Research involving Data and Biospecimens Track

2019 AER Conference

Repeat Breakout Session (C3): Tissue Repositories and Data Banks in the Era of the Revised Common Rule

Speaker(s)

• 

  Julie Ozier, MHL, CHRC, CIP
  

  Director, HRPP, Vanderbilt University and Medical Center
  
• 

  Nicholas A. Wallace, JD
  

  Attorney, Ropes & Gray LLP
  
• 

  Carol Juliet Weil, JD
  

  Program Director, Ethical and Regulatory Affairs, Division of Cancer Treatment and Diagnosis, National Cancer Institute
  

The revised Common Rule introduced the option of broad consent for secondary research, as well as two new exemptions (exemptions seven and eight) for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens when broad consent is used and limited IRB review occurs. These options, and the revised definitions of "human subject," offer new opportunities and challenges for the research enterprise and IRB professionals, but also raise questions about how and whether they can be effectively utilized to facilitate research. With almost a year of implementation underway, this session will review whether institutions have implemented these options and, if so, what the benefits and challenges have been. Have any institutions adopted broad consent and, if so, in what circumstances? What has limited IRB review looked like in practice? Attendee participation and sharing of best practices developed since the revised Common Rule went into effect will be encouraged. During this session, speakers and attendees will:

Learning Objectives:

• Describe the new options of broad consent and exemptions seven and eight in the revised Common Rule, and review requirements for their use, restrictions to waiver and alteration of broad consent, and other problems that may be caused by these requirements
• Use case studies to explore potential challenges in operationalizing the use of these options, including issues with tracking, IRB reviews, etc.
• Review how operational problems might or might not be overcome, and share practical suggestions for institutions as they continue to operate research repositories under the new regulatory framework