B06 - Assessing and Mitigating Risk in SBER: A Case Study Approach

Tuesday, November 16, 2021

1:15 PM – 2:15 PM ET

Location: On-Demand

The risks associated with SBER are often hard to identify, and are dynamic, subjective, and unpredictable. During this session, speakers will present SBER case studies that were designed to help reviewers identify and evaluate the risks presented by SBER participation, and will include a discussion on how to effectively spot issues and employ risk mitigation strategies. Attendees should have an understanding of 45 CFR 46 and different types of risk that SBER studies may present and how to assess risk: benefit ratios before attending this session.

Learning Objectives:

Identify the nature of the risks associated with SBER and factors that may exacerbate the risk of harm
Review applicable regulations and standards
Evaluate strategies for risk mitigation

Presenter(s)

MA

Marianna Azar

Office for Human Research Protections (OHRP)
Amy Ben-Arieh, JD MPH

The Fenway Institute at Fenway Health
Boston, MA
Lara N. Sloboda, PhD

Dana Farber Cancer Insititute
Boston, MA