Conflicting Interests, Benefit-Sharing & University-Industry Relations: A Socio-Ethical Analysis of Commercial Genomics Research

Bryn Williams-Jones, Programmes de bioéthique, Département de médecine sociale et preventive, Université de Montréal

Chris MacDonald, Department of Philosophy, Saint Mary's University

Aims

The aim of this project was to reveal certain aspects of and tensions within the new emerging relations between university researchers and industry partners, through an investigation of the themes of conflict of interest (COI) and benefit-sharing. Since relationships involve, by definition, more than just one party, our project sought to examine these issues in terms of the perspectives and decisions faced by both sides in the university-industry relationship. Specifically, the project aimed to develop a framework for describing what would constitute professional and ethical relationships between university genomics researchers and industry partners.

Summary of Activities

Initially intended to examine COI and benefit sharing in genomics research occurring the context of university-industry relations, we quickly realised that there was an almost total absence of research on university COI in general, aside from the literature focused of clinician-scientists, clinical trials, and medical schools. We thus decided to restrict the scope of the project to a study of university COI; an analysis of benefit sharing was beyond the capacity of our 1 year pilot funding.

With the rise of university-industry relations, there has been increasing concern regarding the possible occurrence of COI in university research activities. To promote integrity and objectivity in research, universities have created a wide range of policies, contracts and committees to address COI and mitigate the potentially serious negative implications, most particularly with regards to the public's trust and confidence in researchers and universities. In general, the formulation and implementation of COI policies differ according to the respective universities' governance approach, i.e., either to manage or avoid COI situations. But as there is no common legal or regulatory structure for addressing COI in Canada (as there is in the US), it is not surprising that the COI policies of Canadian universities vary greatly in both content and form. This raises the following questions: Are university COI policies accessible and understandable? To whom do these policies apply (faculty, staff, students)? Is COI clearly defined in these policies and are procedures laid out for avoiding or remedying such situations?

To begin addressing these important ethical and governance questions, our innovative study (one of the only such analyses of Canadian universities) examined the main COI policies at the Group of Thirteen (G13) leading Canadian research universities. Using online readability analysis tools and an ethical content analysis, we compared the strengths and weaknesses of these documents, with particular attention to their clarity and readability, and their utility in explaining and managing COI. We also conducted an in-depth ethical and legal analysis of one COI policy, that of the Universite de Montreal, to highlight differences in philosophy (and impact) between two common approaches, i.e., policies written in a legalistic or an aspirational style. To begin identifying some of the COI issues arising in genomics research, we conducted informal discussions with key informants in the biosciences (colleagues and students) to elicit their experiences with laboratory culture and the ethical challenges faced by various stakeholders. This allowed us to focus our analysis on professor-student relations in the bioscience laboratory, which we argue is a key element in the generation (and management) of COI.

This small project resulted in an impressive level of productivity. 4 students (3 undergraduates and 1 MA student) were hired as research assistants during the course of the research, and 2 were directly involved in authoring papers and presentations. Initial ideas and final results were delivered via 3 presentations and 3 posters at national and international venues. 1 detailed report was presented to a university committee (UdeM), 4 peer-reviewed publications were developed (1 under revision, 3 to be submitted shortly), and a public website was created. More generally, this pilot grant enabled MacDonald to develop further analyses on COI in the business context, and helped Williams-Jones start preparing a 3 year operating grant application to CIHR to continue investigating COI in the university context.

Outcomes (* student author)

Publications

• Couture, V.*; Smith, E.* & Williams-Jones, B. 2007. Rapport sur les conflits d'intérêts à l'Université de Montréal : éthique, pratiques et politiques, Montreal, QC, report prepared for the Comité sur les conflits d'intérêts a L'Université de Montréal.
• Williams-Jones, B. & MacDonald, C. (under revision) "Conflict of Interest Policies at Canadian Universities: Clarity and Content" Journal of Academic Ethics.
• MacDonald, C. & Williams-Jones, B. "From Supervisor to CEO: Conflict of Interest and Other Ethical Challenges when Students are also Employees" in preparation for Journal of Business Ethics.
• Couture, V.* & Williams-Jones, B. "La gestion des conflits d'intérêts dans les universités" in preparation for Education Management and Policy.
• Smith, E.* & Williams-Jones, B. "Legalistic vs Aspirational: Comparing University Conflict of Interest Policies" in preparation for Higher Education Quarterly.

Presentations

• Williams-Jones, B. & MacDonald, C. "Commercialization & Conflicts of interest: From Supervisor to CEO" The Commercialization of Biotechnology Research in the XXI^st Century: Meeting the Challenges, Centre de recherche en droit public, Université de Montréal, Montréal, QC, Jun 8, 2007.
• Couture, V.* & Smith, E.* "Conflits d'intérêts à l'UdeM : éthique, pratique et politiques" Le forum du GREB : séminaires en bioéthique, Groupe de recherche en bioéthique, Université de Montréal, Montréal, QC, Feb 1, 2007.
• Williams-Jones, B. & MacDonald, C. "University-Industry Relations: Conflicting Interests in Genomics R&D" Genomics & Society: Towards a Socially Robust Science?, CSG and CESAGen, Amsterdam, The Netherlands, Apr 20-21, 2006.

Posters

• Smith, E.*; Couture, V.* & Williams-Jones B. "Conflict of Interest Policies in Canadian Universities: Content, Clarity and Form" People, Process and Progress: Alliance for Commercialization of Canadian Technology Third Annual Conference, Toronto, ON, Nov 18-20, 2007.
• Olivier, C.*; Ozdemir, V. & Williams-Jones, B. "Mapping Conflicts of Interest in University Bioscience Laboratories" People, Process and Progress: Alliance for Commercialization of Canadian Technology Third Annual Conference, Toronto, ON, Nov 18-20, 2007.
• MacDonald, C. & Whellams, M.* "Can Biotech Companies' Corporate Social Responsibility Programmes Contribute to Public Health in Developing Nations?" Genomics in Public Health: 4th International DNA Sampling Conference, CRDP, Montreal, Canada, June 4-7, 2006.

Website

Conflict-of-interest.net