Structural Racism

Photo by Priscilla Du Preez on Unsplash ABSTRACT White bioethicists owe a duty to the field and medicine to participate in anti-racist initiatives in our institutions. Given that medicine is steeped in biological essentialist assumptions about race, it is important that, as awareness of health disparities grows, physicians and medical educators are also educated on structural racism as the root cause. Bioethicists may be uniquely positioned to participate in and spearhead some of this work. There are many avenues for this kind of advocacy; however, this paper focuses on a faculty development initiative. The initiative entailed several workshops with key educators in an urban medical school. This paper will describe the curriculum, including assignments and breakout activities, and recommend future work. INTRODUCTION White bioethicists who work in academic medicine have a professional responsibility to confront anti-Black racism in our institutions. I want to share my experience running a workshop about structural racism based on the cycle of race essentialism (Figure 1). The workshop’s purpose was to shift attention to the sociopolitical forces of domination and oppression that drive racism and to challenge current assumptions like race essentialism. BACKGROUND Race essentialism is the “belief in a genetic or biological essence that defines all members of a racial category.”[1] Medical professionals and larger institutions are only now taking heed of the effects of racism and how they exacerbate racial health disparities in medicine.[2] Without adequate education surrounding the historical and current forces that lead to these disparities, there is a risk that notions of biological racial essentialism that already persist in medicine will be reinforced. Many health professionals incorrectly assume that differences in outcome across races are caused by some inherent or immutable feature of the people who belong to those races. Therefore, the focus for providers lies at the bottom of the figure: racial health disparities. Dorothy Roberts made clear in her book Fatal Invention that race is not a classification of the natural world. It is meaningful only insofar as human behavior and structural oppression have made it meaningful, but it does not delineate distinct biological categories of the human species.[3] The right side of the figure lists two categories that I argue are obscured and inherently overlooked by healthcare practitioners. The forces that we must focus on are those at the top of the figure—racism, power, domination, capitalism, and politics. These are the forces that create and enforce race. They create the notion of strict biological differences across racial lines to maintain systems of power and oppression.[4] Figure 1: Root Causes of Racial Disparities are Obscured from View To most physicians, the notion that blackness is socially or politically constructed rather than an innate biological reality can be difficult to grasp. Healthcare professionals have been treating Black and white bodies differently for centuries.[5] As racial disparities persist, it is important to take a step back and ensure that doctors are educated about the structural reasons for those disparities. This statement brings us to the role of bioethics and the influence of white bioethicists. In an article earlier this year, Dr. Keisha Ray noted that “Bioethics as a whole owes black bioethics and all of the other subgroups that focus on marginalized people’s health a great deal for helping bioethics to remain relevant in a time when people are asking academia to do more to create real, lasting social change.”[6] Bioethicists like me who work in academia need to push our institutions to make that change. The responsibility is arguably even more significant for those who work in academic medicine, which is part of a more extensive American system that has perpetuated racial disparity.[7] l. A Curriculum for Educating Healthcare Practitioners At my institution, I designed a workshop series for educators. The group in the workshop was chosen based on each person’s high number of contact hours with medical students. In addition, they were educational leaders responsible for developing and directing curriculum, handling issues and concerns in the classroom, and determining which faculty would have teaching roles. My objectives were to 1) reveal the right part of the diagram, showing that structural racism and power were the root causes of racial health disparities, and 2) alleviate discomfort and shame when discussing race and racism. Therefore, if the curriculum achieved both objectives, educators would be better equipped to respond empathetically to concerns about racism in medicine and medical school, empowered to work on anti-racist initiatives, and develop trust among one another and with me. My further hope was that we could continue as brainstorming partners in confronting racism. The workshops began with an intentional tone setting to establish commonality and trust. I talked about my whiteness and emphasized that if we couldn't make ourselves vulnerable to being uncomfortable in this space, it would be difficult to be genuine and authentic when discussing race with our students (or patients). I assigned a podcast before each session. The first was about structural racism to establish some facts and a basis of historical knowledge.[8] Then, I assigned a podcast called Truth’s Table, featuring a discussion with Harriet Washington, author of Medical Apartheid.[9] I chose this conversation because it involved three Black women discussing the impact of medical apartheid and centuries of abuse of Black bodies on modern fears and mistrust of the health care system. I wanted the participants to understand patients’ fears of medicine. The third podcast I chose was Howard Stevenson discussing the anxiety that can come up when we discuss race—to help normalize this response and move us beyond our gut reaction toward a more thoughtful and mindful response.[10] Fourth was a podcast with Jennifer Eberhardt, opening up a discussion about bias and microaggressions.[11] And finally, a podcast on anti-racist health systems to start a conversation about moving forward and working together to improve our field.[12] During each session, we did one breakout activity. We talked about how we, as non-Black people, benefit from systems of oppression. We discussed our reactions to racism being called out—often defensiveness and anger—and worked on brainstorming a more mindful response rooted in empathy and curiosity. We practiced the Observe Think Feel Desire (OTFD) framework for addressing microaggressions in the classrooms.[13] And we practiced handling hot moments in the classroom regarding race and racism. Workshop participants conducted a self-assessment following the series. A majority rated themselves as better understanding structural racism and feeling better equipped to handle racism in teaching. But the self-assessment results are neither scientific nor particularly meaningful—I used them primarily as feedback for workshop design. When approached by a black student pointing out racism, I have noticed that faculty who participated are more likely to pause, lower defenses, maintain curiosity and empathy, and seek out other group participants for advice. CONCLUSION Attendees valued the workshop and renewed their dedication to anti-racist practices. Additionally, our medical school has now formed a curricular anti-racist task force. Healthcare practitioners can better serve those seeking care with improved awareness of how past racism influences current behaviors. Faculty development is one way of improving the vestiges of structural racism. We may all have different skills from which to draw for this work—faculty development is certainly not the only avenue. However, structural change is likely even more effective. Those who have power in academic medicine, mainly when some of that power is derived from whiteness, should engage in anti-racist work in our institutions. - [1] Soylu Yalcinkaya N, Estrada-Villalta S, Adams G. The (Biological or Cultural) Essence of Essentialism: Implications for Policy Support among Dominant and Subordinated Groups. Front Psychol. 2017;8:900. Published 2017 May 30. [2] Higgins-Dunn, N., Feuer, W., Lovelace, B., Kim, J. Coronavirus Pandemic and George Floyd Protests Highlight Health Disparities for Black People. CNBC. Jun 11, 2020. https://www.cnbc.com/2020/06/11/coronavirus-george-floyd-protests-show-racial-disparities-in-health.html. [3] Roberts, D. Fatal Invention: How Science, Politics, and Big Business Re-create Race in the Twenty-First Century. New York: The New Press; 2011. 4. [4] Jordan WD. Historical origins of the one-drop racial rule in the United States. Journal of Critical Mixed Race Studies. 2014;1(1). https://escholarship.org/uc/item/91g761b3 [5] Amutah, C., et al. Misrepresenting Race — The Role of Medical Schools in Propagating Physician Bias. NEJM. 2021; 384(9): 872-877. https://www.nejm.org/doi/full/10.1056/nejmms2025768 [6] Ray, K. Black Bioethics and How the Failures of the Profession Paved the Way for Its Existence. Hastings Center Bioethics Forum Essay. 2020. Available at https://www.thehastingscenter.org/black-bioethics-and-how-the-failures-of-the-profession-paved-the-way-for-its-existence/. [7] AMA Equity Strategic Plan. Page 25. https://www.ama-assn.org/system/files/2021-05/ama-equity-strategic-plan.pdf. Accessed Dec 28, 2021. [8] Tarchichi, T.R., Owusu-Onsah, S., and Brown, T.P. Racism in Medicine Part Two – How is Race a Social Determinant of Health? PHM From Pittsburgh Podcast. 2020. https://podcasts.apple.com/us/podcast/phm-from-pittsburgh/id1176709862?i=1000484987639. Accessed November 7, 2021. [9] Washington, H.A. You Okay, Sis? Medical Apartheid with Harriet A. Washington. Truth’s Table. 2019. https://podcasts.apple.com/us/podcast/truths-table/id1212429230?i=1000433010203. Accessed November 7, 2021. [10] Stevenson, H.C. How to Resolve Racially Stressful Situations. TEDMED. 2017. https://www.ted.com/talks/howard_c_stevenson_how_to_resolve_racially_stressful_situations/up-next. Accessed November 7, 2021. [11] Eberhardt, J.L. How Racial Bias Works – And How to Disrupt It. TED Talks Daily. 2020. https://podcasts.apple.com/us/podcast/how-racial-bias-works-how-to-disrupt-it-jennifer-eberhardt/id160904630?i=1000478505882. Accessed November 7, 2021. [12] Khazanchi, R., Nolen, L., Fields, N. Antiracism in Medicine Series – Episode 5 – Racism, Power, and Policy: Building the Antiracist Health Systems of the Future. Clinical Problem Solvers Anti-Racism Podcast Series. 2021. https://clinicalproblemsolving.com/2021/01/19/episode-155-antiracism-in-medicine-series-episode-5-racism-power-and-policy/. Accessed November 7, 2021. [13] Cheung, F., Ganote, C., and Souza, T. Microresistance as a Way to Respond to Microaggressions on Zoom and in Real Life. Faculty Focus. April 7, 2021. https://www.facultyfocus.com/articles/academic-leadership/microresistance-as-a-way-to-respond-to-microaggressions-on-zoom-and-in-real-life/. Accessed November 7, 2021.

