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Mark Donald C. Renosa, DNS, RN, Research Institute for Tropical Medicine
Keywords: ethical caring, clinical research, A personal communication of one of the Review of Literature
nursing, caring researchers colleagues extends the clamor on The continuing need for nursing science to
finding authentic caring experience on clinical personalize care towards varied aspects suggests
Introduction research. the utilization of research to validate, revalidate,
Clinical research nursing practice is unknown and invalidate ways to remain fluid on its progress
There are times when I begin to doubt and
to most practitioners in the world. Generally, the as a discipline and profession (Richardson, 2005).
forget that I am still a nurse, vowed to give
role of clinical research nurses is geared towards The thriving developments brought about by
care and comfort to the sick. Every time I am
production of new treatments or regimens for the nursing research have faceted a myriad of issues
attending to my human subjects, there are
management of past, present, and future and concerns in the past and in the present.
times that I am viewing them as piece[s] of
illnesses, paving the way for the improvement of Notable and significant changes have occurred
information I need just to complete the
overall quality of life. Clinical research nurses are because of the utilization of this evidence-based
research protocol. How can I find caring
accountable to care for human subjects in approach fueling and supporting contemporary
experience in this kind of nursing practice?
research who are at risk and vulnerable to nursing practice (Brim & Schoonover, 2009;
Or should I ask, is there really caring in
adverse events involving biological innovations, Cope, 2003; Prior, Wilkinson, & Neville, 2010;
human experimentation? (N. Gammad,
vaccines, and treatments. This situation brings Profetto-McGrath, Negrin, Hugo, & Smith, 2010).
personal communication, May 14, 2013) Alongside the development of evidence-based
about several issues in clinical research nursing, Notably, there is a dilemma regarding clinical
such as questions in relation to caring in nursing practice, a new lens in its praxis called clinical
research nurses caring insight on human research nursing has flourished and was formally
and compliance to the research protocol. Clinical
subjects and an emerging consensus that defined as a specialty practice of nursing in 2010
research nurses are affected by several queries
involvement of nurses has a negative impact on by the National Institutes of Health (Clinical
along this line; in fact, Elliot (2002) even argued
their caring demeanor that hampers their Research Nursing, 2010). On that end, it emerges
about the serious danger and exploitation of
professional practice. Nurses, then, withdraw from as a new, multidimensional expanded version of
human subjects on issues governing morality and
their caring selves, which in turn closes the the nursing science profession.
care that are dependent solely on research
opportunity for authentic human health However, despite the widespread evidence of
protocols and standards. One important emphasis
experience (Newman, Sime, & Corcoran-Perry, clinical research across the globe, there was no
that emerged was the occurrence of numerous
ethical questions on the use of humans as 1991). Further, the practice becomes more clear definition of the nursing practice until the
subjects for clinical research. problematic when the research design is severely National Institute on Health took the lead to
Seen in this way, I recollect my experience robust because the range of caring is restricted, increase awareness and created a certification
serving in clinical research on vaccine production unbinding the provision of safe and quality process for clinical research (Hastings, 2009). As
and supports the belief that this nursing practice practice, which leads to the separation of the vibrantly cited by Gordon (2008), Scottish
creates a complex scenario of caring bounded by dichotomy of research and nursing. This Executive (2005) elucidated the difference
research protocol. Beyond the idea of clinical highlights a clear spectrum of ethical dilemmas between nurse researchers and clinical research
research in utilitarian perspective, the researcher between the dichotomy of research and nursing nurses. The former are engaged in developing
has been pressed several times to respond to as caring. their own research questions and so do not
unwavering ontological and epistemological This, then, may impose a recurrent inquiry on necessarily need to work in a research-oriented
queries: How can we express our caring to how to address a wide range of ethical issues on milieu, as long as their purpose is to acquire new
human subjects during actual experimentation? human experimentation, on how to observe the knowledge for patient care or practice provision,
How is ethical caring translated in the clinical ethical guidelines on its practice, and on the whereas clinical research nurses are moved
research process? How is ethical caring known importance of adhering to ethics of caring in towards helping to develop new drugs, treatment
in clinical research nursing? and Are clinical clinical research. One must take a brave step to regimens, and caring pathways for patients in
research nurses equally emphatic in the treatment reflect on the current picture vis-a-vis real-life general as data collectors and safety experts
of human subjects? On that note, What, then, experiences of practicing clinical research nurses. meeting the legal requirements as outlined by the
is the essence of ethical caring in clinical research These concerns guided the researcher: amidst International Committee for Harmonisation of
nursing? the glamour of evidence-based research, ethical Good Clinical Practice (1996).
The actual title given to those nurses greater good of future generations, based on the document that guides research involving human
practicing in a clinical research can create assumption that the society has equal access to subjects (Rid & Schmidt, 2010). It has had
confusion as it has different variationsfor societal goods (Mill, 2004). At some point profound influence on the International
example, clinical trial nurse, study nurse, scientists were so fascinated with the idea of Harmonisation on Good Clinical Practice (1996)
and research assistantmaking it problematic omnipotence that they tended to disregard the and several accepted ways to conduct clinical
whether or not to use a title globally (Catania, integrity and value of human life. Gaw (2012) research to date. Good clinical practice requires
2012). With this, a generic title for nurses serving reconstructs an article on Beecher and each clinical research protocol to be examined by
many principal investigators (or becoming Pappworths collaborative articles and books on an accredited institutional ethical committee prior
principal investigators themselves) in producing contemporary research ethics. These two to the start to affirm its scientific proceedings. It
biological treatment modalities and caring prominent people were considered the also tackles the thoroughness of record handling
pathways and vaccines for quality of life has whistleblowers in research ethics of the 20th and keeping and the process of informed consent,
emerged and been made known to the public as century. Among the several controversial studies besides human subjects safety (Sweatman,
clinical research nurse (Grady & Edgerly, 2009; that became known to the public were Nazi 2003). In principle, all governing regulations
Hastings, 2009; Royal College of Nursing, 1998). experiments and the Tuskegee Syphilis Study, released boil down to the protection of human
Nevertheless, the clinical research nurse can which, in turn, changed the entire history of subjects.
