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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 Discussion The results suggest research consent documents are using outdated terms to describe patient information, health care terminology systems need to consider the context of research for use cases, and that there is significant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. 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...

  14. 42 CFR 441.257 - Informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 4 2013-10-01 2013-10-01 false Informed consent. 441.257 Section 441.257 Public... 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, 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...

  16. 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

  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. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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

  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. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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…

  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. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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....

  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. 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...

  15. 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,...

  16. 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...

  17. 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

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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…

  3. 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...

  4. 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...

  5. 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...

  6. 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…

  7. 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...

  8. 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

  9. 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

  10. 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

  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. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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

  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: 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

  10. 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

  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. 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

  15. 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

  16. 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

  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. 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…

  2. [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

  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. 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...

  10. 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…