Clinical Researcher—February 2025 (Volume 39, Issue 1)

PEER REVIEWED

Kayla Trent, MCR, RN, BSN, ACRP-CP

 

 

 

The current shortage of clinical research nurses is critical. High prevalence of moral distress, a known contributing factor to nurse turnover, warrants exploration. While there is a paucity of literature regarding the perspectives and experiences of clinical research nurses specifically, common causes reported in the existing literature include their perceived moral obligations of their nursing identity, limited understanding of research processes, and lack of societal respect for the role. Future research might explore the efficacy of training developed for clinical research nurses with consideration for their identities as nurses and patient advocates. The moral components of distress are compounded by nursing’s lack of recourse in a failing social contract. Society must fulfill its obligations to the nursing profession by ensuring clinical research nurses receive the training and mental health support necessary to be successful in their role. In turn, they can fulfill their obligations to society by providing quality care. Effective reciprocity is essential for a healthy, successful relationship between the clinical research enterprise and society.

Current Status: Critical Shortage

The shortage of clinical research professionals has reached critical status.{1} Included in this group are clinical research nurses (CRNs). These specialized registered nurses face the unique responsibility of providing nursing care for human research participants and upholding the integrity of clinical research studies.{2} From administering direct nursing care of study participants to performing data analyses, CRNs are considered the backbone of a trial and vital to its success.{2–4} Their valuable overlap of nursing skills and research knowledge is well-described by the CRN Domain of Practice, which encompasses five dimensions including 1) Clinical Practice, 2) Human Subjects Protection, 3) Contributing to the Science, 4) Care Coordination and Continuity, and 5) Study Management.{5} Their skilled contributions in these dimensions make them essential to the clinical research enterprise.{1,3}

Concerningly, turnover rates of clinical research professionals reached a five-year high of almost 30% in 2020.{6} Similarly, a 2022 study revealed a quarter of the United States nursing workforce is considering leaving the profession.{7} It is difficult to obtain CRN-specific turnover rate data due to variation in titles and roles among institutions{4}; however, CRNs hold strongly to their identities as nurses and fit into both categories.{8}

To mitigate the ever-growing shortage, organizations have increasingly begun studying contributing factors to CRN turnover. While many factors have been reported, CRNs report experiencing high levels of moral distress, or internal conflict, in their role.{4,9,10} Moral distress rates have been reported as significantly higher among CRNs who contemplate leaving their jobs.{4}

Given the high prevalence of moral distress among CRNs, a deeper understanding of the causes and perspectives should be explored. While non-nurse clinical research professionals’ experiences of moral distress are certainly worth exploring, this paper aims to contextualize moral distress experienced among CRNs by examining the significance of CRNs’ backgrounds and identities as nurses, and to recommend ways to improve the current state.

Overview of Moral Distress

Moral distress is a complex feeling of severe discomfort experienced when one participates in or witnesses clinical situations that go against one’s core beliefs or values without having the ability to change them.{11–13} Situations can become morally distressing when one’s internal values or obligations—perceived or real—conflict with the external actions or inactions of oneself, the actions or inactions of others, or the needs and values of others.{12,14} Moral distress is a subjective experience of internal ethical conflict influenced by each individual’s personal beliefs and life experiences.{12,14} Table 1 outlines common causes found in the literature of moral distress reported among CRNs.

Moral distress is a hazard of work in the nursing profession.{15} Repeated feelings of moral distress compound over time, leading to low job satisfaction, leaving the nursing profession, and depression.{14,16,17} Depression has been shown to significantly increase the risk for suicide among nurses.{18,19} Feelings of shame, anguish, powerlessness, self-doubt, and helplessness threaten nurses’ moral integrity, or sense of self-worth.{11,12,14} These psychological consequences of moral distress affect not only nurses, but also those receiving nursing care.{11} Feelings of deep, unresolved conflict can result in the development of unhealthy coping mechanisms which lead to poor quality nursing care, such as avoidance, poor interdisciplinary communication, and errors.{15,20} For many, identity as a nurse is not only professional, but also deeply personal.{21}

