Kayhan Parsi

It's Alive! Giving Birth to Research Ethics Education

Ethics education is armly integrated into medical school curricula. Every U.S. allopathic medical school offers at least one ethics course, and many schools require at least one for graduation (American Association of Medical Colleges 1998; Dubois and Burkemper 2002). A similar trend has occurred in basic science research training, mainly due to requirements set forth by the National Institutes of Health (NIH). Yet in their article “The Absent Professor: Why We Don’t Teach Research Ethics and What to Do About It,” Arri Eisen and Roberta M. Berry (2002) survey the landscape of ethics education for basic bioscience researchers and and it wanting. In this commentary we will focus on a few issues raised by the authors. First, we will examine the idea of bioscience research as a profession. Second, we will address the merits and limitations of using biomedical ethics as a model for teaching bioscience researchers about research ethics. Lastly, we will explore the practical components of interdisciplinary collaboration among bioscience researchers and other professionals on research ethics. We argue that opening the discourse to this concern is a laudable endeavor, though there are pedagogical issues to arst address. Eisen and Berry argue that bioscience research is a profession, similar to medicine, law, and engineering. A classic deanition of a profession is a collegial community of individuals who undergo signiacant academic study or training in a aeld, circumscribing their own self-interests to serve the needs of clients while ascribing to a code of ethics. In his recent book Beleaguered Rulers, May (2001) surveys several kinds of professionals: physicians, lawyers, engineers, clergypersons, media professionals, professors, and politicians. He omits scientists but would probably include this category of individuals because of their intensive study regimens and because of their devotion to serving the needs of society. While biologists, physicists, physicians, and anthropologists are all different professionals, the process of engaging in research does not automatically confer upon one the status of professional. If bioscience research were a profession, it would behoove the putative profession to develop ethics codes of conduct. But in actuality it is the responsibility of biologists, physicists, physicians, and anthropologists to develop codes of research ethics as part of their professional ethics; many, if not all, already do. Are Eisen and Berry, then, equating professional scientists with basic-science researchers? Professions such as medicine and law have well-developed standards of professional ethics, as reoected in their professional codes. Biologists, chemists, and physicists all have their own codes of conduct. Are Eisen and Berry arguing for a panscience code that would cover all disciplines of science? Why not rely on the existing codes of professional scientists? Eisen and Berry also narrowly focus on “bioscience research” characterized by doing laboratory or “bench” science. This focus is surprising given that there is no human-subjects component to laboratory science research. Certainly such research investigators can beneat from engagement in ethical issues such as conoicts of interest, responsible authorship, and data management, which the authors brieoy outline. But this focus raises the question: Would bioethicists be the appropriate individuals (themselves not a formal profession) to teach bioscience researchers about research ethics, considering that bioethicists are primarily concerned with research ethics relating to human subjects? The connection between the two seems artiacial, albeit perhaps necessary if bioscience research faculty do not take the necessary step toward teaching their own graduate and postdoctoral students about ethics in the course of mentoring. In contrast to professional ethics based on codes that are heavily rule-oriented, the research ethics proposed by Eisen and Berry preserve the best features of science (its freedom and informality) by emphasizing the importance of greater transparency and accountability. In focusing on this “educational initiative that is instrumental and proactive rather than judgmental and reactive,” they are constructing an ethics educational model that is more similar to medical ethics education than legal ethics education. That is, medical ethics education tries to instill in students an appreciation for understanding ambiguity in ethical dilemmas. This is in contrast to legal ethics education, which is oriented toward rules that explicitly outline expected conduct, with little room for reoection. What remains to be determined is how the community of scientists will hold each other accountable when breaches in codes of ethics occur. The authors propose the novel idea of interdisciplinary training in research ethics and its concomitant beneats. Interdisciplinary research and dialogue is highly fruitful for introducing new perspectives on current issues. Practically speaking, however, would biologists, physicians, social scientists—who encounter research ethics issues from vastly different perspectives—be able to offer the kinds of ethics advice that bench scientists readily need? And, would nonbench scientists be sufaciently familiar with the kinds of ethical issues bioscience researchers typically encounter to adequately educate them? The authors also rightly call for greater interaction be-

The bioethicist as public intellectual.

