Negotiating tensions: Ethical issues in clinical research nursing

Abstract

The role of the clinical research nurse is pivotal to the day to day management of clinical

trials. The complex and diverse roles of the registered nurse, as clinical research nurse, are

noted in the literature. The role of the clinical research nurse, for registered nurses, poses

contradictory commitments to the ethics of care inherent in nursing and creates potential

conflicts within the professional identity of nurses. Previous nursing research in this area

has been analyzed and will be elaborated on to further explore the professional tension that

nurses, as clinical researchers, experience. Ethical frameworks guide the work of the

registered nurse and the clinical research coordinator. This paper will include ethical

challenges unique to the role of the clinical research nurse. Implications for nursing

practice will be discussed. A key recommendation suggests that continuing education on

the guiding principles of good clinical practice may assist in negotiating ethical tensions

inherent in clinical research.

Keywords: Clinical research nurse, ethics, nurse identity

1

Introduction

The role of the clinical research nurse

Clinical trials are investigations initiated by a sponsor or industry to determine the

efficacy and safety of new drugs or medical devices in human subjects. Contract research

organizations (CROs) often provide support to industry in clinical trial management.1

The

research team conducting clinical trials consist of investigators, clinical research nurses

(CRNs), laboratory and pharmacy personnel as well as administrative staff. Principal

investigators, physicians who are responsible for the study, delegate most of the day to day

responsibilities to study staff. 1

In collaboration with the principal investigator and study

staff, the CRN will coordinate all aspects of the clinical trial including protocol review and

feasibility, submission and approval of regulatory bodies, patient recruitment and retention,

compliance of study protocol, subject visits and management, education and data

collection.1

The scope of the CRN is complex and the responsibilities are intensive and

multi-faceted. While the role of the CRN may be staffed with non nurses, a registered

nurse or a registered nurse with an advanced degree is often preferred.2 It has been

suggested that the intricacies of the foundational knowledge of pharmacology and patho-

physiology necessary to execute clinical trials demand the expertise of a registered nurse

and that the involvement of nurses in clinical research has been associated with positive

2

outcomes.1,2

Clinical research involves complex and comprehensive scientific studies.

Randomized controlled trials are considered the gold standard of research designs and are

believed to provide the highest level of evidence in clinical research.3 The role of the

clinical research nurse (CRN) is pivotal to the day to day management of the clinical trial.

CRNs, also known as study coordinators, must have detailed knowledge of study protocols

and an understanding of regulatory requirements to assist them in the protection of human

subjects in research.1

The diverse roles of the registered nurse as clinical research nurse have been noted

above. As a registered nurse, the role of the CRN may pose contradictory commitments to

the ethics of care inherent in nursing and create potential conflicts within the professional

identity of nurses. The purpose of this paper is to discuss the ethical frameworks that guide

the work of the registered nurse and the clinical research coordinator. The aim of the

inquiry is to expose the inherent ethical challenges unique to the role of CRN. Implications

for nursing practice will be discussed.

Ethical considerations for the clinical research nurse

Professional Identity

Culture and gender. Occupations are chosen to suit the perception we hold of ourselves.4

3

Nurses are health care professionals who construct their self concept and professional

identity from their public image, their work environment, education and traditional social

and cultural values.5 Internalizing these values provides a framework for nurses’ decision

making and helps in developing a range of beliefs and attitudes about the profession of

which they are a part.4

Caring has been identified as central to nurses’ professional identity. In a Canadian

survey of nurses, across cohort and nursing groups, caring has remained one of the most

important reasons for becoming a nurse and staying in nursing.6 In other studies, altruism,

also considered the moral orientation of care, has been an overall philosophy underlying

professional identity among nurses.7 It has been argued that nurses who see intrinsic

value in their work experience self affirmation when they believe they have made a

difference in the lives of others and that this desire is a transcending aspect of a nurse’s

professional self. 8 This is a necessary part of nursing identity.

