Moral distress in clinical research nurses

Abstract

Background: Clinical research nurses experience unique challenges in the context of their role that can lead to conflict and moral distress. Although examined in many areas, moral distress has not been studied in clinical research nurses.

Research aim: The aim of this study was to examine moral distress in clinical research nurses and the relationship between moral distress scores and demographic characteristics of clinical research nurses.

Research design: This was a descriptive quantitative study to measure moral distress in clinical research nurses using the Measure of Moral Distress – Healthcare Professionals (MMD-HP) administered electronically. Demographic data were also collected.

Participants and research context: Registered nurses working in the clinical research nurse role (N = 322) were recruited through use of social media, emails, digital flyers, and snowball recruitment. Data was analyzed using SPSS. Pearson’s correlation, independent t-test, and one-way ANOVA were performed to explore differences among the demographic variables.

Ethical considerations: This study was approved by the Institutional Review Board at Texas Woman’s University. A consent statement was included, and completion of the questionnaire was construed as consent.

Findings/results: Analysis revealed a mean overall moral distress score of 79.58 (SD = 64.27) and median of 67, with a range of 0–354. Moral distress scores were negatively correlated with clinical research nurse age (r = 0-.156, p < 0.05). Reliability of the MMD-HP was demonstrated with a Cronbach’s alpha of 0.93.

Conclusions: The findings demonstrate that clinical research nurses do experience moral distress and revealed a wide range of scores. Further research is necessary to determine potential patient impact due to moral distress and to develop processes to minimize moral distress in the clinical research setting. This study was conducted during the COVID-19 pandemic, and the digital recruitment methods proved effective in recruiting a wide range of clinical research nurses, both nationally and internationally.

Keywords

Moral distress topic areas research ethics nursing research nurse clinical trials

Introduction

Successful clinical trials require extensive collaboration and coordination with multidisciplinary research teams. At the center of that team is the clinical research nurse (CRN). Clinical research nursing is the specialty nursing practice focused on the care of research participants and the management of clinical trials. Although clinical research nursing is a rapidly emerging specialty and the numbers of CRNs are increasing, clinical research nursing remains a relatively unknown and misunderstood area of nursing outside of the clinical research arena.^1,2,3

From initial protocol development to final study close out, the CRN plays an integral role in the conduct of the clinical trial. The CRN is responsible for the day-to-day management of the clinical trial as well as providing and coordinating research related nursing care to the research participant. As the primary point of contact and advocate for the research participant, the CRN has a vital role in ensuring participant safety, maintenance of informed consent, and safeguarding the human subjects’ rights of the research participant. Additionally, the integrity and fidelity to implementation of the research protocol, along with the collection and recording of research data, are within the purview of the CRN role responsibilities.³ Performing these duties, all the while ensuring human subjects’ protections are being adhered to, often place the CRN in a precarious position balancing the clinical needs of the participant and the requirements of the research.¹ According to Oberle and Allen,⁴ nurses involved in the conduct of clinical trials encounter ethical dilemmas or conflicts when attempting to balance moral obligations versus methodological issues in the care of the patient. Ethical dilemmas related to the risk/benefit of trial participation for the research participant, informed consent, and participant recruitment have also been reported. The ethical dilemmas faced while maintaining equilibrium between care of the research participant and fidelity to the research protocol can lead to ethical conflicts. These conflicts may potentially lead CRNs to experience the phenomenon known as moral distress.^2,4

Moral distress occurs when a nurse knows the morally or ethically correct response to a situation but is unable to act in accordance with their values due to real or perceived constraints.^5,6 As a result, moral integrity is compromised which can impact the emotional, psychological, and physical well-being of the nurse. The nurse may experience sadness, anger, frustration, and helplessness.^7,8 Moral distress has been portrayed in the literature as a primary ethical issue facing the nursing profession and has been described as a threat to nurses’ integrity and quality of patient care. Further, moral distress has been linked to job dissatisfaction, burnout, and turnover.^9,10 Since moral distress was identified and described in the 1980s,¹¹ several studies have examined moral distress in the area of critical care, end-of-life issues, and medical/surgical nursing, as well as in ancillary areas across the healthcare spectrum. While the concept of moral distress has been researched in multiple nursing and non-nursing areas,⁶ moral distress in clinical research nursing has yet to be explored.

