IRB Policy/Operations Track (SBER)

2019 SBER Conference

A07 - Continuing Review or No Continuing Review, That Is the Question

Speaker(s)

• 

  Andrew Hedrick, MPA, CIP
  

  Senior IRB Protocol Analyst, The Ohio State University
  
• 

  Sharon L. Zack, MS
  

  IRB Administrator, Westat
  

Under the revised Common Rule, continuing reviews are no longer required for minimal risk research. This specifically applies to projects reviewed under expedited authority or by full board, including studies that progressed to long-term follow-up or data analysis (even with identifiers), unless the research is FDA-regulated. Formally, the IRB is still responsible for oversight on research conduct and human subject protections. However, the elimination of the regulatory requirement to conduct continuing review annually has created a challenge for HRPPs that may still want to monitor the status of ongoing projects (e.g., how recruitment is progressing) and maintain an overall picture of their active research portfolio. Without formal, ongoing monitoring of project status, notification that the project is over could be the only time, aside from the initial review, that the IRB hears from an investigator. Without a check-in mechanism, will investigators forget about on-going responsibilities (e.g., human subjects training, reporting incidents, changes to consent forms, unanticipated problems, and changes and additions to previously approved research)? During this session, speakers and attendees will:

Learning Objectives:

• Discuss procedures for determining when projects receive continuing review or a status check-in review (e.g., introducing checklists and forms)
• Review how to roll out changes using new procedures and forms, and educate researchers and research staff
• Share data on investigator satisfaction of the process