NIH Grants Policy Statement
Part II: Terms and Conditions of NIH Grant Awards
Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities – File 1 of 11
PART II: TERMS AND CONDITIONS OF NIH GRANT AWARDS
SUBPART B: TERMS AND CONDITIONS FOR SPECIFIC TYPES OF GRANTS, GRANTEES, AND ACTIVITIES
This Subpart includes terms and conditions that vary from,
are in addition to, elaborate on, or highlight the standard requirements and
terms and conditions in IIA because of the type of grant, grantee, or
grant-supported activity. Each chapter of IIB specifies how the coverage
relates to that in IIA and must be used in conjunction with IIA to determine
all of the applicable terms and conditions of a covered type of activity,
grantee, or award.
This Subpart contains the following chapters:
- Multiple Program Director/Principal Investigator
Applications and Awards
- Construction, Modernization, or Major Alteration
and Renovation of Research Facilities (this chapter also includes requirements
for specified A&R activities under non-construction grants)
- Individual Fellowships and Institutional
Research Training Grants (also termed "fellowships" and "training grants")
under the Kirschstein-NRSA program
- Career Development Awards
- Modular Applications and Awards
- Support of Scientific Meetings (Conference
- Consortium Agreements
- Grants to Foreign Institutions, International
Organizations, and Domestic Grants with a Foreign Component
- Grants to Federal Institutions and Payments to Federal
Employees Under Grants
- Grants to For-Profit Organizations
- Research Patient Care Costs.
9 MULTIPLE PROGRAM DIRECTOR/PRINCIPAL INVESTIGATOR APPLICATIONS AND AWARDS
Multiple Program Director/Principal Investigator (multiple
PD/PI) awards are an opportunity for multidisciplinary efforts and
collaboration through a team of scientists under a single grant award. All
PD/PIs share equally 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 PD/PI on an
application or award diminishes neither the responsibility nor the
accountability of any individual PD/PI. The applicant/grantee organization is
responsible for securing and retaining the required written assurance
signatures from each identified PD/PI on all
applications, post-submission information, progress reports, and post-award
prior approval requests and must make these signatures available to NIH or other authorized DHHS or Federal officials upon request.
NIH implementation of Multiple PD/PIs is in accordance with
the January 4, 2005 Office of Science Technology Policy directive to Federal
research agencies. Additional information on Agency implementation plans can be
found at: http://rbm.nih.gov/toolkit.htm.
NIH also maintains a Web site dedicated to the Multiple PD/PI initiative at: http://grants.nih.gov/grants/multi_pi/index.htm.
Applications submitted electronically through Grants.gov for
most award mechanisms permit multiple PD/PIs, with the exception of awards for
which multiple PD/PIs would not be appropriate such as individual fellowship
and career awards, dissertations grants (R36), Pioneer Awards (DP1), Construction Grants (C06/UC6), Grants for Repair, Renovation and Modernization of Existing Research Facilities (G20), and Shared Instrumentation Grants
(S10). Applications submitted on the paper PHS 398
Grant Application may only include multiple PD/PIs if the option is clearly
specified in the Funding Opportunity Announcement. SBIR/STTR applicants may use
the multiple PD/PI option; refer to the SBIR/STTR multiple PD/PI section for
specific requirements affecting small business concerns. For active awards, changing from a multiple PD/PI model to a single PD/PI model or changes in the number or makeup of the PD/PIs on a multiple PD/PI award requires the prior approval of the funding IC (see Change in Status, Including Absence of PD/PI and Other Senior/Key Personnel Named in the NoA).
The decision to submit a multiple PD/PI application is that
of the applicant organization and the PD/PIs, and should be consistent with the
scientific goals of the project. A single applicant organization may designate
multiple PD/PIs from the applicant organization or may designate multiple
PD/PIs from multiple institutions. Multiple organizations may not submit the
same multiple PD/PI application.
