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NIH Clinical Trials

A number of NIH-mandated changes related to NIH clinical trial requirements affect applications with receipt dates on or after January 25, 2018

These key points and selected resources relate to NIH’s 2017-2018 clinical research initiatives – both new changes for 2018 and those that went into effect in 2017. Visit the NIH website: Clinical Trial Requirements for Grants and Contracts for more information.

NIH Clinical Trial Definition

NIH has revised its definition of “clinical trial.”  The revision is designed to make the distinction between clinical trials and clinical research studies clearer and to enhance the precision of the information NIH collects, tracks, and reports on clinical trials.
 
Clinical Trial: 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. (NOT-OD-15-015: Notice of Revised NIH Definition of “Clinical Trial”)

The differences between a clinical trial and a clinical study can be determined using the following four questions (answering “Yes” to all means a study is a clinical trial):

  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? 

Clinical Trial-Specific Funding Opportunities

Effective January 25, 2018, all grant applications with plans to conduct clinical trials must be submitted in response to an FOA which specifically states that clinical trials are allowed. All current parent announcements will no longer allow clinical trials.  There will be some new parent announcements that will allow clinical trials, and the specifics will depend upon the discipline.  Some of the institutes will be joining certain parent announcements specifically for clinical trials, but that’s something to be determined by each individual IC. In addition, some types of awards, namely fellowship grants, do not allow clinical trials.

Clinical Trial-Specific Review Criteria

New review criteria will be used to evaluate applications proposing clinical trials or proposing clinical trial research experience (i.e. individual career development (K) awards, fellowship (F) awards and training (T) awards). New questions related to the following areas will be used to review clinical trials: significance, investigator(s), innovation, approach, environment, and study timeline.

New Human Subjects and Clinical Trial Information Form [FORMS-E]

A new Human Subjects and Clinical Trial Information form will be included in the new FORMS-E Application Packages and will be required for all applications with due dates on or after January 25, 2018. This new form consolidates all Human Subjects and Clinical Trial related information into one place and expands the information required for studies that meet the NIH definition of a clinical trial. If you’re wondering “Where can I find the new form?” or need assistance stepping through the form, NIH created a number of resoruces, including a Preview of FORMS-E Grant Application Form Changes as well as a short (9-minute) Video Walk-through of PHS Human Subjects and Clinical Trials Information. NIH also released a podcast about “Why it’s so important to Submit Applications Early” (MP3 & Transcript).

Clinical Trials Protocol Template

If your application includes phase 2 or 3 clinical trials that require Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications, a NIH-FDA template with instructional and sample text can help you write your protocols. Use of this template is optional. Exemption (IDE) applications, a NIH-FDA template with instructional and sample text can help you in writing your protocols.

Single IRB Policy for Multi-Site Research

For applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, 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 Board (sIRB) to conduct the ethical review required for the protection of human subjects.

Good Clinical Practice Training

Effective January 1, 2017 NIH expects all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice (GCP).

Clinicaltrials.gov Registration and Reporting

A new regulation and NIH policy expanded Clinicaltrials.gov registration and reporting to ALL NIH-funded clinical trials. All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov for competing applications and contract proposals submitted on or after 01/18/2017.

Need help?

Use these resources provided by NIH to help determine if your research study meets the definition of a clinical trial: