Subpart D Panel Review of Pending NIAAA Grant 1 R01 AA13252-01 "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"

The Office for Human Research Protections (OHRP) is soliciting public review and comment pursuant to Department of Health and Human Services (HHS) regulations at 45 CFR 46.407 on the above-referenced research protocol.

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.

OHRP is requesting comments on the following questions related to the study:

1.  What are the potential benefits, 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 the anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result?

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?

To be considered, comments on this proposed research protocol must be received on or before May 29, 2003.  Written comments should be submitted to Ms. Kelley Booher, Division of Policy, Planning, and Special Projects, OHRP, 1101 Wootton Parkway, Suite 200, The Tower Building, Rockville, MD 20852.  Comments may also be submitted via facsimile at 301-402-2071 or by email to: 407panel01@osophs.dhhs.gov .  Following public review and comment, the Secretary of HHS will make a final determination on whether HHS may support this research protocol.  If approved, this research would be supported by a grant awarded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

Please note that some of the information in the following documents is exempt from disclosure under existing Federal statutes and has been redacted.
  1. Federal Register Notice Vol. 68, No. 71, page 17950, dated April 14, 2003, available at  http://www.hhs.gov/ohrp/references/fr04-14.pdf  [PDF document]: Solicitation of Public Review and Comment
  2. Relevant sections of the grant application entitled "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"    [PDF Format  PDF document, see bottom of page to obtain free reader] 
  3. Sample Permission/Assent/Consent Documents;
  4. Rhode Island Hospital IRB's review of protocol: Excerpt from IRB minutes  [PDF Format PDF document, see bottom of page to obtain free reader]   [HTML Format]
  5. Explanation of Rhode Island Hospital IRB's Pediatric Risk Categories  [PDF Format PDF document, see bottom of page to obtain free reader]   [HTML Format]
  6. OHRP's January 13, 2003, letter to the principal investigator, Dr. Mary Carskadon, explaining why review pursuant to 45 CFR 46.407 is restricted to Study 2  [PDF Format PDF document, see bottom of page to obtain free reader]   [HTML Format]

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Updated April 14, 2003