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Multiple Principal Investigators on Individual Research Awards

NIH Implementation Plans and Status Report

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Rationale Traditional single-PI model does not

always work well for multidisciplinary efforts and collaboration

Growing consensus that team science would be encouraged if more than one PI could be recognized on individual awards

Overarching goal: maximize the potential of team science efforts, responsive to the challenges and opportunities of the 21st century.

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Background Recommendations from 2003 NIH Bioengineering

Consortium (BECON) Symposium, “Catalyzing Team Science”

NIH Roadmap 2005 initiative to stimulate interdisciplinary science http://nihroadmap.nih.gov/interdisciplinary/

Directive from Office of Science and Technology Policy (OSTP); 2005.

Request for Information (RFI) issued by the NIH to solicit input on policies and issues of special interest to the health-related research community; 2005.

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Principal Investigator: Definition

“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.

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NIH Implementation: Although OSTP issued a directive that all

Federal agencies should allow multiple PIs on a single award, agencies may develop implementation policies that are specific to their agency.

Therefore, many of the following slides describe implementation requirements that are specific to NIH. For example, the Contact PI and the Leadership Plan are specific to the NIH

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Contact PI The multiple-PI option requires the designation of

a single “Contact PI”. Contact PI is the liaison to NIH, and is

responsible for: all communication between the PIs and the NIH; coordinating progress reports for the project.

Contact PI must meet all eligibility requirements for PI status in the same way as other PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

The role of Contact PI may be rotated among the multiple PIs on an annual basis.

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Eligible Projects/Grant Mechanisms

Projects or activities that clearly require a “team science” approach and which do not fit the single-PI model. Selection of single or multiple-PI option should always be based on the research proposed.

Not synonymous with “big science.” Could include as few as two PIs jointly responsible for the scientific and technical direction of the project.

No upper limit on number of PIs allowed. Initially limited to pilot initiatives. Phased-in

expansion expected to include full range of NIH mechanisms.

Will supplement, and not replace, the traditional single PI model.

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Eligible Projects/Grant Mechanisms

Investigators interested in the multi-PI model are encouraged to contact and discuss the proposed project with an NIH Institute or Center program staff member to determine whether a multiple PI approach to the project is better than the traditional single PI approach.

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Application Format/Content Pilots: RFAs and PAs will include special

application preparation instructions. PHS398 has been modified to permit the entry of

information for more than one PI. SF424 electronic grant application form

http://grants2.nih.gov/grants/funding/424/ can already accommodate more than one PI.

NIH will publish instructions for various mechanisms as multiple-PI option becomes available for a range of investigator-initiated grant mechanisms.

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Leadership Plan Leadership Plan will follow the Research Plan as a new

section Presents the PIs’ and Applicant Organization’s proposed

framework to facilitate and enhance scientific productivity and to protect the project in the case of disagreements.

Describes governance and organizational structure of the research project, including:

communication plans, including reporting to the NIH funding component;

process for making decisions on scientific direction, allocation of resources; publications; intellectual property issues; procedures for resolving conflicts; PIs’ roles and administrative, technical, and scientific

responsibilities for the project, including responsibilities for human subjects or animal studies as appropriate.

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Budgets for Multiple PI Awards Budget allocations to individual PIs will be permitted but

not required. In pilot phase, budget allocations will be informal --

based on decision by the PIs and the institution at the time of award;

allocation request will be recorded on the NIH Notice of Grant Award in a footnote;

grantee institution can choose to set up internal accounts to implement the requested allocation;

accounting within the institution not to be reported back to the NIH.

In the near future, the NIH will explore other options for allocation that could include formal allocation and tracking of separate accounts within an award or the use of linked awards. The NIH will seek feedback and advice from the research community about such options for allocating budgets.

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Awards to Multiple Institutions

When multiple institutions are involved, PIs and their institutions may either:

use traditional subcontract mode, designating one institution as the prime institution and requesting funding for the other institution(s) via subcontract(s); or

submit separate but linked or tethered applications with a request for separate grant numbers (i.e., “linked awards”).

The process for requesting linked awards and policies for managing linked awards are still being developed. Experience gained from the first phase of multiple institution applications, may be used to modify processes.

