Contrasting modes of governance for the protection of humans and animals in Canada: lessons for reform.

• Author: Schuppli, Catherine A.
• Position: Special Issue: Canadian Governance for Ethical Research Involving Humans

"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.

Background

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. In fact, the animal protection system is entirely dependent on humans acting on behalf of animal welfare. Yet it is worth noting that a significant portion of research involving humans deals with persons who lack in whole or in part the capacity for free and informed consent. Also, even when research participants have the capacity for free and informed consent, a variety of problems relating to the consent process may occur such that more reliance needs to be placed on the ethical elements identified above that are common to both human and animal research protection. (7) On the whole, we believe that there are sufficient similarities to provide a basis for comparing the two systems.

History

Historically both types of research have been and remain controversial. In Canada, several examples of misconduct have raised concerns about appropriate protection of human research subjects. For example, brainwashing experiments using LSD were conducted by Dr. Cameron and colleagues at McGill University in the 1950s (8) without patient consent. Two legal cases, Halushka v. University of Saskatchewan (9) in 1965 and Weiss v. Solomon (10) in 1989, involved drug trials where a research subject was harmed but researchers failed to fully disclose risks. Perhaps more well known, were cases of research involving humans in the U.S. (Tuskegee, Willowbrook, etc.). These events generated several waves of concern leading to major reforms in the governance of research involving humans. (11)

On the animal side, there have also been repeated waves of concerns dating back to a very active anti-vivisectionist movement in the 1800s and even earlier. (12) In Britain in the late 1800s, scientific experiments on living animals were the targets of some of the greatest protests involving both the public and scientists. (13) In 1876 the Cruelty to Animals Act was passed by the British government, becoming the world's first national law regulating animal welfare and animal experimentation. (14) Despite the effectiveness of the antivivisection movement, public support for the use of animals in experiments began to grow in the first half of the 19th century as a result of the growing successes of experimental medicine and the gradually accumulating weight of evidence of the utility of animal models for human research. However, the late 1950s and early 1960s saw a resurgence of widespread public attention and concern over the use of research animals in Europe and North America. (15) Over the next 30 years, many developed countries introduced or revised practices for the protection of research animals.

In Canada, the scientific community began formalizing the protection of research animals in 1961. In part this was a reaction to information from the Minister of Justice that his office had been requested to consider legislation concerning the use of research animals in Canada. (16) Recognizing that use of research animals was a sensitive area and that improving the care and treatment of these animals increased the scientific validity of research, the Canadian Federation of Biological Societies established a committee to develop guiding principles on the care of research animals. (17) In 1963 the Medical Research Council (MRC) requested that the National Research Council (NRC) establish a committee to further investigate the care and use of research animals in Canada. The Report of the Special Committee on the Care of Experimental Animals recommended the creation of an outside advisory body "to ensure the uniform application of the guiding principles at the national level and to assist local committees in the effective implementation of these principles for the procurement, facilities, care, and use of laboratory animals." (18) The idea was well supported by scientific and animal protection communities (as determined by a feasibility study (19)), and thus the Canadian Council on Animal Care (CCAC) was created in 1968. The council membership included representatives of researchers involved in the use of animals such as the Canadian Council of Departments of Psychology and the National Cancer Institute of Canada, research institutions such as the Association of Universities and Colleges of Canada (AUCC), and later, other academic societies such as the Canadian Bioethics Society (in 1995). The animal welfare movement was also represented amongst the founding members through the Canadian Federation of Humane Societies (CFHS). The CCAC was financed by MRC and NRC and operated as a sub-committee of the AUCC, until it was incorporated as a non-profit, autonomous and independent body in 1982.

The CCAC mandate is "to work for the improvement of animal care and use on a Canada-wide basis." (20) The mandate is achieved through an institutional assessment program, educational workshops, publications, presentations, production of guidelines for the care and use of animals, and through local voluntary oversight by Animal Care Committees (ACC). In fact, Canada was the leading country internationally to establish local committees to supervise animal research. (21) It should be noted that CCAC guidelines have been distributed widely internationally in both official languages as well as Spanish (at the request of users in Spanish-speaking countries). We note too that CCAC standards are recognized by the American Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) as equivalent to American standards, thereby reducing administrative requirements for Canadian research institutions' eligibility to U.S. Public Health Service funding and to the American College of Laboratory Animal Medicine (ACLAM) accredited programs, and administrative requirements for ACCs. In short CCAC and its standards have a substantial international profile.

Procedural and structural requirements for REBs and ACCs are quite similar. For both committees, membership varies depending upon the needs of each...