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 DOI: 10.1177/1043659614523999

2014 25: 383 originally published online 4 March 2014J Transcult NursSusan L. Rubin

The Clinical Trials Nurse as Subject Advocate for Minority and Culturally Diverse Research Subjects  

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Research Department: Literature Review

The U.S. population is extensively varied and includes many different ethnicities and cultures. Accordingly, the need for ethnic diversification of clinical trial participants is neces-sary to ensure adequate representation of minorities in health-related research. The intricacies of the role of the clin-ical trials nurse (CTN) are wide ranging and varied but are held together by a strong foundation in advocacy for the clinical trial participant. The CTN acts as subject advocate to ensure that the subjects’ rights and safety are protected throughout the clinical trials process. It would follow, there-fore, that as a subject advocate for clinical trial participants, a CTN facilitates diversification in clinical trials by helping to overcome barriers in the recruitment of minority subjects, advocating for minority participants during the informed consent process, and increasing the retention of minority subjects in a culturally sensitive and patient-centered way.

Definitions

The National Institutes of Health (NIH, 1994) defines a minority group as an identifiable subset of the population that is distinguishable by racial, ethnic, and/or cultural back-ground. A CTN is a specialty nursing role that requires a unique framework of knowledge for working with patients involved in clinical trials (Oncology Nursing Society [ONS], 2010). A clinical trial is a research study of human subjects that is designed to answer specific questions about biomedi-cal or behavioral interventions (drugs, treatments, devices, or new ways of using them) and to determine whether or not these interventions are safe and effective (NIH, n.d.).

Background

The minority population is growing within the United States, and by the year 2050, minorities are expected to be the col-lective majority (Reuben, Milliken, & Pardis, 2011). The need for diversity in clinical trials is readily apparent as minorities are underrepresented in clinical trial research. There are significant gaps in evidence pertaining to health outcomes of various ethnicities and how they respond to treatments, medications or interventions (Ezeugwu, Laird, Mullins, Saluja, & Winston, 2011). Diversity of clinical trial participants in research allows results of a clinical trial to be applicable to various populations. In cancer research, for example, there is a known difference in incidence, presenta-tion, and prognosis of cancer among different ethnicities and races; however, most of what is known about cancer is based on research conducted with non-Hispanic White populations (Reuben et al., 2011). African Americans in particular, suffer from the highest incidence of cancer and are more likely to die of cancer than Whites or other minorities (Knobf et al., 2007). Disparities exist in cancer outcomes of minority patients (Dignan et al., 2011) and more effort should be made to include minority subjects in research. The absence of ade-quate representation of minorities in studies is an obstacle to

523999 TCNXXX10.1177/1043659614523999Journal of Transcultural NursingRubinresearch-article2014

1Morgantown, PA, USA

Corresponding Author:Susan L. Rubin, 230 Overlook Road, Morgantown, PA 19543, USA. Email: suzn1013@gmail.com

The Clinical Trials Nurse as Subject Advocate for Minority and Culturally Diverse Research Subjects

Susan L. Rubin, MSN, RN1

AbstractMinority involvement in clinical trials is necessary to promote diversification in health-related research. The clinical trials nurse is uniquely qualified to advocate for and ensure the success of the minority participant in clinical trials research during the processes of recruitment, informed consent, and retention of subjects. This article incorporates a review of literature in conjunction with the American Nurses Association’s standard of practice number 7 regarding ethics to demonstrate how the role of the clinical trials nurse as subject advocate can facilitate successful participation of minorities in clinical trial research.

Keywordsclinical trials nurse, advocate, minority research subject, culture, recruitment, informed consent, retention

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384 Journal of Transcultural Nursing 25(4)

understanding the impact of health-related research (Dignan et al., 2011).

As the need for ethnic diversification in clinical trials grows, the need for subject advocacy grows as well. CTNs are qualified as patient advocates (ONS, 2010) and are in an invaluable position to provide the support that is crucial to the successful participation of minority subjects in clinical trials. Cultural issues influence every aspect of clinical trials participation (Rosse & Krebs, 1999) and minority subjects involved in clinical trials have unique needs during recruit-ment, informed consent, and retention processes. The CTN relies on a strong and ethical nursing background to ensure that these needs are met throughout the clinical trials process.