assume a principal investigator role in research. With the shared weight on safety and
pharmaceutical clinical research only if a Gomes (2010) expounded on his paper that efficiency in clinical research, the anxiety imposed
physician is listed as a subinvestigator (Catania, Nazi experiments were conducted in on all scientists, including clinical research
2012). concentration camps that included freezing nurses, in assuming a safeguard role in the
With this, emergence of the model of care has victims for hypothermia research, testing potable context of an evidence-based milieu needs to be
clarified the nursing care delivery by bringing seawater on gypsies, high-altitude simulation underlined. To put this in perspective, Catania
foundations of clinical actions but has not tests to benefit pilots, and finding cures for war (2012) explored nurses role in safety reporting,
necessarily shed light on on the clinical research wounds. There was a global contention that these which includes (a) detection of adverse events,
nurses ethical caring dilemmas (International experiments abandoned ethics, and they were (b) assessment of adverse events, (c)
Association of Clinical Research Nursing, 2010). considered bad science. The Nuremberg code documentation and recording of adverse events,
The setting of clinical research nursing is well became the landmark document following the and (d) adverse events reporting, alongside their
represented in the nursing literature; however; Nazi experiments outburst in 1947. It primarily usual functions of obtaining informed consent,
there is absent a union of constructs that could be highlights investigators responsibilities in putting determining participant eligibility, gathering
valuable to contemporary caring and the era of utmost importance on human subjects rights. information on serious adverse events, and
innovation. Voluntary consent, the weight of benefits over monitoring human subjects. Nonetheless, it is
risks, and right to withdraw without repercussions also emphasized that integration and utilization of
Clinical Research Nurses and Their Ethics of are emphasized (Ghooi, 2011). nurses knowledge, experience and skills, and
Practice Meanwhile, a failure of ethics and racism on a sound ethical principles takes precedence.
Clinical research sparks an excitement in grand scale described the Tuskegee Syphilis Clinical research nurses then becomes an integral
nurses, as they are to be involved to something Study, in which 600 Black men from Alabama component in protecting the health status of
novel and exceptional in the production of were enrolled; 399 had syphilis, and were human subjects and maintaining the integrity of
scientific and logical evidence. However, they are deliberately denied proper treatment for syphilis to research data.
faced with many difficulties regarding the use of take a fearless historical account of the nature of
humans to generate knowledge on health and the disease (Gamble, 1997; Rusert, 2009; Walker, Clinical Research Nursing and Its Dilemmas
illness. As cited by Dyal (2001), Charlotte Lewy 2009). The study was supposed to take place for The submission of clinical research to nursing
(1983) stated that using human beings as only 6 months; however, it went on for almost 40 expands many hampering dilemmas. Shields and
research guinea pigs is an ethical dilemma of years. Bozeman, Slade, and Hirsch (2009) Pearn (2007) commented on a fundamental
considerable magnitude. Humans are the considered the study a major ethical calamity, as struggle on the science of altruism or
resources in generating useful knowledge it violated the vulnerability of the population encapsulation of the art of commerce, raising the
constructs in clinical research, and are at risk of because it focused mainly on the poor and call for inducements for voluntary human
exploitation. In this regard, this may cause fear to proposed benefits were not clearly explained. subjects. Most are beyond the adversities of
some nurses that science is valued over human Although standard treatment for syphilis at that nurses, such as the use of electronic data
life. time was available in the market, study subjects capture, subject recruitment, safety, and retention
Because of its diverse field, clinical research were deprived of access to penicillin. Following (Alcabes & Williams, 2002; Kolman et al., 2012).
cannot be compared to clinical practice in this event, the Belmont report was released, Hoglund, Helgesson, & Eriksson (2010)
ethically relevant conduct: it has different goals, highlighting three salient principles: self- explicated the ethical dilemmas experienced by
different methods, and different justifications for determination, beneficence, and justice among Swedish research nurses in their usual daily work.
risk of individuals. In view of clinical research research subjects (Rice, 2008). On this end, Twelve respondents mentioned tensions and the
facets, many studies have been conducted ethical precept on clinical research was highly risk of suffering or harm of the patient. It was then
deliberately utilizing and experimenting humans favored. explored that the rising dilemmas were closely
for the conduct of its science from the 17th Notably, alongside the release of the interwoven with the perceived role of being a
century to the present. The grounding of the idea Nuremberg code and the Belmont report, there nurse, which calls for caring, and being an
of utilitarianism as rationale for clinical research have been evolutions in guidelines released on assistant in a research endeavor. As such,
still provokes debate. This point of view still clinical research; one of the major transitions respondents perceived themselves as alarming
dominates the current practice of clinical occurring in the clinical research field was the invisibleslacking the concepts of
research, pronouncing that society has an development in 1964 of the Declaration of belongingness and ethical competence-building
obligation to participate to experiments for the Helsinki, which is considered the cornerstone opportunities.
To further explore the ethical constructs, Anna, could be possible motivators for clinical research enticing a landscape of discovering new
Hoglund, Eriksson, & Helgesson (2010) continued participation. dimension of authentic human health experience.
their study focusing on the perception of ethical Same motivators were also derived by Kost, It was explicated by Newman, Sime, & Corcoran-
guidelines and their role in ethical competence- Lee, Yessis, Coller, & Henderson (2011) as they Perry (1991) that the absence of caring in a
building among Swedish physicians and research also assessed the participants perception of the certain human health experience is not
nurses. Appallingly, results were espoused as to clinical research experience. Eighty-five considered nursing at all. In this light, the unitary
the overall impression that the ethical guidelines participants and 29 professionals in 12 focus transformative paradigm of Newman et al. was
in practice were invaluable in competence groups perceived that the experience was highly utilized as a lens to help translate an essential
building and might limit the decisional stand on valued because of staff relationships, health component in revealing an in-depth or deeper
ethical dilemmas. In turn, this might disrupt the gains, new knowledge, and compensation. context consistent to the evolving world view, thus
progress of professional research demeanors. Respondents were also satisfied with the submerging oneself in the process of authentic
They recommended a paradigm shift on virtues informed consent process, but felt saddened and creative unfolding of human health
and characters whereby their professional thought about nondisclosure of test results and/or experience. Notwithstanding the unpredictability
processes would be connected through the use of unknown study outcomes. Meanwhile, informed of change that may arise from the human
ethical dialogues. consent procedure was underscored by Mueller & experimentation phenomenon in both the nurse
Meanwhile, Wilkes (2005) investigated nurse Instone (2008) in an ethnographic study providing and the one being nursed, the
researchers views on the appropriateness of insight into how changes in protocol requirements interconnectedness of a diverse field on a unified
actions when conducting clinical research. Nurses and patient health status prompted actions and perspective institutes a sound truth and clear
used myriad frameworks on their decisions, judgment during the conduct of clinical research. concepts for meaning constructs. From such a
including their personalmoral values, nursing These governing issues, nevertheless, view, grounding on human science as
competencies, and research rigor. The findings encompass a full range of phenomena philosophical underpinning creates a bridge to
then stressed the vague impression and encountered by nurses. The inescapably substantial and meaningful expressions of nursing
confusion between the dichotomy of nursing and epistemological and ontological issues progress as caring in a clinical research milieu (Boykin &
research roles. This confusion of nurses roles on the core merit of evidence. The products of Schoenhofer, 2001).
