Department of Health
and Human Services (HHS)
and Human Services (HHS)
July 29, 2020
Office of The Director, National Institutes of Health (OD)
Through this Request for Information (RFI), the NIH Office of Laboratory Animal Welfare (OLAW) is seeking input on clarifying guidance to Assured institutions regarding the institutional responsibility to ensure that the research described in NIH grant applications and contract proposals is congruent with corresponding protocols approved by Institutional Animal Care and Use Committees (IACUCs).
Background
The 21st Century Cures Act, section 2034(d), directed the NIH to conduct a review of applicable regulations and policies for the care and use of laboratory animals and to make revisions, as appropriate, to reduce the administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. One of the actions identified in the report Reducing Administrative Burden for Researchers: Animal Care and Use in Research as part of the 21st Century Cures Act is to provide clarification of existing guidance on grant to protocol congruence.
The NIH Office of Laboratory Animal Welfare (OLAW) oversees Public Health Service (PHS)-funded animal activities by the authority of the Health Research Extension Act of 1985 and the PHS Policy on the Humane Care and Use of Laboratory Animals (Policy). The PHS Policy section IV.D. and the NIH Grants Policy Statement (GPS) section 4.1.1.2 require that prior to award, the IACUC has reviewed and approved components of grant applications and contract proposals related to the care and use of live vertebrate animals. The NIH will delay an award for research involving live vertebrate animals until the recipient organization and all performance sites are operating in accordance with an approved Animal Welfare Assurance and the recipient has provided verification of IACUC approval for the proposed activity. Costs for activities with live vertebrate animals may not be charged to NIH grants without valid IACUC approval.
Information Requested
The NIH is seeking input on the institutional responsibilities for conducting grant to protocol congruence review described below.
Clarification of Institutional Responsibilities Regarding Grant to Protocol Congruency
It is an institutional responsibility to ensure that the information the IACUC reviews and approves is consistent with that contained in the application or proposal to be funded. While the IACUC may choose to perform the grant to protocol congruency review, it is not a required IACUC function and may be performed by other institutional personnel qualified to conduct the review, with responsibility designated to a specific office or position (e.g., sponsored programs or compliance office).
The NIH GPS only requires a congruence review to be conducted prior to the initial grant or contract award. Recognizing that obtaining IACUC approval may take several weeks, institutions may wish to proceed as soon as notified of impact score or percentile with IACUC review for applications that have not yet received IACUC approval and that appear to be in a fundable range. Although IACUC approval and congruence review can be conducted at any time following grant application submission, institutions must submit this information prior to award when NIH requests Just in time procedures. This process reduces administrative burden by limiting IACUC review and congruence review to those competing applications likely to be funded.
There is no explicit requirement to do a side-by-side comparison of an application/proposal and the IACUC protocol, and institutions are free to devise a workable mechanism to prevent inconsistencies between the information. A one-to-one relationship between the grant and the approved protocol is not required and it is acceptable for more than one protocol to be associated with one grant and vice versa.
The NIH GPS section 8.1.2.5 allows the investigator to make changes in the methodology and approach of the project without prior approval by NIH grants management. However, the recipient must obtain prior approval from the NIH awarding Institutes and Centers (ICs) for a change in scope, which could include significant changes to IACUC protocols. Once the initial congruency review is completed and submitted to NIH, there is no requirement to amend and resubmit to the NIH either the grant application, the Vertebrate Animals Section, or other documentation unless requested by the NIH awarding IC.
How to Submit a Response
All responses to this RFI must be submitted electronically on the RFI webpage by 10/29/2020, at 11:59 EDT. The comments may be made available on the OLAW website.
Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in responses. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.
Office of Laboratory Animal Welfare (OLAW)
Telephone: 301-496-7163
Email:olaw@mail.nih.gov