1. NIH Clinical Trial Requirements

2. NIH Initiatives to Enhance Clinical Trial Stewardship
Clinical Trial FOAs
Good Clinical Practice
Enhancing Clinical Trial Stewardship at NIH
Registration & Reporting
Single IRB
New Application Forms
Accountability
Transparency
Efficiency
Dissemination
Clinical Trial Review Criteria
Learn more at

3. NIH Might Consider Your Human Subjects Research to be a Clinical Trial
Does your study…
Involve one or more human subjects?
Prospectively assign human subject(s) to intervention(s)?
Evaluate the effect of intervention(s) on the human subject(s)?
Have a health-related biomedical or behavioral outcome?
If “yes” to ALL of these questions, your study is considered a clinical trial
Unsure how to answer the questions? We have a tool that can help!

4. NIH Definition of a 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.

5. Intervention
“An “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.”

6. Health-related Biomedical or Behavioral Outcome
“A “health-related biomedical or behavioral outcome” is defined as the pre- specified goal(s) or conditions(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 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.”

7. Broad Interpretation
“Depending on how broadly one interprets … “to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”, this part of the clinical trials definition may include a wide range of basic behavioral and social science studies that manipulate an independent variable to observe a hypothesized modification of a behavioral process.”
Director, NIH Office of Behavioral and Social Sciences Research, October 18, 2016

8. Resources
To help you determine if your research is an NIH Clinical Trial, refer to these helpful resources: FAQs Case Studies

9. Why is this important? Picking the appropriate NIH funding opportunity
New human subjects and clinical trials form (Forms E)
Complying with NIH Clinical Trials requirements
Registering the study and reporting results on ClinicalTrials.gov (for applications submitted on or January 18, 2017)
Training in Good Clinical Practice required for all study team members engaged in the research (required as of January 1, 2017)
Identifying a single IRB of Record for multisite studies (required for applications submitted as of January 25, 2018)

10. ClinicalTrials.gov Registration
NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
“The purpose of the policy is to promote broad and responsible dissemination of information from NIH-funded clinical trials through ClinicalTrials.gov.  Disseminating this information supports the NIH mission to advance the translation of research results into knowledge, products, and procedures that improve human health.”
ClinicalTrials.gov is a public website designed by NIH and FDA and hosted by the National Library of Medicine.
Must be registered within 21 days after first subject is enrolled
Registration Information - descriptive information, recruitment information, location and contact information, and administrative data.   
Results must be reported with 1 year of final collection of data
 Results Information - includes participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol and statistical analysis plan, and administrative information.   

11. UM Resources
Administrative liaison identified for each unit (typically a grants admin)
Training available from Medical School Research Regulatory Affairs team. Register at:
Office of Research Compliance Review (ORCR) monitoring non- IRBMED unites

12. Good Clinical Practice (GCP) Training
GCP principles constitute international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials
Required for all members of the study team except administrative staff
Training resources for Social/Behavioral Researchers
MyLinc/MICHR/Social and Behavioral Best Practices
CITI – Social and Behavioral Research Best Practices for Clinical Research
Good Clinical Practice for Social and Behavioral Research eLearning Course hosted by the Society of Behavioral Medicine for NIH

13. sIRB Plan for Applicants/Offerors
Application/proposal must include a plan that:
Describes the use of an sIRB that will be selected to serve as the IRB of record for all study sites
Confirms that participating sites will adhere to the sIRB Policy and describes how communications between sites and sIRB will be handled 
Tip: sIRB Plan attachment will be included in the new Human Subjects & Clinical Trials Information form

14. U-M Strategy for NIH Single IRB
Default position is to cede oversight to an external IRB, either a commercial IRB or another academic partner
IRBMED has established relationships with a number of commercial IRBs
Fees for external IRBs must be included in proposal budget
Minimal impact for current IRB-HSBS research portfolio

15. Current IRB Responsibilities for NIH Clinical Trials
Include required language in the consent form: “This trial will be registered and may report results on a publicly available registry of clinical trials.”
Remind investigators about GCP training requirement (but IRB does not track)
Remind investigators about ClinicalTrials.gov registration and to log the NCT number in eResearch
Assist investigators with Single IRB processes

16. Key Resource NIH Clinical Trials for Grants and Contracts
Provides detailed information all NIH requirements
Includes a good explanatory video regarding the new Forms E: