1. What is the definition of Principal Investigator (PI)?
   The Principal Investigator, or Project 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.
   
   
2. Why does NIH allow multiple Principal Investigators on individual research awards?
   This effort represents an NIH Roadmap initiative (see http://nihroadmap.nih.gov/interdisciplinary/) as well as a response to a Federal-wide directive to formally allow more than one Principal Investigator (PI) on individual research awards. In addition, a major recommendation from the 2003 “NIH Bioengineering Consortium Symposium on Catalyzing Team Science” (http://www.becon.nih.gov/becon_symposia.htm) was to allow more than one PI on individual grants. The policy offers new approaches to maximize the potential of “team science” efforts. The multiple PI model supplements, and does not replace, the traditional single Principal Investigator (PI) model. Although the single-PI model clearly continues to work well and encourages creativity and productivity, it does not always encourage 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-PI versus single-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-PI model is relatively small compared with those within the traditional single-PI format, the impact of the research supported through multidisciplinary efforts can be significant.
   
   
3. To what specific type of research efforts is the multiple-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-PI or multiple-PI option should be based on the research proposed to ensure optimal facilitation of the science. The multiple-PI option can encourage multidisciplinary and other types of “team science” projects that are not optimally served by the single-PI model. Projects suitable for the multiple–PI model could include as few as two PIs who are jointly responsible for the scientific and technical direction of the project. An example of a multiple-PI project would be a jointly-directed obesity research effort directed at a series of phenotypes to investigate the primary effect of specific alleles and the functional consequences of these variants. In this example, experts in imaging, 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 as is currently done, that is to providing consultation, collaboration and services (e.g., MRI) instead of sharing in the scientific direction of the project. In the latter case the traditional single-PI model would be the appropriate model. Multiple PI models also may apply to resource-related projects, training grants and other types of NIH supported activities.
   
   
4. To which grant mechanisms does the multiple PI model apply?
   NIH allows applicants and their institutions to identify more than one Principal Investigator (PI) in most research grant applications submitted electronically through Grants.gov (http://www.grants.gov/) using the SF424 R&R application package. Grant applications that now accommodate more than one PI include: R01, R03, R13/U13, R15, R18/U18, R21, R21/R33, R25, R33, R34, R41, R42, R43, R44, and C06/UC6 (see http://era.nih.gov/ElectronicReceipt/strategy_timeline.htm). The multiple PI option will be extended to most other applications when they transition to electronic format. However, some types of applications, including individual career awards (K08, K23, etc.), individual fellowships (F31, F32, etc.), Dissertation Grants (R36), Director’s Pioneer Awards (DP1), and Shared Instrumentation Grants (S10) will not accommodate more than a single PI. The restriction to a single PI will be described in announcements for those programs. Paper applications submitted on PHS 398 application forms allow inclusion of more than one PI only when the multiple PI option is clearly specified in the soliciting Request for Applications (RFA) or Program Announcement (PA). Paper applications submitted with more than one PI when the option is not clearly specified in the Funding Opportunity Announcement may be delayed in the review process or returned to the applicant.
   
   
5. How would the multiple-PI model enhance research conducted within a single institution? Why not limit this model to team science conducted across several institutions?
   The multiple-PI principles are based on the proposed project, not on the number of performance sites or the number of participating institutions. Many projects benefit from collaboration, and formally recognizing all the PI level participants will remove some of the barriers. The need for formal recognition of PIs applies to team science projects within single institutions as well as to those conducted through multiple institutions.
   
   
6. Why not restrict the model to only those grants with direct costs exceeding $500K?
   Team science is not synonymous with large-cost science. Limiting the multiple-PI option to large grants could miss important multidisciplinary research opportunities involving less expensive projects.
   
   
7. Why not simply have applicants use the Program Project Grant (P01) mechanism instead of developing this new model?
   The multiple-PI model is not mechanism-based. The P01 award is for the support of broad-based multidisciplinary and often multifaceted research projects that involve distinct subprojects that address a well-defined major objective or central theme. There are examples of P01 grants that could benefit from the multiple-PI model in the same way as single component research projects. Limiting the multiple-PI option to large, multiple-component grants could miss important research opportunities.
   