Background

Nurses are influenced not only by their personal moral beliefs but are also guided by a professional code of ethics.¹² Ethical dilemmas are faced on a regular basis in the course of nurses’ work and moral decisions are made; however, those decisions cannot always be acted upon due to institutional, hierarchical, or other environmental constraints or perceived constraints. This divergence between an individual’s actions and moral obligations can result in negative feelings or psychological disequilibrium. This resultant experience is known as moral distress.⁶

Moral Distress

Over the past three decades, moral distress has been debated, reconceptualized, and researched in a variety of settings within nursing, as well as across the healthcare spectrum.⁶ Multiple studies have demonstrated the presence of moderate to high levels of moral distress among nurses often related to negative ethical climate and futility of care.^6,13,14 Further, in a study by Whitehead et al.,¹⁵ individuals who had considered leaving a job, who did leave a job, or who were currently considering leaving a job, reported significantly higher levels of moral distress. Although limited, literature describes the impact of moral distress on quality of care given citing nurses’ avoidance of patients, increased pain, longer stays, and inappropriate care.^5,8

Clinical Research Nursing

In 2016, the American Nurses Association recognized clinical research nursing as a nursing specialty. The ANA, in collaboration with the International Association for Clinical Research Nursing (IACRN),¹² published the scope and standards of practice for the clinical research nurse. Despite this recognition and increased awareness, the literature reflects that clinical research nursing remains a relatively unknown area of nursing.¹²

The CRN’s role in the clinical trial is extensive and includes managing the study related administrative tasks as well as providing direct nursing care to the research participants. Responsibilities may include administration of investigational product, assessment of adverse events and response to investigational agents, bedside nursing care of research patients, and coordination and implementation of research-related procedures. Additionally, the CRN must maintain protocol compliance, communicate with the multidisciplinary research team and sponsor, and ensure human subjects protection by following research regulations and policies.^3,16,17

These unique role responsibilities can create a feeling of dual obligation. In a study by Larkin et al.² examining the ethical challenges experienced by clinical research nurses, themes of inability to provide good/do no harm and conflicted allegiances were consistently found among the research nurses sampled. In their study of ethical dilemmas of clinical research nurses, Höglund, Helgesson, and Eriksson¹⁸ found that the primary theme of research interests versus patient interest emerged. Fisher et al.¹⁹ evaluated factors contributing to moral distress in non-nurse research workers conducting community-based drug user research. Respondents endorsed statements related to challenges ensuring human subjects protections and perceived conflict between study compliance and caring for research participants’ needs.

There is a paucity of literature on the specialty of clinical research nursing and less on the impact of ethical challenges and moral distress among CRNs. Issues related to informed consent, conflicted allegiances, and organizational support appear consistently in the limited literature on the subject, suggesting the need for further in-depth studies in this area.^2,18

Research Questions

The following research questions were addressed in this study:

1. Do CRNs experience moral distress in the context of their role?

2. What is the relationship between moral distress scores and demographic characteristics of CRNs?

Research Design

This study used a descriptive quantitative survey design to measure the level of moral distress in CRNs. For the purpose of this study, CRN was defined as registered nurses who were managing or coordinating clinical trials, registered nurses who were providing outpatient or inpatient nursing care exclusively to research participants, or registered nurses who performed a combination of both. Demographic data were collected to include gender, age, years of nursing experience, years of CRN experience, and educational level.

Theoretical Framework

The theoretical framework used to guide this study was the moral distress theory, developed by Mary Corley.⁵ The theory was designed to explain what happens when a nurse feels powerless to act as a moral agent for the patient and experiences moral distress. The theory posits that moral distress or moral comfort is the outcome of ethical challenges and the interrelationships of moral concepts in managing those challenges.⁵ This study applied the principles of the theory to determine whether the dynamic interrelationship of the moral concepts held by the CRN influenced the outcome of moral distress or moral comfort.

Participants and research context

Sample and Setting

Eligible participants were registered nurses actively managing clinical trials or providing nursing care exclusively to patients participating in clinical trials. Because nurses performing the function of CRN often have varying professional titles, the eligibility criteria for this study defined the role by function rather than title in order to capture all registered nurses working in the capacity of a CRN.

