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Multiple Principal Investigators

Frequently Asked Questions for NIH SBIR/STTR Applications
Posted: March 3, 2007
Revised: March 3, 2007

A. General Questions

  1. What is the definition of Principal Investigator (PI)?
  2. 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?
  3. To which grant mechanisms will this apply?
  4. Must the applicant organization always be the small business concern or may a collaborating research institution be the applicant organization?

B. Project Director/Principal Investigator (PD/PI) Roles and Responsibilities

  1. Is there a requirement on projects with Multiple PD/PIs for one, some or all PD/PIs to meet the primary employment requirement specified for SBIR projects?
  2. Is there a minimum person-months requirement to qualify to be a PD/PI?
  3. Currently, the individual(s) designated as PD/PIs on an application must be registered in the eRA Commons. In the case of multiple PD/PIs, who must be registered in the eRA Commons ?
  4. What is the role of the Contact PD/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 PD/PI be reduced to that of a clerk ?
  5. Does scientific advice or consultation alone qualify someone for PI status?
  6. Since co-investigators now can have PD/PI status, won't most applications use the multiple PD/PI model because many participants will want to have PD/PI status?
  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 PD/PI moves, or doesn't produce, who will assume responsibility?

C. Grant Application Format and Content

  1. Does it matter in what order the Multiple PD/PIs are listed on the application?
  2. What “Project Role” should be assigned to the multiple PD/PIs?
  3. How are funds requested for the PD/PIs from other organizations?

D. Peer Review Process

  1. What additional review criteria will be applied?
  2. Will there be special review criteria for resubmission applications and Phase II Competing Renewal applications ?
  3. The Leadership Plan has several components and requirements.  Is each component weighed equally?  What impact would one or more deficiencies have on the Leadership Plan and on the (final score of the) entire application?
  4. 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?
  5. 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?
  6. The application has an outstanding Research Plan and/or outstanding multiple PIs but Leadership Plan is weak or they failed to include Section I (Leadership Plan).  How does this affect the score?
  7. Will the study section review the application on its own merit, or could the reviewers recommend that a Multiple PD/PI application be re-submitted as a single PD/PI application?  Conversely, could a “team science” application with a single PI receive criticism (and a worse score) for not using the Multiple PD/PI model?
  8. Will all PD/PIs receive all review process information?

E. Post-Award Issues

  1. Will there be one progress report for the overall project, or will each PD/PI be required to submit an individual report?
  2. If funds are allocated among the PIs, could one PI be given sole authority to reallocate money?
  3. How will data sharing and issues of confidentiality be handled without having one person in charge?

F. Questions Specific to the Issue of Applications from Multiple Institutions/Organizations

  1. In what format will multiple institution projects be submitted?
  2. Can a project supported through a multiple-PI award include subcontracted sites to the primary site?
  3. Can one organization/institution be designated as the lead?
  4. If the dollars are fluid and subject to reallocation across the participating institutions, how would facilities and administrative (F & A) costs be managed?

A. General Questions

  1. What is the definition of Principal Investigator (PI)?

    The 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.

    Note that the PD/PI must have a formal written appointment with the applicant organization, which must be in the form of an official relationship between the parties, but need not involve a salary or other form of remuneration. The other collaborating institutions/organizations will be supported through subcontracts.

  1. To what specific type of research efforts is the multiple-PD/PI model aimed and in what instances is the model not appropriate?   

    The selection of either the single-PD/PI or multiple-PD/PI option should be based on the research proposed, to ensure optimal facilitation of the science. The multiple-PD/PI option is reserved for “team science” and other types of multidisciplinary 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. However, in a project, for example, where the roles of investigators are to provide consultation, collaboration and services (e.g., MRI) instead of sharing in the scientific direction of the project, the traditional single-PD/PI model would be the appropriate model.  

  1. To which grant mechanisms will this apply?

    Beginning with research grant applications submitted for February 2007 receipt dates, the Multiple PD/PI option will be extended to most research grant applications submitted electronically through Grants.gov (http://www.grants.gov/) using the SF424 R&R application package: R01, R03, R13/U13, R15, R18/U18, R21, R21/R33, R25, R33, R34, SBIR/STTR: R41, R42, R43, R44 , and C06/UC6.

