Publications
Columbia's Bioethics M.S. program benefits from a distinguished, interdisciplinary faculty of physicians, surgeons, and public health scientists and practitioners, who frequently publish research and advance thought leadership in the field. Alumni of the program often contribute to the field through their research and publications as well.
Voices in Bioethics
Voices in Bioethics focuses on pressing bioethical issues. The publication analyzes domestic and global ethical issues found throughout the intersection of medicine, law, philosophy, public health and technology. The contributors are a diverse group of graduate students, graduates of Columbia’s M.S. in Bioethics program, health professionals, researchers, philosophers and professors. Visit voicesinbioethics.library.columbia.edu to read the latest articles and/ or to contribute.
February 2024
This paper explores the custody and removal of homeless individuals as well as their rights and ability to defend themselves from unwanted psychiatric assessments and involuntary hospitalization. Involuntary hospitalization, a form of detention, is contextualized in public policy concerning housing and the social determinants of health, individual rights, the city’s shelter system and the right to shelter, and the racism and discrimination inherent in the distribution of homelessness. Involuntary psychiatric care dismisses personal views on psychiatry and medicine. Some adults who are homeless in New York City are at risk due to policies and practices that Mayor Adams suggests were meant to support adults who are experiencing homelessness and “appear” to have severe mental illness. As housing is a social determinant of health, a proper housing system very well may decrease the societal burden of mental illness. Individuals must not be subjected to nonconsensual psychiatric assessments or care due primarily to their lack of housing. Consensual care may be beneficent and its availability ethically appropriate. Beneficence is not an appropriate justification for involuntary hospitalization, so the additional ethical justification of preventing imminent danger is needed.
January 2024
March 2023
Interpretation of many genetic test results can change over time as new data accumulate. Hence, physicians who order genetic tests may subsequently receive revised reports with important implications for patients' medical treatment—even for patients who are no longer in their care. Several of the ethical principles underlying medical practice suggest an obligation to reach out to former patients with this information. Discharging that obligation can be accomplished, at a minimum, by attempting to contact the former patient with their last known contact information.
July 2023
Narrative therapy is a field of psychotherapy based on the writings and work of Michael White and David Epston. The basic idea behind this approach is grounded in the idea that stories constrain our understanding of ourselves and our ability to engage with the problems we face in life. While understanding traditional psychotherapy concepts, e.g., frame, formulation, transference, countertransference, clinical attunement, and attachment, is valuable for a “psychologically-informed” palliative care practice, a narrative therapeutic approach may provide the palliative care clinician with an additional framework to uncover our patients’ deepest values and guide them to re-author their stories and the problems they face.
May 2023
Mass murder, particularly mass shootings, constitutes a major, growing public health concern. Specific motivations for these acts are not well understood, often overattributed to severe mental illness. Identifying diverse factors motivating mass murders may facilitate prevention. We examined 1,725 global mass murders from 1900-2019, publicly described in English in print or online. We empirically categorized each into one of ten categories reflecting reported primary motivating factors, which were analyzed across mass murderers generally, as well as between U.S- and non-U.S.-based mass-shooters. Psychosis or disorganization related to mental illness were infrequently motivational factors (166; 9.6%), and were significantly more associated with mass murder committed using methods other than firearms. The vast majority (998, 57.86%) of incidents were impulsive and emotionally-driven, following adverse life circumstances. Most mass murderers prompted by emotional upset were found to be driven by despair or extreme sadness over life events (161, 16.13% within the category); romantic rejection or loss, or severe jealousy (204, 20.44% within the category); some specific non-romantic grudge (212, 21.24% within the category); or explosive, overwhelming rage following a dispute (266, 26.65% within the category). Results suggest that policies seeking to prevent mass murder should focus on criminal history, as well as subacute emotional disturbances not associated with severe mental illness in individuals with poor coping skills who have recently experienced negative life events.
November 2023
Artificial intelligence (AI) is changing the way clinicians practice medicine, and recent technological advancements have resulted in consumer-facing products that can respond to users with dynamic and nuanced language. Clinicians typically struggle with serious illness communication, such as delivering news about a poor prognosis. Palliative care clinicians receive extensive training in serious illness communication, but there is a paucity of such highly trained specialists. This article explores the allure of employing AI-powered chatbots to assist nonspecialist clinicians with serious illness communication and highlights the ethical and practical drawbacks. While outsourcing communication to new AI chatbot technologies may be inappropriate, there is a role for AI in training clinicians on effective language to use when discussing serious illness with their patients.
November 2023
Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed consent process; and criteria for waivers of informed consent. In accordance with respect for persons and communities, investigators and IRBs should systematically consider potential group harm when designing and reviewing protocols, respectively. Research participants should be informed about any potential group harm in the consent process. We call for additional public discussion, empirical research, and normative analysis on these issues to determine the right regulatory and policy path forward.
June 2023
We assessed the relationship of epilepsy illness perceptions to antiseizure medication (ASM) adherence. One hundred forty-nine patients (23%) gave responses indicating high adherence. In the adjusted models, for each 1-unit increase in participants’ BIPQ item scores, the odds of high adherence increased by 17% for understanding of their epilepsy (OR = 1.17, 95% CI 1.07–1.27, p < 0.001), decreased by 11% for overall life impact of epilepsy (OR = 0.89, 95% CI 0.82–0.97, p = 0.01) and decreased by 6% for emotional impact of epilepsy (OR = 0.94, 95% CI 0.86–0.99, p = 0.03). No other illness perception was associated with high adherence. Depression, anxiety, and stigma mediated the inverse relationships of high adherence to the overall life impact of epilepsy and the emotional impact of epilepsy. These measures did not mediate the relationship of high adherence to the perceived understanding of epilepsy.
October 2021
The COVID-19 pandemic has been extraordinarily taxing for health care professionals (HCPs). The risk of exposure to SARS-CoV-2, lack of personal protective equipment, financial insecurity, work overload, lack of support, the weighty responsibility of triage decisions, and the distress associated with witnessing health inequities are among the stressors HCPs now face.1 Above all, HCPs in higher-income countries are witnessing many patients who experience severe symptoms (eg, dyspnea, pain, isolation) and are observing a greater volume of very ill and dying patients than at any other time in the past several decades.
Given such unusual circumstances, HCPs need more than ever to take care of themselves. One potentially powerful resource available to them, although often overlooked, is their own spirituality. Although there is increasing literature regarding patient spirituality, less has been written about the spiritual needs of HCPs, especially during the COVID-19 pandemic. This Viewpoint explores several spiritual considerations that may help support HCPs in their daily work, including shifting perspective, searching for meaning, obtaining fulfillment in compassion, and seeking the support of relationships; and also presents resources that may help them in their professional and personal lives not only during the SARS-CoV-2 pandemic but also throughout their careers as healers.
September 2023
The United States has the fastest growing prison population in the world, and elevated incarceration rates, substance use, and human immunodeficiency virus (HIV) prevalence are fueling each other. Yet without a national guideline mandated for HIV care within the prison system, standards for state and federal prisons vary greatly.
June 2023
October 2023
Women with breast cancer have an increased risk of primary ovarian cancer (BR→OV), and women with ovarian cancer have an increased risk of primary breast cancer (OV→BR). This systematic review summarizes risk factors for developing BR→OV and OV→BR.
December 2022
The DSM-5 text revision (DSM-5-TR) is the first published revision of the DSM-5 since its publication in 2013. Like the previous text revision (DSM-IV-TR), the main goal of the DSM-5-TR is to comprehensively update the descriptive text accompanying each DSM disorder on the basis of reviews of the literature over the past 10 years. In contrast to the DSM-IV-TR, in which updates were confined almost exclusively to the text, the DSM-5-TR includes many other changes and enhancements of interest to practicing clinicians, such as the addition of diagnostic categories (prolonged grief disorder, stimulant-induced mild neurocognitive disorder, unspecified mood disorder, and a category to indicate the absence of a diagnosis); the provision of ICD-10-CM symptom codes for reporting suicidal and nonsuicidal self-injurious behavior; modifications, mostly for clarity, of the diagnostic criteria for more than 70 disorders; and updates in terminology (e.g., replacing "neuroleptic medications" with "antipsychotic medications or other dopamine receptor blocking agents" throughout the text and replacing "desired gender" with "experienced gender" in the text for gender dysphoria). Finally, the entire text was reviewed by an Ethnoracial Equity and Inclusion Work Group to ensure appropriate attention to risk factors such as the experience of racism and discrimination, as well as the use of nonstigmatizing language.
November 2023
A number of authors have argued that technological innovation has increased U.S. health care spending. We investigate the impact that pharmaceutical innovation had on the average cost of U.S. health care episodes during the period 2000-2014, using data from the Bureau of Economic Analysis' Health Care Satellite Account and other sources. We analyze the relationship across approximately 200 diseases between the growth in the number of drugs that have been approved to treat the disease and the subsequent growth in the mean amount spent per episode of care, controlling for the growth in the number of episodes and other factors. Our estimates indicate that mean episode cost is not significantly related to the number of drugs ever approved 0-4 years before, but it is significantly inversely related to the number of drugs ever approved 5-20 years before. This delay is consistent with the fact (which we document) that utilization of a drug is relatively low during the first few years after it was approved, and that some drugs may have to be consumed for several years to have their maximum impact on treatment cost. Our estimates of the effect of pharmaceutical innovation on the average cost of health care episodes are quite insensitive to the weights used and to whether we control for 3 covariates. Our most conservative estimates imply that the drugs approved during 1986-1999 reduced mean episode cost by 4.7%, and that the drugs approved during 1996-2009 reduced mean episode cost by 2.1%. If drug approvals did not affect the number of episodes, the drugs approved during 1986-1999 would have reduced 2014 medical expenditure by about $93 billion. However, drug approvals may have affected the number, as well as the average cost, of episodes. We also estimate models of hospital utilization. The number of hospital days is significantly inversely related to the number of drugs ever approved 10-19 years before, controlling for the number of disease episodes. Our estimates imply that the drugs approved during 1984-1997 reduced the number of hospital days by 10.5%. The hospital cost reduction was larger than expenditure on the drugs.