Hold my Hand

Photo by Kelley Sikkema on Unsplash INTRODUCTION Patients seeking abortion services in the United States face several problems, including factual inaccuracies about the procedure, the stigma surrounding the procedure, and barriers to quality care across the country. The problems surrounding abortion pose a threat to patient autonomy and beneficence—ethical principles that are usually upheld in medicine. Abortion doulas can enhance patient autonomy, improve the quality of medical care, help women talk through their emotions or the associated stigma, and provide other benefits that can address the problems surrounding abortion. Their role ranges from discussing emotional decisions and answering patient questions before the procedure, to simply holding their hand in the recovery room. In this paper, I propose that the use of abortion doulas may help address some of the problems surrounding abortion by mitigating factual inaccuracies, stigma, and barriers to quality care. I. Background Abortion doulas were started byThe Doula Project in New York City.[1]They initially worked with New York City public hospitals and eventually expanded to working with Planned Parenthood clinics, as well as other care providers.[2]Over recent years, abortion doulas have been offered in more states such as California, Arizona, and New Hampshire. Abortion doulas can work independently, in a collective, or in an abortion clinic.[3]More often, they work in a collective where they are trained and employed in clinics that are partnered with the organization. Many abortion doulas started working on a volunteer basis. Now, many are funded by donations, which allow their services to be free for patients.[4]When abortion doulas work independently, their rates are based on the specific services that they provide.[5]Patients can seek out abortion doulas through multiple avenues. They can seek out doulas that work independently, work in an abortion clinic, or through doula organizations, such as the Doula Project or The San Francisco Doula Group. II. Doulas The role of a doula has existed since ancient times. The word “doula” comes from the Greek language and translates to “a woman who serves”.[6]In 1969, Dr. Dana Raphael originated the use of the word “doula” in the US to describe a person who guides mothers through childbirth and assists them postpartum, specifically helping them breastfeed.[7]Dr. Raphael encouraged emotionally supporting new mothers through creating the new professional role of a doula.[8] Currently, doulas are trained in helping women emotionally and physically during pregnancy, childbirth, and postpartum. Doulas do not provide medical care, but they provide services such as birthing education, massage, assistance with breastfeeding, and educating mothers about the delivery process, such as knowing what to expect and what can go wrong. Research has demonstrated the effectiveness and benefits of doulas. For example, one meta-analysis compared women who received doula support during childbirth to women who did not. The study showed that doula-supported women had shorter labors, decreased complications with delivery, and rated childbirth as less painful than women without doula support.[9]Psychosocial benefits such as reduced anxiety, decreased symptoms of depression, and positive feelings associated with childbirth were significant for the doula-supported group.[10]In the last couple of decades, doulas have become increasingly popular. More recently, doulas have started a movement labeled “full spectrum doula,” in which the role of a doula in supporting women has expanded beyond birth to include abortion and adoption.[11] III. Ethical Considerations Factual Inaccuracies Complete and accurate medical information is fundamental to informed consent and autonomous decision making. Inaccurate medical information about abortion is very common and can come from multiple sources. Currently, there are 29 states that have policies restricting abortion that are not based on scientific evidence.[12]While both state policies and national media may convey false information to the public about abortion, perhaps what is most surprising is when these inaccuracies are presented to patients by physicians or medical facilities. In most states, policies mandate that any medical facility providing abortions develop and present written material to patients that is intended to educate the patient about the abortion procedure.[13]However, in some states, laws have been passed that mandate the inclusion of misinformation in these materials.[14]Healthcare providers try to mitigate the harm of this inaccurate information by prefacing it with qualifiers, disclaimers, and apologies.[15]However, they are still not able to completely avoid harm from the outdated and misleading information, which also often intends to dissuade patients from receiving an abortion.[16]The most common factual inaccuracies include stating that an abortion leads to an increased risk of breast cancer, that the fetus can feel pain as early as 12 weeks old, and that psychological effects of the procedure can lead to suicide and “post abortion traumatic stress syndrome.”[17]All these statements are false and not supported by scientific evidence; in fact, psychologists and the Diagnostic and Statistical Manual of Mental Disorders(DSM-V) do not recognize a post-traumatic stress syndrome associated with abortion.[18]Furthermore, another common inaccuracy in almost 20 states includes materials with contact information to “Crisis Pregnancy Centers” that provide false information with the intent to deter women from having an abortion.[19] Even once piece of inaccurate information can impede a patient’s ability to make an informed, autonomous decision. When these false facts are given to patients from the hands of trusted medical professionals, it has a more influential impact than when portrayed in media and advertisements. Trust is a core value in the medical profession that determines the patient-physician relationship, and a part of this trust is communicating accurate and up-to-date information; if this trust did not exist in medicine, how would any patient make an informed decision? Where would they turn to for guidance and advice?[20]Challenges to informed consent and autonomy exist throughout medicine, as consent forms are complicated and filled with medical vocabulary that is often hard to understand. Signatures are sometimes scribbled onto forms before a procedure with minimal discussions to assess the patient’s understanding of the many risks and benefits. However, abortions have an additional layer of complexity regarding informed consent due to the religious and moral implications of choosing an abortion, while other common medical procedures, such as an appendectomy, do not carry the same implications. For example, a patient consenting to general surgery would probably not wonder if their physician’s advice against the surgery is due to his or her own moral values, or what the moral weight of the surgery will have on their conscious afterwards. Informed consent, regardless of procedure, should prioritize informed decision-making with evidence-based medicine without moral overtones. When inaccurate, biased, and false information is given to patients from medical institutions, it not only threatens the trust between patients and medical staff, but also prevents women from making an informed decision about their reproductive health. If abortion doulas can be a source of correct, up-to-date medical information, then women can make informed decisions based on thorough and accurate facts that allow them to exercise autonomy. Abortion doulas are well situated to correct the factual inaccuracies patients face for several reasons. First, abortion doulas are trained through a curated program with partnered medical facilities.[21]In other words, abortion doulas are thoroughly trained in patient-centered care that facilitates continuous patient support, which ranges from emotional support to providing accurate medical information when addressing patient concerns. Second, they have the time before the procedure to meet with the patient and discuss pre-abortion care topics such as providing information, addressing concerns, and preparing the patient for potential stigmatization.[22]Simultaneously, the doula can evaluate for any risk factors that may indicate negative emotions after the abortion, such as lack of social support, self-esteem, psychological stability, or multiple abortions.[23]Third, abortion doulas can provide post-abortion care counseling. While the doulas also have limited time with patients after the procedure, they would have more time than other healthcare professionals, such as nurses, to make sure the patient understands the medication regime while also offering psychological counseling for the patient on grief, guilt, and forgiveness.[24]With doulas providing technical post-procedure information, this allows them to answer any more questions that the patient may have about misleading, biased, out-of-date, or false information. Therefore, doulas can enhance patient autonomy by giving more accurate information. IV. Stigma Another critical problem facing patients who seek abortions is the stigma surrounding the procedure itself. An abortion requires many decisions to be made: do you want to be sedated or awake for the procedure? If you are awake, do you want someone to hold your hand or someone to talk to? Do you want to have privacy after the procedure? In fact, the first decision to be made is whether to have the abortion at all. For some women, that decision is immediate, quick, and assured. For others, the decision can be morally conflicting, such as due to religious reasons, society’s stigma, or other reasons. The moral conflict a woman faces when deciding on an abortion is determined by how much moral weight they apply to a fetus or embryo.[25]An abortion can make a woman feel as though they are a bad person or doing something morally wrong, especially if they place more weight on the moral status, or viability, of the fetus or embryo.[26]Regardless of why a woman feels conflicted, the bottom line is that these feelings exist, which can affect their decision-making abilities during the actual process. Our society stigmatizes women for having an abortion, it is our “modern-day Scarlet Letter.”[27]This stigma is under-researched but often theorized to be based on gender-biased roles of women in society.[28]Women who receive an abortion are labeled as “irresponsible” for having an unwanted pregnancy, or “selfish” and “unmotherly” for not wanting children. Therefore, women avoid judgement and prefer privacy during their abortion—but are these choices made because that is truly what a woman desires, or are they making these choices to avoid stigma? And, if they are making these choices to avoid stigma, how does it affect their autonomy as a decision-maker for their own healthcare choices? There is a difference between secrecy and privacy: women may want to keep their abortion decision private, like any other medical decision or health information.[29]However, some women make the decision in secret to avoid judgment and stigmatization. There is evidence that stigma plays a role in every decision of the abortion process. For example, one study explores the reasons why some women prefer to be awake versus asleep during the procedure. Women who choose to be asleep want to be less emotionally present for the fear of “seeing something” during the procedure. On the other hand, women who choose to be awake want to feel present, safe, and receive support during the process.[30]The study also found that most women rated an abortion procedure a “good experience” if care was provided in a discreet and private manner.[31]By preferring anesthesia and privacy, many women try to avoid dealing with the stigma and judgement from others. The stigma also prevents women from seeking or receiving social support.[32]While some women may make these choices because it is what they truly want, others might choose these options to avoid others witnessing their decision and from being stigmatized as a woman who “got an abortion.” Although abortion doulas cannot completely abolish the overarching societal stigma, they can help in several different ways on an individualistic level. Abortion doulas may fit the role of personalizing each experience to fit patients’ specific preferences. Doulas have the time and appropriate training to understand and discuss the emotional burdens that come along with the social stigma that surrounds abortions.[33]They have the training to explore the patient’s reasons for their decisions and can make sure they are comfortable with them. They do so in a non-judgmental way and strive to act as an advocate for the patient.[34]By listening to women and validating their decisions, women may not feel as many negative emotions surrounding the stigma or feel empowered that they made the right decision for themselves, regardless of social labels. This validation and empowerment gives women more agency in their own healthcare decisions while also providing emotional support in a situation that requires many difficult choices. Abortion doulas would become a support system for women, thereby promoting feminist ethics by normalizing emotions in a morally charged decision. They also promote the principal of beneficence by helping patients address any conflict between societal stigma and the woman’s own beliefs and morals. V. Barriers to Quality Care Access to abortion is limited: only 62 percent of American women live in counties with an abortion provider.[35]Many insurance companies do not cover abortions and clinics are often busy with limited availability, staff, and resources. Additionally, many women would need time off from work, childcare, transportation, and other resources to make it to any medical appointments—abortion care is not an exception. Currently, there are no professional programs for abortion providers to offer post-abortion counseling.[36]Additionally, in busy clinics, hospitals, or non-profit organizations such as Planned Parenthood, physicians attempt to provide as many abortions as possible to as many patients, leaving little time for post-abortion care. Provider burn-out is a major problem throughout healthcare, which has become more pronounced throughout the COVID-19 pandemic. Many providers, nurses, and other hospital staff are overworked and underpaid while hospitals themselves are overcrowded and underfunded. Moreover, abortion providers may be especially vulnerable to burn-outas they tend to both their patient’s medical and emotional needs during a procedure that has both physical pain and a plethora of emotion surrounding it.[37]With an increase in patient number due to decreased availability of services and a physician’s responsibility to tend to the patient’s emotional well-being and physical pain, this increases the risk of provider burn-out, which in turn, can affect the quality of medical care given to women receiving abortions.[38] Abortion doulas can fill the role of providing post-abortion care and help alleviate provider burn-out in many ways. First, as mentioned previously, they have the time before the procedure to meet with the patient and discuss pre-abortion care topics, provide information, and answer questions.[39]Secondly, abortion doulas can provide patients with the post-abortion care counseling that many physicians and nurses are not able to provide. This role has multiple effects. While post-abortion counseling can help address factual inaccuracies through answering questions, it can also allow doulas to make sure the patient understands the medication regime and how to deal with the pain that follows the procedure.[40]With doulas providing technical post-procedure information, this relieves understaffed nurses of some of their many tasks and responsibilities in the post-abortion recovery room; this will likely decrease the number of women who come back to the clinic or hospital with complications or additional questions. By discussing various emotions during post-procedure counseling, doulas support women by listening to their feelings. Some women may feel relief and joy after the procedure, while other may feel despair, regret, grief, or shame. When a doula listens to and supports a patient, they validate their emotions and indirectly validate their abortion decision, thereby improving the quality of the experience. Lastly, the integration of doulas into routine abortion care allows physicians and staff to concentrate on the procedure itself.[41]The doula can offer patient-centered, hands-on care to the patient while the rest of the healthcare team focuses on their own technical tasks.[42]Doula support can also decrease the need for more clinic staff in the procedure room by “decreasing the redirection of clinic staff resources,”thus creating a more efficient medical environment.[43]As the historical role of a doctor playing every role is becoming more obsolete, and the idea of a multi-faceted, integrative healthcare team is becoming the norm, it makes sense that an abortion doula can fill a niche on a healthcare team for emotionally laden procedures like abortions. The niche that the doula fills is to support, comfort, and be present with the patient throughout the entirety of the procedure in a nonjudgmental way. While nurses and doctors can be supportive, sympathetic, and caring, their jobs and roles include other responsibilities that do not allow them to be a continuous presence for the patient throughout their visit.[44]By having a person on the healthcare team whose job is to provide patient support, even if it is simply to hold their hand, the patient is more likely to be treated as a whole and provided better quality medical care. CONCLUSION Inaccurate information, stigma, and quality of care barriers are only a few of the many problems facing patients who want to receive an abortion. Each problem poses ethical challenges while also impeding quality medical care and adding to patients’ emotional burdens. Inaccurate facts and stigma hinder an informed decision, and thereby, threaten patient autonomy. The stigma of abortion can also lead to patients experiencing more negative emotions. Furthermore, healthcare barriers include a wide range of problems, from understaffed clinics to provider burn-out, all of which affect the quality and access to care for patients seeking an abortion. Abortion doulas are part of the solution to these problems. They are an extra resource, a set of hands for the patients to hold in the procedure room, and an expert in providing emotional and social support for the patient. They can enhance a patient’s decision-making skills, support the patient’s emotional well-being, answer factual questions, counter stigma, and help provide quality medical care. Therefore, abortion doulas enhance patient autonomy, promote beneficence, improve access to quality abortion care, and fill a necessary role during the abortion process. [1]Shakouri, Shireen Rose "The Doula Project." Ed. Lee, Shannon2019. Print. [2]Shakouri, Shireen Rose "The Doula Project." Ed. Lee, Shannon2019. Print. [3]Onyenacho, Tracey. "Abortion Doulas Help People Navigate the Process. They Say Their Work Was More Crucial Than Ever in the Pandemic." The Lily 2021. Web. 12/29/2021 2021 [4]Onyenacho, Tracey. "Abortion Doulas Help People Navigate the Process. They Say Their Work Was More Crucial Than Ever in the Pandemic." The Lily 2021. Web. 12/29/2021 2021 [5]Onyenacho, Tracey. "Abortion Doulas Help People Navigate the Process. They Say Their Work Was More Crucial Than Ever in the Pandemic." The Lily 2021. Web. 12/29/2021 2021 [6]Dukehart, Coburn. "Doulas: Exploring a Tradition of Support." The Baby Project. National Public Radio 2011. Web2021. [7]Roberts, Sam. "Dana Raphael, Proponent of Breast-Feeding and Use of Doulas, Dies at 90." New York Times 2016. Web2020. [8]Roberts, Sam. "Dana Raphael, Proponent of Breast-Feeding and Use of Doulas, Dies at 90." New York Times 2016. Web2020. [9]Scott, K. D., P. H. Klaus, and M. H. Klaus. "The Obstetrical and Postpartum Benefits of Continuous Support During Childbirth." J Womens Health Gend Based Med 8.10 (1999): 1257-64. Print. [10]Scott, K. D., P. H. Klaus, and M. H. Klaus. "The Obstetrical and Postpartum Benefits of Continuous Support During Childbirth." J Womens Health Gend Based Med 8.10 (1999): 1257-64. Print. [11]Chor, J., et al. "Doulas as Facilitators: The Expanded Role of Doulas into Abortion Care." J Fam Plann Reprod Health Care 38.2 (2012): 123-4. Print. [12]Nash, Elizabeth; Gold, Rachel Benson; Mohamed, Lizamarie; Ansari-Thomas, Zohra; Capello, Olivia "Policy Trends in the States, 2017." Guttmacher Instititue 2018. Web. [13]Richardson, Chinue Turner; Nash, Elizabeth. "Misinformed Consent: The Medical Accuracy of State-Developed Abortion Counseling Materials " Guttmacher Policy Review 9.4 (2006). Print. [14]Buchbinder, Mara, et al. "“Prefacing the Script” as an Ethical Response to State-Mandated Abortion Counseling." AJOB Empirical Bioethics 7.1 (2016): 48-55. Print. [15]Buchbinder, Mara, et al. "“Prefacing the Script” as an Ethical Response to State-Mandated Abortion Counseling." AJOB Empirical Bioethics 7.1 (2016): 48-55. Print. [16]Richardson, Chinue Turner; Nash, Elizabeth. "Misinformed Consent: The Medical Accuracy of State-Developed Abortion Counseling Materials " Guttmacher Policy Review 9.4 (2006). Print. [17]Richardson, Chinue Turner; Nash, Elizabeth. "Misinformed Consent: The Medical Accuracy of State-Developed Abortion Counseling Materials " Guttmacher Policy Review 9.4 (2006). Print. [18]Blevins, Christy A., et al. "The Posttraumatic Stress Disorder Checklist for Dsm-5 (Pcl-5): Development and Initial Psychometric Evaluation." Journal of Traumatic Stress 28.6 (2015): 489-98. Print. [19]Richardson, Chinue Turner; Nash, Elizabeth. "Misinformed Consent: The Medical Accuracy of State-Developed Abortion Counseling Materials " Guttmacher Policy Review 9.4 (2006). Print. [20]Pellegrini, C. A. "Trust: The Keystone of the Patient-Physician Relationship." J Am Coll Surg 224.2 (2017): 95-102. Print. [21]Shakouri, Shireen Rose "The Doula Project." Ed. Lee, Shannon2019. Print. [22]Chor, Julie, et al. "Factors Shaping Women’s Pre-Abortion Communication with Members of Their Social Network." Journal of Community Health 44.2 (2019): 265-71. Print. [23]Harris, Amy A. "Supportive Counseling before and after Elective Pregnancy Termination." Journal of Midwifery & Women’s Health 49.2 (2004): 105-12. Print. [24]Chor, Julie, et al. "Factors Shaping Women’s Pre-Abortion Communication with Members of Their Social Network." Journal of Community ` Health 44.2 (2019): 265-71. Print. [25]Watson, Katie. The Scarlet A Oxford University Press, 2018. Print. [26]Altshuler, A. L., et al. "A Good Abortion Experience: A Qualitative Exploration of Women's Needs and Preferences in Clinical Care." Soc Sci Med 191 (2017): 109-16. Print. [27]Watson, Katie. The Scarlet A Oxford University Press, 2018. Print. [28]Norris, A., et al. "Abortion Stigma: A Reconceptualization of Constituents, Causes, and Consequences." Womens Health Issues 21.3 Suppl (2011): S49-54. Print. [29]Watson, Katie. The Scarlet A Oxford University Press, 2018. Print [30]Altshuler, A. L., et al. "A Good Abortion Experience: A Qualitative Exploration of Women's Needs and Preferences in Clinical Care." Soc Sci Med 191 (2017): 109-16. Print. [31]Altshuler, A. L., et al. "A Good Abortion Experience: A Qualitative Exploration of Women's Needs and Preferences in Clinical Care." Soc Sci Med 191 (2017): 109-16. Print. [32]Norris, A., et al. "Abortion Stigma: A Reconceptualization of Constituents, Causes, and Consequences." Womens Health Issues 21.3 Suppl (2011): S49-54. Print. [33]Basmajian, Alyssa. "Abortion Doulas." Anthropology Now 6.2 (2014): 44-51. Print. [34]Amram, Natalie Lea, et al. "How Birth Doulas Help Clients Adapt to Changes in Circumstances, Clinical Care, and Client Preferences During Labor." J Perinat Educ.2: 96-103. Print. [35]Dennis, Amanda, Ruth Manski, and Kelly Blanchard. "A Qualitative Exploration of Low-Income Women's Experiences Accessing Abortion in Massachusetts." Women's Health Issues 25.5 (2015): 463-69. Print. [36]Harris, Amy A. "Supportive Counseling before and after Elective Pregnancy Termination." Journal of Midwifery & Women’s Health 49.2 (2004): 105-12. Print. [37]Chor, J., et al. "Integrating Doulas into First-Trimester Abortion Care: Physician, Clinic Staff, and Doula Experiences." J Midwifery Womens Health 63.1 (2018): 53-57. Print. [38]Jerman J, Jones RK and Onda T. "Characteristics of U.S. Abortion Patients in 2014 and Changes since 2008." Guttmacher Instititue 2016. Web. [39]Chor, Julie, et al. "Factors Shaping Women’s Pre-Abortion Communication with Members of Their Social Network." Journal of Community Health 44.2 (2019): 265-71. Print. [40]Chor, Julie, et al. "Factors Shaping Women’s Pre-Abortion Communication with Members of Their Social Network." Journal of Community Health 44.2 (2019): 265-71. Print. [41]Chor, J., et al. "Integrating Doulas into First-Trimester Abortion Care: Physician, Clinic Staff, and Doula Experiences." J Midwifery Womens Health 63.1 (2018): 53-57. Print. [42]Chor, J., et al. "Integrating Doulas into First-Trimester Abortion Care: Physician, Clinic Staff, and Doula Experiences." J Midwifery Womens Health 63.1 (2018): 53-57. Print. [43]Chor, J., et al. "Doula Support During First-Trimester Surgical Abortion: A Randomized Controlled Trial." Am J Obstet Gynecol 212.1 (2015): 45.e1-6. Print. [44]Basmajian, Alyssa. "Abortion Doulas." Anthropology Now 6.2 (2014): 44-51. Print.

