June 30, 2003
March 10, 1998
Director of Regulatory Affairs
Office for Protection from Research Risks
National Institute of Health
6100 Executive Blvd., Suite 3B01
Rockville, MD 20892-7507
RE: Protection of Human Subjects: Suggested Revisions to the Institutional Review Board (IRB) Expedited Review List. Fed. Reg. eg 60607, November 10, 1997.
Dear Ms. Einhorn:
The American College of Nuclear Physicians and the Society of Nuclear Medicine would like to thank you for allowing us this opportunity to comment. Together, our organizations represent 12,000 physicians, professors, technologists, radiopharmacists, and scientists in the field of nuclear medicine. We consider the republication of the list that identifies research on human subjects that may be reviewed by the Institutional Review Board (IRB) and the expedited review process a very important issue.
Nuclear medicine has one of the best safety records in the medical field. However, despite the low levels of risk involved in radiopharmaceuticals and its consistent safety record, it is excluded from the expedited review category, thus significantly slowing the time available to get a project through the IRB process.
It is with this in mind that the ACNP and SNM would like to offer the following comments:
It is our opinion that 1.) in cases where the radiation study involves FDA approved radiopharmaceuticals and no investigational drugs are required for the radiation studies, there should be no prohibition on expedited review, and 2.) in the case of radiation-based projects there should be a dosimetric threshold limit above which an IRB review is required. Radiopharmaceutical studies performed in the usual clinical manner, or as a method of documentation of the outcome of other interventions in the protocol, should be eligible for expedited review.
Furthermore, we suggest that the following section as proposed below should be changed.
"6. Collection of data through use of the following procedures:
Many routinely performed diagnostic procedures involving exposure to ionizing radiation do not impose greater than a minimal risk. Expedited review of research studies involving the use of such diagnostic procedures should be permitted based on certain radiation exposure. Moreover, subcategory a, as proposed, does not make sense since MRI and diagnostic infrared imaging, which are later recognized as expeditable subcategories, involves exposure to electromagnetic radiation outside the visible range.
It is therefore our suggestion that this category should be divided into two categories and changed to the following:
Precedence for the minimum risk status of the radiation exposure limits cited above can be found in the FDA regulations, 21 CFR Part 361, "Prescription Drugs for Human Use Generally Recognized as Safe and Effective and not Misbranded: Drugs Used in Research", S. 361.1, Radioactive Drugs for Research Use."
Again, we appreciate this opportunity to express our views on this subject. We hope that our opinions will be given every consideration in this review process, and should you have any questions or wish to discuss our position in further detail, please contact David Nichols, Director of Government Relations, at 703-708-9773.
|Robert L. MeckInburg, MD||H. William Strauss, MD|
|American College of Nuclear Physicians||Society of Nuclear Medicine|