March 2023
Deep brain stimulation (DBS) shows promise for new indications like treatment-refractory schizophrenia in early clinical trials. In the first DBS clinical trial for treatment refractory schizophrenia, despite promising results in treating psychosis, one of the eight subjects experienced both a symptomatic hemorrhage and an infection requiring device removal. Now, ethical concerns about higher surgical risk in schizophrenia/schizoaffective disorder (SZ/SAD) are impacting clinical trial progress. However, insufficient cases preclude conclusions regarding DBS risk in SZ/SAD. Therefore, we directly compare adverse surgical outcomes for all surgical procedures between SZ/SAD and Parkinson's disease (PD) cases to infer relative surgical risk relevant to gauging DBS risks in subjects with SZ/SAD.
October 2022
While mass murders involving academic settings, especially using firearms, are of grave, growing public concern, identifying consistent patterns to aid prevention has proved challenging. Although some characteristics, such as male sex, have been routinely associated with these events, another hypothesized risk factor, severe mental illness, has been less reliably predictive. We isolated cases of mass murder perpetrated at least in part at schools, colleges, and universities from the Columbia Mass Murder Database (CMDD) and categorized them by location (within or outside of the US), and whether firearms were used. Demographic similarities and differences between groups were analyzed statistically wherever possible. We examined 82 incidents of mass murder, by any means, involving academic settings. Nearly half of all incidents (47.6%), and most involving firearms (63.2%), were U.S.-based, whereas those not involving firearms largely occurred elsewhere (88.0%). Consistent with previous reports, perpetrators of mass shootings involving academic settings are primarily Caucasian (66.7%) and male (100%). Severe mental illness (i.e., psychosis) was absent in the majority of perpetrators (firearms: 80.7%; nonfirearms: 68.0%). About half (45.6%) of mass school shootings ended with the perpetrator's suicide. When present, psychotic symptoms are more associated with mass murders in academic settings involving means other than firearms. The question of whether perpetrators of such incidents may perceive their actions as a kind of final act might enhance policy development and/or how law enforcement intervenes.
November 2023
July 2023
Prion disease is a rare, fatal, and often rapidly progressive neurodegenerative disease. Ten to fifteen percent of cases are caused by autosomal dominant gain-of-function variants in the prion protein gene, PRNP. Rarity and phenotypic variability complicate diagnosis, often obscuring family history and leaving families unprepared for the genetic implications of an index case. Several recent developments inspire this update in best practices for prion disease genetic counseling. A new prion-detection assay has transformed symptomatic diagnosis. Meanwhile, penetrance, age of onset, and duration of illness have been systematically characterized across PRNP variants in a global cohort. Clinically, the traditional genotype-phenotype correlation has weakened over time, and the term genetic prion disease may now better serve providers than the historical subtypes Creutzfeldt-Jakob disease, fatal familial insomnia, and Gerstmann-Sträussler-Scheinker disease. Finally, in the age of genetically targeted therapies, clinical trials for prion disease are being envisaged, and healthy at-risk individuals may be best positioned to benefit. Such individuals need to be able to access clinical services for genetic counseling and testing. Thus, this update on the genetics of prion disease and best practices for genetic counseling for this disease aims to provide the information needed to expand genetic counseling services.
November 2023
October 2023
This pilot study aimed to assess the feasibility of a six-session, physician-led narrative medicine group for patients receiving palliative care. Ten patients were recruited by their outpatient providers. Symptom severity and patient dignity scores were collected pre-intervention, at the mid-point, and post-intervention using the Patient Dignity Inventory (PDI) and Edmonton Symptom Assessment Survey (ESAS). Qualitative reports of pain, expectations, and anticipated challenges were collected before the intervention. Participant interviews were conducted after the intervention to assess overall experience in the group, challenges experienced, recommendations for future endeavors, and general feedback.
January 2023
Most research to date has focused on perpetrators of mass murder incidents. Hence, there is little information on victims. We examined 973 mass murders that occurred in the United States between 1900 and 2019 resulting in 5,273 total fatalities and 4,498 nonfatal injuries for a total of 9,771 victims (on average 10 victims per incident). Approximately 64% of victims of mass murder were White individuals, 13% were Black individuals, 6% were Asian individuals, and 14% were Latinx individuals. Given the higher number of nonfatal injuries per non-firearm mass murder event (11.0 vs. 2.8, p < .001), the total number of victims was only 50% higher for mass shootings (5,855 victims) vs. non-firearm mass murder events (3,916 victims). Among the 421 incidents of mass murder in the United States since 2000, Black, Asian, and Native American individuals were overrepresented among victims of mass shootings compared with their representation in the general U.S. population, and White individuals were underrepresented (all p ≤ .002). Findings of racial/ethnic differences were similar among victims of mass murder committed with means other than firearms for Black, Asian, and White individuals. These findings highlight different areas of victimology within the context of these incidents.
November 2023
The prerogative to refuse life-sustaining and life-prolonging interventions via an advance directive is an established legal, ethical, and moral right. Controversy remains as to whether patients with dementia have an equivocal right to refuse assisted feeding at the end of life through an advance directive made when the patient had decision-making capacity.
January 2023
December 2023
To assess whether genetic test results identifying the cause of a child's autism, when accompanied by other neurodevelopmental disorders (NDD), including intellectual disability, alter how parents perceive and treat their child. 28 parents of 22 individuals with autism (mean age: 15 years), usually with other NDDs, were interviewed after receiving genetic diagnoses indicating a de novo mutation through the Simons Foundation Powering Autism Research for Knowledge study. Diagnosis of a de novo genetic variant can alter parental perceptions of offspring with autism and other NDDs. Parents often blamed their child less, saw their child as less in control of symptoms, and developed more patience, framing expectations accordingly. Parents had mixed feelings about receiving genetic diagnoses, with sadness sometimes accompanying reframed expectations. Genetic diagnoses could change views of the child among extended family members, teachers, social service agencies, insurers, and broader communities and society. Genetic testing might also reduce delays in diagnoses of autism among African American, Latino and other children. These data, the first to examine several critical aspects of how parents and others view children with autism and other NDDs after receiving genetic diagnoses, highlight vital needs for education of multiple stakeholders (including geneticists, other physicians, genetic counselors, parents, individuals with autism, social service agencies, insurers, policymakers, and the broader public), research (to include perspectives of extended family members, insurers, social service agencies and teachers) and practice (to increase recognition and awareness of the potential benefits and effects of genetic testing for such children).
January 2024
Genetic diagnoses parents receive concerning their offspring's autism/intellectual disabilities can be 'double-edged' in several ways, having advantages, but also certain disadvantages and limitations. Benefits were medical/scientific (e.g., ending diagnostic odysseys and potentially contributing to research), emotional (e.g., relief, peace of mind and less self-blame), cognitive, social (e.g., validation and confirmation with others - it's 'not just in our head') and financial (e.g., estate planning), now and in the future (e.g., preparing for possible future symptoms, development and availability of treatment and setting realistic expectations). Limitations included a lack of medical treatments related to the genetic diagnosis, a sense of finality and heightened uncertainties which can increase anxieties (e.g., concerning additional symptoms associated with genetic diagnoses and offspring's ability to live independently in the future). Overall, parents were glad to receive the results, seeing the pros outweighing the cons. Parents responded to these tensions in various ways, having mixed feelings, recognizing the trade-offs and/or focusing on their offspring's present needs. Factors such as age of offspring at receipt of genetic diagnosis, parent's scientific background and prior views and degrees of self-blame affected these responses.
October, 2023
Parents of children with autism who receive genetic diagnoses of de novo variants face challenges in understanding the implications for reproductive decision-making. We interviewed 28 parents who received de novo genetic diagnoses for their child's autism and intellectual disability (ID). These genetic variants proved to have reproductive implications for not only the child's parents, but the child and his/her neurotypical siblings, aunts, uncles, and cousins. Parents had often already finished building their families but varied, overall, in whether the results had affected, or might have influenced, their reproductive decisions. Parents' views were shaped by factors related to not only genetics, but also parental age, financial considerations, competing hopes and visions for their family's future, perceived abilities to care for an additional child with similar symptoms, and the extent of the child's symptoms. Members of a couple sometimes disagreed about whether to have more children. Parents pondered, too, the possibility of preimplantation genetic testing, though misunderstandings about it arose. Children with autism vary widely in their abilities to understand the reproductive implications of genetic diagnoses for themselves. Neurotypical offspring were much relieved to understand that their own children would not be affected. While some autism self-advocates have been concerned that genetic testing related to autism could lead to eugenics, the present data, concerning de novo genetic findings, raise other perspectives. These data, the first to explore several key aspects of the reproductive implications of genetic diagnoses for this group, have important implications for future practice, education, and research-e.g., concerning various family members.
January, 2023
These data, the first to explore chaplains' challenges in ending visits/relationships with patients/families, has critical implications for practice, education, and research. Questions arise about the scope/boundaries of chaplains' relationships with patients/families. Interviews were conducted with 23 chaplains who face questions/challenges regarding how to end visits and interactions, including individual conversations and ongoing relationships with patients/families. Chaplains confront uncertainties and rely on verbal- and non-verbal cues to gauge how long to stay with each patient/family, and they are sometimes unsure. These data have critical implications for practice, education, and research.
