What is the definition of Program Director/Principal Investigator (PD/PI)?
The Program Director/Principal Investigator (PD/PI) is defined as the individual(s) judged by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the grant. The applicant organization may designate multiple individuals as PD/PIs who share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the applicant organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program including the submission of all required reports. The presence of more than one identified PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI.
Why does NIH allow multiple-PD/PIs on individual research awards?
This effort represents an NIH Roadmap initiative as well as a response to a Federal-wide directive to formally allow more than one PD/PI on individual research awards. In addition, a major recommendation from the 2003 NIH Bioengineering Consortium Symposium on Catalyzing Team Science was to allow more than one PI on individual grants. The policy offers approaches to maximize the potential of team science efforts. The multiple-PD/PI model supplements, and does not replace, the traditional single-PD/PI model. Although the single-PD/PI model clearly continues to work well and encourages creativity and productivity, it does not always facilitate multidisciplinary efforts and collaboration. Increasingly, health-related research involves teams that vary in terms of size, hierarchy, location of participants, goals, disciplines, and structure. The selection of the multiple-PD/PI versus single-PD/PI option is the decision of the applicant institution and investigators, and must be based on the needs of the research proposed. Although the number of applications submitted using the multiple-PD/PI model is relatively small compared with those within the traditional single-PD/PI format, the impact of the research supported through multidisciplinary efforts can be significant.
To what specific type of research efforts is the multiple-PD/PI model aimed? Can you provide examples of research teams to which this model would, and would not, apply?
The selection of either the single- or multiple-PD/PI option should be based on the research proposed to ensure optimal management of the project. The multiple-PD/PI option can facilitate multidisciplinary and other types of team science projects that are not optimally served by the single-PD/PI model. Projects suitable for the multiple–PD/PI model could include as few as two PD/PIs who are jointly responsible for the scientific and technical direction of the project. An example of a multiple-PD/PI project would be a jointly-directed obesity research effort to identify the relationship of specific alleles to particular phenotypes. In this example, experts in imaging, genetics, clinical obesity research and metabolism might work together as equal partners in the direction of the project. However another applicant with similar goals might structure the roles of similar investigators using a single PD/PI model and collaboration with individuals that offer the necessary expertise. The optimal leadership approach is the decision of the applicant institution and the PD/PI(s).
To which grant mechanisms does the multiple-PD/PI model apply?
The multiple-PD/PI option is extended to most research grant applications submitted electronically through Grants.gov using the SF424 R&R application package. If the multiple-PD/PI model is not allowed, the Funding Opportunity Announcement (FOA) will state that “Multiple Principal Investigators (mPI) are not permitted.” under Section III, Eligible Individuals.
B. Principal Investigator/Program Director Roles and Responsibilities
How is PD/PI defined on a multiple-PD/PI grant?
The PD/PI is defined the same way regardless of the number named on a particular application or award. See Question A.1. above.
Is there a minimum level of effort required to qualify to be a PD/PI?
Each PD/PI must have measurable effort (greater than zero), and the level of effort must be adequate to achieve the proposed goals. Some FOAs include a specific minimal level of effort for PD/PIs, and in those cases the FOA specifications apply.
Is there a ceiling on the number of PD/PIs?
There is no upper limit on the number of PD/PIs, although the involvement of each PD/PI should be justified by the aims of the project. In addition, anyone designated as a PD/PI must meet the criteria given in A.1. A proposal that involves PD/PIs that appear to have questionable qualifications and expertise or appear to make an insufficient contribution to justify a PD/PI role will not fair well in the review process. Except in unusual circumstances a single project, multiple PD/PI grant application (e.g., R01, R21) is unlikely to have more than two to three PD/PIs.
Can there be a Lead PI within the multiple-PD/PI model?
