___________________________________________________________________________________________________________
MEMORANDUM
OFFICE FOR PROTECTION OF
RESEARCH SUBJECTS
2107
Ueberroth Building
169407
RE: Request for Additional Information Prior to Issuing
An Approval Notice
HIV Replication and Thymopoiesis in Adolescents
The Medical
Institutional Review Board (M-IRB) wishes to thank you for your recent
response, which was reviewed by the M-IRB during its
meeting of March 13, 2002. The Committee found that more information is needed prior to
issuing an Approval Notice. The
Committee will be pleased to receive and review, as quickly as possible, your
response to the questions on the following pages.
PLEASE NOTE: No subjects may be contacted, recruited, or enrolled into this
study until an Approval Notice and approved informed consent form(s) have been
issued.
It is the UCLA IRB policy that unless a response is
received from you within 30 days of the date of this letter, your submission
will be withdrawn from the approval process.
Therefore, should there be reasons which make it impossible for you to
respond before 30 days, please advise as soon as possible. If you have any questions, please contact Kathy Casey, Administrator,
M-IRB at (310)825-5344.
Sincerely,
On behalf of the Medical
Institutional Review Board
Please return two copies of your response to:
Office for Protection of
Research Subjects
Medical Institutional Review Board
2107 Ueberroth Building
Campus Mail Code 169407
A. Please respond to the following, and make the necessary changes
to the informed consent form(s) where appropriate; if you disagree with the
Committee’s requests for changes, please explain. (Respond separately to
each numbered item in sequence, employing the same number to identify your
response.)
1. The Board accepted your request to limit enrollment to adults,
pending HHS review of the risks and benefits associated with involvement of
children in this research study. When
research reviewed under category 45 CFR 46.407 is federally funded, it must be
submitted for review and approval by the Secretary of Health and Human Serviced
(HHS), in consultation with appropriate experts. The IRB will submit this project of the Secretary of HHS for
their deliberation. The IRB staff will
contact you when notification of the decision is received.
In the interim, the Board accepts your request to “modify
the substudy temporarily to include subjects 18 years of age or older
only.” However, the Committee noted
that the revised consent forms include language regarding enrollment of “adolescents.” Additionally, an assent form was submitted
with your response. Please modify the
consent forms accordingly, and forward the revised consent forms along with
your response to this correspondence.
2. The Committee also concurs with you request to issue an
administrative approval for the main study, pending further information
regarding the deuterium labeled glucose that will be employed with this study.
Please note: The
Approval Notice will be issued for administrative purposes only. No subjects may be contacted, recruited or
enrolled. The related form(s) will be
held on file with the M-IRB until the following information is received and approved by the M-IRB:
a. Requested detail regarding the use and
administration of the deuterium labeled glucose to be used in the main study.
b. The approval notice and consent documents
reviewed and approved by the IRB of Children’s Hospital Los Angeles.
c. A copy of the Medical Radiation Safety Committee approval for
this study.
d. A copy of your revised Form 740.
B. Please make the following modifications to the informed consent
form: (Please provide bold typeface or underline changes on one copy
for the reviewers and provide two clean copies to be used as the
official version of the consent form.)
1. Please fill-in all large gaps in each consent form.
2. Please indicate in the consent forms the number of subjects
expected to enroll in this study at UCLA and in total.
3. Please clarify at the beginning of the “Procedures” section of
the consent forms that the study procedures may involve a 24 hour stay at UCLA.
4. Please clarify in the “Procedures” section of the consent form
the amount and at what intervals the “sugar solution” will be administered to
subjects during the 24 hour stay at UCLA.
5. Please clarify in the “Procedures” section of the consent forms
what part of the subject’s body will be imaged during the CT scans.