56
N
urses assume a myriad of research roles in stud-
ies involving cardiovascular patient populations.
These “cardiovascular research nurses” may serve
independently as principal investigators on research
protocols or serve supportive roles as study coordina-
tors, research assistants, data collectors, and/or clini-
cians implementing research protocols. Although car-
diovascular research nurses encounter ethical issues in
the day-to-day conduct of their research, little sys-
tematic information exists about these ethical issues
and how cardiovascular nurse researchers address
them. Ethical concerns associated with balancing
patient advocacy, subject advocacy, and study advo-
cacy have been voiced.
1,2
Additionally, the increased
number and scope of related, randomized clinical
Journal of Cardiovascular Nursing
Vol. 20, No. 1, pp 56–61
❘
© 2005 Lippincott Williams & Wilkins, Inc.
Ethical Considerations in
the Recruitment of
Research Subjects From
Hospitalized,
Cardiovascular Patient
Populations
Nalini Jairath, PhD, RN,
Connie M. Ulrich, PhD, RN
Cathaleen Ley, PhD, RN
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.
KEY WORDS: cardiovascular nursing, cardiovascular patients, ethics, informed consent, study
recruitment
Nalini Jairath, PhD, RN
Dean, School of Nursing, The Catholic University of America,
Washington, DC.
Connie M. Ulrich, PhD, RN
Assistant Professor, School of Nursing, University of Pennsylvania,
Philadelphia, Pa.
Senior Fellow, Department of Medical Ethics, Center for Bioethics,
University of Pennsylvania, Philadelphia, Pa.
Senior Fellow, The Leonard Davis Institute of Health Economics,
University of Pennsylvania, Philadelphia, Pa.
Cathaleen Ley, PhD, RN
Assistant Professor, School of Nursing, Towson University, Towson, Md.
The study described in this article was supported through a R15 AREA
Grant NR04496 from the National Institute of Nursing Research.
Corresponding author
Nalini Jairath, PhD, RN, School of Nursing, Gowan Hall, The Catholic
University of America, Washington, DC 20064 (e-mail: jairath@cua.
edu).