All PD/PIs have equal responsibility and accountability for leading and directing the project. The structure and interaction of the PD/PI team will be left up to the PD/PIs and the applicant institution. All PD/PIs must be qualified to serve as PD/PIs and will share responsibility for the project. Although the PD/PIs may identify a leader of the project or a coordinator of the overall team, that is not a role that NIH formally acknowledges. Smaller teams composed of PD/PIs of equal rank within the institution may function best in an equal partnership without an identified coordinator. If any team believes it necessary to identify a spokesperson or coordinator responsible for organizing the leadership team of a particular project, that role and rationale should be explained in the Leadership Plan.
How is the Leadership Team to make decisions? If one PD/PI moves, or doesn’t produce, who will assume responsibility?
Applicants must provide a Leadership Plan in every application proposing a multiple PD/PI approach. The Leadership Plan should describe the roles and areas of responsibility of the named PD/PIs, the process for making decisions concerning scientific direction, allocation of resources, disputes that may arise, and other information related to the management of the proposed team science project. The purpose of the Leadership Plan is to facilitate and enhance scientific productivity and ensure that there is a decision-making process in place. This approach has been used successfully for cooperative agreements and various types of multi-project grants. It may be necessary to identify a single individual who can coordinate the project or serve as a tie-breaker in case of disagreements. Another option is to refer disagreements to an arbitration committee or a designated senior official at the institution. If a PD/PI moves or leaves the project team, the NIH must be notified. The process and the threshold for notification of the NIH for changes in the PD/PIs and other key persons is exactly the same as it is for single PD/PI projects and can be found in the Grants Policy Statement under 188.8.131.52.
What is the role of the Contact PD/PI?
NIH requires the applicant organization to designate one of the PD/PI(s) as the Contact PD/PI. This person is responsible for communication between the PD/PIs and the NIH, but has no special authorities or responsibilities within the project team. In many ways, a contact PD/PI is analogous to a corresponding author on a publication. The Contact PD/PI must serve as a member of the PD/PI team and must meet all eligibility requirements for PD/PI status. In those projects where there is an identified project coordinator, the coordinator could serve as Contact PD/PI or that role could be assigned to another PD/PI. It will be possible, and may even be desirable, for the grantee institution to periodically designate a change in Contact PD/PI. For example, it may be desirable to rotate the role of Contact PD/PI among the multiple PD/PIs on an annual basis at the time of grant renewal. Note that the Contact PD/PI must be associated with the applicant/awarde institution.
Does scientific advice or consultation alone qualify someone for PD/PI status?
No, scientific advice or consultation alone does not qualify someone as a PD/PI. Each PD/PI must share responsibility for the scientific and technical direction of the project as a whole and will remain accountable to the grantee organization and to the NIH for the proper conduct of the project or activity as described in A.1.
Are there implications for applications that propose New Investigators as multiple-PD/PIs?
Multiple-PD/PI applications may include established and/or New Investigators. However, the application will only be considered a New Investigator application when all of the PD/PIs meet the NIH definition of New Investigator. New investigator incentives are applied to applications rather than individual PD/PIs (http://grants.nih.gov/grants/new_investigators/resources.htm) .
I submitted a single-PD/PI application that was not funded. Can I include an additional PD/PI in a resubmission application?
Yes. You can add additional PD/PIs to create a leadership team. Remember that all PD/PIs must have a PD/PI role type in the NIH Commons and that a multiple-PD/PI application must include a Leadership Plan. You also should mention the addition of the new team member(s) when you describe the nature of the revisions in the Introduction section of the amended application. If a new team member will be the Contact PD/PI on the resubmission application, you will be required to indicate a change in PD/PI on the PHS 398 Checklist component; indicating yourself as the “former PD/PI”. However you must still list yourself as a PD/PI in the Senior/Key Person Profile.
Are all of the PD/PIs on a multi-PD/PI application required to be eligible for continuous submission in order to utilize the alternate submission and review procedures available to certain individuals?