was also studied and confirmed by Spilsbury et al. several erudite inquiries are geared toward a Boykin and Schoenhofer (2001) assume that
(2006), who focused on the scope and their competency-based strategic approach on clinical nursing takes place within nursing situations. The
potential contribution to clinical research. research pathways (Royal College of Nursing, clinical research arena professes complex and
Conformingly, nurses faced dilemmas on the 1998). Such development of competency dynamic interactions in which the nurse should be
transition to the clinical research role. The study rekindled a new hope of optimism among clinical knowledgeable of the authenticity and uniqueness
also revealed heightened challenges associated research nurses, who were agog that there was of experience. Guided by Carpers (1978)
with training and management of their critical still something to be done through concerted fundamental patterns of knowing in nursing, which
roles. On the same note, Fisher & Kalbaugh labors. Several scholarly strategies have included are (a) empirics, (b) aesthetics, (c) personal
(2012) identified how research coordinators a revisit to curricular structure, research capacity, knowledge, and (d) ethics, this may then address
manage role and ethical conflicts within clinical extent of knowledge on ethics, laws, drug the dilemma of viewing the person as a mere
research. A qualitative study combining development and management, wide arrays of piece of information or human guinea pig. The
observations was conducted, resulting in the use analytical processes, and outcome evaluation as idea of knowing the person provides a vivid
of altruism to manage different conflicts the frame of reference in determining clinical pathway to clinical research nurses by essentially
between research and care. research effectiveness and efficiency. bringing together the fundamental patterns yet
On the other hand, Davis, Hull, Grady, Nonetheless, there has still been a premeditated appreciating each priceless encounter, creating a
Wilfond, & Henderson (2002) answered the extent element that is overleapedcaring. It is apparent milieu of interconnectedness and sharing in a
to which research coordinators shape the ethical that because of the zealous pressure to produce lived nursing situation. Nonetheless, it was
conduct on clinical research and how their scientific and logical evidence, the concept of highlighted that in the process of knowing the
multiple roles affect the protection of subjects. caring was clearly compromised and conceded as person, a redirection of dynamism and unfolding
Focus-group discussion was utilized, gaining a burden to clinical research nurses. of nursing practice should be the primary focus,
three critical themes signifying the function of In the review of literature, the researcher not the product itself (Boykin, Parker, &
study coordinators, namely (a) patient, (b) found a blank spot on the lived experiences and Schoenhofer, 1994). Therefore, the theory of
subject, and (c) study advocacies. As this role is aesthetic expressions of clinical research nurses Boykin and Schoenhofers nursing as caring was
in constant transition, any crucial misbalance on on ethical caring. This, then, merits a systematic utilized as a guiding framework attuned in
the triad may cause ethical lapses in the process inquiry, as one may wonder on the relevance of responding to nursing situations in fullness and in
of clinical research, cascading to a low rate of the insights on this phenomenon to worldwide harmony with the one being nursed.
subject participation. This was also concluded in clinical research nursing knowledge development.
the study of Ford et al. (2013), looking at potential Thus, it is the researchers interest to fill in this Method
solutions to this rising concern. Fifty-seven gap in literature through the collection of This study utilized a hermeneutic
African Americans and Latinos were utilized as narratives from the participants to explore this phenomenological approach grounded on
respondents, reflecting several barriers to phenomenon. Heideggers philosophy. This approach assumed
participation. Characteristics of study processes that human beings have myriad perspectives,
involved were highlighted as the topmost concern, Theoretical Framework intrinsic depths, and the ability to create and
and it was recommended that they be reinforced With the academic and stimulating aspect of shape their own experiences, and that truth was
by addressing safety concerns and costs clinical research, utilizing ethical caring as patient- composed of many realities (de Freitas, 2007;
associated with participation. Moreover, centered competency focuses on knowing the Wojnar & Swanson, 2007). Thus, the researcher,
increasing the amount of time spent with the person as a whole (Swanson, 1991) and not as being a clinical research nurse, cocreated the
subjects and building on the sense of altruism pieces of information or guinea pigs, data from the lived experiences of the
participants. Furthermore, the researcher himself caricatures, acrylic paints, in any art, on the informed consent was obtained. All participants
became the research instrument and directed his participants appreciation on the concept of were informed about study purposes and
attention to human realities rather than the ethical caring in the clinical research procedures, and because the study involved only
concrete realities of objects (Polit & Beck, 2010), practice. After the completion of the art, the collection of information, there were no
which created a symphony of meanings and researcher let the participants express their anticipated risks for involvement.
understandings (Wojnar & Swanson, 2007). thoughts, to give voice to the lived Transcripts were destroyed after the data
experiences in an ethically caring analysis. A master list of participants names and
Data Collection community. Through art, participants code numbers was kept in a locked cabinet in the
Selection of participants was facilitated expressed ideas and feelings that they event that a participant needed to be contacted
through purposive sampling, which included 10 could not express otherwise. for further information or scheduled for a follow-up
clinical research nurses (age range 2426 years; interview. The researcher secured confidentiality
7 females and 3 males, respectively) who (a) Data Analysis of gathered data by deleting all the transcriptions
were employed at the Research Institute for This study utilized the methods of van Manen and field notes used in the study.
