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Getting Your Research Through IRB (UCHS) Review. Elaine Wethington, Chair Cornell University Committee on Human Subjects (Ithaca) One IRB (established in 1967) 15-16 members Meets monthly Primary reviewer system

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Getting Your Research Through IRB (UCHS) Review

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getting your research through irb uchs review

Getting Your Research ThroughIRB (UCHS) Review

Elaine Wethington, Chair

Cornell University Committee on Human Subjects (Ithaca)

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
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
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
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
  • 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
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
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
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
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
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
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
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 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
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
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