No. If one or more of the PD/PIs is eligible to submit applications under the continuous submission policy, and the application is one that would normally be received on a standard submission date, then the continuous submission process may be used in accord with the policy described in NIH Guide NOT-OD-11-093. Note that continuous submission is limited to R01, R21 and R34 (including AIDS-related) applications submitted for standard due dates, and available for appointed members of an NIH Advisory Group or reviewers with substantial, recent service up to one and a half months after the date of retirement from regular service on the committee. See http://grants.nih.gov/grants/peer/continuous_submission.htm.
Can the Contact PD/PI request additional person-months effort for the additional responsibilities?
Yes, the level of effort in person-months should appropriately reflect the time commitment required by the proposed project. It is not anticipated that serving as Contact PD/PI will entail additional effort, but that may vary from project to project. Because many projects already involve collaborative efforts, the NIH does not expect large increases in the total level of effort required for research projects. Nevertheless, the level of effort should be based on the best estimate of the time required to conduct the proposed project considering the roles and responsibilities described in the Leadership Plan.
Will I lose my New Investigator status if I am a PD/PI on a multiple-PD/PI award award?
If you successfully compete as a multiple PD/PI on a substantial NIH independent research award you will lose your New Investigator status. If you are added to a substantial NIH independent research award after peer review you will not lose New Investigator status. (See http://grants.nih.gov/grants/new_investigators/index.htm.)
How does the application format and content differ from the single-PD/PI application?
Application forms used for Research Project Grants (RPGs) including the Public Health Service (PHS) 398 and the Standard Form (SF) 424 Research and Related (R&R) forms accommodate multiple PD/PIs. Those forms can be found at http://grants.nih.gov/grants/forms.htm. Instructions for including more than one PD/PI and the completion of the Leadership Plan is described in both application guides.
What information should be included in a Leadership Plan?
In applications designating multiple-PDs/PIs, a Leadership Plan is required. A rationale for choosing a multiple-PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for each of the PDs/PIs and other collaborators.
Does a competing revision (supplement) application to a Multiple PD/PI parent grant need to use the same Contact PD/PI?
Yes. The NIH data system links incoming revision applications to the parent record by PD/PI name; maintaining the same contact PD/PI is critical to ensuring that the applications are appropriately joined.
Can a competing revision (supplement) application include multiple-PD/PIs even if the parent grant was not originally reviewed and approved as a multiple-PD/PI project?
Yes, if the FOA allowed multiple PD/PIs. A revision application revises and extends the scope of the previously approved project. Therefore, the revision may include a change in the model used from a single PD/PI to multiple PD/PI. However in this case, a Leadership Plan will be required as part of the revision application.
Can a competing revision (supplement) application to a multiple-PD/PI parent grant include additional PD/PIs?
Yes. A revision application expands the scope of the previously approved project. Therefore, the expansion may include an expansion of the PD/PI team. Expansion of the PD/PI team will require a revised Leadership Plan as part of the revision application.
For applications involving more than one PD/PI, when determining if a modular budget can be submitted is it $250,000 per PD/PI or $250,000 for the entire project?
The $250,000 modular limit is based on the dollar level of the entire application, regardless of how many PD/PIs are involved.
D. Questions Specific to Applications with PD/PIs from Multiple Institutions
In what format should multiple institution projects be submitted?
PD/PIs at different institutions may collaborate on the development of a multiple PD/PI application. However, a single application should be submitted from one institution that identifies all PD/PIs, including those from institutions other than the applicant institution. The standard instructions for submitting consortium budgets should be followed. If funded, NIH will issue the award to the applicant institution which will administer the award using the traditional subcontract approach.
Can a project supported through a multiple-PD/PI award include additional subcontracted sites?
Yes. Multiple PD/PIs at different institutions will be able to use the traditional subcontract mode.
Can one institution be designated as the lead?
The institution submitting the application will be considered the lead institution. The Contact PD/PI must be associated with the institution submitting the application. The other collaborating institutions will be supported through subcontracts.
If the dollars are fluid and subject to reallocation across the participating institutions, how would facilities and administrative (F & A) costs be managed?
