Bars to Grant Awards -- Human Subjects

Purpose

To prevent NIAID from making an award before resolving scientific review group concerns about the protection of human subjects or unacceptable gender, minority, or children inclusion.

Procedure

Missing or insufficient human subjects information may adversely affect an application's priority score and can result in a bar to award.

Peer reviewer recommendations may prevent NIAID from making an award before human subjects documentation is in place and scientific review group concerns are resolved.

• A bar concerning the protection of human subjects is indicated by a code 44 on the summary statement and in the IMPAC database. Find a list of codes at Human Subjects Involvement Codes.
• A bar can also result when reviewers determine that an application does not adequately address inclusion or exclusion of gender, minorities, or children. See Human Subjects Inclusion Codes.

To resolve bars relating to the protection of human subjects, program staff work with applicants and the NIH Office of Extramural Programs (OEP) before a fiscal year closes.

• OEP determines whether an applicant has adequately addressed reviewer concerns so it can remove a bar.
• 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 that OEP change the award's code to 48. Then grants staff can issue a restricted award. See End of Year for more details.

To resolve inclusion issues, an applicant must address the problems and submit information to NIAID program staff. After program staff approve the documentation, grants staff remove any bars.

If an institution does not have a Federalwide Assurance (FWA) from OHRP, NIAID will withhold funding until an FWA is in place. Read more in the Human Subjects Federalwide Assurances SOP.

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 an 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.
  • Find more information below under the Program Staff header.
  • 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.
• If we issue your award in August or September, be sure to read the terms and conditions of award to check for any restrictions.

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

To request that OEP lift a bar to award, do the following:

• For human subjects protection concerns (code 44), request that the applicant institution submit a revised, dated Research Plan, including the Human Subjects Research section.
  • Make sure the resubmission resolves concerns in the summary statement and the institutional business official signs it.
  • When complete, forward that information and an emailto OEP -- use the Request to Remove Human Subjects Bar to Funding template email -- to your division point of contact.
• For unacceptable inclusion codes, ask the applicant institution to send information to adequately address the inclusion or exclusion of women, minorities, and children.
  • Forward the applicant institution's response and your approval of it to the grants management specialist, who will lift the bar.
• Send either request within ten working days of a summary statement's release.

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.
  • If it is not acceptable, send it back to the program officer with a written explanation.

Grants Management Specialists

Below are actions to lift a bar to award, delay an award due to lack of an FWA, and issue a restricted award at the end of a fiscal year.

• Notify the grantee institution and recommend that it apply for an FWA with OHR, following 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.
• After OHRP establishes an assurance, email a request to Contact for NIAID Staff.

Human Subjects Concern. To lift a bar to award reflecting the scientific review group's concerns about human subjects protections:

• Issue an award after OEP has removed the bar to award. Include any restrictions noted in the email from OEP in the terms and conditions of award.
• 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 inclusion codes:

• Obtain the documentation from the applicant institution, including the program officer's comments and written approval.
• Change 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. At the end of a fiscal year, OEP can change code 44 bars to code 48 so NIAID may award an application with restrictions. Usually in early August, OEP notifies grants management specialists when it permits restricted awards for the end of the fiscal year. Go through this process as follows:

• Email OEP Contact for NIAID Staff requesting a change of the award's code to 48. OEP will change the code 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 the concerns to the program officer for review.
  • After the program officer approves, email Contact for NIAID Staff, attaching PDFs of the applicant's response and program staff's approval.
  • OEP will check that the assurance is in place and concerns are adequately addressed.
• After OEP approves, issue a revised award removing the restriction.

To issue a restricted award 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