Tropical Medicine, Philippines (excluding those on (1990) for textual features of the qualitative report
satellite sites); (b) had 2 years or more clinical and incorporated Diekelmann, Allen, & Tanners Results
research experiences; (c) were willing to give (1989) seven-step method of textual analysis to Entering into the deepest-lying meanings of
informed consent; (d) were knowledgeable in help build a meaning-making process and ethical caring, the participants imparted their
speaking English or Filipino, as because reflective awareness of the phenomenon being different points of view on their significant lived
qualitative research is primarily concerned with studied, each of which was based on experiences and aesthetic expressions on clinical
making meanings out of the data gathered (Polit Heideggerian philosophy. Narratives were research nursing. Upon careful observations and
& Beck, 2008), a common vocabulary between translated and analyzed. Words, phrases, and analysis of meanings, three essential themes
the researcher and the participants is essential to statements that described the lived experiences emerged: (a) cocreation of knowing, (b)
acquire a full understanding of the phenomenon of clinical research nurses and those that cocreation of doing, and (c) cocreation of valuing,
to be studied; and (e) were willing to share their appeared to be edifying were identified and with nine subthemes (Table 1). At the end, lived
experiences through art and narration, which highlighted. This was done using van Manens experiences and aesthetic expressions of clinical
would come from the interviews to be utilized as (1990) selective reading approach, where research nurses on ethical caring were described
means of collecting data. Ten participants meanings are formulated from the significant
and interpreted as the knowingdoingvaluing
saturated the data. statements. These meanings were isolated, thus
as systems of cocreations phenomenon.
The study utilized three procedures for data forming themes reflecting Clinical Research
gathering: Nurses experiences. This study also adhered to
Theme 1: Cocreation of Knowing
1. A semistructured interview was utilized that Lincoln and Gubas (1985) criteria in establishing
rigor, which included credibility, transferability, Over the years, nurses gradually moved from
involved predetermined open-ended
dependability, and confirmability. hospitals to clinical research practice and were
questions that allowed spontaneous, in-
Following the formation of themes, the highest tasked with the responsibility of caring for human
depth responses and richness of content
level of hermeneutical analysis, which was the subjects, puzzled and unprepared. As clinical
with approximately 2030-minute or longer
search for constitutive patterns, was conducted. research nurses went into a different and
sessions as permitted and as deemed
necessary. The interview was audiotaped This involved reading each whole interview again, unrecognized practice of nursing, they
using a high-quality tape recorder. The which projected the global perspective of the distinguished the importance of using their
researcher translated all recorded stories while cascading the linkage between education and valued self to guide their actions
information verbatim after every interview. relational themes that existed in all transcriptions. within the clinical research setting. Watson &
The researcher followed the preparation In this way, both the researcher and the Smith (2002), as cited by Bailey (2009), distinctly
and transcription protocol and principles participants journeyed to the core of the postulated that as caring professionals, nurses
based on McLellan, MacQueen, & Neideg phenomenon through constant dialogue. The have to embrace multiple ways of knowing to
(2003). researcher enhanced the interpretation through understand the conglomeration of arts,
2. Field notes were also utilized during each the use of other relevant text and aesthetic humanities, and clinical sciences, that is, being
encounter that recorded gathered expressions. At the end, an eidetic insight, which becoming, evolvingethical, intuitive, personal,
narrations and nonverbal cues, which were was rich in description and interpretation, was empirical, aesthetic, and even metaphysical/
relevant in the study. Because there is a used to enmesh varied layers of meaning on the spiritual ways of knowing and becoming.
danger of either forgetting important experiences. In this case, a germinal theory was Therefore, the link between clinical research
observations or possible manipulation (Polit constructed. nursing and ethical caring is through the process
& Beck, 2008), notes were then written of knowing the personal experience and the
down as soon as important information Ethical Considerations process of acquiring meanings in the whole
manifested to preserve the purity and The clinical research division chief of the clinical research experience.
essence of the information. Research Institute for Tropical Medicine approved
3. Finally, the researcher encouraged this study under an expedited ethical review Art of Unknowing. In every ethical caring act in
participants to explore their experiences procedure. Research protocols and other related clinical research, it can be argued that there
through their own choice of aesthetic procedures and policies of the institution were exists a spectrum of unknowing to a virtue of
expressions. An emphasis was made that properly observed during the course of data knowing within the process of cocreation.
steps can be employed through many collection. Participants who met the criteria were Unknowing has been identified by Mulhall (1993),
subtle choices in creation of aesthetic given a brief description of what would happen to as cited by Heath (1998) and Zander (2007), as
expression, be it in poetic language, ease initial apprehension and anxiety; they were the fifth pattern of knowing and deeply interrelated
musical symphony, painting, photograph, informed of the purpose of the study, and to personal knowing. Unknowing is the nurses
focus becomes not just on cognition but on caring through the spirit of the art of knowing. R-007: Actually, I was thinking that maybe
adapting and enhancing the research praxis. Clinical research nurses may be wounded with there should be . . . what do you call that?
Clinical research nurses become aware of nursing pain over the unrecognized path, but finding the Specialization of nurses or [they] should
situations and draw the dimension of learning with purpose and realizing the ethical caring and have a special subject in school. For even
ones working practice. The subtheme became authentic human health experience shared all the nurses would have an idea of being
evident with responses of the participants: eventually triggers the enhancement and clinical research nurse[s].