Happy New Year from the Editor

Dear readers, advisors, authors, editors, and peer reviewers, As we welcome the new year, we look forward to the opportunity to publish new arguments and pose challenging questions about ethical dilemmas in the realm of medicine, science, and technology. Reflecting on the peer review process at this juncture seems especially important considering the bioethics climate and the challenges in doing justice to ethical dilemmas. Unlike scientific peer review, replicability, reliability, and evaluation of methods are largely irrelevant to much of the bioethics literature, except for empirical research. Much like papers published in law, the humanities, and social sciences, peer reviewing contextual arguments in bioethics requires us to evaluate argument validity and ensure that arguments are based on facts or appropriate hypotheticals. The risk that voices are quieted merely because the editorial staff or peer reviewers would choose the other side of an argument is high and requires mitigation steeped in serious processes built into the peer review system. It is especially important to hear diverse views that represent many points along a continuum during polarized times. The papers that offer conceptual arguments that we tend to publish at Voices in Bioethics call for an examination of logic and argument foremost, with a special emphasis on which conclusions are drawn from the premises supplied. At Voices in Bioethics, the peer review process aims to be inclusive, so we balance our instincts to criticize with our goal to accept as many papers that meet our guidelines as possible. We welcome new arguments, especially ones that highlight overlooked viewpoints, considerations, or stakeholders. We acknowledge how many great ideas result from people who speak English as a second or third language, or who do not use English at all. All of those affected by or who observe an ethical dilemma are welcome to submit their ethics arguments surrounding health care, technology, the environment, and the broader sciences. We are happy to read papers by those outside of bioethics and those with any level of education. We use the peer review questions about mechanics only to inform editors of what the process might entail. We do not accept or reject based on mechanics or style alone. The nature of many bioethics journals is to publish papers that may reflect the bioethics status quo or apply common bioethical frameworks to new problems. In addition to that, we try to showcase new ways of thinking and additional considerations. After all, publishing is not about publishing papers that mimic older well-cited articles or that apply only those frameworks learned in the classroom. It is about giving voice and contributing to an open access ecosystem where new and old ideas coexist, their worth measured not in hits or likes, but in their contribution to ethical analysis. Wishing a happy new year to our advisors, editors, peer reviewers, authors, and readers.

Amending Federal Regulations to Counteract Language Barriers in the Informed Consent Process

Photo by Amador Loureiro on Unsplash ABSTRACT As English is the predominant language of research protocols in the United States, non-English speaking subjects face language barriers during clinical trial enrollment. Federal regulation 45 C.F.R. 46 requires that a research subject receive information about a clinical trial “in language understandable to the subject or the legally authorized representative." A researcher may enroll a subject using short-form consent when a long-form translation in the subject’s native language is not available. However, the abbreviated short form does not adequately inform the subject of the study’s purpose and potential risks. United States Department of Health and Human Services (HHS) leaders should amend federal guidance to provide specific details on obtaining proper informed consent when there is a language barrier. The code of federal regulations should also establish a standard for quality translation services and interpreters. This paper will review current federal regulations and draft policy, analyze literature describing hospital experiences, and discuss non-compliance areas. This author recommends an amendment to federal policy, which is important because it helps ensure the rights of study participants under the principle of justice. INTRODUCTION As English is the predominant language of research protocols in the United States, non-English speaking subjects face language barriers during clinical trial enrollment. Law requires that a research subject should receive information about a clinical trial “inlanguage understandable to the subject or the legally authorized representative.”[1]This law states that a researcher may enroll a subject using a “short-form” consent when a “long-form” translation in the subject’s native language is not available.[2]However, the abbreviated short form does not adequately inform the subject of the study’s purpose and potential risks. Furthermore, the law does not outline a standard for quality translators. United States Department of Health and Human Services (HHS) leaders should amend federal guidance to provide specific details on obtaining proper informed consent when there is a language barrier.[3]The Code of Federal Regulations should also establish a standard for quality translation services and interpreters. This paper will review current federal regulations and draft policy, analyze literature describing hospital experiences, and discuss non-compliance areas. I. Draft Guidance In 1995, HHS issued a policy memo clarifying the informed consent process for individuals who do not speak English.[4]The policy states that the witness required for the signing of consent documents should be fluent in both languages and that the study team should issue a translated short form.[5]The guidance still does not require an official translator in the short-form process. However, if used, the translator may serve as witness as well.[6]The policy does not mention the translator’s language proficiency requirements or whether the institution must provide the translator.[7] In 2014, HHS issued draft guidance to expand upon the requirements for informed consent. Per its disclaimer, the guidance is non-binding and not intended for implementation.[8]First, the guidance attempts to clarify the phrase “language understandable”, by adding “the information presented to potential subjects is in a language, and at a level they can comprehend, including an explanation of scientific and medical terms.”[9]The draft guidance also notes that all potential research subjects needing translation might have a low level of health literacy and education. Suppose the research subjects expect a non-English speaking group of participants for enrollment. In that case, the guidance suggests that the researchers provide a long-form translation of study materials before an institutional review board (IRB) initial review of the “appropriately translated consent documents (i.e., either a long form or a short form with written summary).”[10]To satisfy the guidance, researchers would need to provide multiple translations of the same document as the study progresses and the IRB proposes edits to the long-form English document. Because translating the informed consent forms is costly and time-consuming, having a long form available is not always feasible or practical. Foreseeing this problem, HHS outlined three steps for what to do when a subject’s language is not expected or planned for in the population. First, the guidance suggests that the investigator “determine that there is Sufficient Justification to Enroll the Subject Without Using a Translated Long-form to Document the Subject’s Informed Consent.”[11]Although this provision protects non-English-speaking subjects from uninformed consent, it adds a barrier to enrollment. The investigator must justify the registration of the individual based on the individual’s language. The justification process may delay enrollment, placing individuals at a disadvantage based on their language. If the researcher can adequately justify and use the short-form consent process, the investigator must then translate the long-form consent. After the subject starts participating in research, the investigator then provides the long-form translated document. II. Short Form and Noncompliance Vagueness in the federal regulations has caused disparate interpretation among institutions, leading to noncompliance.[12]Each institution has its own interpretation of 45 CFR 46, also known as the Common Rule, which protects vulnerable research subjects and provides research teams with a short-form template.[13]As noted above, the regulations do not require a translator, nor do they specify the translator’s specific role or qualifications.[14]HHS has not made it clear whether the witness may be a member of the study team or related to the patient, or whether the witness providing interpretation must be independent. Furthermore, it is not clear if the witness is overseeing merely the signing of the document or serving as a witness to the informed consent process.[15]In review of noncompliance areas, the institution should clarify the use of short-form consent, the witness’s role, and impose qualification requirements for translators.[16]Each institution will have its own resources and interpretations. Therefore, non-English speakers will find different translation quality across many research institutions. An individual may receive a different research experience and quality of language resources based on location and the degree to which their language was expected by the research team. This barrier is an implicit form of discrimination and violates the principle of justice. III. Equitable Selection of Subjects Minority populations are underrepresented in research due to a lack of cultural competence and language barriers to subject recruitment.[17]Paradoxically, minority populations are most impacted by many of the diseases for which there are clinical trials.[18]In 2015, researchers surveyed 10,000 studies registered on clinicaltrials.gov.[19]The authors found, “English fluency requirements have been increasing over time, from 1.7% of trials having such requirements before 2000 to 9.0% after 2010.”[20]Researchers who often exclude non-English speaking ethnic minorities claim that diversity may impact whether the studied intervention’s effect is noticed.[21]This manipulation of the subject population goes against the principle of justice outlined in the Belmont Report. Of 14,367 clinical research studies registered on clinicaltrials.gov between 2010 and 2020, 18.98 percent required subjects to be fluent in English.[22]Regulations and institutions do not compel researchers to include non-English speaking subjects; the researcher is not breaking any federal regulations by excluding them. From an ethical standpoint, the deliberate exclusion based on an inability to read/write in English is inequitable and unjust. In 2018, researchers reviewed enrollment rates and staff competency for subject enrollment.[23]Researchers found low levels of cultural competency among research staff and a misunderstanding of the federal regulations.[24]In 2005, researchers reviewed the importance of cultural competency training for healthcare providers.[25]Authors synthesized data based on 34 programs and found that competency programs improved provider “knowledge, attitudes, and skills, and patients’ ratings of care.”[26]However, cultural competency programs did not improve or impact patient compliance and health outcomes.[27]Authors requested more research to evaluate cultural training’s impact on researcher bias and attitudes toward subject inclusion.[28] IV. Institutional Barriers In 2018, researchers conducted a review of approximately 1,500 clinical trials at Boston Children’s Hospital and its Anesthesia Research Unit to identify enrollment barriers for non-English-speaking subjects.[29]The researchers discovered that the number of potential non-English speaking subjects increased, while the number of studies approved to enroll non-English speaking subjects did not grow at the same rate.[30]Of 1,492 studies that were open to enrollment between 2011 and 2016, 714 did not allow non-English speaking subjects.[31]The institution cited six barriers to enrollment that precluded these minority-language populations (Table 1).[32] The barriers described in Categories 1, 3, and 5 are due to a lack of translators, funding, or validated translated material. Categories 2, 4, and 6 may reflect an implicit bias on the institution’s part and suggest a lack of cultural understanding. Some researchers[33]called on the institution to increase cultural awareness and to provide resources to address the effects of the language barrier on enrollment.[34]However, with no set standard on the institutional level, it is up to the researchers to address this discrepancy and uphold the principle of justice. The uneven distribution of resources requires the research subjects to counteract their own language barrier. In many clinical cases, as time is of the essence, a person may need to seek several research options before participating in their desired study. Until each institution discloses its barriers and noncompliance, we have no way of knowing the full extent of this problem. V. Policy Recommendations The current HHS regulations and draft guidance are not sufficient to resolve implicit bias and logistical problems that arise when enrolling non-English speaking subjects. HHS should take the following actions. First, HHS should translate short-form consent forms for the most common languages in the US. HHS should then publish the translated documents for use as a template on its website for centers that lack adequate translation resources. Second, HHS should create a federal database of qualified translators who meet language proficiency benchmarks established by HHS. Individuals listed on this database should provide written translation of study materials and verbal translations during the consent process. The database should contain individuals affiliated and unaffiliated with an institution to track credentials and verify language proficiency. Third, HHS should create a federal fund for institutions to draw from when they need resources for long-form translations or translators. HHS should amend the Common Rule to add specificity. It should define the role of the witness in the short-form consent process to eliminate unequal interpretations across study sites. Second, it should mandate that the IRB obtain strong justification for the exclusion of subjects based on English-fluency criteria. Third, it should recommend cultural competency programs for investigators at the institutional level. VI. Limitations The proposed actions and policy may face objections from the federal government and industry. At the federal level, the government may not have the resources or funding needed to establish a nationwide registry of translators or quality check for fluency. HHS may need to develop a separate office to track these credentials and select a proficiency baseline. Perhaps an independent organization should be contracted by the government to perform these quality checks on a regional basis and call on the states to help fund the project. Also, the federal government may not have adequate resources to create a national fund for institutional-level translation services. One solution may be to include a flat rate of translation in the site budget during start-up activities. The government would be responsible for translations for government-sponsored research when the institution cannot feasibly provide a translation. Research centers can pull from the translator database for institutional studies if they cannot translate in-house. For pharmaceutical corporation-led protocols, industry sponsors may not appreciate the added cost of translation. However, by mandating the fee, the government would eliminate systemic discrimination based on English fluency. VII. Support Researchers should show support for more specific guidance on the institutional level, granted they receive adequate resources to meet the regulations. By clarifying the use of a translator and the role of a witness, and establishing common resources, every institution will benefit. Furthermore, it is crucial to hold institutions accountable for supporting cultural competency initiatives. These programs do not need to be intensive or expensive; there are many resources available to the public on websites such as YouTube. Institutions should make cultural competency programming a mandatory requirement for staff training during the orientation and continuing education. Encouraging cultural competency programs will improve provider attitudes and subject treatment. CONCLUSION Federal regulations do not require the use of resources when enrolling a subject who is non-English speaking, nor do they mandate the inclusion of “unexpected” populations based on language. Lack of clarity and specificity on the federal level places the onus of responsibility on the institution to mitigate language barriers. The lack of universal policy leads to an unequal research experience among institutions and locations. Furthermore, clinical trial sponsors may manipulate data based on limiting the study population and engaging in studies that overly represent homogeneous populations. Influencing the study population will skew results and will not lead to generalizable knowledge. To uphold the principle of justice, the research community must gather its resources to support non-English speaking subjects who wish to participate in research. [1]“45 C.F.R. 46 FAQs,” 45 C.F.R. §46.116 (a)(3), Office for Human Research Protections, last modified 2018, https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/45-cfr-46/index.html#:~:text=Basic%20regulations%20governing%20the%20protection,were%20first%20published%20in%201974. [2]Office for Human Research Protections, “45 C.F.R. 46 FAQs.” [3]“Protection of Human Subjects, 45 C.F.R.§ 46,” United States Department of Health and Human Services, last modified 2018, https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML. [4]Office for Human Research Protections, 45 C.F.R. §46.117(b)(2), “45 C.F.R. 46 FAQs.” [5]The researcher can orally present the information to the subject or LAR, with a witness present, and provide a short-form of consent with a brief written summary of the research. [6]“Informed Consent of Subjects Who Do Not Speak English,” Office for Human Research Protections, last modified February 25, 2016, https://www.hhs.gov/ohrp/regulations-and-policy/guidance/obtaining-and-documenting-infomed-consent-non-english-speakers/index.html. [7]Lad, Pramod M., and Rebecca Dahl. "Overcoming Language Barriers in the Informed Consent Process: Regulatory and Compliance Issues With the use of the ‘Short Form.’” Accountability in Research 21, no. 5 (2014): 315-320. https://doi.org/10.1080/08989621.2013.848801. [8]“Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors Draft Guidance,” Office of the Commissioner, last modified 2014, https://www.fda.gov/media/88915/download. [9]Office of the Commissioner, “Informed Consent Information Sheet Guidance.” [10]Office of the Commissioner, “Informed Consent Information Sheet Guidance.” [11]Office of the Commissioner, “Informed Consent Information Sheet Guidance.” [12]Lad and Dahl, “Regulatory and Compliance Issues.” [13]Lad and Dahl, “Regulatory and Compliance Issues.” [14]Lad and Dahl, “Regulatory and Compliance Issues.” [15]Lad and Dahl, “Regulatory and Compliance Issues.” [16]Lad and Dahl, “Regulatory and Compliance Issues.” [17]Staples, Jeanine N. et al., "Language as a Barrier to Cancer Clinical Trial Accrual: Assessing Consenting Team Knowledge and Practices for Cancer Clinical Trial Consent Among Low English Fluency Patients." Applied Cancer Research 38, no. 1 (2018): 1-7.https://doi.org/10.1186/s41241-018-0065-9. [18]Staples et al., “Language as a Barrier.” [19]Egleston, Brian L. et al., "Characteristics of Clinical Trials That Require Participants to be Fluent in English." Clinical Trials 12, no. 6 (2015): 618-626.https://doi.org/10.1177/1740774515592881. [20]Egleston et al., “Characteristics of Clinical Trials.” [21]Egleston et al., “Characteristics of Clinical Trials.” [22]Muthukumar AV, Morrell W, Bierer BE (2021) Evaluating the frequency of English language requirements in clinical trial eligibility criteria: A systematic analysis using ClinicalTrials.gov. PLoS Med 18(9): e1003758. https://doi.org/10.1371/journal.pmed.1003758 https://doi.org/10.1080/08989620600654043. [23]Staples et al., “Language as a Barrier.” [24]Staples et al., “Language as a Barrier.” [25]Beach, Mary Catherine et al., "Cultural Competency: A Systematic Review of Health Care Provider Educational Interventions." Medical Care 43, no. 4 (2005): 356. https://doi.org/10.1097/01.mlr.0000156861.58905.96. [26]Beach et al., “Cultural Competence,” 8. [27]Beach et al., “Cultural Competence,” 8. [28]Beach et al., “Cultural Competence,” 8. [29]Bernier, Rachel et al., "Inclusion of Non‐English‐Speaking Patients in Research: A Single Institution Experience." Pediatric Anesthesia 28, no. 5 (2018): 415-420. https://doi.org/10.1111/pan.13363. [30]Bernier et al., “Inclusion of Non-English-Speaking Patients.” [31]Bernier et al., “Inclusion of Non-English-Speaking Patients.” [32]Bernier et al., “Inclusion of Non-English-Speaking Patients.” [33]Lad and Dahl, “Regulatory and Compliance Issues.” [34]Bernier et al., “Inclusion of Non-English-Speaking Patients.”

