New Biomedical Research: Regulation, Conflict of Interest and Liability
- 3rd Annual Health Law Day

By Susan Zimmerman

Leading health law academics, practitioners and policymakers joined students, alumni and members of the public on November 22, 2002 at the Faculty of Law's annual Health Law Day, this year focusing on legal and ethical issues in new biomedical research. The conference, organized by Professor Trudo Lemmens and Duff Waring and sponsored by the Centre for Innovation Law and Policy, the Ontario Genomics Institute (Genome Canada) and the Stem Cell Genomics and Therapeutics Network, was attended by over 100 people and received very positive reviews. The day included two plenary sessions and two workshops that explored cutting edge legal and ethical issues in biomedical research.

The opening plenary session provided an overview of Canadian and American approaches to research regulation.  Professor Anna Mastroianni of the University of Washington School of Law and School of Public Health and Community Medicine traced the evolution over the last half-century of U.S. regulation of research involving human subjects.  She described it as a pendulum, swinging from an initial focus on protection, to a recognition of the need for equitable access to inclusion in research - a move spearheaded by persons with HIV/AIDS and breast cancer patients - and more recently, a return to protectionist policies, but policies that reflect a more refined notion of protection - one which relies on processes to balance equitable access to clinical trials with adequate protection of research subjects.

Professor Kathleen Glass of McGill University provided the Canadian perspective, setting out the array of legislative and non-legislative mechanisms that regulate the conduct of human subjects research. She described a number of recurring issues in this area that point to the need for a comprehensive research governance system, and suggested the elements that such a system should include.

Prof. Trudo LemmensThe first workshop dealt with ethical and legal approaches to conflict of interest.  Dr David Naylor, Dean of Medicine at U of T, described how the University of Toronto was tackling issues of conflict of interest raised by some of its recent controversies. He discussed in particular the new publication policies and the attempts to harmonize research policies in the Toronto academic health science complex.  Professor Sheldon Krimsky of Tufts University provided powerful empirical evidence of the growth of commercial interests in academic centres in the United States, and discussed how these interests may affect the independence of academic research. He argued forcefully for a radical overhaul of the drug approval system and for the development of an independent federal drug testing agency. Professor Trudo Lemmens concluded the panel, with a discussion of the legal and ethical issues related to financial recruitment incentives in medical research. He sketched out how financial interests in drug development are pushing commercial research sponsors to use various novel strategies to recruit patients into clinical trials. He indicated how the competition for research subject is affecting medical research and warned that several of these practices violate ethical and legal standards of care and could even provoke criminal sanctions.

Prof. Bernard DickensThe second workshop dealt with stem cell research and Bill C-13 - the Assisted Human Reproduction Act (or Bill C-13 on assisted human reproduction). In his introductory remarks, Glenn Rivard of the federal Department of Justice noted that Health Canada had recently established its own Research Ethics Board, to be chaired by U of T law professor Bernard Dickens.  He went on to describe the intended federal role in the governance of stem cell research.  He explained that the bill sets out a general framework, with most of the details of the regulatory regime to be determined in regulations to be drafted following the bill's passage.  He estimated it would take one to two years after the bill is passed to put regulations in place.  Internationally-renowned developmental biologist Dr Janet Rossant explained the basics of stem cell research and set out some of the concerns of the research community with respect to Bill C-13.  In particular, she emphasized the importance of establishing an independent regulatory body and the importance of moving rapidly to the passage of regulations once the bill becomes law.  Professor Angela Campbell of the University of Ottawa's Faculty of Law (Common Law) discussed the appropriateness of using the criminal law power to regulate reproductive and genetic practices and technologies.  While defending the use of the criminal law power in an area that involves the potential of harm to the individual as well as the potential for "social harms", that is, harms to the values of human life and human dignity, she criticized the lack of a statement of policy or principle in the bill that would provide an explicit rationale for reliance on the criminal law.  This lack could make Bill C-13 difficult to interpret, and vulnerable to a constitutional challenge.

The closing plenary session, Legal Liability in Gene Therapy Research, began with a presentation by Paul Gelsinger. His son Jesse died at the age of 18 as a result of his participation in gene therapy research, an experiment that was later revealed to be both scientifically and ethically unjustified and may have been pushed ahead because of significant financial interests of the principal researchers. Mr Gelsinger gave a moving account of his journey from a father who had complete faith in the integrity of the researchers involved in his son's experimental treatment, to a profound commitment to changing the system that allowed them to perform this invalid experiment. He expressed the view that the huge commercial interests in research are undermining the trust of research subjects in the research enterprise. The next presenter was Alan Milstein, the lawyer who represented the Gelsinger family.  He discussed what he called the three myths of human experimentation: that the institution can manage conflicts of interest; that everybody is watching; and that the informed consent document is evidence of informed consent.  Finally, Mary Thomson, a partner in the litigation group of McCarthy Tétrault, discussed the standards by which liability for adverse outcomes should be judged as gene transfer research moves from research to therapy.  She speculated as to whether a no-fault compensation scheme would be preferable to requiring participants to prove that the researchers failed to adequately disclose information or that a conflict of interest compromised the trial. This last suggestion was hotly debated in the question and answer period.

The conference provided an excellent forum for interdisciplinary debate on how law and regulation can assist in dealing with one of medicine's biggest challenges of today: how to proceed with promising research while protecting human subjects and the integrity of the research process against the potential negative impact of increasing commercial interests. One anonymous health researcher indicated on his/her evaluation form: "Of the many conferences, rounds, workshops, meetings I've attended in my 15 years of clinical research, this was by far the most practical, informative, enlightening and challenging I've attended.  It really helped me identify and integrate ideas and knowledge."