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Transitioning to the clinical research nurse role: a qualitative descriptive study
Umeå universitet, Medicinska fakulteten, Institutionen för omvårdnad. Department of Research & Development, Region Västernorrland, Sundsvall Hospital, Sundsvall, Sweden.ORCID-id: 0000-0002-9033-1297
Umeå universitet, Medicinska fakulteten, Institutionen för omvårdnad.ORCID-id: 0000-0003-1543-6512
Umeå universitet, Medicinska fakulteten, Institutionen för kirurgisk och perioperativ vetenskap, Urologi och andrologi.ORCID-id: 0000-0001-8455-2010
Umeå universitet, Medicinska fakulteten, Institutionen för omvårdnad.ORCID-id: 0000-0003-0661-8269
2022 (Engelska)Ingår i: Journal of Advanced Nursing, ISSN 0309-2402, E-ISSN 1365-2648, Vol. 78, nr 11, s. 3817-3829Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

Background: Studies have reported on the important role of the clinical research nurse in clinical studies. Yet, there is no international consensus about the role's competencies and tasks. Furthermore, the literature offers a little description of the career pathway from a ward-based registered nurse to a clinical research nurse. More knowledge about this specific role could benefit the nursing profession as well as increase the quality of clinical research.

Aim: The aim of the study was to explore Swedish registered nurses' experiences transitioning into the clinical research nurse role.

Design: The study had a qualitative design. Data were collected via semi-structured interviews. Inductive qualitative content analysis was employed.

Methods: Ten participants (i.e., clinical research nurses) were interviewed in the spring of 2017. A semi-structured interview guide was used to address the transition into the clinical research nurse role, experience working in a new role, experience of ethical dilemmas and experience of organizational and professional issues related to the role. The interviews were analysed inductively using qualitative content analysis.

Results: The registered nurses described experiencing reality shock when they became clinical research nurses; that is, it was a challenging and transforming experience. The main theme, a challenging transition, was developed from the four subthemes highlighting that it defied their previous nursing role. They experienced an unclear professional identity, extended professional mandate, increased professional status and growing ethical consciousness in their new role.

Conclusion: The results highlight that registered nurses who became clinical research nurses had needs that were both distinct from and overlapped with those of their former professional role as registered nurses. To avoid reality shocks, the development of clear competence pathways for nurses to become clinical research nurses, including introduction, mentorship and continued support, is necessary. Making their professional title more homogeneous, nationally and internationally, would facilitate role identification and comparisons in research.

Ort, förlag, år, upplaga, sidor
John Wiley & Sons, 2022. Vol. 78, nr 11, s. 3817-3829
Nyckelord [en]
clinical research nurse, clinical study coordinator, clinical trial nurse, interviews, nurse, professional development, qualitative content analysis, registered nurse, role, transition
Nationell ämneskategori
Omvårdnad Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi
Identifikatorer
URN: urn:nbn:se:umu:diva-198502DOI: 10.1111/jan.15397ISI: 000833794400001PubMedID: 35909097Scopus ID: 2-s2.0-85135191472OAI: oai:DiVA.org:umu-198502DiVA, id: diva2:1686164
Forskningsfinansiär
Region VästernorrlandTillgänglig från: 2022-08-08 Skapad: 2022-08-08 Senast uppdaterad: 2023-04-27Bibliografiskt granskad
Ingår i avhandling
1. The registered nurse as a clinical research nurse
Öppna denna publikation i ny flik eller fönster >>The registered nurse as a clinical research nurse
2023 (Engelska)Doktorsavhandling, sammanläggning (Övrigt vetenskapligt)
Abstract [en]

Background: Clinical research studies are important for the developmentof new treatments in healthcare. The quality of clinical research relies on the competence, skills, and knowledge of the research team. Clinical research nurses (CRNs) are important members of clinical research teams as they are responsible for various tasks specified in study procedures. Internationally, nurses have been engaged as CRNs in in many areas of medicine, such as oncological research, for several decades. However, there is a lack of consensus concerning their professional role and a clear work description is lacking. In Sweden, nurses are becoming increasingly involved in research as CRNs, yet the CRN role is undefined as there is no Swedish national competence description that could guide CRNs’ work tasks, requirements for education, and management of ethical issues. Furthermore, the processof becoming a CRN is not understood. Increasing international research into the CRN role has shown that the role differs between countries.There is a lack of Swedish studies, including studies of the process of transitioning from being a registered nurse (RN) to a CRN. Since consensus is lacking concerning the CRN role in Sweden, we need to explore it further and examine how nursing perspectives are influencing it. The overall aim of this thesis was therefore to explore the professional role of CRNs in Sweden and the transition of RNs to being CRNs.

