NIH Clinical Trials Stewardship and Human Subjects Research: What’s New? What Isn’t? What Do I Need to Know?

Beginning in September 2016, the National Institutes of Health launched a multifaceted effort to ensure rigor and efficiency of NIH funded clinical trials research and improve oversight and transparency. This effort has been implemented through a number of NIH Clinical Trial Stewardship Initiatives and Policies during 2017 and 2018. These initiatives and policies have direct impacts on investigators’ development of concepts for new trials, submission and review of clinical trial applications, NIH oversight of funded clinical trials, and the sharing of clinical trials data and findings. This roundtable will include a panel of NIH staff who will discuss these new policies and related regulations pertaining to clinical research and Clinical Trial Stewardship. The panel will clarify and discuss current policies related to the NIH clinical trial definition and Good Clinical Practice Training, as well as the new human subjects and clinical trial application forms, and the use of ClinicalTrials.gov to register and disseminate information about trials. These new procedures and policies will be presented in the context of how Funding Opportunity Announcements and application procedures have changed at NIH. The use of Single-IRBs for multi-site studies and guidelines for developing Data and Safety Monitoring Plans, including Data Safety and Monitoring Boards also will be discussed. This roundtable will be an informational and interactive session for researchers who conduct or plan to conduct NIH-funded clinical trials. The goal is to provide researchers with up-to-date important information about new clinical trials policies, and to provide resources and tools to investigators as they submit new research applications and help them communicate this information to colleagues and mentees at their institutions. Participants are invited to bring to the session questions and examples for discussion.