Budgets, including F&A costs associated with subcontracts, will be determined according to existing policy. Changes in the allocation and the size of subcontracts will be handled in the same way as on single-PD/PI awards.
Do PD/PIs from organizations other than the applicant organization need to be affiliated with the applicant organization through the eRA Commons in order to view information about the application in the eRA Commons?
No. Each PD/PI’s ability to view information about the application is related solely to their Commons account. However, it is critical that the multiple PD/PI application accurately identify the correct eRA Commons user name of each PD/PI, and that each PD/PI have a Commons account with a PD/PI role type.
Are additional review criteria applied to applications with Multiple PD/PIs?
No. As in the review of the traditional single-PD/PI application, peer reviewers will consider whether the designated PD/PIs have appropriate training and experience to carry out the proposed study. Peer review criteria are available at http://grants1.nih.gov/grants/peer_review_process.htm#Criteria.
Are there special review criteria for renewal (Type 2) applications?
The review criteria described at http://grants1.nih.gov/grants/peer_review_process.htm#Criteria apply to all competing applications including renewal and resubmission applications. A renewal submitted as a multiple-PD/PI application requesting support for a project that was previously supported through a single-PD/PI award should state the changes in the project’s direction and management that led the PD/PIs to now propose the multiple-PD/PI model, and state how the research will be enhanced through the multiple-PD/PI approach. In addition, a Leadership Plan is required.
The Leadership Plan has several components and requirements. Is each component weighed equally? What affect would one or more deficiencies in the Leadership Plan have on the impact/priority score of the application?
The Leadership Plan describes the roles and areas of responsibility of the named PD/PIs, the process for making decisions on scientific direction, allocating resources, and resolving disputes that may arise. The reviewers must assess the impact of the deficiencies in relation to the research objectives and to the goals of the project. For example, a poor leadership structure or description will negatively affect both single and multiple PD/PI projects, especially where strong collaboration and communication is necessary.
What happens if one or more PD/PIs are not well qualified for the role according to the stated criteria? Will this affect the score? Can a review committee recommend removal of a PD/PI?
Similar to a single PD/PI application, the qualifications of PD/PIs in the multiple-PD/PI application will affect the review and priority score. All listed PD/PIs must meet the qualifications included in the PD/PI definition. and each must have a clearly identified role on the project. Reviewer comments are included under the “Investigator” criteria and in the evaluation of the leadership approach under the “Approach” criteria. The review committee will not recommend adjustments of the leadership configuration in order to improve the quality of a project. As in single PD/PI applications, reviewers will judge the quality of the application as submitted. The inclusion of individuals who do not appear to be qualified as PD/PIs or have ambiguous roles on the project or within the leadership team will be reflected in the score.
What happens if the proposed research or aims of one of the PD/PIs is recommended for deletion from the proposal in the course of Peer Review?
If reviewers identify major deficiencies, there is a possibility that they may recommend deletion of one or more specific aims, which may affect the budget and perhaps the role of one or more of the PD/PIs. This decision may affect the priority score and may effectively eliminate the PD/PI’s effort. This is the one case where a peer review committee may recommend deletion of a PD/PI.
If an application has an outstanding Research Plan and/or outstanding multiple PD/PIs, but the Leadership Plan is weak or missing, how might the score be affected?
Reviewers will base the final score of an application on all five review criteria (significance, approach, innovation, investigators, and environment). The same consideration and evaluation is expected for applications with multiple PD/PIs as with single PD/PIs. The quality of the Leadership Plan will be considered by the reviewers as part of the assessment of the overall approach and incorporated into the scientific and technical merit determination. A missing or inadequate Leadership Plan will detract from the overall score.
Will all PD/PIs receive peer review process information?
Yes, all PD/PIs must have established eRA Commons accounts with a PD/PI role prior to application submission. All PD/PIs will have access to all the information that is now available to single PD/PIs through the eRA Commons. All PD/PIs will be able to view summary statements and status reports in NIH eRA Commons. For instructions on registration with eRA commons, see http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm.