Nurses are involved in the provision of health care and in every area of the health

care system. As a profession, nurses are expected to espouse professional values of caring

and safeguarding public safety.9 Public opinion polls confirm that Canadians greatly

admire the nursing profession, “they are synonymous with health care, compassion and

good work”. 10

Nurses are embedded in the system’s core and are fully integrated into it

4

structures. They are respected as legitimate, knowledgeable professionals who are

concerned with patient safety.10

As a clinical research coordinator, the registered nurse

offers a public persona and professional identity that may place them in a position of trust.

It is suggested that gender acts as a persistent social structure shaping the

perceptions of the CRN in the workplace.11

Because the clinical team is composed of

predominantly male investigators and predominantly female coordinators, research is seen

to be structured by the traditional dynamics of the nurse doctor relationship serves to

gender the role of the clinical research nurse.11

Although coordinators have less authority

in clinical trials than principal investigators, they have greater daily responsibilities.1, 11

Often overseeing multiple studies, the coordinator must balance many elements of the

clinical trial delegated to them by the principal investigator. CRNs spent more time with

study participants than any other research staff associated with clinical research.1

Much of

the work of nurses, and in turn, clinical research coordinators, depends on the nurse- patient

relationship. These interpersonal relationships are often associated with ‘soft skills’11

that

are highly gender specific and feminized.11

Interpersonal skills are instrumental in the

recruitment and retention of subjects in clinical trials and are valued by the industry in

establishing a trust among participants that they will be taken care of during the study. 12

Because of its association with nursing, the professional identity of the clinical research

5

nurse is also related in altruistic terms.12

Nurses foster a caring holistic approach in the

execution of a clinical trial that humanizes the research process for participants. 13, 14

This

is often helpful in meeting the demands of clinical research.

Ethical Obligations of the Registered Nurse

Care and practice. A care orientation would seem fundamental to the nurse patient

relationship and to the nursing profession. Registered nurses have a responsibility to

provide care that is safe and ethical and are guided in this manner according to their code of

ethics.9 The Code of Ethics is intended for nurses in all contexts and domains of nursing

practice and serves as an ethical basis from which nurses can advocate for environments

that support the delivery of safe, compassionate ethical care.9

Caring and nursing are historically intertwined. 15, 16, 17

Nursing practice is based

upon a commitment to deliver expert care. This commitment to care, the investment in a

caring relationship, is considered the ‘ethic of care’. 17, 18

Nurses care about their patients

in ways that are complex and intimate. An ethic of care has been argued as not only

desirable in nursing practice but needed to guide moral relationships between people.19

Therefore, an ethic of care in nursing practice must not only be understood in terms of

rights and responsibilities but in relationships. Related to the ethic of care is the concept of

advocacy.

6

Advocacy, described as the act of informing and supporting a person so that he or

she can make the best decision possible, 20

has been considered a form of caring and

compassion. Advocacy has become a central part of ethics in professional nursing

practice and is universally considered a moral obligation for nurses.21

Nurses act as patient

advocates because to do so reflects of kind of practice nurses value. In the statement, ‘all

nurses must advocate for a safe and healthy environment,’ the International Council of

Nurse (ICN) Code of Ethics includes a central role for advocacy.21

The ethical dimensions

of providing patient centered care in systems that are constrained for resources are

challenging and increasingly, moral ethical advocacy21

has become a central part of ethics

in professional nursing practice.

The special dynamics and interpersonal characteristics of relationships in nursing

practice has been referred to as relational ethics.22

Advocacy in nursing may be

considered in a relational context. 22

The nature and quality of nurses’ relationships with

their patients cause them moral consideration. Advocacy is not merely the defense of

infringement of patients’ rights but must stem from a philosophy of nursing in which

practice supports and promotes health as it is understood by the individual; it becomes an

‘ethic of practice.’ 23

Professional nurses are inculcated with an identity that is predicated

on patient advocacy and caring. Being a member of the profession brings with it respect

7

and trust of the public. As professionals, nurses have a duty to uphold the standard of the

profession and provide ethical care in keeping with the best interests of the patient.9

