Debra A. DeBruin

Ethics Review of Social, Behavioral, and Economic Research: Where Should We Go From Here?

It is not unusual for researchers to complain about institutional review board (IRB) oversight, but social scientists have a unique set of objections to the work of ethics committees. In an effort to better understand the problems associated with ethics review of social, behavioral, and economic sciences (SBES) research, this article examines 3 different aspects of research ethics committees: (a) the composition of review boards; (b) the guidelines used by these boards to review SBES—and in particular, behavioral health—research; and (c) the actual deliberations of IRBs. The article concludes with recommendations for changes in the review process and with suggestions for filling the gaps in knowledge about the way IRBs work.

Justice and the Inclusion of Women in Clinical Studies: An Argument for Further Reform

Our societys practice of inadequately representing women as subjects of clinical research is unjust, not only because it results in inequalities in the quality and availability of care that have a detrimental impact on womens health, but also because it is linked to womens oppression. Although recent policy changes help to resolve the problems, more must be done. Additional remedies for the injustices of our societys research practices are proposed.

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.

Ethical Guidance for Disaster Response, Specifically Around Crisis Standards of Care: A Systematic Review

Background Terrorism, disease outbreaks, and other natural disasters and mass casualty events have pushed health care and public health systems to identify and refine emergency preparedness protocols for disaster response. Ethical guidance, alongside legal and medical frameworks, are increasingly common components of disaster response plans. Objectives To systematically review the prevalence and content of ethical guidance offered for disaster response, specifically around crisis standards of care (CSCs). Search methods We systematically indexed academic literature from PubMed, Google Scholar, and ISI Web of Science from 2012 to 2016. Selection criteria We searched for peer-reviewed articles that substantively engaged in discussion of ethical guidance for CSCs. Data collection and analysis Researchers screened potential articles for identification and discussion of ethical issues in CSC planning. We categorized and cataloged ethical concepts and principles. Main results Of 580 peer-reviewed articles mentioning ethics and CSCs or disaster planning, 38 (6%) met selection criteria. The systematic review of the CSC ethics literature since 2012 showed that authors were primarily focused on the ethical justifications for CSC (n = 20) as well as a need for ethics guidelines for implementing CSCs; the ethical justifications for triage (n = 19), both as to which criteria to use and the appropriate processes by which to employ triage; and international issues (n = 17). In addition to these areas of focus, the scholarly literature included discussion of a number of other ethical issues, including duty to care (n = 11), concepts of a duty to plan (n = 8), utilitarianism (n = 5), moral distress (n = 4), professional norms (n = 3), reciprocity (n = 2), allocation criteria (n = 4), equity (n = 4), research ethics (n = 2), duty to steward resources (n = 2), social utility and social worth (n = 2), and a number of others (n = 20). Although public health preparedness efforts have paid increasing attention to CSCs in recent years, CSC plans have rarely been implemented within the United States to date, although some components are common (e.g., triage is used in US emergency departments regularly). Conversely, countries outside the United States more commonly implement CSCs within a natural disaster or humanitarian crisis response, and may offer significant insight into ethics and disaster response for US-based practitioners. Conclusions This systematic review identifies the most oft-used and -discussed ethical concepts and principles used in disaster planning around CSCs. Although discussion of more nuanced issues (e.g., health equity) are present, the majority of items substantively engaging in ethical discussion around disaster planning do so regarding triage and why ethics is needed in disaster response generally. Public health implications A significant evolution in disaster planning has occurred within the past decade; ethical theories and frameworks have been put to work. For ethical guidance to be useful, it must be practical and implementable. Although high-level, abstract frameworks were once prevalent in disaster planning-especially in the early days of pandemic planning-concerns about the ethically difficult concept of CSCs pervade scholarly articles. Ethical norms must be clearly stated and justified and practical guidelines ought to follow from them. Ethical frameworks should guide clinical protocols, but this requires that ethical analysis clarifies what strategies to use to honor ethical commitments and achieve ethical objectives. Such implementation issues must be considered well ahead of a disaster. As governments and health care systems plan for mass casualty events, ethical guidance that is theoretically sound and practically useful can-and should-form an important foundation from which to build practical guidance for responding to disasters with morally appropriate means.