Participants were recruited using digital and hard copy flyers, social media, and snowball recruitment from other participants. Additionally, the IACRN and Greater Houston/Galveston chapter of the Society of Clinical Research Associates emailed recruitment information to members and posted the digital flyer on social media sites. Nurses both nationally and internationally participated. The survey was administered electronically, and participants were able to complete the survey on any computer or mobile device that had internet access.

Instrument

Levels of moral distress were measured using the Measure for Moral Distress – Health Professionals (MMD-HP),²⁰ the newly revised version of the widely used Moral Distress Revised (MDS-R) scale.²¹ Permission to use the scale was granted from the author, Dr Ann Hamric (email, 24 April 2019). The MMD-HP is a 27-item instrument that uses a 0–4 Likert-type scale to measure the frequency and intensity of moral distress. Each of the 27 items is a root cause situation that is scored based upon how often it occurs (frequency) and how distressing it is (intensity). The questionnaire also provides space for the respondent to write in additional situations in which they have experienced moral distress. Two additional items measure whether the respondent has ever left a job due to moral distress and if they are currently considering leaving due to moral distress.²⁰ At the suggestion of the Dr Hamric (email, 27 April 2019), three additional situations specific to the CRN role were included. The three items were evaluated for content validity by a panel of experts. The responses to these questions, as well as any written in situations, were analyzed separately.

The MMD-HP has demonstrated reliability with a Cronbach’s alpha of 0.93. Construct validity was evaluated and supported through hypothesis testing and exploratory factor analysis. Frequency and intensity for each item are multiplied (fxd), creating an fxd score (range 0–16). The composite score is obtained by summing the 27 items fxd scores for a range of 0–432 with higher scores indicating higher levels of moral distress.²⁰

Data Collection

Data were collected from September 2019 to June 2020. The MMD-HP²⁰ was administered online via Qualtrics, a secured online survey platform. Data was analyzed using SPSS. Descriptive statistics were calculated and an independent t-test and a one-way ANOVA were performed to explore the individual differences among the demographic variables. Level of significance was set at α = 0.05. A content analysis was conducted on write-in items.

Ethical considerations

The study was approved by the Institutional Review Board (IRB) at Texas Woman’s University (IRB-FY2019-325). The risk to confidentiality was minimal as the online questionnaire was anonymous and identifiers were not collected. A consent statement was included at the beginning of the survey that provided information about the purpose of the study, a description of time commitment, and that participation was voluntary. Completion of the questionnaire was construed as informed consent.

Results

A total of 322 CRNs initiated the questionnaire. Sixty-four cases were deleted due to completing less than half of the survey, one case was deleted due to ineligibility, and 15 cases completed more than half of the questions, but failed to finish the entire survey. In the final analysis, n = 267 cases were included in the demographic analysis and n = 242 cases were included in the moral distress analysis.

Sample characteristics

The sample was predominantly female (n = 241, 93.8%), and participants ranged in age from 22 years to 73 years with a mean age of 47 years (SD = 12.15). Overall years of nursing experience ranged from 1 year to 53 years (SD = 12.89), and clinical research nursing experience ranged from less than a year to 40 years (SD = 9.00). More than half of the CRNs held a baccalaureate nursing degree (n = 148, 57.6%). The CRNs were largely employed in the United States (n = 218, 84.8%) and chiefly working in the coordinator/study manager role (n = 180, 70%).

Moral Distress Scores

The mean moral distress composite score for the total sample was 79.58 (SD = 64.27) with a range of 0–354. The youngest participants had the highest levels of moral distress with a mean score of 99.65 (SD = 58.89) while CRNs over age 60 years reported the lowest levels (M = 57.68, SD = 42.23). Participants with the most years of overall nursing experience and years of clinical research nursing experience had the lowest scores. Participants with 6–10 years of CRN experience reported the highest levels of moral distress (M = 100.34, SD = 68.87) (Table 1).

Table 1.

Mean Moral Distress Scores of Overall Sample, Age, Years of Total Nursing Experience, and Years of CRN Experience.

