HRC 201 Workshop Informed Consent

1. HRC 201 WorkshopInformed Consent Human Subject Protections in Research Tammy Felton-Noyle, Erin Coons, Brenda Schick February 22, 2006 Adapted from FHI Research Ethics Training Curriculum

2. Agenda • Introductions • What is Informed Consent? • Assent/Permission • Waivers • Most Common Problems • Case Studies • Breakout Sessions Adapted from FHI Research Ethics Training Curriculum

3. What is Informed Consent? Informed consent is…”consent given by a competent individual who • Has received the necessary information • Has adequately understood the information • After considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation.” Adapted from FHI Research Ethics Training Curriculum

4. Informed Consent as a Process Informed consent is a communication process: • Between the research and the participant • Starts before the research is initiated • Continues throughout the duration of the study Adapted from FHI Research Ethics Training Curriculum

5. Essential Elements of Informed Consent • Research description • Risks • Benefits • Alternatives • Confidentiality • Compensation • Contacts • Voluntary participation Adapted from FHI Research Ethics Training Curriculum

6. Description of the Research • Research study • Objectives of the study • Expected responsibilities • Procedures involved • Study duration • Explanation of randomization or placebo Adapted from FHI Research Ethics Training Curriculum

7. Description of Risks • Anticipated or foreseeable • Physical, social, psychological • Culturally appropriate Adapted from FHI Research Ethics Training Curriculum

8. Description of Benefits • Reasonably expected • No exaggeration • Benefits available once research is ended Adapted from FHI Research Ethics Training Curriculum

9. Available Alternatives • Alternative procedures or treatment • Advantages and disadvantages • Availability Adapted from FHI Research Ethics Training Curriculum

10. Confidentiality • Degree of confidentiality • Indicate persons or organizations who may have access to the information • Special cultural circumstances Adapted from FHI Research Ethics Training Curriculum

11. Compensation • Available compensation in case of injury • Treatment available and cost • Fair payment for time, travel, or inconvenience • Not coercive Adapted from FHI Research Ethics Training Curriculum

12. Participant Contacts • Contact for research-related questions • Contact for concerns about rights as a participant • Realistic and viable Adapted from FHI Research Ethics Training Curriculum

13. Voluntary Participation • Absolutely voluntary • Right to discontinue at any time • No penalty for refusal Adapted from FHI Research Ethics Training Curriculum

14. Documentation of Informed Consent • Part of the informed consent process • May not always be necessary • HRC review and approval Adapted from FHI Research Ethics Training Curriculum

15. Assent • Assent is an “agreement by an individual not competent to give legally valid informed consent to participate in research (e.g., a child). • Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted; • Assent means the affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent Adapted from FHI Research Ethics Training Curriculum

16. Parental Permission • Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research; • Parent means a child’s biological or adoptive parent; and • Guardian means an individual, who is authorized under applicable state or local law, to consent on behalf of a child to general medical care. Adapted from FHI Research Ethics Training Curriculum

17. Requirements of Researchers to Obtain Assent and Parental Permission • If no greater than minimal risk • Assent of child and permission of at least on parent • If greater than minimal risk with prospect of direct benefit • Assent of child and permission of at least one parent • Anticipated benefit justifies the risk • Anticipated benefit is at least as favorable as that of alternative approaches Adapted from FHI Research Ethics Training Curriculum

18. Requirements cont. • If greater than minimal risk with no prospect of direct benefit • Assent of child and permission of both parents • Minor increase over minimal risk • Likely to yield generalizable knowledge about the child’s disorder or condition • The intervention or procedure presents experiences to the child that are reasonably commensurate with those in the child’s actual or expected situations Adapted from FHI Research Ethics Training Curriculum

19. Requirements cont. • Any other research • Assent of child and permission of both parents • HRC finds the research to present a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children • HHS Secretary approves, after consultation with a panel of experts in pertinent disciplines and following publication in the Federal Register and public comment Adapted from FHI Research Ethics Training Curriculum

20. UCB Policies for Assent and Parental Permission • Assent is required for those aged 7-17. • Verbal assent is allowable for younger children. • Parental permission is required for all circumstances above. Adapted from FHI Research Ethics Training Curriculum

21. Flexibility in the Regulations • Waiver of signed consent * • Oral consent • Waiver of informed consent * • Use of a short form *not acceptable by the FDA unless emergency use of drug or device Adapted from FHI Research Ethics Training Curriculum

22. Waiver of Signed Consent • “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 • That the research presents no more than minimal risk of harm to the subjects and involves no procedures for which written consent is normally required outside of the research context.” 45 CFR 46 117(c) Adapted from FHI Research Ethics Training Curriculum

23. Waiver of Informed Consent or Alteration • Minimal risk • Rights and welfare of participants protected • Research not possible without a waiver • Appropriate information provided Adapted from FHI Research Ethics Training Curriculum

24. Short form • A “written consent document stating that the elements of informed consent required by 46.116 have been presented orally to the subject or the subject’s legally authorized representative. • Witness required to the oral presentation and sign the short form and copy of summary • HRC must approve the written summary and short form • Person obtaining consent must sign summary • Copy of short form and summary will be given to subject Adapted from FHI Research Ethics Training Curriculum

25. Summary—Informed Consent • Moral, not just legal requirement • Comprehensibility essential • Cultural influences • Support information helpful • Possibility for pre-testing • Free of coercion Adapted from FHI Research Ethics Training Curriculum

26. Common Problems of Informed ConsentInvestigator • Not using templates • Lack of editing • Description of purpose is lacking • Description of risks is not clear • Comprehensibility Adapted from FHI Research Ethics Training Curriculum

27. Common Problems of Informed ConsentHRC • Readability statistics flawed • ICD represents the process • Editing ICD • Boilerplate language lengthens ICD Adapted from FHI Research Ethics Training Curriculum

28. Case Study 1: Respect for Persons • What steps can the research staff take to ensure that the informed consent is freely given by all participants? • If a woman chooses not to participate in the study, what can be done to protect her from retaliation from her manager? • If you believe that the women will not be able to give voluntary informed consent, what alternatives could you suggest to the investigator or sponsor? Adapted from FHI Research Ethics Training Curriculum

29. Case Study 2: Informed Consent • Did Dr. ABC forget anything in this consent process? • What questions about risks and benefits might the HRC have about this project? Group Exercise: Draft a consent form together. Adapted from FHI Research Ethics Training Curriculum

30. Breakout • Anthropological study • Oral History • International Research Adapted from FHI Research Ethics Training Curriculum