Abstract ID: 3941

Primary Topic: Education Research

Honing your Clinical Research Proposal for NIH and NCCIH Funding Opportunities
Emmeline Edwards, Ph.D.; Wendy Weber, ND, PhD, MPH, NCCIH/NIH, Bethesda, MD, United States; Wen G. Chen, MMSc., PhD, National Center for Complementary and Integrative Health (NCCIH), Bethesda, MD, United States; Martina Schmidt, PhD; Dave Clark, DrPH, MPH, NCCIH/NIH, Bethesda, MD, United States

Late Breaker: No

Purpose

This workshop will provide attendees with an overview of how to develop an application to NIH or NCCIH that includes human subjects.  The session will focus on how to distinguish between developing a mechanistic study to determine how a complementary or integrative health intervention exerts its effect versus developing an intervention that will be tested to evaluate whether the intervention is beneficial for a given clinical condition or symptom. Attendees will learn about important changes to NIH funding opportunities and application forms, tips for successful grant submissions and review, and specific NCCIH funding opportunities that will support research with human subjects.

Objectives

The workshop will provide an overview of NCCIH’s strategic interests in clinical research by the Director of Extramural Research (Dr. Emmeline Edwards). The NCCIH Clinical Research Branch Chief (Dr. Wendy Weber) will provide an overview of NIH policy changes related to clinical trials and Clinical Research Branch Program Director (Dr. Dave Clark) will present NCCIH funding opportunities for clinical trials focused on clinical outcomes. The NCCIH Basic and Mechanistic Research Branch Chief (Dr. Wen Chen) will summarize how NCCIH encourages applicants to study the mechanisms of complementary and integrative health approaches and the funding opportunities available to support this type of research. A Scientific Review Officer (Dr. Martina Schmidt) will describe key changes to the application forms and how they will impact the review process.  Breakout sessions specific to human subjects basic and mechanistic research or clinical outcomes focused research will allow attendees to interact with NCCIH staff to discuss questions related to submitting an application to NCCIH and NIH generally.

By the end of the workshop, participants will:

1) Know NCCIH strategic priorities for human subjects research for both clinical outcome focused research and basic and mechanistic focused research;

2) Be able to identify which funding opportunity to use to submit a human subjects research application to NCCIH;

3) Understand how the NIH review process will evaluate the information submitted in the new NIH application forms;

4) Understand recent important changes to NIH policy for clinical trials;

Time Frame

10 Min                  NCCIH Strategic Priorities for Human Subjects Research                                 (Emmeline Edwards)

30 Min                  Overview of NIH Policy Changes for Human Subjects Research that Meets the NIH Definition of a Clinical Trial  (Wendy Weber; 20 min talk, 10 min Q&A)

30 Min                  NCCIH Clinical Outcomes Focused Research Funding Opportunities: Feasibility to Efficacy                                 (Dave Clark; 20 min talk, 10 min Q&A)

30 Min                  NCCIH Mechanism Focused Clinical Research Funding Opportunities                                  (Wen Chen; 20 min talk, 10 min Q&A)

20 Min                  Overview NIH Application Form Changes and Impact on Review Process                                 (Martina Schmidt; 15 min talk, 5 min Q&A)

45 Min  Breakouts: Finding the Right Funding Opportunity at NCCIH for Clinical Research  (Human Basic and Mechanistic Research: Wen Chen + BMB PO’s+ Martina Schmidt; Clinical Research: Wendy Weber + Dave Clark + CRB PO’s+ Ashlee Tipton)

The Breakout Sessions will utilize small groups with NCCIH Program Officers and Review Officers. Attendees can choose to participate in a small group focused on clinical outcomes research or a small group focused on human basic and mechanistic research, depending on their own research interests. All small groups will provide an opportunity to address questions and/or discuss following topics: interacting with NCCIH Staff to Develop Your Proposal; finding the best funding opportunity for the research you want to conduct; and how to shape your aims to be responsive to NCCIH funding opportunities. Attendees may choose to switch groups ½ way through.

Faculty

Faculty are listed with specific topic above. 

Emmeline Edwards will focus on NCCIH strategic priorities for human subjects research

Wendy Weber will describe the recent changes to NIH policy related to human subjects research.

Dave Clark and Wen Chen will describe NCCIH Funding Opportunities for human subjects research with Dr. Clark focusing on the clinical outcomes research and Dr. Chen focusing on basic and mechanistic research.

Martina Schmidt will describe how the changes to the application forms for human subjects research are being evaluated in the review process.

All faculty will be involved in small group discussions that will cover funding/proposal development and how to select the right funding opportunity.

Teaching/Learning Strategies

This workshop is planned to maximize interaction among faculty and attendees. While didactic talks are planned for some topics, the schedule has left time for lots of Q&A within most of those talks, and the presenters will ask questions of the attendees to encourage participation. Finally 45 minutes of the 3 hour workshop is reserved for small group discussion among the faculty and attendees. While the faculty have a "discussion guide" of potential topics, there will also be opportunity for attendees to bring up additional topics of interest to them. 

Outline

Didactic lectures with Q&A session for the first 120 minutes (2:1 lecture to Q&A).

Interactive small groups with hands-on activities for last 45 minutes.

If the program committee feels your presentation would be better suited for a different presentation type, such as a symposium (shorter format during the main meeting), would you be willing to adapt your presentation to fit the new format?

Yes

Who is the target audience of the workshop? Are there particular skills or background that are recommended as pre-requests?

The intended audience includes investigators interested in submitting human subjects research applications to NCCIH.

Is this workshop proposed by an organization?

Yes

If yes, please name

National Center for Complementary and Integrative Health

Organization's website

https://nccih.nih.gov/

Has the content (or substantial parts) of this workshop been previously presented or published (note: previous experience presenting the material may be considered a strength as long as continued interest is anticipated)?

Yes

Please provide Location of Presentation and/or Publication Information and date of each presentation

NCCIH hosted a series of webinars about the new human subjects research funding opportunities in the spring of 2017. The webinars were well attended, but did not address all of the NIH policy changes related to clinical trials. We have modified the content to cover both clinical outcome and mechanistic focused clinical trials in this session as well as addressing other NIH policy changes for clinical trials.