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 7 of 11
This chapter includes the requirements for an
applicant/grantee under consortium agreements in which the grantee collaborates
with one or more other organizations in carrying out the grant-supported
research. The grantee, as the direct and primary recipient of NIH grant funds,
is accountable to NIH for the performance of the project, the appropriate
expenditure of grant funds by all parties, applicable reporting requirements,
and all other obligations of the grantee, as specified in the NIHGPS. In
general, the requirements that apply to the grantee, including the intellectual
property requirements in IIA and the program income requirements of the award,
also apply to consortium participant(s). Exceptions are noted in this chapter.
The grantee is responsible for including the applicable requirements of the
NIHGPS in its agreements with collaborating organizations (see Written Agreement in this chapter).
Under grants that include consortium agreements:
- The award will be made to a single grantee with
a single PD/PI (or Contact PD/PI, in the case of multiple PD/PI applications),
even though one or more organizations other than the grantee will carry out
portions of the planned programmatic activity.
- The prime grantee must perform a substantive
role in the conduct of the planned research and not merely serve as a conduit
of funds to another party or parties. This includes being able to provide
appropriate oversight of all scientific, programmatic, financial, and
administrative matters related to the grant.
Applicants are expected to detail their proposed
collaborations as part of the grant application. If the application is approved
as submitted, no further approval is required unless, during performance, the
grantee plans to undertake additional or alternative collaborations that would
constitute a change in the scope of the approved project (see Administrative Requirements—Changes in Project
and Budget in IIA). Applicants for STTR grants should follow the specific
requirements for research collaboration established for that program (see Grants to For-Profit Organizations chapter).
The following information must be provided to NIH as part of
a competing application that proposes consortium arrangements:
- Include all proposed performance sites;
those of the applicant organization and the consortium
- A letter
of commitment or intent signed by the consortium
grant applications must include complete detailed budgets for each consortium participant.
Modular grant applications must include an estimate of consortium total costs
(direct costs plus F&A costs) each year as part of the budget narrative
justification (see Modular Applications and Awards chapter).
For the consortium site, it is appropriate and expected that someone will be designated as the consortium lead investigator responsible for ensuring proper conduct of the project or program at the consortium site. However, this individual must only be assigned the PD/PI role when a multiple PD/PI application is being submitted. Otherwise, this individual should be assigned some other project role in the Senior/Key Personnel section of the application.
The signature (or electronic equivalent) of the AOR/SO on
the application signifies that the applicant organization and all proposed
consortium participants understand and agree with the following statement:
"The appropriate programmatic and administrative personnel
of each organization involved in this grant application are aware of the NIH
consortium agreement policy and are prepared to establish the necessary
inter-organizational agreement(s) consistent with that policy."
NIH may request additional information before award and may
place a special condition(s) on the award.
and Other Requirements
The following highlights several areas within the consortium
relationship that the grantee needs to address with consortium organizations
receiving subawards under a grant to ensure
compliance with NIH requirements. The requirement for a written agreement
addressing these and other areas is specified in this section.
Note that most of these requirements only apply to a
grantee's consortium relationships with subawardees.
When the relationship is with a vendor that is providing routine goods and
services within normal business operations that are ancillary to the operation
of the research program, the public policy requirements listed below do not
apply. The vendor must also be providing similar goods and services to many
different purchasers and provide them in a competitive environment.
The grantee must enter into a formal written agreement with
each consortium participant that addresses the negotiated arrangements for
meeting the scientific, administrative, financial, and reporting requirements
of the grant, including those necessary to ensure compliance with all
applicable Federal regulations and policies and facilitate an efficient
collaborative venture. At a minimum, this agreement must include the following:
- Identification of the individual who will serve as the consortium lead investigator and other individuals responsible for the research activity at each consortium participant along with their roles and responsibilities.
- When multiple PD/PIs are involved at different
organizations, only the Contact PD/PI is required to have the official relationship
with the applicant organization. PD/PIs in the leadership team at other
organizations must have a documented relationship with a consortium
organization, but need not be employees. Any consortium agreement must address
the unique aspects to these individuals holding the PD/PI role.
