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Bars to Grant Awards—Human Subjects SOP

Lock icon: This link will not work for public visitors.Some links will work for NIAID staff only.

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

Purpose

To prevent NIAID from making an award before resolving scientific review group (SRG) 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.

SRG recommendations may prevent NIAID from making an award before human subjects documentation is in place and SRG 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 II 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 reviews just-in-time (JIT) documentation to determine whether an applicant has adequately addressed reviewer concerns so it can remove a bar.
    • If OEP still has concerns or feels that the JIT documentation is fragmentary, it will request additional information.
    • If OEP feels that all concerns have been addressed, it will change the code in IMPAC II, lift the bar, note any restrictions, and notify program and grants staff.
  • If an application still has a bar at the end of a fiscal year, grants staff may request that OEP change the award's code from 44 to 48 to allow grants management staff to issue a restricted award. See End of Year for more details.
  • Requests go through NIH's Lock icon: This link will not work for public visitors.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. Each division has created its own process for using HS-PAS.
  • This procedure usually takes a few weeks but may take longer depending on the time of year.

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 HHS's Policy and Guidance 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. Find more information below under the Program Staff header.
  • 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 44), 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 (AOR) signature.
    • Submit the information via HS-PAS and indicate the assigned grants management specialist for “IC Staff Who Need Access to This File.”
  • 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 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.
  • If the documentation is acceptable and complete, send a request to lift the bar, along with documentation, to OEP though Lock icon: This link will not work for public visitors.HS-PAS. You can delegate this task to program officers.
    • Add program officer, grants management specialist, and DEA Policy Shop mailing list as additional contacts under "IC Staff Who Need Access to This File." They will 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 information from a program officer.

Grants Management Specialists

Below are actions to lift a bar to award 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 Lock icon: This link will not work for public visitors.Human Subjects SOP for more details.

Human Subjects Concern.

To lift a bar to award reflecting the SRG's concerns about human subjects protections:

  • Issue an award after OEP removes the bar to award. If OEP includes restrictions, put them 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 permits NIAID to award applications with restrictions on human subjects research. However, it does not permit NIAID to award applications with code 44 bars to award.

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

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 Lock icon: This link will not work for public visitors.HS-PAS to request a change of the award's code to 48. OEP will change the code and email you terms for the award for the restriction.
  • After receiving restriction language from OEP, add it to 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.
  • 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 through Lock icon: This link will not work for public visitors.HS-PAS.

Applicants or grantees with questions should read Communicating With NIAID—How to Get 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

Lock icon: This link will not work for public visitors.End-of-Year Funding Timelines and Processes SOP

NIH's Lock icon: This link will not work for public visitors.Policy Topic: Human Subjects Protection

Lock icon: This link will not work for public visitors.OEP-HS Procedures for Changing Codes

Lock icon: This link will not work for public visitors.HS-PAS Instructions for Submissions

Human Subjects in Research Requirements SOP

IMPAC SOP

Trans NIAID Clinical Research Toolkit​​​

Last Updated June 23, 2015

Last Reviewed May 28, 2015