Common use of Regulatory Background Clause in Contracts

Regulatory Background. The Department of Health and Human Services (DHHS) regulations at 45 CFR 46.114 states: “Cooperative research projects are those projects covered by this policy which involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. With the approval of the department or agency head, an institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.” The following standards apply where an institution holding an Office of Human Research Protections- approved Assurance wishes to avoid duplication of effort, in accordance with DHHS regulations at 45 CFR 46.114, by relying upon the IRB review of another Assurance-holding institution: 1. The review arrangement must be approved in writing by the Office of Human Research Projects and by appropriate officials of the institutions involved. 2. The institution relying upon another institution's IRB has a responsibility to ensure that the particular characteristics of its local research context are considered, either (i) through knowledge of its local research context by the reviewing IRB; or (ii) through subsequent review by appropriate designated institutional officials, such as the Chairperson and/or other members of its local IRB.