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The Challenges of Ethics Consulting in the Biotechnology Industry

Main | Consulting Surveys | Survey Responses | Bibliography | Codes of Ethics

About

Advances in biomedical research and technology have captured the public’s imagination, fueling both unbridled optimism and profound uneasiness about their impact on our lives. Many of those advances have been the focus of national and international debates, ranging from the acquisition of human embryos in stem cell research to the risks associated with genetically modified crops, and subsequent policy implementation. Biotechnology companies, from small start-ups to multi-national pharmaceutical and bioagricultural conglomerates, are key stakeholders in those debates, since they are often at the forefront of discoveries in medicine and agriculture that have been the target of public scrutiny and governmental oversight. It makes sense, therefore, that these companies engage others in considering the ethical issues raised by their work. Moreover, if we are to realize the benefits of biotechnology research, there must be strong public confidence in and support for the industry and those who advise them.

One way for companies to secure advice is by retaining “ethics consultants.” Little is currently known about the prevalence of such consultants, their use by companies, and the impact of their advice. This existing gap in our knowledge, however, has not, diminished debate over the proper roles and functions that ethics consultants can and should play in advising biotechnology companies. These debates reflect, in part, uncertainties held by both ethics consultants and the companies that hire them about the proper role and duties of such consultants. Some view the ethics consultant as a “public guardian,” whose primary duty is to serve the public interest and, when necessary, to blow the whistle on companies that make the “wrong” decision. Others consider that the consultant is expected to give the company his/her best advice and leave the final decision to the “client.” There are those who believe that ethicists should never consult for companies or, if they do, not accept compensation, which is likely to cloud further the perception by others of their role as public guardian. Others, however, believe that companies are entitled to obtain such advice and that, in general, the public interest is more likely to be served if the advice given by ethics consultant’s is considered in whatever decision process the companies employ. Moreover, as experts providing wanted and needed advice, some believe they deserve to be compensated for their efforts, although even among those favoring compensation there is variation in what level is appropriate so that they are not seen as merely “hired guns.” These matters are complicated because there is no consensus about what “professionalism” requires of ethics consultants, who come from a range of disciplines or backgrounds, including social science, philosophy, medicine, religious studies, and law. How one is expected to act in a consulting role for industry is not embodied in consensual standards adopted by the community of bioethics consultants.

To learn more about the landscape of ethics consulting for the biotechnology industry, AAAS launched a project in 2004 to examine policies and practices related to such consulting and to prepare resources that both consultants and industry might find useful as they negotiate their working relationships. In early 2005, we undertook a survey of biotechnology companies to gather data on their use of ethics consultants. Several months later, we added a survey of individual bioethicists to try to determine their involvement in such consulting and their experiences. (In our project, we defined “ethics consultants” as persons “specifically approached by the company for advice on ethical issues, regardless of his/her training or position.” The consultants could be based either inside or outside the company.) The survey instruments we used and the responses they generated are posted on this web site. We also searched the literature and professional codes of ethics for additional information and guidance on ethics consulting, and, as a result of those efforts, we have produced an annotated bibliography and a resource that highlights provisions in codes of ethics that offer guidance to those engaged in consulting. Both of those items are also on this web site (see links above).

This project collected data on the “ethics consulting landscape” so that the ongoing debates can be better informed and empirically grounded. There is no intent to derive or impose from outside some set of guidelines on those engaged in or seeking assistance from such consulting. Although the data collected by the project may help to guide such efforts, the latter must include a wide range of stakeholders and take into account the interests of biotechnology companies in securing ethics advice, the imperative to preserve the independence and credibility of those consultants advising companies, and the public’s interest in promoting ethical research in the corporate sector.

While more work needs to be done beyond this project to document current consulting practices and policies, we hope that its findings and products, which can be accessed via the links above, can contribute to the discussions now underway.

Project by the American Association for the Advancement of Science
Project Co-Directors: Audrey R. Chapman, Ph.D., and Mark S. Frankel, Ph.D.
Project funded by The Greenwall Foundation, NY.

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