Boundaries and Balances Track

Breakout Session Series D

D03 - Tissue Repositories and Data Banks in the Era of the Revised Common Rule

Faculty(s)

• 

  Mark Barnes, JD, LLM

  Partner
  Ropes & Gray Law Firm
  Harvard University and Brigham and Women’s Hospital

Speaker(s)

• JK

  Julie Kaneshiro, MA

  Deputy Director
  Office for Human Research Protections
• 

  Susan Stayn, JD

  Senior University Counsel
  Stanford University

The revised Common Rule introduces the option of broad consent and limited IRB review 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. 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. 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