   
8. Why did NIH eliminate the departmental ranking tables and what other tools areavailable to allow institutions to determine their relative ranking?
   With the advent of awards that include multiple PIs from different departments it is impossible to attribute costs to any specific department within a medical school. Accordingly, the NIH no longer publishes Departmental Ranking Tables for medical schools. However, a web-based tool is available that allows grantee institutions to determine the dollars awarded to any one organization or department, and download aggregate data on a fiscal year basis for analysis (see http://report.nih.gov/award/trends/FindOrg.cfm). Additional award information is provided through the Research Portfolio Online Reporting Tool (RePORT) at http://report.nih.gov/index.aspx.
   
   
9. Is a Multiple PI application eligible for MERIT (R37) nomination?
   Yes. However the entire PI team would need to meet the MERIT nomination criteria.
   
   
10. I have a MERIT (R37) grant as a single PI. Can this be converted to a Multiple PI project at the time of the T-4 extension application?
    No. The conversion from a single to a multiple PI application must receive peer review by an initial review group. MERIT T-4 applications do not receive this level of peer review—they receive an administrative review by NIH IC staff prior to the review of the IC Council/Board. Single PI R37s will remain single PI until the next time they undergo peer review.
    

B. Principal Investigator Roles and Responsibilities

1. How will Principal Investigator (PI) be defined on a multiple PI grant? Will the role of the PI be diminished?
   The "Principal Investigator," "Program Director" or "Project Director" is defined the same way regardless of the number named on a particular application or award. See Question A.1. above. The presence of more than one identified PI on an application or award diminishes neither the responsibility nor the accountability of any individual PI. Each PI is responsible and accountable for all components of the project.
   
   
2. Can only senior investigators be a PI? Can a New Investigator be a PI? Can a postdoctoral fellow be an investigator?
   All investigators designated as PI must meet the definition of PI described in the answer to Question A.1. above. All PIs must have an identified leadership role on the project and must be designated in a PI role type by the applicant institution. Some institutions do not consider postdoctoral fellows to be eligible for a PI role type.
   
   The multi-PI option is designed to facilitate scientific collaboration and to recognize all members of the leadership team. It is not designed to create a new stage in the career development of junior investigators. All listed PIs must assume a leadership role and must have the full support of their institution in the indicated role. Peer review will examine the roles and responsibilities, governance and organizational structure of the proposed leadership team and will determine whether team members have the necessary expertise to carry out the proposed project. A new investigator can be a PI on a multiple PI application and award.

3. Is there a minimum person-months requirement to qualify to be a PI?
   No, there is not a minimum person-months requirement for individuals identified as PIs. The reviewers will assess whether the level of effort is adequate to achieve the proposed goals. If there are deficiencies in this regard, it will negatively impact the score.
   
   
4. Is there a ceiling on the number of PIs? This could result in a large number for the overall grant.
   There is no upper limit on the number of PIs, athough the involvement of each PI should be justified by the aims of the project. In addition, anyone designated as a PI must meet the criteria given in Question A.1 above. A proposal that involves PIs that appear to have questionable qualifications and expertise or an insufficient contribution or role will not fair well in the review process. In most cases, single project grant applications using the multiple PI option (e.g., R01, R21) will have two to three PIs depending upon the work scope.
   
   
5. Do multiple PIs make it difficult to differentiate between the responsibilities of PIs, co-PIs, and/or collaborators?
   All investigators designated as PI should meet the definition described in A.1, above. The review committee will examine the application as submitted so the roles of each named PI or collaborator must be clear and appropriate considering the project described. Only the applicants’ institutions can decide who should be a PI. It will not be appropriate for individuals who would normally be listed as co-investigators to be elevated to PI status. The multiple-PI option is reserved for team science efforts and will need to be justified in the Leadership Plan in the application. The NIH does not recognize the “co-PI” designation.
   
   
6. Can there be a Lead PI within the Multiple PI model?
   All PIs have equal responsibility and accountability for leading and directing the project. The structure and interaction of the PI team will be left up to the PIs and the applicant institution. All PIs must be qualified to serve as PIs and will share responsibility for the project. Although the PIs may identify a leader of the project or a coordinator of the overall team, that is not a role that NIH formally acknowledges. See Question B.8. concerning the role of the Contact PI. Smaller teams composed of PIs of equal rank within the institution may function best as 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 the Leadership Plan.
   
