The most popular method of examining IRB decisions has been to watch how several different IRBs respond to the same protocol. In the 1980s these studies were done with “mock” protocols (Goldman and Katz 1982) or with “mock IRBs.” In the 1990s, with the rise of multi-center trials, there was less need to create mock protocols – researchers were gaining first-hand experience with different IRB reactions to the same protocols, and a few of these researchers began to analyze and write about the variations they saw (Silverman et al. 2001; Stair et al., 2001).
Studies of informed consent and recruitment include analysis of the readability of consent forms (Goldstein et al. 1996), in-depth studies of subjects’ understanding of what their consent involved (Corrigan 2003), and surrogate consent for people with dementia to problems with broad consent for the use of blood donations to a biobank (De Vries et al. 2013; Tomlinson et al. 2015). For the most part, researchers interested in questions about conflicts of interest have studied administrative rules and procedures. In 2000, Cho and her colleagues studied policies on faculty conflicts of interest at 89 universities in the US. They discovered wide variation in the management of these conflicts and concluded that this variation “may cause unnecessary confusion among potential industrial partners or competition among universities for corporate sponsorship that could erode academic standards” (Cho et al. 2000: 2203). Ethnographic studies on scientists conducting research with human embryonic stem cells by Wainwright, Williams and their colleagues (2007) are another example of social science’s growing interest in research ethics. Other lines of work include the study of therapeutic misconception (Henderson et al. 2006; Kim et al. 2009) and the experience of research subjects and the professional roles of those involved, as well as key research practices when pharmaceutical drug studies are used as an alternative to standard medical care (Fischer 2009).
The professionalization of bioethical expertise
The question of what moral expertise is and what legitimizes someone to speak as a “bioethicist” remains an ongoing issue within bioethics which has gained increased attention from a sociological perspective (De Vries et al. 2009). While bioethics has been widely institutionalized in the US, bioethicists’ struggle to find a collectively acceptable way of organizing themselves has been more challenging than the creation of an intellectual framework. Despite establishing training programs, occupational associations, graduate programs, and journals all over the country, there has been an ongoing debate about what credentials should be required for those working in hospital ethics committees and institutional review boards that review and approve research involving human subjects. Hospital accreditation in the US requires institutions to have an ethics committee, normally made up of various health and social work professionals, local clergy, community members, and administrators. What qualifies one to participate in ethical decision-making? In the late 1990s the credentials of ethics committee members were debated on the “biomed-l listserv.” The discussion reflected the ambivalence about professionalization among bioethicists at that time. It began with a simple question: do any members of the hospital ethics committee need to be licensed/certified? The responses varied. At one end were those suspicious of licensing; others found licensure to be a useful tool. Still others reflected on the problem of credentialing in bioethics because, given the different backgrounds of participants, there could be no unified basis for judging the competency of any candidate. In the case of this “profession in transition,” the task of separating sheep from goats was complicated by the fact that the best-known bioethicists have not had professional training in bioethics. The founders of bioethics come from a variety of backgrounds, with degrees in philosophy, medicine, theology, and law. When interviewed in 1992 (by Raymond DeVries), many of these “original bioethicists” insisted that the proper way to become a bioethicist was to first get an advanced degree in one of these fields and then to come into bioethics. They justified this position by explaining that bioethics was a rich, interdisciplinary field that drew some of its best insights from the conversation between disciplines. To narrow the focus of training to bioethics would diminish the field.
The need for certification continued to be debated by bioethicists through the first decade of the new century. In 1998, the ASBH adopted and published the report of the Task Force on Standards for Bioethics Consultation, a report that takes a strong stand against certification. The Task Force rejected certification for a number of reasons, including: 1) a fear that certification would increase the risk of displacing providers and patients as the primary moral decision makers, and 2) concern that certification could undermine the disciplinary diversity of bioethics (see American Society for Bioethics and Humanities 1998; Aulisio et al. 2000; Churchill 1999). Around the same time, however, the National Bioethics Advisory Council – in its report Ethical and Policy Issues in Research Involving Human Participants (2001) – recommended that “all investigators, IRB members, and IRB staff should be certified prior to conducting or reviewing research involving human participants.”
As the field grew, and bioethics consultation became more established in medical centers, attitudes about certification began to change, in ways that sociologists of the professions would expect. With no way to separate “real” bioethicists from “pretenders” (Anspach 2010), the demand for an agreed upon professional identity became critical and led many bioethicists to rethink their stance on professional education. As a result, university-based masters and PhD programs in bioethics flourished (Lee and McCarty 2016). The ASBH continued to explore the possibility of certifying ethics consultants, and in 2018, after several task forces considered the question (Horner et al. 2020), the organization moved ahead with the creation of a certification program (https://asbh.org/certification/content-outline).
A survey of the “coming generation” in bioethics (Parnami et al. 2012) found that the bioethicists of the future are finding their way to the profession in a number of different ways and availing themselves of the many new programs created to train those seeking a career in bioethics. Among the reasons given for pursuing bioethics training are personal encounters with the health care system, having an undergraduate course in bioethics, and the desire to add knowledge of bioethics to an existing career. Would-be bioethicists expressed frustration with the plethora of possible pathways to a bioethics career, including masters’ programs, certification, acquiring a PhD in a related field, or obtaining a PhD in bioethics. Members of the coming generation also expressed frustration with the job market for those with graduate level training in bioethics, pointing out the absence of a clear pipeline from educational programs to jobs in bioethics consultation or the regulation of research. The professionalization of bioethics is altering not only the nature of bioethical expertise, but also its authority in American health care, moving the field from its original critical, “prophetic” role, to a more “priestly” role that affirms medical authority (Hauschildt and DeVries 2019).
CONCLUSION
Medical sociology and bioethics came into being in the second half of the twentieth century and in the same place – namely the US – with a similar focus on patient rights, and neither paid attention to the other. When sociologists began to examine this new field of bioethics, they often were critical of the enterprise, pointing to the limits of “a monistic conception of ethical universalism … coupled with a tendency to disregard context” (Fox and Swazey 2008). The recurrent social science critique of bioethics has hampered a more theoretical and richer empirical approach to the emergence and development of bioethics. At the same time, it has helped construct and identify bioethics as a new territory, a distinctive object (Callahan 1999) to study. One of the early collection of essays on the relationship between bioethics and social science (De Vries and Subedi 1998) was a strongly critical appraisal of the bioethical enterprise and a call for more convergence between the two as conceptualized by Zussman (2000). In 2001, a second anthology appeared (Hoffmaster 2001), using qualitative research methods that called attention to the multiple contexts that generated both bioethics problems and debates about those problems. Recent social scientific examinations of bioethics