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BIOETHICS AND BIOTECHNOLOGY: An Executive Education Program

The  Bioethics and Biotechnology: An Executive Education Program was created in partnership with biotechnology industry leaders, with support from the Greenwall Foundation. Bioethics faculty worked with biotechnology company executives over a two-year period to identify ethical issues faced by the industry and to develop educational materials to help executives and their staffs integrate ethics into their corporate operations.   The process of creating training materials challenged companies to become aware of the actual ethical cases they were confronting daily and challenged university ethics scholars to address the complexities of day-to-day decision making in the real world.  

The process for developing training materials included:

  • Identifying leaders in the biotechnology industry to partner in developing the course

  • Engaging the CEO or president and top management of each company to get their buy-in and to provide internal support for the project – critical to getting senior level participation

  • Identifying two or three key company contacts to help develop the training program and bring the key staff members into the process as needed, e.g. for focus groups

  • Conducting employee focus groups to explore issues that are affecting both the industry in general and that company specifically

  • Developing case-based education modules and test these at each company

The process of developing the training module was enriched by the quality of thought and experience brought by participants from the partner companies.  In going through the process, they addressed their assumptions about science, research, and business, as well as different perspectives that industry peers brought to the discussion.  One company used the training sessions as a departure point for their internal ethics committee discussions.  In addition, the Biotechnology Industry Organization (BIO), under the direction of then Vice President Michael Werner, showcased the project manual at BIO conferences and meetings.  

Project Faculty:
Faculty members on this project were from Johns Hopkins University Phoebe R. Berman Bioethics Institute, Georgetown University Law Center, the Georgetown University Kennedy Institute of Ethics, and the University of Virginia Institute for Practical Ethics and Public Life.

Project Need: 
A recurring concern voiced by biotech leaders who understand the implications of bioethical issues is that the industry as a whole can be jeopardized in a moment by negligent error in attending to ethical considerations and by insensitivity to the moral concerns being raised by the general public.  Executives expressed significant interest in ethics education for those 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.
 
Project Solution:  
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 we 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 the 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. 

Corporate Partners:
Genzyme Corporation in Boston, MA and Affymetrix in Palo Alto, CA were partners on this project. 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 believed a bioethics course would be an important resource for the industry. Both Genzyme and Affymetrix managers dedicated significant time and resources to the project. 

Focus Groups:
To gather the relevant information, we conducted focus groups with key executives and other staff.   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 subject research, and 3. conflicts of interest.  During the second focus groups, we further explored the employees’ understanding of the identified ethical issues and identified key participants to assist in developing case studies for their companies’ sessions. 

Course Development:
Corporate executives believed that three training sessions would be appropriate for the trial training sessions.  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 subject 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:
The final training modules developed in this project are provided below. The may be used and adapted with attribution and free of charge.

BIOETHICS AND BIOTECHNOLOGY

CASE STUDIES