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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

15 CONSORTIUM AGREEMENTS

15.1 General

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 participant(s);
• A letter of commitment or intent signed by the consortium participant(s); and
• Non-modular 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.

15.2 Administrative 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.

15.2.1 Written Agreement

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 research effort.
• 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 (see Administrative 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).

15.2.2 Public 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.

15.2.4 Approval Authorities

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

15.2.5.1 Exempt 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).

15.2.5.2 Nonexempt Property

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.

15.2.6 Audit

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).