|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Guidance for Reviewers|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
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:
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:
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:
NIH may request additional information before award and may place a special condition(s) on the award.
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:
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).
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.
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.
The 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).