- Procedures for directing and monitoring the
- Procedures to be followed in reimbursing each
consortium participant for its effort, including dollar ceiling, method and
schedule of reimbursement, type of supporting documentation required,
procedures for review and approval of expenditures of grant funds at each
organization and timing of applicable reporting requirements. This includes provisions on access to core facilities and resources and whether access will be provided as a fee-for-service.
- If different from those of the grantee, a
determination of policies to be followed in such areas as travel reimbursement
and salaries and fringe benefits (the policies of the consortium participant
may be used as long as they meet NIH requirements).
Terms that establish whether the Financial Conflict of Interest policy of the awardee Institution or that of the subrecipient will apply to the subrecipient’s Investigators.
If the subrecipient’s Investigators must comply with the subrecipient’s Financial Conflict of Interest policy, the subrecipient shall certify as part of the written agreement that its policy complies with the 2011 revised FCOI regulation (42 CFR 50 Subpart F). If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the Financial Conflict of Interest policy of the awardee Institution for disclosing Significant Financial Interests that are directly related to the subrecipient’s work for the awardee Institution.
If the subrecipient’s Investigators must comply with the subrecipient’s Financial Conflict of Interest policy, the written agreement shall specify time period(s) for the subrecipient to report all identified Financial Conflicts of Interest to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to provide timely FCOI reports, as necessary, to the PHS as required by the regulation.
Alternatively, if the subrecipient’s Investigators must comply with the awardee Institution’s Financial Conflict of Interest policy, the written agreement shall specify time period(s) for the subrecipient to submit all Investigator disclosures of Significant Financial Interests to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to comply timely with its review, management, and reporting obligations under the 2011 revised FCOI regulation.
- A provision addressing ownership and disposition
of data produced under the consortium agreement. This includes whether cell lines, samples or other resources will be freely available to other investigators in the scientific community or will be provided to particular investigators only.
- A provision making the NIH data sharing and inventions
and patent policy, including a requirement to report inventions to the grantee
Requirements—Availability of Research Results: Publications, Intellectual Property
Rights, and Sharing Research Resources in IIA), applicable to each
consortium participant and its employees in order to ensure that the rights of
the parties to the consortium agreement are protected and that the grantee can
fulfill its responsibilities to NIH.
- Expectations for authorship and co-authorship on publications.
- Provisions regarding property (other than
intellectual property), program income, publications, reporting, and audit
necessary for the grantee to fulfill its obligations to NIH.
- Incorporation of applicable public policy
requirements and provisions indicating the intent of each consortium
participant to comply, including submission of applicable assurances and
certifications (see Public Policy
Requirements, Objectives, and Other Appropriation Mandates in IIA).
Policy Requirements and Objectives
The grantee is responsible for determining whether a
consortium participant, including foreign consortium participants under
domestic or foreign grants, has filed assurances with NIH that would cover its
activities within the consortium and, if not, for ensuring that any required
assurances or certifications are submitted to NIH. See Public Policy Requirements, Objectives,
and Other Appropriation Mandates in IIA for the full statement of these
requirements and their applicability to consortium participants.
The grantee is responsible for ensuring that all sites
engaged in human subjects research have an appropriate OHRP-approved assurance
and IRB approval of the research consistent with 45 CFR 46 (see Guidance
on Engagement of Institutions in Human Subjects Research http://www.hhs.gov/ohrp/policy/engage08.html),
and for complying with NIH prior approval requirements related to the addition
of sites not included in the approved application (see Administrative Requirements—Changes in Project
and Budget in IIA). The list of organizations with approved assurances is
available at the OHRP Web site: http://www.hhs.gov/ohrp/.