Public intellectuals have long played a role in American culture, filling the gap between the academic elite and the educated public. According to some commentators, the role of the public intellectual has undergone a steady decline for the past several decades, being replaced by the academic expert. The most notable cause of this decline has been both the growth of the academy in the twentieth century,which has served to concentrate intellectual activity within its confines, and the changing nature of the media, which has framed the way in which information is conveyed to the public. We argue that although bioethics has developed primarily within the academic tradition and utilized the role of expert when dealing with the public, bioethicists are well suited to don the mantle of the public intellectual. Indeed, because they address issues in medicine and science of great relevance for the general public, bioethicists have a duty to revitalize the tradition of public intellectuals as a necessary complement to the important, but narrower role of expert.

Global health and service learning: lessons learned at US medical schools.

Background : Interest in global health is rapidly increasing amongst US medical students. Many students aspire to incorporate global health into their future careers, while others seek international opportunities to better prepare themselves for domestic practice. US medical schools have begun responding to this burgeoning interest with varying intensity and through a number of different strategies. Conclusions : Three important themes involved include: increasing the academic rigor of programming, fostering sustainable site partnerships, and encouraging mentorship and reflection for the students involved. Finally, the growing practice of service learning might also play a helpful role in integrating these themes into expanding global health programs.

The Political Satirist as Public Intellectual: The Case of Jon Stewart

genuine “healing” that the faux “closure” the death penalty promises (Prejean 1994, 131–144). Third, she engages the political system in what is ultimately a series of battles in which victories are few and small. In general, the story of efforts to gain justice for particular inmates will be a story of failure. Efforts to create a more widespread appreciation of the reasons why the death penalty should be abolished face an uphill battle against the fear of criminals and the belief that state-sponsored violence and slaughter must be an effective remedy for victimization. To be sure, her efforts along with those of such high-profile groups as Barry Scheck’s Innocence Project have greatly increased awareness of the possibility of execution of an innocent person. These have also led to just outcomes in some cases and restraint in the use of the death penalty in some states. But for the most part, if an ordinary human being makes the pursuit of a more just system his or her vocation, he or she typically ends up frustrated or heartbroken.

Developing an Evaluation Tool for Assessing Clinical Ethics Consultation Skills in Simulation Based Education: The ACES Project

The American Society for Bioethics and Humanities has created a quality attestation (QA) process for clinical ethics consultants; the pilot phase of reviewing portfolios has begun. One aspect of the QA process which is particularly challenging is assessing the interpersonal skills of individual clinical ethics consultants. We propose that using case simulation to evaluate clinical ethics consultants is an approach that can meet this need provided clear standards for assessment are identified. To this end, we developed the Assessing Clinical Ethics Skills (ACES) tool, which identifies and specifies specific behaviors that a clinical ethics consultant should demonstrate in an ethics case simulation. The aim is for the clinical ethics consultant or student to use a videotaped case simulation, along with the ACES tool scored by a trained rater, to demonstrate their competence as part of their QA portfolio. The development and piloting of the tool is described.

Physician, Know Thyself: The Role of Reflection in Bioethics and Professionalism Education

Reflection in medical education is becoming more widespread. Drawing on our Jesuit Catholic heritage, the Loyola University Chicago Stritch School of Medicine incorporates reflection in its formal curriculum and co–curricular programs. The aim of this type of reflection is to help students in their formation as they learn to step back and analyze their experiences in medical education and their impact on the student. Although reflection is incorporated through all four years of our undergraduate medical curriculum, this essay will focus on three areas where bioethics faculty and medical educators have purposefully integrated reflection in the medical school, specifically within our bioethics education and professional development efforts: 1) in our three–year longitudinal clinical skills course Patient Centered Medicine (PCM), 2) in our co–curricular Bioethics and Professionalism Honors Program, and 3) in our newly created Physician’s Vocation Program (PVP).

