Scientific disciplines can differ on what elements of a study are necessary to meet the definition of a “clinical trial.” Some investigators conducting human subjects research may not know that NIH considers their study to be a clinical trial - - a term defined broadly by NIH as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
At the International Congress of Integrative Medicine and Health (ICIMH), four panelists from NCCIH will present a session, “Human Subjects Research, NIH Clinical Trials Policy, and Implications for Your Research,” to explore recent policy changes at NIH that influence the submission, review, and oversight of research involving human participants. Examples of those changes include newly formatted funding opportunity announcements (FOAs), new grant application forms and elements, a requirement for training in good clinical practice, and requirements for registering and reporting NIH-funded clinical trials. All align with NIH’s ongoing efforts to enhance the rigor and reproducibility of clinical research.
In this session:
- Dr. Wendy Weber, Acting Deputy Director of NCCIH and Chief of the Clinical Research in Complementary and Integrative Health Branch in the Center’s Division of Extramural Research (DER), will provide an overview of recent NIH policy changes, how they will affect investigators who conduct human subjects research, and some NCCIH clinical trial-specific FOAs.
- Dr. Wen Chen, Acting Chief of DER’s Basic and Mechanistic Research in Complementary and Integrative Health Branch, where she is also a Program Director, will discuss how FOAs can be used to conduct basic and mechanistic research involving people, and how the new policies influence this type of research.
- Dr. Martina Schmidt, Chief of the NCCIH Office of Scientific Review, will present examples of special attachments and expanded review criteria included in NCCIH clinical trial-specific FOAs.
- Mrs. Christine Wishnoff, Health Specialist in DER’s Office of Clinical and Regulatory Affairs, will summarize oversight activities the Center uses to assure rigor and reproducibility—including subject accrual and retention plans, data and safety monitoring plans, and occasional onsite monitoring.
Speakers will share resources (e.g., an online NIH tutorial), and a question-and-answer period will be included. If you're attending ICIMH and interested in learning more about funding for NIH cliinical trials, please join us on Wednesday, May 9, from 1:30 to 2:45 p.m.
*Anita McRae-Williams directs outreach programs in the Division of Extramural Research (DER) at NCCIH. The Division of Extramural Research develops and oversees NCCIH-funded research and research training programs. Mrs. McRae-Williams develops and executes comprehensive outreach strategies to attract diverse research stakeholders to new NCCIH funding opportunities and establish or strengthen ties with the research community.