Michael
Carome, MD
Director,
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 speckman@oprs.ucla.edu if you have any
questions.
Sincerely,
Steven
Peckman
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