1. The Institutional Review Board “IRB”

2. Historical Perspective Standards evolved from experiments done on human subjects without their permission. –Human atrocities during WW1 and especially WW2 –Nuremberg Trials

3. Institutional IRB Most major medical and rehabilitation centers conducting research will have their own IRB Smaller hospitals and other types of facilities may not have their own IRB –Example: NYC BOE and other school systems May rely on other insitutions –Two applications/approvals may be required

4. IRB Function Reviews research proposals of all individuals or group wishing to do research with human or animal subjects –Students –Faculty –Research Scientists –Clinicians

5. IRB Membership a Comprised of investigators, faculty and others Often a mixed of backgrounds –“ IRB members [at Hunter College] are from the following departments/schools: Educational Foundations and Counseling Programs, Nursing, Economics, Social Work, Urban Affairs and Planning, Sociology, Psychology, History, Political Science, Geography, Urban Public Health, Center for Puerto Rican Studies, Curriculum & Teaching and Center for Urban and Community Health. We also have several community members” –Application requires careful wording a http://www.hunter.cuny.edu/irb/about_our_staff.htm

6. Chief Concerns of the IRB Subject/Patient/Participant –Safety –Privacy –Confidentiality IRB’s will request information concerning method and related Literature but only in a cursory (outline) form

7. Application Process Complete an application –Include copy of proposal Title through Methods section Many institutions require investigators to take and pass a tutorial (often online) –Often based on NIH guidelines Important: No data are permitted to be collected or analyzed without IRB approval

8. Changes on Procedures Should the methods or procedures change in a substantive way amendments to the original IRB application may be required.