[Federal Register Volume 68, Number 71 (Monday, April 14, 2003)]
[Notices]
[Pages 17950-17951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9051]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Public Review and Comment on Research Protocol: 
Alcohol, Sleep, and Circadian Rhythms in Young Humans, Study 2--Effects 
of Evening Ingestion of Alcohol on Sleep, Circadian Phase, and 
Performance as a Function of Parental History of Alcohol Abuse/
Dependence

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, HHS is soliciting public review and comment 
on a proposed research protocol entitled ``Effects of Evening Ingestion 
of Alcohol on Sleep, Circadian Phase, and Performance as a Function of 
Parental History of Alcohol Abuse/Dependence.'' The proposed research 
would be supported by a grant awarded by the National Institutes of 
Health, National Institute on Alcohol Abuse and Alcoholism. Public 
review and comment are 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. May 29, 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 e-mail to: [email protected].

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; 
e-mail [email protected].

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 and documents 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 Lifespan Office of Research 
Administration, Rhode Island Hospital, to review a protocol entitled 
``Effects of Evening Ingestion of Alcohol on Sleep, Circadian Phase, 
and Performance as a Function of Parental History of Alcohol Abuse/
Dependence'' pursuant to the provisions of HHS regulations at 45 CFR 
46.407. This research protocol proposes to study the effects of a small 
or moderate evening dose of alcohol on sleep, waking performance, and 
circadian phase in a total of 64 adolescents (15 to 16 years of age) 
and young adults (21 to 22 years of age), and examine how the effects 
may differ between individuals who have a parent with a history of 
alcohol dependence and those who do not. The research protocol is 
proposed to take place at E.P. Bradley Hospital, an affiliate of 
Lifespan, the parent corporation of Rhode Island Hospital, and was 
reviewed by the Rhode Island Hospital IRB. The Rhode Island Hospital 
IRB is the IRB of record for E.P. Bradley Hospital.
    After reviewing this research proposal, the Rhode Island Hospital 
IRB determined that this study involving children as research subjects 
could not be approved under HHS regulations at 45 CFR 46.404, 46.405, 
or 46.406, but was suitable for review under 45 CFR 46.407. The Rhode 
Island Hospital IRB 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. 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 potential benefits of the research, if any, to the 
subjects and to children in general; (2) what are the types and degrees 
of risk that this research presents to the subjects; (3) are the risks 
to the subjects reasonable in relation to

[[Page 17951]]

the anticipated benefits, if any, to the subjects, and the importance 
of the knowledge that may reasonably be expected to result; and (4) 
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?
    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 e-mail to: [email protected].
    Materials available for review on the OHRP web page (available at: 
http://ohrp.osophs.dhhs.gov/panels/407-01pnl/pindex.htm) include: 
relevant sections of the grant application; sample consent, parental 
permission and assent documents; the Rhode Island Hospital IRB's 
deliberations on the protocol; an explanation of Rhode Island 
Hospital's Pediatric Risk Categories; and OHRP's January 13, 2003, 
letter to the principal investigator, Dr. Mary Carskadon, explaining 
why review pursuant to 46.407 is restricted to Study 2. A paper copy of 
the information referenced here is available upon request.

    Dated: April 7, 2003.
Richard H. Carmona,
Surgeon General and Acting Assistant, Secretary for Health.
[FR Doc. 03-9051 Filed 4-11-03; 8:45 am]
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