed decisions to participate in research. Simulations of an informed consent process were videotaped to document the process. Focus groups were conducted to determine community attitudes towards a computer-based informed consent process. Hybrid focus groups were conducted to determine the most acceptable hardware device. Usability testing was conducted on a computer-based consent prototype using a touch-screen kiosk. Based on feedback, a computer-based consent was developed. Representative study participants were able to easily complete the consent, and all were able to correctly answer the comprehension check questions. Community involvement in developing a computer-based consent proved valuable for a population-based genetic study. These findings may translate to other types of informed consents, including those for trials involving treatment of genetic disorders. A computer-based consent may serve to better communicate consistent, clear, accurate, and complete information regarding the risks and benefits of study participation. Additional analysis is necessary to measure the level of comprehension of the check-question answers by larger numbers of participants. The next step will involve contacting participants to measure whether understanding of

  4. Informed consent document improvement does not increase patients' comprehension in biomedical research

    PubMed Central

    Paris, Adeline; Brandt, Christian; Cornu, Catherine; Maison, Patrick; Thalamas, Claire; Cracowski, Jean-Luc

    2010-01-01

    AIMS International guidelines on ethics in biomedical research require that the informed consent of all enrolled participants is obtained. A written document describing the research, the informed consent (IC) document, must be given to all participants by the investigator. Most IC documents are long, containing much information. The aim of the present study was to determine whether the modification of the IC document by a working group or systematic improvement in its lexicosyntactic readability can improve comprehension of the written information given to patients participating in biomedical research. METHODS One hundred and fifty-nine patients were randomized to read one of the three versions of the IC document: unchanged document, document modified using systematic improvement of lexicosyntactic readability and document modified by a working group. RESULTS Neither the improvement in the lexicosyntactic readability, nor the intervention of the working group significantly improved the score of objective comprehension for the subjects included in this study: it was 66.6 (95% confidence interval 64.0, 69.2) for the control group, 68.8 (66.2, 71.4) for the group with the document improved for lexicosyntactic readability and 69.2 (66.0, 72.4) for the group who read the document improved by the working group (P= 0.38). CONCLUSIONS We failed to show that improving IC document comprehension through a lexicosyntactic approach or by a working group leads to better comprehension. PMID:20233193

  5. The menopause, hormone replacement therapy and informed consent: are women in an underresourced country adequately aware?

    PubMed

    Maharaj, N R; Gangaram, R; Moodley, J

    2007-04-01

    Recent evidence on the long-term effects of HRT have resulted in increased emphasis being placed on individualised counselling, patient choice and informed consent when managing the menopause. We assessed whether women in an underresourced country have adequate knowledge of the menopause/HRT to engage in patient - provider discussions and provide full informed consent for HRT. Specific 'knowledge scores' for the menopause and HRT were developed and utilised in structured questionnaires to determine the existing levels of knowledge in 150 women from different racial, educational and occupational backgrounds. Some 92% were aware of the menopause and 54% were aware of HRT. Specific knowledge about the menopause and HRT overall was low (39% and 38%, respectively). There was a significant association between higher education levels, race and occupational status on the knowledge of the menopause but not of HRT. Television, radio and pamphlets were the preferred sources to gain further information. There is a need to create awareness and provide further education to women in underresourced countries about the menopause and HRT to empower them to make informed choices about their health during this period. PMID:17464817

  6. Evaluating Medical Students' Skills in Obtaining Informed Consent for HIV Testing

    PubMed Central

    Roberts, Laura Weiss; Geppert, Cynthia; McCarty, Teresita; Obenshain, S Scott

    2003-01-01

    OBJECTIVE To evaluate fourth-year medical students' abilities to obtain informed consent or refusal for HIV testing through a performance-based evaluation method. DESIGN Student competence was assessed in a standardized patient interaction in which the student obtained informed consent or refusal for HIV testing. A previously validated 16-item checklist was completed by the standardized patient. A subset was independently reviewed and scored by a faculty member to calculate interrater reliability for this report. Student feedback on the assessment was elicited. SETTING School of Medicine at the University of New Mexico. PATIENTS/PARTICIPANTS All senior medical students in the class of 2000 were included. INTERVENTIONS A 10-minute standardized patient interaction was administered within the context of a formal comprehensive performance assessment. MEASUREMENTS and MAIN RESULTS Seventy-nine students participated, and most (96%) demonstrated competence on the station. For the 15 specific items, the mean score was 25.5 out of 30 possible points (range, 13 to 30; SD, 3.5) on the checklist. A strong positive correlation (rs = .79) was found between the total score on the 15 Likert-scaled items and the score in response to the global item, “I would return to this clinician” (mean, 3.5; SD, 1.0). Scores given by the standardized patients and the faculty rater were well correlated. The station was generally well received by students, many of whom were stimulated to pursue further learning. CONCLUSIONS This method of assessing medical students' abilities to obtain informed consent or refusal for HIV testing can be translated to a variety of clinical settings. Such efforts may help in demonstrating competence in performing key ethics skills and may help ensure ethically sound clinical care for people at risk for HIV infection. PMID:12542585

  7. Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: An empirical study

    PubMed Central

    2013-01-01

    Background Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent. Methods The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa. Results The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists

  8. Expanding the boundaries of informed consent: disclosing alcoholism and HIV status to patients.

    PubMed

    Spielman, B

    1992-08-01

    Since informed consent became legally required in the therapeutic setting, the risks physicians were to disclose have been limited to the risks of particular procedures. Two recent court decisions in which disclosure of surgeons' alcoholism and positive human immunodeficiency virus status was required may begin to erode that limit. The grounds for this expansion of disclosure requirements were inherent in the 20-year-old "materiality" standard for disclosure; nevertheless, the change they signal is profound. These cases may signal a trend that, in the long term, could result in a shift in physician-patient communication and a significant loss of privacy for physicians. PMID:1497019

  9. Informed consent in the ethics of responsibility as stated by Emmanuel Levinas.

    PubMed

    Benito, Javier Jiménez; García, Sonia Ester Rodríguez

    2016-09-01

    In this paper we analyze some of the major difficulties of informed consent (IC). We consider insufficient to base IC on the principle of autonomy. We must not forget that the patient may be in a situation of extreme vulnerability and the good doctor should assume a degree of commitment and responsibility with his/her decisions. Our aim is to introduce the ethics of responsibility of Levinas in practice and theory of IC in order to generate a beneficent medical practice in which the supervision and overseeing of the patient do not undermine his/her autonomy. PMID:27021386

  10. Mandating audio-video recording of informed consent: are we right in enforcing this?

    PubMed

    Agrawal, A R; Joshi, R P; Shah, V

    2014-07-01

    Medicines are the result of experimentation carried out in animals and humans. However, there are numerous instances in the history of medicine where humans were subjected to undue risks and abuses, requiring regulations for their safety. Idea of informed consent has found its presence in medical literature from the times of Hippocratic Oath propagating principles of '...never do harm to anyone' and physician directed care of patients. This was revived in post-world war II era in the form of Nuremberg code and the declaration of Helsinki in response to various debilitating experimentations done on prisoners in concentration camps and elsewhere. Complete information and voluntary participation forms the ethical tenets of these acts and the same has been reflected in various guidelines enacted worldwide, which are sufficient to make sure that patient consent is obtained in fair and just manner. Despite this, there have been undesirable lapses in the conduct of clinical trials. This situation worsens, when intentional lapses in conduct of trial hamper the ability of socially and economically disadvantaged communities in developing countries to make free and informed decision. PMID:24942306

  11. Limitations of informed consent for in utero gene transfer research: implications for investigators and institutional review boards.

