Michael Carome, MD
Office for Human Research Protections
Department of Health and Human Services
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, MD 20852
RE: Review of Research Under 45 CFR 46.407
UCLA IRB #01-11-064, HIV Replication and Thymopoiesis in Adolescents, Principal Investigator: Paul Krogstad, MD
Sponsor: National Institutes of Health
Dear Dr. Carome,
On behalf of the University of California, Los Angeles (UCLA), Institutional Review Board (IRB), I am forwarding the above referenced protocol to you, per 45 CFR 46.407, for review by a panel of experts convened by the HHS Secretary. The UCLA IRB reviewed the proposal and after careful consideration, the Board found that they could not approve the research under 45 CFR 46.404, 405, or 406.
The investigator requests, in a substudy of the proposed research, to administer deuterium labeled glucose over a 24 hour period to healthy adolescents as a control group. If the deuterium labeled glucose has inadequate sensitivity, the subjects will be asked drink deuterium labeled water during a 24 hour stay in the General Clinical Research Center (GCRC).
Though the IRB found that the research is not designed to provide direct benefit to any of the subjects, it does present a reasonable opportunity to further understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children specific to the affects of HIV infection on immune status and the thymus, which may lead to better treatments for HIV infection. The IRB also found that the administration of radioactive materials to seronegative adolescents did not address a particular disorder or condition of that specific subject population, as required under 45 CFR 46.406, since they are healthy control subjects.
The Food and Drug Administration indicated in a February 25, 1997 letter from Solomon Sobel, MD, Director, Division of Metabolic and Endocrine Drug Products that “If a substance does not otherwise require submission of an IND, then that substance enriched with a stable isotope does not require and [sic] IND either. Thus, IND’s are not required for metabolic tracer studies using isotope-enriched substances such as water, glucose, and individual amino acids.”
I appreciate your prompt attention to this matter. Please do not hesitate to contact me at 310.825.5344 or email@example.com if you have any questions.
Associate Director-Human Subjects Research
Enclosures: 1. UCLA IRB Submission #01-11-064, including NIH grant proposal
2. UCLA IRB December 17, 2001 correspondence to Dr. Krogstad
3. Dr. Krogstad’s February 21, 2002 response to the IRB
4. UCLA IRB April 3, 2002 correspondence to Dr. Krogstad
5. Dr. Krogstad’s May 13, 2002 response to the IRB
a. February 25, 1997 letter from Solomon Sobel, MD, FDA regarding IND
cc w/o enclosures: Principal Investigator Paul Krogstad
Director Judith Brookshire