NIH Clinical Trial-Specific Funding Opportunities


For due dates on or after January 25, 2018, NIH will require that all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials.


Applications/proposals involving clinical trials with due dates on or after January 25, 2018 must be submitted to an FOA or request for proposal (RFP) that explicitly states it will accept clinical trials. After January 25, 2018, NIH will no longer accept clinical trial applications through existing parent announcements.

  • All FOAs will specify the allowability of clinical trials in Section II. Award Information
  • All clinical trial FOAs will specify allowability of clinical trials in the FOA title
  • FOAs that accept clinical trials will incorporate specific review criteria to ensure that reviewers appropriately consider clinical trial-related information 

Special Considerations for Training, Fellowship, and Career Development Awards

Please visit the NIH website for more information about limitations related to training, fellowship, career development awards and clinical trials.

Definition of a Clinical Trial

The NIH defines a clinical trial as "A research study1  in which one or more human subjects2 are prospectively assigned3 to one or more interventions4 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.5 Please visit the NIH website, NIH's Definition of a Clinical Trial for more information on the definition. Please feel free to contact the MSU HRPP with any questions.

1See Common Rule definition of research at 45 CFR 46.102(d).

2See Common Rule definition of human subject at 45 CFR 46.102(f).

3The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

4An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.  Examples include:  drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

5Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.  Examples include:  positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.

More Information

Please visit the NIH website: