Contracts Involving Human Subjects

Purpose

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.

Procedure

NIAID issues an unrestricted award that allows an offeror to conduct research on human subjects research if both of these criteria are met:

• The offeror has both a HHS Office of Human Research Protections (OHRP)-approved Federalwide assurance and 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 was resolved during negotiation.

NIAID issues a restricted award when one or both of those criteria are not met. The contract includes language restricting research on human subjects until the issues are resolved.

This SOP describes the restricted award process.

Offerors

• Follow the instructions in the solicitation regarding human subjects.
• Address the human subjects evaluation factors described in the request for proposals. The human subjects evaluation may include these factors: Protection of Human Subjects From Research Risks, Inclusion of Women and Minorities, Inclusion of Children, and Data and Safety Monitoring.
• File an acceptable Federalwide assurance with the HHS Office of Human Research Protections. Follow Step-by-Step Instructions for Filing a Federalwide Assurance for Institutions Within the United States or the Instructions for Filing a Federalwide Assurance for International (non-U.S.) Institutions.
• 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 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 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 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 subject factor and include an explanatory statement for that rating in the technical evaluation report (TER).

Project Officers

• 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 and to determine whether the offeror has a HHS Office of Human Research Protections-approved Federalwide assurance and certification of IRB approval, if required before award.
• 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 a 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 lift restrictions, 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 Officers

• During negotiations with the offeror, use the written questions provided by the project officer to discuss the human subjects evaluation factors.
• You may award a restricted contract if an unacceptable rating for human subjects is not resolved before the offeror submits the Final Proposal Revisions at the end of negotiations.
• To issue a restricted contract, follow these steps:
  • Ensure that the contract includes terms that restrict research on human subjects until the contractor resolves the unacceptable rating.
• 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 352.270-14, Restriction on Use of Human Subjects, in Section H.
    • This restriction applies to all U.S. or foreign collaborating sites and subcontractors.
    • The contractor must ensure that collaborators and subcontractors comply.
    • Verify whether an organization has an OHRP-approved Federalwide assurance in OHRP's Human Research Protections Database.
  • If an apparent successful offeror does not have certification of IRB approval, include the Human Subjects article in Section H.
• Notify OHRP when the restricted award is issued.
• Notify the NIH OEP if the proposal to be awarded has an unacceptable rating on the Protection of Human Subjects From Research Risks or Data and Safety Monitoring factors.
• After NIAID issues a restricted award, work with the project officer to monitor and ensure that the contractor is not conducting research involving human subjects until the restrictions are resolved.
• To lift contract restrictions after award, work with the project officer to follow these steps:
  • For the Protection of Human Subjects From Research Risks or Data and Safety Monitoring factors, work with the project officer and OEP staff to resolve an unacceptable rating.
• For the Inclusion of Women and Minorities and Inclusion of Children factors, the project officer may determine that an unacceptable rating has been adequately resolved.
  • The project officer provides a written determination to the contracting officer.
  • Include the determination in the contract file.
• Notify OHRP that the restriction is lifted.

Contacts

Contact for NIAID Staff

NIH Office of Extramural Programs
Contact for NIAID Staff

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 deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

Decision Trees for Human Subjects Requirements

Grants Management Infonet Policy Topic: Human Subjects Protection

HHSAR 352.270-8, Protection of Human Subjects

NIH Manual Issuance 6380-1, Contracts Involving Human Subjects

Office for Human Research Protections

Trans NIAID Clinical Research Toolkit