[Federal Register Volume 67, Number 152 (Wednesday, August 7, 2002)]
[Notices]
[Pages 51283-51284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19871]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Proposed Recommendation Regarding Support of Research Protocol: 
Precursors to Diabetes in Japanese American Youth

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

[[Page 51284]]

Department of Health and Human Services.

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), gives notice that a panel of experts was convened pursuant to 
the requirements of 45 CFR 46.407 for review of a proposed protocol 
entitled ``Precursors to Diabetes in Japanese American Youth.'' This 
proposed research would include children as research subjects. OHRP has 
reviewed the protocol and findings of the expert panel and proposes to 
recommend approval for HHS support of this research protocol, subject 
to the stipulation of a modification of the protocol and consent forms 
in accordance with expert recommendations. Public comment is solicited 
regarding this proposed recommendation pursuant to the requirements of 
45 CFR 46.407.

DATES: To be considered, comments must be received on or before 5 p.m. 
on August 21, 2002.

ADDRESSES: Please send comments to: Clifford C. Scharke, Division of 
Policy Planning and Special Projects, Office for Human Research 
Protections, 1101 Wootton Parkway, Suite 200, The Tower Building, 
Rockville, MD 20852. Comments also may be sent via facsimile at (301) 
402-2071 (not a toll free number) or by e-mail to 
[email protected].

FOR FURTHER INFORMATION CONTACT: Clifford C. Scharke, 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) 402-5218 (not a toll free 
number) or by e-mail to [email protected].

SUPPLEMENTARY INFORMATION: The HHS regulations regarding the protection 
of human research subjects, 45 part 46, permit HHS to conduct or fund 
research involving children only if the research falls within one of 
the following categories: research not involving greater than minimal 
risk (45 CFR 46.404); research involving greater than minimal risk but 
presenting the prospect of direct benefit to the individual subjects 
(45 CFR 46.405); research involving greater than minimal risk and 
presenting no prospect of direct benefit to individual subjects, but 
likely to yield generalizable knowledge about the subject's disorder or 
condition (45 CFR 46.405); and research not otherwise approvable which 
presents an opportunity to understand, prevent, or alleviate a serious 
problem affecting the health or welfare of children (45 CFR 46.407). In 
accordance with Sec. 46.407, HHS will conduct or fund research 
involving children which an Institutional Review Board (IRB) has 
determined does not meet the requirements of 45 CFR 46.404-46.406 only 
if (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 of HHS, after consultation with a panel of experts in 
pertinent disciplines and following opportunity for public review and 
comment, has determined either: (1) That the research in fact satisfies 
the conditions of Section 46.404, Section 46.405, or Section 46.406, as 
applicable, or (2) the following: (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; (iii) adequate provisions are made for soliciting 
the assent of children and the permission of their parents or 
guardians, as set forth in Sec. 46.408.
    OHRP received a request from the University of Washington of 
Seattle, Washington to convene a panel of experts pursuant to 45 CFR 
46.407 to review a protocol entitled ``Precursors to Diabetes in 
Japanese American Youth'' (1 R01 DK59234-01). The long-term aim of the 
proposed study is to increase understanding about the metabolic changes 
that precede the development of type 2 diabetes in children and the 
influence of Asian ethnicity on the diabetes risk. The institution's 
designated IRB determined that the research does not meet the 
requirements of 45 CFR 46.404, 46.405, or 46.406, but is suitable for 
review under 45 CFR 46.407. Although the IRB found that the research 
was not designed to provide direct benefit to subjects, it found 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.
    The panel of experts convened by OHRP, under authority delegated by 
the Secretary of HHS, found that the protocol presented a reasonable 
opportunity to further the understanding of a serious problem affecting 
the health or welfare of children and recommended modifications to the 
protocol to further minimize the risks to the children and to the 
consent forms. The experts found that if these recommended 
modifications are implemented, the research would be conducted in 
accordance with sound ethical principles, with adequate provisions for 
assent and permission, and would be in conformance with the 
requirements of 45 CFR 46.407 and 46.408. The summary report of the 
findings of the expert panel members is available from OHRP, upon 
request.
    OHRP proposes to recommend approval of HHS support of this research 
protocol, subject to the stipulation that the protocol and consent 
forms be modified in accordance with the expert recommendations, to the 
satisfaction of the IRB and the funding authority, prior to the 
involvement of human subjects. Public review and comment on this 
proposal is hereby solicited pursuant to the requirements of 45 CFR 
46.407.

    Dated: June 27, 2002.
Eve E. Slater, F.A.C.C.,
Assistant Secretary for Health.
[FR Doc. 02-19871 Filed 8-6-02; 8:45 am]
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