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The following highlights several areas within the consortium relationship that the recipient 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 recipient'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 recipient 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 recipient 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 recipient 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 Researchhttp://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 recipients also apply to consortium participants and subprojects. The primary recipient 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 recipient 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 recipient does not have an Assurance and the animal work will be conducted at an institution with an Assurance, the recipient must obtain an Inter-institutional Assurance from OLAW. Under the Inter-institutional Assurance, the recipient 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 recipient 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 organizations: http://grants.nih.gov/grants/olaw/assurance/500index.htm).
The recipient 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 recipient must flow down the cost principles of 45 CFR 75, Appendix IX to a consortium participant that is a hospital. This includes the application of F&A rates in determining consortium budgets and the reimbursement of costs.
Recipients must use an approved federally recognized indirect cost rate negotiated between the subrecipient and the Federal Government. If no such rate exists, the recipient must use either a rate it has negotiated with the subrecipient, including commercial organizations (except for the SBIR/STTR program, as described in 220.127.116.11,or a de minimis indirect cost rate of 10 percent of modified total direct costs (MTDC) if the subrecipient has never received a negotiated indirect cost rate from the Federal Government. Recipients are reminded that F&A reimbursement rates are restricted for certain classes of awards. If the consortium participant is a Federal organization, direct costs will be limited and no F&A will be provided.. (See Reimbursement of Facilities and Administrative Costs.) For more information on allowable costs to Federal organizations, see Grants to Federal Institutions and Payments to Federal Employees Under Grants.
The recipient is responsible for obtaining NIH awarding IC approval for any actions to be undertaken by consortium participants that require prior approval. Recipients may establish requirements for review of consortium participants' activities consistent with those requirements and with any authorities provided to the recipient; however, a recipient may not provide any authority to a consortium participant that the recipient has not been provided under its NIH award.
Regardless of whether there is a change in scope, in all cases, if a recipient (or consortium participant) proposes the transfer of work to a foreign site, awarding IC prior approval is required.
If the recipient provides exempt property to a consortium participant or authorizes a consortium participant to purchase property that would be considered exempt if acquired by the recipient, the recipient may vest title in the consortium participant upon transfer or purchase or may reserve the right to do so at a later time. The recipient 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 recipient provides nonexempt property to a consortium participant or authorizes a consortium participant to purchase property that would be considered nonexempt if purchased by the recipient, title to such property must remain with the recipient or be vested in the recipient upon acquisition of the property. The recipient may establish use, accountability, and disposition requirements for the property, provided they are consistent with, and do not impair, the recipient's ability to comply with the requirements of 45 CFR 75.318, as appropriate.
The recipient must require consortium participants to comply with the requirements of 45 CFR 75 Subpart F or 45 CFR Parts 75.501(h) through 75.501(k), as applicable, for audit of NIH grant funds expended by consortium participants. A consortium participant also may be a direct NIH recipient or contractor or may be receiving funds only under the consortium agreement. Regardless, if a non-profit consortium participant meets the 45 CFR 75.501 threshold criterion of aggregate annual expenditures of $750,000 or more under applicable Federal awards, the recipient must receive a copy of that organization's 45 CFR 75.501 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 recipient is responsible for monitoring the organization's activities to ensure compliance with NIH requirements. The recipient may not require a consortium participant to have an audit and charge the audit costs to NIH grant funds unless required or authorized by 45 CFR 75.501(h) through 75.501(k).