Section VIII:

Review Types/Process

WPP #: VIII-7

Title 7:

Review of Grant Applications

Effective Date:

05-13-14

Revision History:

06-07-04; 12-03-04; 06-21-06; 11-01-06

Policy Statement

Federal regulations at 45 CFR 46.103(f) require that each application or proposal for HHS-supported human subject research be reviewed and approved by the IRB. The purpose of this review is to ensure that the research described in the application or proposal is consistent with any corresponding protocol(s) submitted to the VCU IRB. Review of the grant application will occur when investigator submits: (1) a new grant application, (2) a resubmission of a grant application, or (3) a competing continuation of a grant application to the VCU IRB.

NOTE: The VCU Office of Sponsored Programs will not sign off for funds to be released for human research until it receives proof of IRB review/approval of the new grant application, resubmission, or competing continuation.

Description and Procedures

  1. Initial Review of Grant Application

    VCU IRB review and approval of a grant application refers only to those portions of a research application that pertain to the rights and welfare of human research subjects. Considerations of the panel regarding human subject protections may include, but are not limited to, the Criteria for IRB approval of research as specified in 45 CFR 46.111.

    Other examples for review areas (from OHRP Guidance): (i) the number and qualifications of collaborating investigators and other members of the research team; (ii) cooperating institutions or performance sites that may require separate or additional IRB review or an Assurance of Compliance; (iii) characteristics of proposed research facilities that may affect subject safety or the confidentiality of data; (iv) the feasibility of financial commitments made to subjects; and (v) the cost of proposed subject protection measures, such as consent monitors or translators.

  2. Continuing Review of Grant Applications:

    Non-competing continuation applications are reviewed annually by sponsors and are not reviewed by the IRB at the time of continuing review.

References

NIH Grants Policy Statement
OHRP Guidance: Review of Grant Applications
45 CFR 46.111