Variable	M	SD	N
Total	79.58	64.274	242
Age (years)
20–29	99.65	58.89	26
30–39	97.82	75.01	44
40–49	63.67	59.51	57
50–59	85.69	67.55	75
60 years and older	57.68	42.23	40
Total years nursing experience
0–2	77.90	64.56	20
3–5	93.25	57.73	20
6–10	89.69	60.81	39
11–20	82.49	77.08	51
>20 years	79.88	60.10	111
Years CRN experience
0–2	75.76	71.51	51
3–5	77.65	52.66	51
6–10	100.34	68.87	41
11–20	77.34	65.73	64
>20 years	70.33	58.88	33

CRNs working in the bedside role had higher levels of moral distress (M =108.04, SD = 81.92) than CRNs working in the coordinator role or a combination of both. Participants who were considering leaving their current position due to moral distress (M = 135.56, SD = 74.72) had higher levels of moral distress than those who are not considering leaving (M = 68.82, SD = 56.19).

Individual item scores (fxd) were calculated and ranked. The scale range for individual item scores is 0–16. The mean item score was 2.99 (SD = 2.40) with a range of 0–16. The highest-ranking individual item was, “be required to care for more patients than I can safely care for” (M = 4.63, SD = 4.98). The three CRN specific items were calculated separately from the group. The highest mean item score of the CRN specific items was “Experience conflict between obligation to provide care that is best for the patient and compliance with the study protocol” (M = 4.13, SD = 4.71) (Table 2).

Table 2.

Items with Highest Mean Moral Distress Scores and CRN Specific Items.

	Moral DistressM (SD)
Be required to care for more patients than I can safely care for	4.63 (4.98)
Witness low quality of patient care due to poor team communication	4.49 (4.61)
Watch a patient suffer because of a lack of provider continuity	4.35 (4.68)
Follow the family’s insistence to continue aggressive treatment even though I believe it is not in the best interest of the patient	4.22 (4.56)
Have excessive documentation requirements that compromise patient care	4.12 (4.83)
Clinical research nurse specific items
Experience conflict between obligation to provide care that is best for the patient and compliance with the study protocol	4.13 (4.71)
Feel pressure to enroll patient on clinical trials even though you feel they are not eligible	3.94 (4.55)
Be required to enroll patients on clinical trials even though you know that the treatment is not working	3.85 (4.77)

Relationship to Demographic Characteristics

Pearson’s product-moment correlations were conducted to examine the relationship between age, years of nursing experience, and years of CRN experience with moral distress. A small, negative correlation between age and moral distress scores was demonstrated. The relationship between moral distress and years of nursing experience and CRN experience were not statistically significant (Table 3).

Table 3.

Pearson’s Product-Moment Correlations for Age, Years of Nursing Experience, and Years of CRN Experience with Moral Distress Composite Score.

Variable	r	p
Age	-0.156	0.02*
Years of nursing experience	-0.083	0.20
Years of CRN experience	-0.053	0.41

*p < 0.05.

Independent samples t-tests were conducted to examine differences of moral distress scores by gender, highest nursing degree, and intent to leave current position due to moral distress. Participants who indicated that they are considering leaving their jobs had significantly higher moral distress scores (M = 135.56, SD = 74.72) than those who are not considering leaving (M = 68.82, SD = 56.19). A large effect size (d = 1.01) was demonstrated.²² (Table 4)

Table 4.

Means and Standard Deviations for Moral Distress Scores by Gender, Highest Nursing Degree, and Intention to Leave Position.

Variable	n	M	SD	T	p	d ^a
Gender Ψ		—	—	-0.480	0.63	0.15
Female	228	78.87	64.82	—	—	—
Male	13	87.69	56.19	—	—	—
Highest nursing education Ψ	—	—	—	−1.59	0.12	0.24
Undergraduate	173	75.18	58.80	—	—	—
Graduate^b	68	91.44	75.89	—	—	—
Considering leaving due to MD	—	—	—	6.42	0.00**	1.01
Yes	39	135.56	74.72	—	—	—
No	203	68.82	56.19	—	—	—

Ψ Equal variances not assumed statistics reported.

**p < 0.05.

^aCohen’s d = (M₂ - M₁) ⁄ SD_pooled.

^bone case missing.

