Jeffery Mark Sauer – Alumni
University of Miami Law Review – 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.
Maura Priest – Student
The Hastings Center – 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 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.
Joseph J. Fins – Faculty
The New York Times – 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?”
Amy Scharf and Elizabeth Dzeng – Alumni
Health Affairs – 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?
Nora Jacobson – Faculty
Research in Nursing & Health – 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 partici- pants 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 esti- mated using arcsine transformation. The qualitative data were subjected to con- ventional content analysis. Participants in the group shown the recruitment materials revised by CARDS were more likely to say they understood the docu- ments, 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.
Maura Priest – Student
Public Affairs Quarterly – 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.
Carl Erik Fisher, Katrina Hui, Cara Angelotta – Faculty
Society for the Study of Addiction – 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.
Adira Hulkower, Tia Powell – Student
Hastings Center Report – 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.
James Colgrove – Faculty
Public Health Ethics – 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.
Donna Hanrahan – Alumni
Annals of Health Law – 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.
Maura Priest – Student
Acta Analytica – 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.
Maura Priest – Student
Public Affairs Quarterly – 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.
Lisa Kearns, Beth Roxland – Alumni
The Hill – 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.
Matthew Dias – Student
Ampersand – 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.
Maura Priest – 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.
Rachel Yarmolinsky – Alumni
AMA Journal of Ethics – 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 a 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?
Nora Jacobson – Faculty
Journal of Empirical Research on Human Research Ethics – 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.
Anne Dalle Ave – Student
American Journal of Transplantation – 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.
Robert A. Pearlman, Mary Beth Foglia, Ellen Fox, Jennifer H. Cohen, Barbara L. Chanko, and Kenneth A. Berkowitz – Faculty
The American Journal of Bioethics – 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.
Matthew Dias – Student
Ampersand – 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.
Kira Peikoff – Student
Newsweek – 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."
Anne Laure Dalle Ave, David Shaw, James L Bernat – Student
Journal of Medical Ethics – 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.
Kira Peikoff – Student
The New York Times – 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.
Lillian Ringel, Judith Ahronheim – Alumni
National Center for Disaster Medicine and Public Health – 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.
Matthew Dias – Student
Bioethics.net – 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.
Lisa Kearns, MS, MA – Student
Bioethics.net – 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.
Carl Erik Fisher, Romilda Nellen, Anja Frei, Anne Catherine Beichl, Nina Hiestand, Alice Huber, Anna Buadze, Dominique Eich –
BMC Psychiatry – 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.
Bergstresser, Sara M. – Student
The American Journal of Bioethics – 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.
Kearns, Lisa; Caplan, Arthur L. – Student
Hartford Courant – 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.
Hui, K., Fisher, C. – Student
Journal of Medical Ethics – 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.
Castellanos, E., Bergstresser, S.M. – Student
4S Annual Meeting – 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.
Marcus-Toll, D. – Student
Fordham Law Review – 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.
Bush, L. – Student
The American Journal of Bioethics – 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.
Peikoff, K. – Student
Cosmopolitan – 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."
Hui, K. – Student
The American Journal of Bioethics – February 12, 2014
Our ability to assess morality is tinged with anthropocentrism and constrained by our human capacities, values, and scientific methodology.
Bergstresser, S. M. – Student
The Anthropology of Religious Charisma: Ecstasies and Institutions – December 18, 2013
Sara May Bergstresser argues the figure of the saint is a site of symbolic convergence.
Anekwe, O.N. – Student
Academic Medicine – 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.
Hui, K. – Student
AJOB Neuroscience – 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.
Bergstresser, S.M., Brown, I.S., Colesante, A. – Student
Psychiatric Services – 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.
Klitzman, R., Appelbaum, P. S., & Chung, W. – Faculty
Journal of the American Medical Association – 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.
Bergstresser, S.M. – Student
The American Journal of Bioethics – 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.
Klitzman, R., Appelbaum, P. S., Fyer, A., Martinez, J., Buquez, B., Wynn, J., ... & Chung, W. K. – Faculty
Genetics in Medicine – 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.
Appelbaum, P. S. – Faculty
JAMA Psychiatry – 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.”
Bayer, R., Gostin, L., & Marcus-Toll, D. – Student
The New England Journal of Medicine – November 29, 2012
Legal and policy issues have emerged related to the proposed graphic warning labels on cigarette packaging.
Fisher, C. E., Dunn, L. B., Christopher, P. P., Holtzheimer, P. E., Leykin, Y., Mayberg, H. S., ... & Appelbaum, P. S. – Faculty
Annals of the New York Academy of Sciences – 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.
Candilis, P. J., Lidz, C. W., Appelbaum, P. S., Arnold, R. M., Gardner, W., Garverich, S., ... & Simon, L. J. – Faculty
IRB – 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.
Lidz, C. W., Appelbaum, P. S., Arnold, R., Candilis, P., Gardner, W., Myers, S., & Simon, L. – Faculty
Academic Medicine – 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.
Siegal, G., Bonnie, R. J., & Appelbaum, P. S – Faculty
The Journal of Law, Medicine & Ethics – 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.
Rothenberg, K., Bush, L. – Student
Houston Journal of Health Law and Policy – 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.
Klitzman, R., Chung, W., Marder, K., Shanmugham, A., Chin, L. J., Stark, M., ... & Appelbaum, P. S. – Faculty
Journal of Genetic Counseling – 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.
Klitzman, R., & Appelbaum, P. S – Faculty
Science – 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.
Lidz, C. W., Simon, L. J., Seligowski, A. V., Myers, S., Gardner, W., Candilis, P. J., ... & Appelbaum, P. S. – Faculty
Journal of Empirical Research on Human Research Ethics – 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.
Hoge, S. K., & Appelbaum, P. S. – Faculty
The International Journal of Neuropsychopharmacology – 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.
Rothenberg, K., Bush, L. – Student
Genetics in Medicine – January 19, 2012
Dramatic narratives can bring to life images of differing perspectives and values when experiencing innovations in medicine.
Bush, L., Rothenberg, K. – Student
Genetics in Medicine – 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.
Christopher, P. P., Leykin, Y., Appelbaum, P. S., Holtzheimer, P. E., Mayberg, H. S., & Dunn, L. B. – Faculty
Depression and Anxiety – 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.
Bergstresser, S.M. – Student
International Journal of Feminist Approaches to Bioethics – 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.