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 overall impact/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.
• Requests go through NIH's Human Subjects Protection Assessment System (HS-PAS). Staff use the system to track the progress of their requests, send supporting documents, and communicate with OEP.

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 the Office for Human Research Protections (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

• Contact your program officer if you see a problematic code in your summary statement.
• 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 has his or her title and signature block.
• If your institution does not have an FWA approved by 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 we issue your award in August or September, be sure to read the terms and conditions of award to check for any restrictions.

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 updated Human Subjects Research section.
  • Make sure the institution has resolved concerns in the summary statement and included its institutional business official's signature.
  • If the new information is enough to lift the bar, forward documentation to your division point of contact, who sends it to OEP or advises you on what else to do. Use the Request to Remove Human Subjects Bar to Funding template email.
• 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.
• If the documentation is acceptable and complete, send a request to lift the bar, along with documentation, to OEP though HS-PAS. You can delegate this task to program officers.
  • Add program officer, grants management specialist, and NIAID DEA DART mailing list as additional contacts under "IC Staff Who Need Access to This File." They get a confirmation email with link to view the request.
  • If you delegate the task, make sure you are included on the list of additional contacts.
  • Only staff who are listed as additional contacts have permission to view the request.
• If the documentation is incomplete or not acceptable, send it back to the program officer with a written explanation.
• Finish the review within two working days after receiving the email from a program officer.

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. Do not make code changes on your own -- this is OEP's responsibility.

See GMP's Human Subjects Research—Assurances, Approvals, Certifications, and Bars to Award SOP for more details.

• Notify the grantee institution and recommend that it apply for an FWA, 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 removes the bar to award. If OEP includes restrictions, put those 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.

• Use HS-PAS to request 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.
  • When you send the request, add program officer, division coordinator, and the NIAID DEA DART mailing list as additional contacts under "IC Staff Who Need Access to This File." They get a confirmation email with link to view the request.
  • Only staff who are listed as additional contacts have permission to view the request.
• Include the restrictions on the Notice of Award and remind the grantee to read the terms and conditions of 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, add PDFs of the applicant's response and program staff's approval to your HS-PAS request.
  • OEP checks that 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 contact OEP through HS-PAS.

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

End-of-Year Funding Timelines and Processes SOP

Grants Management Infonet Policy Topic: Human Subjects Protection

HS-PAS Instructions for Submissions

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 RePORTER SOP

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

Trans NIAID Clinical Research Toolkit