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Scope of the Regulations

With certain delineated exceptions, the HHS regulations apply to all research conducted with HHS funds, both inside and outside the United States. All institutions receiving HHS funding in any area must have an ethical policy governing all human research conducted at that institution, regardless of the source of funding. Many institutions have also assured HHS that all research in the institution, irrespective of HHS funding, will be reviewed and conducted pursuant to the HHS regulations. These regulations require investigators supervising cooperative research projects to ensure that all other participants abide by the HHS regulations:

Cooperative research projects are those projects, normally supported through grants, contracts, or similar arrangements, which involve institutions in addition to the grantee or prime contractor (such as a contractor with the grantee, or a subcontractor with the prime contractor). In such instances, the grantee or prime contractor remains responsible to the Department for safeguarding the rights and welfare of human subjects. Also, when cooperating institutions conduct some or all of the research involving some or all of these subjects, each cooperating institution shall comply with these regulations as though it received funds for its participation in the project directly from the Department, except that in complying with these regulations institutions may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort. (sec. 46.114)

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