IRB The purpose of IRB is to ensure the rights of research subjects are protected In accordance with the ethical standards of the U.S. Department of Health.

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Presentation transcript:

IRB The purpose of IRB is to ensure the rights of research subjects are protected In accordance with the ethical standards of the U.S. Department of Health and Human Services, all research involving human subjects requires approval by the IRB prior to the start of the research project.

Process Varies from institutions to institution online training program (CITI, NIH) IRB application Consent surveys, questionnaires, ads/flyers to solicit subjects, interview protocols, grant proposal

Informed Consent Not a single event or simply a form to be signed Elements of the consent process: Explanation of the project What subjects will do Voluntary choice to participate and withdraw Potential Benefits, Discomfort and Risks Confidentiality Attestation to age Contact information Costs/Reimbursements Termination of Participation and/or withdrawal by subject Online surveys: waiver of a signature for informed consent

Consent Story

Review Types Exempt: minimal risk with nonvunerable populations Expedited: minimal risk with vunerable populations (minors, prisoners, pregnant women, fetuses, cognitively impaired persons) Also includes the use of video or audio taping Full review

So when you arrive home… Plan your strategy Date of submission Line up your materials (surveys, interview protocols, consent forms) Ask before submitting

Questions, Comments, Concerns?