Bars and Restrictions to Grant Awards—Human Subjects SOP

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

Some links will work for NIAID staff only.

Purpose

To prevent NIAID from making an unrestricted award before resolving scientific review group (SRG) concerns about the protection of human subjects or unacceptable sex, minority, or age group inclusion.

Procedure

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

SRG recommendations may cause NIAID to restrict or hold an award until human subjects documentation is in place and SRG concerns are resolved.

  • A restriction concerning the protection of human subjects is indicated by a code 48 on the summary statement and in the IMPAC II database. Find a list of codes at Human Subjects Involvement Codes.
  • A bar to award can result when reviewers determine that an application does not adequately address inclusion or exclusion of sex, minorities, or age groups. See Human Subjects Inclusion Codes.

To resolve concerns relating to the protection of human subjects, program staff should work with applicants and the appropriate Grants Management Program (GMP) staff.

  • Program staff reviews just-in-time (JIT) documentation to confirm that the applicant has provided an active institution review board (IRB) approval date and to determine if an applicant has adequately addressed reviewer concerns.
    • Program staff can request additional information if he or she still has concerns.
    • Once program staff feels that all concerns have been addressed, he or she can email GMP staff to resolve the award restriction (changing the human subjects involvement code from 48 to 10, E4, 30, etc.).
    • Program should send GMP staff any additional documentation requested from the grantee and add a comment in the PO checklist indicating that “the protection of human subject concerns have been resolved.”
  • If an application is still tagged with Code 48 at the end of the fiscal year, GMP staff may issue a restricted award.
  • This procedure generally takes several weeks—review periods will vary depending on the time of year and can change on a case by case basis.

To resolve inclusion issues, an applicant must address the problems and submit information to NIAID program staff. After program staff has approved the documentation, grants staff should be notified of the resolution and forwarded any supporting documentation.

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 Research Using Human Subjects under Research With Special Considerations and at HHS Regulations & Policy on human subjects.

Applicants and Grantees

  • Contact your program officer if you see a problematic code in your summary statement.
  • Using the Just-in-Time (JIT) module in eRA Commons, send all material that NIAID requests. Work with your (IRB) as necessary to ensure that Human Subject concerns have been appropriately addressed. Find more information on submitting materials below under the “Program Staff” header.
    • The IRB is responsible for review and approval of finalized human subjects’ research protocols
  • If your institution does not have an FWA approved by OHRP, contact OHRP to acquire an FWA.
  • If NIAID issues your award in August or September, be sure to read the terms and conditions of award to check for any restrictions found in Section IV of the Notice of Award.

Scientific Review Officers

  • Educate reviewers in human subjects policies and instruct them to assess the acceptability of proposed human subjects research.
  • In the summary statement, document the final human subjects assessment and reasons for any unacceptable determinations.

Program Staff

Roles differ by division. Here is the general process:

  • For human subjects protection concerns (code 48), do the following if the grant is likely to be funded:
    • 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 authorized organizational representative’s signature.
    • Contact the assigned grants management specialist and provide the supporting documentation along with a request or the appropriate code change. Copy your division point of contact on the message.
    • Include a comment in the PO checklist indicating that “the protection of human subject concerns have been resolved.”
  • For unacceptable inclusion codes
    • Ask the applicant institution to send information to adequately address the inclusion or exclusion of women, minorities, or age groups.
    • Forward the response and your approval of it to the grants management specialist.
    • Indicate any changes to the Inclusion Codes.
    • You may ask applicants to submit information using the Just-in-Time module in eRA Commons.
  • Send either request within ten working days of a summary statement's release.

Division Point of Contact

Roles differ by division. Here is the general process.

  • Assist program officers with questions concerning complex human subjects issues.
  • Review documentation related to removing human subjects bar to funding.
    • Keep in mind, the applicant’s IRB holds final authority for ethical review and approval, and NIH policy states that an active IRB approval is adequate documentation of an awardee institution having acceptable human subject protocol and procedures
  • Send a request to lift the bar, along with documentation, to the assigned GMP staff. You can delegate this task to program officers if the documentation is acceptable and complete.
    • If you delegate the task, make sure you are copied on any communications.
  • 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 information from a program officer.

Grants Management Specialists

Below are actions to resolve an award restriction, lift a bar to award, and issue a restricted award at the end of a fiscal year. Do not make code changes before receiving and documenting the supporting information from program staff.

See the GMP Human Subjects SOP for more details.

Human Subjects Concern. To resolve an award restriction reflecting SRG concerns about human subjects protections

  • Change the award’s human subjects involvement code in IMPAC II from 48 to 30, E4, 10, etc.
  • Issue an award. If program staff include restrictions, put them in the terms and conditions of award.
  • File the applicant's response and program's concurrence in the official electronic grant file.

Unacceptable Sex, Minority, or Age 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, NIAID may award applications with restrictions on human subjects research.

NIAID decides late in the fiscal year whether to make restricted awards and may instead decline to fund applications with Code 48 restrictions.

To make restricted awards at the end of a fiscal year, grants management staff do the following:

  • Confirm with a branch chief that NIAID will issue the restricted award.
  • Use the restrictive language from Office of Extramural Research’s Human Subjects Research Awards: Example of Restrictive Terms; add it to the Notice 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 the electronic grant file.
  • 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

NIAID staff should contact OEP by emailing Office of Extramural Programs—Human Subjects.

Applicants or grantees with questions should read Contacting Program Officers and Grants Management Specialists.

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

Links

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