Ethical considerations in the recruitment of research subjects from hospitalized, cardiovascular patient populations.

Cardiovascular research nurses play important roles in ensuring that subject recruitment is conducted in an ethically defensible manner. However, these nurses encounter many ethical challenges in the course of research. Sole reliance on regulatory mechanisms such as institutional review board oversight and adherence to legal requirements does not necessarily ensure human subjects' protection or the scientific integrity of researchers (J Law Med Ethics. 2002;30:411-419). Therefore, this article discusses 3 additional ethical considerations associated with recruiting hospitalized cardiovascular patients for research studies. These include (a) the role of the family and patient-delegated "gatekeepers," (b) the effect of transient and subtle mental status changes upon the consent process, and (c) the effect of conflicting patient priorities. This content is illustrated using the authors' experiences recruiting hospitalized coronary artery bypass graft surgical patients for a research study.