Ethical Challenge & Solution in Social Behavioral Research

1. Ethical Challenge & Solution in Social Behavioral Research Melody Lin December 2012

2. Objectives • Apply regulation & ethical principles • Develop review parameter • Roles & responsibilities • Do actions protect human subjects

3. 45 CFR 46 • Understand regulations’ flexibility and aplly to SBER research

4. Ethical principles • The 3 ethical principles are: • Respect • Beneficence • Justice • EP are the basis for the regulations

5. Primary Ethical Concerns (SBER) • Informed consent • Confidentiality • Privacy • Risk category • Psychological risk • Social risk • Economic risk • Subject selection

6. Areas of IRB Review Use regulations, ethical principles, institutional guidance and their expertise to review research for: • Respect • Recruitment • Informed consent • Confidentiality procedures • Beneficence • Subject compensation • Background literature • Investigator experience • Research design • Justice • Risks and benefits • Subject selection practices

7. Application of the Regulation • Do not provide direct guidance on each of these ethical concerns • Ethical issues are briefly mentioned: • Informed consent requirement (46.116) • Confidentiality • In relation to informed consent (46.116(a)(5) • Privacy • IRB approval criteria (46.111) • Risk • IRB approval crietria (46.111) • Meeting or exceeding “minimal risk” (46.102)(i)

8. Review Challenges • Regulations do not provide ethical guidance • IRBs are not experienced in application of the regulations to non-medical research • A one-size fits all approach may not work • Lack of guidance creates confusion and tension

9. Regulations Allow for Flexibility • Exempt status • Expedited review via subcommittee • Waiver of informed consent and documentation • General open-mindedness in consideration of various research design choices

10. Exempt Review Examples • Use of biological samples • Involvement of school children in educational research • Survey gathering non-sensitive data

11. Expedited Review: Examples • Effect of stride frequency on oxygen uptake while running uphill • Knowledge and attitudes on contraception and reproductive health in residents of a small Mexican town • A comparison of standard vs. hearing aid processing in cell phones for the hearing impaired

12. Full Committee: Examples • Interviews with law enforcement agents, armed group leaders, drug users, and drug dealers on the drug trade in several Asian Countries • Testing weight-reduction strategies for breast cancer survivors • Study of social rejection and depression using deception

13. So, We Understand • IB member responsibilities are highly complex • Social and behavioral sciences studies are highly complex • Each study must be reviewed case by case • Regulations allow for flexibility • IRB members and administrative staff should be well-trained and supported by the institution

14. What to Do? • Improve understanding and relevant application • Streamline process and compliance • Determine whether actions actually protect subjects • Where to focus?

15. Where Do We Begin? • PI creates a good protocol • Produces valid, worthwhile science • Responds ethically, not bureaucratically, to regulations • Demonstrates sensitivity to the context, culture and needs of subjects • Shows understanding of the consent process, risk & benefit privacy & confidentiality, and the consultative role fo the IRB

16. Demonstrate Ethical Practices • Conduct valid research (using accepted scientific methods) • Appropriate sampling (to get valid results) • Respect people and their communities • Protect research participants • Benefit individuals and society • Create a basis for socially beneficial polices • Disseminate findings effectively • Facilitate the application of finding

17. Stakeholders • Regulatory • Institutions • Research subjects

18. Shared Responsibilities • Stakeholders have complementary and competing goals: • Legal concerns • Academic freedom • Human rights

19. Supportive? Controlling? Inconsistent? Fearful? Restrictive? Helpful? Powerful? Arbitrary? Facilitative? One dimensional? Mysterious? Uninformed? Perception of the IRB See JERHRE, March 2006 for results of study perceptions of iRBs

20. Opportunities or Challenges? • Collaborate – us/them or team approach? • Communicate – challenge or Facilitate? • Cooperate – problem or solutions?

21. Collaboration, Communication and Cooperation • Increase collaboration • Minimize confrontation • Improve communications • Reduce barriers • Value added decisions • Shared visions and responsibility • Opportunities to partner in research endeavors

22. Tips for the IRB • Organizational perception • IRB composition/support • Educate, guide and consult • Streamline • Meet the investigators • Appropriate flexibilty

23. Identify Challenge • Protocol review/approval • Appropriate consent process/documentation • Appropriate risk assessment • Turn around time • Consent form details • Knowledge of research design • Use of exempt and expedited review • Providing education

24. The Review Process • Does one size fit all? • Consider methodology • Disciplines involved • Risk assessment/management • Infomred consent

25. Proactive Site Visits • Create an opportunity to see the research in action • Create an environment where on-site monitoring is accepted/valued • Enhance IRB awareness of practical issues from the investigator’s perspective • Promote communication between researchers and the IRB • Increase opportunities for training of ethical/responsible research practices

26. Tip for Investigators • Take RESPONSIBILITY become EMPOWERED • Knowledge is power – know the Federal regulations, institutional policy / guidance • Opportunities to learn • Protocol submission • Communicate • Ethical awareness • Use resources

27. Resources • Both NIH and NSF have developed guidance specific to SBER research http://obssr.od.nih.govhttp://www.nsf.gov/bfa/dias/policy/hsfaqs/jsp • National listserve • irbforum@irbforum.org