1. PRAC - December 4, 20061 Archived File The file below has been archived for historical reference purposes only. The content and links are no longer maintained and may be outdated. See the OER Public Archive Home Page for more details about archived files.archivedOER Public Archive Home Page

2. PRAC - December 4, 20062 NIH Multiple PI Initiative Peer Review Advisory Committee December 04, 2006 Walter T. Schaffer, Ph.D.

3. PRAC - December 4, 20063 Multiple PI Initiative: Why?  Principal Investigators (PIs) sometimes work in teams  Many projects dependent on collaboration  Growing consensus that team science is discouraged by recognition of only one PI.  Other Federal agencies have recognized co-PIs for years

4. PRAC - December 4, 20064 Multiple PI Initiative: Need for More than one PI?  Need for change expressed in: Recommendations from NIH Bioengineering Consortium (BECON) Symposium 2003 NIH Roadmap initiative to stimulate interdisciplinary science 2004 Directive from Office of Science and Technology Policy January 2005 (OSTP)

5. PRAC - December 4, 20065 Multiple PI Initiative: Community Support?  Requests for Information (RFIs) issued by OSTP and NIH in July 2005 OSTP found overwhelming support for concept of listing more than one PI NIH explored nuances including:  apportionment to individual PIs  The use of linked awards for projects spanning more than one institution  Discontinuation of Departmental Ranking Tables The NIH RFI also revealed strong support for the ability to recognize more than one PI.

6. PRAC - December 4, 20066 Multiple PI Pilot  Extensive system redesign to handle more than one PI  Multiple PI offered as an option in 9 RFAs and PAs beginning in May 2006.  More than 210 applications were received through the pilots; more than 60 named multiple PIs. About 30% included multiple PIs Expect lower usage rate.  Made small number of awards associated with first RFA  Interviewed PIs and Reviewers to finalize definitions, instructions to applicants, and review criteria  Published in Notice that appeared in the NIH Guide on November 20  Following Principles have emerged

7. PRAC - December 4, 20067 Core Principle #1: PIs are PIs  PIs on a Multiple PI grant are designated by the applicant institution  PIs have the authority and responsibility to direct the project and they work as a team to lead and direct the project.  Each PI is accountable to the applicant organization for the proper conduct of the project.  The presence of more than one PI does not diminish the responsibility or accountability of any PI  Definition of PI in Appendix to this slide set and in all funding announcements, application packages and on the multiple PI website.  To avoid confusion, the term “Co-PI” will not be used by NIH

8. PRAC - December 4, 20068 Core Principle #2: Multiple PI is an Option not a Requirement  The decision to apply with more than one PI is the responsibility of the investigators and the applicant institution.  Decision must be consistent with the scientific goals of the project  PIs on a Multiple PI grant are accountable for all aspects of the project.

9. PRAC - December 4, 20069 Core Principle #3: Multiple PIs Does Not Imply More Than ONE PROJECT  The application is the same as it would be for a single PI, with the exception of an expanded list of PIs and a Leadership Plan.  The project is reviewed as a single project, regardless of the PI number.  If PIs are at multiple institutions, project is managed using a consortium agreement or subaward. Linked awards will be possible in the future, after the development of systems support.

10. PRAC - December 4, 200610 Core Principle #4: All PIs will be Recognized in NIH Reports  All PIs listed in all documents/databases Applications IMPAC II NIH Commons (all PIs must have PI Role-Type Commons account) QVR Review assignment and scoring reports Summary statements Notice of Grant Award CRISP

11. PRAC - December 4, 200611 How will multiple PIs work together to lead a project?  A Leadership Plan must accompany the application. Rationale for having multiple PIs Decision making process Allocation of funds or resources (when desired) Process for resolving conflict PIs’ roles and administrative, technical, and scientific responsibilities for the project

12. PRAC - December 4, 200612 How will Multiple PI Applications be Reviewed?  Minimal modification of standard review criteria The relationship, roles, and responsibility of the collaborating PIs will be assessed as a part of the “Approach”. The qualification of all PIs will be assed under “Investigators” If multiple environments are employed the quality will be assessed under “Environment”

13. PRAC - December 4, 200613 How will the budget be allocated if requested?  Institutions/PIs may request allocation in the Leadership Plan.  If an award is to be made, the requested allocation may be displayed as a footnote on the Notice of Grant Award. will not limit institutional authority to mange the funds Will not impose additional prior approval or reporting requirements.  For PIs are at different institutions manage using a consortium or subaward arrangement Linked awards are expected to be offered once systems are ready

14. PRAC - December 4, 200614 How will NIH interact with the PI team?  Institution must designate a primary point of contact – a Contact PI. This individual is listed first on the application and will be indicated on all documents. The contact PI must be associated with the applicant/awardee institution.  When requested by the grantee institution at the time of a non-competing application, another member of the leadership team may assume the role of contact PI.  Contact PI has no extra authority or responsibility other than serving as a contact point for the project.

15. PRAC - December 4, 200615 Impact on New Investigator Policies  Since New Investigator incentives are applied to applications: NIH policies related to New Investigators will be applied only when all PIs involved are classified as New Investigators The New Investigator Box on the application may be checked only when all PIs involved are classified as New Investigators For the purpose of classification as a New Investigator, serving as a PI on a multiple PI grant will be equivalent to serving as a PI on a single PI grant.

16. PRAC - December 4, 200616 Plans for Deployment of Multiple PI Option  Begin with research grant applications submitted electronically on SF 424 R&R for February 2007 receipt dates  MP permitted on applications for: R01, R03, R13/U13, R15, R18/U18, R21, R21/R33, R25, R34, R41, R42, R43, R44, and C06/UC6  Will not apply to some awards like individual fellowships and career awards, dissertation grants (R36), Shared Instrumentation Grants (S10), or Pioneer Awards (DP1)  In the future extend the multiple PI option to most other research grant applications when they transition to an electronic format.  Some paper applications (PHS 398) will allow inclusion of more than one PI, but only when clearly indicated in the soliciting RFA or PA.  See Guide Notice published on November 20 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html

17. PRAC - December 4, 200617 Future Considerations  Develop ability to manage research projects spanning more than one institution using linked awards in addition to subcontracts  Develop the capacity to recognize non-PI key contributors  Assess the desirability of permitting formal apportionment of funds to identified components of a project or the associated PIs.

18. PRAC - December 4, 200618 Appendix: NIH Definition of Principal Investigator  “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 PIs who share the authority and responsibility for leading and directing the project, intellectually and logistically. Each 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 PI on an application or award diminishes neither the responsibility nor the accountability of any individual PI.  Note: in documents associated with electronic applications the PI is called the PD/PI (Project Director/Principal Investigator)

19. PRAC - December 4, 200619 Appendix: Changes in Review Criteria 1. Significance. Does this study address an important problem? 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? 2. 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? 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? 3. 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? 4. Investigators: 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? Do the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable). 5. Environment: Do(es) the scientific environment(s) 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(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?