NOTE: THIS GUIDANCE DOCUMENT HAS BEEN ARCHIVED BECAUSE OHRP IS NO LONGER INVOLVED IN THE PROCESS FOR ISSUING RESTRICTED AWARDS.

July 1, 1998

To:Extramural Program Management Committee (EPMC)
Grants Management Advisory Committee (GMAC)
Review Policy Committee (RPC)
Acquisitions Management Committee (AMC)

From: Director, Office for Protection from Research Risks

Subject: Revised Language for Restricted Awards

In past years, especially during the month of September, the Office for Protection from Research Risks (OPRR) has been asked by funding components to allow the award of grants, contracts, or cooperative agreements with restrictions on the use of funds for research involving human subjects or animals. This is often required because of insufficient time to obtain the appropriate Assurances of Compliance before the award must be made to meet awarding component deadlines.

Assurances are required of institutions proposing to involve either human subjects or animals in research supported by the Department of Health and Human Services, in order to meet the Federal requirements contained in the regulations for protection of human subjects (Title 45 CFR Part 46) and the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy). Assurances must be approved by OPRR prior to the award of support for research proposing to involve human subjects or animals.

Steps in obtaining Assurances include the following: (1) the funding component makes a written request and sends to OPRR essential documents (e.g., grant application, contract proposal, Summary Statement, Technical Evaluation Summary); (2) OPRR requests applicants to submit Assurance(s) for the applicant and any associated performance sites; (3) applicant responds to OPRR's request; (4) OPRR evaluates and negotiates the Assurance(s); and (5) OPRR approves the Assurance(s). Although telephone, e-mail, and facsimile communication can speed this process, completion of all these steps often requires several weeks or longer.

In consultation with the Office of General Counsel, OPRR has revised the standard restricted award language for use in notices of award. Restricted awards to institutions for activities and/or performance sites not covered by an applicable Assurance approved by OPRR can be made only after OPRR is informed and has taken appropriate action in response. Funding components should monitor such awards very closely to ensure that all performance sites meet Assurance and IRB or IACUC review requirements prior to involvement of human subjects or animals.

The following language must be included on all restricted awards:

(1) If human subjects are to be involved:

NOTICE: UNDER GOVERNING REGULATIONS, FEDERAL FUNDS ADMINISTERED BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES SHALL NOT BE EXPENDED FOR RESEARCH INVOLVING HUMAN SUBJECTS, AND INDIVIDUALS SHALL NOT BE ENROLLED IN SUCH RESEARCH, WITHOUT PRIOR APPROVAL BY THE OFFICE FOR PROTECTION FROM RESEARCH RISKS OF AN ASSURANCE TO COMPLY WITH THE REQUIREMENTS OF 45 CFR 46 TO PROTECT HUMAN RESEARCH SUBJECTS. THIS RESTRICTION APPLIES TO ALL COLLABORATING SITES WITHOUT OPRR-APPROVED ASSURANCES, WHETHER DOMESTIC OR FOREIGN, AND COMPLIANCE MUST BE ENSURED BY THE AWARDEE.

(2) If live vertebrate animals are to be involved:

NOTICE: UNDER GOVERNING POLICY, FEDERAL FUNDS ADMINISTERED BY THE PUBLIC HEALTH SERVICE (PHS) SHALL NOT BE EXPENDED FOR RESEARCH INVOLVING LIVE VERTEBRATE ANIMALS WITHOUT PRIOR APPROVAL BY THE OFFICE FOR PROTECTION FROM RESEARCH RISKS OF AN ASSURANCE TO COMPLY WITH THE PHS POLICY ON HUMANE CARE AND USE OF LABORATORY ANIMALS. THIS RESTRICTION APPLIES TO ALL PERFORMANCE SITES (e.g., COLLABORATING INSTITUTIONS, SUBCONTRACTORS, SUBGRANTEES) WITHOUT OPRR-APPROVED ASSURANCES, WHETHER DOMESTIC OR FOREIGN.

Placing a restriction on an award should be a last resort. Funding component personnel are encouraged to review their portfolios for those activities that may be funded and that involve human subjects or animals. Prompt submission of necessary information to OPRR, as soon as it is known that an award is likely to be made, may enable successful negotiation and approval of an Assurance prior to funding component deadlines.

Requests for OPRR action should be directed to 496-7041 (human subjects) or 496-7163 (animals). Upon receipt of the request for use of this restriction, OPRR will take the following steps: (1) lift the bar to funding in the Wylbur/IMPAC II database for grant proposals in question and inform the awarding unit that the bar has been lifted; (2) reinstitute the bar after the award is made; and (3) pursue obtaining the Assurance in the usual manner.

We appreciate your attention to this important matter.

Gary B. Ellis, Ph.D.