Recruitment of Minority Subjects

The American Nurses Association (ANA) Standard 7 addresses the concept of ethics and describes as part of the scope and standard of professional performance that the nurse should promote equal health care for consumers (ANA, 2010). Equitable consumer health care also calls for equitable participation of minority populations in clinical trials. One of the CTN’s responsibilities in a clinical trial may include recruitment of subjects. CTNs can assess for and implement plans to overcome barriers to recruitment relating to under-served populations or patient demographic influences (ONS, 2010). Minority participation in clinical trials is dispropor-tionately low and participation of African Americans is declining, despite federal and research programs aimed at increasing enrollment (Baquet, Henderson, Commiskey, & Morrow, 2008). There are several barriers to recruitment that the CTN may face when attempting to recruit minority sub-jects in clinical trials including a lack of awareness or access to trials, socioeconomic, historical, and cultural/language fac-tors. The Nursing Code of Ethics states that the nurse is to promote, advocate, and protect patient’s rights, health, and safety and the nurse’s commitment is to the patient either as an individual, family, group, or community (Fowler, 2009). It is this nursing background that the CTN applies to surmount potential barriers to recruitment of minority subjects, thereby increasing diversification in trials research.

Barriers to Recruitment

Access to Trials

Health care disparities still exist in minority populations and limited access to health care results in limited access to clin-ical trials. A lack of awareness or access to clinical trials is linked to poor enrollment of minorities in trials (Baquet et al., 2008; Barrett, 2002). The CTN can help mitigate this disparity by spending time and networking in a particular

community and by seeking advice from representatives to ascertain what the cultural values and needs of the partici-pants are (Gul & Ali, 2010; Knobf et al., 2007). For exam-ple, a CTN employed at a research site may collaborate with local hospitals or health clinics to help promote awareness of clinical trials in a particular community. This may involve presentations at local health fairs and community or faith-based organizations. The CTN advocates for clinical trials and provides a generalized education about the clinical trials process (ONS, 2010). Involvement in a community builds trust and helps cultivate respect between participants and researchers (Knobf et al., 2007). The CTN has a clear per-spective on how clinical trials are carried out at the commu-nity level and can make sure protocols are practical for potential participants (Barrett, 2002). A CTN can help pro-mote awareness of clinical trials in underserved or underrep-resented populations, thus contributing to the diversification of research participants.

Socioeconomic Factors

Minorities tend to have social and economic disadvantages that contribute to health disparities (Lo & Garan, 2008). Patients may be reluctant to participate in clinical trials due to a perceived financial burden or as a result of practical concerns such as lack of transportation, child care issues or an inability to take time off of work (Baquet et al., 2008; Knobf et al., 2007). Duties of a CTN include coordinating subject study visits and helping to overcome barriers to recruitment that may be influenced by demographic factors or by being members of underserved populations (CRN 2010 Domain of Practice Committee [2009]; ONS, 2010). The CTN should assess the subject’s ability to meet the required protocol of the study such as frequency of visits to clinic, out-of-pocket expenses that may occur as a result of participation and potential finan-cial implications resulting from time off work (Ocker & Pawlik-Plank, 2000). Dignan et al. (2011) found that recruit-ment of minority populations can be successful if the life cir-cumstances of the subject are considered and accommodated.

The CTN can address the needs of minority subjects and individualize plans to ensure successful participation in clini-cal trials. Individual patient preferences or needs should always be considered and addressed to ensure successful completion of a participant in a clinical trial. Individual needs may include cultural values, socioeconomic concerns, educa-tional needs, symptom management, as well as practical issues that need to be addressed to ensure successful comple-tion of the trial. The CTN uses holistic patient care including clinical assessment to address the needs of a patient (ONS, 2010). The individualized care plan not only takes into account that the requirements of the study be met but also addresses the needs of each subject, increasing recruitment as well as retention throughout the clinical trials process.