    PubMed

    Burger, I M; Wilfond, B S

    2000-05-01

    Only 10 years after the first human gene transfer protocols were approved for adults and children, researchers have begun to consider gene transfer on the fetus. While preliminary animal research is ongoing, the enthusiasm and pace of research in this area suggest that human protocols for in utero gene transfer research may be seriously considered in the foreseeable future. Federal guidelines for fetal research rely on minimizing risk and informed consent to protect the "rights and welfare" of both the fetus and pregnant woman. However, in utero gene transfer research poses special challenges to informed consent. This research represents an innovative approach for very ill subjects and takes place in the prenatal setting. These features may converge to undermine the expectant parents' comprehension of, and voluntariness for participation in, research. In this case, informed consent may not be able to bear the weight of adequately protecting the fetus from undue research risks. To compensate for this limitation, and using the regulations for pediatric research as a guide, a greater emphasis should be placed on the benefit/harm assessment rather than informed consent. Selecting diseases/patients where good alternative treatments exist may maximize informed consent, yet this may be a trade-off that exposes the fetus to greater relative risks. On the other hand, selecting diseases/patients without good alternative treatments to prolong life may convey an overestimation of the potential benefits of these interventions, and although care should be taken to strive to improve understanding of these limitations, misunderstanding may persist. However, selecting diseases/patients with no good alternatives might make serious risks more tolerable, and this should take precedence over informed consent. The limitations of informed consent brought into focus by the special features of in utero gene transfer research may be relevant to a broader range of innovative investigations

  12. Duty to Inform and Informed Consent in Diagnostic Radiology: How Ethics and Law can Better Guide Practice.

    PubMed

    Doudenkova, Victoria; Bélisle Pipon, Jean-Christophe

    2016-03-01

    Although there is consensus on the fact that ionizing radiation used in radiological examinations can affect health, the stochastic (random) nature of risk makes it difficult to anticipate and assess specific health implications for patients. The issue of radiation protection is peculiar as any dosage received in life is cumulative, the sensitivity to radiation is highly variable from one person to another, and between 20 % and 50 % of radiological examinations appear not to be necessary. In this context, one might reasonably assume that information and patient consent would play an important role in regulating radiological practice. However, there is to date no clear consensus regarding the nature and content of-or even need for-consent by patients exposed to ionizing radiation. While law and ethics support the same principles for respecting the dignity of the person (inviolability and integrity), in the context of radiology practice, they do not provide a consistent message to guide clinical decision-making. This article analyzes the issue of healthcare professionals' duty to inform and obtain patient consent for radiological examinations. Considering that both law and ethics have as one of their aims to protect vulnerable populations, it is important that they begin to give greater attention to issues raised by the use of ionizing radiation in medicine. While the situation in Canada serves as a backdrop for a reflective analysis of the problem, the conclusions are pertinent for professional practice in other jurisdictions because the principles underlying health law and jurisprudence are fairly general. PMID:25749428

  13. Taking part in a pharmacogenetic clinical trial: assessment of trial participants understanding of information disclosed during the informed consent process

    PubMed Central

    2013-01-01

    Background This study is the first to examine the understandings that participants have of the consent process in a pharmacogenetic trial of anti-depressant medication. Methods This was a qualitative cross sectional study. There were 76 participants residing in London, Mannheim, Arhuus and Poznan. Results Only one quarter of participants (none in Poznan) could articulate the concept of pharmacogenetics. Heritability and testing medication were also given as the purpose of the trial. Most participants had not appreciated harms that could derive from the trial. Even when shown the consent sheet, participants were confused about DNA profiling. There was evidence that participants appreciated weekly contact with researchers. Most said they would participate in a trial again but would like choice over the intervention they were assigned to. Conclusion Participants in this study showed a poor level of informed consent. Although this is not the first time this argument has been made, it is in the case of a pharmacogenetic trial. Further work should investigate the associations between extraneous factors such as information and social support on beneficial or untoward outcomes of antidepressant treatment. PMID:24025622

  14. 78 FR 36815 - 30-Day Notice of Proposed Information Collection: Statement of Consent: Issuance of a U.S...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... Notice of Proposed Information Collection: Statement of Consent: Issuance of a U.S. Passport to a Minor Under Age 16 ACTION: Notice of request for public comment and submission to OMB of proposed collection of information. SUMMARY: The Department of State has submitted the information collection...

  15. Email-Based Informed Consent: Innovative Method for Reaching Large Numbers of Subjects for Data Mining Research

    NASA Technical Reports Server (NTRS)

    Lee, Lesley R.; Mason, Sara S.; Babiak-Vazquez, Adriana; Ray, Stacie L.; Van Baalen, Mary

    2015-01-01

    Since the 2010 NASA authorization to make the Life Sciences Data Archive (LSDA) and Lifetime Surveillance of Astronaut Health (LSAH) data archives more accessible by the research and operational communities, demand for data has greatly increased. Correspondingly, both the number and scope of requests have increased, from 142 requests fulfilled in 2011 to 224 in 2014, and with some datasets comprising up to 1 million data points. To meet the demand, the LSAH and LSDA Repositories project was launched, which allows active and retired astronauts to authorize full, partial, or no access to their data for research without individual, study-specific informed consent. A one-on-one personal informed consent briefing is required to fully communicate the implications of the several tiers of consent. Due to the need for personal contact to conduct Repositories consent meetings, the rate of consenting has not kept up with demand for individualized, possibly attributable data. As a result, other methods had to be implemented to allow the release of large datasets, such as release of only de-identified data. However the compilation of large, de-identified data sets places a significant resource burden on LSAH and LSDA and may result in diminished scientific usefulness of the dataset. As a result, LSAH and LSDA worked with the JSC Institutional Review Board Chair, Astronaut Office physicians, and NASA Office of General Counsel personnel to develop a "Remote Consenting" process for retrospective data mining studies. This is particularly useful since the majority of the astronaut cohort is retired from the agency and living outside the Houston area. Originally planned as a method to send informed consent briefing slides and consent forms only by mail, Remote Consenting has evolved into a means to accept crewmember decisions on individual studies via their method of choice: email or paper copy by mail. To date, 100 emails have been sent to request participation in eight HRP

  16. Standard operating procedure for audio visual recording of informed consent: an initiative to facilitate regulatory compliance.