Growing Up With Autism: Challenges and Opportunities of Parenting Young Adult Children with Autism Spectrum Disorders

As the parent and stepparent of a child with autism, we witness a world that is quite different from parents with only neurotypical children. Tantrums don’t vanish after the age of three. Aggression is a way of life. Simple communication is a constant challenge. And dreams of a child’s future have to be altered and adapted. In the narratives that accompany this commentary, we see that the challenges of raising a child with autism do not necessarily diminish with age; they may, however, change because children with autism become adults with autism and this presents a new set of both challenges and opportunities. The current epidemic of young children with autism is giving rise to yet another epidemic—the rising number of young adults who are autistic. As one of the authors here mentioned, “the system is in for a tsunami of new individuals needing medical care of all types, needing continued supports for housing and vocational training, communication, occupational and physical therapy” (Cornell). According to a recent study published in Pediatrics, “[y]outh with an ASD have poor postsecondary employment and education outcomes, especially in the fi rst 2 years after high school” (Shattuck, 2012). With the rising number of children being diagnosed with autism, this employment disparity is likely to be exacerbated until or unless the workforce adapts to and accommodates the needs and skills of persons with autism. The needs of young adults with autism are only recently beginning to receive more attention from the media. But for these children’s parents, this issue has always been personal. The emotions on display in these narratives are heartfelt—even raw at times—and seem to swell like the wave of a tsunami itself as parents are now confronting what should be the independence of adulthood. With barriers to employment, health care and housing, young adults with autism remain largely dependent upon their parents. While the topic of transition to adulthood for those with autism is a vast one, implicating the need for wide scale policy change, certain themes emerge in these personal narratives that we wish to focus on here, which may well serve as a guide for that change.

The Dread Disease: Cancer in the Developing World

The triumvirate of HIV/AIDS, tuberculosis, and malaria have dominated our public health focus in the developing world. Having claimed millions of lives, these infectious diseases have prompted a large-scale response. Concomitant with these efforts has been a burgeoning bioethics literature examining global health and distributive justice. A scholarly wasteland only a decade ago, there is now a growing and rich literature that aims to unpack our moral obligations when it comes to diseases that affect the majority of the world (many living in absolute poverty). Now, added to the persistent challenges posed by infectious diseases is the growing burden of diseases such as cancer, which disproportionately affect developing nations. The rates of noncommunicable chronic diseases, including cancer, continue to increase in low-income countries. (1) Recent estimates suggest that the case fatality from cancer may be as high as 74.5 percent in low-income countries, compared to 46.3 percent in high-income countries. (2) Survival rates for some cancers, such as testicular and breast cancers, have been positively related to country income. (3) Additionally, low education levels, poor health literacy, and advanced presentation of different cancers lead to further difficulties for people in developing countries. The disparity between cancer resource allocation in lower and higher income countries is stark--about 5 percent of total global funds dedicated to cancer are spent in developing countries. (4) Together with an estimate that 80 percent of disability-adjusted life years lost to cancer worldwide occur in developing countries, (5) a renewed focus on solutions to cancer care in resource-poor settings is past due. Disparities in treatment and survival outcomes are perpetuated by a lack of adequate evidence-based guidelines and treatment algorithms for cost-effective cancer care in developing countries. (6) Most countries have not implemented effective national control strategies that can save lives. (7) Promising models of cancer control in lower- and middle-income country health systems exist, however, and there has already been some discussion of established models in Mexico and Colombia, which both have national insurance plans, and of nascent scale-up efforts ongoing in Rwanda, Malawi, and Haiti. (8) At the heart of scaling up cancer care in resource-poor settings is the pervading assumption that cancer care cannot be provided efficiently or equitably. There are least two problems with this assumption. First, a more generalized version of this assumption has been disproved; there are examples of successfully scaled-up HIV/AIDS and tuberculosis treatment programs in resource-poor settings. (9) Second, the assumption that meaningful cancer care is not feasible in lower-income countries imparts a particular view of reality that reinforces inequity. As John Seffrin of the American Cancer Society has forcefully pointed out, global cancer disparities illustrate a collective failure to actualize the universal human right to access an adequate standard of health, and these disparities in cancer care and mortality demonstrate some of the most glaring social inequalities in health. (10) CanTreat International, also known as the Informal Working Group on Cancer Treatment in Developing Countries, recently highlighted three key lessons learned from the HIV/ AIDS movement that may be applicable to cancer care. (11) First, access to cancer treatment should be mandatory. The World Health Organizations current list of essential chemotherapies is a start in this direction. Second, cancer control needs to be mainstreamed into comprehensive health systems along with ways to provide high-quality care in order to detect and address cancer effectively. Third, advocacy and education are essential, including efforts to define public health priorities and treat cancers within the existing health system to continue to improve cancer interventions and the health system as a whole. …

