Policies and Resources
Reminder: Beginning January 1, 2018, 1) all key personnel, including students, who are conducting research involving human subjects and/or identifiable, private participant data and 2) faculty members listed as a the faculty advisor on a student investigator's application are required to complete a human subjects education training course or show proof of a valid training certificate prior to IRB protocol approval for new applications, continuing review applications, and amendment requests. Visit the Training Tab for more information.
Policies
- Clinical Trials Registration & Results Reporting
Public registration of clinical trial information is required:
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- When conducting an Applicable Clinical Trial (ACT) per U.S federal regulations (). This includes:
- Controlled clinical trials of FDA-regulated drugs or biologics (Phases II - IV); and
- Controlled clinical trials and pediatric post-market surveillance of FDA-regulated devices (other than small feasibility studies).
- When conducting a clinical trial funded by the National Institutes of Health (NIH)
per . If the answer is 鈥測es鈥� to all four of the following questions, then the research
study would be considered a clinical trial according to the NIH definition:
- 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 being evaluated a health-related biomedical or behavioral outcome?
- For publication in a journal that follows the , which requires registration of clinical trials in a public trials registry as a condition of consideration for publication.
- When conducting an Applicable Clinical Trial (ACT) per U.S federal regulations (). This includes:
Where to Register:
When to Register: Per federal regulations and NIH policy, new qualifying trials/studies must register no later than 21 days after the first participant is consented.
Who Should Register: The individual responsible for registering a clinical trial/study is considered the "Responsible Party."
Reporting Results: Federal regulations and NIH policy require the Responsible Party to report results information for the clinical trial no later than one (1) year after the Primary Completion Date indicated in the registration record. The Primary Completion Date is the "date that the last subject was examined or received an intervention to collect final data for the primary outcome measure" of the study. Specific steps for reporting your results can be found at: .
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). A final rule was published in the Federal Register on January 19, 2017, and was amended to delay the effective and compliance dates on January 22, 2018 and June 19, 2018. The revised common rule takes effect January 19, 2019.
The Belmont Report was written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human subjects. In 1981, with this report as foundational background, HHS and the Food and Drug Administration revised, and made as compatible as possible under their respective statutory authorities, their existing human subjects regulations.
RESOURCES
- Revised Exempt Categories - Table Overview
- Revised Exempt Categories - Detailed Description
- Revised Exemption Decision Charts