Clinical considerations for allied professionals on research ethics--Vulnerable research participant populations: ensuring ethical recruitment and enrolment.

摘要

This article aims to explore a central element of ethical research-protecting the safety and dignity of potentially vulnerable research participants. It examines the origins of the concern for vulnerable participants, who they may be, and what processes are in place to ensure their safety and dignity, and how researchers can build safeguards into their protocols and their practices.Maya, a 75-year-old woman with atrial fibrillation, gave her informed consent for participation in a clinical trial involving randomized comparison of antiarrhythmic drug treatment versus catheter ablation. Maya was randomized to catheter ablation, On the procedure date, she appeared confused and thought she was simply picking up medication. Her husband insisted that the procedure should go ahead-Maya has periodic spells of confusion but was clear and capable when the consent form was signed.