December, 2023
Critical questions arise about how contextual factors affect hospital chaplains. We interviewed 23 chaplains in-depth. Hospitals’ religious or other institutional affiliation, geography, and leadership can influence chaplains both explicitly/directly and implicitly/indirectly—for example, in types/amounts of support chaplains receive, scope of chaplains’ roles/activities, amounts/types of chaplains’ interactions, chaplains' views of their roles and freedom to innovate, and patients’, families’ and other providers’ perceptions/expectations regarding spiritual care. These data have critical implications for research, practice, and education.
March, 2023
Hospital chaplains aid patients confronting challenges related to palliative and end-of-life care, but relatively little is known about how chaplains view and respond to such needs among Muslim patients, and how well.
December, 2023
Patients often ask, “why me?” but questions arise regarding what this statement means, how, when and why patients ask, how they answer and why. Interviews were conducted as part of several qualitative research studies exploring how patients view and cope with various conditions, including HIV, cancer, Huntington's disease and infertility. A secondary qualitative analysis was performed. Many patients ask, “why me?” but this statement emerges as having varying meanings, and entailing complex psychosocial processes. Patients commonly recognize that this question may lack a clear answer and that asking it is irrational, but they ask nonetheless, given the roles of unknown factors and chance in disease causation, psychological stresses of illness and lack of definitive answers. Patients may focus on different aspects of the question – e.g., on possible causes of illness (Why me? – whether God or randomness is involved) and/or on whether they are being singled out and/or punished (Why me vs. someone else?). Patients frequently undergo dynamic processes, confronting this question at various points, and arriving at different answers, looking for explanations that have narrative coherence for them, and make sense to them emotionally. Social contexts can affect these processes, with friends, family, providers or others rejecting or accepting patients' responses to this question (e.g., beliefs about whether the patient is being punished and/or these questions are worth asking). Anger, depression, despair and/or resistance to notions about the roles of randomness or chaos can also shape these processes. While prior studies have each operationalized “why me?” in differing ways, focusing on varying aspects of it, the concept emerges here as highly multidimensional, involving complex processes and often affected by social contexts. These data, the first to examine key aspects and meanings of the phrase, “why me?” have critical implications for future practice, research and education.
July, 2023
Patients may feel “lucky” or “unlucky” regarding disease, but questions arise about what they mean. Interviews suggest that US patients often invoke luck in trying to understand why diseases occur and treatments succeed/fail, and do so in the context of religious and spiritual beliefs, struggling with whether luck comes from God; and feeling luck is involved at various points, whether good or bad, regarding the whole or just aspects of an illness, and reflecting personal traits or single events. Social contexts can affect these views. These data have critical implications for researchers, physicians, nurses, chaplains, other providers and patients.
December, 2023
To assess whether genetic test results identifying the cause of a child's autism, when accompanied by other neurodevelopmental disorders (NDD), including intellectual disability, alter how parents perceive and treat their child. 28 parents of 22 individuals with autism (mean age: 15 years), usually with other NDDs, were interviewed after receiving genetic diagnoses indicating a de novo mutation through the Simons Foundation Powering Autism Research for Knowledge study. Diagnosis of a de novo genetic variant can alter parental perceptions of offspring with autism and other NDDs. Parents often blamed their child less, saw their child as less in control of symptoms, and developed more patience, framing expectations accordingly. Parents had mixed feelings about receiving genetic diagnoses, with sadness sometimes accompanying reframed expectations. Genetic diagnoses could change views of the child among extended family members, teachers, social service agencies, insurers, and broader communities and society. Genetic testing might also reduce delays in diagnoses of autism among African American, Latino and other children. These data, the first to examine several critical aspects of how parents and others view children with autism and other NDDs after receiving genetic diagnoses, highlight vital needs for education of multiple stakeholders (including geneticists, other physicians, genetic counselors, parents, individuals with autism, social service agencies, insurers, policymakers, and the broader public), research (to include perspectives of extended family members, insurers, social service agencies and teachers) and practice (to increase recognition and awareness of the potential benefits and effects of genetic testing for such children).
Klitzman, R., Di Sapia Natarelli, G., Sinnappan S., Garbuzova E., Al-Hashimi, J. , “Reading” the Room: Healthcare Chaplains’ Challenges, Insights and Variations in Entering Rooms and Engaging with Patients and Families.
May, 2023
Recent research has described broad types of healthcare chaplains’ activities, but many questions remain about how these professionals perform these tasks, whether variations occur, and if so, in what ways. Twenty-three chaplains were interviewed in-depth. Chaplains described engaging in highly dynamic processes, involving both verbal and non-verbal interactions. They face challenges and vary in ways of starting interactions, using verbal and non-verbal cues, and communicating through physical appearance. In these processes, when entering patients’ rooms, they seek to “read the room,” follow patients’ leads, look for cues, match the energy/mood in the room, and adjust their body language appropriately, while maintaining open-ended stances. They face choices of what, if anything, to communicate through clothing (e.g., wearing clerical collars or crosses) and can confront additional challenges with members of groups different than their own, at times requiring further sensitivity. These data, the first to examine challenges chaplains confront entering patients’ rooms and engaging in non-verbal communication, can enhance understandings of these issues, and help chaplains and other healthcare professionals provide more sensitive and astute context-based care. These findings thus have critical implications for education, practice, and research concerning chaplains and other providers.
Klitzman, R., Remien, R. H., Beyer, C. Challenges in Arranging to Waive Parental Consent in HIV Prevention Studies of Adolescent Men Who have Sex with Men: The Case of HPTN 078
March, 2023
Including adolescent men who have sex with men (AMSM) in HIV prevention and treatment studies without parental permission is vital, but has often faced barriers. We examine the case of recent Institutional Review Boards (IRB) reviews of an HIV treatment and prevention study that requested waiving parental permission at four United States sites, but received different responses from each institution. IRBs varied in whether and how they weighed parental rights against AMSMs’ rights and individual and social benefits, and potential harms (e.g., if a parent disapproves of the adolescents’ sexual behavior). One IRB “tabled” the decision to receive advice from the university Office of General Counsel (OGC), despite state laws allowing minors to consent to HIV testing and treatment without parental permission. Another IRB consulted the university’s Chief Compliance Officer (CCO), which thought the waiver was inconsistent with state law, which discusses “venereal disease,” but not HIV. University attorneys may have competing priorities, however, and thus interpret relevant laws differently. This case raises critical concerns, highlighting needs for advocates for AMSM, researchers, IRBs and others at institutional, governmental, and community levels to educate policymakers, public health departments, IRB chairs, members, and staff, OGCs and CCOs about these issues.
Klitzman, R., Sinnappan, S., Garbuzova, E., Al-Hashimi, J. Di Sapia Natarelli, G.
Barriers and Facilitators Faced by Hospital Chaplains in Communicating With Lesbian, Gay, Bisexual, Transgender and Questioning Patients
August, 2023
Chaplains address religious, spiritual and existential issues with heterosexual patients but critical questions arise of whether chaplains do so with lesbian, gay, bisexual, transgender and questioning (LGBTQ) patients, too, and if so, how.
Klitzman, R., Overturning Roe v Wade: Implications for Academic Medical Centers
August, 2023
The June 2022 reversal of Roe v Wade has not only harmed countless pregnant women but has also created critical challenges for academic medical centers (AMCs). Several states prohibit anyone from “aiding and abetting” abortions. Texas even allows citizens to earn financial rewards for suing such providers or others. Several states allow abortions only in “medical emergencies,” raising questions about the exact definition of this term. Rates of unwanted and high-risk pregnancies with complications, and self-managed abortions will likely increase. AMCs need to prepare accordingly to determine how to define the terms “aiding and abetting” and “life-saving” and educate trainees on precisely what state and local laws permit. Physicians and trainees must know whether they can legally mention abortion as an option, and/or refer patients out-of-state—if so, how, and to whom? They also need to understand how to treat ectopic and high-risk pregnancies and fetuses with anomalies, and counsel women either facing these issues, or contemplating self-managed or unregulated abortions. Patients can raise reproductive and abortion issues with not only obstetricians and gynecologists (OB/GYNs), but, in addition, internists, family, adolescent, and emergency physicians, pediatricians, psychiatrists, researchers, and others. Educators thus need to develop and provide appropriate training in multiple fields.
Koch, S., Klitzman, R., Reliance on Fossil fuels: Ethical implications for Intensivists
February, 2023
We are living in the Anthropocene, the geological era in which humanity has altered the planet. Geochemical manifestations include air pollution and climate change due to exponential use of fossil fuels, and massive distribution of manufactured materials, such as plastic, concrete, pesticides, fertilizers and aluminum. All of these changes harm people’s health and quality of life, and are interconnected with the daily practice of intensive care medicine.
Lebowitz M.S., Tabb K., Appelbaum P.S., Asymmetric Causal Attributions to Environmental Influences for Prosocial Versus Antisocial Behavior
June, 2023
Several recent studies have explored how people may favor different explanations for others’ behavior depending on the moral or evaluative valence of the behavior in question. This research tested whether people would be less willing to believe that a person's environment played a role in causing them to exhibit antisocial (as compared to prosocial) behavior. In three experiments, participants read a description of a person engaging in either antisocial or prosocial behavior. Participants were less willing to endorse environmental causes of antisocial (vs. prosocial) behavior when the environmental influence in question was witnessing others behaving similarly, either during childhood (Experiment 1) or recently (Experiment 2), or being directly encouraged by others to engage in the behavior described (Experiment 3). These results could be relevant to understanding why people resist attributing wrongdoing to causes outside of individual control in some cases.
Lee SS.-J., Caruncho M., Chung W.K., Johnston J., Tabb K., Appelbaum P.S.
Individualized Interventions for Rare Genetic Conditions and the Research-Treatment Spectrum: Stakeholder Perspectives
March 21, 2023
Advances in the study of ultrarare genetic conditions are leading to the development of targeted interventions developed for single or very small numbers of patients. Owing to the experimental but also highly individualized nature of these interventions, they are difficult to classify cleanly as either research or clinical care. Our goal was to understand how parents, institutional review board members, and clinical geneticists familiar with individualized genetic interventions conceptualize these activities and their implications for the relationship between research and clinical care.