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Historical Factors

Another frequently cited barrier to recruitment of minority subjects is fear or mistrust of medical professionals and researchers (Baquet et al., 2008; Barrett, 2002; Knobf et al., 2007). This distrust is strongest in African Americans and Native Americans (Knobf et al., 2007) and stems from a his-tory of oppression, as well as unethical research studies such as the Tuskegee Experiment. The Tuskegee Experiment was a 40-year study that included more than 400 Black men who had syphilis and were deceived by researchers and denied effec-tive treatment (Jones, 2008). Nurses who work in clinical trials research are in a unique position to help overcome the mistrust associated with research as society respects and trusts nurses (Steinke, 2004). The CTN can help reinstate trust in the research process by building a relationship with the participant and ensuring that the subject’s best interests are safeguarded. Establishing a trusting relationship begins with the informed consent process in which the CTN provides information about trial risks and benefits, addresses any misconceptions or fears, and gives ample time to the potential participant to carefully consider his or her options to make the best personal choice regarding trial participation without coercion (Barrett, 2002).

Cultural Barriers

Cultural preferences may present a challenge to the CTN recruiting minority subjects. The CTN as subject advocate should be a culturally aware and sensitive member of the research team and should help address and accommodate cultural preferences. For example, in some cultures such as the Latino culture, it may be beneficial if a woman’s husband is present when presenting study information. The Latino culture places high value on family and husband (Knobf et al., 2007) and the presence of the husband may be reassuring to the family. However, care must be taken to respect the individual’s autonomy in a situation where someone in a controlling social role may have a different opinion in regard to trial participation (Lo & Garren, 2008).

Another example of cultural variance exists in the Native American culture when referring to cancer. In this culture, simply speaking about cancer can be challenging, as some Native Americans believe that talking about cancer leads to an occurrence of the disease (Knobf et al., 2007). Native Americans may also have a fear that genetic research may conflict with their beliefs about tribal origins and the history of and culture of their people (Lo & Garren, 2008). If cultural preferences are respected by the CTN during the research process, the potential subject may have more of an inclina-tion to participate in a trial.

The CTN may be the first person of the research team who approaches potential trial participants. The person making the initial contact with the subject should be

knowledgeable about the study’s aims and intricacies, and this person must be aware of the cultural values of the study population (Gul & Ali, 2010). A CTN increases minority participation in clinical trials using a culturally sensitive approach (Ehrenberger & Lillington, 2004). The initial contact is important to recruitment (Gul & Ali, 2010) and the CTN must be a reliable, educated, and culturally sensi-tive resource during recruitment and informed consent pro-cesses culminating in diversification of clinical trials research participants.

Informed Consent

The ANA Standard 7 on ethics includes responsibilities for the graduate-level–prepared specialty nurse. A graduate-level–prepared nurse will promote autonomy of the patient by informing the consumer of risks and benefits and allow-ing the consumer to consent or refuse treatment (ANA, 2010). The CTN’s role as subject advocate is apparent dur-ing the informed consent process. As subject advocate, the CTN has a duty to safeguard patient rights and ensure that all aspects of informed consent are followed. Nurses take a patient-centered approach to the informed consent process (Barrett, 2002) and are important resources when addressing diverse populations. Responsibilities of the CTN may encompass initial informed consent as well as continual con-sent throughout the trial, educating participants and helping to recognize and surmount potential barriers to the informed consent process (ONS, 2010). Informed consent requires that the purpose of the study be addressed as well as risks and benefits, alternative treatments, confidentiality, compensa-tion and that participation in the trial is voluntary (Rosse & Krebs, 1999).

The potential candidate for clinical trial enrollment must understand that enrollment is voluntary and they are free to withdraw if they wish. The CTN can explain to the patient how scientific advances are achieved, review the patient’s role and rights in the study, and provide the participant with sources for more information (Robins-Sadler, Lantz, Fullerton, & Dault, 1999). Nurses approach patients in a holistic and patient-centered way that ensures that patients are treated in a dignified and respected manner (Barrett, 2002). It is this approach that allows the CTN to promote a therapeutic relationship with the participant. The CTN addresses any concerns that the clinical trial participant may have and makes sure that continual education is maintained throughout the process in an effort to meet ongoing informed consent requirements.

Language Barriers to Informed Consent

Language barriers are an ever-present concern when obtain-ing informed consent of a subject whose primary language is

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different from the person seeking consent (Schenker, Wang, Selig, Ng, & Fernandez, 2007). The current statistics show 11 million people in the United States report that they speak English “not at all” or “not well” (Schenker et al., 2007). The CTN can help overcome this particular barrier by collaborat-ing with the principal investigator running the trial, as well as interpreter services to ensure that the consent form is trans-lated into the subject’s primary language in accordance with the Code of Federal Regulations (45 C.F.R. 46.116), which states that the consent form should be in a “language under-standable to the subject or representative.” The form is then submitted to an institutional review board for approval before presenting it to the potential research participant (Resnik & Jones, 2006).

