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 award before an institution has its research misconduct documentation in place.
Procedure
To receive funding for any grant except a conference grant, institutions have to establish and maintain an assurance that certifies they have a process for responding to allegations of research misconduct as described in federal regulation 42 CFR Part 93.
Institutions establish their assurances the first time their institutional business officials sign the SF 424 Cover page. The grants management specialist forwards the cover pages to the HHS Office of Research Integrity (ORI), which establishes a record for each institution and sends a welcome letter.
ORI will impose a bar to award for any institution that has not submitted its annual report.
Recipient Institutions
- File an Annual Report on Possible Research Misconduct through the ORI Assurance Program - Annual Report System.
- Keep policies and procedures updated at all times.
- If contacted by ORI, produce compliance documents immediately.
- For more on institutional responsibilities, see the NIH Research Integrity portal.
Grants Management Specialists
- Look out for red bars and yellow warnings in eRA Modules and Services.
- Yellow warning means an institution has not established an assurance with ORI but should still receive its award. These warnings are most often used for new institutions.
- Red bar means an institution failed to update its ORI research misconduct assurance or make required modifications to its institutional policy. Do not issue its award.
- To lift a bar or warning, email the ORI assurance program manager.
- ORI collects the documents necessary to lift the bar or remove the warning, then updates IMPAC and notifies NIAID.
- If ORI recommends terminating an award or will not lift the red bar, immediately consult with NIAID’s chief grants management officer (CGMO), who will decide the next appropriate action. If the CGMO concurs that terminating the award is the appropriate outcome, determine what approval(s) and additional documentation are required.
Contacts
ORI assurance program manager—Contact for NIAID Staff
Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at deaweb@niaid.nih.gov.