Is there one renewal (type 2) application and progress report for the overall project, or is each PD/PI required to submit an individual report?
There is a single renewal application and a single progress report for a multiple PD/PI award, even when more than one institution is involved.
How will resource sharing and issues of confidentiality be handled?
The Leadership Plan should outline the governance and organizational structure of the research project, including communication plans and procedures for resolving conflicts. This includes resource sharing and confidentiality policies. The presence of more than a one PD/PI does not excuse the PD/PIs from official requirements. Resource sharing must be addressed in the Resource Sharing section of the Research Plan in the application.
Can a grant with a single PD/PI add an additional PD/PI during a non-competing year to become a multiple PD/PI project? Similarly, can a multiple PD/PI project change to a single PD/PI project during a non-competing year?
With appropriate justification, such changes are possible; however, the prior approval of the funding IC must be sought by the Authorized Organization Representative. Consistent with NIH policy allowing replacement of a PD/PI on a single or a multiple PD/PI project as described in the Grants Policy Statement (GPS) Section 184.108.40.206 - Change in Status, Including Absence of PD/PI and Other Senior/Key Personnel Named in the NoA, NIH will permit a single PD/PI project to become a multiple PD/PI project (if consistent with the FOA), and a multiple PD/PI project to change the number or makeup of the PD/PIs, including change to a single PD/PI project, during non-competing years. Such requests require prior approval and must be submitted in accord with Section 8.1.3 of the GPS - Requests for Prior Approval. In addition to a written scientific justification for the change as described in the GPS at Section 220.127.116.11, the following must be included in a formal request to change or add a PD/PI on a multiple PD/PI award: biographical sketch of the PD/PI(s) to be added and information on other sources of support, any budgetary implications of the changes, any proposed changes in scope, and an updated leadership plan. To change a multiple PD/PI award to a single PD/PI award, the justification must address whether the shift to a single PD/PI award will affect the scope of work, any budgetary implications of the change, and describe how the single PD/PI will address the absence of any scientific or technical expertise or responsibility previously provided by another PD/PI. Only approvals from the Grants Management Officer are considered valid. See NIH Guide Notice OD-11-118.
I thought that NIH required peer-review of a multiple PD/PI award and that is it not possible to change from a single PD/PI model to a multiple PD/PI model, or to go from a multiple PD/PI model to a single PD/PI model,without peer review.
When NIH began recognizing multiple PD/PIs in 2007, peer review of the use of the multiple PD/PI model was required, i.e., it was not possible to change from a single PD/PI award to a multiple PD/PI model or from a multiple PD/PI model to a single PD/PI model, without peer review. After several years of experience with the multiple PD/PI model NIH determined that there are legitimate circumstances under which it would be in the best interest of an active project to change from a single PD/PI model to a multiple PD/PI model, or from a multiple PD/PI model to a single PD/PI, and that peer review of the Leadership Plan is not essential in these cases. Accordingly, NIH policy was revised to permit such changes with the prior approval of the Grants Management Officer (GMO). This is consistent with NIH policy on change of PD/PI, and requires a strong scientific justification related to the funded project. Note that if the arrangements proposed by the grantee, including the qualifications of any proposed replacement or addition, are not acceptable to the NIH awarding IC the grant may be suspended or terminated. See NIH Guide Notice OD-11-118 for additional information.
My grant is currently a single PD/PI grant and I'm applying for an administrative supplement. Can I add PD/PIs as part of the administrative supplement request to convert this to a multiple PD/PI grant?
No. The single or multiple PI approach in the parent award must be retained in the administrative supplement.
My grant is currently awarded as a multiple PD/PI grant and I'm submitting an administrative supplement request that uses the PHS 398 Face page. Who should we list as the PD/PI for the supplement?
The administrative supplement request should list the current contact PD/PI on the face page. This is for internal NIH tracking purposes.