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Office for Human Research Protections (OHRP)OHRP CorrespondenceOHRP occasionally posts correspondence with institutional review boards, investigators, research institutions, or federal agencies when we believe that others may find our discussion of issues referenced in the correspondence useful for understanding the applicability and interpretation of the Department of Health and Human Services (HHS) regulations for the protection of human subjects in research (45 CFR part 46). OHRP will obtain permission from the other correspondent(s) involved before posting such correspondence. OHRP welcomes comments on the viewpoints expressed in the correspondence. Comments may be submitted to OHRP by email at ohrp@hhs.gov. Please include the date and subject matter of the correspondence, given below, in the email subject field. Alternatively, comments may be submitted by mail to: Office for Human Research Protections Comments received, including any personal information provided, will be made available to the public upon request. This memorandum to the Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI), provides clarification regarding several issues related to the implementation of changes to protocols and informed consent documents for NCI/CTEP-sponsored clinical trials in a manner that satisfies the requirements of the Department of Health and Human Services regulations for the protection of human subjects (45 CFR part 46). Quality Improvement Activities Designed to Reduce Catheter-related Infections (July 30, 2008) This letter culminates exchanges between OHRP and Dr. Peter Pronovost at Johns Hopkins University School of Medicine regarding whether the HHS regulations would apply to certain planned activities implementing a program designed to reduce catheter-related infections at a number of locations across the country, and certain supplementary activities. Dr. Pronovost has agreed to the posting of this letter. |
Last Updated: October 3, 2008
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