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, all research involving human subjects requires approval by the IRB prior to the start of the research project.

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

3. Not a single event or simply 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

4.  Exempt  Expedited  Full review