Vulnerable research participants: anyone may qualify.

Although the Code of Federal Regulations has provided guidelines regarding research involving vulnerable participants, persons not traditionally identified may also be considered vulnerable at a given time due to emergent or acute illness, end-of-life needs, or circumstances encountered that challenge capacity to provide informed consent. In this column, the author presents an overview of institutional review board roles, responsibilities, processes, and suggestions regarding assessment of vulnerability and capacity to consent that is responsive to current societal and healthcare needs.