The Pitfalls of the Ethical Continuum and its Application to Medical Aid in Dying

Photo by Hannah Busing on Unsplash INTRODUCTION Religion has long provided guidance that has led to standards reflected in some aspects of medical practices and traditions. The recent bioethical literature addresses numerous new problems posed by advancing medical technology and demonstrates an erosion of standards rooted in religion and long widely accepted as almost axiomatic. In the deep soul-searching that pervades the publications on bioethics, several disturbing and dangerous trends neglect some basic lessons of philosophy, logic, and history. The bioethics discourse on medical aid in dying emphasizes similarity over previously recognized important distinguishing features. For example, it overplays a likeness between assistance in dying and the withdrawal of life-saving technology. In many bioethics’ topics, arguments based on a logical continuum are used to question the lines demarcating important moral differences. l. The Line Between Ethical and Not: Logic Based on Continuum Careful case selection, often either end of a continuum, allows the tearing down or ridiculing of many rules and codes across most professions and fields of interest. This situation holds true for traffic laws as well as medical ethics guidelines. It is relatively simple for those who desire to attack a particular viewpoint by selecting a case that makes that position seem untenable. In the ethics realm, good and bad medicine exist at opposite ends of an ethical continuum, with many practices lying in between. For example, much of medical ethics exists between the Nazi criminal physicians and the most sainted nurse or physician. A gradual progression occurred over less than two decades from a utilitarian position that supported limited euthanasia for those with certain mental illnesses to genocide. German society embraced a utilitarian ethic in which the value of human life no longer was intrinsic but instrumental.[1] Many morally significant points on a continuum were then ignored as the misguided utilitarian policy rampantly continued. A point in the continuum to distinguish between ethically justifiable and that which is not can be difficult to identify compared to the two extremes. This continuum is not unique to ethics but can be applied to almost any other aspect of human life and endeavor. Between a severely ill schizophrenic person and a superbly well-adjusted individual, there is a continuum of mental and psychological function. The existence of a continuum should not paralyze thinking and prevent us from drawing lines and identifying moral differences based on objective criteria as well as moral philosophy. Yet, by focusing on a continuum, many bioethicists use logic to disregard dividing lines between an "ethical" and an "unethical" act. Unfortunately, sometimes bioethicists draw revolutionary conclusions that would change the scope of medical practices which is accepted as ethical. There are many examples of similar shifts on the continuum. Many authors argue for the ethical permissibility of abortion by pointing out that the human fetus is no different in various characteristics, one arguing it is as like an ape or chick as it is like a person,[2] and does not achieve unique human and individual characteristics until well into the first year of life.[3] While human fetuses arguably do not have certain distinctive qualities of personhood, most people shy away from the logical next conclusion: permitting infanticide. For example, Joshua Lederberg condemns infanticide, in the face of biological illogic, because of our emotional commitment to infants, to me, a relatively weak explanation. Sir Francis Crick suggests we might consider birth at two days of life in order to decide whether an infant is a "suitable" member of society.[4] Giublini and Minerva suggest that infanticide should be permissible since late pregnancy abortions are permissible, arguing there is no significant difference between a fetus just before birth and an infant just after birth.[5] Clearly the continuum approach would allow for subjective arguments in favor of later infanticide at other points many days post-birth. Years ago, with a cynical tone, I mentioned infanticide as a further step on the continuum beyond abortion, and I was rightly shouted down as being deliberately provocative to assert the logic would ever stretch so far. While it is not an accepted mainstream position, the movement in academic settings from widespread condemnation to limited possible acceptance of infanticide has taken place in an incredibly short time. Public opinion and medical opinion in these areas have shifted dramatically in a short time. In another area, from a biological and chemical point of view, there is a continuum from man down to a single carbon atom. Yet, it would not seem logical to ignore the emotional differences, the meaning of personhood, or the moral distinction between killing an insect and killing a person. ll. A False Continuum: Medical Aid in Dying I assert that there has been an erosion of ethical guidelines in recent years attributable to using continuums to camouflage important distinctions. James Rachels’ work on active and passive euthanasia, which contends that the two are ethically identical, exemplifies that logic.[6] He illustrates this thesis, using a continuum to compare different scenarios with like consequences as morally equivalent, by comparing the deliberate drowning of a child with a deliberate failure to rescue a drowning child when easily able to do so. The author's comparison proposes that since much of the medical profession has already made peace with withholding treatment in order to hasten death, consistency inexorably demands that we permit active euthanasia as well.[7] When permission for active euthanasia was first introduced, it was limited exclusively to patients suffering severely from an intractable, incurable, and irreversible disease. These guidelines have been continuously eroded. There is now a substantial serious consideration for permitting active euthanasia of healthy elderly individuals who feel that they have completed their lives and are "tired of living."[8] There are many moral and factual differences along the ethical continuum. In human life, there is a difference between a live baby and a fetus, between a viable fetus and one that is not, between a fetus and a zygote, and between a zygote and a sperm cell. Similarly, there is a difference between pulling a trigger to kill someone and not interfering in preventing his death, which is reprehensible though both may be. There is a difference between not resuscitating an 80-year-old man with cancer when his heart stops and injecting him with a fatal dose of potassium chloride. I argue that an overt act of taking life repels civilized human beings is to be commended and encouraged as the reverence for human life or even for just a moment of human life is one of the great contributions of our civilization. CONCLUSION As an orthodox Jew, I feel that divinely inspired guidelines that have stood the test of centuries shape my beliefs, and such guidelines contradict medical aid in dying. I cannot speak to the viewpoint of those who do not access religion in defining their moral stance, nor do I implicate them in the current bioethics' trends, as I am not aware of the personal role of religion in the lives of most such authors. While many nonreligious people have a firm philosophical grounding and oppose medical aid in dying, I suggest that in the absence of any religious or other absolute standards, developing logically defensible ethical guidelines may be challenging. At the least, religion may play a role in defining the points on the continuums that are ethically meaningful and refuting the trending beliefs that if the endpoint is the same, allowing different methods of arriving at that end are somehow ethically equal. The continuum of ways death may result does not negate analysis of whether death is brought about in ways that recognize the importance of life. The German philosopher Hans Jonas said, "It is a question whether without restoring the category of the sacred, the category most thoroughly destroyed by the scientific enlightenment, we can have an ethics able to cope with the extreme powers that we possess today and constantly increase and are compelled to use."[9] While countries vary on the role of religion in policy, with many emphasizing freedoms of religion, a recent position paper released by a group of Jewish, Christian, and Moslem leaders (the three Abrahamic religions) suggested the need for agreement on the unique sanctity of human life.[10] I would recommend that such a document serve as an example of consensus on critical foundational bioethical guidelines for democratic secular societies. - [1] Alexander L (1949) Medical science under dictatorship. New England Journal of Medicine, 241, p39-47 DOI10.1056/NEJM194907142410201 [2] Lederberg J. (1967) A geneticist looks at contraception and abortion, Annals of Internal Medicine 67, sup 2, 25-27. https:/doi.org/10.7326/0003-4819-67-3-25 [3] Ibid. [4] Editorial, Sociology: Logic of biology. Nature 220, 429 (1968) https://www.nature.com/articles/220429b0 [5] Giublini A Minerva F (2013) After-birth abortion: why should the baby live. J Med Ethics 39, 261- [6] Rachels J (1975) Active and passive euthanasia. New England Journal of Medicine 292, 78-80 [7] Ibid. [8] Cohen-Almagor R Euthanizing people who are "tired of life". in Euthanasia and Assisted Suicide-Lessons from Belgium. Ch 11 of Euthanasia and Assisted Suicide, Cambridge University Press pp173-187. 2017 and DOI; https://doi.org/10.1017/9781108182799.012 [9] Hans Jonas, Technology and Responsibility: Reflections on the New Tasks of Ethics, 1972, found as Chapter IX, Philosophical Essays, 1980. https://inters.org/jonas-technology-responsability [10] A position paper of the Abrahamic Monotheistic religions on matters concerning the end-of-life. Vatican Press 28 October 2019 https://press.vatican.va/content/salastampa/en/bollettino/pubblico/2019/10/28/191028f.html

