The Institutional Review Board

“IRB”

Historical Perspective

• Standards evolved from experiments done on human subjects without their permission.– Human atrocities during WW1 and especially

WW2– Nuremberg Trials

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

IRB Function

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

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 wordinga http://www.hunter.cuny.edu/irb/about_our_staff.htm

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

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

Changes on Procedures

• Should the methods or procedures change in a substantive way amendments to the original IRB application may be required.