Getting Your Research Through IRB (UCHS) Review

1. Getting Your Research ThroughIRB (UCHS) Review Elaine Wethington, Chair Cornell University Committee on Human Subjects (Ithaca) http://www.osp.cornell.edu/Compliance/UCHS/homepageUCHS.htm

2. One IRB (established in 1967) • 15-16 members • Meets monthly • Primary reviewer system • By faculty legislation, has purview over research conducted by administrative offices and student health service as well as by faculty and students • Includes physicians, psychologists, sociologists, participatory action researchers, ethnographers, the campus Environmental Safety officer, Cooperative Extension faculty member, Law School faculty member, and community members

3. Types of Review – Set by Federal Legislation • Exempt – UCHS is not required to provide continuing review – but requires application to UCHS • Expedited – one person reviews – takes on average a week to clear UCHS • Full review – requires full committee to meet in person and discuss the protocol • All materials must be received three weeks in advance of next UCHS meeting • Some protocols have required two-three meetings to clear UCHS

4. Informed Consent • Different disciplines have different perspectives on how to obtain informed consent • Cornell IRB (by faculty legislation) represents the different perspectives • Most review time is spent on issues related to informed consent • Best guide: The Belmont Report (on the UCHS web site)

5. What are the biggest issues in review? • Making sure the consent process and forms are open, informative and clear • Documenting informed consent for studies in developing nations • Assuring parental consent for studies involving children • Assuring proper debriefing for experimental studies that involve deception • Assessing decision capacity among older adults

6. Common Problems Investigators Can Easily Avoid • Use the UCHS web site for guidance –we have to tell people about things that are on the website • http://www.osp.cornell.edu/Compliance/UCHS/homepageUCHS.htm • Cornell follows federal standards on informed consent. • Documented on the web site • Make sure you send all of the forms in – parental consent form, child’s assent form, health care proxy, protocols, questionnaires, etc.

7. Avoiding Delays in Review • Consent forms should be written clearly and at an appropriate reading level – 8th grade • Consent forms with grammatical errors and typos signal an inexperienced or “careless” investigator • This point cannot be overemphasized • Make clear in the application who will be obtaining consent, and how • Remember: community members and members of other disciplines are reading your application

8. Answer all questions on the application form fully and completely • If you are applying for a waiver of written consent, you must have a scientific justification that committee members can find readily in your application • If you are applying for a waiver of fully informed consent (e.g. deception; waiver of parental consent) you must have a scientific justification

9. Assessing Risk in Relation to Benefits • Relatively few studies at Cornell are judged to pose more than minimal risk to subjects • Tough cases – where there is limited information in the literature that assesses potential for harm in relationship to benefits • General population/survey research asking sensitive questions • Deception research in psychology

10. Risk/Benefit Assessment • Social/behavioral research rarely results in direct benefits to individuals, yet risks can be serious • In most social/behavioral research studies we review, the only risk of harm is a breach of confidentiality • Our IRB gives a lot of feedback to investigators on both issues

11. How to Avoid Delays, Part 2 • Attach a copy of your research proposal, but answer all questions on the application form clearly and completely • Make sure that what you say on your application and in your proposal is completely consistent • Describe completely and clearly how YOU have evaluated the risk level of your study, and how you came to that conclusion. Cite the scientific literature!

12. Privacy/Confidentiality Issues • Different disciplines have different perspectives and practices on data security and confidentiality • E.g. experimental psychologists videotape for coding purposes then destroy tapes quickly • Linguists sometimes preserve tapes indefinitely for historical purposes (e.g. disappearing languages)

13. Typical Issues Considered • UCHS gives lots of feedback on: • Research conducted via email or on web sites • CU has developed secure technology – use it! • Proper training of research assistants • People collecting the data have to know the procedures • Data security issues for sensitive data or where absolute confidentiality is promised • Taping (we follow New York state law – very strict)

14. New Developments in Privacy/Confidentiality • New report from the National Academies recommends tightening review standards for privacy and confidentiality protection (when promised) in social and behavioral research • Health Insurance Portability and Accountability Act (as of April, 2003) is having unpredicted effects on social research • UCHS will have to add, not subtract time to reviews

15. What We Will Have to Add • More questions about how respondent names are secured on computers • More questions about how the data (if identifiable) are kept secure from unauthorized access • How you would plan to de-identify and distribute the data (if required to do so by federal policy) • More questions about “private health information” • More questions about how videotapes/audiotapes are secured

16. More Cautions • The context of social and behavioral research is changing • Follow The Belmont Report – this is the gold standard in the U.S. • Everyday people are much more concerned about their privacy than they used to be • Researchers and subjects use different definitions of what is “confidential” • Risks are perceived very differently as well