Notice Number: NOT-OD-06-054
Key Dates
Release Date: April 7, 2006
Update: The following update relating to this announcement has been issued:
- April 26, 2006 - Frequently Asked Questions - Replacing PI Signature with Institutional Compliance Requirement.
Issued by
National Institutes of Health (NIH), (http://www.nih.gov)
The purpose of this Notice is to inform the grantee community of a change regarding the signature of the Principal Investigator (PI) as a part of applications, post-submission information, progress reports, and post-award prior approval requests and the corresponding implementation of a new Institutional compliance requirement to secure and retain the PI signature as part of the institutional review/approval process.
The signature of the Principal Investigator is no longer required as a part of a submitted application. Instead, a new compliance requirement is now implemented whereby the applicant organization agrees to secure and retain at the organization a written assurance from the Principal Investigator (PI) prior to submitting an application to the PHS. While this assurance is no longer required as part of the submitted application, it remains a compliance requirement. Therefore, organizations must retain a unique signature and date for each submitted application. This assurance must be available to the sponsoring agency or other authorized HHS or Federal officials upon request. Such an assurance must include at least the following certifications: (1) that the information submitted within the application is true, complete and accurate to the best of the PI's knowledge; (2) that any false, fictitious, or fraudulent statements or claims may subject the PI to criminal, civil, or administrative penalties; and (3) that the PI agrees to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of the application. When multiple PIs are proposed in an application, this assurance must be retained for all named PIs.
This change is effective with competing applications submitted for submission/receipt dates May 10, 2006 and thereafter.
Changes to Specific Applications
PHS 398 Application
This change applies to all competing applications prepared using the PHS398 application for submission/receipt dates May 10, 2006 and thereafter. The Face Page (Form Page 1) of the PHS398 has been revised to remove the PI signature item; corresponding instructions have also been deleted. Part III Policy/Assurances/Definitions has been revised to now include the Principal Investigator Assurance as an institutional compliance requirement. See NIH Guide Notice NOT-OD-06-056 for additional details on changes to the PHS398.
Applications Using the SF424 Family of Forms
This change applies to all competing applications submitted electronically through Grants.gov using the SF424 family of forms and is effective for submissions with Open datesMay 10, 2006 and thereafter. The PI verification step in the eRA Commons is being eliminated. Instead, once an application package has been successfully submitted through Grants.gov, all errors corrected, and the application assembled by the eRA Commons , PD/PIs and AOR/SOs will have two business days to review the application. If everything is acceptable, no further action is necessary. The application will automatically move forward in the process after two business days. If, however, it is determined that the some part of the application was lost or didn't transfer correctly during the submission process, the AOR/SO will have the option to Reject the image and submit a Changed/Corrected application. See NIH Guide Notice NOT-OD-06-055 for additional details.
Annual Progress Reports (PHS2590)
This policy also applies to all progress reports submitted using the PHS2590 form. The Face Page (Form Page 1) of the PHS2590 has been revised to remove the PI signature item. Comparable instructions have also been deleted. See NIH Guide Notice NOT-OD-06-058 for additional details on changes to the PHS2590.
The equivalent PI approval currently developed in the eRA Commons E-SNAP module will be removed in the future.
Prior Approval Requests
Effective immediately, this policy also applies to all requests for NIH prior approval. The signature of the PI is no longer required on requests submitted to the agency; however, the grantee institution must secure and retain such documentation within their own internal processes.
In all cases, this assurance must be available to the sponsoring agency or other authorized HHS or Federal officials upon request.
Inquiries
Questions concerning this guide notice may be directed to:
Division of Grants Policy
Office of Policy for Extramural Research Administration
National Institutes of Health
Telephone: (301) 435-0938
Email: [email protected]
and Human Services (HHS)
