Conducting Human Subjects Research

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Presentation transcript:

Conducting Human Subjects Research Responsible Conduct of Research January 2017

Overview Definition and Authority Background / Ethical foundations What requires IRB review Tips

What is an IRB? IRB = Institutional Review Board A group registered with the federal government that is formally designated to review and monitor research involving human subjects.

IRB Authority Federal regulations FDA: 21 CFR 56 Federally-funded research: 45 CFR 46 (the Common Rule) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities. 21 CFR 56.109(a), 45 CFR 46.109(a)

Background Mostly reactive Nuremberg; Tuskegee syphilis study

Obedience to Authority Stanley Milgram

Tea Room Trade Study Laud Humphreys

Ethical and Regulatory Foundations

What requires IRB review? Designed, Systematic Investigation Contribute to GENERALIZABLE knowledge

What requires IRB review? Human Subject A living individual about whom an investigator obtains: (1) data through intervention or interaction with the individual OR (2) private, identifiable information

IRB Criteria for Approval Risks are reasonable relative to benefits Risks to subjects are minimized Privacy & confidentiality protected Adequate safety monitoring plan Written informed consent obtained Consent process provides all required info Subject selection is equitable Additional safeguards for protected & vulnerable populations

Not always easy…

Tip #1 Records and specimens can be “human subjects”, even if you are not obtaining them directly from the individuals.

Tip #2 Consent is not just a document…. It is a process.

Loss of Confidentiality Tip #3 “Risk” does not only mean physical risk Psychological Legal Loss of Confidentiality Reputation

Tip #4 Vulnerable Populations = additional requirements Prisoners Children Pregnant Women

Tip #5 Multiple IRB Involvement Each institution involved in the research must obtain IRB approval, from Its own IRB A commercial IRB The IRB of one of the other institutions

Tip #6 IRB review takes time – plan ahead

Tip #7 Contact Us Phone: (617) 496-2847 Email: cuhs@fas.harvard.edu 1414 Massachusetts Avenue, 2nd floor (Bank of America building)