The Roles of Fellows and Trainees in NIH Supported Clinical Trials

NIH encourages fellows supported on NIH NRSA Fellowship awards and trainees supported on NIH NRSA Training awards to receive training in clinical research, including in the conduct of clinical trials. Under a mentor’s guidance, fellows and trainees can gain experience in the wide variety of research skills specific to clinical trials including, but not limited to: developing a clinical trial protocol; applying the principles of informed consent and requirements for human subjects research; learning about random assignment of participants to different intervention arms; analyzing trial endpoints; and/or implementing quality control standards.

Given the value of gaining clinical research experience early in one’s career, you may wonder why NIH fellowship and training funding opportunity announcements (FOAs) indicate they do not support “independent clinical trials”. NIH fellowships and training grants provide support for the individuals and, for the most part, do not provide sufficient funding to actually conduct an independent clinical trial.  For this reason, NIH expects the individual receiving research funding for the clinical trial (i.e., the sponsor or mentor) to assume responsibility for and oversight of the trial and any activities that the trainee or fellow undertakes related to the trial (reporting, etc.). The fellow/trainee may absolutely participate with the sponsor or mentor in some or even all of the clinical trial activities as part of their training but cannot independently lead the study.

As you develop an application for an NIH fellowship, take the time to clearly delineate the distinct roles and responsibilities of the fellow versus the sponsor or mentor, and make sure to clearly show how the mentor will provide appropriate oversight of clinical trial related activities. This can be done in the Sponsor and Co-Sponsor attachment for the sponsor and the Research Strategy for the fellow.

Please visit our webpage on Clinical Trial-specific Funding Opportunities and consult our FAQs for more information.