QRTI Newsline --- Wednesday September 8, 2010

The FDA IRB Registration Rule is effective Tuesday, July 14, 2009.

This registration will be accomplished through a modified version of the database used by the Office for Human Research Protections (OHRP). (Please note: the database for electronic submission of IRB registrations will not be available until July 14, 2009.)

A guidance document on the FDA IRB Registration Rule will be available shortly through a link from http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.

Electronic Submission System for FWAs (Federalwide Assurance) and IRB Registrations

To register:

http://ohrp.cit.nih.gov/efile/

To determine if an institution has an approved FWA, or if an institution or organization has a registered IRB, please check http://ohrp.cit.nih.gov/search/search.aspx.


To see the regulation:

Institutional Review Boards; Registration Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-682.htm

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