  1. Must the applicant organization always be the small business concern or may a collaborating research institution be the applicant organization?

    The small business concern (SBC) is ALWAYS the applicant/awardee organization, regardless of whether the project is submitted as an SBIR, STTR, single-PD/PI or multiple PD/PI application. The research institution is a subcontractor to the SBC. Also, note that the STTR applicant organization must officially affiliate the PD/PI with the SBC in the Commons if the PD/PI is not an employee of the SBC. See the B.3 below for steps to affiliate a PD/PI to the applicant organization/institution.


B. Principal Investigator(s) Roles and Responsibilities

  1. Is there a requirement on projects with Multiple PD/PIs for one, some or all PD/PIs to meet the primary employment requirement specified for SBIR projects?

    SBIR projects: For both Phase I and Phase II, at least one PD/PI must meet the primary employment requirement.  Occasionally, deviations from this requirement may occur. Such deviations must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator. Primary employment means that more than one half of the PD/PI's time is spent in the employ of the SBC at the time of award and during the conduct of the proposed project. The individual who serves as the Contact PD/PI must meet the primary employment requirement, but other PDs/PIs need not meet this requirement.

    STTR projects: No; as is the case for an STTR project with a single PD/PI, the PD/PI is not required to be employed by the SBC. However, the Contact PD/PI, the first PD/PI listed, must have a formal appointment with, or commitment to, the SBC, which must be in the form of an official relationship between the parties, but need not include a salary or other form of remuneration.

  1. Is there a minimum person-months requirement to qualify to be a PD/PI?

    SBIR Applications: No. There is no minimum person-months requirement for individuals identified as PD/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. 

    STTR Applications: Yes. Each PD/PI must commit a minimum of 1.2 calendar months (10% effort) to the project and each PD/PI must have a formal appointment with or commitment to the applicant small business concern (SBC), which is characterized by an official relationship between the SBC and that individual. ( Person Months website and calculator: http://grants.nih.gov/grants/policy/person_months_faqs.htm#q2)

  1. Currently, the individual(s) designated as PD/PIs on an application must be registered in the eRA Commons. In the case of multiple PD/PIs, who must be registered in the eRA Commons?

    All PD/PIs must be registered and be assigned the PD/PI role in the eRA Commons prior to the submission of the application. Note: While each PD/PI must hold a PD/PI account in the Commons. PDs/PIs do not register with Grants.gov. Only the applicant organization registers with Grants.gov..

    In addition, all PDs/PIs at the applicant organization must be affiliated with that organization.  When PDs/PIs are located at another organization , only the contact PI (the PI named on the SF424 (R&R) Cover) must be affiliated with the applicant small business concern (SBC) ; other PD/PIs need not be affiliated with the SBC, but must be affiliated with their own organization to be able to access the Commons . This affiliation must be done by the AOR/SO or their designee who is already registered in the Commons .

    NOTE: All PD/PIs will have equal access to information related to the application or grant (e.g., Summary Statement, Notice of Grant Award) 

    To affiliate the PD/PI with the small business concern:

    1. PD/PI gives Commons user ID and email address to the administrator of the applicant organization/institution. (The email address must be the one that is contained in the Personal Profile for the PD/PI.)
    2. Administrator logs into the Commons. (The administrator can be the Signing Official, Administrative Official, or the Accounts Administrator.)
    3. Administrator selects "Administration" tab and then "Accounts" tab.
    4. Administrator selects "Create Affiliation" tab.
    5. Administrator enters the Commons User ID and Email address into the appropriate fields and clicks "Submit."

    On the Research & Related Senior/ Key Person Profile, in the Credential, (e.g., agency login) Field, the Commons UserName must be provided for all individuals assigned the PD/PI Role.

  1. What is the role of the Contact PD/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 PD/PI be reduced to that of a clerk?