    PubMed

    Parikh, P M; Prabhash, K; Govind, K B; Digumarti, R; Pandit, S; Banerjee, I; Biyani, R; Deshmukh, A; Doval, D; Bhattacharyya, G S; Gupta, S

    2014-01-01

    The office of the Drugs Controller General (India) vide order dated 19 th November 2013 has made audio visual (AV) recording of the informed consent mandatory for the conduct of all clinical trials in India. We therefore developed a standard operating procedure (SOP) to ensure that this is performed in compliance with the regulatory requirements, internationally accepted ethical standards and that the recording is stored as well as archived in an appropriate manner. The SOP was developed keeping in mind all relevant orders, regulations, laws and guidelines and have been made available online. Since, we are faced with unique legal and regulatory requirements that are unprecedented globally, this SOP will allow the AV recording of the informed consent to be performed, archived and retrieved to demonstrate ethical, legal and regulatory compliance. We also compared this to the draft guidelines for AV recording dated 9 th January 2014 developed by Central Drugs Standard Control Organization. Our future efforts will include regular testing, feedback and update of the SOP. PMID:25104190

  17. Informed consent in the psychosis prodrome: ethical, procedural and cultural considerations.

    PubMed

    Morris, Sarah E; Heinssen, Robert K

    2014-01-01

    Research focused on the prodromal period prior to the onset of psychosis is essential for the further development of strategies for early detection, early intervention, and disease pre-emption. Such efforts necessarily require the enrollment of individuals who are at risk of psychosis but have not yet developed a psychotic illness into research and treatment protocols. This work is becoming increasingly internationalized, which warrants special consideration of cultural differences in conceptualization of mental illness and international differences in health care practices and rights regarding research participation. The process of identifying and requesting informed consent from individuals at elevated risk for psychosis requires thoughtful communication about illness risk and often involves the participation of family members. Empirical studies of risk reasoning and decisional capacity in young people and individuals with psychosis suggest that most individuals who are at-risk for psychosis can adequately provide informed consent; however ongoing improvements to tools and procedures are important to ensure that this work proceeds with maximal consideration of relevant ethical issues. This review provides a discussion of these issues in the context of international research efforts. PMID:25403748

  18. Doctor-patient relationships in global society. Informed consent in dentistry.

    PubMed

    Katrova, L G; Freed, J R; Coulter, I D

    2001-01-01

    The concept for initiation of treatment only after the explicit consent of the patient, based on preliminary information, is the most important element determining the relationship between patient and doctor nowadays. The application of this concept in dentistry and its inclusion in the professional documents regulating these relationships needs more comprehensive and modern conditions-relevant analysis of ethical, legal and professional aspects of the problem. The purpose of the study was to define the modern view of informed consent and its application in dentistry in different social environment. The general and specific features of the evolution of the problem and the social practice in Bulgaria, The European Community and Northern America are discussed in the context of the global tendency for free movement of patients and mutual recognition of professional qualification. The results suggest that despite the different degree of social and economical development in different countries the interest in the problem grows significantly and harmonization of legislation for health protection is based on the new social decree in the construction of doctor-patient relationships. It is expected that the comparative studies in this field will promote the improvement of dentists' training and improvement of scientific and expert exchange in solving problems of patents' rights and professional ethics. PMID:15354497

  19. Informed consent in human subject research: a comparison of current international and Nigerian guidelines.

    PubMed

    Fadare, Joseph O; Porteri, Corinna

    2010-03-01

    Informed consent is a basic requirement for the conduct of ethical research involving human subjects. Currently, the Helsinki Declaration of the World Medical Association and the International Ethical Guidelines for Biomedical Research of the Council for International Organizations of Medical Sciences (CIOMS) are widely accepted as international codes regulating human subject research and the informed consent sections of these documents are quite important. Debates on the applicability of these guidelines in different socio-cultural settings are ongoing and many workers have advocated the need for national or regional guidelines. Nigeria, a developing country, has recently adopted its national guideline regulating human subject research: the National Health Research Ethics Committee (NHREC) code. A content analysis of the three guidelines was done to see if the Nigerian guidelines confer any additional protection for research subjects. The concept of a Community Advisory Committee in the Nigerian guideline is a novel one that emphasizes research as a community burden and should promote a form of "research friendship" to foster the welfare of research participants. There is also the need for a regular update of the NHREC code so as to address some issues that were not considered in its current version. PMID:20235864

  20. [Terms of informed consent for users of dental clinics in Brazil: legal and ethical issues].

    PubMed

    Sales-Peres, Sílvia Helena de Carvalho; Sales-Peres, Arsênio; Eleutério, Adriana Silveira de Lima; de Oliveira, José Luiz Góes; Gigliotti, Mariana Pracucio

    2011-01-01

    The consent of patient before the beginning of any procedure has to be a respected condition, without any exception. It is necessary the patients to be aware of their health status, their specific needs, the intention of each treatment, the alternatives plans (including no treatment), to know their prognostic, risks, consequences, limitations, and to be aware of their responsibilities and those of your dentist, resulting in the success of the treatment. The Informed Consent (TCLE) aims to fortify and to clarify the position of the patient, being established the rights and duties of both parts - patient and professional. The integral knowledge of the treatment will minimize the anxiety of the patient and treatment complications, and promote greater quality of dental services and improve the satisfaction of both dentist and patient. However, there are few articles in Brazil about this, but there are some ethics problems involving dental clinics regarding this document of information for the patient. Therefore, the aim of this work is to carry through a critical revision on the subject demonstrating the importance of the TCLE in the Brazilian dental clinics. PMID:21503427

  1. Medical Comics as Tools to Aid in Obtaining Informed Consent for Stroke Care

    PubMed Central

    Furuno, Yuichi; Sasajima, Hiroyasu

    2015-01-01

    Abstract Informed consent has now become common in medical practice. However, a gap still exists between doctors and patients in the understanding of clinical conditions. We designed medical comics about “subarachnoid hemorrhage” and “intracerebral hemorrhage” to help doctors obtain informed consent intuitively, quickly, and comprehensively. Between September 2010 and September 2012, we carried out a questionnaire survey about medical comics with the families of patients who had suffered an intracerebral or subarachnoid hemorrhage. The questionnaire consisted of 6 questions inquiring about their mental condition, reading time, usefulness of the comics in understanding brain function and anatomy, pathogenesis, doctor's explanation, and applicability of these comics. The results showed that 93.8% responders would prefer or strongly prefer the use of comics in other medical situations. When considering the level of understanding of brain function and anatomy, pathology of disease, and doctor's explanation, 81.3%, 75.0%, and 68.8% of responders, respectively, rated these comics as very useful or useful. We think that the visual and narrative illustrations in medical comics would be more helpful for patients than a lengthy explanation by a doctor. Most of the responders hoped that medical comics would be applied to other medical cases. Thus, medical comics could work as a new communication tool between doctors and patients. PMID:26131830