Methods: Both quantitative (studies I and II) and qualitative (studies III and IV) methods were used. The analyses are based on data from questionnaires and individual interviews of CRNs in Sweden. In study I, descriptive statistics and test–retest analyses were used to analyze the validity and reliability of the translated CTNQ-SWE. In study II, descriptive statistics and one-way ANOVA were used to analyze reported work tasks, perceptions, and differences between groups of CRNs. In studies III and IV, qualitative content analysis according to Graneheimet al., (2004) was used to analyze the transition, i.e., becoming and being a CRN.

Results: CRNs perform new and diverse work tasks and are often involved throughout the study process, with the greatest activity in data management and the actual conducting and evaluation of clinical studies (e.g., scheduling and performing procedures and tests according to the research protocols). There is seldom any work description or competence framework to guide nurses through the transition to the CRN role, placing them in an uncertain position where they must struggle to adaptiv to their new role and work tasks. To perform these new work activities, CRNs need more support as well as education in research procedures, regulations, and ethics. During the transition, CRNs improve their knowledge of research, regulations, and ethics and increase their experience of clinical research practice and collaboration in networks. They also learn and develop from dealing with challenging situations, such as the informed consent process. Furthermore, problem solving, study requirements, and ethical reasoning are emphasized as challenging. When passing through the different phases of transition to the CRN role, the nurses achieve expanded competence, change didentity, and growing confidence as informal leaders. CRNs also advocate for patient rights and mentor others involved in research, but they simultaneously lack acknowledgement and a formal leadership role.

Conclusions and clinical implications: This thesis provides important insights into the CRN role in Sweden. It highlights the transition of RNs to becoming CRNs as well as their experiences of working as and becoming CRNs. The thesis reports that CRNs, overall, seem to be satisfied with their work, but some of their experiences highlight that skills, education, and organizational structures require improvement; forexample, appropriate introduction and support are required during the transition to the CRN role. Ethical challenges call for ongoing discussion in research teams. One conclusion is that CRNs’ competences and tasks need to be clarified. Developing clear competence pathways for nurses to become CRNs, including mentorship and support, could be one way of acknowledging CRNs’ important work, thereby creating a better outlook for high-quality clinical research procedures. Making the CRN professional title more homogeneous nationally and internationally would make comparisons easier. This would clarify CRNs’ work tasks and role in Sweden and extend the nursing perspective on ethics. This thesis adds to a slowly growing body of literature on the CRN role and is relevant to both practitioners and policymakers. Additionally, it illustrates a need to develop both educational and mentoring support aswell as career pathways for RNs to become CRNs, which could improve the quality of clinical research in Sweden.

Ort, förlag, år, upplaga, sidor
Umeå: Umeå universitet, 2023. s. 64
Serie
Umeå University medical dissertations, ISSN 0346-6612 ; 2233
Nyckelord
clinical research nurses, ethical challenges, interviews, nursing, professional role, questionnaire, transition
Nationell ämneskategori
Omvårdnad
Identifikatorer
urn:nbn:se:umu:diva-207416 (URN)978-91-8070-030-6 (ISBN)978-91-8070-031-3 (ISBN)
Disputation
2023-05-26, Aula Biologica, Biologihuset, Umeå, 09:00 (Svenska)
Opponent
Handledare
Tillgänglig från: 2023-05-05 Skapad: 2023-04-27 Senast uppdaterad: 2023-05-04Bibliografiskt granskad

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Backman Lönn, BeatriceHörnsten, ÅsaStyrke, JohanHajdarevic, Senada

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