Mishkin AD, Zabinski JS, Holt G, Appelbaum PS
Ensuring Privacy in Telemedicine: Ethical and Clinical Challenges
November 8, 2022
Data privacy in telemedicine has been extensively considered and reviewed in the literature, such as explorations of consent, who can access information, and the security of electronic systems. However, privacy breaches are also a potential concern in the physical setting and surroundings of the patient. Here we review clinical situations in which there is unanticipated loss of privacy, as well as potential physical and psychological safety concerns for the patient and others when privacy is limited. We identify ethical concerns and explore the challenges of supporting full true autonomous decision-making in this situation. We close with preliminary recommendations at the patient, clinician, and systems levels to help ensure privacy is maintained.
Natri H, Chapman CR, et al.
Ethical Challenges in Autism Genomics: Recommendations for Researchers
September, 2023
Equitable and just genetic research and clinical translation require an examination of the ethical questions pertaining to vulnerable and marginalized communities. Autism research and advocate communities have expressed concerns over current practices of genetics research, urging the field to shift towards paradigms and practices that ensure benefits and avoid harm to research participants and the wider autistic community. Building upon a framework of bioethical principles, we provide the background for the concerns and present recommendations for ethically sustainable and justice-oriented genetic and genomic autism research. With the primary goal of enhancing the health, well-being, and autonomy of autistic persons, we make recommendations to guide priority setting, responsible research conduct, and informed consent practices. Further, we discuss the ethical challenges particularly pertaining to research involving highly vulnerable individuals and groups, such as those with impaired cognitive or communication ability. Finally, we consider the clinical translation of autism genetics studies, including the use of genetic testing. These guidelines, developed by an interdisciplinary working group comprising autistic and non-autistic individuals, will aid in leveraging the potential of genetics research to enhance the quality of life of autistic individuals and are widely applicable across stigmatized traits and vulnerable communities.
Shain J, Michel A, May MS, Qunaj L, El-Sadr W, Chung WK, Appelbaum PS, Jacobson JS, Justman J, Neugut AI.
Cancer Genetic Mutation Prevalence in Sub-Saharan Africa: A review of Existing Data
December 27, 2023
Predictive analytic tools raise notable ethical challenges in medicine—especially when applied to children and adolescents, where patient autonomy can conflict with parental authority. Historically, these tools generally have failed to achieve clinical utility in psychiatry. Emerging evidence suggests that quantifying cumulative environmental exposures (the “exposome”) may change this. Because exposomic research was inspired by and shares principles with genomic research, the ethics of psychiatric exposomic risk scores (ERS) might seem analogous to those of psychiatric polygenic risk scores (PRS), on which there is a growing literature
Smith WR, Appelbaum PS, Lebowitz MS, Gülöksüz S, Calkins ME Kohler CG, Gur RE, Barzilay R.
The ethics of risk prediction for psychosis and suicide attempt in youth mental health
June 21, 2023
Predictive analytic tools raise notable ethical challenges in medicine—especially when applied to children and adolescents, where patient autonomy can conflict with parental authority. Historically, these tools generally have failed to achieve clinical utility in psychiatry. Emerging evidence suggests that quantifying cumulative environmental exposures (the “exposome”) may change this. Because exposomic research was inspired by and shares principles with genomic research, the ethics of psychiatric exposomic risk scores (ERS) might seem analogous to those of psychiatric polygenic risk scores (PRS), on which there is a growing literature
Strand G.R., Sobeck K., Hoffman D.N.
A National Survey of Hospice Aid-in-Dying Policy Availability and the Impact of Legal Mandates
August 25, 2023
The field of aid in dying is expanding in the United States. Terminally ill patients face difficulties in navigating this legal process. A combined lack of support by hospice facilities and inability to access end of life policy information limits patients’ ability to make fully informed decisions on where to receive care. The purpose of this article is to survey and report on the current state of publicly available medical aid in dying policy nationally with a focus on hospice facilities and providers.
Ethical Research When Abortion Access is Legally Restricted
Sugarman, J., Wenner, D. M., Rid, A., Henry, L. M., Luna, F., Klitzman, R., et al.
June 22, 2023
The legal landscape surrounding abortion in the United States has shifted dramatically since the Supreme Court's June 2022 decision in Dobbs v. Jackson Women's Health Organization eliminated a nationwide right to abortion (1). In the year since, roughly half of US states have expanded abortion restrictions. Some consequences of heightened restrictions—including increased maternal morbidity and mortality and deepening socioeconomic and racial inequities—have quickly come into view. However, little attention has focused on the ethical, legal, and practical implications that such restrictions have for research involving people who could become pregnant during research and research staff. Notably, limited access to abortion can pose risks to clinical research participants and potentially compromise the scientific and social value of some research. As a result, assessments of potential research risks and benefits may be altered. We outline points for various stakeholders [such as sponsors, investigators, research sites, and institutional review boards (IRBs)] to consider in addressing these issues.
Knowledge and beliefs about epilepsy genetics among Hispanic and non-Hispanic patients
Trujillo S, Wetmore JB, Camarillo IA, Misiewicz S, May H, Choi H, Siegel K, Chung WK, Phelan JC, Yang LH, Leu CS, Bergner AL, Ottman R.
June 24, 2023
Hispanics continue to face challenges when trying to access health care, including epilepsy care and genetic-related health care services. This study examined epilepsy genetic knowledge and beliefs in this historically underserved population.
Confusing Equity for Ethics Standards: Where Do We Go from Here?
Voigt L. P., Klitzman, R., McLeod-Sordjan, R.
April 10, 2023
The country’s leading hospital accreditation body recently eliminated 168 standards after a comprehensive review that considered three questions: Does the requirement still address an important quality and safety issue? Is it redundant? Are the time and resources needed to comply with the requirement commensurate with the estimated benefit to patient care and health outcomes?
Pharmacovigilance against racial capitalism
Harriet Washington
September 9, 2023
In 1852, abolitionist physician James McCune Smith, the first African American known to have earned a medical degree, exposed the pervasive conception of the Black American as a dangerous creature and described how this was a manufactured image: “The Negro with us is not an actual physical being of flesh and bones and blood, but a hideous monster of the mind, ugly beyond all physical portraying, so utterly and ineffably monstrous as to frighten reason from its throne, and justice from its balance, and mercy from its hallowed temple…It is a constructive Negro, that haunts with grim presence the precincts of this republic, shaking his gory locks over legislative halls and family prayers.” This illusory Black American, unsupported by facts and purely mythical, can also be seen in contemporary racist stereotypes about substance use. The Golem of today's criminally “drug-crazed” Black American, for example, has been ably dissected by Columbia University's Carl Hart, in his 2013 book High Price: A Neuroscientist's Journey of Self-Discovery That Challenges Everything You Know About Drugs and Society.
The U.S. Army needs to pay the Black St. Louis residents it secretly experimented on
Harriet Washington
October 3, 2023
Revelations that the U.S. Army sprayed a carcinogen throughout St. Louis’ predominantly Black Pruitt-Igoe housing development as part of an early Cold War-era program to study what would happen in a biological warfare attack may be shocking to some people, but the details aren’t new to those aware of this country’s history of secret, unethical and often racist medical experimentation.
Abortion Restriction and Mental Health
Katherine L. Wisner, MD, MS; Paul S. Appelbaum, MD
February 8, 2023
In June 2022, the US Supreme Court’s decision in Dobbs v Jackson Women’s Health Organization reversed the nearly 5-decades-old precedent of constitutionally guaranteed access to abortion. The ramifications of the Court’s decision are immense, not only for the 1 in 4 US pregnant people who seek abortions but also for psychiatric practice. Unwanted pregnancies generate severe stress for individuals with limited resources to access safe abortions that may be several hundred miles or more away, which disproportionately affects racial and ethnic marginalized groups, people with disabilities, and unmarried pregnant individuals. Since abortion was legalized in 1973, generations of medical personnel have had no experience with the profound emotional distress and desperation experienced by patients seeking an abortion under restrictive laws. The philosopher George Santayana’s observation is poignant here: “Those who cannot remember the past are condemned to repeat it.”
Human/AI relationships: challenges, downsides, and impacts on human/human relationships
Anne Zimmerman · Joel Janhonen · Emily Beer
October 4, 2023
Advances in artificial intelligence have resulted in objects that behave and sound like humans and exude a more human feel. Therefore, the relationships between humans and technology have evolved, becoming more personal and complex. Some AI is harmful to humans due to the nature of the human relationship with it. We explore examples ranging from chatbots to AI romantic partners. While humans must better protect themselves emotionally, tech companies must create design solutions as well as be transparent about profit motives to address the growing basket of harms. We propose solutions including alignment with AI principles that promote well-being, prevent exploitation, and acknowledge the importance of human relationships.
Politicizing Deference to the FDA Considering the Alliance for Hippocratic Medicine Cases
Anne Zimmerman
April 17, 2023
The Food and Drug Administration (FDA) approved mifepristone for terminating pregnancy in 2000. On April 7, 2023, a Texas court issued a preliminary injunction suspending FDA approval in Alliance for Hippocratic Medicine, et al., v. U.S. Food and Drug Administration, et al. On April 12, the Fifth Circuit Court of Appeals partially overruled, allowing the drug approval to persist, yet partially granted the motion for a stay pending appeal on the FDA decision to make mifepristone available by mail. On April 14, 2023, the Supreme Court ordered an administrative stay on the Texas District Court ruling. (The status of mifepristone will remain as it was prior to the order until Wednesday April 19.) Deference to administrative agencies is grounded in the Administrative Procedure Act and steeped in public policy and legal theory and practice. Agencies have subject-matter expertise, and they are well positioned to interpret statutes as well as regulations they enact. The FDA has a public health mandate. Deference to agencies generally presumes Congress would want agencies that promulgate regulations to oversee disputes about their application. Judicial oversight is also a fundamental part of the system of checks and balances. Many argue that the FDA could have published an interpretation preventing the current controversy, although it is likely the same plaintiffs would challenge any interpretation or policy guidance. This article examines deference considering the Alliance for Hippocratic Medicine opinion and the FDA’s broad mandate. The Fifth Circuit was silent on deference to the FDA and the Supreme Court has not relied on Chevron deference in recent cases when it could have, leaving the public unsure of the doctrine, and its application to the FDA. Kisor v. Willkie, a recent Supreme Court case applying Auer v. Robbins,is a helpful guide.
