What to Expect

THE NEW REGULATIONS WILL IMPACT

  • studies approved on or after July 2018.
  • A few of our Institutional practices for research
  • iRIS & IRB Applications changes
  • Informed Consent template changes
  • MCHS IRB policies, standard operating procedures and resource guide changes

MCHS IRB ACTIONS

  • The MCHS Human Research Protections Program (HRPP), and the MCHS IRB are working  collectively to interpret the new Common Rule elements and update the MCHS policies, processes and iRIS system to accommodate the changes while maintaining a high-level of subject protection.  As these are worked through we will be educating the research investigators, and their teams so that everyone is prepared to follow the revised Common Rule by July 2018.

MCHS DECISIONS MADE TO DATE

  • MCHS has determined that at this time we will not implement the utilization of Broad Consent referenced in the Revised Common Rule, until further guidance is provided and the organization has had ample time to access how this could be implemented.
  • This decision will then eliminate the use of two new categories (7) & (8) proposed for exemptions.
  • MCHS has also decided that it will require a "status update" report for minimal risk research projects which will no be required to submit a continuing review to the Institutional Review Board (IRB).
  • MCHS IRB will continue to assess its criteria for whether MCHS IRB will serve as the single-IRB-of-Record (sIRB) or cede review to another institution or a commercial IRB

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 as multiple sites
  • Domestic research only

See MCHS's NIH Single IRB-of-Record (sIRB) webpage for more information

NIH Clinical Trial Policies for sIRB - https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm

NIH Definition of a Clinical Trial