    The "Contact” PD/PI is responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials, and for coordinating progress reports for the project. The Contact PD/PI must be from the small business.

    Serving as Contact PD/PI confers no special responsibilities or authorities 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 real PD/PI 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 or that role could be assigned to another PD/PI.  It will be possible, and may even be desirable, for the grantee organization to periodically designate a change (on competing applications only) in Contact PD/PI.

    Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.”  The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

  1. 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.  The PD/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 the definition described in A.1, above. 

  1. Since co-investigators now can have PD/PI status, won't most applications use the multiple PD/PI model because many participants will want to have PD/PI status.

    It is certainly not the intent for co-investigators to be routinely elevated to PD/PI status. The multiple-PI option is reserved for team science efforts in which the PD/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.  Most investigator-initiated research grants are one investigator's scientific ideas.  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 that the number of applications that involve multiple PD/PIs will be small compared to the overall portfolio.

  1. Without a single, designated person in charge, how will decisions be made?  Decisions by committee may not work well in research endeavors.  If one PD/PI moves, or doesn't produce, who will assume responsibility?

    The NIH requires 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 on scientific direction, allocating resources, resolving disputes that may arise, and other information related to the management of the proposed team science project. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. For samples plans, see http://grants1.nih.gov/grants/multi_pi/sample_leadership_plans.pdf.

    The purpose of the Leadership Plan is to facilitate and enhance scientific productivity and to protect the project in the case of disagreements. 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 organization. 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 PI project.

    If budget allocation 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 may be reflected in a footnote on the Notice of Award.


C. Grant Application Format and Content

  1. Does it matter in what order the Multiple PD/PIs are listed on the application?

    Yes. The first PD/PI listed must be affiliated with the applicant small business concern ( SBC) organization submitting the application and will serve as the Contact PD/PI. For both the SBIR Phase I and SBIR Phase II, the primary employment of the “Contact PD/PI” must be with the SBC at the time of award and during the conduct of the proposed project . Occasionally, deviations from this requirement may occur. Such deviations must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator.

  1. What “Project Role” should be assigned to the multiple PD/PIs?

    All such individuals must be assigned the PD/PI role. Do not assign any individual the role of “Co-PD/PI” as this role is not currently used by NIH and other PHS agencies.

    If including individuals classified as “Other Significant Contributors (OSCs),” use the “Other” category and indicate “Other Significant Contributor” as the role in the “Other Project Role Category.” OSCs should be listed last after all other Senior/Key Persons have been listed.

  1. How are funds requested for the PD/PIs from other organizations?

    Funding for PD/PIs from other organizations must be requested via a subcontract with the small business applicant/awardee organization using the Research & Related Subaward Budget Attachment(s) Form. 


D. Peer Review Process

  1. What additional review criteria will be applied?  

    There will be no “additional review criteria.”  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. The following NIH review criteria will accommodate applications that include multiple PD/PIs as well as those that involve a single PD/PI. 

    Significance: Does the proposed project have commercial potential to lead to a marketable product, process or service? Does this study address an important problem? What may be the anticipated commercial and societal benefits that may be derived from the proposed research? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the application lead to enabling technologies (e.g., instrumentation, software) for further discoveries? Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs?

    Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Is the proposed plan a sound approach for establishing technical and commercial feasibility? Are the milestones and evaluation procedures appropriate? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

    Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

    Investigator(s): Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI(s) and other researchers, including consultants and subcontractors (if any)? Do the PD/PIs and investigative team bring complementary and integrated expertise to the project (if applicable)? Are the relationships of the key personnel to the small business and to other institutions/organizations appropriate for the work proposed?

    Environment: Do(es) the scientific and technological environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Is there sufficient access to resources (e.g., equipment, facilities)?

  1. Will there be special review criteria for resubmission applications and Phase II Competing Renewal applications?

    The review criteria shown in D.1., above, will apply to all competing applications including revised applications and Competing Renewal applications.  A Phase II Competing 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.  In addition, the application should state how the research will be enhanced through the multiple-PD/PI approach .

