IRB Guidebook for Investigators

IRB Guidebook for Investigators (HTML)
Updated November 11, 2008 (Also available as a PDF)

Exemption approval is valid for 1 year only and exempt status must be recertified each year, if the research is not complete, by submitting a "Continuing Review" IRB Exemption Review Application. If the research is complete, the investigator should submit a "Final Report" IRB Exemption Review Application.

Additional Guidance Related to IRB Review
The UAB IRB Guidebook is assembled from many sources of information. Some of those are listed below. All guidance information is to be used in accordance with the UAB IRB Guidebook, UAB policy, and other sources, as applicable.

UAB

Data Protection and Security Policy (March 19, 2007)
Consent Language for UAB Students and Employees (July 25, 2006)
Billing Compliance Language for Consent Forms (June 5, 2006)
Protocol Oversight Review Form (December 29, 2003)
Change to IRB's 800 telephone number (February 19, 2003)
Fees for Copies of Regulatory Documents (September 9, 2002)
Revised Instructions for Research involving Children and Adolescents (September 6, 2000)
UAB Policy and Cross Reference Manual (From UAB ISS)

HHS

Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection (May 12, 2004)

NIH

Policies and Guidance on Human Stem Cell Research (October 7, 2004)
Guidance on Informed Consent For Gene Transfer Research (March 22, 2004)

OHRP

Human Subject Regulations Decision Charts (September 24, 2004)
Guidance on Research Involving Coded Private Information or Biological Specimens (August 10, 2004)
Guidance on the Use of Expedited Review Procedures (September 24, 2003)
Guidance on the Involvement of Prisoners in Research (May 23, 2003)
2009 International Compilation of Human Subject Protections (November 2008)
All OHRP Guidance Documents

FDA

Guideline for Good Clinical Practice (ICH)
International Conference on Harmonisation (version: 10 June 1996)

Mail or deliver all IRB materials and correspondence to
Room 470, Administration Building (AB)
701 20th Street South, Birmingham, AL 35294-0104
Phone 205-934-3789 — Fax 205-934-1301

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