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Standard Operating Procedure Table of Contents
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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.
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.
- 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.
- 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.
Lack of Federalwide Assurance. If no human subjects FWA is
on file with OHRP:
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:
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
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