Good clinical practice and the clinical research nurse

The research subject and compliance. The goal of clinical research is to develop

generalized knowledge that improves human health or increases understanding of human

biology.24

Clinical trials test potential treatment, specifically drugs, biologics or medical

devices to determine if they should be approved for wider use in a general population.25

Clinical trials in Canada are performed under strict conditions and follow Good Clinical

Practices (GCP), international ethical and scientific quality standards for designing,

conducting, recording and reporting trials that involve the participation of human

subjects.25

This regulatory framework is meant to protect the rights, health and safety of

participants in the trial, to ensure that trials are well designed and conducted by trained

professionals and to ensure that trial data is credible.25

The CRN adheres to these ethical

guidelines in order to protect subjects and to preserve the integrity of data collected.26 ,27

Compliance with GCP assures the public that the rights, safety and well being of trial

subjects are protected. 27

The CRN has obligations to the principal investigator, to

regulatory authorities and to the study sponsor to adhere to these guidelines and to comply

strictly with the protocol as a way of producing reliable data and information about new

8

therapies.26

The study coordinator also has responsibility to the patient as advocate and

caretaker. In the realm of clinical research, the CRN embodies the ‘catch all’ role for the

management of the administration of the clinical trial, as well as the management and

protection of the human research subject.1

The CRN is often responsible for the recruitment and retention of study subjects.

There is a strong emphasis placed on the interpersonal skills of coordinators to get subjects

to enrol in the study and to motivate them to follow the protocol.12

Notwithstanding the

ethical guidelines, it is necessary for the CRN to understand that for the sponsor or

pharmaceutical company, drug development is a goal of the clinical trial and that it is the

coordinator’s responsibility to actively recruit subjects for the study and to gather data that

will be used to support the development of the investigational product.

Discussion

Conflicting roles and resulting tensions

Research and care. Generally, nurses feel responsible for the welfare of those who need

care and current nursing practice appears to reflect the changing needs of patients. The

goals of clinical research however, are not necessarily synonymous with nursing goals.

Nurses feel conflicted in their role as CRN and moral distress may be the result of

9

negotiating tensions that arise in the research setting. 13

Maintaining balance in the

commitments to all stakeholders involved in clinical research is often fraught with tension

and conflict for the CRN as ethical practice at the research site is often less related to the

treatment of human subjects and more focused on the data that are produced in the study.13

The major contributor to this tension is the fact that clinical research is not a

therapeutic activity devoted to the personal care of patients. Clinical trials are designed for

answering a scientific question. Even the language of the clinical trial process denotes the

objectifying, positivistic orientation of the scientific method. For example, the term,

patient, ubiquitous in nursing care, is replaced with the term, subject. However, the

prevailing ethical framework views clinical trials through a therapeutic lens. 28

The

mainstream ethical approach to clinical trials attempts to view clinical trials as a scientific

experiment aimed at producing knowledge that can help improve the care of future patients.

28 This makes it possible to perform clinical trials without sacrificing the therapeutic

obligation of providing individualized care and constitutes ‘therapeutic misconception”. 28

One of the hardest lessons for nurses, in the role of the CRN, is that research is not care.13

There is a need for coordinators to distinguish between research and care however

prioritizing the goals of research over the best therapeutic outcome for individual

participants is difficult.13

Clinical research coordinators experience role conflict in which

10

their obligations to the patient must be balanced with their obligations to the study sponsor.

For example, coordinators understand that randomization means that subjects may receive a

placebo instead of the active treatment in a clinical trial. As CRNs, nurses are challenged

to reconcile the fundamental understanding that experimental treatments may have adverse

or unanticipated effects, or may have no discernible effect. Patients may express a sense

that the experimental treatments will be beneficial or provide a “last hope” for improved

health outcomes. Coordinators have characterized their positions as generating three

overlapping and sometimes competing ethical responsibilities: patient advocacy, as it

pertains to individual well being, subject advocacy as a participant of the study and study

advocacy relating to compliance with the protocol.26, 29

Nurses must juggle what is

ethically paramount in nursing, the best interest of their patients, with the larger interests of

science and conduct of the trial.

