As the new millennia moves along, the world is increasingly aware that diseases do not respect borders and can be spread through simple means such as the seasonal migration of birds.
It is also growing knowledge that poor health and poor access to healthcare systems have a debilitating and destabilizing impact on world economies, societies, and diplomatic relations.
As a result of these realizations, scientific research is becoming increasingly global in nature; research questions and answers are no longer limited to the confines of the local laboratory. Scientists are taking their projects to new heights by collaborating with partners in other countries who bring unique resources to the table.
These unique resources range from unique populations to state-of-the-art diagnostic tools. NIH supports collaborative projects and encourages scientists to take advantage of the benefits that can be gained by being in such a partnership.
However, coordinating efforts, policies, procedures, and budgets can be a daunting task. The following information may simplify matters for collaborators on NIH-funded grants.
Important Grant Terms
- Parent or prime grantee -- institution receiving a grant or cooperative agreement, which assumes legal, financial, and scientific responsibility for the funds and research. The parent grantee may choose to contract with other institutions to perform a portion of the research.
- Non-U.S. investigator or collaborator -- researcher employed by an institution outside the U.S. that performs any significant element or segment of a research project.
- Principal investigator (PI) -- qualified person or persons designated by an applicant institution to direct an NIH-supported research project or program and who usually writes the grant application. PIs also oversee scientific and technical aspects of a grant and the day-to-day management of the research.
- Consortiums -- established participants in the research plan, which are included in the grantee’s application and outlined in a formal agreement.
- Facilities and administrative (F&A) costs -- costs that are incurred by a grantee for common or joint objectives and cannot be identified specifically with a particular project or program.
- Federalwide Assurance (FWA) -- online form every institution and collaborating institution conducting human subjects research must file with the Office for Human Research Protections to establish policies and procedures to protect human subjects as required by 45 CFR Part 46.
- 45 CFR Part 46 -- Code of Federal Regulations covering protection of human subjects. 45 CFR Part 46 is divided into four subparts: A, B, C, and D. Subpart A, known as the Common Rule, governs human subjects research for virtually all relevant federal agencies; Subparts B, C, and D address special areas.
Types of Agreements
- Fee for service contracts -- agreements used to provide a routine service to the grantee. Fee for service contracts are generally accomplished through a purchase order. They are used to fill gaps in research when the research requirements exceed the capacity of the grantee to accomplish.
- Subcontract -- contract between a prime contractor and a subcontractor to furnish supplies or services for a prime contract or subcontract.
- Subaward agreement -- also known as a consortium agreement. Collaborative arrangement in support of a research project in which part of an activity is carried out through a formal written agreement between a grantee and one or more other organizations.
- The agreement should be a written agreement between the applicant and each collaborating organization and must be negotiated in accordance with NIH Grants Policy requirements. The business offices of both organizations may need a formal agreement describing the research roles and their understanding of the arrangement.
- Key elements that should be addressed are:
- Details of the scientific scope of work.
- Any terms of award stated on the Notice of Award that are applicable to the consortium.
- Any NIH administrative requirements that the consortium needs to adhere to.
- Any NIH report requirements that the consortium needs to adhere to.
- The key PI and other personnel at each consortium site along with their roles and responsibilities.
- Procedures for directing and monitoring the research.
- Procedures to be followed in reimbursing each consortium participant for its effort.
- Policies to be followed such as travel reimbursement, salaries, and fringe benefits.
- Conflict of interest requirements of the collaborating organization and a provision addressing ownership and disposition of date.
Roles of Partners on NIH-Funded Grants
- Parent or prime grantee or grantee institution
- Is the legally responsible component for all the research and activities involved in the grant.
- Receives the grant award, even though one or more organizations (other than the parent grantee) may carry out portions of the planned activity.
- Submits to NIH all administrative requirements and documentation for all components.
- Is responsible for all changes in regards to the project and budget.
- Provides the NIH with a list of all proposed performance sites and consortium participants.
- Collects from each consortium site a detailed budget to include F&A cost for the first year and all future years.
- Performs a substantive role in the conduct of the planned research.
- Is responsible for obtaining approval from NIH for any consortium changes involving a change in scope of the project or a change of project aims.
- Ensures there is no change in scope of an approved project if additional or alternative collaborators or consortiums are added after the grant has been reviewed.
- May not serve as a conduit of funds to another party.
- May not transfer research to new foreign components without prior approval from NIH.
- Ensures that consortium participants comply with the audit requirements of OMB Circular A-133 or 45 CFR 74.26(d).
- Subcontract, consortium, or subcomponent
- Foreign consortium participants under foreign grants must have assurances filed with NIH. These assurances must cover the activities within the consortium in relation to the project.
- Consortium sites engaged in human subjects research must have an OHRP-approved FWA and institutional review board approval of the research consistent with 45 CFR Part 46.
- Consortium agreements must adhere to the U.S. government-wide cost principles and NIH cost policies.
- Expenditures must conform to the requirements of allowable and unallowable costs.
- Foreign consortiums must have their funding and payment information reflected in a formal written agreement with the prime grantee.
- Sites engaged in research involving the use of vertebrate animals must have an appropriate animal welfare assurance and an institutional animal care and use committee. IACUCs independently determine that an institution is meeting requirements to ensure humane care and use of animals and complying with regulations.
- Non-U.S. grantees are allowed up to 8 percent limited F&A costs on total direct costs excluding equipment. This 8 percent limited F&A rate should be used to support the costs of complying with NIH requirements. Examples include: costs related to creating an institutional review board, costs accrued while ensuring the protection of human subjects and animal welfare as well as the prevention of research misconduct.
Contact for Article Questions or Comments
Maryam Oladipupo
Office of International Extramural Activities, NIAID International Grants
and Contracts
Email: oladipupom@niaid.nih.gov
Phone: +1 301 451-7372
Visit the NIAID International Grants and Contracts Web site. |
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