Major Changes

  • Continuing Review - Is no longer required for some studies which involve minimal risk. This includes studies in which the only remaining activity is the analysis of identifiable data/ biospecimens or follow-up activities for clinical data.
  • Exemptions - There are new categories and clarification of existing categories. “Limited HRRC- Review” is required for some categories. This review is similar to the expedited review process. Other exemptions may qualify for “self-determination”.
  • Informed Consent - There is a new section: “Key Elements”. Rearrangement of the content in the informed consent is designed to help subjects determine whether or not they wish to participate.  Broad consent may be an option in certain cases.
  • Single IRB-of- Record (sIRB) -  IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB (academic, commercial or hospital-based) starting January 20, 2020.  

Expectation

Expect to see the following for new studies after January 19, 2018:

     1.        HRRC application changes

     2.       Informed consent template revisions

     3.       HRRC Operation Manual updates

     4.       GVSU HRRC standard operating procedure updates 

    

Administrative Actions

The Office of Research Compliance and Integrity is working to interpret the new Common Rule elements and update the University's policies, business processes, and protocol submission systems to accommodate the changes while continuing to protect its subjects.  

What You Can Do

Check this website periodically for new information.  We will continue to add information through January 2018, as it becomes available.



Page last modified September 14, 2017