Spotlight on students! Join us in Career Central to attend one of this year's student presentations and hear directly from the next generation of regulatory leaders.
This paper explores the evolution of informed consent and privacy laws within the human subject research regulatory landscape. The history of informed consent illuminates the reactive nature of human subject research regulations codified in the Common Rule. Although HIPAA privacy laws originally bolstered human subject autonomy and protection, revisions are now necessary. A few modern changes to the original regulatory framework need addressing: the surge of secondary research entities, the surge of big data, and disjointed regulatory interpretation. These realities bring unaddressed challenges like new recipients of human subject information and poorly regulated methodologies. A multidisciplinary solution that includes legislative reform, additional ethical guidelines, education, and stakeholder collaboration can fill regulatory gaps.
Learning Objectives:
Upon completion of this session, participants should be able to explain certain components of the Revised Common Rule of 2019
Upon completion of this session, participants should be able to describe at least 2 present challenges that weaken our current privacy and informed consent practices
