Terms and Conditions for Cooperative Agreements
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, Public Health Service (PHS), and National Institutes of Health (NIH) grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility for the project as a whole resides with the awardees, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
Principal Investigator (Awardee) Responsibilities
The Program Director(s)/Principal Investigators(s) (PD/PI) will have the primary responsibility for:
- All aspects of the study, including any modification of study design, conduct of the study's quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators. The awardee agrees to accept close coordination, cooperation, and participation of NIDCD staff in those aspects of scientific and technical management of the study as stated in these terms and conditions commensurate with the degree of potential risk to study subjects and the complexity of the study.
- Upon implementation of the protocol, each field center, whether a single institution or a consortium of institutions, will follow the procedures required by the protocol regarding study conduct and monitoring, patient management, data collection, and quality control.
- Managing involvement of industry or any other third party in the study. Except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by the NIDCD.
- Making all study materials and procedure manuals available in the public domain. Awardees are expected to publish and publicly disseminate results, data, and other products of the study, concordant with governance policies and protocols. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NIDCD/NIH.
- Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
- Have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. NIDCD staff may use information obtained from the data for the preparation of internal reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards, subject to Government rights of access consistent with HHS, PHS, and NIH policies.
- Provide guidance and support in the development, assembly, and submission of all required regulatory documents, e.g., those regarding the use of investigational drugs, to the Food and Drug Administration.
- Serve as a resource to provide scientific/programmatic support during the accomplishment of the research by participating in the design of the activities, advising in the selection of sources or resources (e.g., determining where a particular reagent can be found), provision of research resources and reagents available from the NIDCD grantees and contractors, advising in management and technical performance, or participating in the preparation of publications.
- Review the progress of the study, and of each participating facility, through consideration of the annual reports, site visits, patient logs, etc. This review may include, but is not limited to, compliance with the study protocol, meeting patient enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting.
- Oversee the adequacy of adverse event management and reporting, and have regular communications with the PD(s)/PI(s) and study team, which may include attendance at the safety monitoring (or Data and Safety Monitoring Board) and related committee meetings.
- Monitor progress of study milestones. At each scheduled interim review, compare actual enrollment to the benchmarks and criteria identified in the application and negotiated prior to award.
Studies in which recruitment milestones are not met as per criteria established pre-award, or for which regulatory approval has not been met within one year, and which are deemed unlikely to improve sufficiently to bring the study to completion within an acceptable budget or time frame, may be closed for lack of progress following review and consideration by NIDCD staff.
If a study is finally determined to lack feasibility and will no longer accrue subjects, awardees are required to submit a close-out plan to NIDCD staff within three months of a decision either by NIDCD staff or the grantee that an awarded study is no longer feasible. The plan must be approved and signed by the Institutional Official and the PI(s)/PD(s) listed on the award prior to submission.
The NIDCD may terminate or curtail the study (or an individual award) in the event of:
- Failure to implement the study protocol;
- A substantial shortfall in participant recruitment, follow-up, data reporting and dissemination, quality control, or other major breach of the protocol;
- Substantive changes in the agreed-upon protocol with which the NIDCD does not concur;
- Reaching a major study objective substantially before schedule with persuasive statistical evidence, or;
- Human subject ethical issues that may dictate a premature termination.
Additionally, an agency program official or Institute/Center (IC) program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Areas of joint responsibility include:
- Data Safety Monitoring Board: An independent Data and Safety Monitoring Board, if required, will be established jointly by the PD(s)/PI(s) and the NIDCD. The Data and Safety Monitoring Board will review interim results periodically as established in the data and safety monitoring plan and report to the NIDCD Program Director. The NIDCD Program Director will report in writing to the PD(s)/PI(s) on the recommendations of the DSMB and the NIDCD concurrence/non-concurrence of the DSMB recommendations. The PD(s)/PI(s) will assume responsibility for reporting of the DSMB and the NIDCD recommendations to their Institutional Review Board.
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel will be convened. It will have three members: one designee of the PD(s)/PI(s), chosen without NIH staff voting; one NIH designee; and a third designee, with expertise in the relevant area, who is chosen by the other two. In the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.