Examples of Federal Policy in a sentence
Although not within the scope of the Federal Policy or other federal laws, regulations or policies governing IRB reliance, for Participating Institutions that so wish, this Agreement also permits and serves as documentation of reliance on a Reviewing IRB or on a Reviewing IRB Institution for a determination whether Research is exempt from some or all of the requirements of the Federal Policy (“Exemption Determination”).
Research: Any human subjects research within the meaning of the Federal Policy or within the meaning of any other federal human subjects protection regulations or policies; any investigation/clinical investigation within the meaning of the FDA Clinical Investigation Regulations; and any other human subjects research for which any Participating Institution seeks or is required to rely on a Reviewing IRB.
With respect to Research under Ceded Review, a Relying Institution will promptly notify the Reviewing IRB of any potential noncompliance with the Federal Policy, other applicable federal human subjects protection regulations or policies, and/or the FDA Clinical Investigation Regulations, as applicable, or with the requirements or determinations of the Reviewing IRB by the Relying Institution or its Personnel in connection with the Research.
With respect to Research submitted for an Exemption Determination, a Reviewing IRB/Reviewing IRB Institution will perform the Exemption Determination (including, as applicable, any Limited IRB Review) in accordance with the requirements of the Federal Policy.
Unless it is an Independent IRB Organization, the Institution must (i) maintain an assurance of compliance with the Federal Policy (defined in Exhibit A) with at least one federal department or agency (“Assurance”), even if it does not engage in federally funded research; and (ii) require IRB review and provide institutional oversight of its non-exempt human subjects research regardless of funding source.
With respect to Research requiring documentation of consent, a Reviewing IRB will provide or distribute to the Relying Institution(s) and Site Investigator(s) or other Personnel informed consent forms or broad consent forms (as applicable under Federal Policy) to use for the Research.
A Reviewing IRB/Reviewing IRB Institution will maintain IRB membership on its IRB(s) that satisfies the requirements of the Federal Policy (regardless of the Federal Policy’s applicability to the Research) and that satisfies any additional requirements of other federal human subjects protection regulations or policies or the FDA Clinical Investigation Regulations, as applicable to the instance of Research.
The reliance on a Reviewing IRB or on a Reviewing IRB Institution for a determination whether Research is exempt from some or all of the requirements of the Federal Policy.