Memorandum to the National Cancer Institute Regarding IRB Review of Protocol and Informed Consent Changes (September 29, 2008)
OHRP has posted its September 29, 2008 memorandum to Dr. Jeffrey Abrams, Acting Associate Director, Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI) in the belief that others may find useful OHRP’s clarifications regarding several issues related to the implementation of changes to protocols and informed consent documents for NCI/CTEP-sponsored clinical trials.
On March 20, 2008, CTEP issued a memorandum to NCI/CTEP-sponsored cooperative groups explaining implementation of revised CTEP procedures for handling amendments to cooperative group protocols and enrollment of new subjects in these protocols in situations in which new or modified risk information is considered to represent no more than a minor alteration in the overall risk-benefit relationship for subjects. On April 7, 2008 CTEP issued its first Action Letter under the revised CTEP procedures to investigators conducting CTEP/NCI-sponsored clinical trials involving the use of lapatinib (IND 70252). In response to CTEP’s March 20 memorandum and April 7 Action Letter, both OHRP and CTEP received many inquiries from institutional review board administrators and NCI/CTEP-sponsored cooperative group investigators expressing confusion about several issues. OHRP’s September 28, 2008 memorandum provides clarification regarding these issues.
The links below provide a copy of OHRP’s September 29, 2008 memorandum to Dr. Abrams. OHRP welcomes comments on the content of this memorandum. Comments on this or other topics may be submitted to OHRP by email at ohrp@hhs.gov. Please include the phrase “September 29, 2008 memorandum to NCI” in the subject field. Alternatively, comments may be submitted to:
Office for Human Research Protections
1101 Wootton Parkway
The Tower Building, Suite 200
Rockville, MD 20852
Comments received, including any personal information provided, will be made available to the public upon request.
Letter [PDF - 66KB]
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