NIH Clinical Trials Research Requirements

As the largest federal funder of clinical trials in the United States, NIH is committed to investigating high priority questions, avoiding duplication, exercising good stewardship over public resources, respecting ethical obligations to participants, and promoting broad, transparent, timely, and responsible dissemination of information. NIH requirements for clinical trials research have been recently updated to enhance the accountability and transparency of the biomedical research enterprise as well as increase the sharing of clinical trials results.

Clinical Trials and Healthcare Delivery Research

Relevant Funding Opportunity Announcements (FOAs) supported by the Healthcare Delivery Research Program are being (re)issued to indicate whether clinical trials are Required, Optional or Not Allowed. Some healthcare delivery studies may meet the criteria for a clinical trial in which case, NIH clinical trials policies must be followed. For a list of current FOAs, please see visit the HDRP web page, Currently Open Funding Opportunity Announcements Relevant to Healthcare Delivery Research.

Defining Clinical Trials Research and Selecting an Appropriate Funding Opportunity Announcement (FOA)

Starting January 25, 2018 any application proposing a clinical trial must respond to a FOA accepting clinical trials research. As a research investigator, it will be important to follow the steps outlined below to ensure that you apply to an appropriate funding announcement.

Step 1. Determine if research study meets the NIH definition of a clinical trial.

Use the following set of questions to determine if your research study meets the NIH definition of a clinical trial. Answering YES to all four questions indicates that the study is a clinical trial. Answering NO to any one of the questions indicates that it is not a clinical trial. Several case studiesExternal Web Site Policy are available as examples.

  1. Does the study involve human participants?
  2. Are the participants prospectively assigned
    to an intervention?
  3. Is the study designed to evaluate the effect of the
    intervention on the participants?
  4. Is the effect being evaluated a health-related
    biomedical or behavioral outcome?

This figure shows the wide range of study types that can incorporate clinical trials research, including mechanistic, exploratory/development, pilot/feasibility, other interventional, or behavioral.

Step 2. Determine if there is an appropriate FOA available for your clinical trials research.

Applications involving one or more clinical trials must be submitted through a FOA that explicitly states one of the following in the title and in Section II: Clinical Trial Required or Clinical Trial Optional. FOAs that accept clinical trials will incorporate specific review criteriaExternal Web Site Policy to ensure that reviewers appropriately consider trial-related information. FOAs that do not accept clinical trials will be labeled as Clinical Trial Not Allowed.

Policies for Conducting Clinical Trials Research

If you plan to submit an application to conduct clinical trials research, please be sure to learn about and understand the following policies.

  • Human Subjects and Clinical Trial Information Form
    An updated application formExternal Web Site Policy that consolidates all Human Subjects and Clinical Trial related information into one place and also expands the information required for studies that meet the NIH definition of a clinical trial will be required for all applications that include clinical trials (FORMS-E).
  • Good Clinical Practice (GCP) Training
    NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials must receive training in Good Clinical PracticeExternal Web Site Policy.
  • Single IRB for Multi-site Research
    NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review BoardExternal Web Site Policy (sIRB) to conduct the ethical review required for the protection of human subjects.
  • Registering & Reporting NIH-funded Clinical Trials
    All NIH-funded clinical trials are expected to register and submit results informationExternal Web Site Policy to Clinicaltrials.govExternal Web Site Policy, as per the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information.

For more information on NIH Clinical Trials Requirements, please visit: Web Site Policy

For additional HDRP Grantsmanship Resources, please visit:

Last Updated: 16 May, 2019