Exceptions to Written Informed Consent in Human Subject Research By:Khristy Bozylinski, MS Written Informed Consent What is the purpose of consent forms in human subject research? (45 CFR 46.116) Adequately inform participants/representatives about a study in language understandable to the participant/representative without using exculpatory language Minimize the possibility of coercion or undue influence Why does the IRB review consent forms? (45 CFR 46.116(a)(b) Ensure the 8 basic elements of informed consent are adequately contained in the consent document Foundation for Informed Consent Requirements Belmont Report The Ethical Principles and Guidelines for Research Involving Human Subjects Basic Ethical Principles Respect for Persons Beneficence Justice Applications Informed Consent Assessment of Risk and Benefits Selection of Subject Respect for Persons Participants should be treated as autonomous individuals Persons able to make own decisions Those with diminished autonomy (illness, mental disability) are provided additional protections Evaluation to sign consent Legal Authorized Representative sign consent Written Informed Consent Regulations Written informed consent is required by both FDA and DHHS regulations DHHS – 45 CFR 46.116 “General requirements for informed consent” FDA – 21 CFR 50.20 “General requirements for informed consent” The IRB has the authority to waive the written informed consent requirement Based on federal regulations Exceptions To Written Informed Consent DHHS Exceptions – (Minimal Risk Studies) Waiver or Alteration of Informed Consent Requirements 45 CFR 46.116(d) Waiver for Written Documentation 45 CFR 46.117(c) FDA Exceptions – (Greater than Minimal Risk) Exception from General Requirements (Emergency Use) 21 CFR 50.23 Exception from Informed Consent Requirements for Emergency Research 21 CFR 50.24 DHHS Exception Regulations Minimal Risk Studies 45 CFR 46.116(d) 45 CFR 46.117(c) Waiver/Alteration of Waiver for Written Informed Consent Documentation Waiver/Alteration of Informed Consent Requirements 45 CFR 46.116(d) (d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that: (1) the research involves no more than minimal risk to the subjects; (2) the waiver or alteration will not adversely affect the rights and welfare of the subjects; (3) the research could not practicably be carried out without the waiver or alteration; and (4) whenever appropriate, the subjects will be provided with additional pertinent information after participation. Application of 45 CFR 46.116(d) Most common application of the regulation: Retrospective Chart Reviews Assessing treatment outcomes Examining chemistry values Waiver of the Requirement for Written Documentation 45 CFR 46.117(c) (c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research. Application of 45 CFR 46.117(c) Most common application of regulation: Questionnaires Evaluating the effectiveness of programs Interviews Evaluate the quality of services Example Which regulation best applies to the following proposed research study? Researcher wants to examine the outcomes of patients who received clinically indicated radiation treatment for breast cancer Collect limited data from medical records of all individuals who have undergone the radiation in past 5 years, about 7,000 performed Data will be coded Example Which regulation best applies to the following proposed research study? Researcher wants to evaluate the effectiveness of an exercise intervention program All individuals taking the exercise class will be asked to fill out a questionnaire asking how they feel about the program and if they believe it is helping them achieve their fitness goal Questionnaire will not have any identifying information Individuals do not have to complete the questionnaire to remain in the fitness program FDA Exceptions to Informed Consent Greater Than Minimal Risk 21 CFR 50.23 21 CFR 50.24 Emergency use, not Emergency medicine research research No data collection Data collection No existing protocol IRB approve protocol and consent form(s) 21 CFR 50.23 Exception from General Requirements (Emergency Use) Investigator and a physician who is not otherwise participating in the clinical investigation certify: Individual is in a life threatening situation that necessitates the use of the test article Informed consent can’t be obtained because of an inability to communicate with individual Time is not sufficient to obtain consent from the individual’s legal representative No alternative method approved to provide equal or greater likelihood of saving the life of the individual 21 CFR 50.24 Exception from Informed Consent Requirements for Emergency Research The IRB and a licensed physician who is a member of the IRB or consultant to the IRB find that: Individual is in a life threatening situation and available treatments are unproven or unsatisfactory Obtaining informed consent is not feasible as a result of their medical condition and intervention must be administered before consent from individual’s legal representative is feasible No reasonable way to identify prospectively individuals likely to become eligible Participation holds prospect of direct benefit because the individual is in a life threatening situation that necessitates intervention Consultation with community representatives Public disclosure to community where potential participants will be drawn Example Which regulation best applies to the following proposed research study? Researcher wants to examine the clinical impact of an investigational drug, requiring an IND, in the resuscitation of patients in the emergency room Drug must be administered within 30 minutes of presenting to the emergency room to be effective The risks of the drug are not completely known but no other standard of care treatment methods are of known benefit to patients presenting with this condition It is not possible to prospectively identify individuals who would be eligible Data will be collected IRB’s Responsibilities Always consider the principle of respect for persons Assess potential risks before granting waivers Ensure risks are minimized Regulations: Tools to assess ethical considerations Ensure the protection of research participants Amdur, R, Bankert, E. Institutional Review Board: Management and Function. Massachusetts: Jones and Bartlett Publishers, 2002. United States Department of Health & Human Services: Office for Human Research Protections (OHRP) Website: http://www.hhs.gov/ohrp/ United States Food & Drug Administration Website: http://www.fda.gov/
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