[Federal Register Volume 68, Number 114 (Friday, June 13, 2003)]
[Notices]
[Pages 35415-35416]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 03-14942]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Public Review and Comment on Research Protocol: 
Sleep Mechanism in Children: Role of Metabolism

AGENCY: Department of Health and Human Services, Office of the 
Secretary, Office of Public Health and Science, Office for Human 
Research Protections.

ACTION: Notice.

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SUMMARY: The Office for Human Research Protections (OHRP), Office of 
Public Health and Science, Department of Health and Human Services 
(HHS) is soliciting public review and comment on a proposed research 
protocol entitled ``Sleep Mechanisms in Children: Role of Metabolism.'' 
The proposed research would be supported by a grant awarded by the 
National Heart, Lung, and Blood Institute, National Institutes of 
Health. Public review and comment are

[[Page 35416]]

solicited regarding the proposed research protocol pursuant to the 
requirements of HHS regulations at 45 CFR 46.407.

DATES: To be considered, written or electronic comments on the proposed 
research must be received on or before 4:30 p.m. July 28, 2003.

ADDRESSES: Submit written comments to: Ms. Kelley Booher, Division of 
Policy, Planning, and Special Projects, Office for Human Research 
Protections, 1101 Wootton Parkway, Suite 200, The Tower Building, 
Rockville, MD 20852, telephone number (301) 402-5942 (not a toll-free 
number). Comments also may be sent via facsimile at (301) 402-0527 or 
by email to: 407panel03@osophs.dhhs.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Leslie K. Ball, Office for Human 
Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 
200, Rockville, MD 20852; telephone (301) 496-7005; fax (301) 402-0527; 
email LBall@osophs.dhhs.gov.

SUPPLEMENTARY INFORMATION: All studies conducted or supported by HHS 
which are not otherwise exempt and which propose to involve children as 
subjects require institutional review board (IRB) review in accordance 
with the provisions of HHS regulations for the protection of human 
subjects at 45 CFR part 46, subpart D. Pursuant to HHS regulations at 
45 CFR 46.407, if an IRB reviewing a protocol to be conducted or 
supported by HHS does not believe that the proposed research involving 
children as subjects meets the requirements of HHS regulations at 45 
CFR 46.404, 46.405, or 46.406, the research may proceed only if the 
following conditions are met: (a) The IRB finds that the research 
presents a reasonable opportunity to further the understanding, 
prevention, or alleviation of a serious problem affecting the health or 
welfare of children; and (b) the Secretary, after consultation with a 
panel of experts in pertinent disciplines (for example: science, 
medicine, education, ethics, law) and following opportunity for public 
review and comment, determines either: (1) That the research in fact 
satisfies the conditions of 45 CFR 46.404, 46.405, or 46.406, or (2) 
that the following conditions are met: (i) The research presents a 
reasonable opportunity to further the understanding, prevention, or 
alleviation of a serious problem affecting the health or welfare of 
children; (ii) the research will be conducted in accordance with sound 
ethical principles; and (iii) adequate provisions are made for 
soliciting the assent of children and the permission of their parents 
or guardians, as set forth in 45 CFR 46.408.
    HHS received a request from the Albert Einstein College of 
Medicine's Committee on Clinical Investigations (the Albert Einstein 
CCI, which serves as Albert Einstein's IRB) pursuant to 45 CFR 46.407. 
The principal investigator, Dr. Gabriel Haddad, proposes to measure 
glycogen, glutamate turnover rate, and glutamate-glutamine cycling in 
wakefulness and sleep in adolescent children ages 13 to 17 years. The 
investigator also proposes to study a subset of children in the same 
manner following sleep deprivation. The study would involve three 
visits to the Children's Hospital at Montefiore Medical Center. 
Measurements will be made using NMR spectroscopy following intravenous 
infusion of \13\ C-acetate and \13\ C-glucose. The long term aims of 
the study are to better understand (a) sleep; and (b) the diseases 
afflicting children and adults that impact on their sleep; and (c) 
sleep-related diseases that impact on neurocognitive, cardiovascular, 
behavioral, and other functions. This study would be funded by the 
National Heart, Lung, and Blood Institute, National Institutes of 
Health (NIH), under grant number HL 070919.
    After reviewing this research proposal, the Albert Einstein CCI 
determined that this research could not be approved under 45 CFR 
46.404, 46.405, or 46.406 but was suitable for review under 45 CFR 
46.407. The Albert Einstein CCI found that the research presented more 
than minimal risk and did not offer the prospect of direct benefit to 
subjects, but found that the research presented a reasonable 
opportunity to further the understanding, prevention or alleviation of 
a serious problem affecting the health or welfare of children.
    Experts in relevant disciplines have reviewed this protocol and 
each have provided recommendations to the Secretary of HHS. Public 
review and comment are hereby solicited pursuant to the requirements of 
45 CFR 46.407. The Secretary will consider the experts' recommendations 
and the public comments in making a final determination regarding 
whether HHS may support this research.
    In particular, comments are solicited on the following questions: 
(1) What are the types and degrees of risk that this research presents 
to the subjects; (2) what are the potential benefits, if any, to the 
subjects and to children in general; (3) does the research present a 
reasonable opportunity to further the understanding, prevention, or 
alleviation of a serious problem affecting the health or welfare of 
children; (4) if conducted as proposed in the above-cited protocol, 
would the research be conducted in accordance with sound ethical 
principles; and (5) have adequate provisions been made for soliciting 
the assent of children and the permission of their parents or 
guardians? In formulating a response to question (4), commenters may 
wish to consider whether the proposed protocol satisfies all the 
requirements under HHS regulations at 45 CFR 46.111 (criteria for IRB 
approval of research).
    All written comments concerning this matter should be submitted to 
Ms. Kelley Booher, Division of Policy, Planning, and Special Projects, 
Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, 
The Tower Building, Rockville, MD 20852, telephone number (301) 402-
5942 (not a toll-free number). Comments also may be sent via facsimile 
at (301) 402-2071 or by email to: 407panel03@osophs.dhhs.gov.
    Materials available for review on the OHRP web page (available at: 
http://ohrp.osophs.dhhs.gov/panels/407-03pnl/pindex.htm) include: 
correspondence from the research institution referring the proposed 
protocol to the Secretary of HHS for consideration under 45 CFR 46.407; 
the Albert Einstein CCI protocol application; the Albert Einstein CCI 
deliberations on the proposed research; the parental permission and 
assent forms; relevant excerpts of the NIH grant application; and 
reports from each of the experts pursuant to 45 CFR 46.407. A paper 
copy of the information referenced here is available upon request.

    Dated: June 5, 2003.
Cristina V. Beato,
Principal Deputy Assistant Secretary for Health.
[FR Doc. 03-14942 Filed 6-12-03; 8:45 am]
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