Table 1: Common Causes of Moral Distress Among CRNs

Common Causes Found in the Literature	Examples
System Challenges	•        Limited opportunity to provide input{4} •        Investigator disregard for staffing shortages{4} •        Perceived by organization, colleagues, and the public as “not real nurses”{8}
Conflicting Professional Obligations	•        Feeling “caught” between fidelity to participants and fidelity to protocol{10} •        Feeling pressured to enroll{10} •        Discomfort with offering investigational vs. standard therapy{10}
Role Uncertainty	•        Difficulty with professional identity in transitioning from bedside to clinical research nursing specialty{8} •        Prolonged experience of feeling novice{8} •        Limited understanding of fundamental scientific concepts and research design{8}
Exposure to Difficult Populations and Diseases	•        Distress in witnessing human suffering{10} •        Feeling powerless to “help” (e.g., poor prognosis, ineligible for trial involving investigative treatment of rare disease, children with terminal disease){10}

Overview of Nursing’s Social Contract

In Nursing’s Social Policy Statement: The Essence of the Profession, the American Nurses Association (ANA) describes the nursing profession as a societal subgroup bound in contract with the society it serves.{22} Society expects the nursing profession to meet specific obligations such as Caring Service, Skilled Practice, Ethical Conduct, and more.{22} Similarly, the nursing profession expects society to meet specific obligations such as Respect for the Profession, Advocacy for Protection in Hazardous Service, Ensuring a Sustainable Workforce, and more.{22} Ethical and moral integrity are the foundation of society’s expectations of nursing, and individuals who self-identify as the type of person society needs feel deeply, personally “called” to the profession.{23,24}

The nursing profession consistently gains the highest ethical rating among Americans as measured by Gallup, an American analytics company renowned for its public opinion surveys.{25} This rating demonstrates society’s approval of the nursing profession, indicating nurses’ fulfillment of their contractual obligations. Nurses are individuals born of their society and its beliefs, entering the profession with a preconceived construct of what it means to be a nurse.{24} This image of what a nurse “should be” becomes the standard of measurement for their moral integrity, or self-worth.{24} Identifying as a nurse is an integral part of not only individuals’ understanding and expression of themselves as a person of moral integrity, but also of society’s recognition and expectations of them as such.

Moral Distress Among CRNs: Causes and Perspectives

Obligation to Advocacy

Moral identity is essential to an individual’s well-being, and a sense “doing good” for other humans facilitates an ultimate alignment between an individual’s self-identity and social identity as a person of moral integrity.{26} A common theme among CRNs’ reported experiences of moral distress is the feeling of “inability to provide good/do no harm” in their role.{4} In a study by Tinkler et al., CRNs describe times when their uncertainty about the benefits of a trial prevented them from recruiting participants.{8} These CRNs liken themselves to salespeople when describing their feelings about approaching patients for studies the CRN felt were more burdensome than beneficial.{8} They perceive their actions to be significantly divergent from personal and societal expectations of nursing, identifying instead with the perceived moral integrity of a salesperson. Of note, salespersons receive the lowest ethical ratings per the same Gallup surveys in which nurses rank highest, further emphasizing the perceived moral gap.{25}

The ANA’s Code of Ethics for Nurses with Interpretive Statements outlines nonnegotiable ethical standards to which nurses are obligated in their commitment to society. Among these obligations is patient advocacy, which is a responsibility of nurses across all specialties, including CRNs, that is held in high regard in their relationships with patients.{8,10,27} Being a patient advocate has been described by CRNs as the first and foremost “primary responsibility” of their role as a nurse.{8,10}

In a study by Nsiah et al., nurses report understanding their role as patient advocates to mean they are responsible for “protecting patients from present and anticipated injuries.”{27} One way nurses fulfill this obligation of patient advocacy is by providing evidence-based, patient-centered care. Through evidence-based practice, nurses are exposed to clinical research results implementation, having minimal exposure to the process involved in generating the data.{28} A strong sense of moral obligation to protect patients, lack of knowledge of the research process, and limited understanding of nursing’s ethical obligations in human subjects research are all contributing factors to internal conflict felt by CRNs when offering investigational interventions versus standard of care therapies.

CRNs also report experiencing moral distress when feeling underappreciated and undervalued.{29} Non-research nurses often challenge the legitimacy of the CRN professional identity as “nurse” by not only physically preventing the CRNs from performing the actions required of their role, but also by implying CRNs’ actions do not qualify as nursing actions.{8,29} Questioning of authenticity threatens CRNs’ moral integrity, or self-worth, and can invoke a sense of purposelessness—all of which can lead to decreased job satisfaction and leaving the role or nursing profession entirely.{4,14}

CRNs face challenges stemming directly from their training, experiences, and identities as nurses formed prior to entering the clinical research arena. Thus, moral distress among CRNs should be considered through a slightly different lens than non-nurse clinical research professionals, with respect to the foundational nursing aspect of their backgrounds and identities. To distance CRNs from the societal issues experienced by nursing as a profession would further reinforce the idea that CRNs are not “real” nurses. Rather, consideration of the CRN role with special attention to their needs as nursing professionals could harmonize their identities as nurses and clinical research professionals.