The Two-Patient Framework for Research During Pregnancy: A Critique and a Better Way Forward

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Partner notification in the context of HIV: an interest-analysis

Codes of confidentiality play an essential role in the intimate discourses in many learned professions. Codes with various prescriptions exist. The Hippocratic Oath for example, prescribes rewards to the secret keeper, for keeping secret what ought to be kept secret, and punishments for failing. In public health practice, partner notification, arguably is one endeavor that tests the durability of this secret keeping doctrine of the health professional. We present an interest-analysis of partner notification in the context of HIV service rendition. Using principles-based analysis, the interests of the individual, the state/public health, and the bioethicist’s are discussed. The public health interests in partner notification, which are usually backed by state statutes and evidence, are premised on the theory that partners are entitled to knowledge. This theory posits that knowledge empowers individuals to avoid continuing risks; knowledge of infection allows for early treatment; and that knowledgeable partners can adapt their behavior to prevent further transmission of infection to others. However, persons infected with HIV often have counter interests. For instance, an infected person may desire to maintain the privacy of their health status from unnecessary disclosure because of the negative impacts of disclosure, or because notification without a matching access to HIV prevention and treatment services is detrimental. The interest of the bioethicist in this matter is to facilitate a resolution of these conflicted interests. Our analysis concludes that governmental interests are not absolute in comparison with the interests of the individual. We reiterate that any effort to morally balance the benefits of partner notification with its burdens ought to first recognize the multivalent nature of the interests at play.

Key populations and human rights in the context of HIV services rendition in Ghana

BackgroundIn line with its half century old penal code, Ghana currently criminalizes and penalizes behaviors of some key populations – populations deemed to be at higher risk of acquiring or transmitting Human Immunodeficiency Virus (HIV). Men who have sex with men (MSM), and sex workers (SWs) fit into this categorization. This paper provides an analysis of how enactment and implementation of rights-limiting laws not only limit rights, but also amplify risk and vulnerability to HIV in key and general populations. The paper derives from a project that assessed the ethics sensitivity of key documents guiding Ghana’s response to its HIV epidemic. Assessment was guided by leading frameworks from public health ethics, and relevant articles from the international bill of rights.DiscussionGhana’s response to her HIV epidemic does not adequately address the rights and needs of key populations. Even though the national response has achieved some public health successes, palpable efforts to address rights issues remain nascent. Ghana’s guiding documents for HIV response include no advocacy for decriminalization, depenalization or harm reduction approaches for these key populations. The impact of rights-restricting codes on the nation’s HIV epidemic is real: criminalization impedes key populations’ access to HIV prevention and treatment services. Given that they are bridging populations, whatever affects the Ghanaian key populations directly, affects the general population indirectly.SummaryThe right to the highest attainable standard of health, without qualification, is generally acknowledged as a fundamental human right. Unfortunately, this right currently eludes the Ghanaian SW and MSM. The paper endorses decriminalization as a means of promoting this right. In the face of opposition to decriminalization, the paper proposes specific harm reduction strategies as approaches to promote health and uplift the diminished rights of key populations. Thus the authors call on Ghana to remove impediments to public health services provision to these populations. Doing so will require political will and sufficient planning toward prioritizing HIV prevention, care and treatment programming for key populations.