The animal welfare
requirements that apply to grantees also apply to consortium participants and
subprojects. The primary grantee is responsible for including these
requirements in its agreements with collaborating organizations, and for
ensuring that all sites engaged in research involving the use of live
vertebrate animals have an approved Animal Welfare Assurance and that the activity
has valid IACUC approval. The approval of more than one IACUC is not required
if the grantee and performance site(s) have Assurances; the institutions may
exercise discretion in determining which IACUC reviews research protocols and
under which institutional program the research will be conducted. If the prime
grantee does not have an Assurance and the animal work will be conducted at an
institution with an Assurance, the grantee must obtain an Inter-institutional
Assurance from OLAW. Under the Inter-institutional Assurance, the grantee and
performance site agree that the research will be conducted under the auspices
and program of animal care and use of the performance site's Assurance. The grantee
is further responsible for complying with NIH prior approval requirements
related to the addition of sites not included in the approved application (see Administrative Requirements—Changes in
Project and Budget—Prior Approval Requirements in IIA). The list of organizations with
approved assurances is available at the OLAW Web site (domestic institutions: http://grants.nih.gov/grants/olaw/assurance/300index.htm, and foreign institutions: http://grants.nih.gov/grants/olaw/assurance/500index.htm).
15.2.3 Allowable and Unallowable Costs
The grantee must include in consortium agreements the
applicable government-wide cost principles and NIH cost policies described in
the Cost Considerations chapter in IIA and,
as appropriate, requirements related to allowable and unallowable costs in
other sections of IIB. For example, a university grantee must flow down the
cost principles of OMB Circular A-122 to a consortium participant that is a
non-profit research organization. This includes the application of F&A
rates in determining consortium budgets and the reimbursement of costs.
Grantees are responsible for negotiating F&A rates with consortium participants that receive awarded funds under NIH grants, unless the consortium participant is a foreign organization, the award is for training purposes or the consortium participant has a negotiated rate agreement. If the consortium participant is a foreign organization or the award is for training purposes, F&A will be limited in accordance to policy for those classes of awards.
The grantee is responsible for obtaining NIH awarding IC
approval for any actions to be undertaken by consortium participants that
require prior approval. Grantees may establish requirements for review of
consortium participants' activities consistent with those requirements and with
any authorities provided to the grantee; however, a grantee may not provide any
authority to a consortium participant that the grantee has not been provided
under its NIH award.
Regardless of whether there is a change in scope, in all
cases, if a grantee (or consortium participant) proposes the transfer of work
to a foreign site, awarding IC prior approval is required.
15.2.5 Tangible Personal Property
If the grantee provides exempt property to a consortium
participant or authorizes a consortium participant to purchase property that
would be considered exempt if acquired by the grantee, the grantee may vest
title in the consortium participant upon transfer or purchase or may reserve
the right to do so at a later time. The grantee also may establish its own use,
disposition, and accountability requirements, provided they are consistent with
the NIH right to transfer title (see Administrative
Requirements—Management Systems and Procedures—Property Management System
Standards—Equipment and Supplies in IIA).
If the grantee provides nonexempt property to a consortium
participant or authorizes a consortium participant to purchase property that
would be considered nonexempt if purchased by the grantee, title to such
property must remain with the grantee or be vested in the grantee upon
acquisition of the property. The grantee may establish use, accountability, and
disposition requirements for the property, provided they are consistent with, and
do not impair, the grantee's ability to comply with the requirements of 45 CFR 74 or 45 CFR 92, as appropriate.
grantee must require consortium participants to comply with the requirements of
OMB Circular A-133 or 45 CFR 74.26(d), as applicable, for audit of NIH grant
funds expended by consortium participants. A consortium participant also may be
a direct NIH grantee or contractor or may be receiving funds only under the
consortium agreement. Regardless, if a non-profit consortium participant meets
the OMB Circular A-133 threshold criterion of aggregate annual expenditures of
$500,000 or more under applicable Federal awards, the grantee must receive a
copy of that organization's A-133 audit and take appropriate action based on
any findings that relate to the consortium agreement. If a consortium
participant will not reach that expenditure threshold, the grantee is
responsible for monitoring the organization's activities to ensure compliance
with NIH requirements. The grantee may not require a consortium participant to
have an audit and charge the audit costs to NIH grant funds unless required or
authorized by OMB Circular A-133 or 45 CFR 74.26(d).