An important part of the CRN’s work in recruiting study subjects is the process of

obtaining informed consent. A consent form has both a legal and ethical function which

sometimes conflict with the practicalities of recruiting individuals to participate in

research. 30

Consent forms have been criticized as lengthy, bureaucratic and difficult to

read. Even when individuals are given sufficient time and encouragement to read a consent

form, many consistently fail to read the entire document. Much attention is paid to the

11

process of informed consent of subjects in clinical trials however, the interaction between

the person soliciting consent and the prospective participant can shape the recruitment

encounter. Huntington & Robinson suggest that ‘a research coordinator’s skill in

generating trust is a factor affecting participation of study subjects that may be unrelated to

the specific risks and benefits of the study at hand.’ 30

In obtaining an individual’s

agreement to participate in a trial, the coordinator must establish a rapport and sense of

trust. The study coordinator must explain the information and interpret the subject’s

responses. The attempt to clarify a subject’s interest in the study may be misinterpreted as

badgering or coercing the patient.30

Being perceived as part of the authority system of the

hospital may allow the CRN to gain additional level of trust and influence and therefore

exert power over the decisional process. The nuances of recruitment are subtle, but require

the close attention of the CRN in research trials.

Clinical trials are designed so that subjects are randomized to different arms of the

study, whether it is an active treatment or a placebo.13

In a care setting, treatments for

patients are not decided in a random fashion. Each case is judged individually; this is what

it means to provide therapeutic care for patients.28

Recent changes in nursing philosophy

see the patient at the center of decision making; maximizing patient participation in a

collaborative environment.31

The essence of ‘patient centered health care’31

is that

12

patients occupy the central, organizing role of the entire health care system and the system

is accessible and is designed to serve them. Patient centered health care is often understood

by what it is not - ‘technology centered, doctor centered, hospital centered, disease

centered. 31

However, in the design and implementation of a scientific clinical trial

attention to individual needs would wreak havoc on experimental design and the validity

and generalizability of studies. In many ways, strict compliance with all aspects of the

research suggests a standardization of nursing practice. Individual nursing judgments about

patient care are replaced with more objective measurements and standardization tools.

Interprofessional relationships in the clinical research setting

CRNs may oversee multiple studies simultaneously and must verify that details of

each study are done according to the protocol. This involves managing significant

paperwork as well as people. It is important that the CRN maintain relationships with

principal investigators and hospital staff involved in different aspects of the trial.

It is acknowledged that physicians have lower levels of involvement in clinical

trials.11

Principal investigators delegate many aspects of the trial to clinical research staff.

Fisher argues that the investigator- coordinator relationship re-inscribes a gendered

hierarchy.11

Investigators in clinical trials are predominantly male with medical degrees, in

contrast to coordinators who are predominantly female nurses.12

Because of the nature of

13

this type of relationship, investigators and coordinators are not equal and the skills and

expertise of the coordinator are subordinated. Often the nurse coordinator will seek to re-

dress the power imbalance by fostering a professional relationship with the principal

investigator.

Primary care nurses, lab and pharmacy staff are often delegated to perform specific

tasks in a clinical trial.1 Treating patients enrolled in a clinical trial may be perceived as

adding to the workload of these departments. Primary care nurses have reported

dissatisfaction with their role in clinical trials, often feeling segregated from research staff

and considered as bystanders in the overall picture.32

In coordinating the care of subjects,

as well as the overall execution of trial protocols, the CRN must establish collegial

relationships with all stakeholders.

In some institutions, clinical research positions are dependent upon the funding that

is associated with robust clinical trial recruitment and enrolment. Clinical trials are often

funded on a cost recovery basis. The funds generated through the clinical trial contracts

offset the wages of the study coordinator, research assistant and other associated costs.

Typically, nurses are not compensated in this way. This situation introduces another

potential ethical concern as coordinators are very aware that the level of recruitment and in

14

some cases, the number of subjects screened, generate income and are tied to the

institution’s ability to fund the department.