  2. Medical Comics as Tools to Aid in Obtaining Informed Consent for Stroke Care.

    PubMed

    Furuno, Yuichi; Sasajima, Hiroyasu

    2015-07-01

    Informed consent has now become common in medical practice. However, a gap still exists between doctors and patients in the understanding of clinical conditions. We designed medical comics about "subarachnoid hemorrhage" and "intracerebral hemorrhage" to help doctors obtain informed consent intuitively, quickly, and comprehensively.Between September 2010 and September 2012, we carried out a questionnaire survey about medical comics with the families of patients who had suffered an intracerebral or subarachnoid hemorrhage. The questionnaire consisted of 6 questions inquiring about their mental condition, reading time, usefulness of the comics in understanding brain function and anatomy, pathogenesis, doctor's explanation, and applicability of these comics.The results showed that 93.8% responders would prefer or strongly prefer the use of comics in other medical situations. When considering the level of understanding of brain function and anatomy, pathology of disease, and doctor's explanation, 81.3%, 75.0%, and 68.8% of responders, respectively, rated these comics as very useful or useful.We think that the visual and narrative illustrations in medical comics would be more helpful for patients than a lengthy explanation by a doctor. Most of the responders hoped that medical comics would be applied to other medical cases. Thus, medical comics could work as a new communication tool between doctors and patients. PMID:26131830

  3. To Tell the Truth, the Whole Truth, May Do Patients Harm: The Problem of the Nocebo Effect for Informed Consent

    PubMed Central

    Wells, Rebecca Erwin

    2012-01-01

    The principle of informed consent obligates physicians to explain possible side effects when prescribing medications. This disclosure may itself induce adverse effects through expectancy mechanisms known as nocebo effects, contradicting the principle of nonmaleficence. Rigorous research suggests that providing patients with a detailed enumeration of every possible adverse event can actually increase side effects. Describing one version of what might happen (clinical “facts”) may actually create outcomes that are different from what would have happened without this information (another version of “facts”). This essay argues that the perceived tension between balancing informed consent with nonmaleficence might be resolved by recognizing that adverse effects have no clear black or white “truth.” This essay suggests a pragmatic approach for providers to minimize nocebo responses while still maintaining patient autonomy through “contextualized informed consent,” which takes into account possible side effects, the patient being treated, and the particular diagnosis involved. PMID:22416745

  4. Information Services of Maritime Industry

    NASA Astrophysics Data System (ADS)

    Palazov, Atanas; Stefanov, Asen

    2015-04-01

    The ultimate goal of modern oceanography is an end user oriented product. Beneficiaries are the governmental services, coast-based enterprises and research institutions that make use of the products generated by operational oceanography. Direct potential users and customers are coastal managers, shipping, offshore industry, ports and harbours, fishing, tourism and recreation industry, and scientific community. Indirect beneficiaries, through climate forecasting based on ocean observations, are food, energy, water and medical suppliers. Five general classes of users for data and information are specified: (1) operational users that analyze the collected data and produce different forecasts serving to impose regulation measures; (2) authorities and managers of large-scale projects needing timely oceanographic information, including statistics and climatic trends; (3) industrial enterprises, safety of structures and avoiding of pollution; (4) tourism and recreation related users aiming protection of human health; (5) scientists, engineers, and economists carrying out special researches, strategic design studies, and other investigations to advance the application of marine data. The analysis of information received during the extensive inquiry among all potential end users reveals variety of data and information needs encompassing physical, chemical, biological and hydrometeorological observation. Nevertheless, the common requirement concerns development of observing and forecasting systems providing accurate real-time or near-real time data and information supporting decision making and environmental management. Availability of updated information on the actual state as well as forecast for the future changes of marine environment are essential for the success and safety of maritime operations in the offshore industry. For this purpose different systems have been developed to collect data and to produce forecasts on the state of the marine environment and to provide

  5. Negotiating decisions during informed consent for pediatric Phase I oncology trials.

    PubMed

    Marshall, Patricia A; Magtanong, Ruth V; Leek, Angela C; Hizlan, Sabahat; Yamokoski, Amy D; Kodish, Eric D

    2012-04-01

    During informed consent conferences (ICCs) for Phase I trials, oncologists must present complex information while addressing concerns. Research on communication that evolves during ICCs remains largely unexplored. We examined communication during ICCs for pediatric Phase I cancer trials using a stratified random sample from six pediatric cancer centers. A grounded theory approach identified key communication steps and factors influencing the negotiation of decisions for trial participation. Analysis suggests that during ICCs, families, patients, and clinicians exercise choice and control by negotiating micro-decisions in two broad domains: drug logic and logistics, and administration/scheduling. Micro-decisions unfold in a four-step communication process: (1) introduction of an issue; (2) response; (3) negotiation of the issue; and (4) resolution and decision. Negotiation over smaller micro-decisions is prominent in ICCs and merits further study. PMID:22565583

  6. Information, consent and treatment of patients with Morgellons disease: an ethical perspective.

    PubMed

    Söderfeldt, Ylva; Groß, Dominik

    2014-04-01

    Morgellons is a medically contested diagnosis with foremost dermatological symptoms. Patients experience fibers emerging from the skin, together with a range of other somatic, psychiatric, and neurological complaints. Within the medical community, it is generally held to be a variation of delusional parasitosis/delusional infestation, which is usually treated with antipsychotics. Little attention has been paid in the literature to the ethical aspects of treating patients with Morgellons disease. The communicative strategies suggested in the literature display significant ethical issues, primarily the use of therapeutic privilege, i.e. withholding information from the patient. Since this limits patient autonomy, that approach is ethically problematic. Instead, the physician has an ethical obligation to respect the patient's autonomy, provide full information, and seek consent before initiating a psychiatric referral. PMID:24671866

  7. Ethical aspects of informed consent for the collection, preservation and use of cells and tissues in biological banks for research purposes.

    PubMed

    Petrini, Carlo

    2012-01-01

    This article explores the current and proposed requirements for informed consent for research with biological samples. The establishment of biobanks and the capabilities of collecting, storing, and using cells and tissues for research purposes have noticeably grown. With new abilities come new challenges to ethical questions of consent, specifically concerning genetic information, and unanticipated usage. This paper summarizes these issues in the context of levels of informed consent, subject risk, individual vs. societal benefits, anonymity, legal consensus. PMID:23115828

  8. Quality of an Informed Consent Prior to a Surgical Intervention? Experience of a Teaching Hospital

    PubMed Central

    Kurt, Engin; Ucar, Muharren; Atac, Adnan

    2016-01-01

    Objective: To determine how far the information given by the physicians for the informed consent prior to the surgical intervention is comprehended by the patients. Methods: The study was carried out between July 1st, 2012 and July 1st, 2013 at Gulhane Medical Faculty. A total of 400 patients, who were in the third postoperative day after various surgical procedures (orthopedics, urology, ophthalmology, plastic surgery and breast surgery), were included in the study. Results: Of all the patients, 73.5% stated that the operative information was provided by physicians, whereas 22.7% claimed that no information was given in this regard. The patients who knew the name of the disease was 78%, while 18.3% did not know. Of all the patients, 25.7% knew the name of the operation, in contrast to of 52.3% who did not know it. About 12.5% of patients stated that they were not informed about the likely complications during the surgery, whereas 13.7% of patients reported that they were not informed about the post-operative complications. Conclusion: The verbal information and the written texts, different approaches such as drawings and visual materials (i.e. video’s and photographs) should be considered while providing information to the patients. While doing so the level of education of the community should also be taken into account. PMID:27022376

  9. [Current legal framework conditions for running and utilization of biobanks. Part 2: data protection and informed consent].