   
7. Without a single, designated person in charge, how will decisions be made? Decisions by committee may not work well in research endeavors. If one PI moves, or doesn’t produce, who will assume responsibility?
   Applicants must provide a Leadership Plan in every application proposing a multiple PI approach. The Leadership Plan should describe the roles and areas of responsibility of the named 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 is currently used 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 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 PIs and other key persons is exactly the same as it is for single PI projects.
   
   
8. What is the role of the Contact PI? Could the Contact PI have responsibility for overall project management (i.e., functioning as a “Lead PI”), or will the role of the Contact PI be reduced to that of a clerk?
   When multiple PIs are proposed, NIH requires identification of one PI who will be designated as the "Contact PI." This person will be responsible for communication between the PIs and the NIH, but has no special authorities or responsibilities within the project team. In many ways, a contact PI is analogous to a corresponding author on a publication. The Contact PI must serve as a real PI and must meet all eligibility requirements for PI status. In those projects where there is an identified project coordinator, the coordinator could serve as Contact PI or that role could be assigned to another PI. It will be possible, and may even be desirable, for the grantee institution to periodically designate a change in Contact PI. For example, it may be desirable to rotate the role of Contact PI among the multiple PIs on an annual basis at the time of grant renewal.
   
   
9. Does scientific advice or consultation alone qualify someone for PI status?
   No, scientific advice or consultation alone does not qualify someone as a PI. The PIs 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. above.
   
   
10. Since co-investigators now can have PI status, won’t most applications use the multiple PI model? Many participants will want to have PI status.
    NIH does not intend or expect for co-investigators to be routinely elevated to PI status. Most investigator initiated research grants are one investigator’s scientific ideas. The multiple-PI option is reserved for team science efforts in which the PIs share responsibility and authority for the scientific and technical direction of the project and accountability to the grantee organization and to the NIH for the proper conduct of the project or activity. Multiple-PI applications will need to justify use of this approach in a clear and convincing manner, and this will be addressed in the peer review process. The NIH expects the number of applications that involve multiple PIs to be small compared to the overall portfolio.
    
    
11. How will issues of potential abuse and coercion be handled? For example: some investigators may join a research team only if given PI status. Other applicants may “pad” a grant application by listing senior investigators as PIs.
    The NIH cannot address the politics within applicant institutions. However, the multiple-PI application instructions and the peer review criteria are clear. All PIs must have a defined role on the project and must provide a convincing case that they will function as a part of the leadership team. The PIs 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. This must be clearly and convincingly presented in the Leadership Plan section of the grant application which will be considered by peer reviewers.
    
    
12. The NIH makes an effort to recruit new PIs to science. Do new investigators have an advantage or disadvantage in multiple PI applications?
    Multiple PD/PI applications may include senior and 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 (http://grants.nih.gov/grants/new_investigators/resources.htm) are applied to applications rather than individual PD/PIs. Consistent with the policy that all PIs on a multiple PI grant will have all the authorities and responsibilities assumed by PIs on single PI grants, an individual who serves as a PI on an R01, for example, awarded as a multiple PI grant will no longer be classified as a new investigator on subsequent applications. Thus, serving as a PD/PI on a multiple PD/PI grant is equivalent to serving as a PD/PI on a single PD/PI grant.
    
    
13. I submitted a single PI application that was not funded. Can I include an additional PI when I submit a resubmission application? (Question Added: 01/16/2007)
    Yes. If you become the Contact PI on the revised application, you can add additional PIs to the leadership team. Remember that all PIs must have a PI role type in the NIH Commons and that a Multiple PI application must include a Leadership Plan. You should also mention the addition of the new team members when you describe the nature of the revisions in the Introduction section of the amended application. If the added team member will be the Contact PI on the resubmission application, you will be required to indicate a change in PI on the PHS398 Checklist component; indicating yourself as the “former PI”. However you must still list yourself as one of the collaborating PIs in the Senior/Key Person Component.
    
    
14. Are all of the PIs on a multi-PI application required to be appointed regular members of charter CSR or other NIH study sections in order to utilize the alternate submission and review procedures that are available to a single PI who is an appointed regular member of a charter study section? (Question added 07/10/2008)
    No. If one or more of the PIs is an appointed member of a Study Section, 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-08-026. Note that continuous submission is limited to R01, R21 and R34 (including AIDS-related) applications submitted for standard due dates, and available for appointed regular members of Study Sections up to one and a half months after the date of retirement from regular service on the committee.
    