R-009: Sometimes we need to change those refinement of their nursing knowingmaking it a Clinical research praxis and human subjects
practices we have as nurses. So sometimes research-as-praxis geared on thoughtful reflection are both demanding greater levels of
even if we know the things to be done, we that allows world-transforming acts. personalization of the experience and placing
need to consult it first so and so. So there, nursing under increasing press As cited by Dyal
we need to live by the protocol. That even if Situated cognition. On a clearer lens, one ure to cocreate meanings with them. When a
we knew the right thing but since its not element flourished and took the limelight above clinical research nurse begins to question the
what protocol is saying, you are not allowed the two subthemes, which was their positive view nursing situation, one should go beyond this
[to do] it. on the profession that, despite the notable reflectiveexpressive inquiry utilizing a
Clinical research nurses portrayed the reality struggles, still they opt to stay to the ethical caring systematized body of knowledge, the knowing
of ethical caring on the norms of our capacity to side of the research praxis. In this case, situated embodied to potential attributes in empowering
accept and enhance the different nursing cognition was knowing the practice and being the vulnerable subjects for their fullest potentials
situations. Additionally, knowledge in nursing can able to aspire for continuous improvement, towards cocreation and transformation. This will
be found on nursing situations (Boykin & supporting Germanas (2007) argument that in then be essential to the ethical caring journey, and
Schoenhofer, 2001) and in this case, on clinical order to gain intimate relationships, one must with that, an authentic human health experience
research praxis. What the research praxis needs grasp order and chase for spontaneous changes. will be expressed and achieved. With this goal,
more than brilliant minds is flexible clinical Clinical research nurses willingness to the knowing domain for clinical research nursing
research nurses who can bend to emerging ethical caring blossoms through the grounding of
unknow and know the clinical research praxis
standards and to various human subjects with the unitarytransformative paradigm. Knowing the
through experience, learning, and understanding
whom they deal every day. Flexibility enhances clinical research through the cocreation of
commences the unfolding of meanings that
nurses ability to be reflective and finds workable meanings with their personal caring dimension
establishes the ethical caring domain. Yet, as
solutions to situations (Gustafsson, Asp, & shapes and sustains the nursing as ethical caring.
more knowledge becomes known, hopes,
Fagerberg, 2008). Clinical research requires a Newman et al. (1991) translated it as an essential
appreciation, and changes occur. Mayeroff
wider range of reflection through moral courage of component in revealing an in-depth context
(1971), as cited by Schoenhofer (2002),
shifting and enhancing the language of nursing consistent to the evolving worldview, thus
postulated that hope and commitment are strong
theories. In fact, OCallaghan (2005) strongly submerging oneself in the process of authentic
components of caring. This is true with the and creative unfolding of human health
affirmed that reflection allows the person to
participants accounts of a handful promise of experience. It was an uneasy path for the clinical
understand and translate meanings that contradict
hope that continuously shed meanings on their research nurses to cocreate meanings with
theory and practice. Clinical research nursings
essential ethical care does not change; what whole ethical caring experience. human subjects, and for the whole clinical
changes is how nursing fulfills its caring role. In R-002: Its not expanding today but I believe research nursing practice as there was no
turn, this enables the clinical research nurses to its starting to escalate now, my feeling [is existing knowledge to validate and balance their
have heightened awareness of the depth and that a] few years from now more expansion praxis. Knowing the ideologies of the clinical
intricacies of nursing knowledge. of clinical research nursing will happen. research praxis was just a fundamental step to
Participant R-008 expressed through an oil- R-003: If youll think of looking forward, this achieve ethical caring in the profession.
pastel artwork that whereas ethical caring is an investigational product once approved will The cocreation of knowing described by the
abstract, it is also a process, that caring varies in have an impact to the future of the children clinical research nurses was based on meanings
the moment and develops over time. Through and many people will receive its benefits. clearly achieved through valued time. Sufficing
acquisition of knowledge, experience, and More so, the prevention of the diseases and the unpredictability of change that may arise from
competence one may continuously grow as an its eradication. the clinical research phenomenon of both the
ethical carer in a research-oriented milieu. Because of their appreciation of the researchs nurse and the one being nursed, the
Learning through experience in clinical meaning, clinical research nurses become fully interconnectedness of diverse fields on a unified
research nursing, regardless of the meaning of an engaged in their practice and can suggest an perspective institutes a sound truth and clear
individuals (the nurses) experience, speaks of awakening and innovation of a unique nursing concepts for the model of care.
applicability. It is an ethical and professional knowledge (Billay, Myrick, Luhanga, & Younge,
responsibility of nurses to utilize the knowledge of 2007). Also, the study of Scott, White, Johnson, & Theme 2: Cocreation of Doing
their discipline; however, there is a continuous Roydhouse (2012) suggests that clinical research Equally important, aside from the cocreation of
growth of inquiry in clinical research nursing, nurses should have a broad range of knowledge knowing through meanings, the participants also
which emphasizes greater attention to the and skills relating to clinical research in order to shared their research actions and processes to
synthesis of its knowledge development. Clinical deeply conduct their roles. Innovation is apparent achieve the full meaning of the ethical caring
research nurses are able to fully understand the in the transcriptions below, as participants domain in clinical research nursing. One takes the
unique situation and plan interventions within the recommended the need to have a solid dramatic shifts on trying to nurture the doing
therapeutic milieu (Bonis, 2009). Yet they foundation on an undergraduate degree in intentionality of the nursing milieu. Schoenhofer
continue to grapple on how to sustain such nursing: (2002) depicted intentionality as formed through
enhancement in day-to-day practice and its R-006: Since little was known about it, it structuring meaning: as clinical research nurses
particular contexts. Clinical research nurses put creates a problem. Better if there would be a enter into the profession, they are fueled with the
so much emphasis on the development of ethical field, or like training or [a] subject in school. simple intent of commitment that grows and
flourishes in living nursing as ethical caring. fullest account of ethical care to human subjects, processes, commitment, and resilience and much
Participants shared their experiences on adapting making them feel frustrated and disappointed. time beyond the normal working hours to promote
to new paradigms in the clinical research arena Participants recounted: caring while at the same time undertaking the
and how they managed to take into work R-007: At first, its good but sometimes standard procedures research entails (Higgins et
demands that eventually unfolded cocreation of seems like becoming negative. Sometimes al., 2010). Commitment was explored by Trigg
research innovations and processes. you have to do this because it is in the (1973), as cited by Boykin and Schoenhofer
Challenges to the research process. Clinical protocol even if its against your will. (2001), that this presupposes certain beliefs and
research is a complex activity. Because of its R-004: Seems that you are not really also involves a personal dedication to the actions
complexity, clinical research nurses become functioning as a nurse, its like what you implied by them. These beliefs and this
vulnerable. Transcripts mentioned the difficulties want to do would not be possible because dedication were regarded as moral obligations
clinical research nurses may face in rendering its not written in the protocol. important in the practice of clinical research
care to human subjects enclosed in a restricted Participant R-007 even emphasized in her nursing. It was noted that by feeling, knowing, and
research environment. As they continued to know colored-pastel sketch her experience of being believing, nurses may exhibit both theoretical
the research dynamics, they were caught in a taken away by research protocol and becoming ethical knowledge and moral action knowledge
situation that tried their decision-making skills. cold-blooded in doing the clinical research (Sarvimaki, 1995, as cited by Cronqvist, Theorell,
Doing clinical research is such an avenue for process: Burns, & Lutzen, 2004). By expressing their
clinical research nurses to uphold the knowledge R-007: A nurse should be caring. awareness and reflection on the research
gained through the ways of knowing. However, Sometimes it seems that what Im doing is spectrum, they provided a clear view of balancing
weighing the goals of clinical research over the not in my heart. Thats it. There are times their moral obligations and work responsibilities.
