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Notice

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

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AGENCY:

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

ACTION:

Notice.

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: 407panel01@osophs.dhhs.gov.

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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 LBall@osophs.dhhs.gov.

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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 Start Printed Page 17951the 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: 407panel01@osophs.dhhs.gov.

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.

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Dated: April 7, 2003.

Richard H. Carmona,

Surgeon General and Acting Assistant, Secretary for Health.

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[FR Doc. 03-9051 Filed 4-11-03; 8:45 am]

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