Executive Program in Bioethics and Biotechnology

The Executive Program in Bioethics and Biotechnology was a two-year project to explore the most effective ways to provide executive education in ethics, with particular attention to bioethics and business ethics. The goal was to reach senior executives and managers in private biotechnology companies who are challenged daily by profound ethical questions in health care, science and business. Funding for the project was provided by the Greenwall Foundation.

Need: Significant interest in ethics education has been expressed by executives and others involved in day-to-day decision making in biotech companies. Recent attention in Congress and in the press also documents the need from both a societal and an industry perspective for serious reflection on ethical issues that are being raised by new biotechnology. The great time demands on industry executives, however, make it difficult to free time for off-site seminars.

Solution: To create a program to address this need, faculty from the University of Virginia Institute for Practical Ethics and Public Life joined in partnership with faculty from the Johns Hopkins University Bioethics Institute, the Georgetown University Law Center, and the Georgetown University Kennedy Institute of Ethics.

The goal was to develop a prototype course that individual firms can use on site and that can lead to a fuller examination of the complex bioethical issues in the biotechnology industry. The educational template created in partnership with biotechnology companies will allow organizations to develop a vehicle for employees to talk about ethical issues across departments and positions within companies, and perhaps even to begin a dialogue with external groups.

According to information gathered during the first research phase of the project, to be most effective for executives, the course would best take place in the context of their organizations and would involve not only the organization's leadership but also others in mid-level positions. This "systems approach" facilitates the incorporation of ethics into the organizational structure and thus increases the likelihood of long term, meaningful impact. This course template can then be adapted for different courses in ethics to be used by biotech firms around the world.

Process: We focused on developing a structure and content that would be relevant in addressing the most significant bioethical issues facing the biotech industry and individual companies. We determined that limiting corporate involvement to an advisory role would not give us the level of detail and information necessary, so we researched the field and selected two companies to work closely with us to create the course. In return for participating in focus groups and piloting the training sessions, these companies benefited from the knowledge and experience around key issues in bioethics that project faculty could bring to their companies.

Corporate Partners
We approached Genzyme Corporation in Boston, MA and Affymetrix in Palo Alto, CA as potential partners, and both companies quickly and graciously agreed to work with us. These corporations were selected based on their reputation and leverage in the field, their geographic diversity, and their business lines. Senior executives at the companies felt a bioethics course would be an important resource for the industry and were excited to be a part of the project. Both Genzyme and Affymetrix dedicated significant time and resources to help create a valuable program and our contacts at each company have been both knowledgeable and extremely supportive.

Focus Groups
To gather the relevant information, we decided that in-depth conversations with key executives and other staff were critical. We held several focus groups; separate meetings with key executives, and in-depth follow-up conversations. We were fortunate to have enthusiastic and thoughtful participation from many people at each company.

Initial focus groups with each company were held in December 2001. Our goal for these groups was to hear what participants believed were the key bioethical issues within their companies and within the overall industry. From these discussions with senior executives and other staff, we identified critical ethical issues and selected the initial topics for the training sessions. These topics included: 1. privacy/data, and 2. human subjects research, and 3. conflicts of interest.

During the second focus groups, we further explored the employees' level of sophistication with respect to the identified ethical issues. We also left the meetings with valuable information to clarify the level of content and type of format needed for each training session. In addition, faculty identified key participants to assist in developing case studies for their companies' sessions. These case studies are used in the training manual.

Course Development
We determined, and executives concurred, that three sessions would be appropriate for the trial training sessions. Each session was moderated by three participating faculty. These sessions focused on the practical, looking at how to develop corporate models for identifying ethical red flags and thinking through cutting-edge issues.

The two sessions for upper middle management focused on general bioethics education, with specific attention to managing information and human subjects research issues. The session for senior executives focused on conflict of interest. The sessions were two hours each, with informal discussions frequently continuing after the allotted time. The format was a 45-minute substantive presentation with the remaining time focused on a related case discussion.

Manual - Development and Distribution
The 191-page manual, entitled "Bioethics and Biotechnology: An Executive Education Program" has over eighty pates of introduction to "Ethics in Biotechnology," under the rubrics of "Understanding Ethics" and "Using Ethics." The remainder of the manual is devoted to eight detailed cases. Cases were edited based on feed back from the companies and included with teaching notes to help biotech executives lead sessions internally. To distribute the final template, we are working with the Biotech Industry Organization, which wants to increase the awareness of bioethical issues within the biotech industry. BIO showcased the Executive Education Program in Bioethics at its national meeting in Washington, D.C. in June, 2003. Plans currently are underway to adopt the program in a number of biotech corporations.