Student Subjects in Research

Photo by Mikael Kristenson on Unsplash ABSTRACT Students represent a vulnerable population within faculty-led research at universities because of the incentivized extra credit option. Therefore, other forms of participation in should be offered, to ensure that their choice to undergo becoming a student participant is fully their autonomous choice. INTRODUCTION Extra credit— two words college students love hearing. As an undergraduate student, I was no different. Ranging from subjects like chemistry to psychology to political science, there was no lack of extra credit opportunities in the courses I took to fulfill my social science major and pre-medical requirements. Participating in my professors’ research studies seemed to be a mutually beneficial opportunity at first glance; I would receive a few extra points to buffer my grade in case I did poorly on an exam, and my professors would be able to easily recruit the participants they needed to churn out scientific findings. BACKGROUND Social sciences research, especially psychology research, which has been labeled “the science of the behavior of the college sophomore,” routinely includes students. For instance, 77 percent of all articles in two major psychology journals included research done with students.[1] There is literature describing how common recruitment of students from undergraduate or medical school classes in the US is, a practice documented since the 1920s.[2] Indeed, students enrolled in the Psychology 10 course at UCLA, for example, are not just incentivized to do so, but in fact, are “required to serve as psychological research subjects for a total of six hours or write three abstracts on articles from psychology journals, or do a combination of both.” [3] Professors widely use student participants in academic research because of their accessibility, convenience, and willingness to participate. However, such prevalent recruitment of undergraduate students as study subjects poses several ethical questions, necessitating more stringent regulation. ANALYSIS Incentivizing research participation with rewards may unduly influence students, tempting them to participate in research they would otherwise not want to engage. According to the Association for Clinical Research Professionals, undue influence “implies that individuals will agree to participate in research without a rational consideration of the information provided in the informed consent process”.[4] Undue influence typically involves providing financial incentives to individuals in great need of money, but undue influence pertains to non-financial incentives as well. For instance, my general chemistry professor offered authorship promises to students who could travel to Mexico and bring back samples of alcohol served at resorts for his study, which aimed to analyze the chemical content of resort alcohol. More often, professors use extra credit as an incentive. Though such an incentive may not seem highly harmful, students who are worried or anxious about their grades are in a particularly vulnerable position and may very well fail to deeply consider the risks or implications of participating in research that offers extra credit. Especially in intensive courses that may be graded on a curve, additional credit may seem like an unspoken requirement rather than an option. This was the case in some of my undergraduate courses; my organic chemistry professor offered extra credit to students who completed writing assignments designed to measure whether writing explanations of chemical reactions affected student understanding and performance in the course. Unsurprisingly, the majority of students participated in the research study, seeing it as integral to their grades. Furthermore, students are subject to an inherent, unbalanced power dynamic between themselves and their instructors. A student’s academic or professional standing may rely on the professor, who may boost grades or agree to write a letter of recommendation. Academic faculty members are on a payroll and thus retain a primary fiduciary responsibility to teach, educate, and protect their students.[5] However, many faculty members also advance and develop new scientific and academic knowledge through research positions. In studies that have student participants, professors can experience a conflict of interest while exercising their roles as researchers and instructors. These dual roles are especially risky in a study when a student participant must divulge personal information, which is then accessible to the professor. Students ought to participate in research out of their own volition, without the added pressure of benefits and risks reflected in their grades, recommendations, or professor relationships. It is also essential to consider the ethical principle of justice in this space and whether findings from the research using student samples are meant to be implemented in policy or clinical efforts within a broader, more diverse population. A 2010 study published in the journal Behavioral and Brain Sciences found that two-thirds of subjects in American psychology research were undergraduates studying psychology.[6] This finding raises the question of how such a disproportionate sampling has impacted the effect of clinical psychology on populations who may not have similar levels of education or socioeconomic status as the average college student. In general, student samples have historically been much more homogenous than non-student samples, which often leads to difficulties in replicating findings in the general population.[7] Nevertheless, researchers have an obligation to society to produce equitable results, and their research designs and sampling methods ought to reflect that. l. Counterarguments and Benefits of Student Research Granted, there is undoubtedly valuable research that seeks to study student populations exclusively, resulting in data relevant to student populations specifically. Additionally, critics may contend that research involving student subjects rarely poses major risks that call beneficence into question. One may also argue that research participation can be a helpful, behind-the-scenes learning experience for students to experience how to conduct research. Some studies and research designs involving students provide tangible benefits to students. For instance, studies that supplement current course material would provide valuable insight into key concepts and, thus, be acceptable. ll. Recommendations So how can institutions and individuals better regulate and ensure ethical practices within this area which has gone relatively unchecked? First, researchers should make an effort to randomly select a diverse sample if they intend the research to have far-reaching implications. Student participants are certainly easier to obtain and more accessible, but as the Belmont Report states, “the selection of research subjects needs to be scrutinized in order to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.”[8] Academia must seriously re-evaluate whether students are being “systematically selected” simply because of their accessibility, through additional training modules or educational videos upon hire. This isn’t to say that research should completely exclude student participation; rather, researchers should make more of an active effort to recruit a variety of participants without solely targeting students through student-specific incentives like extra credit. There are unique ethical dilemmas that arise with power imbalances and convenient sampling. Thus, research that necessitates student-specific sampling must be carried out and regulated carefully. Research incentives can still be offered, but any incentive involving extra credit should be coupled with a diverse range of alternatives that take a similar amount of time to complete. The ability to participate in and contribute to research is a privilege; working students may not be able to take time off to participate in research, so researchers should offer them some other compensated work that suits their schedules. Also, students and non-students should receive similar compensation, something impossible if extra credit is the form of compensation. To avoid a conflict of interest, professors should avoid recruiting current students for their personal research. Separating roles may also address some pressing concerns about the confidentiality of subjects, who might feel more comfortable answering research questions without the fear of having their own professor read or listen to them. A much better method for enrolling student participants is to randomly assign students who have voluntarily signed up through an online platform to studies run by professors who are not directly related to the student. During studies that use student participants, informed consent and attention to general research ethics are essential. From the start, students should be educated about informed consent and how power may alter the voluntariness of their consent. Students should also be clear about the incentives available to them, the risks of participating in such research, the ensured confidentiality of their responses, and their ability to opt-out of the study at any time. Even after the study concludes, students should be able to voice any concerns through an anonymous survey or hotline. Simultaneously, researchers and professors should debrief participants. Ultimately, these post-study efforts would increase the transparency of research involving student subjects while furthering the field of academia by identifying areas of ethical improvement. CONCLUSION Currently, most universities and IRBs have guidelines for research involving student subjects and there are various federal and state regulations protecting research subjects.[9],Yet students remain susceptible to a host of ethical issues, including undue influence, lack of justice, and the sense they would be penalized for opting out. With increased and standardized oversight initiatives such as the ones outlined above, universities can work towards ensuring a more ethical space for students to participate in and learn from the research efforts of faculty members. - [1] Burnett JJ, Dune PM. An appraisal of the use of student subjects in Marketing Research. Journal of Business Research. 1986;14(4):329-343. doi:10.1016/0148-2963(86)90024-x [2] Prescott HM. Using the student body: College and university students as research subjects in the United States during the Twentieth Century. Journal of the History of Medicine and Allied Sciences. 2002;57(1):3-38. doi:10.1093/jhmas/57.1.3 [3] “Sona Instructions for Undergraduate Participants • UCLA Department of Psychology.” UCLA Department of Psychology, 14 Sept. 2021, https://www.psych.ucla.edu/undergraduate/subject-pool-experiment-participation/sona-instructions-for-undergraduate-participants/. [4] Borasky, David, et al. “Paying Subjects to Take Part in Research: A New Perspective on Coercion and Undue Influence.” ACRP, 13 Mar. 2019, https://acrpnet.org/2019/03/12/paying-subjects-to-take-part-in-research-a-new-perspective-on-coercion-and-undue-influence/. [5] Ferguson, Linda M., et al. “Students' Involvement in Faculty Research: Ethical and Methodological Issues.” International Journal of Qualitative Methods, vol. 3, no. 4, 2004, pp. 56–68., https://doi.org/10.1177/160940690400300405. [6] Giridharadas, Anand. “A Weird Way of Thinking Has Prevailed Worldwide.” The New York Times, The New York Times, 25 Aug. 2010, https://www.nytimes.com/2010/08/26/world/americas/26iht-currents.html. [7] Peterson, Robert A. “On the Use of College Students in Social Science Research: Insights from a Second-Order Meta-Analysis.” Journal of Consumer Research, vol. 28, no. 3, 2001, pp. 450–461., https://doi.org/10.1086/323732. [8] Office for Human Research Protections (OHRP). “The Belmont Report.” HHS.gov, 16 June 2021, https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html#xbenefit. [9] U. S. department of education protection of human subjects. Home. https://www2.ed.gov/about/offices/list/ocfo/humansub.html. Published August 4, 2020; Students as Subjects. Massachusetts Institute of Technology COUHES. https://couhes.mit.edu/guidelines/students-subjects. Accessed December 2, 2021. Accessed November 28, 2021.