Ineffective Reciprocity

Effective education and training are necessary for CRNs to successfully fulfill their obligations to society. Per the social contract, society is obligated to ensure nurses have access to quality education and training. Moral distress caused by inadequate training and undervaluation of the CRN role demonstrate a lack of “Protection in Hazardous Service” and lack of “Respect and Just Remuneration”—both of which are societal obligations to the nursing profession.{23} Success of the nursing profession and, in turn, the success of society depend on effective reciprocity in the relationship.

In the current state of nursing’s social contract, recourse of breaking contract is unequal between the two sides. If society perceives nursing does not meet its obligations, society can choose to withhold its obligations to nursing. The profession could lose authority, funding, and much more. However, if nurses perceive society does not fulfill its obligations, nurses have an ethical and moral obligation to continue providing quality care—regardless.{30} Ineffective reciprocity in nursing’s relationship with society can result in nurses feeling unappreciated and burned out, contribute to turnover, and result in nurses leaving the profession entirely.{14,31,32}

Society’s unfulfilled obligations negatively impact CRNs, society, and the clinical research enterprise. For example, a hazardous work environment can lead to morally distressed CRNs who inhibit subject recruitment.{8} Low subject recruitment can lead to unsuccessful clinical trials. Resources depleted on failed clinical trials can lead to staffing shortages, creating a hazardous work environment for the CRN. Figure 1 illustrates the cycle of detriment caused by ineffective reciprocity for all stakeholders in a clinical research context.

Figure 1: Negative Outcomes in CRN – Society Relationship of Ineffective Reciprocity

Effective Reciprocity

In September 2023, the ANA proposed re-imagining nursing’s relationship with society as a covenant rather than a transactional, breakable contract.{30} A social covenant would promote effective reciprocity between nursing and society. Society, by supporting the success of the nursing profession, directly impacts the quality of care it receives. Figure 2 illustrates these benefits in a clinical research context.

Figure 2: Positive Outcomes in CRN – Society Relationship of Effective Reciprocity

Potential Improvement

Training for Clinical Research Nurses

While thorough training in regulations and guidelines is required for all clinical research professionals, additional training for CRNs should address topics such as advocacy with special consideration for CRNs’ professional and moral identities as nurses. Personal and societal preconceptions of what makes a “good” nurse should be challenged and discussed in a supportive environment. Emphasizing ways in which CRN contributions support the goals and values of nursing might facilitate a sense of personal and professional fulfillment.

Effective Onboarding

Nurses who enter a research role must be adequately prepared not only as skilled nurses, but also as skilled clinical research professionals. In a 2020 survey that asked clinical research professionals why they were considering leaving their jobs, 10% of respondents reported they were seeking better training or education.{6} The Joint Task Force for Clinical Trial Competency offers a Core Competency Framework that can be used to guide skills-development of clinical research professionals in eight domains, including “Scientific Concepts and Research Design” and “Ethical and Participant Safety Considerations.” This resource can be used to facilitate the transition of registered nurses to a research role.

Mental Health Skills and Support

A situation which causes internal conflict within one person may have no effect on others experiencing the same situation, making it difficult to identify in oneself and others.{12,14,33} While it is inevitable that nurses face distress in their work, exposure to morally distressing experiences must be minimized to uphold the social contract.{11} When exposure is unavoidable, nurses must be adequately and effectively supported in navigating moral distress as the psychological response that it is.{11,20}

The American Association of Critical-Care Nurses states “One of the key difficulties in addressing moral distress is first recognizing it.”{33} Nurses must learn to first identify their distress as a feeling without automatically equating it to their self-worth, then navigate the experience in a healthy way. Effective skills and resources to support CRNs’ mental and physical well-being must be incorporated into training and regarded with the same significance as professional skillsets.

Conclusion

Moral distress is highly prevalent among CRNs. These clinical research professionals face unique moral challenges after transitioning from traditional nursing roles into clinical research roles. Common causes of moral distress reported by CRNs provide insight to a lack of reciprocity in the current state of nursing’s social contract.

Consequences of a non-reciprocal relationship have a negative impact on all stakeholders involved in clinical research. CRNs must receive standardized onboarding to the research role and mental health support. CRNs might also benefit from specialized training tailored to their nursing backgrounds.