    PubMed

    Haier, J

    2013-10-01

    Informed consent of donors of biomaterials represents an essential pillar of legal conformity of business organizations even for biobanks. For the assessment of self-determination of donors and freedom of research for users of biobanks there is a general consensus on the necessity for a social and individual agreement for the participation of donors in research projects. However, demands are often made for which the legal implementation is at least contentious and can be considered as excessive and biased. In part 2 of this review series the current legal foundation of data protection and informed consent is summarized on the basis of normative and ethical principles. With respect to appropriation of data and biosamples it can be deduced that by conformation to corresponding framework conditions the informed consent of donors in particular can be constructed independent of the project. PMID:24005718

  10. Women's Voices in Maternity Care: The Triad of Shared Decision Making, Informed Consent, and Evidence-Based Practices.

    PubMed

    Moore, Jennifer E

    2016-01-01

    The United States is the only industrialized nation that has experienced dramatic increases in the use of maternity interventions resulting in poor birth outcomes. It is speculated that the increased rates of maternal mortality and other outcomes are attributed to the current maternity model of care focused on the overuse of interventions, such as induction of labor, in otherwise healthy pregnant women. The overuse of induction of labor to artificially speed up the birth process has been linked to an increase in preterm and cesarean births. The cost of these interventions and poor outcomes has been substantial. The purpose of this article is to present concepts that demonstrate the challenges and value of informed, shared decision making, informed consent, and women's use of evidence within the context of maternity care. To highlight these important concepts, this article presents original findings from a secondary analysis of data on induction of labor. Findings from this analysis further highlight the importance of including women as part of informed, shared decision making in models of maternity care. PMID:27465453

  11. 75 FR 62913 - 30-Day Notice of Proposed Information Collection: Form DS-3053, Statement of Consent or Special...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-13

    ... age of 16. The primary purpose of soliciting the information is to ensure that both parents and/or all... Notice of Proposed Information Collection: Form DS-3053, Statement of Consent or Special Circumstances: Issuance of a Passport to a Minor Under Age 16, OMB Control Number 1405-0129 ACTION: Notice of request...

  12. 75 FR 35120 - 60-Day Notice of Proposed Information Collection: Form DS-3053, Statement of Consent or Special...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-21

    ... Notice of Proposed Information Collection: Form DS-3053, Statement of Consent or Special Circumstances: Issuance of a Passport to a Minor Under Age 16, OMB Control Number 1405-0129 ACTION: Notice of request for...) approval for the information collection described below. The purpose of this notice is to allow 60 days...

  13. 77 FR 74044 - 60-Day Notice of Proposed Information Collection: Statement of Consent: Issuance of a U.S...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-12

    ... Notice of Proposed Information Collection: Statement of Consent: Issuance of a U.S. Passport to a Minor Under Age 16 ACTION: Notice of request for public comment. SUMMARY: The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below....

  14. Ethical challenges in the care of persons with hepatitis C infection: a pilot study to enhance informed consent with veterans.

    PubMed

    Geppert, Cynthia M A; Dettmer, Elizabeth; Jakiche, Antonie

    2005-01-01

    Psychiatric and addictive disorders are often considered contraindications to hepatitis C virus (HCV) treatment. In this pilot study, the ability of 30 veterans to provide informed consent for combined antiviral HCV therapy was examined with a mental health assessment protocol specifically geared to evaluate capacity in this area. The results showed that subjects lacked essential knowledge regarding the course of the disease and the nature of antiviral treatment despite receiving prior counseling. Informed consent assessments of candidates for HCV treatment may identify deficits that are responsive to intervention, thereby allowing patients with comorbid psychiatric and addictive disorders to receive effective HCV treatment. PMID:16145183

  15. Longitudinal Study of Informed Consent in Innovative Therapy Research: Experience and Provisional Recommendations from a Multicenter Trial of Intracerebral Grafting

    PubMed Central

    Cleret de Langavant, Laurent; Sudraud, Sophie; Verny, Christophe; Krystkowiak, Pierre; Simonin, Clémence; Damier, Philippe; Demonet, Jean-François; Supiot, Frédéric; Rialland, Amandine; Schmitz, David; Maison, Patrick; Youssov, Katia; Bachoud-Lévi, Anne-Catherine

    2015-01-01

    Background There is an urgent need to assess and improve the consent process in clinical trials of innovative therapies for neurodegenerative disorders. Methods We performed a longitudinal study of the consent of Huntington’s disease patients during the Multicenter Fetal Cell Intracerebral Grafting Trial in Huntington’s Disease (MIG-HD) in France and Belgium. Patients and their proxies completed a consent questionnaire at inclusion, before signing the consent form and after one year of follow-up, before randomization and transplantation. The questionnaire explored understanding of the protocol, satisfaction with the information delivered, reasons for participating in the trial and expectations regarding the transplant. Forty-six Huntington’s disease patients and 27 proxies completed the questionnaire at inclusion, and 27 Huntington’s disease patients and 16 proxies one year later. Results The comprehension score was high and similar for Huntington’s disease patients and proxies at inclusion (72.6% vs 77.8%; P > 0.1) but only decreased in HD patients after one year. The information satisfaction score was high (73.5% vs 66.5%; P > 0.1) and correlated with understanding in both patients and proxies. The motivation and expectation profiles were similar in patients and proxies and remained unchanged after one year. Conclusions Cognitively impaired patients with Huntington’s disease were capable of consenting to participation in this trial. This consent procedure has presumably strengthened their understanding and should be proposed before signing the consent form in future gene or cell therapy trials for neurodegenerative disorders. Because of the potential cognitive decline, proxies should be designated as provisional surrogate decision-makers, even in competent patients. PMID:26010368

  16. A qualitative study using traditional community assemblies to investigate community perspectives on informed consent and research participation in western Kenya

    PubMed Central

    2012-01-01

    Background International collaborators face challenges in the design and implementation of ethical biomedical research. Evaluating community understanding of research and processes like informed consent may enable researchers to better protect research participants in a particular setting; however, there exist few studies examining community perspectives in health research, particularly in resource-limited settings, or strategies for engaging the community in research processes. Our goal was to inform ethical research practice in a biomedical research setting in western Kenya and similar resource-limited settings. Methods We sought to use mabaraza, traditional East African community assemblies, in a qualitative study to understand community perspectives on biomedical research and informed consent within a collaborative, multinational research network in western Kenya. Analyses included manual, progressive coding of transcripts from mabaraza to identify emerging central concepts. Results Our findings from two mabaraza with 108 community members revealed that, while participants understood some principles of biomedical research, they emphasized perceived benefits from participation in research over potential risks. Many community members equated health research with HIV testing or care, which may be explained in part by the setting of this particular study. In addition to valuing informed consent as understanding and accepting a role in research activities, participants endorsed an increased role for the community in making decisions about research participation, especially in the case of children, through a process of community consent. Conclusions Our study suggests that international biomedical research must account for community understanding of research and informed consent, particularly when involving children. Moreover, traditional community forums, such as mabaraza in East Africa, can be used effectively to gather these data and may serve as a forum to