  1. The Leadership Plan has several components and requirements.  Is each component weighed equally?  What impact would one or more deficiencies have on the Leadership Plan and on the (final score of the) entire 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 have to assess the impact of the deficiency as it relates 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.

  1. 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/PI in the multiple-PD/PI application will impact the review and priority score.  All listed PD/PIs must meet the qualifications included in the PD/PI definition. All PD/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 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. 

  1. 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?

    There is a possibility that peer review may recommend deletion of the specific aims and budget of one of the PD/PIs because of major deficiencies.  This decision would also impact the priority score and effectively eliminate the PD/PI's effort.  This is the one case where a peer review committee recommends deletion of a PD/PI.

  1. The application has an outstanding Research Plan and/or outstanding multiple PD/PIs but Leadership Plan is weak or they failed to include Section I (Leadership Plan).  How does this affect the score?

    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 will be incorporated into the scientific and technical merit determination. A missing or inadequate leadership plan will detract from the overall score.

  1. Will the study section review the application on its own merit, or could the reviewers recommend that a Multiple PD/PI application be re-submitted as a single PD/PI application?  Conversely, could a “team science” application with a single PD/PI receive criticism (and a worse score) for not using the Multiple PD/PI model?

    Each application will continue to be reviewed on its own merit, as submitted by the small business. 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.

  1. Will all PD/PIs receive all review process information? 

    Yes, all PD/PIs, who must be listed in NIH Commons in a PD/PI role, will have access to all the information that is now available to single PD/PIs. All PD/PIs will be able to view summary statements and status reports in NIH eRA Commons system https://commons.era.nih.gov/commons/. It will be essential for all named PD/PIs on multiple-PD/PI applications to establish accounts in Commons as PD/PIs prior to the submission of the application. For instructions on registration with eRA commons, see http://era.nih.gov/ElectronicReceipt/preparing.htm.    


E. Post-Award Issues

  1. Will there be one progress report for the overall project, or will each PD/PI be required to submit an individual report?

    Yes. There will be a single progress report for multiple PD/PI applications.     

  1. If funds are allocated among the PD/PIs, could one PD/PI be given sole authority to reallocate money?

    No.  A basic principle of the multiple-PD/PI model is that each named PD/PI is equally responsible and accountable for the research project.  Re-allocation of funds must be via a joint decision of the PD/PIs, and the process for re-allocation should be included as part of the approach described in the Leadership Plan.

  1. How will data 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 data sharing and confidentiality policies; the presence of more than a single PD/PI does not excuse the PD/PIs from official requirements. Note that the NIH policy on data sharing applies only to applications with large budgets http://grants.nih.gov/grants/policy/data_sharing/index.htm). NIH policy states that applications requesting $500,000 or more in direct costs for any single year are required to include a plan for data sharing or to state why data sharing is not possible. Data sharing must be addressed in the Significance and Budget sections of the application, and a description of the data sharing plan (or an explanation for its absence) must appear at the end of the Research Plan section.


F. Questions Specific to the Issue of Applications from Multiple Institutions/Organizations

  1. In what format will multiple institution projects be submitted?

    Multiple PD/PIs at different institutions/organizations will collaborate on the development of a single application during the initial roll-out in February 2007.  Awards will be administered using the traditional subcontract approach.  In the future, the NIH anticipates that projects that span more than one institution/organization could be managed using linked awards.  The availability of that option will be announced at some point in the future. 

  1. Can a project supported through a multiple-PD/PI award include additional subcontracted sites?

    Yes.  Multiple PD/PIs at different institutions/organizations will be able to use the traditional subcontract mode. In the future, such projects may be administered using linked awards.   

  1. Can one organization/institution be designated as the lead?

    Yes, the small business submitting the application will be the lead organization.  The Contact PD/PI must be located at the organization submitting the application.  Note that the PD/PI must have a formal written appointment with the applicant organization, which must be in the form of an official relationship between the parties, but need not involve a salary or other form of remuneration. The other collaborating institutions/organizations will be supported through subcontracts.

  1. If the dollars are fluid and subject to reallocation across the participating institutions/organizations, 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.   


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