Multiple PI Implementation Update
Notice Number: NOT-OD-06-069
Key Dates
Release Date: May 11, 2006
Issued by
National Institutes of Health (NIH), (http://www.nih.gov)
The National Institutes of Health will recognize multiple Principal Investigators
(PI) on a selected set of grant programs beginning in September, 2006 (http://grants2.nih.gov/grants/multi_pi/).
This notice reminds the research community that the multiple PI option will
be available only for programs involved in the pilot;
that all participating PIs will need to be registered on the NIH Commons
prior to submission; and that Multiple PI applications must include a leadership
plan. Finally, this notice describes the management strategies for
Multiple PI projects that are in place for the pilot initiatives and special
review criteria that will be used for these pilots. Other policies
and management strategies will be announced as they are developed.
Pilot Multiple PI Programs: The following program
announcements (PAs), Requests for Applications (RFAs) and Notices describe
programs involved in the Multiple PI Pilot. It should be noted that Multiple
PI leadership is an option only for those applicants responding to the Pilot
Initiatives. Although the modified PHS 398 form accommodates multiple
PIs, applications with multiple PIs that are not submitted in response
to the pilot initiatives may be delayed or in some cases may not be reviewed.
- NOT-AT-06-003 -
Update to PAR-06-108 and RFA-AT-06-001,
Developmental Centers for Research on Complementary and Alternative
Medicine: Addition of the Option to Include Multiple Principal Investigators
- NOT-LM-06-004 -
Update to PA-06-094,
NLM Research Grants in Biomedical Informatics and Bioinformatics:
Addition of the Option to Include Multiple Principal Investigators
- NOT-DK-06-007 -
Multiple PI Update to RFA-DK-05-014:
The Obese and Diabetic Intrauterine Environment: Long-term Metabolic
or Cardiovascular Consequences in the Offspring
- RFA-CA-07-004 -
Small Animal Imaging Resource Program (U24)
- PAR-06-389 -
Basic and Translational Research Opportunities in the Social Neuroscience
of Mental Health (R01) [SF424 (R&R)]
- PAR-06-406 – In
Vivo Cellular and Molecular Imaging Centers (ICMICs) [P50]
With the exception of PAR-06-389 these programs will be submitted
using the 4/2006 Interim revision of the PHS 398 form (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-056.html). PAR-06-389
will pilot electronic submission for R01s using the Standard Form 424
(R&R). All such programs are announced in the NIH Guide for
Grants and Contracts http://grants2.nih.gov/grants/guide/index.html and
on the Multiple PI Website at http://grants2.nih.gov/grants/multi_pi/index.htm. Please
note that all PIs listed on applications employing the multiple PI
option must be registered in the NIH Commons in advance of submission (see http://era.nih.gov/ElectronicReceipt/preparing.htm) . For
electronically submitted applications in response to PAR-06-389, the
Commons ID is a required field for all PD/PIs (see
the Credential field in the Senior/Key Person Profile component).
All Multiple PI projects are required to include a new section describing
the leadership of the project.
(For applications submitted in paper using the PHS398 this is now section
I in the PHS398 Research Plan. For applications submitted electronically
using the SF424 (R&R) follow the instructions provided in the Application
Guide.).
Section I. Multiple Principal Investigator Leadership Plan:
For applications designating multiple PIs, a new section entitled Leadership
Plan is now included as Section I, of the research plan. The governance and
organizational structure of the research project are described, including
communication plans, process for making decisions on scientific direction,
allocation of resources, publications, intellectual property issues, and
procedures for resolving conflicts. The roles and administrative, technical,
and scientific responsibilities for the project or program are delineated
for the PIs, including responsibilities for human subjects or animal studies
as appropriate. Note that single PI applications and applications
that are not submitted in response to the announcements included in the Pilot
are not to include a Leadership Plan. Examples of leadership
plans are available on the Multiple PI website at http://grants.nih.gov/grants/multi_pi/index.htm.
Management Strategies Available for Programs in the Pilot: Three
management strategies for these projects are being tested. These strategies
are likely to evolve as the pilot phase of implementation informs the
process.
