The NINDS Terms of Award for Clinical Research Studies will apply to all grants that involve human subjects and that are perceived by the NINDS to pose a greater than minimal risk to participants. (Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination).
The final version of the study protocol should be submitted to the NINDS program official prior to the start of study enrollment.
- Changes in Protocol Design and Status
To help ensure the safety of subjects enrolled in NINDS -funded studies, the Awardee must provide the NINDS with copies of documents related to all major changes in the status of ongoing protocols, including:
- Amendments to the protocol
- Termination of the protocol
- Temporary suspension of the protocol
- Changes in informed consent or IRB/EC approval status
- Temporary suspension or permanent termination of patient accrual
- Other problems or issues that could affect the human subjects in the studies
Notification of any of the above changes must be made within three (3) working days by e-mail, followed by a letter from the Principal Investigator, detailing the change of status notification to the local IRB/EC and a copy of any responses from the IRB/EC. Changes should not be implemented without written approval from the NINDS program official.
Funding support recommended for each year of the project is only an estimate and is contingent upon favorable review by NINDS staff of the progress of the project, sufficient subject accrual, and demonstrated need for the funds. Funds awarded for patient care costs may not be used for any other purpose without the prior written approval of the NINDS.
Personnel funds must be managed in a way that allocates personnel effort and salary charges in accordance with the work being carried out in this project. Specifically, if accrual is delayed or lags, or if the needs of the project do not require full personnel effort and salaries as awarded, proportionate reductions in effort and salary charges will be instituted as needed both at the parent grant site and at participating sites. NINDS personnel will provide guidance as needed for determining appropriate personnel charges and levels of effort.