The nurse involved in clinical trials has a primary duty to educate and inform the patients or subjects, and should be cognizant of the vulnerability of the minority subject whose primary language is not English. The CTN can convey infor-mation using nontechnical language when explaining the purpose of the trial. Language and literacy of the participant should be assessed as well (Steinke, 2004) and can be screened for by the CTN. The informed consent process needs to be sensitive to the subject’s and family’s beliefs, preferences, and values (Rosse & Krebs, 1999; Steinke, 2004). As a culturally aware member of the research team, the CTN incorporates individual preferences and values through expanded knowledge of cultural tendencies and by thorough communication with individual participants. It is this approach that will further the success of minority involvement in clinical trials.

Ethics of the Consent Process

The ethics associated with the informed consent process include respect for persons, beneficence, and justice (Steinke, 2004). The ethical concept of “respect for persons” empha-sizes the autonomy of the subject and the duty to protect those who are not able to make their own autonomous deci-sions (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Beneficence implies that no harm befalls the subject, and risks of participation are minimized and benefits are maxi-mized (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Finally, the concept of justice encompasses the idea that the burdens and benefits of research should be shared (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). The CTN can help to ensure that minority involvement is being sought for an ethically justifiable reason, a reason that will benefit the subject or race. The CTN and the principal investigator have a moral responsibility to evaluate risks and benefits for the trial participant, to make sure that the subject is properly informed to make autonomous decisions, and to ensure that all subjects are treated equitably (Steinke, 2004).

Retention of Subjects

The ANA Standard 7 on ethics includes in the responsibili-ties of the nurse that he or she keep a professional and thera-peutic relationship with the health care consumer (ANA, 2010). The relationship that exists between a clinical trial participant and the CTN can be especially relevant in main-taining retention of subjects throughout the trial. According to Davis, Broome, and Cox (2002), the participant who is most likely to leave a study is an older minority subject with limited education, many health concerns, high stress level, and has inconsistent usage of health care. Cooperation of subjects during the trial is dependent on a trusting relation-ship with the research team and the subject’s efforts should be appreciated (Gul & Ali, 2010). The CTN’s role encom-passes various aspects in regard to retention of subjects including educating the subject, facilitating access to trials, ensuring that the patient’s rights are safeguarded throughout the trial, and above all else, being a trustworthy person who will advocate for all subjects.

The CTN maintains subject participation by frequent contact and personalized attention to trial participants which aids in the retention of subjects (Berger, Neumark, & Chamberlain, 2007; Davis, Broome, & Cox, 2002). This includes e-mails, visits to the home, and telephone calls (Berger et al., 2007). Assistance from nurses should be val-ued as a means of retaining participants throughout the study and the nurse should be flexible and aware of the sub-ject’s needs (Berger et al., 2007). The CTN is a liaison between the trial participant and the rest of the research team (Bell, 2009) and works with the other members of the team to ensure that any barriers to retention (cultural, socio-economic, historical, or language) are addressed and over-come whenever possible.

Gap in Literature

The role of the CTN is evolving, and the responsibilities of the CTN are many, and vary between sites and institutions. The literature is scarce as it relates to the role of the CTN as subject advocate for minority populations. Future implica-tions for research should include the impact of the CTN’s involvement on recruitment, informed consent, and retention of minority subjects.

Conclusion

The CTN holds an integral position as a member of a research team conducting clinical trials. Perhaps one of the most important aspects of the CTN’s role is to advocate and pro-tect the rights and interests of the subjects involved, and this aspect of the CTN’s role is beneficial to the successful par-ticipation of minorities in research. Whether it is in the recruitment phase, the informed consent process or the reten-tion of subjects, the CTN’s responsibilities have a general

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foundation in subject advocacy. The growing need for diver-sity in clinical trials is evident, and the involvement of a CTN will help precipitate that diversity.

Author’s Note

This article was written to fulfill partial requirements for a master’s of nursing degree with a major focus of clinical trials research.

Acknowledgments

This article was accepted under the editorship of Marty Douglas, PhD, RN, FAAN.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, author-ship, and/or publication of this article.

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