The Virtual Graduate Program in Bioethics: The Mission, the Students, and the Hazards

The American Society of Bioethics and Humanities Status of the Field Committee (ASBH) report on graduate education raises a number of issues in a most provocative way. Such issues include adequate academic preparation for bioethics work, placement of graduates, and the growth of “interdisciplinarity.” There is a temptation to reoect in an open-ended way about the status of “bioethics today” and fail in our responsibility, both as bioethicists and as initiators of an innovative Webbased M.A. program,1 to interpret the results and try to build on the lessons learned. To avoid succumbing to this temptation, we will conane ourselves to two points:

Patents: The Public Interest versus the Private Privilege

Pharmaceutical companies have become a favorite whipping boy of physician groups, consumer activists, and certain politicians. These companies spend a great deal on the advertising and marketing of their products, but they also make a lot of money and have one of the highest proat margins of any industry. Yet, as David Resnik and Kenneth De Ville (2002) carefully argue, making a lot of money is no crime.1 In fact, this strong anancial incentive is what drives drug makers to spend millions of dollars in research and development, looking for that breakthrough drug that will give their investors impressive returns. Why should the government ever have the moral authority to abrogate a pharmaceutical company’s patent, thereby jeopardizing this implicit incentive scheme? Resnik and De Ville provide a useful analytical framework in determining whether the federal government should ever have the moral authority to override the intellectual property rights of pharmaceutical companies. They offer a utilitarian justiacation for deferring to these property rights. They concede, however, “that these rights are not absolute and can be violated to promote social values or state interests under certain conditions.” Their argument is carefully constructed in that they are not just defending the intellectual property rights of pharmaceutical companies but are also concerned about the potential fruits of pharmaceutical research and development that can potentially help the public. This prompts us to ask a few questions: what is the nature of a patent right? Are pharmaceutical products different from other patented products? Does existing law already provide adequate compensation for governmental takings? Considering that even civil liberties may be curtailed during times of national emergency, do property rights merit more protection? Patents are complex legal entities. Black’s Law Dictionary deanes a patent as “[t]he exclusive right to make, use, or sell an invention for a speciaed period (usu. 17 years), granted by the federal government to the inventor if the device or process is novel, useful, and nonobvious” (Garner 1999). As Resnik and De Ville discuss, the rationale behind granting a patent is not primarily to reward the inventor, but rather to encourage public disclosure of an invention so that when the patent expires, the public can have free access to the invention (Kintner and Lahr 1975). The ultimate goal of the patent process is to serve the public interest. One commentator has dubbed the tension here as the “incentives-access paradigm” that is at the heart of the intellectual property debate (Lunney 1996). A tension arises between the goal of incentivizing people to create useful products for the public while assuring that the public has access to these products. This balancing act becomes even more controversial and political when the products are not just luxury consumer goods but pharmaceutical products that can potentially save lives. This brings us to our second question: are pharmaceuticals in a different moral category from the majority of patented products? Resnik and De Ville lump pharmaceuticals with other “vital” products, such as computer software, computer hardware, research databases, and automobiles. One would be hard-pressed, however, to equate a potentially life-saving drug with a car or even a computer. The fact that pharmaceutical products may have an inherent and immediate impact upon the health and safety of the public puts them in a different moral category. If anything, the onus should be placed upon the patent holder of a potentially life-saving product to show why the product’s patent should not be overridden if the government wishes to override the patent during a public emergency. Aside from the overriding importance of public health and safety, current patent law and remedies adequately protect intellectual property interests when the government chooses to override a patent. First, a patent is not an absolute right but a privilege granted by the government. The government can therefore reasonably limit the scope of the privilege in the interest of the public. In addition, the existing law already provides adequate compensation for governmental takings. Finally, considering that some commentators have defended the curtailment of certain civil liberties during times of national emergency, property rights should not merit even more protection (Posner 2001). The current law adequately protects companies in the event of compulsory licensure. As Resnik and De Ville point out, compulsory licensure is a “taking” by the gov-