All PD/PIs must be qualified and have appropriate expertise
to serve as a PD/PI and the appropriate level of authority and responsibility
to direct the project or program as part of the leadership team. Each PD/PI
must have a defined role on the project. There is no limit on the number of
PD/PIs that may be designated, and no minimum person months requirement, except
STTR applicants where each PD/PI must commit a minimum of 1.2 calendar months
(10%) effort (see Grants to For-Profit Organizations—SBIR
and STTR Programs—Multiple PD/PI Applications and Awards).
Contact PD/PI. The applicant organization must designate one
of the PD/PIs as the Contact PD/PI to serve as a primary point of contact. The
Contact PD/PI must be listed first on the application and must be associated
with the applicant organization. The Contact PD/PI is responsible for
communication between the PD/PIs and the NIH, but has no special authorities or
responsibilities within the leadership team. Responsibilities of the Contact
PD/PI may include communication between the leadership team and the NIH,
assembly of the application materials, and coordination of progress reports. On
complex projects the Contact PD/PI may request additional effort for
coordination responsibilities if necessary.
eRA Commons Registration Required. All PD/PIs must have established eRA Commons accounts with a PI role prior to application
submission. When multiple PD/PIs are at different organizations, all
organizations must also be registered in the eRA Commons. If the contact PD/PI is at a different institution from the applicant
organization, then the applicant organization must also affiliate the contact
PD/PI with their institution. Beyond the contact PD/PI, it is not necessary for
all other PD/PIs to be affiliated with the applicant organization.
Leadership Plan. All multiple PD/PI applications are required
to include a Leadership Plan. The purpose of the Leadership Plan is to
facilitate and enhance scientific productivity and establish a decision-making
process. The Plan must describe a rationale for choosing the multiple PD/PI
approach. The governance and organizational structure of the leadership team
and the research project should be described, including communication plans,
process for making decisions on scientific direction, and procedures for
resolving conflicts. The roles and administrative, technical, and scientific
responsibilities for the project or program should be delineated for the
PD/PIs, including responsibilities for human subject studies or studies with vertebrate animals as appropriate.
New Investigators (Including Early Stage
Investigators). Multiple PD/PI
applications may designate senior and new investigators, including early stage
investigators. However, the application will only be considered a new
investigator application when all of the PD/PIs meet the NIH definition of new
investigator, and will only be considered an early stage investigator
application when all of the PD/PIs meet the NIH definition of early stage
investigator. For the purposes of classification as a new investigator, serving
as a PD/PI on a substantial independent PD/PI research award is equivalent to serving as a PD/PI on a substantial independent PD/PI research award. Thus, if a new investigator successfully competes as a PD/PI on a substantial independent multiple PD/PI grant, she or he no longer qualifies as a new (or early stage) investigator on a substantial independent single PD/PI application. However, if a new investigator is added as a PD/PI to an active substantial independent research award, the individual will retain his or her new investigator status.
Multi-Project Applications. Assuming the FOA for Multi-project
applications (e.g., P01, P30) specifically allows multiple PD/PIs, applications may include multiple lead investigators for subprojects as well as multiple PD/PIs for the entire program. Do not confuse lead investigator(s) of a subproject or component of a multi-project application with multiple PD/PIs of the entire program. Lead investigator(s) of subprojects or components are not automatically considered to be PD/PIs of the entire application. When a lead investigator of a subproject or component is also a PD/PI of the entire program, that individual must specifically be designated as a PD/PI of the application.
general, multiple PD/PI applications will submit a single budget for the entire
project. This applies to both modular and detailed budgets. When determining if
a modular budget should be submitted, the $250,000 threshold is for the entire
project, not per PD/PI. When multiple PD/PIs are at different institutions, the
standard instructions for submitting consortium budgets apply. Applicants can
choose to include budget allocation information for specific PD/PIs as part of
the Leadership Plan. In the event of an award, the requested allocations may be
reflected in a term in the NoA (see Leadership Plan
Renewal or Resubmission Applications. A renewal or resubmission application may
change from a single PD/PI to multiple PD/PIs, or may change the number or makeup of the multiple PD/PIs, however, the applicant must
provide a rationale for the change in the Introduction, and include the
required Leadership Plan in the application. Likewise, a previously submitted
multiple PD/PI application may change to a single PD/PI application in a
renewal or resubmission; the applicant must provide a rationale for the change
in the Introduction.