Values in AI: bioethics and the intentions of machines and people
Anne Zimmerman, Joel Janhonen, Michael Saadeh, Camille Castelyn & Heikki Saxén
December 12, 2022
Artificial intelligence has the potential to impose the values of its creators on its users, those affected by it, and society. The intentions of creators as well as investors may not comport with the values of users and broader society. Users also may mean to use a technological device in an illicit or unexpected way. Devices change people's intentions as they are empowered by technology. What people mean to do with the help of technology reflects their choices, preferences, and values. Technology is a disruptor that impacts society as a whole. Without knowing who intends to do what, it is difficult to rely on the creators of technology to choose methods and create products that comport with user and broader societal values. The AI is programmed to accomplish tasks according to chosen values or is doing so through machine learning and deep learning. We assert that AI is quasi-intentional and changes people's intentions. Investors wishing to promote or preserve public health, wellbeing, and wellness should invest in ethical, responsible technology. Environmental, social, and governance (ESG) considerations and metrics should include ethical technology, wellness, public health, and societal wellbeing. This paper concludes that the process by which technology creators infuse values should be couched in bioethical and general ethical considerations, reflective of potential multiple intentions, and should entail a willingness and process to adapt the AI after the fact as the circumstances of its use change.
Mitochondrial Replacement Therapy: How a Government for the People, Failed the People
Author: Jeffery Mark Sauer, Bioethics Alumnus
November 7, 2018
Despite having the potential to significantly reduce the passage of many lethal diseases and devastating birth defects, mitochondrial replacement therapy—a controversial medical procedure in which mitochondrial RNA from a healthy female replaces the mitochondrial RNA from the intended mother in vitro—will have no place in the United States anytime soon. Under the guise of purported safety concerns and ethical dilemmas, the Republican Congress used its “power of the purse” to halt any and all research furthering mitochondrial replacement therapy, notwithstanding the fact that many leaders in the medical community have advocated for further research. Several developed countries have already implemented limited applications of the procedure. However, as long as Congress continues to abuse its constitutional appropriations power in a manner inconsistent with the original intent of the framers, policies that can greatly benefit society as a whole will be sacrificed in the name of partisanship and narrow-mindedness.
Are Obese Children Abused Children?
Author: Maura Priest, Bioethics Student
August 16, 2018
In 2010, a South Carolina mother was taken to court when her fourteen‐year‐old son reached 555 pounds. An article on the story reported, “His mother, Jerri Gray, lost custody of her son and is being charged with criminal neglect. Gray is facing 15 years on two felony counts, the first U.S. felony case involving childhood obesity.” If the caretakers of obese children are negligent, then they are also morally and legally blameworthy. I want to suggest, however, that important ethical differences exist between negligent or abusive caretakers and the caretakers of obese children and that these differences ought to make a moral and legal difference. The distinctions are nuanced, and the ethical pictures in cases of abuse, neglect, and obesity are far from black and white. However, the various types of harm that children face from their caretakers should be placed in neither the same ethical nor the same legal category.
When children are beaten or sexually molested, the justification for taking them out of the home is clear: the caretakers are violating the rights of their children. Similarly, with neglect, caretakers are failing to provide their children with the necessities to which they are entitled. The central question that I want to address in this article is whether the actions (or inaction) of caretakers that allow a child to become obese are morally or practically analogous to physical abuse or neglect. Ultimately, I will argue that parenting that allows a child to become obese is so morally different from both abuse and neglect that it is best understood as falling outside these categories altogether. This conclusion has important moral, practical, and legal implications.
Brain Injury and the Civil Right We Don’t Think About
Author: Joseph J. Fins, Bioethics Faculty
August 24, 2017
“If we reconceived rehabilitation as education, no one would graduate after a six-week course of care. Instead, we would promote lifelong learning as a means to achieve a recovered life. If there is a legal obligation to educate the developing brain, should there not be a correlative responsibility to those whose brain are in a process of redevelopment and recovery?”
"I'm Willing To Try Anything:" Compassionate Use Access to Experimental Drugs and the Misguided Mission of Right-to-Try Laws
Authors: Amy Scharf and Elizabeth Dzeng, Bioethics Alumni
June 14, 2017
Some patients facing death take drastic, or even desperate measures in order to prolong their lives. Such actions often include taking unapproved, investigational drugs. In the U.S., a program known as Compassionate Use, or Expanded Access, allows terminally ill patients who meet certain medical criteria to apply (through their physicians) to the Food and Drug Administration (FDA) and the drug manufacturers for access to drugs that are undergoing FDA clinical trials. At first blush, it may appear that there should be no legal, political, or ethical controversies surrounding the concept of expanded access. How can one possibly deny a dying patient even the slightest chance of prolonged life or recovery? Is there a side effect worse than certain death?
I am a Refugee, an Immigrant and an American
Author: Bela Fishbeyn, Bioethics Alumna
March 27, 2017
Can Lay Community Advisors Improve the Clarity of Research Participant Recruitment Materials and Increase the Likelihood of Participation?
Author: Nora Jacobson, Faculty
March 24, 2017
Despite decades of effort, lower-income people and ethnic minorities continue to be underrepresented as participants in health research. A group of racially and ethnically diverse, lower-income community members (Community Advisors on Research Design and Strategies: CARDS1) was trained to review study designs and procedures and provide recommendations to researchers for increasing participation and making research materials more understandable to members of underrepresented communities. In this mixed methods study, one participant group (n 1⁄4 55) was shown research materials (recruitment documents and a consent form) developed by a research team and approved by the local IRB. A second group (n 1⁄4 45) was shown the same materials after they had also been reviewed and revised by CARDS. Interviews, which included both fixed- response and open-ended questions, were used to assess reactions of participants in both groups to the materials, including their hypothetical willingness to volunteer for the research described. Group differences were examined using the Chi-square distribution test. Proportional difference effect sizes were estimated using arcsine transformation. The qualitative data were subjected to conventional content analysis. Participants in the group shown the recruitment materials revised by CARDS were more likely to say they understood the documents, more likely to ask for more information about the study, and more likely to say they would participate in the research. Results of content analysis suggested a four-phase sequential process for deciding whether to participate in the research.
Health Care Justice and Its Implications for Current Policy of a Mandatory Waiting Period for Elective Tubal Ligation
Author: Lillian Ringel, Bioethics Alumna
March 24, 2017
Paternalism, Autonomy, and Food Regulation
Author: Maura Priest, Bioethics Student
March 24, 2017
In 2012, former New York City mayor Michael Bloomberg proposed legislation that would ban the sale of sugary drinks in containers larger than 16 ounces. The growth of the obesity epidemic suggests that proposals for similar measures will increase in coming years. As public health officials' focus shifts, campaigns against smoking are being replaced with campaigns against sugar, fat, and carbs. Governments may be quick to propose regulations that incapacitate our ability to make bad health choices. Prima facie, it may seem that any inquiry into the justificatory grounding of Bloomberg's proposal or other "food bans" would be nothing more than re-engagement with familiar issues regarding paternalism, coercion, liberty, and respect for persons. Governments have a long history of approving legal mandates concerning smoking, narcotics, seat belts, vaccinations, and more. Philosophical discussions on the aforementioned have a prolific literature, and Bloomberg's ban might seem like just an addition to the list. If so, we should simply re-engage old arguments and apply them to the matter at hand. But this would be a mistake.
An Interview with Tom Beauchamp, Early Bioethics Innovator
Author: Elizabeth Galt, Bioethics Alumna
March 24, 2017
Criminalizing Substance Use in Pregnancy: Misplaced Priorities
Authors: Carl Erik Fisher, Katrina Hui, Cara Angelotta, Bioethics Faculty
February 28, 2017
Chemical endangerment’ laws in the United States mark an increasingly growing trend to punish women with substance use disorder. These measures are counterproductive. They create barriers to substance use treatment and prenatal care, disproportionately affecting minority and low-income women. Contingency management programs and expansion of social services would be more effective in protecting children and women and improving the problem more generally.
The Connected Heart Texts Your Doc When Something's Wrong
Author: Kira Peikoff, Bioethics Alumna
January 18, 2017
A Good Death
Authors: Adira Hulkower and Tia Powell, Bioethics Students
January 11, 2017
A good death is hard to find. Family members tell us that loved ones die in the wrong place—the hospital—and do not receive high-quality care at the end of life. This issue of the Hastings Center Report offers two articles from authors who strive to provide good end-of-life care and to prevent needless suffering. We agree with their goals, but we have substantial reservations about the approaches they recommend. Respect for the decisions of patients and their surrogates is a relatively new and still vulnerable aspect of medical care. For thousands of years, patients and surrogates had no say in medical decision-making. Today, standards support shared decision-making, but these articles both carve out exceptions to those standards, limiting the rights of patients and families in decisions about specific end-of-life treatments. As bioethics consultants in an acute care setting, we frequently confront conflicts similar to those described by Jeffrey Berger and by Ellen Robinson and colleagues. In such cases, our service emphasizes redoubled efforts at communication and mediation. Focusing on goals and values, rather than interventions, produces the best possible collaboration in health care decision-making. Cases in which we would overturn a surrogate's recommendations regarding palliative sedation or do-not-resuscitate orders are rare and require careful processes and clear evidence that the surrogate's choice is contrary to patient values.