  17. Community engagement and informed consent in the International HapMap project.

    PubMed

    Rotimi, Charles; Leppert, Mark; Matsuda, Ichiro; Zeng, Changqing; Zhang, Houcan; Adebamowo, Clement; Ajayi, Ike; Aniagwu, Toyin; Dixon, Missy; Fukushima, Yoshimitsu; Macer, Darryl; Marshall, Patricia; Nkwodimmah, Chibuzor; Peiffer, Andy; Royal, Charmaine; Suda, Eiko; Zhao, Hui; Wang, Vivian Ota; McEwen, Jean

    2007-01-01

    The International HapMap Consortium has developed the HapMap, a resource that describes the common patterns of human genetic variation (haplotypes). Processes of community/public consultation and individual informed consent were implemented in each locality where samples were collected to understand and attempt to address both individual and group concerns. Perceptions about the research varied, but we detected no critical opposition to the research. Incorporating community input and responding to concerns raised was challenging. However, the experience suggests that approaching genetic variation research in a spirit of openness can help investigators better appreciate the views of the communities whose samples they seek to study and help communities become more engaged in the science. PMID:17575464

  18. Confidentiality, informed consent and children's participation in the Saudi biobank governance: a comparative study.

    PubMed

    Alahmad, G H; Dierickx, K

    2014-11-01

    The growth of research biobanks has created many new ethical challenges worldwide. This article outlines and discusses key issues in the governance of Saudi Biobank, a newly established national biobank in Saudi Arabia launched in 2014. The Saudi Biobank project includes human biological samples from participants aged 10-70 years and aims to conduct an extensive study on the influence of genes, environment and lifestyle in common diseases. We examined the strengths and weaknesses of Saudi Biobank's governance as well as the similarities and differences with 4 other biobanks (in the United Kingdom, Iceland, Estonia and Canada). Three different ethical issues are discussed in detail: confidentiality, informed consent and children's participation in research. We evaluated these issues in relation to international ethical guidelines and Islamic law. The insights gained may be useful in developing national biobanking regulations in other Islamic countries, particularly in countries of the Eastern Mediterranean Region. PMID:25601806

  19. Achieving Informed Consent for Cellular Therapies: A Preclinical Translational Research Perspective on Regulations versus a Dose of Reality.

    PubMed

    Anderson, Aileen J; Cummings, Brian J

    2016-09-01

    A central principle of bioethics is "subject autonomy," the acknowledgement of the primacy of the informed consent of the subject of research. Autonomy requires informed consent - the assurance that the research participant is informed about the possible risks and benefits of the research. In fact, informed consent is difficult when a single drug is being tested, although subjects have a baseline understanding of the testing of a pharmacological agent and the understanding that they can stop taking the drug if there were an adverse event. However, informed consent is even less easily achieved in the modern arena of complex new molecular and cellular therapies. In this article, we argue that as science confronts new issues such as transplantation of stem cell products, which may live within the participant for the rest of their lives, researchers must carefully consider and constantly re-examine how they properly inform subjects considering participation trials of these novel therapeutic strategies.For example, the manufacture of a vial of a cell product that consists of a collection of growing cells is very different than the production of a vial of identical pills, which can be presumed to be identical. The scientific concepts on which these cellular approaches are based may seem alien and incomprehensible to a research subject, who thinks of a clinical trial as simply the selection and testing of the most efficacious pharmaceutical agent already proven to work in preclinical animal studies. The research subject would be wrong. PMID:27587445

  20. Taking social relationships seriously: Lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast

    PubMed Central

    Gikonyo, Caroline; Bejon, Philip; Marsh, Vicki; Molyneux, Sassy

    2008-01-01

    Individual informed consent is a key ethical obligation for clinical studies, but empirical studies show that key requirements are often not met. Common recommendations to strengthen consent in low income settings include seeking permission from community members through existing structures before approaching individuals, considering informed consent as a process rather than a single event, and assessing participant understanding using questionnaires. In this paper, we report on a qualitative study exploring community understanding and perceptions of a malaria vaccine trial (MVT) conducted in a rural setting on the Kenyan Coast. The MVT incorporated all of the above recommendations into its information-giving processes. The findings support the importance of community level information-giving and of giving information on several different occasions before seeking final individual consent. However, an emerging issue was that inter-personal interactions and relationships between researchers and community members, and within the community, play a critical role in participants' perceptions of a study, their decisions to consent or withdraw, and their advice to researchers on study practicalities and information to feedback at the end of the trial. These relationships are based on and continually tested by information-giving processes, and by context specific concerns and interests that can be difficult to predict and are well beyond the timescale and reach of single research activities. On the basis of these findings, we suggest that the current move towards increasingly ambitious and stringent formal standards for information-giving to individuals be counter-balanced with greater attention to the diverse social relationships that are essential to the successful application of these procedures. This may be assisted by emphasising respecting communities as well as persons, and by recognising that current guidelines and regulations may be an inadequate response to the

  1. Patient and public attitudes towards informed consent models and levels of awareness of Electronic Health Records in the UK

    PubMed Central

    Riordan, Fiona; Papoutsi, Chrysanthi; Reed, Julie E.; Marston, Cicely; Bell, Derek; Majeed, Azeem

    2015-01-01

    Background The development of Electronic Health Records (EHRs) forms an integral part of the information strategy for the National Health Service (NHS) in the UK, with the aim of facilitating health information exchange for patient care and secondary use, including research and healthcare planning. Implementing EHR systems requires an understanding of patient expectations for consent mechanisms and consideration of public awareness towards information sharing as might be made possible through integrated EHRs across primary and secondary health providers. Objectives To explore levels of public awareness about EHRs and to examine attitudes towards different consent models with respect to sharing identifiable and de-identified records for healthcare provision, research and planning. Methods A cross-sectional questionnaire survey was administered to adult patients and members of the public in primary and secondary care clinics in West London, UK in 2011. In total, 5331 individuals participated in the survey, and 3157 were included in the final analysis. Results The majority (91%) of respondents expected to be explicitly asked for consent for their identifiable records to be accessed for health provision, research or planning. Half the respondents (49%) did not expect to be asked for consent before their de-identified records were accessed. Compared with White British respondents, those from all other ethnic groups were more likely to anticipate their permission would be obtained before their de-identified records were used. Of the study population, 59% reported already being aware of EHRs before the survey. Older respondents and individuals with complex patterns of interaction with healthcare services were more likely to report prior awareness of EHRs. Individuals self-identifying as belonging to ethnic groups other than White British, and those with lower educational qualifications were less likely to report being aware of EHRs than White British respondents and

  2. Cognitive Investigation Study of Patients Admitted for Cosmetic Surgery: Information, Expectations, and Consent for Treatment

    PubMed Central

    Cogliandro, Annalisa; La Monaca, Giuseppe; Tambone, Vittoradolfo; Persichetti, Paolo