The Next Era of Biomedical Research

Photo by Clément Hélardot on Unsplash INTRODUCTION The history of biomedical research in the United States is both inspiring and haunting. From the first public demonstration of anesthesia in surgery at Massachusetts General Hospital to the infamous Tuskegee Experiment, we see the significant advances made for the medical field and the now exposed power dynamics that contribute to injustices when they are left unmonitored.[1] Over the past century, biomedical research led to positive change but also reinforced structural racism. Henrietta Lacks, whose tissue was used without her consent to generate HeLa cells, and the Tuskegee study research subjects, who were denied an existing treatment for syphilis, exemplify how biomedical research in the US has been a vector for exploiting minority groups in exchange for knowledge creation. As we usher in the age of computational medicine, leaders of the field must listen to calls from communities around the country and world to decrease the prevalence of structural racism in the next wave of medical advances.[2] We are vulnerable to perpetuating structural racism through algorithms and databases that will drive biomedical research and aid healthcare systems in developing new methods for diagnosing and treating illness. With guidelines from governmental funding agencies and inclusivity of racial and ethnic minorities in research and development communities, we can inch closer to a more just future for our nation's health. BACKGROUND Many health systems rely on commercial software to store and process their patient’s data. This software commonly comes with patented predictive algorithms that help providers assign a risk score to patients based on health needs. However, biases held by algorithm developers can reflect racial disparities and incorporate them in the algorithms if proper counterbalances are not in place to audit the work of algorithm designers.[3] Despite the recent digitization of healthcare data across the United States, racial bias has already found its way into healthcare algorithms that manage populations. ANALYSIS l. Use of Algorithms One landmark study that interrogated a widely used algorithm demonstrated that Black patients were considerably sicker than white patients at a given risk score, evidenced by signs of uncontrolled disease.[4] The algorithm predicted the need for additional help based on past expenditures, and we historically spend less on Black patients than white patients. Rectifying this bias would lead to three times as many Black patients receiving additional resources. The algorithm produces a treatment gap due to a history of unequal access to care and lower spending on people of color compared to white people in the healthcare system. The disconnect between the clinical situation and historical resource allocation exemplifies how certain predictors may produce an outcome that harms patients. The study shows that using a proxy measure for healthcare spending to quantify how sick a patient is instead of using physiologic data can amplify racial disparities. This example highlights the need for collaboration between clinicians, data scientists, ethicists, and epidemiologists of diverse backgrounds to ensure model parameters do not perpetuate racial biases. ll. Use of Big Data in Algorithm Creation In addition to eradicating algorithms that make decisions based on proxy measures encoding racial inequities, we must also be diligent about the content of databases employed in algorithm development. Racial disparities in a database may result from the intentional selection of a homogenous population or unintentional exclusion due to systemic issues such as unequal distribution of resources. For example, a genetic study conducted in a Scandinavian country is more likely to be racially homogenous and not generalizable to a broader population. Applying algorithms derived from homogenous populations to either diverse populations or to different homogenous populations would fail to account for biological differences and could result in a recess of care when used beyond the appropriate population. Additionally, companies like Apple or FitBit could de-identify consumer data collected using their wearable sensors and make it available in research. This is problematic because the demographic distribution of people who have access to their technology may not reflect the general population. To combat these potential disparities, we must construct freely accessible research databases containing patients with diverse demographic characteristics that better model the actual populations that a given model will serve. lll. Government-Based Safeguards Armed with an understanding of how systemic bias is integrated into algorithms and databases, we must strive to construct safeguards that minimize systemic racism in computational biomedical research. A potential way to step forward as a society would be aligning incentives to produce the desired results. Governmental agencies wield enormous power over the trajectory of publicly funded research. Therefore, it is crucial that computational biomedical research funding is regulated by procedures that encourage diverse researchers to investigate and develop healthcare algorithms and databases that promote our nation's health. For example, the National Institutes of Health (NIH) has set forth two large initiatives to catalyze equitable growth of knowledge and research in healthcare artificial intelligence (AI). The first initiative is the Artificial Intelligence/Machine Learning Consortium to Advance Health Equity and Researcher Diversity (AIM-AHEAD), which focuses on increasing diversity in researchers and data within AI/machine learning (ML). The program states that “these gaps pose a risk of creating and continuing harmful biases in how AI/ML is used, how algorithms are developed and trained, and how findings are interpreted.” Increased participation of researchers and communities currently underrepresented in AI/ML modeling can prevent continued health disparities and inequities. Programs like AIM-AHEAD are crucial to reducing the risk of creating and continuing harmful biases in biomedical research. With the four key focus areas of partnerships, research, infrastructure, and data science training, AIM-AHEAD and its future incarnations can promote health equity for the next era of medicine and biomedical research. The second initiative announced by the NIH is known as the Bridge to Artificial Intelligence (Bridge2AI) program.[5] This program has a different approach to tackling systemic racism and bias by focusing on the content and process of AI/ML research. Two key components of AI/ML research are rich databases and algorithm development protocols. To develop reproducible and actionable algorithms, researchers must have access to large, well-labeled databases and follow best practices in their development of algorithms. However, large databases are not readily available across the healthcare research ecosystem. As a result, many investigators struggle to gain access to databases that would enable them to carry out AI/ML research at their home institution. A movement toward more freely available databases like the Medical Information Mart for Intensive Care (MIMIC) and electronic Intensive Care Unit (eICU) through the PhysioNet platform created at the Massachusetts Institute of Technology Laboratory for Computational Physiology can improve access to data for research.[6] By adopting the practice of freely available databases commonly used in the AI/ML research communities outside of medicine, MIMIC and eICU lowered the barrier to entry for data scientists interested in health care. The improved access from MIMIC and eICU has led to over 2,000 publications to date. While this is a solid foundational step for the healthcare AI/ML research community, it is essential to reflect on progress and ensure that freely accessible databases are racially and geographically diverse. In this manner, Bridge2AI will facilitate the expansion of healthcare databases that are ethically sourced, trustworthy, and accessible. Without government programs such as AIM-AHEAD and Bridge2AI, the US biomedical research community is at higher risk of perpetuating systemic racism and biases in how AI/ML is used, how algorithms are developed, and how clinical decision support results are interpreted when delivering patient care. lV. Private Sector Standards Even with the proper incentives delivered from governmental agencies, there can be a disconnect between the public and private sectors, leading to racial bias in algorithms used in patient care. Privately funded AI/ML algorithms used in care decision-making should be held to the same ethical standards as those developed by publicly funded research at academic institutions. Publicly funded research is usually peer-reviewed before publication, giving reviewers a chance to evaluate algorithmic bias or deficiencies. Algorithms used in care may have avoided similar scrutiny. Corporations have an inherent conflict between protecting intellectual property and providing transparency of algorithmic design and inputs. The Food and Drug Administration (FDA) is responsible for regulating AI/ML algorithms. It has classified them as Software as a Medical Device (SaMD), focusing on the development process and benchmarking.[7] The importance of holding privately funded algorithm development to the same standards as publicly funded research is highlighted in a September 2020 review of FDA-approved AI/ML algorithms. All SaMD approved by the FDA are registered by private companies.[8] Regulators must be well-versed in structural racism and equipped to evaluate proprietary algorithms for racial bias and maintain oversight as population data drifts occur and the algorithms continue to optimize themselves. The FDA role is crucial to clinical use of SaMD. CONCLUSION Computational decision support using algorithms and large databases has the potential to transform the way we deliver care. However, governments should plan how they will prevent structural racism and associated inequities from running rampant in the new systems. Racial bias and mistreatment are engrained in the history of medical research. In the newly formulated digital world, these biases are potentially even more dangerous. They now can propagate quietly in the background, masked under layers of computer code that very few people understand how to write and interpret. It will be possible for a doctor to unconsciously propagate bias because an algorithm is nudging the doctor’s behavior to make the best treatment decision for their patient. Healthcare leaders must be vigilant in guiding the development of algorithms and databases to minimize systemic racism. Guidance from funding agencies to uphold minimum quality standards, a transparent vetting process for algorithms by governing bodies like the FDA, and a diverse community of researchers and developers will allow us to curb the spread of structural racism in research and build equitable tools for diagnosing and treating illness. The real question is: will the age of digital medicine also lead to a more equitable healthcare system? - [1] About the USPHS Syphilis Study. Accessed August 18 2021. https://www.tuskegee.edu/about-us/centers-of-excellence/bioethics-center/about-the-usphs-syphilis-study; MGH. MGH Firsts. Accessed August 18 2021. https://libguides.massgeneral.org/mghhistory/firsts. [2] Geneviève LD, Martani A, Shaw D, Elger BS, Wangmo T. Structural racism in precision medicine: leaving no one behind. BMC medical ethics. 2020;21(1):1-13. [3] Barocas S, Selbst AD. Big data's disparate impact. Calif L Rev. 2016;104:671. [4] Obermeyer Z, Powers B, Vogeli C, Mullainathan S. Dissecting racial bias in an algorithm used to manage the health of populations. Science. 2019;366(6464):447-453. [5] NIH. Bridge to Artificial Intelligence. Accessed August 17 2021. https://commonfund.nih.gov/bridge2ai. [6] PhysioNet. PhysioNet: The Research Resource for Complex Physiologic Signals. Accessed August 17 2021. https://physionet.org. [7] FDA. Software as a Medical Device (SaMD). Accessed August 16 2021. https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd. [8] Benjamens S, Dhunnoo P, Meskó B. The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database. npj Digital Medicine. 2020;3(1):1-8.

Religious Exemptions

