THIS DOCUMENT HAS BEEN ARCHIVED BECAUSE IT NO LONGER REPRESENTS CURRENT OHRP POLICY.
September 13, 1993
|Subject:||Local Institutional Review Board (IRB) Review of Multicenter Clinical Trials Sponsored by the Division of Aids (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID)|
This letter is being forwarded to investigators participating in multicenter clinical trials sponsored by the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). Its purpose is to clarify procedures for local Institutional Review Board (IRB) review of protocols that include DAIDS - approved sample informed consent documents:
|(1)||OPRR requires that each local IRB receive a copy of the DAIDS-approved sample informed consent document and the full DAIDS-approved protocol as a condition for review and approval of the local informed consent document. It is the investigator's responsibility to provide these documents to the local IRB.|
Any deletion or substantive modification
of information concerning risks or alternative procedures contained
in the sample informed consent document must be justified in
writing by the investigator and approved by the IRB. In addition,
DAIDS reminds investigators that informed consent documents should
fully reference all research- related procedures and their risks,
even those which might be considered relatively routine in non-research
|(3)||The justification for and approval of deletions or modifications of information concerning risks or alternative procedures must be reflected in the IRB minutes. Investigators must forward copies of such IRB-approved changes, with their justifications, as part of the materials required by DAIDS for site registration. DAIDS will notify OPRR when such changes raise questions regarding the adequacy of the informed consent process.|
Melody H. Lin, Ph.D.
Division of Human Subject Protections
Office for Protection from Research Risks
Joseph A. Meschino, Ph.D.
Chief, Pharmaceutical and Regulatory Affairs Branch
Division of AIDS, NIAID