Fetal Risk, Fetal Purity, and the Perils Posed by Pregnant Women

Howard Minkoff and Mary Faith Marshall (2016) explore the astonishing though commonly asserted claim that pregnant women should not expose their fetuses to risk. They offer insights from moral psychology to shed considerable light on questions about how to ethically manage risk in pregnancy. I argue that their analysis does not fully resolve questions about the case studies they centrally consider, and offer suggestions about how their analysis might be supplemented. Minkoff and Marshall (2015) consider a prominent assertion that women ought not to be allowed to choose home birth, given its elevated neonatal mortality rate compared to hospital birth. They remind readers about the distinction between relative and absolute risk, and the misleading nature of relative risk claims. They note that trial of labor after cesarean delivery (TOLAC) is associated with roughly the same magnitude of risk as home birth, but providers nevertheless exhibit greater willingness to embrace the former. They contend that this is an example of motivated reasoning: “A person’s attitude may determine the significance attached to a level of risk as much as a level of risk determines an individual’s attitude” (Minkoff and Marshall 2016, 5). This analysis fits neatly with Mary Douglas’s insight that “risk” is a forensic concept. Elsewhere I join with colleagues to explore how Douglas’s view helps demonstrate that judgments about risk in pregnancy raise issues of social justice (DeBruin et al. in press). Here I focus on how her view provides support for Minkoff andMarshall’s analysis of motivated reasoning. According to Douglas (1990), all cultures need a way to indicate judgments of responsibility for (prevention of) unfavorable outcomes. “Sin” and “taboo” serve this function for religious cultures but do not suit our more secular culture. “Risk” bears the connotation of scientific authority, a secular parallel for divine authority. We tend to think of “risk” as a purely descriptive concept capturing the probability of an event occurring combined with the magnitude of harms or losses involved. But as a forensic term, “risk” is laden with moral significance—with cultural norms about acceptable versus objectionable behavior and attributions of responsibility. Thus, “risk” provides fertile ground for motivated reasoning. For example, the judgment that pregnant women should not expose their fetuses to risk reflects widely held social norms about acceptable versus objectionable behavior during pregnancy. That it is quite literally impossible to avoid exposing fetuses to risk does little or nothing to undermine the norm—philosophers’ insistence that “ought” implies “can” be damned. As Douglas maintains, “It is futile to study risk perception without systematically taking the cultural bias into account” (Douglas 1990, 11). Minkoff and Marshall further examine our culture’s moral attitudes toward risk in pregnancy by exploring the “nettlesome question” of whether parental obligations to born children apply to fetuses as well. They argue that recognition of the moral status of the pregnant woman forbids the extension of these obligations to fetuses, since enforcement of such obligations would violate the woman’s autonomy and bodily integrity. At the very least, they contend, obligations to fetuses cannot be stronger than those to born children. They proceed to consider results of a thought experiment that run counter to their view. Participants in a conference of the American College of Obstetricians and Gynecologists were polled for their views on two hypothetical scenarios. The first involves a pregnant woman, at term, who experiences a cord prolapse when dilated to 5 cm. Both the woman and the fetus are healthy, with no noteworthy risks. The woman refuses a cesarean delivery for “seemingly trivial reasons.” Sixty-six percent of participants indicated (via anonymous audience response technology) that they would request a court order for a cesarean section. The second scenario involves a 2-weekold infant who develops an illness that will be quickly fatal unless the baby receives a bone-marrow transplant from her mother. Again, the scenario stipulates that the mother refuses for “seemingly trivial reasons.” Thirty-eight percent of participants indicated that they would seek a court order requiring the mother to provide marrow.

Ethics-sensitivity of the Ghana national integrated strategic response plan for pandemic influenza

BackgroundMany commentators call for a more ethical approach to planning for influenza pandemics. In the developed world, some pandemic preparedness plans have already been examined from an ethical viewpoint. This paper assesses the attention given to ethics issues by the Ghana National Integrated Strategic Plan for Pandemic Influenza (NISPPI).MethodsWe critically analyzed the Ghana NISPPI’s sensitivity to ethics issues to determine how well it reflects ethical commitments and principles identified in our review of global pandemic preparedness literature, existing pandemic plans, and relevant ethics frameworks.ResultsThis paper reveals that important ethical issues have not been addressed in the Ghana NISPPI. Several important ethical issues are unanticipated, unacknowledged, and unplanned for. These include guidelines on allocation of scarce resources, the duties of healthcare workers, ethics-sensitive operational guidelines/protocols, and compensation programs. The NISPPI also pays scant attention to use of vaccines and antivirals, border issues and cooperation with neighboring countries, justification for delineated actions, and outbreak simulations. Feedback and communication plans are nebulous, while leadership, coordination, and budgeting are quite detailed. With respect to presentation, the NISPPI’s text is organized around five thematic areas. While each area implicates ethical issues, NISPPI treatment of these areas consistently fails to address them.ConclusionsOur analysis reveals a lack of consideration of ethics by the NISPPI. We contend that, while the plan’s content and fundamental assumptions provide support for implementation of the delineated public health actions, its consideration of ethical issues is poor. Deficiencies include a failure to incorporate guidelines that ensure fair distribution of scarce resources and a lack of justification for delineated procedures. Until these deficiencies are recognized and addressed, Ghana runs the risk of rolling out unjust and ethically indefensible actions with real negative effects in the event of a pandemic. Soliciting inputs from the public and consultation with ethicists during the next revision of the NISPPI will be useful in addressing these issues.