Free to Consume? Anti-Paternalism and the Politics of New York City’s Soda Cap Saga
Author: James Colgrove, Bioethics Faculty
January 7, 2017
2012, New York City Mayor Michael Bloomberg proposed capping the size of sugary beverages that could be sold in the city’s restaurants, sporting and entertainment facilities and food carts. After a lawsuit and multiple appeals, the proposal died in June 2014, deemed an unconstitutional overreach. In dissecting the saga of the proposed soda cap, we highlight both the political perils of certain anti-obesity efforts and, more broadly, the challenges to public health when issues of consumer choice and the threat of paternalism are involved.
Combating Resistance: Federal Efforts to Reduce Overuse, Curb Misuse, and Incentivize the Development of Antibiotic Drugs
Author: Donna Hanrahan, Bioethics Alumna
January 1, 2017
This article addresses the public health issue of antibiotic resistance and recommends statutory responses to reduce the overuse, curb misuse, and incentivize the development of novel antibiotic drugs. It then suggests that the Food and Drug Administration (FDA) impose a Risk Evaluation and Mitigation Strategy (REMS) restriction on novel antibiotic drug products to conserve their use and prevent misuse. Further, this article urges Congress to be swift and bold in implementing statutory reform to halt antibiotic resistance by passing the Promise for Antibiotics and Therapeutics for Health (PATH) Act to incentivize innovation in antibiotic development by creating a new regulatory approval pathway for antibiotic drugs. Until a new regulatory regime surrounding antibiotics is established, policymakers should work creatively within existing statutory frameworks to curb resistance by using the Orphan Drug Act (ODA) to spur antibiotic innovation and the Controlled Substance Act (CSA) to promote antibiotic conservation.
The Imperative for Conceptual Accuracy in Memory Modification
Authors: Carl Erik Fisher and Katrina Hui, Bioethics Faculty
December 6, 2016
Vaccine Refusal Revisited — The Limits of Public Health Persuasion and Coercion
Author: James Colgrove, Bioethics Faculty
October 6, 2016
Your Next Antibiotic Might Be a Virus
Author: Kira Peikoff, Bioethics Alumna
September 15, 2016
Inferior Disagreement
Author: Maura Priest, Bioethics Student
September 1, 2016
Literature in the epistemology of disagreement has focused on peer disagreement: disagreement between those with shared evidence and equal cognitive abilities. Additional literature focuses on the perspective of amateurs who disagree with experts. However, the appropriate epistemic reaction from superiors who disagree with inferiors remains underexplored. Prima facie, this may seem an uninteresting set of affairs. If A is B’s superior, and A has good reason to believe she is B’s superior, A appears free to dismiss B’s disagreement. However, a closer look will show otherwise. I first distinguish competent from incompetent inferiors and then argue that disagreement from the former often gives superiors reason to adjust credence and reevaluate belief. In other words, epistemic inferiority alone is insufficient grounds for dismissing opinion. More nuanced difficulties arise with incompetent inferiors. When superiors disagree with incompetents, this might provide evidence to bolsterbelief credence; however, agreement from incompetents can defeat justification. In either instance, inferior opinion carries epistemic weight. Yet, this fails to cover all ground; at times, superiors learn nothing from inferior disagreement. I finish by exploring these uninformative disagreements, how to distinguish them from the informative cases, and the proper epistemic reactions thereof.
Why Children Should be Allowed to Vote
Author: Maura Priest, Bioethics Student
July 1, 2016
The United States has an ugly record of unjust disenfranchisement. Initially, only property-owning white males could exercise this essential political right. As time went on, progressive legislation began to rectify these grave wrongs. Property ownership is no longer mandated, poll taxes have been eliminated, and the vote has been expanded to women and minorities. However, there remains a class of the unjustly disenfranchised: those old enough to reason, to make rational and informed decisions, yet denied basic political privileges because of age. This paper argues that the current voting age in the United States conflicts with fundamental liberal principles. It considers a wide range of arguments that attempt to justify youth disenfranchisement and concludes that all such arguments fail. It then briefly argues that youth voting is more likely to help society rather than hurt it. Although arguments in this paper focus on voting in the United States, much of what is said applies to all liberal democracies.
Federal "Right to Try" Bill: Wrong on the Law, and Wrong For Patients
Authors: Lisa Kearns and Beth Roxland, Bioethics Alumni
June 28, 2016
On June 16, Jordan McLinn, a seven-year old boy who suffers from Duchenne muscular dystrophy, joined other patients, their advocates, and members of Congress at a rally on the Capitol lawn in support of a federal “right to try” bill. At first blush, the Trickett Wendler Right to Try Act (S. 2912) would grant McLinn and other dying patients an automatic right to pre-approval, or “compassionate,” access to experimental drugs that appear promising in early testing but that have not yet completed clinical trials and been approved by the FDA. Unfortunately, the new federal bill, like similar state laws, is both legally ineffective and ethically troubling.
Ethics of Advances in Human Embryonic Stem Cell Research
Author: Matthew Dias, Bioethics Student
June 16, 2016
For several decades, scientists have reasoned that stem cells—and human embryonic stem cells (hESC) especially—have the potential to improve human health. In particular, research indicates that the properties unique to hESC (e.g., plasticity, potency) can benefit our understanding of, and approaches to, regenerative medicine and embryology. For instance, understanding how these cells might (i) mitigate or treat diseases such as Alzheimer’s, Parkinson’s, cancer, and diabetes, and (ii) produce vital insights into human development, is a priority within the scientific research enterprise, but one whose methodologies and ethics should be thoroughly monitored and reviewed in accordance with advances in medicine.
Blame After Forgiveness
Author: Maura Priest, Bioethics Student
June 1, 2016
When a wrongdoing occurs, victims, barring special circumstance, can aptly forgive their wrongdoers, receive apologies, and be paid reparations. It is also uncontroversial, in the usual circumstances, that wronged parties can aptly blame their wrongdoer. But controversy arises when we consider blame from third-parties after the victim has forgiven. At times it seems that wronged parties can make blame inapt through forgiveness. If third parties blame anyway, it often appears the victim is justified in protesting. “But I forgave him!” In other cases, however, forgiveness seems irrelevant: B can forgive A, but it can still seem that third parties can aptly blame A for the wrong against B. This perplexity adds a dimension to ongoing discussion regarding criteria for apt blame and the related issues of standing and fittingness. This paper explores the status of third party blame after forgiveness. I argue that while post forgiveness blame is often inapt, in many other cases forgiveness is irrelevant. This difference is explained by appeal to the various relationships third parties might have to wronged parties, and how these differences affect the ways we blame and thereby blame’s aptness.
Ethics for Ethicists? The Professionalization of Clinical Ethics Consultation
Author: Rachel Yarmolinsky, Bioethics Alumna
May 5, 2016
Professionalism and codes of ethics are intrinsically tied. As professions establish themselves, their members write codes of ethics to help define the professions and who can be considered a professional. The codes explain why and how professions are deserving of trust, establish standards with specific guidelines for ethical practice, and designate who will have the authority to enforce standards. Do clinical ethicists need a code of ethics?
In IVF, Questions About ‘Mosaic’ Embryos
Author: Kira Peikoff, Bioethics Alumna
April 18, 2016
Planning for Ancillary Care Provision: Lessons From the Developing World
Author: Nora Jacobson, Bioethics Faculty
March 19, 2016
As part of a study designed to assess a new strategy for increasing health research participation by members of underrepresented populations in the United States, we explored expectations about volunteering for research among people from lower income and largely minority communities in Madison, Wisconsin. Members of these communities often saw research participation as a means to access health care that might otherwise be unavailable to them. In light of persistent structural barriers to access, and the resulting health disparities, we argue that one cannot assume the existence of a “fair exchange” in which a community is likely to benefit from the results of research conducted with members of that community. We use ethical analysis and empirical research conducted in the developing world to explore how investigators in the United States might think about their obligations to provide ancillary care.
Ethical Issues in the Use of Extracorporeal Membrane Oxygenation in Controlled Donation After Circulatory Determination of Death
Author: Anne Dalle Ave, Bioethics Student
March 3, 2016
The use of donor extracorporeal membrane oxygenation (ECMO) to improve graft outcomes by some controlled donation after circulatory determination of death (cDCDD) programs raises ethical issues. We reviewed cDCDD protocols using ECMO and the relevant ethical literature to analyze these issues. It is not obvious if ECMO in cDCDD improves graft outcomes. In our opinion, ECMO implemented before death can interfere with end-of-life care and damage bodily integrity. By restoring systemic circulation, ECMO risks invalidating the preceding declaration of death, if brain and cardiac perfusion is not adequately excluded because of malfunction or misplacement of the supra-diaphragmatic aortic occlusion balloon. The use of ECMO is not compatible with the acronym DCDD, since circulation is restored after the determination of death. Because of these deficiencies, we conclude that other techniques are preferable such as rapid recovery or in situ cold infusion. If ECMO is performed, it requires a specific informed consent and transparency.