    
15. Can the contact PI request additional person-months effort for the additional responsibilities? (Question Added: 03/30/2009)
    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 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.
    

C. Allocation of Funds

1. Why will the NIH permit funds to be allocated to the individual PIs? It would seem that allocation of funds in this manner could undermine the research effort by fragmenting the team.
   Experience suggests that institutional recognition of faculty and staff for the purpose of promotion, tenure, and space allocation, frequently includes an assessment of the ability to attract externally-sponsored research awards and the financial impact of those awards. In many institutions, clear assignment of funds may determine credit and clarify relationships between PIs. Accordingly, there is concern that a PI who simply receives credit as a PI without the designation of a specific budget may not have PI status in his or her institution. This might result in the undesirable formation of multiple classes of PIs. Accordingly, applicants may request allocation of funds to individual PIs in the leadership plan. NIH recognizes requested allocations to specific components of a project and associated PIs by using an informal footnote on the Notice of Award (NoA). The NoA will indicate that the institution and the PIs have requested allocation in a manner previously indicated in the application that may be adjusted at the time of award. The grantee institution may then establish special accounts to reflect the information in the footnote. The footnote will not imply that the institution must implement this allocation, and the NIH will not track the allocation requested.
   
   NIH is aware that the costs of research do not necessarily represent the intellectual contribution of collaborators. Some institutions may choose not to use the financial metrics in decisions about advancement in favor of more sophisticated methods to assess a PI’s contribution to scientific knowledge.
   
   
2. Allocation of funds may be a good idea at the institutional level, but what is the benefit of having NIH impose additional layering? Some institutions are already apportioning credit and dollars internally.
   At this time NIH does not routinely impose formal allocations such as separate line items on the NoA or separate awards to support specific components of a project. The NIH understands that projects benefit from the ability to re-allocate resources in response to the changing directions and needs of the research project. The re-allocation of funds during the project period will be via a joint decision of the PIs, and the process should be described in the Leadership Plan section of the application.
   
   The NIH will continue to assess the need for formal apportionment options and if desired by a substantial segment of the research community will pursue development of a business model and electronic systems to accommodate such designations. Multiple electronic systems would require modification, which is a complex and lengthy process. If formal allocation schemes, such as separate accounts and linked awards, are implemented in the future then additional levels of NIH oversight regarding re-allocation and re-budgeting may be necessary.
   
   
3. Why not credit all PIs through an expansion of CRISP without linking to dollars?
   The Multiple PI initiative includes the capacity to display the names of all involved PIs in NIH’s "Computer Retrieval of Information of Scientific Projects (CRISP)" at http://crisp.cit.nih.gov/. In addition, all PIs are recognized in NIH reports and systems, e.g., in the NIH eRA database, on Summary Statements, and on the Notice of Award. In many cases this will provide appropriate documentation for full crediting. At some institutions, however, there may be a need to document the allocation of funds as well.
   
   
4. Will budget allocations to the individual PIs be permitted or required?
   Allocation of funds by the grantee institution is permitted, but is not required. NIH will indicate an informal allocation of funds to components of the project and associated PIs by stating the requested apportionment as a footnote on the Notice of Award (NoA). The NIH will not determine whether the institution implements the requested allocation or track the allocation in subsequent reports. For projects that include PIs at multiple institutions, funds will be allocated to collaborating institutions using subcontracts to fund the components of the project that occur at different institutions (see H.2. below). As indicated above, NIH will assess the need to develop additional options for allocation of funds based on comments and advice from the research community.
   

D. Grant Application Format and Content

1. How does the application format and content differ from the single 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 PIs. Those forms can be found at http://grants.nih.gov/grants/forms.htm. Instructions for including more than one PI and the completion of the Leadership Plan is described in both application sets. In addition, all RFAs and PAs that permit multiple PIs include special instructions and peer review criteria to accommodate multiple-PIs. The multiple PI option is extended to most other applicable applications and awards as they transition to SF424 electronic grant application forms. PHS 398 paper applications proposing Multiple PIs may only be submitted in response to specific RFAs and PAs that offer the multiple PI option.
   
   
2. What information should be included in a Leadership Plan?
   In applications designating multiple PDs/PIs, the “Multiple PD/PI Leadership Plan” section of the research plan must be provided. 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 the PDs/PIs and other collaborators.
   
