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How Do New NIH Human Subjects Policies Impact Training and Career Development Awards?

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

NCCIH Training Officer, Division of Extramural Research
National Center for Complementary and Integrative Health

View Dr. Mudd’s biographical sketch

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 ClinicalTrials.gov

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 ClinicalTrials.gov 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 lanay.mudd@nih.gov.

This page last modified March 06, 2018