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Peer Review The standard five review criteria will be

applied to multiple-PI applications, with the following additional text applied to the “Approach” criterion: “For applications designating multiple PIs,

does the Leadership Plan ensure that there will be sufficient coordination and communication among the PIs? Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts?”

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Peer Review (cont’d) As in review of traditional single-PI applications,

peer reviewers will consider whether the designated PIs have appropriate training and experience to carry out the proposed study.

Inclusion of a “weak” or inappropriate PI will reflect negatively on both the “Approach” and “Investigators” review criteria

All PIs on a multiple-PI application are responsible for the intellectual development and direction of scientific and technical activities supported by the grant as a whole. Therefore, the PI’s role is more critical than that of “co-investigator” or other collaborator.

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Post Award Investigators will have maximum flexibility to respond to

new scientific opportunities within the overall scope of the funded project. Tracking and paperwork will be kept to a minimum.

Re-allocation of funds and revisions to the Leadership Plan during the project period:

via a joint decision of the PIs; implemented at the institutional level; no need for approval by NIH, beyond the normal requirements

for any grant. NIH plans to simply track most revisions through the

noncompeting continuation (Type 5) application, as it currently does for any changes to the scientific direction that are within the scope of the funded project.

Policies involving linked awards are still being developed.

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Communications/Reporting All named PIs on multiple-PI applications must

establish accounts in eRA Commons prior to the submission of the application.

All PIs will be able to view summary statements and status reports in NIH eRA Commons system https://commons.era.nih.gov/commons/.

NIH requests for information will be conveyed to the multiple PIs through the Contact PI.

All PIs on funded multiple-PI grants will eventually be credited through the NIH’s “Computer Retrieval of Information on Scientific Projects” (CRISP) http://crisp.cit.nih.gov/

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Web site

http://grants2.nih.gov/grants/multi_pi/index.htm

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Timeline Multiple-PI option will be available for

applications submitted in response to selected RFAs or PAs with May or June 2006 receipt dates.

Additional pilots will be conducted in the fall of 2006; some of these will test the processing of multiple-PI applications submitted electronically through Grants.gov. http://grants.gov/

All pilots involving RFAs and PAs will be announced through Notices in the NIH Guide for Grants and Contracts http://grants1.nih.gov/grants/guide/index.html.

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Timeline (cont’d) It is likely that the multiple-PI option will become available

for most investigator-initiated research grant mechanisms submitted for January 2007 and later application receipt dates.

This second phase of system development will generally follow the implementation schedule for the SF424 electronic grant application form, which can accommodate the multiple-PI option.

The second phase of development will include consideration of:

Linked awards Apportionment of funds to individual PIs Recognition of all key personnel

As part of the implementation process, continued advice will be solicited from the extramural community.

Tentative Multi-PI Timeline

October

MAY JUNAUG SEP OCT NOV DEC JAN FEB JULMAR APR AUG SEPJUL OCT NOV DEC

Complete eRA build for tethered Apps/Linked

Permit tethered Multi-PI applications/linked, Invest-Init.?

2008

Fs T32 Ps

2005

Receive first Multi-PI pilot applications

Submit 398 to OMBfor Clearance

Invest-Init. Multi PI RPG Applications

Issue pilot RFAs & PAs

NOV DECFEB MAR APR MAY JUN JUL AUG JANSEP OCT FEB MAR APR MAY JUN

2007

JAN

2006

Develop language for pilot RFAs & PAs

Meet with NSF on Tethered Apps/Linked

Receive last of the Multi-PI pilot applications

Identify Business Options for Tethered Apps/Linked

External groups on tethered Apps/Linked

Evaluate pilots – use of Multi-PI/Linked Awards

Develop Requirements for Tethered Apps/Linked

Scope eRA/Grants.gov tethered Apps/Linked

R03,R21 R01 Ks,G11

Electronic Receipt

Multi-PI Pilots

Issue Regulations at 42CFR52for Comment Build System for

Linked, Invest-Init

Multi-PI Timeline as of March 14, 2006

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Questions?

http://grants2.nih.gov/grants/multi_pi/index.htm