- Upcoming Changes to the Common Rule: Implementation Delayed Revisions to the Federal Policy for the Protection of Human Subjects (“Common Rule”) scheduled to become effective on January 19, 2018 have been delayed. The effective date and compliance date for the Revised Common Rule is now July 19, 2018. The existing Common Rule remains in effect, and will continue to be applied to research conducted at Syracuse University. The IRB is in the process of identifying and revising its policies, templates, and procedures as necessary, and will be engaging with the Syracuse University research community to provide guidance as the new compliance deadline approaches. If you would like more information, the official version of changes to the Common Rule is published in the Federal Register, and a helpful summary is available from the Council on Governmental Relations (COGR).
- Common Rule Information
- NIH (National Institutes of Health) Information
Major Regulation Changes
- Continuing Review
No longer required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.
New categories and clarification of existing categories. Some exemptions may require “limited IRB review” (similar to an expedited review process), while others may qualify for “self-determination”.
- Informed Consent
A new “Key Elements” section and a rearrangement of content is designed to facilitate a potential subject’s decision to participate or not.
- Single IRB-of-Records (sIRB)
IRB oversight for most federally-funded collaborative research projects located in the United States will be required to use a single IRB (commercial, academic, or hospital-based) starting January 20, 2020.
What to Expect
The new regulations do not impact studies approved prior to July 19, 2018.
For new studies, expect to see:
- IRB application changes
- Informed consent template revisions
- IRB standard operation procedure updates
What You Can Do
Check this website periodically for new information.
Other Regulatory Changes
The National Institutes of Health (NIH) is implementing a variation of the Single IRB-Of-Record policy beginning January 25, 2018. The NIH sIRB policy applies to:
- NIH-sponsored multi-site studies, where the same protocol is used at multiple sites.
- Domestic research only.
NIH Clinical Trial Policies
The NIH has issued several other policies and guidance designed to “enhance the accountability and transparency of clinical research”:
- Revised clinical trial definition (1/25/2015)
- Required Good Clinical Practice training (1/18/2017)
- ClinicalTrials.gov registration and reporting of results (1/18/2017)
- Use of the new Human Subjects and Clinical Trials form (part of the NIH funding application package, Forms-E) (1/25/2018)
NIH’s definition of a clinical trial is broad, encompassing a wide range of activity which now may include behavioral studies (e.g., studies that manipulate an independent variable to observe a hypothesized modification of a behavioral process).
NIH Definition of a Clinic 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.
Where to Find Help
To help you identify whether your NIH-funded research would be considered a clinical trial under this definition and, therefore, subject to all the related policies (e.g., NIH sIRB, ClinicalTrials.gov registration and reporting, etc.), the NIH offers the following resources:
- FAQs and case studies
- NIH Deputy Director’s blog
- NIH Clinical Trials Policy website
The Office of Research Integrity & Protections has moved!
We are now located in 214 Lyman Hall.
Hours of Operation
8:00am-4:30pm-summer (Approximately May 15-August 15)