Abstract ID: 3567

Primary Topic: 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

Overview

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.

Rationale

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.

Objectives

  • Understand how NIH policy changes for human subjects research may impact investigators’ ongoing research studies and future applications for NIH funding.
  • Identify which funding opportunity announcements can be utilized by investigators who want their applications assigned to NCCIH for funding consideration.
  • Assist investigators in deciding which available funding opportunity is the best fit for the types of research that NCCIH supports.
  • Understand new review criteria for NIH defined clinical trial applications.
  • Learn about NCCIH methods for oversight of human subjects research to enhance rigor and reproducibility goals at NIH.
  • Learn about resources available to investigators to assist them in the application process.

Methods/Session Format

  • Dr. Wendy Weber will provide an overview of the NIH policy changes and how they will impact investigators who conduct human subjects research. She will also provide an overview of the NCCIH clinical trial specific FOAs. 15 minutes
  • Dr. Wen Chen will provide an overview of how the FOAs that can be used to conduct basic and mechanistic research in human subjects and how the new policies impact this type of research. 10 minutes
  • Dr. Martina Schmidt will provide examples of special attachments and expanded review criteria that are included in NCCIH clinical trial specific FOAs. 10 minutes
  • Mrs. Christine Wishnoff will summarize the oversight activities NCCIH uses to assure rigor and reproducibility including subject accrual and retention plans, data and safety monitoring plans, and in some cases on-site monitoring. 10 minutes
  • Q&A – 15 minutes

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.

Outline

  • Overview of NIH Policy changes for human subjects research
  • Summary of the impact these policy changes will have on investigators’ ongoing research as well as new applications
  • Overview of NCCIH specific funding opportunities for clinical research, and basic and mechanistic research with human participants
  • Summary of the new elements of clinical trial applications to NIH, new form components, special attachments, and updated review criteria
  • Description of the oversight activities NCCIH uses to assure rigor and reproducibility