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NCCIH Research Blog

NCCIH Research Blog

NCCIH blogs about research developments related to complementary health practices. Check in regularly to keep up with the latest findings.

Lanay M. Mudd, Ph.D.
Lanay Mudd, Ph.D.
March 06, 2018

If you are considering applying for an NIH training or career development award, you may be thinking, “How do I know which funding opportunity announcement (FOA) to choose? Clinical Trial Required? Clinical Trial Not Allowed?” If so, you are not alone!

NIH has launched a series of initiatives to enhance the accountability and transparency of clinical research. The NIH Clinical Policy Web page provides full details on the following changes:

ALL Research Involving Human Participants

  • New FORMS-E to collect human subjects information
  • Use of a single Institutional Review Board (IRB) for multisite studies
  • Certificates of confidentiality for research that uses identifiable sensitive information

Research That Meets the NIH Definition of a Clinical Trial

  • Clinical trial-specific FOAs
  • New review criteria
  • Training in Good Clinical Practice
  • Expanded registration and results reporting in

How do these new clinical research policies impact training and career development awards? 

First, NIH will not support independent clinical trials through Training (T32, T35) or Fellowship (F30, F31, or F32) mechanisms. All training and fellowship FOAs are now being issued as “No Independent Clinical Trials Allowed.” This change in NIH policy aligns with NCCIH’s longstanding policy to not accept applications proposing new, freestanding clinical studies or trials through training or fellowship FOAs. Although F and T awards do not allow independent clinical trials, mentored clinical trial research experiences are encouraged and may be included in submissions responding to these FOAs.

Second, most Career Development (K) mechanisms have been reissued as two FOAs, with one titled “Clinical Trial Required” and the other titled “Independent Clinical Trial Not Allowed.” Links to the reissued FOAs are provided on NCCIH’s Training and Career Development Opportunities Web page. If your application does not include human subjects research, you should select the “Independent Clinical Trial Not Allowed” FOA and prepare your application accordingly. 

If your K-award application includes human subjects, you will need to determine whether your research is a clinical trial, which is defined 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.” This definition includes a wide range of trials, including mechanistic, exploratory, pilot/feasibility, behavioral, and efficacy trials. NIH has created a decision tool and many case study examples to help you determine whether your proposed study meets the NIH definition of a clinical trial. Please contact a Program Director if you aren’t sure. 

If you are proposing a K-award with a new, freestanding clinical trial, you will need to apply to the “Clinical Trial Required” FOA, which will have clinical trial-specific review criteria, and you will be required to follow the policies on Good Clinical Practice training and registration and reporting. If you are proposing research that does not meet the definition of a clinical trial, or if the clinical trial you are working on is not freestanding (e.g., you are proposing to add measures to an ongoing clinical trial), you will need to apply to the “Independent Clinical Trial Not Allowed” FOA. All applications proposing research involving human subjects, regardless of their clinical trial status, now use FORMS-E and must also comply with the single IRB and certificate of confidentiality policies.

Hopefully, this overview has helped you get more familiar with the new NIH human subjects and clinical trial policies. We know that there have been a lot of changes, so if you are still in doubt about which FOA to choose, contact me at

March 05, 2018
NCCIH Research Blog Team

Information about three upcoming lectures on pain and pain managementby NCCIH-funded researchers on pain and its management (forming NCCIH’s Spring 2018 Integrative Medicine Research Lecture Series).

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Lanay M. Mudd, Ph.D.
March 01, 2018
Lanay M. Mudd, Ph.D.

In this blog post, NCCIH Training Officer Dr. Lanay Mudd discusses research training and career development opportunities.

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Merav Sabri, Ph.D.
February 20, 2018
Merav Sabri, Ph.D.

In this blog post Dr. Merav Sabri discusses funding opportunities for small businesses – the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.

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Martina Schmidt
January 26, 2018
Martina Schmidt, Ph.D.

In this blog post, Dr. Martina Schmidt addresses the merits of joining NCCIH/NIH as a health scientist administrator/scientific review officer.

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Partap S. Khalsa, D.C., Ph.D.
January 19, 2018
Partap Khalsa, D.C., Ph.D.

On Friday, February 9, the National Advisory Council for Complementary and Integrative Health (NACCIH) will hold its second meeting of Fiscal Year 2018. NCCIH grantees, potential applicants, and others may find it useful to hear updates on the Center’s activities, policies, and funding priorities. We will provide a livestream of the meeting’s open session via NIH Videocast from 10:00 a.m. to 3:05 p.m. ET.

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This page last modified September 24, 2017