    2015-01-01

    Background In all branches of medicine, it is the surgeon's responsibility to provide the patient with accurate information before surgery. This is especially important in cosmetic surgery because the surgeon must focus on the aesthetic results desired by the patient. Methods An experimental protocol was developed based on an original questionnaire given to 72 patients. The nature of the responses, the patients' motivation and expectations, the degree of patient awareness regarding the planned operation, and the patients' perceptions of the purpose of the required consent for cosmetic surgery were all analyzed using Fisher's exact test. Results Candidates for abdominal wall surgery had significantly more preoperative psychological problems than their counterparts did (P=0.035). A significantly different percentage of patients under 40 years of age compared to those over 40 years of age searched for additional sources of information prior to the operation (P=0.046). Only 30% of patients with a lower educational background stated that the preoperative information had been adequate, whereas 92% of subjects with secondary schooling or a postsecondary degree felt that the information was sufficient (P=0.001). A statistically significant difference was also present between patients according to their educational background regarding expected improvements in their quality of life postoperatively (P=0.008). Conclusions This study suggests that patients require more attention in presurgical consultations and that clear communication should be prioritized to ensure that the surgeon understands the patient's expectations. PMID:25606489

  3. Procedures of recruiting, obtaining informed consent, and compensating research participants in Qatar: findings from a qualitative investigation

    PubMed Central

    2014-01-01

    Background Very few researchers have reported on procedures of recruiting, obtaining informed consent, and compensating participants in health research in the Arabian Gulf Region. Empirical research can inform the debate about whether to adjust these procedures for culturally diverse settings. Our objective was to delineate procedures related to recruiting, obtaining informed consent, and compensating health research participants in the extremely high-density multicultural setting of Qatar. Methods During a multistage mixed methods project, field observations and qualitative interviews were conducted in a general medicine clinic of a major medical center in Qatar. Participants were chosen based on gender, age, literacy, and preferred language, i.e., Arabic, English, Hindi and Urdu. Qualitative analysis identified themes about recruitment, informed consent, compensation, and other research procedures. Results A total of 153 individuals were approached and 84 enrolled; the latter showed a diverse age range (18 to 75 years); varied language representation: Arabic (n = 24), English (n = 20), Hindi (n = 20), and Urdu (n = 20); and balanced gender distribution: women (n = 43) and men (n = 41). Primary reasons for 30 declinations included concern about interview length and recording. The study achieved a 74% participation rate. Qualitative analytics revealed key themes about hesitation to participate, decisions about participation with family members as well as discussions with them as “incidental research participants”, the informed consent process, privacy and gender rules of the interview environment, reactions to member checking and compensation, and motivation for participating. Vulnerability emerged as a recurring issue throughout the process among a minority of participants. Conclusions This study from Qatar is the first to provide empirical data on recruitment, informed consent, compensation and other research procedures in a general

  4. Improving Validity of Informed Consent for Biomedical Research in Zambia Using a Laboratory Exposure Intervention

    PubMed Central

    Zulu, Joseph Mumba; Lisulo, Mpala Mwanza; Besa, Ellen; Kaonga, Patrick; Chisenga, Caroline C.; Chomba, Mumba; Simuyandi, Michelo; Banda, Rosemary; Kelly, Paul

    2014-01-01

    Background Complex biomedical research can lead to disquiet in communities with limited exposure to scientific discussions, leading to rumours or to high drop-out rates. We set out to test an intervention designed to address apprehensions commonly encountered in a community where literacy is uncommon, and where complex biomedical research has been conducted for over a decade. We aimed to determine if it could improve the validity of consent. Methods Data were collected using focus group discussions, key informant interviews and observations. We designed an intervention that exposed participants to a detailed demonstration of laboratory processes. Each group was interviewed twice in a day, before and after exposure to the intervention in order to assess changes in their views. Results Factors that motivated people to participate in invasive biomedical research included a desire to stay healthy because of the screening during the recruitment process, regular advice from doctors, free medical services, and trust in the researchers. Inhibiting factors were limited knowledge about samples taken from their bodies during endoscopic procedures, the impact of endoscopy on the function of internal organs, and concerns about the use of biomedical samples. The belief that blood can be used for Satanic practices also created insecurities about drawing of blood samples. Further inhibiting factors included a fear of being labelled as HIV positive if known to consult heath workers repeatedly, and gender inequality. Concerns about the use and storage of blood and tissue samples were overcome by a laboratory exposure intervention. Conclusion Selecting a group of members from target community and engaging them in a laboratory exposure intervention could be a useful tool for enhancing specific aspects of consent for biomedical research. Further work is needed to determine the extent to which improved understanding permeates beyond the immediate group participating in the intervention

  5. 20 CFR 401.105 - Disclosure of personal information without the consent of the subject of the record.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... the consent of the subject of the record. 401.105 Section 401.105 Employees' Benefits SOCIAL SECURITY...-wide systems of records, these records are subject to OPM's rules on access and disclosure at 5 CFR... include information about a much greater number of persons than our administrative records,...

  6. 20 CFR 401.105 - Disclosure of personal information without the consent of the subject of the record.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the consent of the subject of the record. 401.105 Section 401.105 Employees' Benefits SOCIAL SECURITY...-wide systems of records, these records are subject to OPM's rules on access and disclosure at 5 CFR... include information about a much greater number of persons than our administrative records,...

  7. 20 CFR 401.105 - Disclosure of personal information without the consent of the subject of the record.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the consent of the subject of the record. 401.105 Section 401.105 Employees' Benefits SOCIAL SECURITY...-wide systems of records, these records are subject to OPM's rules on access and disclosure at 5 CFR... include information about a much greater number of persons than our administrative records,...

  8. 20 CFR 401.105 - Disclosure of personal information without the consent of the subject of the record.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the consent of the subject of the record. 401.105 Section 401.105 Employees' Benefits SOCIAL SECURITY...-wide systems of records, these records are subject to OPM's rules on access and disclosure at 5 CFR... include information about a much greater number of persons than our administrative records,...

  9. 20 CFR 401.105 - Disclosure of personal information without the consent of the subject of the record.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... the consent of the subject of the record. 401.105 Section 401.105 Employees' Benefits SOCIAL SECURITY...-wide systems of records, these records are subject to OPM's rules on access and disclosure at 5 CFR... include information about a much greater number of persons than our administrative records,...

  10. 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…

  11. Informed consent, participation in, and withdrawal from a population based cohort study involving genetic analysis

    PubMed Central

    Matsui, K; Kita, Y; Ueshima, H

    2005-01-01

    Design: Descriptive analyses. Setting and participants: The study evaluated two non-genetic subcohorts comprising 3166 people attending for a health checkup during 2002, and two genetic subcohorts comprising 2195 people who underwent a checkup during 2003. Main outcome measurements: Analysis endpoints were differences in participation rates between the non-genetic and genetic subcohorts, differences between providing non-extensive and extensive preliminary information, and changes in participation status between baseline and at 6 months. Results: Participation rates in the genetic subcohorts were 4·7–9·3% lower than those in the non-genetic subcohorts. The odds ratios (OR) of participation in genetic research were between 0·60 and 0·77, and the OR for withdrawal from the research was over 7·70; providing preliminary extensive information about genetic research reduced the withdrawal risks (OR 0·15 for all dependent variables) but worsened participation rates (OR 0·63–0·74). Conclusions: The general population responded sceptically towards genetic research. It is crucial that genetic researchers utilise an informative and educational consent process worthy of public trust. PMID:15994356

  12. 7 CFR 1220.112 - Industry information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE SOYBEAN PROMOTION, RESEARCH, AND CONSUMER INFORMATION Soybean Promotion and Research Order Definitions § 1220.112 Industry information. The... markets, new marketing strategies, or increased efficiency for the soybean industry, and activities...

