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OHRP's new transparency includes correspondence
Here's a sample of a recent letter
The Office for Human Research Protections (OHRP) of Rockville, MD, recently added "OHRP Correspondence" to its Regulations and Policy Guidance portion of its Web site as part of an effort to improve transparency and provide some specific examples of how to interpret various guidelines.
OHRP will post correspondence with IRBs, investigators, research institutions, or federal agencies when the correspondent gives OHRP permission. The agency's goal is to provide information that might be useful to other institutions for understanding Department of Health and Human Services (HHS) regulations regarding the protection of human subjects under 45 CFR part 46.
One recent correspondence is a Sept. 29, 2008, Memorandum to the National Cancer Institute (NCI) regarding IRB review of protocol and informed consent changes. Here is an excerpt from that six-page memorandum:
"A. Temporary Suspension of New Subject Enrollment When CTEP [Cancer Therapy Evaluation Program] Identifies New or Modified Risk Information that Requires Changes to the Description of the Reasonably Foreseeable Risks or Discomforts in Informed Consent Documents.
For NCI/CTEP-sponsored clinical trials, informed consent must be *documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative (45 CFR 46.117(a)). This written consent document must embody all elements of informed consent required by HHS regulations at 45 CFR 46.116(a) and (b), including a description of any reasonably foreseeable risks or discomforts to the subjects.
As we previously communicated to CTEP, when CTEP identifies or learns about new or modified risk information that necessitates changes to the description of the reasonably foreseeable risks or discomforts during the obtaining of informed consent in order to satisfy the requirements of HHS regulations at 45 CFR 46.116(a)(2) (or any other element of informed consent required under 45 CFR 46.116(a) or (b)), such changes to the informed consent documents, as well as any accompanying changes to the protocol, must be reviewed and approved by the IRB before the changes are initiated, except when necessary to eliminate apparent immediate hazards to subjects (45 CFR 46.103(b)(4)(iii) and 46.117). In these circumstances, new subjects cannot be enrolled until revised informed consent documents, and any proposed changes to the protocol, have been reviewed and approved by the IRB….
[Editor's note: For more information on the OHRP correspondence program go to: http://www.hhs.gov/ohrp/policy/correspond/]