Responsible Conduct of Research Track

2019 AER Conference

B16 - Agents and Rogues—The Limits of Agency, Institutional Engagement, and Institutional Responsibility

Speaker(s)

• 

  Robert S. Bienkowski, PhD, CIP, CHRC, ECoP
  

  Director, Office of Research Compliance, Central Michigan University
  
• 

  Joseph Crossno, MS, CPIA
  

  Assistant Director, Office of Research Compliance, Central Michigan University
  

This session will explore the limits of agency, institutional engagement, and institutional responsibility when a faculty member "goes rogue" and conducts unapproved human subjects research. Two scenarios will be discussed: (1) when research is conducted at the university and uses institutional resources; and (2) when research based on intellectual property developed by a faculty member is licensed to an offsite company founded by the faculty member. Attendees will participate in developing recommendations for strengthening compliance oversight activities to detect unapproved research conducted on campus, and analyzing the limits of compliance oversight when research is conducted by an entity with which the university has an arms length relationship. During this session, speakers and attendees will:

Learning Objectives:

• Review the concepts of agency and engagement as treated in the revised Common Rule, OHRP guidance, institutional standard operating procedures, and IRB and institutional procedures for responding to allegations of conducting unapproved research
• Analyze compliance monitoring processes to detect unapproved research involving human subjects conducted using institutional resources, and develop recommendations for improvement
• Discuss the limits of compliance oversight authority when evaluating how a licensee conducts human subjects research