Photo 3701647 © Jeremy Swinborne | Dreamstime.com INTRODUCTION Among the many unclear issues as interpretations of Employment Division v. Smith arise in the context of vaccination mandates is a simple question: Does any exception to a law at all (whether for a group or an individual) render a law not “generally applicable and religion-neutral” in the eyes of the current Supreme Court? I. Background Prior to Employment Division v. Smith,[i] Sherbert v. Verner[ii] set forth the free exercise test which called for strict scrutiny requiring a compelling state interest and the use of the least restrictive means to achieve the state interest when a law poses a substantial burden to the exercise of religion. Sherbert had a broad holding that prior to Smith applied to laws whether neutral on their face or not, and whether the asserted discrimination was intentional or not. One issue with Sherbert was that judges were not especially adept at judging the sincerity of beliefs and the importance of religious rituals to individuals, making it difficult to determine whether a law imposed a “substantial burden” on the practice of a religion. Employment Division v. Smith holds that laws that are generally applicable and religion-neutral need not be justified by a compelling government interest even if they do have the effect of (unintentionally) burdening a religious practice.[iii] Smith, decided in 1990, altered and narrowed judicial discretion in evaluating neutral laws that may impede the free exercise of religion. Justice Scalia aligned free exercise with other First Amendment rights.[iv] He also alleviated the need for judges to determine the burden on and the sincerity of religious beliefs in instances of neutral laws. “Smith therefore diminished judicial power to grant religious citizens exemptions from their civic obligations...”[v] Yet a carveout was maintained for laws that have a “mechanism for individualized discretion”; strict scrutiny still applies to those. Lukumi[vi] (1993) reaffirmed yet distinguished Smith. In Lukumi, the law in question was adopted to ensure that a religious group would be rendered unable to sacrifice animals. The law had numerous exemptions (clearly people may kill animals for many non-essential reasons like hunting and fishing for sport, etc.) and the lawmakers seemed to have the intent of interfering with animal sacrifice. It was not considered generally applicable on various grounds and the Lukumi Court states, “As we noted in Smith, in circumstances in which individualized exemptions from a general requirement are available, the government "may not refuse to extend that system to cases of 'religious hardship' without compelling reason." Ibid., quoting Bowen v. Roy, 476 U. S., at 708 (opinion of Burger, C. J.).”[vii] In Lukumi, arguably there were so many exceptions, the rule was clearly targeting religious sacrifices. The Court applied strict scrutiny and the law was deemed unconstitutional. II. The Current Supreme Court and Laws Outside of Smith The current and recent cases indicate that some justices on the Supreme Court assert that the caselaw supports religious exemptions to a broad array of laws. Two arguments support this result: either a limited interpretation of “generally applicable and neutral” or a slightly different tactic which argues that any laws with individual exceptions call for strict scrutiny. (One argument is that those which allow exceptions are not generally applicable and neutral, and thus fall outside of Smith and they require strict scrutiny;[viii] the other is that a law can be generally applicable and neutral, but if it has a system for exceptions, then it is subject to strict scrutiny.[ix]) In John Does 1-3 v. Mills, the Supreme Court denied an injunction on October 29, 2021. The case concerns Maine’s vaccine mandate and will be heard on the merits. Gorsuch dissented from the denial of injunctive relief. He applied Smith, Lukumi, and Fulton v. Philadelphia[x] saying that because there is a medical exemption, the law is not “generally applicable”[xi] and strict scrutiny will apply. Thomas and Alito joined Gorsuch. The Gorsuch dissent also implies that the Maine medical exemption may be somewhat bogus saying Maine finds the “mere trepidation over vaccination as sufficient” if it is expressed in medical rather than religious terms.[xii] Justice Barrett, joined by Kavanaugh, concurred in the denial of the injunction, but clarified that her reasoning was a wish to avoid giving a “merits preview” by enjoining the law, based on the applicants’ likelihood of success, noting the case is “the first to address the questions presented.”[xiii] III. Do Medical Exemptions Negate the Possibility of a Neutral and Generally Applicable Law? Are they a de facto “mechanism for individual exemption”? To me, it seems that under the current law, a medical exemption could make the absence of a religious exemption more problematic. The big issue now is whether Barrett and Kavanaugh and any (even all) other justices are likely to find the medical exemption is a “mechanism for individual exemptions” or whether it otherwise more simply makes a law not neutral or generally applicable. In previous recent COVID-19 cases, the argument of emergency authority was prominent. Caselaw regarding emergency use of governmental powers trumped some constitutional arguments and led to disparate COVID-19 caselaw.[xiv] For example, some courts applied Jacobson v. Massachusetts,[xv] giving deference to public health authorities while others applied strict scrutiny.[xvi] At the Supreme Court level, Justices Sotomayor, Kagan, and Breyer have been more willing to analyze COVID-19 regulations according to emergency powers.[xvii] a. In Favor of the Gorsuch Reasoning The Gorsuch dissent will require the state to offer proof of some rationale for why a medical exemption would be more acceptable, less dangerous, etc. than a religious one. Because there is a medical exemption, the causal nexus between the state’s goals and the restrictions will matter. For example, in Fraternal Order of Police v. Newark, a requirement that police be clean shaven was invalidated because there was a medical exception.[xviii] The problem with the rule was that the government interest in uniformity was not violated any more or less whether the person was noncompliant due to medical as opposed to religious reasons. Gorsuch correctly applied similar reasoning arguing that those not in compliance with the Maine vaccine mandate due to religious exemptions posed no more danger than those noncompliant due to medical conditions.[xix] An opposing side might argue that by the numbers, and without a need for a doctor’s signature, more people would apply for and receive religious exemptions, thus harming the ability to reach herd immunity more, or posing more risk of community spread. b. But, on the other hand There are many laws with medical exemptions. It would not seem right that they be subject to strict scrutiny for failing to offer religious outs as well. For example, places without motorized vehicles could allow motorized wheelchairs. Indeed, the ADA may even call for special treatment in many circumstances where religious special treatment would not be granted. Disability law often requires variances, changing zoning to allow ramps, or other accommodations.[xx] It does not appear that every disability accommodation equates to a need to allow a corresponding religious accommodation, nor that strict scrutiny would apply. Zoning cases are common where churches seek exceptions from historical landmark regulations and the results of those cases vary.[xxi] One of the biggest vulnerabilities of the Smith ruling is that arguably all laws have an individualized enforcement aspect. While it may not be an official exemption or a “mechanism for individual exemption”, individuals have the ability to use courts to challenge laws, there are laws that rely on wishy washy terms, like “good cause”, and there are groups whose failure to comply with laws may be traditionally ignored. In each of those scenarios, those seeking religious exemptions may have a stronger case, and eventually may chip away at Smith. c. Would a Different Built-In Exemption Preclude Application of Smith? Application of Smith may depend on whether the exemption is discretionary or built in. For example, if an exemption said anyone may apply for an exemption with good cause, religious ones should be fairly and equally considered. If an exemption reads anyone with an autoimmune disease is exempt, the class of people exempt would be delineated (unlike the Maine language) rather than discretionary as with the open-ended medical exemption language of the Maine statute. In the case of a class-like exemption, the argument that the law is neutral and generally applicable would be stronger. Smith was not really meant to declare that laws with any categories would be vulnerable to free exercise challenges. Similarly, objective criteria in providing exemptions differs. When criteria for exemptions are made clear, the religious argument could be weaker. However, the Gorsuch argument that in the end the religious objector poses no more danger to others than the medical (or other maybe conscientious, financial, or physical) objector may be the winning argument. IV. Side Note: Another Consideration for Neutral Laws In Roman Catholic Diocese of New York, Justice Kavanaugh created a peer group limitation in applying Smith. Kavanaugh found that a law that limited gatherings at religious services was not neutral. The law had various categories of entity.[xxii] An interesting twist is that other entities similar to churches in objective concrete ways (like theaters) were closed altogether, so arguably religion was favored over those, but disfavored compared to essential businesses (like food stores). The orange and red zones in the challenged Cuomo Executive Order did have specific rules for places of worship. Gorsuch referred to Lukumi in his concurrence and went directly to strict scrutiny without sincerely entertaining the concept that the Executive Order was a neutral and generally applicable law. That is in keeping with his dissent in Does 1-3 v. Mills. Yet, it remains possible to argue that laws with objective, defined categories may still be neutral and generally applicable. V. Time to Abandon Jacobson at this Juncture of COVID-19 Jacobson applies in public health emergencies and, while in recent Supreme Court cases, many justices rightly pointed to the emergency as a reason to compromise important rights, the emergency aspect of the pandemic is waning. In many areas, the positive rate is quite low, businesses are returning to normal, and the vaccination rate is high. As such, the abandonment of strict scrutiny in favor of Jacobson’s emergency deference to public health entities, something Gorsuch failed to entertain in South Bay Pentecostal Church v. Newsom[xxiii] anyway, is arguably no longer warranted. Deference to the state and to experts must be limited to emergencies. Justices Kagan, Breyer, and Sotomayor who rightly cautioned against “armchair epidemiology”[xxiv] during the height of the COVID-19 pandemic might return to stricter stances on protecting rights as the emergency dies down or becomes localized, and as increasing methods and treatments arise, like the COVID-19 pill by Merck. The calculus of whether we need strict COVID-19 regulations is dynamic. This is not a static emergency with powers to be left in place unconditionally. CONCLUSION The argument that vaccination is a civic and moral obligation that people should engage in regardless of religious beliefs is stronger in an emergency. Whether deemed to include a “mechanism for individual exemptions” or just declared not neutral or generally applicable, laws offering any exceptions are more vulnerable to free exercise claims. Under the current Supreme Court composition, anticipating that laws may face strict scrutiny is wise—Smith is unlikely to shield seemingly neutral laws in the face of free exercise cases. That is not necessarily a bad outcome in a country that purports to allow religious freedom and can do so safely. Strict scrutiny is merely a protection that would ensure the public that laws are meaningful, achieve compelling purposes, and do so without unnecessarily impeding fundamental rights. Yet one bad outcome of a rule that says if there are medical exemptions so must there be religious ones is that lawmakers will write laws that are more absolute, rigid, and unyielding to legitimate claims. [i] 494 U.S. 872 (1990). https://supreme.justia.com/cases/federal/us/494/872/#tab-opinion-1958253 [ii] 374 U.S. 398 (1963). https://supreme.justia.com/cases/federal/us/374/398/#tab-opinion-1944463 [iii] Smith, at 879 (religion does not excuse people from compliance with neutral laws.) [iv] Kaplan, Carol M., “The Devil is in the Details: Neutral, Generally Applicable Laws and Exemptions from Smith,” New York University Law Review, October 2000. https://www.nyulawreview.org/wp-content/uploads/2018/08/NYULawReview-75-4-Kaplan.pdf [v] Kaplan, at 1053. [vi] Lukumi Babalu Aye, Inc. v. City of Hialeah 508 U.S. 520 (1993). https://supreme.justia.com/cases/federal/us/508/520/#tab-opinion-1959281 [vii] Lukumi, at 537. [viii] Keeler v. Mayor of Cumberland. 940 F. Supp. 879 (D. Md. 1996) https://law.justia.com/cases/federal/district-courts/FSupp/951/83/1381605/; Kaplan, at 1066. [ix] Kaplan, at 1062, citing Swanson v. Guthrie Indep. Sch. Dist., 135 F. Supp. 694 (10th Cir 1998). [x] Fulton v. Philadelphia, 593 U.S. __ (2021) [xi] Does 1-3 v. Mills, 595 U.S. ____(2021). Gorsuch, dissent, p. 2. https://www.supremecourt.gov/opinions/21pdf/21a90_6j37.pdf [xii] Does 1-3 v. Mills, Gorsuch dissent, p. 3. [xiii] Does 1-3 v. Mills, Barret, concurring. https://www.supremecourt.gov/opinions/21pdf/21a90_6j37.pdf [xiv] Zimmerman, A. “Weeding Out Disingenuous Emergency Orders: A Consistent Ethical Justification to Determine Whether to Apply Jacobson V. Massachusetts’ Deferential Approach or the Tiered Scrutiny That Would Apply Absent an Emergency”. 2021. Voices in Bioethics, vol. 7, May 2021, doi:10.7916/vib.v7i.8037. [xv] 197 US 11 (1905). [xvi] Zimmerman, A. 2021. doi:10.7916/vib.v7i.8037. [xvii] South Bay Pentecostal Church v. Newsom (2021), Kagan, dissenting, joined by Breyer and Sotomayor (Justices are “not scientists”.) [xviii] Kaplan, at 1079, citing Fraternal Order of Police v. City of Newark, 170 F. 3d 359 (3d Cir. 1999). [xix] Does 1-3 v. Mills, Gorsuch dissent, p. 4. [xx] https://www.ada.gov/comprob.htm [xxi] Keeler v. Mayor of Cumberland (provisions deemed individualized exemptions so religious deserve strict scrutiny and consideration); Rector of St. Bartholomew’s Church v. City of New York (2d Cir. 1990)(discretion does not negate Smith if it is not discriminatory so religious does not get strict scrutiny); see Kaplan at 1066. [xxii] Cuomo executive order established zones. https://esd.ny.gov/cluster-action-initiative-faq [xxiii] 592 US __ (2021). https://www.supremecourt.gov/opinions/20pdf/20a136_bq7c.pdf [xxiv] South Bay Pentecostal Church v. Newsom (2021) (dissent).

