Common Rule

Posted January 16, 2018

 

Delayed Again? 

The Article—“Delay of the Revisions to the Federal Policy for the Protection of Human Subjects”—suggests that January 19, 2018, may come and go without full implementation.

Major Proposed 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. (taken from WEBSITE)
  • 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-Record (sIRB) – IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB (commercial, academic, or hospital-based) starting January 20, 2020. NIH sIRB starting January 25, 2018.

Effects on Research Community

New Studies

  • myIRB application changes
  • Informed consent template revisions
  • HRPO Procedures updates
  • HRPO/IRB workload changes

Existing Studies

  • HRPO may choose to apply the new rules to minimize burden for research community

Research Community’s Role

  1. Check this webpage often for updates
  2. Call SWAT! with questions

WU HRPO/IRB’s Role

The WU Human Research Protection Office (HRPO) along with our staff, IRB, institutional officials and research community are working collectively to interpret the new Common Rule parts and update the University’s policies, business processes, and myIRB system to accommodate the changes while maintaining a high-level of subject protection.