IRB Basics Track

2019 AER Conference

11/3/2019 5:46 PM

C07 - Covering All Your Bases: Considerations and Tips for How to Identify and Apply the Appropriate Federal Regulations for IRB Review

Speaker(s)

• 

  Danielle Giltner, JD, CIP
  

  Associate Director, Human Research Protection Program, Indiana University
  
• 

  Warren Capell, MD
  

  Clinician-Scientist, CPC Clinical Research; Associate Professor of Medicine, Division of Endocrinology, Metabolism, and Diabetes; Associate Faculty, Center for Bioethics and Humanities, University of Colorado Denver
  
• 

  Leslie M. Howes, MPH, CIP
  

  Director, Office of Regulatory Affairs and Research Compliance, Harvard T.H. Chan School of Public Health
  

This interactive session will assist IRB staff, chairs, and members with the initial review of non-exempt human subjects research. This session will provide the basic training necessary to determine whether a study qualifies for expedited or full board review; identify which regulations apply (e.g., Common Rule, FDA, the Family Educational Rights and Privacy Act, Health Insurance Portability and Accountability Act of, and other agency requirements), and what/how/where determinations should be documented (e.g., IRB minutes vs. reviewer checklist). During this double session, speakers and attendees will:

Learning Objectives:

• Revisit the ethical principles underlying regulatory protections for research involving human subjects
• Identify and discuss regulations that impact IRB review and how to identify when they should be considered
• Discuss the criteria for expedited review and models for documenting reviews and when referral to a convened IRB may be warranted
• Practice applying the 111 criteria to various case examples
• Note: This is a double session and will end at 12:45 PM.