Bars to Grant Awards -- Human Subjects

Purpose

To prevent NIAID from making an award before human subjects assurances are in place and study section concerns and unacceptable gender, minority, and children codes are resolved.

Procedure

Initial peer review may be adversely affected if human subjects information is missing or insufficient.

Stemming from initial peer review recommendations, a bar to grant award prevents NIAID from making an award before all human subjects documentation is in place and scientific review group concerns are resolved.

A grant application with a human subjects code of 44 in IMPAC (also on the summary statement) indicates a bar to award that must be resolved before funding. NIH places bars on an application for either of the following reasons:

• An applicant institution does not have a human subjects assurance.
• The scientific review group has concerns with the application.

For a list of codes, go to Human Subjects Involvement Codes and Human Subjects Inclusion Codes.

Program and grants staff work with the NIH Office of Extramural Programs (OEP) to resolve code 44 bars to award before a fiscal year closes. OEP determines whether an applicant has adequately addressed concerns for a bar's removal. If so, OEP changes the code in IMPAC, lifts the bar, notes any restrictions, and notifies program and grants staff. This procedure usually takes a few weeks but may take longer.

If an application still has a bar at the end of a fiscal year, grants staff must request a temporary lift of the bar to issue a restricted award. OEP lifts the bar just long enough for grants staff to award the application with a restriction, and then OEP restores the bar. See End of Year for more details.

A grant application with a code indicating unacceptable gender, minority, or children inclusion indicates that the scientific review group determined that the application did not adequately address inclusion or exclusion of these study populations. To resolve concerns, an applicant must address unacceptable codes and submit the information to program staff. After program staff approve the documentation, grants staff will remove any bars.

Learn more about human subjects requirements at NIAID Human Subjects Policy on the Research Funding Web site and in the HHS Office for Human Research Protections: Policy Guidance (Human Subjects).

Applicants and Grantees

• If your institution does not have a Federalwide Assurance (FWA) approved by the Office for Human Research Protections (OHRP), contact OHRP to acquire an FWA.
  • Follow Step-by-Step Instructions for Filing a Federalwide Assurance for Institutions Within the United States or Instructions for Filing a Federalwide Assurance for International (non-U.S.) Institutions.
  • Read the Human Subjects Federalwide Assurances SOP.
• If you see an unacceptable code on your summary statement, contact your program officer. A human subjects code of 44 or unacceptable gender, minority, or children codes indicate a bar to award.
• For either scenario, submit all materials requested by your program officer. Your institution's business official must sign the cover letter for the documents or forward them in an email that reflects his or her title and signature block.

See the sections below for details.

Scientific Review Officers

• Educate reviewers in human subjects policies and instruct them to assess the acceptability of proposed human subjects research by following PHS 398 instructions (for paper applications) or Grants.gov Application Guide SF 424(R&R) instructions (for electronic applications).
• In the summary statement, document the final human subjects assessment and reasons for any unacceptable determinations.

Program Staff

Human subjects protection concerns and unacceptable gender, minority, and children codes. To lift a bar to award, do the following:

• For human subjects protection concerns, request that the applicant institution submit a revised Research Plan and date the Human Subjects Research section. Send this request within ten working days of a summary statement's release. The resubmission should resolve any concerns indicated in the summary statement. The business official must sign this.
• For unacceptable gender, minority, or children codes, request that the applicant institution provide information to adequately address the inclusion or exclusion of women, minorities, and children. Send the request within ten working days of a summary statement's release.
• Gather all documentation related to the resolution of concerns (code 44), signed by the applicant's business official. When complete, forward this information with the appropriate Request to Remove Human Subjects Bar to Funding template email to your division point of contact.
• Forward the applicant institution's response regarding unacceptable gender, minority, and children codes and your approval to the grants management specialist who will lift the bar.

Division Point of Contact

• Assist program officers with questions concerning complex human subjects issues.
• Review the documentation attached to a Request to Remove Human Subjects Bar to Funding email for content and completeness. Finish the review within two working days after receiving the email from a program officer.
• If the documentation is acceptable and complete, forward the cover email and attached documents to Contact for NIAID Staff and copy the grants management specialist and the NIAID DEA DART mailing list.

Grants Management Specialists

• Notify the grantee institution and recommend that it apply for a Federalwide Assurance with OHRP and follow Step-by-Step Instructions for Filing a Federalwide Assurance for Institutions Within the United States or Instructions for Filing a Federalwide Assurance for International (non-U.S.) Institutions. See the Human Subjects Federalwide Assurances SOP.
• Once OHRP establishes an assurance and gives it a number, email a request to Contact for NIAID Staff to lift the bar.

Human Subjects Concern. To lift a bar to award because of human subjects concerns identified by the scientific review group:

• Issue an award after OEP has removed the bar to award and all other required documentation has been received and found acceptable. Include any restrictions noted on the email from OEP.
• File the applicant's response, program's concurrence, and OEP's approval in the official electronic grant file.

Unacceptable Gender, Minority, and Children Codes. To lift a bar to award because of unacceptable codes:

• Obtain the documentation that the applicant institution submits. The documentation should reflect the program officer's approval.
• Change the unacceptable codes to "R" indicating resolution, file the documentation in the electronic grant file, and issue the award based on the documentation and the program officer's approval.

End of Year. To temporarily lift a code 44 human subjects bar to award so NIAID may award an application at the end of a fiscal year with restrictions:

• OEP will notify grants management specialists, usually in early August, when it permits restricted awards for the end of the fiscal year.
• Email OEP Contact for NIAID Staff requesting a temporary lift of the application's bar.
• OEP will lift the bar and send you an email reflecting the restriction terms for the award.
• Include the restrictions on the Notice of Award and remind the grantee to read the terms and conditions of award. The restrictions will prevent the grantee from spending funds until OHRP approves the assurance, paperwork is submitted to resolve concerns, and a revised award notice has been issued.
• After the end of the fiscal year, OEP will restore the bar to award.
• Follow up on required assurances and documentation addressing human subjects concerns. Send documentation regarding resolution of concerns (code 44) to the program officer for review, and if approved, send an email with PDF attachments of the applicant's response and program staff's approval to Contact for NIAID Staff.
• OEP will review the documentation that the assurance has been obtained and concerns have been adequately addressed. Afterwards, OEP will remove the bar, and grants staff will issue a revised award removing the restriction.

To temporarily lift a bar for unacceptable gender, minority, and children codes:

• Change the "U" to "C" (for Conditional) and issue a restricted award.
• Follow up with the grantee, obtain the required documentation, and forward it to the program officer for review. Once approved, issue a revised Notice of Award removing the restriction.

Contacts

NIAID Points of Contact for issues involving bars to awards:

• DAIDS -- Contact for NIAID Staff and back-up Contact for NIAID Staff
• DAIT -- Contact for NIAID Staff
• DMID -- Contact for NIAID Staff

NIAID staff should email Contact for NIAID Staff.

Applicants or grantees with questions should Contact Staff for Help.

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov.

Links

Bars to Grant Awards SOP

Decision Trees for Human Subject Requirements

Protection of Human Subjects: Assurance Identification/IRB Certification/Declaration of Exemption form

End-of-Year Funding Timelines and Processes SOP

Grants Management Infonet Policy Topic: Human Subjects Protection

Human Subjects in Research Requirements SOP

OER Human Subjects Web Site: NIH Procedures Related to Human Subjects Research and OEP End-of-Fiscal Year HS Code Change Procedures

IMPAC and CRISP SOP

Trans NIAID Clinical Research Toolkit