One-way ANOVA was conducted to explore the impact of country employed, CRN role, and previous history of leaving a position on moral distress scores. There was a statistically significant difference at the p <. 05 level in moral distress scores of CRNs who had previously left a position or considered leaving a position due to moral distress and CRNs who had not left a position due to moral distress. The calculated effect size using eta squared was 0.10, indicating that the difference in means was moderate to large.²² Post-hoc comparisons using Games-Howell indicated that the mean moral distress score for CRNs who had not previously left a position due to moral distress (M = 52.37, SD = 57.72) was significantly different from CRNs who had previously left a position (M = 96.35, SD = 69.71) and CRNs who had considered leaving, but did not (M = 95.14, SD = 56.58). The mean scores between groups in CRN roles and country employed were not statistically significant.

Write-In Items

In addition to the questionnaire items, the MMD-HP provides space for participants to write in and score additional situations in which they have experienced moral distress. A total of 52 write-in items were analyzed for themes and concepts. There was a wide variety of concepts within the items. The following six themes were identified, (1) system, (2) human subjects’ protections, (3) research integrity, (4) communication, (5) patient/clinical, and (6) inappropriate delegation. The system theme had by far the most items (n = 22), with inappropriate delegation (n = 3) the fewest (Table 5).

Table 5.

Themes for Write-in Items.

Theme (Number of Items)	Item Examples
System (22)	Providers continue enrollment despite severe staffing shortages
	Delays with study coordination impacting patient’s care
	Lack of transparency of administrators regarding the impact of COVID-19 pandemic
	No one listens to us
Human subjects’ protections (8)	Consenting a patient who is unsure about their own goals of careInvestigator mentioning a trial and not emphasizing risk
Human subjects’ protections (8)	Dangerous protocol
Research integrity (7)	Asking for waivers for eligibility for clinical trials for patients who are not appropriate for the trial
Research integrity (7)	Principal investigator (PI) saying adverse events were not related, but they clearly were
Communication (6)	Clear consistent instructions from leadership, that is, recruit patients over current work
Patient/clinical (6)	Having clinical trial subjects and patients
Patient/clinical (6)	Insurance company denies patient participation on a clinical trial
Inappropriate delegation (3)	Investigators require study coordinators to determine treatment decisions and oversee trials with little input
Inappropriate delegation (3)	PI delegating physician tasks to CRN

Reliability of the MMD-HP

Reliability coefficients were estimated for the overall MMD-HP scale and the four subscales using Cronbach’s alpha coefficient. The total instrument had good internal consistency, with a Cronbach’s alpha coefficient of 0.93. The four subscales also demonstrated good reliability with Cronbach’s alpha coefficients ranging from 0.80 to 0.86.

Discussion

The MMD-HP is a recently revised instrument and scores that constitute high versus low levels of moral distress have not yet been elucidated. One suggestion by the authors is to calculate the mean moral distress scores for participants considering leaving their position due to moral distress and for those not considering leaving their position due to moral distress.²⁰ Individuals intending to leave due to moral distress should have higher levels of moral distress than those who are not considering leaving; therefore, providing a guide for what indicates high and low scores. The CRNs that were considering leaving their current position due to moral distress had a mean score of 135.56. Those who are not had a mean moral distress score of 68.82. Using the benchmark scores of 136 as a high level and 69 as a low level of moral distress, the overall mean score of the sample (M = 79.58) suggests that CRNs do experience moral distress. Further, by using a score of 136 as an indicator of high levels of moral distress, it can be extrapolated that nearly 20% (n = 47) of the CRNs experience high levels of moral distress.

Three other studies used the MMD-HP to measure moral distress in nurses. Epstein et al.²⁰ conducted initial validation studies of the MMD-HP and explored moral distress scores in clinical nurses, as well as physicians and others patient-facing healthcare professionals. In another study, Latimer et al.²³ used the MMD-HP to measure moral distress in mechanical circulatory support nurses. Sheppard et al.²⁴ examined moral distress and nurses’ intent to leave employment during the COVID-19 pandemic. Compared with the mean moral distress scores in the Epstein et al.,²⁰ Latimer et al.,²³ and Sheppard et al.²⁴ studies, the CRNs demonstrated lower mean moral distress scores, but similar ranges in scores.¹⁴

The moral distress theory postulates that institutional constraints are the foremost reason for moral distress.⁵ This position is corroborated in this study as the system level root had the highest mean item scores among the subscales, and the system theme for the write-in items had by far the highest number of items attributed to it. The highest scoring item, “be required to care for more patients than I can safely care for,” is consistent with the write-in items that indicate high workload as a cause of moral distress. Workload issues were also among key findings in the reviewed literature.^25,26 This item was the third highest scored item in the Epstein et al.²⁰ study, proving that patient load is an ever-present problem in nursing.