human subjects condition becomes problematic that it seems like you have to do it just to The participants regarded their different roles and
(Fisher & Kalbaugh, 2012). Participants vividly finish the day or to just simply do it . . . well, I responsibilities as priceless ethical acts anchored
recounted the care given to human subjects in a was thinking of several things to be done through commitment by maintaining the
restricted environment: after vaccination . . . I was like a robot, just ideologies of clinical research experience. They
R-005: Its like, in clinical research, you just doing it but with a half heart. conveyed:
need to do, what [you ought] to do. Participant R-007 was weeping the entire R-009: You can see sometimes the need to
R-007: I am so afraid to make [a] mistake, of session, describing that clinical research made work more than the required hours . . .
course you will be scolded by your superior, her a half human in the beginning. The struggles sometimes you have to go on . . . weekends,
if its not in the protocol then that can be a to provide the best and valued care come from holidays because there are deadlines to
deviation. finding what is right for human subjects anchored meet.
R-004: So its like youre thinking of the through the love of nursing. This was supported On the other hand, R-003 also shared that in
safety of the patient and you want to do this, by Watson (2003), as she declared that it is our order to achieve the fullest ethical care to human
but because the protocol says none, its not humanity that both wounds us and heals us, and subjects, one should take seriously the
possible. those whom we serve; and in the end it is only documentation process:
R-009: Since this is [a] clinical research love that matters. This is done by maintaining R-003: You need to be vigilant in all your
setting, you have to follow what the protocol the symbiosis of caring and research. It was doings, the documentation should be
is telling you . . . Just like that. further strengthened that the development of the detailed and should be accurate. Because
It was clearly explicated that clinical research capacity to care and doing the significance of we are dealing with lives of people under
nurses were faced with ethical dilemmas and ethical care will be attained in a particular time, research.
claimed to have protocol-centered nursing care. within a particular frame of reference, and within As the findings imply, the sagacity of social
Hoglund et al. (2010) clearly discussed that there the specific context of its defined role of service in accountability was evidently upheld and endowed
exists a tension between clinical research nurses praxis. with a promising level of ethical demeanor.
responsibility towards the research and Clinical research nurses were empowered to
responsibility towards the human subject Compassionate commitment on research make a difference, to hold themselves and others
involved. A conflict of interest between the need spectrums. Ethical challenges have important to account, and to decide how their ways of doing
for the study results and doing no harm to human implications for clinical research nurses daily could enhance ethical care. There appeared to be
subjects highlights the ethical dilemma. Further, practice. It is good to note that clinical research an underlying assumption here that altruism
they argued that this dilemma is rooted in the nurses urge that ways be found to promote ethical towards human subjects on the part of clinical
premise of the perceived role conflict of being a development that goes beyond the research research nurses is necessary. Jansen (2009)
nurse providing the possible best care with that of protocol to a more personalized, person-centered argued that altruism and clinical research are
being an assistant in the research study. practice. In response to these challenges, clinical exposed to ethical complexities. It was
Matsumoto, Nagamura, Ogami, Yamashita, & research nurses were stimulated to reflect championed that the mere possibility that
Kamibeppu (2011) also confirmed through their critically and creatively on their work in relation to someone did not expose human subjects to risks
study on nursing staff involved in oncology clinical human subjects well-being. This can be or harm justified the practice as caring. However,
research that the most common difficulty confirmed through participant R-005 0 s narration; altruism was sometimes used in different way, a
expressed by respondents is caring for subjects she cited an example on how to achieve ethical negative manner. This is true with the findings of
throughout the entire clinical research process. caring beyond clinical research protocol: Fisher and Kalbaugh (2012) in which a context of
They were expected to have a border role; R-005: Like how to correct the deviation, selfish altruism was described. Sometimes
however, it was identified that nurses had how to handle those mistakes, how will you clinical research coordinators were shaped
negative attitudes towards the work because of avoid it and not . . . cause more serious differently by the ethical complexities, as they
the notable unique challenges. Because of the issue[s] or damage. tend to create moral pressure on human subjects
nature of clinical research protocols, clinical Clinical research nursing, therefore, involves a just to adhere to research protocolthat the
research nurses were restricted in rendering the wider range of understanding on research interest was not focused on human subjects but
on maintaining professional nursing identity. subjects needs. The concept of doing appears to process highlights the inconsistencies between
Giuffra (2013), on the other hand, rebutted that provide a potentially useful construct to describe care and research protocol and prompts the
the nursing was not a military profession that is the attributes clinical research nurses went clinical research nurses to propose changes to
programmed to deal with a war. Altruism is the through after knowing the ideologies of clinical meet human subjects needs. By embedding the
heart of the storythat the values we live in and research. In that context, cocreations of doing challenges and objectivity of clinical research,
espouse should be reexamined and reshaped. then is defined herewith as clinical research compassionate recruitment as a second facet of
Henceforth, always putting human subjects safety nurses ways of innovating and enhancing the ethical caring as doing may then be expressed.
