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NOT-OD-06-054: NIH Announces Change in Business Process: Replacing Principal Investigator Signature on Grant Applications, Progress Reports, and Prior Approval Requests with an Institutional Compliance Requirement

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1. As per NOT-OD-06-054, NIH Announces Change in Business Process: Replacing Principal Investigator Signature on Grant Applications, Progress Reports, and Prior Approval Requests with an Institutional Compliance Requirement, “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.” The Guide Notice also states that “this assurance must be available to the sponsoring agency or other authorized HHS or Federal officials upon request”.
2. Is it the intention of NIH that institutions should have the PI provide all three assurances along with his/her signature? If so, does this apply to prior approval requests as well as new, competing, and non-competing applications?
3. When submitting an application, it is understood that the grantee must retain an original signature on file for our PI/Co-Investigator. Are they also required to have this same signature/assurance for the PI on a subcontract that is included as part of our submission?
4. With the PI/PDs signature on applications, progress reports and post-award prior approval request forms now replaced with a PI assurance on file with the grants office, does the grantee organization need a hard copy on file for Final Invention Statements if the PI is submitting it via eRA Commons?
5. In the second paragraph of this Guide Notice, it states that the organization must retain an assurance from the PI “prior to submitting an application to the PHS.” Does the requirement for maintaining a record of assurance from the PI apply to only NIH applications, or is this notice meant to apply for all PHS applications?
6. If the eSNAP application is not submitted through the central SO office, but through the PI instead, is a new assurance required? (These are viewed as a "scientific report" rather than an application so does the new assurance requirement apply?)
7. Is it acceptable for the PI to delegate authority to someone else to sign for him/her?

1. As per NOT-OD-06-054, NIH Announces Change in Business Process: Replacing Principal Investigator Signature on Grant Applications, Progress Reports, and Prior Approval Requests with an Institutional Compliance Requirement, “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.” The Guide Notice also states that “this assurance must be available to the sponsoring agency or other authorized HHS or Federal officials upon request”.
   The applicant organization may secure a “written assurance” from the PI in either a traditional “handwritten” format or through alternative methods.   Examples of an alternative method for obtaining the PI assurance might include:
   
   1)  An electronic or on-line review/approval system that distinctly captures the PI assurance
   2) A scanned copy of a PI signature certifying to an assurance
   3)  A faxed copy of a PI signature certifying to an assurance
   4)  An e-mail from a unique e-mail account belonging to a PI containing the appropriate assurance
   
   However, whichever method is chosen, the organization must be able to ensure authenticity of the signature.  As per NOT-OD-06-054, “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."
2. Is it the intention of NIH that institutions should have the PI provide all three assurances along with his/her signature? If so, does this apply to prior approval requests as well as new, competing, and non-competing applications?
   The requirement is a single assurance which cannot be broken apart. It applies to all applications (new, renewals, resubmissions, revisions) and progress reports.
   
   For prior approvals, the assurance requirement is slightly different. The applicant organization must secure and retain the PIs dated signature (verifying review and approval) for the specific request and be able to prove its authenticity.
3. When submitting an application, it is understood that the grantee must retain an original signature on file for our PI/Co-Investigator. Are they also required to have this same signature/assurance for the PI on a subcontract that is included as part of our submission?
   NIH does formally recognize “Co-I.” As NIH begins to recognize multiple PIs, this institutional assurance requirement will apply to all individuals assigned the role of PI. Then it will be the responsibility of the prime institution to secure and retain such an assurance from all PIs, regardless of their institutional affiliation. Since the role of Co-I has never required a signature be submitted to the NIH as part of the application, there is no change in any assurance associated with that particular role.
   
   The NIH does not currently require signatures from the subcontract grantee to be submitted as part of the application. The prime institution may require such, but those are not currently a requirement as part of the submitted application. Therefore, this change in the PI assurance requirement does not change the information submitted to NIH from a subcontract organization. It continues to be the responsibility of the prime and subcontract organizations to determine the appropriate documentation between the two institutions.
   
   As per the NIH Grants Policy Statement, http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600259 - “The grantee must enter into a formal written agreement with each consortium participant that addresses the negotiated arrangements for meeting the scientific, administrative, financial, and reporting requirements of the grant, including those necessary to ensure compliance with all applicable Federal regulations and policies and facilitate a smoothly functioning collaborative venture.”
4. With the PI/PDs signature on applications, progress reports and post-award prior approval request forms now replaced with a PI assurance on file with the grants office, does the grantee organization need a hard copy on file for Final Invention Statements if the PI is submitting it via eRA Commons?
   Currently, in the eRA Commons Closeout system, the PI assures that “...to the best of [their] knowledge and belief, no inventions were conceived or first actually reduced to practice during the course of the work under the referenced DHHS grant or award for the specified period.” We are still in the process of determining what effect this policy change has on all Commons applications.
   
   For now, this PI certification will remain as currently designed. However, NIH will be evaluating removing this and retaining only the similar certification from the authorized organizational representative. Should that happen, then the responsibility to retain this type of certification will become that of the organization.
5. In the second paragraph of this Guide Notice, it states that the organization must retain an assurance from the PI “prior to submitting an application to the PHS.” Does the requirement for maintaining a record of assurance from the PI apply to only NIH applications, or is this notice meant to apply for all PHS applications?
   This NIH Guide Notice pertains to all applications using the PHS398 and all progress reports using the PHS2590. However, other agencies that use these forms and instructions are still in the process of determining implementation. There may be other notices published that address other agencies using the PHS398 and PHS2590. The NIH suggests you contact the other agency for guidance.
6. If the eSNAP application is not submitted through the central SO office, but through the PI instead, is a new assurance required? (These are viewed as a "scientific report" rather than an application so does the new assurance requirement apply?)
   No. ESNAP provides grantee organizations with the option of delegating submit authority to PIs. The PI/PD will still be able to submit eSNAPs if the SO has delegated him/her the authority to do so. This in no way alters the responsibility of the authorized organizational representative/signing official with respect to complying with the required assurances and certifications.
   
   We are still in the process of determining what effect this policy change has on all Commons applications, including eSNAP, particularly when the PI is delegated submit authority. For now, the PI assurance in eSNAP will remain as currently designed. However, NIH will be evaluating removing this and retaining only the similar certification from the authorized organizational representative. Should that happen, then the responsibility to retain this type of certification will become that of the organization.
7. Is it acceptable for the PI to delegate authority to someone else to sign for him/her?
   No. In the PHS 398, the NIH allows delegation for the AOR in the case where a “For” signature is necessary. However, for the PI, the NIH requires a dated original signature, in ink. “For” or “Per” signatures are not acceptable.