   If budget allocation within the grantee institution is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations will be reflected in a footnote on the Notice of Award that indicates the allocations requested by the institution (see C.1. above).
   
   
3. Does a competing revision application (previously called a supplement) to a Multiple PI parent grant need to use the same Contact PI? (Question Added: 09/05/2007)
   Yes. The NIH data system links incoming revision applications to the parent record by PI name; maintaining the same contact PI is critical to ensuring that the applications are appropriately joined.
   
   
4. Can a competing revision application include Multiple PIs even if the parent grant was not originally reviewed and approved as a Multiple PI project? (Question Added: 09/05/2007)
   Yes. A revision application expands the scope of the previously approved project. Therefore, the expansion may include a change in the model used from a single PI to multiple PI. However in this case, a Leadership Plan will be required as part of the revision application so that the multiple PI approach can be clearly described.
   
   
5. Can a competing revision application to a Multiple PI parent grant include additional PIs? (Question Added: 09/05/2007)
   Yes. A revision application expands the scope of the previously approved project. Therefore, the expansion may include an expansion of the PI team. Expansion of the PI team would required a revised Leadership Plan as part of the revision application so that changes in leadership can be clearly described.
   
   
6. I'm preparing a resubmission application. The previous version was a single PI only, but now I want to submit it using the Multiple PI model. Is this still a resubmission or is this now a new application? Same question applies to a renewal application that was previously funded as a single PI award. Is this a renewal or new application? (Question Added: 09/05/2007)
   In most cases, changing from single PI to Multiple PI would not in itself change the scope of the application enough for it to now be considered "new." Those applications would still be considered resubmissions or renewals, respectively.
   
   
7. For applications involving more than one PD/PI, when determining if a modular budget can be submitted is it $250,000 per PI or $250,000 for the entire project? (Question Added: 09/05/2007)
   The $250,000 modular limit is based on the dollar level of the entire application, regardless of how many PD/PIs are involved.
   
   
8. Is the Leadership plan part of the page limitation for the Research Plan? (Question Added: 03/30/2009)
   No. The Leadership Plan section of the grant application is not subject to a page limit.
   

E. Peer Review Process

1. What additional review criteria are applied?
   As in the review of the traditional single-PI application, peer reviewers will consider whether the designated PIs have appropriate training and experience to carry out the proposed study. There is no “additional review criteria.” The following NIH review criteria is currently in effect and accommodates applications that include multiple PIs as well as those that involve a single PI:
   
   Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
   
   Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
   
   Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
   
   Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
   
   Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
   
   
2. Are there special review criteria for renewal (Type 2) applications?
   The review criteria shown in E.1. above will apply to all competing applications including renewal and resubmissionapplications. A renewal submitted as a multiple-PI application requesting support for a project that was previously supported through a single-PI award should state the changes in the project’s direction and management that led the PIs to now propose the multiple-PI model, and state how the research will be enhanced through the multiple-PI approach. In addition, a Leadership Plan should be provided (see D.2. above).
   
   
3. Why would reviewers need to see the Leadership Plan? Shouldn’t the Leadership Plan be tentative and subject to change along with the direction of the science? May the Leadership Plan be submitted just-in-time for only those applications with fundable scores?
   Although the Leadership Plan is subject to change, its inclusion within the grant application provides the reviewers with important information on the proposed approach of the project as well as the roles of the PIs. The Leadership Plan must be included in the application to facilitate peer reviewers’ understanding of the complexities of the science and of project management.
   
   
4. 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 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 PI projects, especially where strong collaboration and communication is necessary.
   
   
5. What happens if one or more 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 PI?
   Similar to a single PI application, the qualifications of PIs in the multiple-PI application will impact the review and priority score. All listed PIs must meet the qualifications included in the PI definition. All PIs 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 PI applications, reviewers will judge the quality of the application as submitted. The inclusion of individuals who do not appear to be qualified as PIs or have ambiguous roles on the project or within the leadership team will be reflected in the score.
   
   
6. What happens if the proposed research or aims of one of the PIs is recommended for deletion from the proposal in the course of Peer Review?
   There is a possibility that peer reviewers may recommend deletion of the specific aims and budget of one of the PIs because of major deficiencies. This decision would also impact the priority score and effectively eliminate the PI’s effort. This is the one case where a peer review committee recommends deletion of a PI.
   
