State of the science/evidence base for integrative modalities
Secondary Topic: Research Methodology
Human subjects research, NIH clinical trials policy, and implications for your research
Wendy Weber, ND, PhD, MPH; Wen Chen, Ph.D.; Martina Schmidt, PhD; Christine Wishnoff, MPH, NCCIH/NIH, Bethesda, MD, United States
Late Breaker: No
Scientific disciplines can differ on what elements of a study are necessary to meet the definition of a clinical trial. NIH defines the term broadly, “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.” As NIH finalizes the implementation this definition, many changes will impact investigators submitting applications with human subjects including: newly formatted funding opportunity announcements, new grant application forms and elements, GCP training certification requirements, and registering and reporting requirements for funded projects. These elements have been implanted as part of NIH’s ongoing efforts to enhance rigor and reproducibility of clinical research.
For example, NIH defines intervention as a manipulation of a person or a person’s environment to modify one or more health-related biomedical or behavioral processes and/or endpoints. Researchers in complementary and integrative health studying the basic science or mechanisms of these approaches may find that their projects now fall within the rubric of NIH clinical trials.
This session will include a brief overview of the NIH clinical trial definition and several new policies related to the implementation of this definition. Presenters will orient participants to the newly-implemented categories of NIH funding opportunity announcements to help investigators submit applications for peer review. Speakers will also provide an overview of how NCCIH is implementing these policy changes with attention to the new NCCIH clinical trial specific funding opportunity announcements. Panelists also will provide links to online resources they can access to aid them in understanding these major policy changes at NIH.
Much of the research presented at the International congress on Integrative Medicine and Health is fully or partially funded by the National Center of Complementary and Integrative Health (NCCIH). Nearly sixty percent of the research supported by NCCIH includes human participants. Thus, the majority of the applications submitted to NCCIH by investigators attending the ICIMH meeting will be impacted by these policy changes at NIH. This session will inform attendees about the policy changes, why they were made, and how it will directly impact them as they apply for funding from NIH and NCCIH specifically. The session relates to both the policy and clinical research themes of the Congress.
This will be a state of the science lecture from 4 panelists updating the participants on significant NIH policy changes impacting the submission, review, and oversight of human subjects research.