Moving toward a social covenant could strengthen society’s value of its contributions to the CRN profession by emphasizing its ability to facilitate quality nursing care and scientific advancements. Effective reciprocity built on value and respect is foundational to building healthy CRN professionals and a healthy society.

Acknowledgement

The author wishes to express gratitude to Carolyn Jones, DNP, MSPH, CRN-BC, FAAN, whose expert guidance and insights, in addition to her published works referenced in the article, helped shape this manuscript.

References

1. Freel SA, Snyder D, Bastarache K, Jones CT, Marchant M, Rowley L, Sonstein S, Lipworth K, Landis S. 2023. Now is the time to fix the clinical research workforce crisis. Clinical Trials 20(5):457– https://pubmed.ncbi.nlm.nih.gov/37264897/
2. Fisher C, Griffith C, Lee H, Smith H, Jones C, Grinke K, Keller R, Cusack G, Browning S, Hill G. 2022. Extending the description of the clinical research nursing workforce. J Res Nurs 27(1-2):102– https://pubmed.ncbi.nlm.nih.gov/35392207/
3. Bevans M, Hastings C, Wehrlen L, Cusack G, Matlock AM, Miller-Davis C, Tondreau L, Walsh D, Wallen GR. 2011. Defining clinical research nursing practice: results of a role delineation study. Clin Transl Sci 4(6): 421– https://pubmed.ncbi.nlm.nih.gov/22212223/
4. Showalter BL, Malecha A, Cesario S, Clutter P. 2022. Moral distress in clinical research nurses. Nurs Ethics 29(7-8):1697– https://pubmed.ncbi.nlm.nih.gov/35730358/
5. National Institutes of Health Clinical Center, Nursing and Patient Care Services. 2009. CRN 2010 Domain of Practice Committee. Building the Foundation for Clinical Research Nursing: Domain of Practice for the Specialty of Clinical Research Nursing. http://www.cc.nih.gov/nursing/crn/DOP_document.pdf
6. Henderson L. 2020. Salary Survey: A Healthy Trajectory for Clinical Research Professionals. Applied Clinical Trials Online 29(2). https://www.appliedclinicaltrialsonline.com/view/salary-survey-healthy-trajectory-clinical-research-professionals
7. Smiley RA, Allgeyer R, Shobo Y, Lyons K, Letourneau R, Zhong E, Kiminski-Ozturk N, Alexander M. 2023. The 2022 national nursing workforce survey. Journal of Nursing Regulation 14(2S):S1–S92. https://www.journalofnursingregulation.com/article/S2155-8256(23)00047-9/fulltext
8. Tinkler L, Smith V, Yiannakou Y, Robinson L. 2018. Professional identity and the Clinical Research Nurse: A qualitative study exploring issues having an impact on participant recruitment in research. Journal of Advanced Nursing 74(2):318–28. https://pubmed.ncbi.nlm.nih.gov/28792610/
9. Hernon O, Dalton R, Dowling M. 2020. Clinical research nurses’ expectations and realities of their role: A qualitative evidence synthesis. Journal of Clinical Nursing 29(5-6)667– https://pubmed.ncbi.nlm.nih.gov/31794099/
10. Larkin ME, Beardslee B, Cagliero E, Griffith CA, Milaszewski K, Mugford MT, Myerson JM, Ni W, Perry DJ, Winkler S, Witte ER. 2019. Ethical challenges experienced by clinical research nurses:: A qualitative study. Nurs Ethics 26(1)172– https://pubmed.ncbi.nlm.nih.gov/29281934/
11. Čartolovni A, Stolt M, Scott PA, Suhonen R. 2021. Moral injury in healthcare professionals: A scoping review and discussion. Nurs Ethics 28(5):590– https://pubmed.ncbi.nlm.nih.gov/33427020/
12. Epstein EG, Delgado SA. 2010. Understanding and Addressing Moral Distress. OJIN: The Online Journal of Issues in Nursing. https://ojin.nursingworld.org/table-of-contents/volume-15-2010/number-3-september-2010/understanding-moral-distress/
13. Ferrell BR. 2006. Understanding the moral distress of nurses witnessing medically futile care. Oncol Nurs Forum 33(5)22– https://pubmed.ncbi.nlm.nih.gov/16955120/
14. Burston AS, Tuckett AG. 2013. Moral distress in nursing: contributing factors, outcomes and interventions. Nurs Ethics 20(3):312– https://pubmed.ncbi.nlm.nih.gov/23275458/
