See the Glossary for more terms.
Some links will work for NIAID staff only.
This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.
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.
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.
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.
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.
Roles differ by division. Here is the general process.
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 SOP for more details.
Human Subjects Concern. To lift a bar to award reflecting the scientific review group's concerns about human subjects protections:
Unacceptable Gender, Minority, and Children Codes. To lift a bar to award because of unacceptable inclusion codes:
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:
To issue a restricted award for unacceptable gender, minority, and children codes:
NIAID Points of Contact for issues involving bars to awards:
NIAID staff should contact OEP through 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 email@example.com.
Bars to Grant Awards SOP
Decision Trees for Human Subject Requirements
End-of-Year Funding Timelines and Processes SOP
NIH's Policy Topic: Human Subjects Protection
OEP-HS Procedures for Changing Codes
HS-PAS Instructions for Submissions
Human Subjects in Research Requirements SOP
Trans NIAID Clinical Research Toolkit
Last Updated November 20, 2014
Last Reviewed February 11, 2013