   
7. If an application has an outstanding Research Plan and/or outstanding multiple 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 PIs as with single 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.
   
   
8. Will the study section review the application on its own merit, or could the reviewers recommend that a Multiple PI application be re-submitted as a single PI application? Conversely, could a “team science” application with a single PI receive criticism (and a worse score) for not using the Multiple PI model?
   Each application will continue to be reviewed on its own merit, as submitted by the PI(s). Reviewers are instructed that it is not their role to advise the applicant or to redesign the proposed project or to suggest other ways of conducting the research. Following receipt of the summary statement for an application that is unlikely to be funded, applicants are always encouraged to contact their NIH Program Officials. Program Officials can discuss the advisability of resubmission and possible revisions, based on comments in the summary statement.
   
   
9. Will all PIs receive all review process information?
   Yes, all PIs must have established eRA Commons accounts with a PI role prior to application submission, which will provide access to all the information that is now available to single PIs. All PIs will be able to view summary statements and status reports in NIH eRA Commons system https://commons.era.nih.gov/commons/. For instructions on registration with eRA commons, see http://era.nih.gov/ElectronicReceipt/preparing.htm.
   

F. NIH Funding Policies

1. It is possible that this model will result in larger grants? Will the NIH Institutes and Centers have additional funds to support the Multiple PI model? Will all NIH Institutes and Centers have similar funding policies regarding these applications?
   The NIH does not intend for the multiple-PI model to result in larger grants (see Question A.5). Some teams of researchers who in the past submitted their proposals as single-PI applications may find that the multiple-PI option is better suited to a future proposal. In addition, investigators who in the past did not pursue NIH funding at all, due to perceived constraints of the single-PI model, may for the first time wish to seek NIH support for their multidisciplinary, team science efforts. In either case it does not necessarily follow that grants will have larger budgets. Grants with an increased work scope caused by merging two related research projects into one grant application will not fare well in peer review.
   
   The NIH Institutes and Centers (ICs) are aware of the need to anticipate the submission of large grant applications and to manage large awards. The official NIH policy http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html requires applicants planning to submit an investigator-initiated new, renewal, resubmission, or revision application requesting $500,000 or more in direct costs for any year (exclusive of consortium F&A) to contact NIH IC program staff 6 weeks before submitting the application. Discussions with program staff should occur as plans for the study are being developed. This applies to both single-PI and multiple-PI applications.
   
   Some ICs may announce specific initiatives to encourage multidisciplinary team science and some of these may have special budget guidelines. Potential applicants are encouraged to contact their NIH program directors and to access the IC’s websites http://www.nih.gov/icd/ for Institute-specific programs. The NIH Guide for Grants and Contracts http://grants.nih.gov/grants/guide/index.html includes all Funding Opportunity Announcements including Requests for Applications (RFAs) and Program Announcements (PAs), some of which will be directed toward multidisciplinary team science.
   
   2. Will this become NIH’s favored research model, thereby rewarding big science and putting small science at a disadvantage?
   No. The model is aimed specifically at those team science projects that do not fit into the single-PI model. It is designed to supplement, and not replace, the traditional single-PI model. Moreover, team science is not synonymous with large science. Although there may be specific exceptions, the NIH does not expect the average cost of a grant to increase when the multiple-PI option is used.
   

G. Post-Award Issues

1. Does the increased oversight by NIH run counter to modular grants and expanded authority, both of which give PIs more flexibility?
   No. The PIs supported under the multiple-PI model will have no less flexibility than PIs of single-PI awards. Most of the oversight requirements should be met through the noncompeting continuation (Type 5) application.
   
   Monitoring the awards will be facilitated through enhancements to NIH’s administrative databases and modification of reports, such as those available through the eRA Commons https://commons.era.nih.gov/commons/.
   
   Changes in PIs during the award period, including substantial changes in level of effort, will require prior approval from the NIH in the same way that such changes are currently required.
   
