Academic journal article
By Schuppli, Catherine A.; McDonald, Michael
Health Law Review , Vol. 13, No. 2-3
"The cover of a recent edition of Time magazine features a research subject in a cage with the caption 'human guinea pigs,' signifying perhaps that human subjects are no more protected from research abuses than are laboratory animals." (1) However, as Barnes and Florencio state: "Ironically, in certain respects, animal research is more stringently regulated than is human subjects research" and note how this is the case in the U.S. (2) In this article, our argument will be that the governance of research involving animals in Canada is not only more stringent but better, in other respects, than the governance of research involving humans. This analysis offers insight and suggests a rationale for reforming the governance of research involving humans.
There are many similarities between the two governance systems, including:
* Similar histories and many common ethical concerns centring on the tension between the social benefits of research and the interests of the research subjects;
* Use of local review committees to assess research proposals as part of the process of research approval; and
* National guidelines enforced by conditional research funding.
Yet we find major features of the governance system in animal research that are either absent or underdeveloped in human research. These include:
* At the national level, arm's length, independent, and transparent oversight of research;
* A national system of quality assurance and accreditation/certification for local systems of protection;
* Systematically gathered and publicly available information on the volume and type of research;
* A national curriculum of education mandated for those conducting or involved in research using animals.
Below we describe in more detail these similarities and differences. We begin with a brief description of research involving animals and the connections it has to research involving humans and why the two systems might learn from each other. After making comparisons in six key areas of governance (compliance, independence, transparency, accountability, quality assurance and education), we offer some hypotheses about the reasons for significant differences between these areas of governance and draw some lessons for the reform of research involving humans. Given that this article is part of a special issue on Canadian governance for research involving humans, we assume that readers will be more familiar with human research than animal research, and so go into more detail about the latter.
There are many reasons why the governance system of research animals is applicable to the system for humans. In biomedical research, animal and human studies are inextricably linked. Much knowledge and many assumptions about human biology have their basis in animal models. In fact, the history of using animal models dates back to 300 A.D.. (3) Currently, when pharmaceutical products or new procedures demonstrate promise for human use, testing for safety and efficacy in animals is required before testing may begin in humans. (4) Many of the fundamental
ethical issues and principles in research involving animals are similar to those for research involving humans. Both recognize the importance of research that benefits humans or animals, or that advances our knowledge, as long as this is achieved in an ethically appropriate manner, including meeting substantive standards related to potential harm, benefit, and social value, as well as procedural standards, such as independent ethical review. (5)
Some of the basic principles differ (for example, respect for human dignity versus maintaining animals "in a manner that provides for their physical comfort and psychological well-being" (6)) but they both provide a rationale for the protection of research subjects. Clearly such principles as free and informed consent and respect for privacy and confidentiality do not apply to animals. …