02-19871. 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, Department of Health and Human Services.

ACTION:

Notice.

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 [phone] (not a toll free number) or by e-mail to [e-mail].

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: [phone] (not a toll free number) or by e-mail to [e-mail].

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 § 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 § 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.