285f69dd584298c941aca285ff7a83fa.ppt
- Количество слайдов: 16
Getting Your Research Through IRB (UCHS) Review Elaine Wethington, Chair Cornell University Committee on Human Subjects (Ithaca) http: //www. osp. cornell. edu/Compliance/UCHS/ho mepage. UCHS. htm
• 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
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
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)
• 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
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/ho mepage. UCHS. 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.
Avoiding Delays in Review • Consent forms should be written clearly and at an appropriate reading level – 8 th 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
• 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
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
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
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!
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)
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)
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
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
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
285f69dd584298c941aca285ff7a83fa.ppt