Competing Revision Applications. A competing revision application to
an existing Multiple PD/PI grant must be submitted using the same Contact PD/PI
as the parent grant, and may propose changes in the Leadership Plan or in the
composition of the leadership (by adding or removing PD/PIs), and should
provide a rationale for any such changes. A competitive revision to a single
PD/PI grant may be submitted proposing multiple PD/PIs provided a Leadership
Plan is also included.
Review and Award
The review criteria applied to multiple PD/PI applications
are the same criteria applied to single PD/PI applications and each application
will be evaluated on its own merit (see The Peer
Review Process in Part I). Peer reviewers will consider each PD/PI's
qualifications and identified role in the project. The leadership approach will
be used to facilitate understanding of the complexities of the science and the
management of the project. The quality of the Leadership Plan will be
considered as part of the assessment of the overall approach, and incorporated
into the scientific and technical merit determination. Peer reviewers will not
recommend that individual PD/PIs be removed; however, reviewers may recommend
deletion of the specific aims and budget of a PD/PI, which would effectively
remove the PD/PI's effort.
All PD/PIs are listed on the Summary Statement, in the NoA, and in NIH databases.
9.5 Post-Award Administration
If multiple PD/PIs are from multiple organizations, NIH will
issue the award to the applicant organization which will administer
the award using consortium or subaward arrangements
in accord with the Consortium Agreements chapter. Budgets,
including F&A costs associated with subawards,
will be determined according to existing policy. Changes in the allocation and
the size of subawards will be handled in the same way
as single PD/PI awards.
Responsibility for all required reports is shared by the
PD/PIs and the grantee institution. Only one of each required report should be
submitted. Although all PD/PIs are responsible for the content of all reports,
only one PD/PI should upload information in the eRA Commons. As with most other Commons features, only the grantee Signing Official
may submit the reports to NIH, including closeout reports (final invention
statement, progress report and financial status report).
Requests for administrative supplements must be submitted
from an authorized official at the grantee organization and include the grant
number and name of the Contact PD/PI in the request. For all applications,
post-submission information, progress reports, and prior approval requests including requests to add or drop a PI, the
grantee organization remains responsible for securing and retaining the
required written assurance signatures from each identified PD/PI.
A change in Contact PD/PI may be designated in a non-competing
continuation progress report; the Contact PD/PI must be a member of the
existing leadership team and associated with the grantee
organization. Revision of the Leadership Plan during the project period may be
accomplished through a joint decision of the PD/PIs and reported in a
non-competing continuation progress report.
All existing prior approval requirements apply to multiple
PD/PI awards, including the change in status of any one of the PD/PIs or the addition of a PD/PI; refer to Administrative Requirements—Prior
Approval Requirements in IIA. If a PD/PI withdraws from the grant or is no
longer able to work on the project, a revised Leadership Plan or description of the impact on the project of a change to a single PD/PI award must be submitted as part of the prior approval request. NIH will evaluate the request considering
the project as a whole, including the impact on the scope of work and budget.
If the Contact PD/PI changes institutions, the grantee
institution will need to consider options. Since it is required that the
Contact PD/PI be affiliated with the grantee institution in the Commons, the
institution may choose to designate another PD/PI as the Contact. Another
option would be to relinquish the grant and allow it to be transferred. Contact
PD/PIs considering transferring should consult with the NIH awarding IC early
in the process to discuss options.