above the research protocol makes it mandatory nursing as ethical caring through research Clinical research illustrates an ethical breadth
for ethical caring. processes. This has to be understood as an concerning human participation and highlights the
iterative process involving the construction and growing awareness of the many factors that can
Human subjects safety. Clinical research nursing deconstruction of experience. This emphasizes impact an individual or communitys research
to date has not yet fully proven its worth and the premise that clinical research nurses should experience. In fact, several studies show the
dignity to the world. It may not be recognized as practice ethical caring as doing in accord with protection of human subjects continuously to fall
one of the leading advanced practices in nursing; what they wanted to do for themselves under short in clinical research (Iacona & Carling-
still, it uniquely provides care to all human research protocol circumstances. The ethical gap Jenkins, 2012; Shepherd & Riley, 2012). In order
subjects in various settings regardless of creed, on human subjects will be filled through to enable clinical research nurses to articulate a
beliefs, or cultural perspectives. Participants competence and skillful innovation of research research environment that is comforting, the
highlighted that maintaining safety is a processes; in that way, the clinical research monitoring of human subjects should be reshaped
supplementary way of rendering ethical caring to practice will be anticipatory, comforting, and re-empowered, which is considered the third
human subjects: protecting, and preserving (Swanson, 1999, as facet in doing. Thomas (2004) particularly
R-008: The root of clinical trial[s] is good cited by Bailey, 2009). stressed that safety in research is imperative
clinical practice, which is geared on human Conversely, Roachs (1984) attributes of because it is not usually part of the standard care
subjects safety. So it is a must that ethical professional caring seemed to address the because participation is highly voluntary. The
caring be based on safety of the patient. evolving trend, synchronizing the concept of nurse must always be aware of the risks involved
R-007: All patients should be safe. Its knowing and doing in clinical research. As noted, and should extend an arm on familiarizing
difficult to have mistake[s]. they included (a) compassion, (b) competence, guidelines and regulations that pertains to human
Participants portrayed the need to create an (c) confidence, (d) conscience, (e) commitment, subjects protection. It is then argued that
environment that optimizes the role of clinical and (f) comportment as components of because of the complexities of the research
research nurses to engage in value-based professional practice, and in that way appreciation environment, clinical research nurses should
procurement for the human subjects rather than of the preciousness of the human subject through modify their usual nursing actions, aligning to
focusing on research protocol; they could thus these acts, although bounded by research research protocol to meet the needs of the
spend time on patient education, prepare for care protocol, projects a coherent approach in institution, the nursing self, and the human
coordination, and increase their interaction with illuminating phenomenon within a restricted but subject.
subjects, thus increasing the cocreation of doing coherent milieu. As such, the doing processes go The sustained commitment to transform the
of the nurse and the one being nursed. Participant through systematized facets of meaning and whole research process enables clinical research
R-002 reemphasized: nursing process development. These then are nurses to provide health-promoting interventions
R-002: By means of safety follow-up, those translated into more specific and innovated acts to maintain human subjects health, free from
surveillance, because here in clinical of doing as ethical caring. adverse events and reactions to investigational
research, surveillance sometimes is the The doing process in ethical caring starts with products. A key learning is about how to do it in
heart, those safety follow-ups, that is the innovative planning. Having explored the an ethical waydealing sensitively with human
heart of the work. If they are sick, you need importance of knowing in ethical caring, clinical subjects, engaging in activities for subjects
to ensure theyre safe. research nurses assume a planning role that safety, and staying involved with safety decisions.
It was clearly raised by Oberle & Allen (2006) should mirror clinical practice. Before they can These symbolic acts of doing bridge nurses being
that clinical research nurses are faced with even start extending their ethical caring skills, and becoming with human subjects, allowing for
methodological issues and notions of ethical clinical research nurses begin as unknowers, goodness and hope in valuing the experience
precepts within the context of moral obligations. striving to unclothe the domain of clinical research (Arman & Rehnsfeldt, 2007). The experiences of
As perceived, clinical research nurses are taught and eventually extend their knowledge in clinical research nurses here strengthen the need
to offer therapeutic presence to human subjects; trainings, meetings, and review of research to appreciate and recognize the context of the
however, these are not taken into fullest protocol. On that end, clinical research nurses clinical research praxis.
consideration in the protocol design. The moral may find solutions that impede their delivery of In this view, a doing responsibility and
dilemma begins when a nurse is conflicted on care. inclination towards ethical care will avoid mistrust
choices between contravening the research The quality of ethical care that they provide issues with human subjects. The parties, nurse
protocol and following the professional obligation begins by transforming and making a difference in and human subject, will authentically grow in their
to do good (beneficence) and to do no harm themselves as nurses. Upholding the nursing clinical research experience if they understand
(nonmaleficence). This could be a very difficult values of compassion, clinical research nurses the value of their humanness. Their value must be
dilemma for a nurse. It is significant to note, then, may journey with human subjects in highlighting engaged with their role of protecting each other
that scientific advancement potentially creates a the authentic human health experience without from pain and danger brought by clinical research
moral distress to clinical research nurses. violating the research protocol. Clinical research activities. Yarborough (2009) pointed out the
For these reasons, the doing ethical caring nurses then should act as ethical doers in importance of creating a culture of safety and of
concept provides a parallel avenue to realign ensuring and understanding the rights and developing accountability practices in the
actions of clinical research nurses necessary to responsibilities of human subjects and preventing research enterprise to enhance trustworthiness. If
override some research instances to meet human them from coercion and misinformation. The human subjects perceive that they are ethically
Table 2
Reengineered Concepts of Doing Facets in Clinical Research Nursing
Facet Definition
Creative collaboration The nurse and human subject perceive the experience as authentic, leading to cocreation of
processes, the highest facet of doing.
Human subject retention The ability of clinical research nurses to minimize dropouts in human experimentation.
Monitoring human subjects The ability to respond to the need of human subjects.
Compassionate recruitment By merging the compassionate domain with research, clinical research nurses take into account the
vulnerability of human subjects, thus having a sound ethical consideration in enrolling in clinical research.
