Transcript How to Get Your Proposal Through Human Subjects

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
mepageUCHS.htm
• One IRB (established in 1967)
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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
mepageUCHS.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 – 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
• 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