This session will review ethical and regulatory protections for vulnerable populations in human subjects research, with an emphasis on differences between pediatric and adult participants. Topics will include definitions of vulnerability, informed consent, assent, surrogate decision-making, and risk-benefit assessment. Also discussed will be practical approaches to evaluating adults participants' decision-making capacity, while pediatric-specific issues, such as developmental capacity, parental permission, and minimal-risk standards, will be compared to challenges in adult vulnerable populations, including cognitive impairment, critical illness, and socioeconomic barriers.

The session will also address emergency research, deferred consent, and equity in recruitment. Interactive case discussions will help participants apply ethical principles and practical strategies to strengthen participant protection and research integrity.

CEU: 1.0 ACRP

Speakers:

• Elena Alferova, Clinical Research Regulatory Coordinator, UCSD Moores Cancer Center

• Muhammad Waseem, MD, MS, Research Director, Emergency Medicine, Lincoln Medical Center, Bronx New York