NIH Implementation Plans and Status Report

Multiple Principal Investigators
on Individual Research Awards
NIH Implementation Plans and
Status Report
4/11/06
Rationale
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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.
4/11/06
Background
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Recommendations from 2003 NIH Bioengineering
Consortium (BECON) Symposium, “Catalyzing
Team Science”
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NIH Roadmap 2005 initiative to stimulate
interdisciplinary science
http://nihroadmap.nih.gov/interdisciplinary/
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Directive from Office of Science and Technology
Policy (OSTP); 2005.
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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.
4/11/06
Principal Investigator:
Definition
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“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.
4/11/06
NIH Implementation:
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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
4/11/06
Contact PI
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The multiple-PI option requires the designation of
a single “Contact PI”.
Contact PI is the liaison to NIH, and is
responsible for:
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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.
4/11/06
Eligible Projects/Grant
Mechanisms
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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.
4/11/06
Eligible Projects/Grant
Mechanisms
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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.
4/11/06
Application Format/Content
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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.
4/11/06
Leadership Plan
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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.
4/11/06
Budgets for Multiple PI Awards
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Budget allocations to individual PIs will be permitted but
not required.
In pilot phase, budget allocations will be informal -
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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.
4/11/06
Awards to Multiple
Institutions
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When multiple institutions are involved, PIs and
their institutions may either:
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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.
4/11/06
Peer Review
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The standard five review criteria will be
applied to multiple-PI applications, with
the following additional text applied to the
“Approach” criterion:
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“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?”
4/11/06
Peer Review (cont’d)
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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 “coinvestigator” or other collaborator.
4/11/06
Post Award
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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:
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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.
4/11/06
Communications/Reporting
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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/
4/11/06
Web site
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http://grants2.nih.gov/grants/multi_pi/index.htm
4/11/06
Timeline
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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.
4/11/06
Timeline (cont’d)
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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:
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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.
4/11/06
Tentative Multi-PI Timeline
Develop language for
pilot RFAs & PAs
Submit 398 to OMB
for Clearance
Issue pilot
RFAs & PAs
Receive last of the MultiPI pilot applications
Receive first Multi-PI
pilot applications
External groups on
tethered Apps/Linked
JAN FEB MAR APR MAY
JUN JUL AUG
Scope eRA/Grants.gov
tethered Apps/Linked
2005
SEP OCT NOV DEC
JAN
FEB MAR APR MAY JUN
R01
R03,R21
2006
Invest-Init. Multi PI
RPG Applications
Identify Business Options
for Tethered Apps/Linked
Meet with NSF on
Tethered Apps/Linked
Develop Requirements for
Tethered Apps/Linked
Electronic Receipt
Evaluate pilots – use of
Multi-PI/Linked Awards
Issue Regulations at 42CFR52
for Comment
Ks,G11
2007
Multi-PI Pilots
Complete eRA build for
tethered Apps/Linked
Build System for
Linked, Invest-Init
October
Permit tethered
Multi-PI
applications/linked, Invest-Init.?
Fs
T32
JUL AUG SEP
Ps
OCT NOV
DEC JAN
FEB MAR APR MAY JUN
JUL
2008
Multi-PI Timeline as of March 14, 2006
AUG SEP OCT NOV DEC
Questions?
http://grants2.nih.gov/grants/multi_pi/index.htm
4/11/06