- Multiple PIs at One Institution – Informal Allocation.
In this strategy, a single application is submitted, and a single
award is made to the institution. The PIs and their institution
may request a division of the budget either in the application or
at the time of award. The request will be noted on the Notice of
Grant award as a footnote. Implementation of the request is
left to the Institution. Communication between the PIs and the NIH
is delegated to a single contact PI, but all PIs will have access
to all documents pertaining to the project via the NIH Commons. The
contact PI designation may rotate among the PIs on an annual basis.
- Multiple PIs at Multiple Institutions – Subcontract/Consortium
Model. In this strategy, a single application is submitted,
and a single award is made to the applicant institution. Note
that the contact PI must be located at the applicant institution. The
components of the project at the other Institutions will be supported
using a traditional consortium/subcontract arrangement. The
relationship between the institutional partners must be designed
to support all components of the project including those at the
secondary institutions. All PIs, including those at the consortial
institutions, will have access to documents pertaining to the project
via the NIH Commons. The contact PI designation may rotate only
among those PIs who are located at the applicant/awardee Institution.
- Multiple PIs at Multiple Institutions – Linked Awards
Model (only available through NOT-DK-06-007 and NOT-LM-06-004 ).
In this strategy, linked applications are submitted by each partnering
Institution, and will be associated and reviewed as a single project. If
an award is made, each of the involved institutions will receive
a separate grant to fund the collaborative project. The
institution with the contact PI submits a full application while
other institutions submit mini-applications that include Institution-specific
information but lack an Abstract and Research Plan. The mini-applications
refer to the full application; all applications are linked by a
common project title and by cross-references within each application.
All of the applications are reviewed together as a single project. PIs
and their Institutions will collaborate to produce identical annual
Progress Reports, which detail progress on the project as a whole,
thus enabling the project to be administered as a single project.
The contact PI, which may rotate between the PIs on an annual basis,
is responsible for communication with the NIH for the project as
a whole. The NIH will communicate with the individual Institutions
for Institution-specific issues. Please note that this option
will only be available during the pilot and for special programs
such as RFAs and PAs until administrative systems have been built
to handle large numbers of applications and awards of this type.
A fourth management strategy, Multiple
PIs at One Institution – Formal Allocation,
is being considered by the NIH. This strategy would either involve
multiple awards to one institution or the allocation of funds within
the Notice of Grant award mandating the generation of sub-accounts
within an Institution. This would provide individual budgets for
different components of the project that might be managed by different
PIs. The NIH is gathering input from the scientific community concerning
the utility of this model, but it is not being piloted at this
time.
REVIEW CRITERIA for ALL APPLICATIONS in the Multiple PI Pilot: The
review criteria normally employed for NIH research grant applications
have been modified slightly to accommodate both single and multiple
PI applications. The revised language for multiple PI applications
is indicated in bold font below:
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?
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 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?
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
or methodologies, tools, or technologies for this area?
Investigators: Are the principal investigator(s) and
key personnel appropriately trained and well suited to carry out this
work? Is the work proposed appropriate to the experience level(s) of
the principal investigator(s) and other researchers? Do the principal
investigator(s) and investigative team bring complementary
and integrated expertise to the project (if applicable)?
Environment: Does the scientific 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(s), or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
MULTIPLE PI IMPLEMENTATION TIMELINE: The first Multiple
PI awards will be issued in September, 2006. The NIH anticipates that
Multiple PI leadership will be an option for most research project
grant applications beginning with the February 1, 2007 application
receipt date. After that, Multiple PIs are likely to be an option for
other grant mechanisms as they transition to electronic submission. Note: The
NIH does not anticipate using linked awards for applications received
outside of the pilot program until computer systems can be developed
to provide an efficient method for handling linked applications and
for recognizing and reporting on linked awards. The NIH
expects systems to be in place that will accommodate general use of
linked applications and awards during Fiscal Year 2008. Prior
to that time, linked awards will be available only when announced in
advance for a specific initiative.