Vaccine Hesitancy Narratives

Photo by Hush Naidoo Jade Photography on Unsplash INTRODUCTION In this collection of narratives, the authors describe their own experiences with and reflections on healthcare worker vaccine hesitancy. The narratives explore each author’s engagement with different communities experiencing vaccine hesitancy, touching on reasons for hesitancy, proposed solutions, and legal aspects. Author’s names appear above their narratives. l. Johanna T. Crane Vaccine hesitancy, defined as “a delay of acceptance or refusal of vaccination despite the availability of vaccination services,”[1] is a worldwide but locally shaped phenomenon that pre-dates the COVID-19 pandemic.[2] Contrary to some portrayals, vaccine hesitancy is not the same as the more absolute antivaccination stance, or what some call “anti-vax.” Many people who are hesitant are not ideologically opposed to vaccines. Hesitancy is also sometimes framed as anti-science, yet reluctance to vaccinate is often about managing risk, trustworthiness, and doubt in the context of uncertainty; it represents an effort to “talk back to science” about unaddressed needs and concerns.[3] In the US, the newness of the vaccines, the unprecedented speed at which they were developed, and their remaining under emergency use authorization at first complicated public confidence. Political polarization and racial and social inequality shape vaccine acceptance and public distrust as well. While vaccine acceptance has increased in the months since the vaccines first became available, many eligible individuals have not yet been vaccinated, including a significant number of healthcare workers.[4] Vaccine hesitancy among healthcare workers may seem surprising, especially given their frontline experience – I confess that it surprised me at first. But when I began interviewing health care workers for a study on COVID vaccine roll-out at community health centers, I learned to take a more complex view. Although the study was focused on patient vaccine access,[5] many of the frontline health care workers we spoke with also described hesitancy among some of their colleagues (and, in a few cases, themselves). From these conversations, I learned that these “healthcare heroes” are also regular people and members of communities. Their concerns about COVID vaccination often reflect the prevailing concerns advanced in their communities, such as worries about vaccine side effects and safety. Like other workers, some fear missing work and losing income, as not all healthcare employers offer paid time off for vaccination or recovery. (Importantly, reluctance to vaccinate is highest among healthcare workers in lower-paid positions with little job security, such as clerks, housekeepers, patient care assistants, and home health aides.)[6] For some healthcare workers of color, the protection offered by the vaccine sits in tension with both current and historical experiences of medical abuse and neglect. Some interviewees, fully vaccinated themselves, rejected the framework of “hesitancy” entirely, arguing that Black and Brown reluctance to be vaccinated first should be understood through the lens of “self-protection”. Due to the nature of their work, healthcare workers have faced great social pressure to vaccinate and vaccinate first. This is understandable, given that vaccination against COVID-19 protects not only workers themselves but aligns with the ethical duty to prevent harm to patients by reducing the risk of transmission in healthcare settings. When the FDA approved COVID-19 vaccines under emergency use authorization in December 2020, many healthcare workers were extremely grateful to be designated “1a” – the first group prioritized to receive the shots.[7] For many bioethicists, prioritization of healthcare workers represented a recognition of the extreme risks that many front-line workers had endured since the onset of the pandemic, including critical shortages in PPE. But it is important to remember that for some workers, going first may have felt like serving as guinea pigs for new vaccines that had yet to be granted full FDA approval. For these individuals, the expectation that they would vaccinate first may have felt like an additional risk rather than a reward. Healthcare workers who are hesitant to vaccinate may feel ashamed or be subject to shaming by others;[8] this may make it difficult to discuss their concerns in the workplace. Throughout the pandemic, healthcare workers have been lauded as “heroes”, and some healthcare employers have promoted vaccination among their workforce as a “heroic” action. This messaging implies that waiting to vaccinate is shameful or cowardly and is echoed in opinion pieces and op-eds describing unvaccinated people as “selfish” or “free riders.”[9] By fostering the proper dialogue, we can respond respectfully to hesitancy among healthcare workers while still working towards the goal of increased vaccination. We in the bioethics and medical community should be willing to listen to our colleagues’ concerns with respect. Top-down approaches aimed at “correcting” hesitancy cannot address the more fundamental issues of trust that are often at stake. Instead, there must be dialogue over time. Conversations with a trusted healthcare provider have a crucial role.[10] Blaming and shaming rhetoric, whether explicit or implicit, gets us nowhere – in fact, it likely moves us backward by likely exacerbating any existing distrust or resentment that workers may hold toward their employers.[11] Lastly, the onus of trust must be with institutions, not individuals. There is a lot of talk about getting communities of color, and Black people, particularly, to "trust" healthcare institutions and the COVID vaccines. This racializes trust and puts the burden on harmed communities rather than on institutions acting in trustworthy ways.[12] Dialogue, respect, and trustworthiness must guide us even in the new era of workplace mandates. Mandates make these strategies even more important as we look toward an uncertain future. As Heidi Larson, founder of the Vaccine Confidence Project, recently said, “We should not forget that we are making people's future history now. Are people going to remember that they were treated respectfully and engaged?”[13] ll. Kara Simpson Since the release of the vaccine for COVID-19 in late 2020, there have been robust discussions within the medical community, the media, and political arenas about vaccine hesitancy among healthcare workers. The public became aware that healthcare workers, the first group to become eligible for the vaccine, were not rushing to “take the shot.” Many people’s opinions were aligned by race, ethnicity, socioeconomic status, and political affiliation. People of color were one of the first groups to be labeled vaccine hesitant as our experiences of distrust of the medical community and the politicization of the vaccine explained the low turnout.[14] It was not uncommon to hear, “this vaccine just came out; let’s wait and see if there are side effects.” Interestingly, many people in the healthcare community and in the public did not understand why healthcare workers of color remained hesitant. Trust is a vital component of any viable relationship, especially in the clinical realm. To have successful health outcomes, it is essential for clinicians to build trusting relationships with their patients and peers. Many people of color are distrustful towards the medical institution due to the years of systemic racism and abuses that they have experienced, witnessed, or learned about. Healthcare workers of color are not excluded from the experiences of their communities outside of work. In fact, I assert that healthcare of color may have an additional burden of hesitation because of their lived experiences of distrust in receiving care and inequality within their professional environment. These dual traumas can work in tandem to strengthen hesitancy. I assert that building trusting clinical relationships will address hesitancy over time. Currently, many healthcare workers are worried about vaccine mandates. For a group of people that have experienced intergenerational enslavement and marginalization, mandates feel coercive and serve as a reminder of how “lesser” bodies are considered unworthy of voice, fundamental human rights, independent decision making. To call the vaccine mandate paternalistic would be an understatement. An unintended result of vaccine mandates will be the reinforcement of hesitancy and distrust of the medical institution as trust and coercion cannot coexist. This mandate will give more power to the conspiracy theories and harm those who already do not seek or receive adequate health care because of systemic inequalities. Furthermore, mandates can also dissuade people of color from becoming healthcare workers, and others may leave the field. In essence, vaccine hesitancy is a symptom of a much larger problem: the distrust of the medical establishment. As bioethicists, our mission should be to support interventions that foster “trustworthiness” of the institutions rather than those that cause trauma. Several organizations have proposed mask mandates and weekly testing as a measure to protect the population at large and still respect the autonomy of the unvaccinated.[15] lll. Jennifer Breznay I work in a very large community teaching hospital in Brooklyn, and we were extremely hard hit by COVID in March 2020. I worked on inpatient medical units and witnessed a lot of suffering. And after nine months of fear and despair about COVID’s toll, I felt tremendous frustration in December when I heard that many healthcare workers would reject the vaccine. As the co-chair of the Bioethics Committee, I drafted a statement recommending vaccination for all employees. When the draft was revised and approved by the Bioethics Committee, I began to discuss it with employees, and I appreciated different perspectives I had not heard before. In the end, rather than releasing the statement, we directed our efforts at creating a dialogue. I also volunteer at a not-for-profit which operates seven early childhood education centers in Northern Brooklyn. The Executive Director invited me to collaborate on strategies to encourage staff vaccination, and we decided to offer a Zoom conference to 20 members of the staff. I was extremely nervous about how the audience would perceive me, a white doctor whom they did not know. I felt awkward about coming to them with an agenda. And there was also the question of whether I was an appropriate messenger compared to a person of color. Yet, I felt like I shouldn't back away from this. So, I chose to simply disclose my discomfort at the beginning of the Zoom. I said, “Thanks for having me. You know, as a white physician, I understand you might have concerns about trusting what I say. Four hundred years of inequity and abuse by the healthcare system can create a lot of mistrust, but I’m here to try to answer your questions.” Ultimately the Executive Director reported that the Zoom was successful in stimulating a lot of conversation among the staff about the vaccine. I think the critical piece is the intimate but open conversation, where you can elicit values. lV. Ashley L. Stewart In the rural areas of our state, healthcare institutions are inextricably tied to their communities. Rural hospitals hire from, serve, and function in the community where they are located. Successful implementation of a vaccine roll-out in such rural areas requires explicit recognition of the role and influence of the community. After identifying issues common to the area, rural institutions can address them. Even when rural institutions find that healthcare worker concerns seem to be unique or personal, they are often related to the larger concerns of the community.[16] Community-based increased vaccine hesitancy may coincide with an underlying issue, such as lack of information rather than principled or experience-based resistance.[17] When the vaccines became available, rural vaccination coordinators encountered a wealth of misinformation that left many people initially undecided. Compounding this lack of information, workers expressed a sense of fear about the professional consequences of voicing concerns, especially in tight-knit communities. Many workers expressed concern about being judged merely for sharing their questions or decisions.[18] They also felt that saying or doing something to promote the value of vaccination might change their relationship with members of the community where they live and work.[19] As there was a fear of engaging in productive conversations, it was difficult for them to find valuable information, and the lack of information discouraged them from being vaccinated. Vaccine coordinators wanted to get information to the entire community based on the most current research and release unbiased, consistent, and timely information from sources all people in the community could trust, including from multiple sources at once. Communication must focus on answering many types of questions, which must often be done in private or anonymously. Where poorly supported or incorrect information is widely available, sharing objective information is crucial to turning the tide of distrust. If the healthcare community dismisses concerns or assumes that answering questions based on misinformation is a waste of time, the community-based institutions will further the distrust. Some may feel that vaccine coordinators should not address misinformation directly, yet avoidance has been widely unsuccessful.[20] Being respectful and non-judgmental in answering questions posed by people who do not know what is true can be hard, but in rural communities, answering completely and honestly without judgment is a critical component of any effort to inform people. Telling people to get vaccinated “for the greater good” can sound the same as being told not to get a vaccine because it is “bad” if both sources of information fail to back up their claims. Ultimately rural institutions are respected because they are a resource to their communities, a priority we must preserve. It is also critical to treat everyone respectfully regardless of vaccine status.[21] People may perceive mandates, divisive policies, or disrespectful treatment of people based on vaccination status as discriminatory or coercive, weakening the appeal of vaccination. Such practices may make people less trusting and more anchored to their position as they come to see vaccination proponents as untrustworthy or authoritarian. We must work to maintain respect for human autonomy. Using unethical means to achieve even a just end will not lead to a “greater good” but rather to the perception that people in positions of authority would achieve a result “by any means necessary.” V. David N. Hoffman The central moral quandary that arises whenever vaccine hesitancy among healthcare workers is discussed is whether workers who refuse to get vaccinated should or could be fired. We should clarify that we are applying a definition of mandate in the employment context for private employers, the violation of which results in loss of employment. Government-controlled provider organizations are just now weighing in on this topic and are generally pursuing strategies that impose periodic, usually weekly, testing requirements for those workers who decline to get vaccinated. In the private sector, employers can require their employees to do a great many things as a condition of employment, and one of them is to get vaccinated against COVID -19. In the most prominent case to date, just such a mandate gave rise to a lawsuit in Texas involving Houston Methodist Hospital. In that case, 170 employees asserted that an employer should not be allowed to force them to get vaccinated. The judge held that, while no employer can force an employee to get vaccinated, no employer is obligated to continue the employment of any employee who declines to follow rules established by that employer, including the obligation to get vaccinated.[22] In Texas, what the judge said is you are not being forced to get vaccinated, but your employer is allowed to set limits and conditions on employment, including vaccination. Employees do not have an obligation to get vaccinated, but they also have no right to their jobs. That is because of a widely misunderstood legal concept: “employment at will.” Employment at will sounds like a rule that employees can do what they want at work, but in fact, employment at will means only that you can quit your job whenever you want (we do not permit indentured servitude). At the same time, your employer can fire you at any time, for any reason or no reason, unless the reason is a pretext and involves one of the protected statuses (race, color, religion, sex, or national origin, and in some jurisdictions gender orientation, gender identity). Generally, any employers, including hospitals, can decide that if someone is not willing to get a vaccination, or if they are not willing to complete sexual harassment training or participate in the hospital’s infection control program, that is the employee’s right, but it will mean that an employer can similarly decline to continue providing employment. The evolution of this hesitancy discussion will be influenced by the narrower debate playing out in the court of public opinion, and the courts of law, over the enforceability of New York’s recently enacted vaccine mandate. Regardless of whether that mandate survives, with or without medical and religious exemptions, healthcare employers will be left with a profound ethical dilemma. At the end of all the litigation, if there is a religious exemption, employers will always be burdened with the responsibility to determine whether an individual employee has asserted a genuine and sincere religious objection to vaccination and whether the employer is able to provide an accommodation that is safe and effective in protecting the interests of co-workers and patients. The anticipated federal mandate, which reportedly will have a test/mask alternative, will only make this ethical task more challenging. This leads to the final point in this analysis, which is that while private employers, including hospitals, can deprive an individual of their employment if those individuals refuse to get vaccinated, just because an employer can do so does not mean it should do so.[23] - [1] MacDonald NE. Vaccine hesitancy: Definition, scope and determinants. Vaccine. 2015;33(34):4161-4164. doi:10.1016/j.vaccine.2015.04.036 [2] Larson HJ, de Figueiredo A, Xiahong Z, et al. The State of Vaccine Confidence 2016: Global Insights Through a 67-Country Survey. EBioMedicine. 2016;12:295-301. doi:10.1016/j.ebiom.2016.08.042 [3] Larson H. Stuck: How Vaccine Rumors Start - and Why They Don’t Go Away. Oxford University Press; 2020; Benjamin R. Informed Refusal: Toward a Justice-based Bioethics. Sci Technol Hum Values. 2016;41(6):967-990. doi:10.1177/0162243916656059 [4] Deepa Shivaram, In The Fight Against COVID, Health Workers Aren't Immune To Vaccine Misinformation September 18, 2021. NPR Special Series: The Coronavirus. https://www.npr.org/2021/09/18/1037975289/unvaccinated-covid-19-vaccine-refuse-nurses-heath-care-workers [5] Crane JT, Pacia D, Fabi R, Neuhaus C, and Berlinger N. Advancing Covid vaccination equity at Federally Qualified Health Centers: A rapid qualitative review. Accepted and awaiting publication at JGIM. [6] Ashley Kirzinger. “KFF/The Washington Post Frontline Health Care Workers Survey - Vaccine Intentions.” KFF, 22 Apr. 2021, https://www.kff.org/report-section/kff-washington-post-frontline-health-care-workers-survey-vaccine-intentions/. [7] Johanna Crane, Samuel Reis-Dennis and Megan Applewhite. “Prioritizing the ‘1a’: Ethically Allocating Scarce Covid Vaccines to Health Care Workers.” The Hastings Center, 21 Dec. 2020, https://www.thehastingscenter.org/prioritizing-the-1a-ethically-allocating-covid-vaccines-to-health-care-workers/. [8] “'I'm Not an Anti-Vaxxer, but...' US Health Workers' Vaccine Hesitancy Raises Alarm.” The Guardian, Guardian News and Media, 10 Jan. 2021, https://www.theguardian.com/world/2021/jan/10/coronavirus-covid-19-vaccine-hesitancy-us-health-workers. [9] Gerson M. If you are healthy and refuse to take the vaccine, you are a free-rider. Washington Post. April 15, 2021. [10] Crane JT, Pacia D, Fabi R, Neuhaus C, and Berlinger N. Advancing Covid vaccination equity at Federally Qualified Health Centers: A rapid qualitative review. Accepted and awaiting publication at JGIM. [11] Larson H. Stuck : How Vaccine Rumors Start - and Why They Don’t Go Away. Oxford University Press; 2020. [12] Benjamin R. Race for Cures: Rethinking the Racial Logics of ‘Trust’ in Biomedicine. Sociology Compass. 2014;8(6):755-769. doi:10.1111/soc4.12167; Warren RC, Forrow L, David Augustin Hodge S, Truog RD. Trustworthiness before Trust — Covid-19 Vaccine Trials and the Black Community. N Engl J Med. Published online October 16, 2020. doi:10.1056/NEJMp2030033 [13] Offri D. Heidi Larson, Vaccine Anthropologist. New Yorker. Published online June 12, 2021. Accessed August 11, 2021. https://www.newyorker.com/science/annals-of-medicine/heidi-larson-vaccine-anthropologist [14] Razai M S, Osama T, McKechnie D G J, Majeed A. Covid-19 Vaccine Hesitancy Among Ethnic Minority Groups. BMJ 2021; 372 :n513 doi:10.1136/bmj.n513 [15] Dasgupta, Sharoda, et al. “Differences in Rapid Increases in County-Level COVID-19 Incidence by Implementation of Statewide Closures and Mask Mandates — United States, June 1–September 30, 2020.” Annals of Epidemiology, vol. 57, Sept. 2021, pp. 46–53., https://doi.org/10.1016/j.annepidem.2021.02.006. [16] Do, Tuong Vi C et al. “COVID-19 Vaccine Acceptance Among Rural Appalachian Healthcare Workers (Eastern Kentucky/West Virginia): A Cross-Sectional Study.” Cureus vol. 13,8 e16842. 2 Aug. 2021, doi:10.7759/cureus.16842; Danabal, K.G.M., Magesh, S.S., Saravanan, S. et al. Attitude towards COVID 19 vaccines and vaccine hesitancy in urban and rural communities in Tamil Nadu, India – a community-based survey. BMC Health Serv Res 21, 994 (2021). https://doi.org/10.1186/s12913-021-07037-4 [17] Scott C. Ratzan MD, MPA, MA, Lawrence O. Gostin JD, Najmedin Meshkati PhD, CPE, Kenneth Rabin PhD & Ruth M. Parker MD (2020) COVID-19: An Urgent Call for Coordinated, Trusted Sources to Tell Everyone What They Need to Know and Do, Journal of Health Communication, 25:10, 747-749, DOI: 10.1080/10810730.2020.1894015 [18] Huang, Pien. “Some Health Care Workers Are Wary of Getting COVID-19 Vaccines.” NPR, NPR, 1 Dec. 2020, https://www.npr.org/sections/health-shots/2020/12/01/940158684/some-health-care-workers-are-wary-of-getting-covid-19-vaccines. Portnoy, Jenna. “Several Hundred Virginia Health-Care Workers Have Been Suspended or Fired over Coronavirus Vaccine Mandates.” The Washington Post, WP Company, 4 Oct. 2021, https://www.washingtonpost.com/local/covid-vaccine-mandate-hospitals-virginia/2021/10/01/b7976d16-21ff-11ec-8200-5e3fd4c49f5e_story.html. [19] Jennifer A. Lueck & Alaina Spiers (2020) Which Beliefs Predict Intention to Get Vaccinated against COVID-19? A Mixed-Methods Reasoned Action Approach Applied to Health Communication, Journal of Health Communication, 25:10, 790-798, DOI: 10.1080/10810730.2020.1865488 [20] Lockyer, Bridget, et al. “Understanding Covid-19 Misinformation and Vaccine Hesitancy in Context: Findings from a Qualitative Study Involving Citizens in Bradford, UK.” Health Expectations, vol. 24, no. 4, 4 May 2021, pp. 1158–1167., https://doi.org/10.1101/2020.12.22.20248259. Scott C. Ratzan & Ruth M. Parker (2020) Vaccine Literacy—Helping Everyone Decide to Accept Vaccination, Journal of Health Communication, 25:10, 750-752, DOI: 10.1080/10810730.2021.1875083. [21] Zimmerman, Anne. Columbia Academic Commons, 2020, Toward a Civilized Vaccination Discussion: Abandoning the False Assumption That Scientific Goals Are Shared by All, https://academiccommons.columbia.edu/doi/10.7916/d8-rzh0-1f73. [22] Bridges, et al v. Houston Methodist Hospital et al, https://docs.justia.com/cases/federal/districtcourts/texas/txsdce/4:2021cv01774/1830373/18 [23] David N. Hoffman, “Vaccine Mandates for Health Care Workers Raise Several Ethical Dilemmas,” Hasting Center Bioethics Forum. August 2021. https://www.thehastingscenter.org/vaccine-mandates-for-health-care-workers-raise-several-ethical-dilemmas/