 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.

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

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

Poor, Rural Black American Men In The South Thought They Were Receiving "Free Health Care" From The United States Government "The United States government did something that was wrong– deeply, profoundly, morally wrong. It was an outrage to our commitment to integrity and equality for all our citizens … clearly racist!" — President William Jefferson "Bill" Clinton's apology for the Tuskegee Syphilis Experiment to the eight remaining survivors, May 16th, Tuskegee Experiment Test Subjects

 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

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