1.  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 (Title 45 Part 46), all research involving human subjects requires approval by the IRB prior to the start of the research project.  http://www.hhs.gov/ohrp/humansubjects/gui dance/45cfr46.html

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

5. 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

7.  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

8.  Plan your strategy  Date of submission  Line up your materials (surveys, interview protocols, consent forms)  Ask before submitting