Mary Faith Marshall

The OHRP and SUPPORT - Another view

A group of physicians, bioethicists, and scholars in allied fields agrees with the Office for Human Research Protections about the informed-consent documents in SUPPORT.

Clinical report - Maternal-fetal intervention and fetal care centers

The past 2 decades have yielded profound advances in the fields of prenatal diagnosis and fetal intervention. Although fetal interventions are driven by a beneficence-based motivation to improve fetal and neonatal outcomes, advancement in fetal therapies raises ethical issues surrounding maternal autonomy and decision-making, concepts of innovation versus research, and organizational aspects within institutions in the development of fetal care centers. To safeguard the interests of both the pregnant woman and the fetus, the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics make recommendations regarding informed consent, the role of research subject advocates and other independent advocates, the availability of support services, the multidisciplinary nature of fetal intervention teams, the oversight of centers, and the need to accumulate maternal and fetal outcome data.

The Paradigm of the Paradox: Women, Pregnant Women, and the Unequal Burdens of the Zika Virus Pandemic

The Zika pandemic provides biomedical scientists, clinicians, public health advocates, and governments a unique opportunity to advance reproductive justice by addressing the paradoxes outlined in this essay. The circumstances in which pregnancies occur are morally relevant to women’s reproductive life decisions, to the provision of reproductive health care, and to the development of reproductive health policy. Whether the Zika pandemic might foster context-driven reproductive pandemic planning and response is yet to be determined. Maintaining the status quo will surely increase a range of global health disparities and further stratify reproduction, producing predictable and preventable outcomes in which some people receive the necessary care and resources to achieve family building while others are neglected. Women and men should be able to count on biomedical researchers to answer the questions that need answering without undue influence from political agendas. Women should be able to continue pregnancies and count on public health assistance and help for children with Zika-related disabilities, or prevent or end a Zika-affected pregnancy. Pandemic responses that don’t further these ends are morally unacceptable.

The Charleston Policy on Cocaine Use During Pregnancy: A Cautionary Tale

he conflict between pregnant women freely using cocaine and the well-being of fetuses presents a difT ficult social problem. Since 1985, at least 200 women, in thirty states, have been criminally prosecuted for using illicit drugs or alcohol during pregnancy Such policies enjoy considerable public and political support. Nonetheless, treatment programs that include referral to law enforcement officials raise serious ethical and legal issues for hospitals and health care providers. In this paper, we assess the development of one medical university’s controversial treatment program for pregnant women addicted to cocaine. In October 1989, the Medical University of South Carolina (MUSC) instituted a new program, called the Interagency Policy on Management of Substance Abuse During Pregnancy (Interagency Policy), designed “to ensure appropriate management of patients abusing illegal drugs during pregnancy.”’ This program required some pregnant women to seek drug counseling and prenatal care under the threat of criminal sanctions. This bold manner of dealing with the problem attracted national attention. Five years later, on September 1, 1994, MUSC agreed to discontinue the policy, which, by that time, had resulted in the arrest of forty-two pregnant women who had tested positive for cocaine but did not follow up on recommended treatment for chemical dependency The academic medical center, located in Charleston, South Carolina, made the change in a settlement with the Civil Rights Division of the Department of Health and Human Services (DHHS). After the policy was discontinued, the federal Office of Protection from Research Risks (OPRR) determined that the program constituted human experimentation conducted without req-

Social justice in pandemic preparedness

Pandemic influenza planning in the United States violates the demands of social justice in 2 fundamental respects: it embraces the neutrality of procedural justice at the expense of more substantive concern with health disparities, thus perpetuating a predictable and preventable social injustice, and it fails to move beyond lament to practical planning for alleviating barriers to accessing care. A pragmatic social justice approach, addressing both health disparities and access barriers, should inform pandemic preparedness. Achieving social justice goals in pandemic response is challenging, but strategies are available to overcome the obstacles. The public engagement process of one states pandemic ethics project influenced the development of these strategies.

Educational Approaches to the Responsible Conduct of Clinical Research: An Exploratory Study

Purpose To identify best practices in education related to the responsible conduct of clinical research (RCCR). Method American Society for Bioethics and Humanities (ASBH) members involved with teaching RCCR were asked to complete an online survey, followed by an in-depth telephone interview. The online survey asked about respondents’ RCCR teaching, trainees, and institutional context. The phone interview involved discussions about teaching strategies, institutional context, and needs. The study was conducted between 2003 and 2005. Results Forty-eight respondents to the online survey indicated a breadth of topics being covered in RCCR curricula; 35 respondents indicated that their RCCR teaching applied toward institutional RCCR requirements. Among the 21 instructors interviewed, many described a wide variety of teaching responsibilities. Recommended teaching strategies included fostering interactive discussion, using skills-based exercises such as designing IRB applications, accommodating students’ individual interests in curriculum design, involving experienced researchers, involving trainees early in their careers as well as requiring continuing education, and designing a curriculum with a clear view of educational objectives. Interviewees described the institutional supports they needed, and they noted that insufficient support sometimes undermines RCCR teaching goals. Participants generally agreed that RCCR education should be required. Conclusions Strong agreement among participants concerning recommended strategies for teaching RCCR provides useful, if provisional, guidance to instructors and institutions charged with providing such training. The study suggests a need for substantial investments in RCCR training, studying outcomes, and developing mechanisms to ensure the quality of instruction.