Ethics Consultation Quality Assessment Tool: A Novel Method for Assessing the Quality of Ethics Case Consultations Based on Written Records
Authors: Robert A. Pearlman, Mary Beth Foglia, Ellen Fox, Jennifer H. Cohen, Barbara L. Chanko, and Kenneth A. Berkowitz, Bioethics Faculty
February 25, 2016
Although ethics consultation is offered as a clinical service in most hospitals in the United States, few valid and practical tools are available to evaluate, ensure, and improve ethics consultation quality. The quality of ethics consultation is important because poor quality ethics consultation can result in ethically inappropriate outcomes for patients, other stakeholders, or the health care system. To promote accountability for the quality of ethics consultation, we developed the Ethics Consultation Quality Assessment Tool (ECQAT). ECQAT enables raters to assess the quality of ethics consultations based on the written record. Through rigorous development and preliminary testing, we identified key elements of a quality ethics consultation (ethics question, consultation-specific information, ethical analysis, and conclusions and/or recommendations), established scoring criteria, developed training guidelines, and designed a holistic assessment process. This article describes the development of the ECQAT, the resulting product, and recommended future testing and potential uses for the tool.
NPRM Public Comment Deadline Has Passed—Implications for Revisions to the Common Rule and the Future of Human Subjects Protections
Author: Matthew Dias, Bioethics Student
February 8, 2016
The January 6, 2016 closure of the public comment period for revisions to the Common Rule concluded several contentious months in the bioethics world.
Restricting Choices of Childbearing Women
Author: Bela Fishebyn, Bioethics Alumna
February 1, 2016
NASH is the 21st Century's Looming Public Health Threat
Author: Kira Peikoff, Bioethics Student
January 30, 2016
"According to liver experts, NASH is a silent public health time bomb that may soon overload our health care system with hospital admissions....Doctors say its incidence has exploded in the last two decades thanks in part to the growing prevalence of obesity."
An Analysis of Heart Donation After Circulatory Determination of Death
Authors: Anne Laure Dalle Ave, David Shaw and James L Bernat, Bioethics Students
January 22, 2016
Heart donation after circulatory determination of death (DCDD) has provoked ethical debate focused primarily on whether heart DCDD donors are dead when death is declared and when organs are procured.
CPR Survival Rates Can Differ Greatly by City
Author: Kira Peikoff, Bioethics Student
December 7, 2015
If you have a stroke, your odds of survival are similar whether you are in Boston or Boise. But not so if you fall victim to cardiac arrest.
Caring for Older Adults in Disasters: A Curriculum for Health Professionals – Lesson 6-1, Ethical-Legal Special Considerations for the Older Adult Population
Authors: Lillian Ringel and Judith Ahronheim, Bioethics Alumni
December 1, 2015
The purpose of this curriculum is to enable educators to teach health professionals about caring for older adults in disasters. A wide range of health professions can use this curriculum.
Can Clinicians Maim Healthy Organs? The Case of Jewel Shuping
Author: Matthew Dias, Bioethics Student
November 5, 2015
This October, reports surfaced that a psychologist deliberately blinded a North Carolina woman named Jewel Shuping, per her request. Thirty-year-old Shuping suffers from Body Integrity Identity Disorder (“BIID”), a psychiatric condition in which individuals experience an overwhelming, lifelong desire to develop a disability—most often by amputating a limb but sometimes by maiming an organ.
Gov. Brown’s Veto of Right-to-Try Bill
Author: Lisa Kearns, MS, MA, Bioethics Student
October 20, 2015
The conservative press’s reaction to Gov. Jerry Brown’s veto of California’s “right-to-try” bill recently was surprising—not because of the vitriol expressed, or because the writers strongly supported the legislation, which was overwhelmingly popular in the state.
How Bioethics Can Help Students with the Multiple Mini-Interviews for Medical School
Authors: Robert Klitzman, Bioethics Faculty and Lillian Ringel, Bioethics Alumna
September 1, 2015
After the Supreme Court Decision on Lethal Injection Drug, More Questions
Authors: Lillian Ringel and Stephanie Holmquist, Bioethics Alumni
July 5, 2015
Adult Attention-Deficit/Hyperactivity Disorder and Nicotine Withdrawal: A Qualitative Study of Patient Perceptions
Authors: Carl Erik Fisher, Romilda Nellen, Anja Frei, Anne Catherine Beichl, Nina Hiestand, Alice Huber, Anna Buadze, Dominique Eich
June 16, 2015
Nicotine use has been reported to ameliorate symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD). Furthermore, adults with ADHD have a relatively high prevalence of cigarette smoking and greater difficulty abstaining from smoking. Overall, though, there is scant literature investigating the beliefs, perceptions and experiences of smokers with ADHD regarding smoking cessation and withdrawal.
The Proper Locus of Professionalization: The Individual or the Institutions?
Author: Bela Fishebyn, Bioethics Alumna
May 13, 2015
Health Communication, Public Mistrust, and the Politics of “Rationality”
Author: Sara M. Bergstresser, Bioethics Student
April 9, 2015
There is a basic lack of trust in information that is disseminated through official sources, and this has troubling implications for the future of public health in the United States and beyond… our attentions should shift away from the case itself and toward the reestablishment of trust in public health.
‘Right to Try’ Law Won’t Grant Access to Unapproved Drugs
Authors: Lisa Kearns and Arthur L. Caplan, Bioethics Students
April 6, 2015
Last month, the General Assembly's Public Health Committee unanimously approved and sent to the House floor a bill that purports to grant terminally ill patients access to medicines and therapies not yet approved by the federal Food and Drug Administration. This type of "right to try" legislation has been championed as a quick, merciful end run around the lengthy FDA process for approving new drugs. Thirteen states have already passed such laws. Connecticut should not join them.
When Ideology Trumps: A Case for Evidence Based Health Policies
Author: Bela Fishebyn, Bioethics Alumna
March 18, 2015
The Ethics of Molecular Memory Modification
Author: K. Hui and C. Fisher, Bioethics Students
December 31, 2014
Novel molecular interventions have recently shown the potential to erase, enhance and alter specific long-term memories. Unique features of this form of memory modification call for a close examination of its possible applications. While there have been discussions of the ethics of memory modification in the literature, molecular memory modification (MMM) can provide special insights.
The Mexican and Transnational Lives of Corn: Technological, Political, Edible Object
Authors: E. Castellanos and S.M. Bergstresser, Bioethics Students
November 28, 2014
Sara May Bergstresser examines corn as a case study to illuminate the historical and cultural dimensions of environmental and technological dialogues in Latin America.
Web Roundup: Ebola
Author: S.M. Bergstresser, Bioethics Student
August 31, 2014
We should care about the Ebola epidemic for reasons that extend beyond our own fears of contagion.
TinkerGone Viral: Diverging Threshold Tests for Analyzing School Regulation of Off-Campus Digital Student Speech
Author: D. Marcus-Toll, Bioethics Student
July 17, 2014
Threshold tests (to determine whether to apply the substantial disruption test to off-campus student speech) that courts have developed neither safeguard the rights of students nor meet the needs of schools adequately.
Fearing Punishment for Bad Genes
Author: K. Peikoff, Bioethics Student
April 7, 2014
Many people avoid genetic tests because they fear reprisal from employers and health insurers.
In the Best Interest of the Child: Psychological and Ethical Reflections on Traditions, Contexts, and Perspectives in Pediatric Clinical Genomics
Author: L. Bush, Bioethics Student
March 4, 2014
There is a disconnect between the best interests of a child and “tradition” in the context of pediatric genetic testing and sequencing.
For 30 Years I Couldn't Walk, Until I Took One Pill
Author: K. Peikoff, Bioethics Student
February 26, 2014
"Elizabeth Davis was bullied out of school, hid her condition from teenage dates, and struggled to keep up with her two children without the use of her legs. But a late-in-life diagnosis changed everything."
Moral Anthropocentrism Is Unavoidable
Author: K. Hui, Bioethics Student
February 12, 2014
Our ability to assess morality is tinged with anthropocentrism and constrained by our human capacities, values, and scientific methodology.
Padre Pio to "Papa Buono"
Author: S. M. Bergstresser, Bioethics Student
December 18, 2013
Sara May Bergstresser argues the figure of the saint is a site of symbolic convergence.
Artist’s Statement: Doctor-Patient
Author: O.N. Anekwe, Bioethics Student
December 14, 2013
Obiora Anekwe discusses his art collage, Doctor-Patient, which shows a doctor and a nurse weighing and confirming the height of a man in the Tuskegee Syphilis Study.
Letter to the Editor
Author: K. Hui, Bioethics Student
October 20, 2013
It is unsurprising that doctors fail to come clean on medical error given our society’s climate of malpractice.
The Illusion of Post Hoc Autonomy
Author: K. Hui, Bioethics Student
September 11, 2013
While a basic kind of autonomy may be all that is necessary for agency, unconscious influences on decision making remain a serious threat to autonomy.
Political Engagement as an Element of Social Recovery: A Qualitative Study
Authors: S.M. Bergstresser, I.S. Brown and A. Colesante, Bioethics Students
August 15, 2013
Taking a qualitative approach, Sara May Bergstresser describes consumer attitudes toward political participation and the association between political engagement and social recovery.
Return of Secondary Genomic Findings vs Patient Autonomy: Implications for Medical Care
Authors: R. Klitzman, P. S. Appelbaum, and W. Chung, Bioethics Faculty
July 31, 2013
In April 2013, the American College of Medical Genetics (ACMG) recommended that clinical laboratories conducting whole genome sequencing (WGS) and whole exome sequencing (WES) for specific clinical indications should also analyze and report any mutations identified from a list of 57 genes considered medically actionable, regardless of whether patients wish to receive the results.1 These recommendations have sparked a heated debate with profound implications for countless physicians and their patients.
The Person at the Center
Author: S.M. Bergstresser, Bioethics Student
July 17, 2013
Various theories and interventions have linked the capabilities approach to health policy, mental health services, and broader questions of social integration for consumers of mental health services.
Researchers’ Views on Return of Incidental Genomic Research Results: Qualitative and Quantitative Findings
Authors: R. Klitzman, P. S. Appelbaum, A. Fyer, J. Martinez, B. Buquez, J. Wynn, and W. Chung, Bioethics Faculty
June 27, 2013
Comprehensive genomic analysis including exome and genome sequencing is increasingly being utilized in research studies, leading to the generation of incidental genetic findings. It is unclear how researchers plan to deal with incidental genetic findings.