Innovative planning Clinical research nurses provide a platform of restricted but coherent plans anchored with knowing to
ignite the authentic health experience.
cared for, then minimal human subject dropout practice, valuing must be sensitive enough to R-002: You are following them up through
will be experienced and the fourth facet of doing bridge the gap of research and nursing and be phone calls, you are conducting health
will be attuned, which is human subject retention. explored on its unique ethical constructs. teaching to them, like I felt that health
The reengineered facets of doing (Table 2) teachings is the best way caring is being
offer a transformative shift in contemporary Creative unfolding moment by moment. It was delivered.
nursing practice, particularly focusing on the found out that clinical research nurses are This only proved that regardless of struggles
newer paradigm that includes the view of the genuinely concerned about the extension of their that clinical research nurses faced in the clinical
human subject as a whole person and as a ethical caring hands, and that they want to research field, still they could wholeheartedly
cocreator in valuing and finding meaning in the address the existing conditions that hamper their look for caring values to achieve the
experience. Through the integration of these delivery of ethical care. It was proved that transmission of authentic human health
forms of reengineered knowledge, clinical whenever nurses choose to practice the experience to human subjects. The nurses
research nurses can expand a unique moral profession, whether its in academe, hospitals, choice to say yes to the gift of nurturing and
quandry and can make a meaningful contribution community health facilities, or specialized enhancing personhood for herself and for human
to the realm of ethics and nursing science in research settings isnt what matters mostits the subjects proves its roots in nursing as caring
cocreating authentic human health experience; identity they build. Boykin and Schoenhofer (Schoenhofer, 2002). Clinical research nurses
creative collaboration will exist on its end. (2001) expressed that caring is lived moment to are continuously upgrading their skills, which
focus not only on clinical knowledge but on the
moment and is continuously unfolding. This is
Theme 3: Cocreation of Valuing level of extending ethical care to human
factual to clinical research nursing as the
Ranheim (2009) explicated that all caring subjects. The preparation set forth opens new
development of ethical caring occurs and
meanings are intertwined, interrelated, and doors for these clinical research nurses to
develops over time. Developing the fullest
inseparable and that they exist in dynamic contribute innovations. Little by little, this act of
potential for the expression of self as caring
movement. Our being affects caring and caring caring creates a scenario where one can
person is dominant in this field of nursing practice.
affects our being. A synthesis can be drawn then experience nursing as caring, intentional and
It was further confirmed as an interesting and authentic, in a highly controlled environment
that there is a clear correlation of knowing to
somewhat fundamental liberation of ethical care in (Boykin and Schoenhofer, 2001).
doing and of doing to valuing, and that they can
clinical research: Creative unfolding is really happening and
all move in the same direction. Given the clear
ethical obligation, nursing as valuing should be R-009: So, technically, as a nurse, what I am caring moments are inherent and embodied
thoroughly integrated in clinical research doing, since the protocol was saying that we through clinical research nurses intentionality. A
practice. The cocreations of knowing, doing, and are allowed to advise. There. So I think, shared intentionality is cocreated within the
valuing may lead to the development of a through advice, we can render caring to our human subjects as clinical research nurses enter
responsive ethical caring culture in the clinical patients even if they are our subjects. into their lives and come to know them as caring
research field. R-010: Ahh . . . when I am calling then to persons in that way, growing and living in nursing
When reflecting upon their experiences, the ask if they are feeling good every 2 weeks, if as caring unfolds (Boykin & Schoenhofer, 2001).
respondents related knowing and doing in their they are experiencing any sickness and I am These then reflect that being part and parcel of
caring activities. The meanings, innovations, and also asking if what happened to them. So building a culture of safe and service excellence
processes gained through experiential thats [it]. in human subject care is now one of the highest
knowledge enabled them to create an inner It was highlighted through participants priority domains that should looked into.
space of freedom in which they could choose to narratives that as nurses by soul, they still
provide ethically right decisions and even managed to find priceless moments of connection Shared humanity. Fagerstrom (2006), as cited by
respond effectively to the needs of human with human subjects through their valuable caring Rundqvist, Sivonen, & Delmar (2011), discussed
subjects treating them as whole and complete. values. Participants shared their little ways of that nurses are confronted with the dilemma of
To further allow such grounding and to translate rendering nursing care despite the stringent deciding to be good or bad because of the
the real impact of knowing and doing in the research protocol: several ethical issues that arises in the
General Discussion
In this light, the process that clinical research
nurses undergo as they take on the challenge of
rendering ethical care towards human subjects in
caring in the practice. Understanding oneself as a a restricted research environment may be
human being may influence how people described and interpreted through this emerging
germinal theory (Figure 1). These connecting
understand, grow, and nurture in the world
(Boykin & Schoenhofer, 2001). The art depicted
Aesthetic Expression 6
that knowing the value of clinical research and
taking hold of nurses humanity creates a diffusion R-004: Be the Change
of research and care. As a result, ethical caring
emerges.
Meanwhile, participant R-003 explicated,
through the medium of colored pastels, that
ethical caring was based on the concept of
knowing all the guidelines and standard operating
procedures of the research protocol. Clinical
research nurses may struggle in finding the best
avenue to render care to human subjects; still, the
participant perceived that rendering ethical care
may be successfully achieved if one may continue
to fill in those gaps of knowledge in clinical
research. The participant clearly espoused that a
clinical research nurse may render
unquestionable ethical care if one is competent
enough and values taking the road less traveled
(Carper, 1978).
Further, participant R-004 supported ethical
caring through becoming the change agent the
society needs. It was clearly explained, through
colored pastels, that clinical research nurses
really work hard to fill those caring gaps in clinical
unifying the dichotomy of research and ethical protocol-driven environment. Because the York, NY: Jones & Bartlett, National League
caring. The practical significance of this demands in human research are changing, the for Nursing Press.
foundation is aligned to the nursing profession, nursing profession should also learn to strategize Bozeman, B., Slade, C., & Hirsch, P. (2009).
practice, and discipline. how it can align its objectives and philosophies to Understanding bureaucracy in health science
meet such demands and needs of individuals, ethics: Toward a better institutional review
Ethical Caring Defined family, and community and in a macro context. board. American Journal of Public Health, 99,
Building a culture of ethical caring does not Through knowingdoingvaluing as systems 15491556.
happen overnight; rather, it entails the tedious of cocreations, all clinical research nurses who Brim, C., & Schoonover, H. (2009). Lessons
progression from knowing to doing to valuing. The are entering the discipline will be more adaptive, learned while conducting a clinical trial to
harmony derived from the integrated review of responsive, accountable, and responsible to their facilitate evidence-based practice: The
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