Legistrothanatry: A New Specialty for Assisting in Death

����� The debate on physician-assisted suicide and voluntary euthanasia is still active and unresolved. Clear resolution in the near future seems unlikely, because moral visions of the acceptable and unacceptable are diverse, and arguments on practical grounds are supported by little data. Suicide itself is viewed by some as morally unacceptable, but most of that opinion is religiously based. Because we are a secular, pluralistic society, suicide should be viewed, if not as morally acceptable, at least as lying within an individuals moral purview and not subject to legal prohibition [I]. If suicide should not be subject to legal prohibition on moral grounds, then it seems difficult tojustify on moral grounds, prima facie, prohibiting assisted suicide or its close cousin, voluntary euthanasia. There is afundamental difference, however, between suicide and assisted suicide: the former is ultimately chosen and executed by one person with a single set ofvalues; the latter draws in a second person with a second set ofvalues. While the second person may be concerned only with the interests of the suicide subject, there is potential that he may act in his own interest, based on his own values, in encouraging and assisting suicide [2] . Thus, there is an important empirical question that looms larger under conditions of assisting suicide than suicide: to what extent and with what frequency is the act ofsuicide motivated by the best interests ofthe subject? Self-serving motivation by the assister may be an attendant risk ofa permissive social attitude toward assisted suicide; debate on the subject has provided no clear answers because few unequivocal data are available. Objective evidence that the interests of second or third parties will frequently motivate assisters to encourage suicide would argue stronglyfor legal prohibition of assisted suicide; whereas evidence tiiat this will seldom occur

Is Broader Better

In their article “A Broader Understanding of Moral Distress,” Campbell, Ulrich, and Grady (2016) correctly assert that moral distress is well established in the nursing literature and is gaining attention in other health care professions. These are significant points. For decades, moral distress simmered quietly in the health care professions—unstudied, unacknowledged, and insidiously damaging careers. Today, the phenomenon is finally receiving the attention it deserves at the bedside, in institutional boardrooms, in the classroom, and on research priority lists. As the authors state, “Moral distress is, first and foremost, a practical problem.” The current understanding of moral distress has identifiable boundaries, and, while not perfect, has utility in practice and evolving research. We argue that the authors’ broader definition of moral distress dilutes the concept to such a degree as to render it impractical—too nebulous to be effectively taught, studied, used in practice, or, frankly, respected any longer as a powerful phenomenon in bioethics. The authors are not the first to attempt to redefine moral distress. At least 13 previous articles have offered new definitions since Jameton first coined the term in the 1980s (e.g., Hamric 2014; McCarthy and Deady 2008; Thomas and McCullough 2015; Varcoe et al. 2012). Nearly all of the earlier attempts have maintained the same core element: being compelled to act in a way that one believes is morally wrong but feels powerless to change. Campbell, Ulrich, and Grady move away from this central understanding into

The Barnes Case: Taking Difficult Futility Cases Public

Futility disputes are increasing and courts are slowly abandoning their historical reluctance to engage these contentious issues, particularly when confronted with inappropriate surrogate demands for aggressive treatment. Use of the judicial system to resolve futility disputes inevitably brings media attention and requires clinicians, hospitals, and families to debate these deep moral conflicts in the public eye. A recent case in Minnesota, In re Emergency Guardianship of Albert Barnes, explores this emerging trend and the complex responsibilities of clinicians and hospital administrators seeking to replace an unfaithful surrogate demanding aggressive therapy. Use of the courts requires the coordinated commitment of significant institutional resources, management of intense media scrutiny and individual and organizational courage to enter the unpredictable world of litigation. Given the dearth of legislative guidance on medical futility, individual clinicians and institutions will continue to bear the difficult responsibility for resolution of individual futility disputes. The Barnes case illustrates how one institution successfully used the judicial system to replace an unfaithful surrogate, cease the provision of inappropriate aggressive care, and stimulate a community dialogue about appropriate care at the end of life.

The Barnes Case

Futility disputes are increasing and courts are slowly abandoning their historical reluctance to engage these contentious issues, particularly when confronted with inappropriate surrogate demands for aggressive treatment. Use of the judicial system to resolve futility disputes inevitably brings media attention and requires clinicians, hospitals, and families to debate these deep moral conflicts in the public eye. A recent case in Minnesota, In re Emergency Guardianship of Albert Barnes, explores this emerging trend and the complex responsibilities of clinicians and hospital administrators seeking to replace an unfaithful surrogate demanding aggressive therapy. Use of the courts requires the coordinated commitment of significant institutional resources, management of intense media scrutiny and individual and organizational courage to enter the unpredictable world of litigation. Given the dearth of legislative guidance on medical futility, individual clinicians and institutions will continue to bear the difficult responsibility for resolution of individual futility disputes. The Barnes case illustrates how one institution successfully used the judicial system to replace an unfaithful surrogate, cease the provision of inappropriate aggressive care, and stimulate a community dialogue about appropriate care at the end of life.