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Restricted Awards for Contracts Involving Human Subjects SOP

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This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.


To enable NIAID to restrict the use of award funds for an otherwise apparent successful offeror who does not meet all requirements for conducting human subjects research.


NIAID issues an unrestricted award that allows an offeror to conduct research on human subjects research if:

  • The offeror has an HHS Office of Human Research Protections (OHRP)-approved Federalwide Assurance.
  • The offeror has a certification of institutional review board (IRB) approval.
  • The proposal received an acceptable rating from the scientific review group (SRG) on the human subjects evaluation, or the issue that caused the restriction was resolved during negotiation.

NIAID issues a restricted award when one of these criteria is not met. The contract includes language restricting research on human subjects until the issues that caused the restriction are resolved.

This SOP describes the restricted award process.


  • Follow the instructions in the solicitation regarding human subjects.
  • Address the human subjects evaluation factors described in the solicitation. The human subjects evaluation may include these factors: Protection of Human Subjects From Research Risks, Inclusion of Women and Minorities, Inclusion of Children, HIV Antiretroviral Treatment Trials, and Data and Safety Monitoring.
  • File an acceptable Federalwide Assurance with the HHS Office of Human Research Protections. See File a New Federalwide Assurance (FWA).
  • If the solicitation requires it before award, provide a properly completed Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption form, OMB No. 0990-0263 (available here), certifying institutional review board (IRB) review and approval of the protocol with your technical proposal.
  • When research involving human subjects will take place at collaborating sites or other performance sites, complete and file Form OMB No. 0990-0263 (available here) certifying IRB review and approval of the research at each performance site.
  • As required by Section L of the solicitation, submit documentation of training in the protection of human research participants with your technical proposal.

Scientific Review Program Staff

  • Ensure that scientific review group (SRG) members rate each proposal as “acceptable” or “unacceptable” for each of the human subjects evaluation factors included in the solicitation.
  • Instruct SRG members to note their ratings on the Technical Evaluation Score Sheet (TESS).
  • If a participating SRG member finds a human subjects evaluation factor to be "unacceptable," ensure he or she provides written comments supporting the finding.
  • Document final SRG rating of each proposal against each human subjects factor and include an explanatory statement for that rating in the technical evaluation report (TER).

Contracting Officer's Representative (COR)

  • In the acquisition plan, identify whether you expect the resultant contract or contracts to involve human subjects.
  • Review proposals to identify any concerns with the offeror’s response to the solicitation’s human subjects evaluation.
  • Use the comments in the TER and any concerns identified in the review to develop questions that will form the basis of discussions with the offeror regarding the human subjects evaluation. Provide the written questions to the contracting officer.
  • Confirm whether the offeror has an OHRP-approved Federalwide Assurance and certification of IRB approval, then provide your findings in writing to the contracting officer.
  • During discussions, work with the contracting officer to ensure the offeror's revisions adequately resolve any concerns raised by the SRG.
  • After NIAID issues the restricted award, work with the contracting officer to monitor and ensure that the contractor is not conducting research involving human subjects until NIH lifts the restrictions.
  • To determine if the restriction should be lifted by the contracting officer, follow these steps.
    • For the Protection of Human Subjects from Research Risks or Data and Safety Monitoring factors, work with the contracting officer and with Office of Extramural Programs (OEP) staff to resolve an unacceptable rating.
    • For the Inclusion of Women and Minorities and Inclusion of Children factors, determine when an unacceptable rating has been adequately resolved. Provide a written determination to the contracting officer.

Contracting Officer

  • During negotiations with the offeror, use the written questions provided by the COR to discuss the human subjects evaluation factors.
  • To issue a restricted award, follow these steps:
    • Ensure that the contract includes terms that restrict research on human subjects until the contractor resolves the unacceptable rating or provides the necessary FWA or IRB approval.
    • Include the appropriate articles listed below in Section H, Special Contract Requirements, of the contract.
      • If an apparent successful offeror is not covered by an OHRP-approved Federalwide Assurance, include HHSAR 352.270-6, Restriction on Use of Human Subjects, in Section H.
      • If an apparent successful offeror does not have certification of IRB approval, include the appropriate Human Subjects article in Section H.
    • Notify OHRP when the restricted award is issued if the restriction was based on an IRB or FWA issue.
    • Notify the NIH OEP if the proposal to be awarded has an unacceptable rating on the Protection of Human Subjects From Research Risks.
  • After NIAID issues a restricted award, work with the COR to monitor and ensure that the contractor is not conducting research involving human subjects until the restrictions are resolved.
  • Once the issues that resulted in restriction are resolved, modify the contract to remove the clause or clauses restricting the use of human subjects. Any problems regarding human subjects protection must be resolved through OEP, following NIH Policy Manual Chapter 7410, and must be documented in the Source Selection Determination.


Lock icon: This link will not work for public visitors.Contact for NIAID Staff—DEA

Lock icon: This link will not work for public visitors.Contact for NIAID Staff—NIH Office of Extramural Programs

See the Office of Acquisitions staff listing for the appropriate contract specialist.

If you have knowledge to share or want more information on this topic, email with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.


Decision Trees for Human Subjects Requirements

HHSAR 352.270-4, Protection of Human Subjects

NIH Policy Manual 7410-Review and Documentation of Protections for Human Subjects in Extramural Grant Applications and Research and Development

NIH's Lock icon: This link will not work for public visitors.Policy Topic: Human Subjects Protection

Office for Human Research Protections

Trans-NIAID Clinical Research Toolkit

Last Updated April 13, 2016

Last Reviewed January 28, 2016