Announcements and News

NEWS

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.

  • Exemptions

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:

  1. IRB application changes
  2. Informed consent template revisions
  3. 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.

https://grants.nih.gov/policy/clinical-trials/definition.htm

 

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

8:30am-5:00pm-academic year

8:00am-4:30pm-summer (Approximately May 15-August 15)