  13. 7 CFR 1220.112 - Industry information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE SOYBEAN PROMOTION, RESEARCH, AND CONSUMER INFORMATION Soybean Promotion and Research Order Definitions § 1220.112 Industry information. The... markets, new marketing strategies, or increased efficiency for the soybean industry, and activities...

  14. 7 CFR 1220.112 - Industry information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE SOYBEAN PROMOTION, RESEARCH, AND CONSUMER INFORMATION Soybean Promotion and Research Order Definitions § 1220.112 Industry information. The... markets, new marketing strategies, or increased efficiency for the soybean industry, and activities...

  15. Lethal autonomy: the malfunction of the informed consent mechanism within the context of prenatal diagnosis of genetic variants.

    PubMed

    Dunne, C; Warren, C

    1998-01-01

    In this article, Cara Dunne and Catherine Warren challenge the current role of genetic counselors in advising expectant mothers about potential genetic defects of their fetuses. They show that genetic counselors sometimes provide one-sided negative information to women undergoing prenatal diagnosis of genetic variants. This biased information promotes abortion of what are considered "defective" fetuses. The misleading information provided by the genetic counselors and the termination of the pregnancies is akin to the eugenics movement. The authors describe the early 20th century eugenics movement, explore the origin and development of the Human Genome Project, analyze the current role of genetic counseling, and explain the importance of the informed consent process to the exercise of autonomy. Dunne and Warren conclude by offering methods by which to restructure the informed consent mechanism to offer a more balanced assessment of the risks and benefits associated with genetic disability. PMID:9807244

  16. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

    PubMed Central

    2013-01-01

    Background Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. Purpose To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods. Methods The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique. Results Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for

  17. Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials

    PubMed Central

    McRae, Andrew D; Weijer, Charles; Bennett, Carol; Dixon, Stephanie; Taleban, Julia; Skea, Zoe; Eccles, Martin P; Brehaut, Jamie C; Donner, Allan; Saginur, Raphael; Boruch, Robert F; Grimshaw, Jeremy M

    2011-01-01

    Objectives To investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association’s Declaration of Helsinki and the International Committee of Medical Journal Editors’ uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has improved over time, and to identify characteristics of cluster randomised trials associated with reporting of ethics practices. Design Review of a random sample of published cluster randomised trials from an electronic search in Medline. Setting Cluster randomised trials in health research published in English language journals from 2000 to 2008. Study sample 300 cluster randomised trials published in 150 journals. Results 77 (26%, 95% confidence interval 21% to 31%) trials failed to report ethics review. The proportion reporting ethics review increased significantly over time (P<0.001). Trials with data collection interventions at the individual level were more likely to report ethics review than were trials that used routine data sources only (79% (n=151) v 55% (23); P=0.008). Trials that accounted for clustering in the design and analysis were more likely to report ethics review. The median impact factor of the journal of publication was higher for trials that reported ethics review (3.4 v 2.3; P<0.001). 93 (31%, 26% to 36%) trials failed to report consent. Reporting of consent increased significantly over time (P<0.001). Trials with interventions targeting participants at the individual level were more likely to report consent than were trials with interventions targeting the cluster level (87% (90) v 48% (41); P<0.001). Trials with data collection interventions at the individual level were more likely to report consent than were those that used routine data sources only (78% (146) v 29% (11); P<0.001). Conclusions Reporting of research ethics protections in cluster

  18. Individual genetic and genomic research results and the tradition of informed consent: exploring U.S. review board guidance

    PubMed Central

    Simon, Christian M.; Shinkunas, Laura; Brandt, Debra; Williams, Janet K.

    2015-01-01

    Background Genomic research is challenging the tradition of informed consent. Genomic researchers in the United States, Canada, and parts of Europe are encouraged to use informed consent to address the prospect of disclosing individual research results (IRRs) to study participants. In the U.S., no national policy exists to direct this use of informed consent, and it is unclear how local Institutional Review Boards (IRBs) may want researchers to respond. Objective and Methods To explore publicly accessible IRB websites for guidance in this area, using summative content analysis. Findings Three types of research results were addressed in 45 informed consent templates and instructions from 20 IRBs based at centers conducting genomic research: 1) IRRs in general 2) incidental findings (IFs), and 3) a broad and unspecified category of, “significant new findings” (SNFs). IRRs were more frequently referenced than IFs or SNFs. Most documents stated that access to IRRs would not be an option for research participants. These nondisclosure statements were found to coexist in some documents with statements that SNFs would be disclosed to participants if related to their willingness to participate in research. The median readability of template language on IRRs, IFs, and SNFs was greater than a 9th grade level. Conclusion IRB guidance may downplay the possibility of IFs, and contain conflicting messages on IRR nondisclosure and SNF disclosure. IRBs may need to clarify why separate IRR and SNF language should appear in the same consent document. The extent of these issues, nationally and internationally, needs to be determined. PMID:22361295

  19. Fair Shares and Sharing Fairly: A Survey of Public Views on Open Science, Informed Consent and Participatory Research in Biobanking

    PubMed Central

    Joly, Yann; Dalpé, Gratien; So, Derek; Birko, Stanislav

    2015-01-01

    Context Biobanks are important resources which enable large-scale genomic research with human samples and data, raising significant ethical concerns about how participants’ information is managed and shared. Three previous studies of the Canadian public’s opinion about these topics have been conducted. Building on those results, an online survey representing the first study of public perceptions about biobanking spanning all Canadian provinces was conducted. Specifically, this study examined qualitative views about biobank objectives, governance structure, control and ownership of samples and data, benefit sharing, consent practices and data sharing norms, as well as additional questions and ethical concerns expressed by the public. Results Over half the respondents preferred to give a one-time general consent for the future sharing of their samples among researchers. Most expressed willingness for their data to be shared with the international scientific community rather than used by one or more Canadian institutions. Whereas more respondents indicated a preference for one-time general consent than any other model of consent, they constituted less than half of the total responses, revealing a lack of consensus among survey respondents regarding this question. Respondents identified biobank objectives, governance structure and accountability as the most important information to provide participants. Respondents’ concerns about biobanking generally centred around the control and ownership of biological samples and data, especially with respect to potential misuse by insurers, the government and other third parties. Although almost half the respondents suggested that these should be managed by the researchers’ institutions, results indicate that the public is interested in being well-informed about these projects and suggest the importance of increased involvement from participants. In conclusion, the study discusses the viability of several proposed models

  20. Bioethics and power: Informed consent procedures in post-socialist Latvia.

    PubMed

    Putniņa, Aivita

    2013-12-01

    This paper explores two lines of development in the donor consent procedures in post-Soviet Latvia. The paper is based on secondary analysis of interview, focus group discussion data, and media and legal text material collected throughout three previously conducted research projects on organ transplantation, population genome project and xenotransplantation focusing on the historical development of the issues of donor consent across these three fields of medical technologies. The paper argues that the quality of consent depends not as much on political and legal change per se as on the strengthening of the position of both medical specialists and donors, facilitating bonds between the two. PMID:23608599