Attachment A: Recommendations on Assurances and Engagement

FINAL RECOMMENDATIONS ON ASSURANCES AND ENGAGEMENT

As Approved by SACHRP on March 13, 2014

RECOMMENDATION #1: 

SACHRP recommends that 45 CFR 46.103 be revised or reinterpreted, in its entirety, as follows:

46.103 Assuring compliance with this policy -- research conducted or supported by any Federal Department or Agency.

(a) Departments and agencies will conduct or support research covered by this policy only if the institution receiving the grant, contract, or cooperative agreement has provided an assurance, and only if that institution has certified to the department or agency head that the research has been reviewed and approved by an IRB, and will be subject to continuing IRB review.

(b) The assurance shall be provided by an individual authorized to act for the institution and to assume on behalf of the institution the obligations imposed by this policy and shall be filed in such form and manner as the department or agency head prescribes.

(c) Certification of IRB approval is required when the research is supported by a federal department or agency and not otherwise exempted or waived under §46.101(b) or (i). Institutions shall certify within 30 days after receipt of a request for such a certification from the department or agency, that the application or proposal has been approved by the IRB. If the certification is not submitted within this time limit, the application or proposal may be returned to the institution.

RECOMMENDATION #2: 

SACHRP recommends that the items currently specified to be included in assurances under 45 CFR 46.103(b)(1-5) be addressed in other sections apart from the assurance process, as they are under counterpart FDA regulations.

RECOMMENDATION #3: 

SACHRP recommends that the assurance of compliance required under 45 CFR 46.103 be provided through the grant-making process, as one of multiple “Representations and Certifications” already made by institutions when they apply for federal grants, contracts or cooperative agreements.  The intent of this recommendation is to replace the current Federalwide Assurance (FWA) as the model for providing assurance.

RECOMMENDATION #4: 

SACHRP recommends that sub-awardees not be required to provide separate assurances of compliance, but that collaborating research sites (including prime, subs and unfunded sites) have the discretion and responsibility to negotiate the terms of agreements amongst themselves, depending on the circumstances of the project and the nature of collaboration.  These agreements should address, among other obligations and oversight mechanisms, the number and location of IRBs needed to review the research. Sub-awardees should identify the responsible Institutional Official who is legally authorized to commit the institution to the terms of these agreements.