Patient Safety Research: Magnifying Silent Voices

Contributor: Seth Stephens

Patient safety has always been an important part of nursing. Over the course of my twenty years as a nurse I have had the opportunity to see nurses escalate broken care processes and issues that have saved patient lives, and I’ve seen how systems errors can result in patient deaths. Several years ago, one such instance that resulted in the death of a patient instigated a desire in me to better understand how involvement in medical errors and adverse events affected the clinical judgement of nurses, which is where I began my PhD journey.
After several years of learning in didactic courses and wading through scholarly inquiry and philosophy, I came to the point of beginning work on my dissertation, the first phase of which was a small pilot feasibility study. Once I had obtained approval from my university Institutional Review Board, I set about attempting to find three registered nurses who would agree to be interviewed to discuss a medical error or adverse event that they had been involved in. Participant recruitment proved to be a difficult task, given the subject matter that I was interested in, and I had feedback from several colleagues suggesting that nurses may not be willing to discuss such stigmatizing subject matter with me, an unknown investigator. As any typical graduate student would, I went to the literature to further investigate this and to identify some strategies that might be helpful. Over the last several years, most, if not all of my graduate work has focused on patient safety issues, so I was well aware of the deficit of theoretical work around patient safety research, but I had yet to delve into specific ethical issues related to patient safety research.

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Patient Safety Ethics Issues Identified in Current Literature

Generally speaking, the majority of literature surrounding the ethics of patient safety research centers around a few major issues; whether patient safety interventions should be consider research or quality improvement, who has oversight of patient safety research, and when informed consent should be obtained. In a systematic review by Whicher and colleagues (2015) Each of these issues is discussed. They noted that discussions regarding research versus quality improvement have been ongoing for several years and identified a few specific criteria that could be utilized to categorize patient safety interventions as true research or quality improvement work: the intent of the project to generate new knowledge, whether the project has a flexible or steadfast protocol, if the funding for the project is internal (from the institution where the project is occurring) or external, and the intent to produce generalizable results.

Additionally, there has been debate related to who should oversee patient safety research; traditionally, those projects have been subject to institutional review board oversight. That said, there has been a relatively recent move to have these types of projects, particularly projects whose potential to harm participants is no greater than the risk that might be associated with traditional care, be reviewed and approved by a board specifically designed to review quality improvement work. Finally, the subject of informed consent; generally speaking, there is consensus that if an intervention has the potential to cause greater than minimal risk to the participant, informed consent is needed. More interestingly, there is the issue of obtaining informed consent from health care workers involved in the research. Patient safety research may involve the monitoring of healthcare workers’ actions or the scrutiny of their decisions, this has the opportunity to make them the focus of the project; when is it necessary to obtain their consent? One suggestion regarding this is that, if the project involves placing the healthcare worker at greater risk of physical or mental harm than they might typically experience while at work, or if the data collection involves elements that an employer is not normally allowed to have, then informed consent is needed.

The World Health Organization (2013) also published a report specifically addressing the ethical issues in patient safety research. This report echoed several of the topics covered by the systematic review published by Whicher et al. (2015) and also addressed privacy and confidentiality, a researcher’s duty to intervene, and withholding information from research participants. The report does provide some specific guidance around these topics; however, the section on privacy and confidentiality was exclusively related to patients, rather than healthcare workers who might be the subject of patient safety research. To be clear, Whicher and colleagues (2015) did mention these issues as well, however, they were specifically described as being either rarely mentioned in the literature or only mentioned once in the available literature.

Helpful Communication Strategies for Healthcare Workers Participating in Patient Safety Research

While all of this information is quite interesting, I did not find it particularly helpful to address my conundrum regarding participant recruitment. A consistent finding in patient safety literature regarding involvement in medical errors and adverse events is the consistent feeling of shame and judgement that health care workers feel towards their selves and their perceptions of how colleagues might feel about them. Eventually, I was able to find an initial participant who was referred by a mutual acquaintance. The participant was very interested in my personal background and education, I got the sense that her knowing that I was a nurse as well, provided some comfort. As the interview began, the participant was very closed off, providing very short answers only. I went to great efforts to demonstrate how confidentiality would be maintained and insist that there was no need to discuss matters that were uncomfortable, even insisting that it wasn’t necessary to disclose the actual event to me, and that my interest was more related to how that event effected care of subsequent patients. As the interview progressed, the participant became more open, and before the end of the interview, they did disclose the specifics of the event, but it took time to build a rapport and trust between us.

Snowball sampling was always part of my recruitment strategy, but I did not realize how instrumental that it would be. The final two interview participants were referred by the initial participant. These later participants specifically mentioned that the initial interview participant strongly encouraged them to share their experiences. One of these participants was very insistent that the results of the interview be utilized to help other nurses and that their involvement was solely based on the fact that they wanted to help others learn from their situation. I found that these later participants were far more open to sharing their specific experiences early on in the interview than the initial participant was.

Final Thoughts

My experience demonstrates the potentially sensitive nature of patient safety research and the importance of confidentiality and creating a safe space for participants to be able to speak freely. As I move forward to begin work on my full dissertation, I have made some updates to my interview script and interview question orders. I’ve added a more full introduction of myself and my educational background and nursing experience, in order to help give participants a sense that, as a nurse, I can understand and empathize with their stories. I’ve also added my credentials to the recruiting flyer, so that potential participants will know that I’m a nurse. I’ve rearranged my interview questions to keep more personal or probing questions later in the interview in an effort to help to allow the participant to become more comfortable with me, before I ask more difficult questions. I also plan to encourage participants to refer colleagues to participate in the study, now knowing that this type of recruitment might be the most fruitful source of participants. Finally, I will more fully review confidentiality safeguards as part of my initial introduction to the project. I’m hopeful that these changes will increase subject recruitment and provide for a richer data gathering experience.


Whicher, D. M., Kass, N. E., Audera-Lopez, C., Butt, M., Jauregui, I. L., Harris, K., Knoche, J., & Saxena, A. (2015). Ethical Issues in Patient Safety Research: A Systematic Review of the Literature. Journal of Patient Safety, 11(3), 174-184. https://10.1097/PTS.0000000000000064

World Health Organization (WHO). (2013). Ethical Issues in Patient Safety Research: Interpreting Existing Guidance.;jsessionid=697F525B6CB284A68022A9E91A30B376?sequence=1

About Seth Stephens

Dr. Seth Stephens is an acute care nurse practitioner and has been a practicing nurse for twenty years. He completed his DNP at Texas Tech University Health Science Center in Lubbock, TX and is currently working to complete a PhD in Nursing Science at Texas Women’s University in Houston, TX. Dr. Stephens’ passion is patient safety and quality improvement and working with patients and providers in cardiovascular services. His mission is to support healthcare teams in new and innovative ways to make patient care as safe and effective as possible.

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