SBER Track

2019 AER Conference

11/11/2019 2:10 PM

A18 - Certificates of Confidentiality (CoCs)

Speaker(s)

• 

  Mary Ramirez, MA, CIP
  

  Assistant Director, Health Sciences and Behavioral Sciences IRB, University of Michigan
  
• 

  Adam C. Berger, PhD
  

  Director, Division of Clinical and Healthcare Research Policy, NIH
  
• LL

  Lyndi Lahl, RN, MS
  

  Human Research Protections Officer, Division of Human Subjects Research, Office of Extramural Research, National Institutes of Health
  

HHS now automatically issues CoCs for all NIH-funded studies involving the collection of identifiable, sensitive data. The NIH specifies that “identifiable, sensitive information” includes data where an individual is identified, or where there is a “very small risk” of an individual being identified through scientific practices or statistical methods. CoCs often cause confusion for SBER investigators and IRBs, particularly around the protections they afford and mandatory reporting. During this session, speakers and attendees will:

Learning Objectives:

• Outline the changes to the CoC system under the 21st Century Cures Act
• Review the scope of legal protection and privilege afforded to researchers under a CoC, including a review of the applicable regulations and federal guidance
• Discuss the implications for informed consent, and how CoCs interface with other protective laws and possible disclosures