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SBER Track
2019 AER Conference
11/11/2019 2:10 PM
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
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: