Challenges and strategies for recruitment and retention of vulnerable
research participants: Promoting the benefits of participation
Robin Gemmill, RN, MSN
, Anna Cathy Williams, RN, BS,
Liz Cooke, RN, MN, Marcia Grant, RN, DNSc
City of Hope, Division of Nursing Research and Education, Department of Population Sciences, Duarte, CA 91010, USA
Received 2 November 2009; revised 18 January 2010; accepted 3 February 2010
Abstract The purpose of this article was to describe recruitment and retention of vulnerable hematopoietic cell
transplant patients participating in a longitudinal intervention study. Utilizing Swanson's theory of
caring model, nurse researchers facilitated patients' visualization of how study participation could
enable them to share their experience and further clinical insights.
© 2012 Elsevier Inc. All rights reserved.
As we investigate cutting-edge cancer therapies, it is
important to remember how vulnerable the patient is during
diagnosis and treatment. Approaches are needed to help
facilitate successful recruitment and retention (R&R) of
vulnerable populations. The Swanson's theory of caring
model provides an excellent tool for creating a safe,
respectful therapeutic environment when initiating and
maintaining communication with any research study partic-
ipant, especially those deemed vulnerable.
R&R of vulnerable research participants can be a very
challenging task for the nurse researcher, especially when
researching a sensitive topic such as cancer or palliative care.
Individuals dealing with a cancer diagnosis or end-of-life
issues face many physical and psychological threats to their
well-being. The potential for exploitation should be
minimized as much as possible. Principles governing the
conduct of research in human subjects provide a guide for
ethical research invoking three basic principles: (a) respect
for persons, understood as informed consent; (b) benefi-
cence, balancing risk of harm with study benefits; and (c)
justice, the selection of participants (Beauchamp, 2008).
This report also emphasizes the importance of protecting the
vulnerable study participant.
Patients undergoing allogeneic hematopoietic cell trans-
plant (HCT) are especially vulnerable because of the
potentially lethal disease and treatment consequences.
Other factors affecting this reality are (a) early hospital
discharge patterns with assumption of care by the patients and
their care partners; (b) complex and toxic treatments; (c)
prolonged, highly variable, and uncertain recovery; and (d)
long-term complications such as graft-versus-host-disease.
The nurse researcher studying the HCT patient experience
has a responsibility to be aware of the special concerns raised
by the proposed research (ANA American Nurses Associa-
tion Code of Ethics for Nurses Interpretative Statements,
2009) and the importance of ensuring that the research that is
done will benefit the vulnerable participant (Anderson &
Hatton, 2000). The interests of the study participant take
precedence over study accrual and retention. Thus, successful
recruitment and long-term retention of the vulnerable patient
becomes a delicate balance between protecting potential
study participants from physical and emotional distress
associated with the study and maintaining study integrity.
Numerous strategies have addressed the challenges.
These include (a) anticipation and planning for unexpected
issues, (b) fostering support among providers (Northouse
et al., 2006; Resnick et al., 2003; Sherman et al., 2005), (c)
addressing clinician concerns (Chiang, Keatinge, & Wil-
liams, 2001), and (d) monitoring R&R throughout the study
period (Sherman et al., 2005). Few strategies provide
guidance on how best to approach and interact with the
potential vulnerable study participant to enhance successful
Available online at www.sciencedirect.com
Applied Nursing Research 25 (2012) 101 – 107
Corresponding author. Tel.: +1 626/256-HOPE ext.; fax: +1 626/301-8941.
E-mail address: email@example.com (R. Gemmill).
0897-1897/$ – see front matter © 2012 Elsevier Inc. All rights reserved.