In 2017, the National Institutes of Health (NIH) announced or implemented a variety of requirements and changes regarding research projects sponsored by NIH that include clinical trials. They are as follows:
1. Broad Definition of a Clinical Trial for NIH
The first and most important piece of information is determining whether a study (current or future) involves a clinical trial according to NIH. In 2014, NIH clarified and broadened the definition of a clinical trial. According to NIH, “It encompasses a wide range of trial types: mechanistic, exploratory/ developmental, pilot/feasibility, behavioral, and more.” If the answer to ALL four following questions is yes, then a proposed research meets the NIH definition of a clinical trial.
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
If you need help determining whether your current or a future study would be considered by NIH to be a clinical trial, see the NIH webpage on the definition that includes case studies, FAQs and other resources that can help (NIH updated this webpage, including the case studies, on January 4, 2018). Further, NIH has released a new podcast,: “Understanding the Definition of a Clinical Trial and What That Means for You” as resource in this area.
2. Good Clinical Practice Training
The NIH Good Clinical Practice (GCP) training policy, issued September 16, 2016 states that 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 GCP. The policy describes clinical trial staff as those who are responsible for study coordination, data collection, and data management.
The policy does not specify that a particular GCP course or program be taken. It includes links to the following free GCP training courses:
- national drug abuse treatment clinical trials network GCP web-based training
- society of behavioral medicine gCP for social and behavioral research elearning course
NIH expects investigators and clinical trial staff to retain documentation of their training and, as needed, provide it to NIH upon request. Further NIH expects investigators and clinical trial staff to maintain their GCP training through refresher courses in GCP topics every three years. Individuals should forward copies of their GCP training documentation to RIS.
3. Registering and Reporting NIH-Supported Clinical Trials in ClinicalTrials.gov
The NIH dissemination of NIH-funded clinical trial information policy, issued September 16, 2016 states that effective January 18, 2017, NIH expects all NIH-funded awardees and investigators conducting clinical trials funded by NIH will ensure that their NIH-funded clinical trials are registered at, and that summary results information is submitted to, ClinicalTrials.gov by the stipulated timeframes. These include:
- Registering a clinical trial at ClinicalTrials.gov no later than 21 days after enrolling the first participant; and,
- Submitting results information no later than one year after the primary completion date of the clinical trial. Primary completion date is the date that the final subject was examined or received an intervention for the purpose of collecting the data for the primary outcome measure.
Further, the revisions to the federal human subjects protections regulations that took effect in January 2019 require federally-funded clinical trials post one IRB-approved version of a consent form that has been used to enroll participants on a designated public website (one of which is ClinicalTrials.gov). The form must be posted after recruitment closes, and no later than 60 days after the last study visit. Information about this posting requirement is available at https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/index.html.
There are additional requirements for clinical trials that are also subject to Food and Drug Administration (FDA) regulations.
Clinical trials conducted by UNH investigators must be registered by investigators under the UNH organizational account in ClinicalTrials.gov. To get a record created for a new clinical trial in the UNH ClinicalTrials.gov organizational account, please contact Karen Jensen in UNH Sponsored Programs Administration (SPA) or Julie Simpson in UNH Research Integrity Services (RIS).
4. Applying to a Funding Opportunity Announcement that Specifically Allows for Submission of Clinical Trials Applications
For due dates on or after January 25, 2018, NIH will require that all applications involving clinical trials be submitted through a Funding Opportunity Announcement (FOA) that specifically allows clinical trials. FOAs will specify the allowability of clinical trials in Section II. Award Information.
5. New Human Subjects and Clinical Trial Information Forms
For due dates on or after January 25, 2018, NIH will require that all applications involving clinical trials use the new FORMS-E Application Packages. FORMS-E Application Packages will start being published on October 25, 2017 for FOAs with due dates on or after January 25, 2018. NIH as developed a very informative video tour of the new FORM-E Application Package.
NIH has a comprehensive Clinical Trial Requirements for Grants and Contracts webpage that contains information about the above requirements and others related to clinical trials. Information is also available at the following NIH webpages:
NIH created an electronic protocol writing tool to facilitate the development of clinical trials. It has a protocol template to help behavioral and social science researchers create protocols for clinical trials measuring social or behavioral outcomes, or testing behavioral/social science interventions.
Please contact your UNH SPA Grant and Contract Administrator, or Melissa McGee or Julie Simpson in RIS with questions about NIH-sponsored research involving clinical trials.
The Knowledge Base contains forms, instruction and training material, policies, guidance, tools, and other resources to support your research efforts by topic area.
Melissa McGee, Compliance Officer
Research Integrity Services
Service Building, Room 106B
51 College Road
Durham, NH 03824
Phone: (603) 862-2005
Julie Simpson, Director,
Research Integrity Services
Service Building Room 107
51 College Road
Durham, NH 03824
Phone: (603) 862-2003