.

Figure 1. Balancing commitments in clinical research nursing

Negotiating tensions in the role of clinical research nurse

Patient advocacy is at the center of nursing practice ethos and nurses are committed

CARE RESEARCH

CODE OF

ETHICS

GCP

GUIDELINES

ADVOCACY COMPLIANCE

PATIENT

CENTERED

OUTCOMES

VERIFIABLE

EVIDENCE

15

through their code of ethics to serve patient interests.9,20

The CRN may struggle to

maintain a balance in the commitment to the patient, and in clinical research, the subject.

In addressing the tensions and ethical dilemmas that may arise out of perceived

incongruence, the CRN must reflect on unique ways to manage the conflict (Figure 1).

Fisher & Kalbourgh suggest that altruism is adopted by CRNs as a strategy to handle

various conflicts they experience in a difficult job.12

Understanding their work in altruistic

terms, that they are helping to advance scientific knowledge and developing new treatments

that will benefit patients and societies, may help the coordinator to minimize the conflict

between research and care. CRNs view participation in clinical trials as beneficial because

medical and nursing interactions are much richer due to time spent with patients/subjects,

one on one. 12

Reframing their work in this manner may act as a strategy to manage the

tensions they experience. The linking of altruism and care, however, could alternately be

perceived as further gendering the work, whereby the coordinator’s identity is associated

with a female profession that is undervalued. 11

CRNs are challenged to reconcile the inherent tension between care for the

patient/subject and the potential for benefitting science and society. Being critically

conscious of the tacit nature of these inherent tensions, may help coordinators understand

their roles as complementary with an overall goal of providing safe, ethical patient care.

16

Implications for practice

Nurses must be acknowledged for their work associated with clinical research.

Increasingly, there is a move to formalize the research coordinator role and to establish an

internationally recognized body of research professionals for human subject research. 27

Delineating the various coordinator roles and responsibilities and standardizing

qualifications for the position would ensure high ethical and scientific rigour is met in

conducting each trial.27

Learning on the job and feeling professionally isolated have been

issues raised by nurses in the clinical research role.27,33

Many nurses are not prepared for

the role of CRN. Sessions designed to orient new staff have been dubiously named, “Sink

or Swim: Diving into Clinical Trials,” and may capture the sense of chaos a new

coordinator feels. This underscores the need for advanced education in this domain.

Familiarity with the role and responsibilities, as well as the guiding principles of good

clinical practice, will help the new coordinator negotiate the ethical tensions and balance

the conflicting commitments inherent in clinical research. Nursing education programs

could be adapted to include more specific training related to clinical research.

Nursing administration has a professional responsibility to recognize the

needs for CRNs and provide tools for professional development. Attending research

conferences and other related workshops may serve to create a network for coordinators to

17

feel supported and foster a learning environment. Providing resources in this manner may

allow coordinators to more fully understand the nuances and complexities associated with

clinical research.

Conclusion

Clinical research coordinators are critical to the success of clinical trials. Caring

and advocacy has long been associated with the nursing profession. As professionals,

nurses have a duty to uphold the standard of the profession and provide ethical care in

keeping with the best interests of the patient. The complex and diverse roles of the

registered nurse, as clinical research nurse, pose contradictory commitments to the ethics of

care inherent in nursing and create potential conflicts within the professional identity of

nurses. There is a need for coordinators to distinguish between research and care, however,

prioritizing the goals of research over the best therapeutic outcome for individual

participants is difficult. Nurses must juggle what is ethically paramount in nursing, the best

interest of their patients, with the larger interests of science and conduct of the trial.

Familiarity with the role and responsibilities, as well as continuing education on the

guiding principles of good clinical practice, will help the new coordinator negotiate the

ethical tensions and balance the conflicting commitments inherent in clinical research.

18

Acknowledgements

The author would like to acknowledge Dr. Kim Bergeron for her support.

Conflict of Interest

The author declares no conflicts of interest.

Funding

The author received no funding from any agency.

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