Public Safety, Mental Disorders, and Guns
Author: P. S. Appelbaum, Bioethics Faculty
April 3, 2013
In the aftermath of the shooting of 20 schoolchildren and 6 teachers in Newtown, Connecticut, on December 14, 2012, attention quickly focused on the presumed link between mental disorder and violence. With no more than rumors to rely on, the media speculated wildly on the gunman's diagnosis and drew parallels to earlier shootings involving persons with mental illness. Wayne LaPierre, executive vice president of the National Rifle Association, announced at a press conference that the problem of violence was largely due to people with mental illness, “genuine monsters . . . that are so deranged, so evil, so possessed by voices and driven by demons, that no sane person can even possibly comprehend them.”
Repackaging Cigarettes — Will the Courts Thwart the FDA?
Authors: R. Bayer, L. Gostin, and D. Marcus-Toll, Bioethics Students
November 29, 2012
Legal and policy issues have emerged related to the proposed graphic warning labels on cigarette packaging.
The Ethics of Research on Deep Brain Stimulation for Depression: Decisional Capacity and Therapeutic Misconception
Authors: C. E. Fisher, L. B. Dunn, P. P. Christopher, P. E. Holtzheimer, Y. Leykin, H. S. Mayberg, and P. S. Appelbaum, Bioethics Faculty
July 19, 2012
Research on deep brain stimulation (DBS) for treatment-resistant depression appears promising, but concerns have been raised about the decisional capacity of severely depressed patients and their potential misconceptions about the research. We assessed 31 DBS research participants with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), a well-validated capacity measure, and with a scale to measure therapeutic misconception, which occurs when subjects do not recognize key differences between treatment and clinical research. Correlations with baseline depressive symptoms were explored. Subjects’ performance on the MacCAT-CR was excellent, but therapeutic misconception was still apparent. A trend toward significance was found in the correlation between baseline depression ratings and total therapeutic misconception score. Responses to open-ended prompts revealed both reassuring and concerning statements related to expectations of risk, benefit, and individualization. Even severely depressed patients did not manifest impairments in their capacity to consent to DBS research. Therapeutic misconception, however, remained prevalent.
The Silent Majority: Who Speaks at IRB Meetings?
Authors: P. J. Candilis, C. W. Lidz, P. S. Appelbaum, R. M. Arnold, W. Gardner, S. Garverich, and L. J. Simon, Bioethics Faculty
July 14, 2012
Institutional review boards (IRBs) are almost universally considered over-worked and under-staffed, at the same time requiring substantial commitments of time and resources. Although some surveys report average IRB memberships of 15 persons or more, federal regulations require only five. We present data on IRB meetings at 8 of the top 25 NIH-funded academic medical centers in the U.S., indicating substantial contributions from primary reviewers and chairs during protocol discussions but little from other members. The implications of these data for current IRB functioning are discussed and an alternative model proposed.
How Closely Do Institutional Review Boards Follow the Common Rule?
Authors: C. W. Lidz, P. S. Appelbaum, R. Arnold, P. Candilis, W. Gardner, S. Myers, and L. Simon, Bioethics Faculty
July 12, 2012
Between November 2006 and July 2009, the authors observed, audio-recorded, transcribed, and coded protocol reviews from 20 IRB meetings at 10 leading academic medical centers. They also reviewed each of the applications discussed to identify the Common Rule criteria--(1) risk minimization, (2) risk/benefit comparison, (3) equitable subject selection, (4) informed consent, (5) data monitoring to ensure safety, (6) privacy protection and confidentiality, and (7) protection of vulnerable subjects--that were both relevant to the study and not adequately addressed in the application. They then determined if the IRB addressed each of the relevant and not discussed Common Rule criteria in their discussions.
Personalized Disclosure by Information-on-Demand: Attending to Patients' Needs in the Informed Consent Process
Authors: G. Siegal, R. J. Bonnie, and P. S. Appelbaum, Bioethics Faculty
July 12, 2012
Obtaining informed consent has typically become a stylized ritual of presenting and signing a form, in which physicians are acting defensively and patients lack control over the content and flow of information. This leaves patients at risk both for being under-informed relative to their decisional needs and of receiving more information than they need or desire. By personalizing the process of seeking and receiving information and allowing patients to specify their desire for information in a prospective manner, we aim to shift genuine control over the informational process to patients. A new paradigm of Information on Demand, such as we suggest, would also enhance legal certainty, achieve greater congruence between the information patients want and the information they receive and promote more meaningful patient-physician interactions, a desirable outcome that has been difficult to achieve by other means.
Manipulating Fate: Medical Innovations, Ethical Implications, Theatrical Illuminations
Authors: K. Rothenberg and L. Bush, Bioethics Students
June 14, 2012
Theatre provides a framework to reflect upon how the ethical, legal, and social implications of emerging technologies evolve over time and how attempts to control fate through medical science have shaped-and been shaped by-personal and professional relationships.
Attitudes and Practices Among Internists Concerning Genetic Testing
Authors: R. Klitzman, W. Chung, K. Marder, A. Shanmugham, L. J. Chin, M. Stark, and P. S. Appelbaum, Bioethics Faculty
May 15, 2012
Many questions remain concerning whether, when, and how physicians order genetic tests, and what factors are involved in their decisions. We surveyed 220 internists from two academic medical centers about their utilization of genetic testing. Rates of genetic utilizations varied widely by disease. Respondents were most likely to have ordered tests for Factor V Leiden (16.8 %), followed by Breast/Ovarian Cancer (15.0 %). In the past 6 months, 65 % had counseled patients on genetic issues, 44 % had ordered genetic tests, 38.5 % had referred patients to a genetic counselor or geneticist, and 27.5 % had received ads from commercial labs for genetic testing. Only 4.5 % had tried to hide or disguise genetic information, and <2 % have had patients report genetic discrimination.
To Protect Human Subjects, Review What Was Done, Not Proposed
Authors: R. Klitzman and P. S. Appelbaum, Bioethics Faculty
March 30, 2012
Retrospective review could improve the efficiency—and perhaps the effectiveness—of human subjects research oversight.
The Advance Notice of Proposed Rule-making (ANPRM) released in 2011 by the U.S. Department of Health and Human Services (HHS) (1) recommends many important changes to federal regulations on protection of human research subjects. Perhaps most important, through the 74 questions it poses, it offers the opportunity to rethink approaches to research oversight. The current regulatory model of prospective review, based on what researchers say they plan to do, focuses the attention of Institutional Review Boards (IRBs, which must approve proposed research) and researchers on perfecting protocols and consent forms rather than interacting with subjects.
The Participation of Community Members on Medical Institutional Review Boards
Authors: C. W. Lidz, L. J. Simon, A. V. Seligowski, S. Myers, W. Gardner, P. J. Candilis, and P. S. Appelbaum, Bioethics Faculty
February 1, 2012
The goal of this study was to describe the contributions of community members (unaffiliated members) who serve on institutional review boards (IRBs) at large medical research centers and to compare their contributions to those of other IRB members. We observed and audiotaped 17 panel meetings attended by community members and interviewed 15 community members, as well as 152 other members and staff. The authors coded transcripts of the panel meetings and reviewed the interviews of the community members. Community members played a lesser role as designated reviewers than other members. They were infrequently primary reviewers and expressed hesitation about the role. As secondary or tertiary reviewers, they were less active participants than other members in those roles. Community members were more likely to focus on issues related to confidentiality when reviewing an application than other reviewers. When they were not designated reviewers, however, they played a markedly greater role and their discussion focused more on consent disclosures than other reviewers. They did not appear to represent the community so much as to provide a nonscientific view of the protocol and the consent form.
Ethics and Neuropsychiatric Genetics: A Review of Major Issues
Authors: S. K. Hoge, and P. S. Appelbaum, Bioethics Faculty
January 25, 2012
Advances in neuropsychiatric genetics hold great hopes for improved prevention, diagnosis and treatment. However, the power of genetic testing to identify individuals at increased risk for disorders and to convey information about relatives creates a set of complex ethical issues. Public attitudes are inevitably affected by the shadow of eugenics, with its history of distorting scientific findings to serve socio-political ends. Nonetheless, the growing availability of genetic tests means that more patients will seek genetic information and physicians must manage the process of informed consent to allow meaningful decisions.
Genes and Plays: Bringing ELSI Issues to Life
Authors: K. Rothenberg and L. Bush, Bioethics Students
January 19, 2012
Dramatic narratives can bring to life images of differing perspectives and values when experiencing innovations in medicine.
Dialogues, Dilemmas, and Disclosures: Genomic Research and Incidental Findings
Authors: L. Bush and K. Rothenberg, Bioethics Students
December 12, 2011
Research and bioethical communities need to engage in further dialogue on the controversial issues arising from sequencing, reflecting on these unresolved dilemmas to enrich the policy process.
Enrolling In Deep Brain Stimulation Research For Depression: Influences On Potential Subjects' Decision Making
Authors: P. P. Christopher, Y. Leykin, P. S. Appelbaum, P. E. Holtzheimer, H. S. Mayberg and L. B. Dunn, Bioethics Faculty
November 17, 2011
Ethical concerns regarding early-phase clinical trials of DBS for treatment-resistant depression (TRD) include the possibility that participants' decisions to enroll might be motivated by unrealistic expectations of personal benefit or minimization of risks.
The Death of Esmin Green: Considering Ongoing Injustice in Psychiatric Institutions
Author: S.M. Bergstresser, Bioethics Student
April 6, 2011
Using the case of Esmin Green, Sara May Bergstresser shows how feminist bioethics can offer a unique perspective on power imbalances within social, political, and institutional aspects of psychiatry.
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