15. Boyle DA, Bush NJ. 2018. Reflections on the Emotional Hazards of Pediatric Oncology Nursing: Four Decades of Perspectives and Potential. Journal of Pediatric Nursing 40:63– https://pubmed.ncbi.nlm.nih.gov/29776481/
16. Lang KR. 2008. The professional ills of moral distress and nurse retention: is ethics education an antidote? Am J Bioeth 8(4):19–21; author reply W1– https://pubmed.ncbi.nlm.nih.gov/18576246/
17. Mewborn EK, Fingerhood ML, Johanson L, Hughes V. 2023. Examining moral injury in clinical practice: A narrative literature review. Nurs Ethics. https://pubmed.ncbi.nlm.nih.gov/37246774/
18. Davidson E, Gordon Y, Parra M, Choflet A, Lee K, Barnes A, Harkavy-Friedman J, Zisook S. 2021. Job-related problems prior to nurse suicide, 2003-2017: mixed methods analysis using natural language processing and thematic analysis. Journal of Nursing Regulation 12(1):28– https://www.journalofnursingregulation.com/article/S2155-8256(21)00017-X/fulltext
19. Paidipati CP, Lozano AJ, West J, Huang L, Hanlon AL, Ulrich CM. 2023. Understanding the mediated relationship between moral distress, depression, and suicide risk in undergraduate nursing students. Nursing Outlook 71(3):101. https://pubmed.ncbi.nlm.nih.gov/37054498/
20. Miller GE, Holmes D. 2024. Self-Deception in Clinical Nursing Practice: A Concept Analysis. Clinical Nursing Research 33(1):114– https://pubmed.ncbi.nlm.nih.gov/37872731/
21. Einboden R. 2020. SuperNurse? Troubling the Hero Discourse in COVID Times. Health 24(4):343–
22. American Nurses Association. 2015. Guide to Nursing’s Social Policy Statement. Nursebooks.org.
23. American Nurses Association. 2010. Nursing’s Social Policy Statement: The Essence of the Profession 3rd ed.:178. Nursesbooks.org.
24. Flaming D. 2005. Becoming a nurse: “It’s just who I am.” Medical Humanities 31(2):95– https://mh.bmj.com/content/medhum/31/2/95.full.pdf
25. Brenan M. 2023. Nurses Retain Top Ethics Rating in U.S., but Below 2020 High. Gallup. https://news.gallup.com/poll/467804/nurses-retain-top-ethics-rating-below-2020-high.aspx
26. Cui P, Mao Y, Shen Y, Ma J. 2021. Moral Identity and Subjective Well-Being: The Mediating Role of Identity Commitment Quality. Int J Environ Res Public Health 18(18). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8465947/
27. Nsiah C, Siakwa M, Ninnoni JPK. 2019. Registered Nurses’ description of patient advocacy in the clinical setting. Nurs Open 6(3):1124– https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6650676/
28. Chien LY. 2019. Evidence-Based Practice and Nursing Research. J Nurs Res 27(4):e29. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6641093/
29. Kunhunny S, Salmon D. 2017. The evolving professional identity of the clinical research nurse: A qualitative exploration. J Clin Nurs 26(23-24):5121– https://pubmed.ncbi.nlm.nih.gov/28859249/
30. Fry-Bowers E, Hylton Rushton C. 2023. Re-imagining nursing’s social contract with the public. American Nurse Journal 18(9):14– https://www.myamericannurse.com/re-imagining-nursings-social-contract-with-the-public/
31. Martin B, Kaminski-Ozturk N, O’Hara C, Smiley R. 2023. Examining the Impact of the COVID-19 Pandemic on Burnout and Stress Among U.S. Nurses. J Nurs Regul 14(1):4– https://pubmed.ncbi.nlm.nih.gov/37035777/
32. Shanafelt T, Trockel M, Ripp J, Murphy ML, Sandborg C, Bohman B. 2019. Building a Program on Well-Being: Key Design Considerations to Meet the Unique Needs of Each Organization. Academic Medicine 94(2):156– https://pubmed.ncbi.nlm.nih.gov/30134268/
33. American Association of Critical Care Nurses. Resources for Moral Distress. https://www.aacn.org/clinical-resources/moral-distress

Kayla Trent, MCR, RN, BSN, ACRP-CP, (kboh7892@gmail.com) is a Senior Clinical Research Associate – RN. She developed this paper while studying in the Master of Clinical Research program in The Ohio State University College of Nursing.