Although the added CRN items did not rank highest among item scores, the item that addressed the feeling of dual obligations, “experience conflict between obligation to provide care that is best for the patient and compliance with the study protocol,” which is frequently cited in the literature as a primary cause of ethical conflict^{2,18,25,27,28} had the fifth highest item score. The other two added CRN items that focused on pressures to enroll patients scored on the mid-high level. Notably, pressure to enroll patients for various reasons made up 10% of the write in items.

It is unclear why CRNs had lower moral distress scores than nurses in the comparative studies. Many factors may have influenced the results. As cited as a limitation of this research, the MMD-HP was designed for use in the clinical setting, and as such, the items may not have captured unique ethical situations of the CRN. If that was the case, however, it would be presumed that the added CRN items would have had the highest item scores.

Another possible explanation for the low mean moral distress score may be related to the methodology and use of an online questionnaire. It was noted that nine participants (3.5%) entered straight zeros, which could be an indicator that the participants did not read the questions, did not understand the instructions for the questions, or simply straightlined. Straightlining is a term that describes the behavior when a respondent to a questionnaire uses the same response for all items in that set.²⁹ Certainly, the other explanation for the comparatively lower moral distress scores is that moral distress is not experienced at as high a level or incidence by CRNs as clinical nurses.

Demographic Characteristics and Moral Distress

In this study, age had a small negative correlation with moral distress scores, with the lowest scores from CRNs 60 years of age and older. In previous studies of moral distress, significant relationships between age, years of experience, and education have been inconsistent. Research has demonstrated both positive, negative, and no correlation to years of experience and age.^15,8,13,30 In a study with non-nursing research staff, a negative correlation between age and moral stress scores was also demonstrated.¹⁹ An explanation might be that an older nurse would have had more ethics training or had developed better coping skills; however, the lack of significant correlation and findings related to years of nursing and CRN experience contradict that thinking.

While not significantly different, CRNs who work at the bedside reported higher mean moral distress scores than those who work in the coordinator position. The moral distress scores of the bedside CRNs were comparable to the scores of the nurses in the Epstein et al.²⁰ study. Possible explanations are that bedside CRNs experience more moral distress or, as previously mentioned, the MMD-HP has more of a clinical focus and captures the issues more associated to a clinical nurse.

Consistent in previous studies is the correlation between moral distress scores and history of leaving a job or intent to leave current job due to moral distress.^15,18,24 This study supported that finding. CRNs who had previously left a position or had considered leaving a position due to moral distress had significantly higher moral distress scores than those who have not left or considered leaving as a result of moral distress. Similarly, moral distress scores of CRNs who are considering leaving are significantly higher than those who are not.

Conclusions

The findings demonstrate that clinical research nurses do experience moral distress and reveal a wide range of scores. Further research is necessary to determine potential patient impact due to moral distress and to develop processes to minimize moral distress in the clinical research setting. This study was conducted during the COVID-19 pandemic, and the digital recruitment methods proved effective in recruiting a wide range of clinical research nurses, both nationally and internationally.

Limitations

As with all research, this study had limitations. The MMD-HP was designed for use in the clinical setting²⁰; however, the instrument demonstrated good reliability, indicating that moral distress was indeed consistently measured. Additionally, with an anonymous, Web-based, self-report study, the status of respondents cannot be confirmed and is vulnerable to inaccurate response rates based on poor recall or response bias.

Footnotes

Acknowledgments

The authors would like to thank Dr Ann Hamric for granting permission to use the MMD-HP²⁰ as well as all the CRNs who took part in this study.

Declaration of Conflicting Interests

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

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Texas Nurses Association District 9 Foundation.

ORCID iD

Brandi L Showalter

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, et al. Moral distress in nurses providing direct patient care at an academic medical center. Worldviews Evidence-Based Nurs 2017; 14(2): 128–135.