   
2. The multiple-PI model appears to require increased oversight and tracking by the NIH. How will NIH ensure that this additional administrative layering does not impede research? For example, what documentation will be needed to revise the Leadership Plan, post-award?
   It is understood that investigators supported through grants must have maximum flexibility to respond to new scientific opportunities, within the overall scope of the funded project. The NIH will keep any additional tracking or reporting requirements to a minimum in order to ensure that the multiple-PI model is attractive to institutions and PIs. Re-allocation of funds and even revisions to the Leadership Plan during the project period will be via a joint decision of the PIs and their institution(s). These changes will be implemented at the institutional level, with no need for approvals by NIH, beyond the normal requirements for any grant. NIH plans to track most revisions through the noncompeting continuation (Type 5) application, where changes in the governance or organization structure of the Leadership Plan should be described. Such changes would normally be considered analgous to changes to the scientific direction that are within the scope of the funded project.
   
   
3. Is there one renewal (type 2) application and progress report for the overall project, or is each PI required to submit an individual report?
   There is a single renewal application and a single progress report for a multiple PI award, even when more than one institution is involved.
   
   
4. If funds are allocated among the PIs, could one PI be given sole authority to reallocate money?
   No. A basic principle of the multiple-PI model is that each named PI is equally responsible and accountable for the research project. Re-allocation of funds must be via a joint decision of the PIs, and the process for re-allocation should be included as part of the approach described in the Leadership Plan.
   
   
5. How will resource sharing and issues of confidentiality be handled without having one person in charge?
   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 single PI does not excuse the PIs from official requirements. Resource sharing must be addressed in the Resource Sharing section of the Research Plan in the application.
   
   
6. Can a grant with a single PI add an additional PI during a non-competing year to become a multiple PI project? (Question Added: 01/25/2007)
   No. The NIH requires input from peer reviewers to judge the appropriateness of the multiple PI approach using the review criteria described in Question E-1. As in the past and with prior approval from the NIH, a PI can replace an existing PI on a single-PI project or a multiple PI project as described in the section of the Grants Policy Statement called “Change in Status, Including Absence, of Principal Investigator and other Key Personnel”.
   
   
7. Can the applicant organization submit a Change of PI request if a PI on a multiple-PI award is no longer able to work on the project? (Question Added 9-11-08)
   Yes. Change in status, including absence of the PI, is a prior approval item for all PIs. Contact your assigned grants management specialist to discuss this and refer to the NIH GPS section on Prior Approval.
   
   
8. My grant is currently a single PI grant and I'm applying for an administrative supplement. Can I add PIs as part of the administrative supplement request to convert this to a multiple PI grant? (Question Added 9-11-08)
   No. Changing a grant from single PI to multiple PIs requires competitive peer review. Administrative supplements receive only an NIH IC staff review and thus cannot be used to convert a project from single PI to multiple PIs.
   
   
9. My grant is currently awarded as a multiple PI grant and I'm submitting an administrative supplement request that uses the PHS398 Face page. Who should we list as the PD/PI for the supplement? (Question Added 9-11-08)
   The administrative supplement request should list the current contact PI on the face page. This is for internal NIH tracking purposes.
   
   
10. My grant is currently awarded as a multiple PI grant and I'm submitting an administrative supplement request. Can the administrative supplement add a new PI? (Question Added 9-11-08)
    No. The PI Leadership Team and Leadership Plan must be peer reviewed; therefore, an administrative supplement cannot be used to add new PIs.
    

H. Questions Specific to the Issue of Applications from Multiple Institutions

1. In what format should multiple institution projects be submitted?
   PIs at different institutions may collaborate on the development of a multiple PI application. A single application should be submitted from one institution, and should identify all 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.
   
   
2. Can a project supported through a multiple-PI award include additional subcontracted sites?
   Yes. Multiple PIs at different institutions will be able to use the traditional subcontract mode.
   
   
3. Can one institution be designated as the lead?
   The institution submitting the application will be considered the lead institution. The Contact PI must be located at the institution submitting the application. The other collaborating institutions will be supported through subcontracts.
   
   
4. Without a single PI, who will oversee the various sites in a multi-site project (in addition to the science this would include personnel issues, conduct, etc.)
   The process for this oversight should be described in the Leadership Plan. In this section of the application the governance and organizational structure should be tailored to the research project.
   
   
5. 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-PI awards.
   
   
6. Do 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 PIs ability to view information about the application is related solely to their PI Commons account. However, it is critical that the multiple PI application accurately identify the eRA Commons user name of each PI.
   

Comments or Questions?

• Please send email to multi_PI@mail.nih.gov.