Translating ethics into law: duties of care in health research involving humans.

• Author: Zimmerman, Susan V.

In the field of health research, good governance has two primary goals: to ensure that the research conducted is scientifically valid, and that it is conducted in an ethical manner, protecting the physical and psychological integrity of the research participant. Since the emergence of research ethics boards (REBs) in Canada, responsibility for good governance is too often conflated with the responsibility for research review. Ideally, however, good governance results from an assumption of obligations by all those engaged in the research enterprise. Research ethics boards are not the sole repository of this responsibility. As a recent statement by medical journal editors pointed out: "In return for the altruism and trust that make clinical research possible, the research enterprise has an obligation to conduct research ethically and to report it honestly." (1) This statement applies not only to clinical research but equally to all types of research involving humans.

The first goal of this paper is therefore to identify the actors who make up the research enterprise and, very briefly, to sketch the nature of the role that each of them may play in the good governance of research involving humans. Some of these obligations are set by statute or regulation, some by ethics policies or guidelines. I will then consider which of these ethical obligations may constitute a duty of care under the common law. (2)

Finally, I will briefly discuss how ethics policies, guidelines and practices can be integrated into or adopted by the legal system through incorporation into statutes and regulations or by judicial interpretation. Through such integration, they can help to establish the standard of care that defines the nature and extent of these legal duties.

The Research Enterprise

For the purposes of this very brief article, I will simply list the range of actors in the research enterprise and sketch in point form some of their diverse obligations for the proper conduct of health research involving humans. This by no means exhaustive list permits a preliminary consideration of which of these obligations may form the basis for a legal duty of care.

1. The Researcher

   * Conducts the research, and is therefore directly responsible for the welfare of the participant.

   * Is responsible for conducting the research in accordance with the protocol as designed, and as approved by any review body; the researcher is therefore accountable not only to the participant but also to the designer of the protocol (if the researcher did not design it him/herself), to the sponsor of the research, to the review body, and to any regulatory body.

2. The Research Sponsor

   * Funds the research and is therefore responsible for ensuring that the research is both scientifically and ethically valid, respects applicable laws and regulations and follows relevant policy guidelines.

   * Where the sponsor is a public body, it must also consider whether the proposed research serves the public interest.

   * Sponsors have an obligation to make the results of trials publicly available, so that the scientific community and ultimately, society in general, may benefit from the knowledge acquired through the unpaid participation of members of the public.

3. The Research Institution

   * Institutions where research involving humans is conducted have an obligation to the participants to ensure that the research is both valid and ethical; they also owe this obligation to the general public, as trust in the review process builds faith in the research enterprise, without which many people would not agree to participate in research.

   * Research institutions also have an obligation to ensure that their employees and those carrying out research on their premises, or using their name (and reputation) conduct themselves in accordance with institutional policies and ethical standards.

   * Those who establish or hire REBs (that is, research institutions with institutional REBs or corporations making use of private REBs) also have an obligation to ensure that these bodies are able to operate independently, by putting in place the necessary safeguards against conflict of interest.

4. The Review Body

   * The research ethics board, whether public or private, is responsible for reviewing the research design to ensure that it is scientifically valid and ethically sound; in performing this review, its primary obligation is to protect the research participant.

   * It must also ensure that the research serves a meaningful scientific purpose.

5. Government

   * Both the provincial government and the federal government have a role to play in regulating the conduct of research involving humans;

   * For the federal government, this obligation derives from its responsibility for the regulation of drugs and medical devices;

   * For provincial governments, it derives from their responsibility for matters relating to health as well as their responsibility for the regulation of professionals, especially health professionals.

6. Public Agencies

   * Public bodies, such as the Canadian Institutes of Health Research (CIHR), that fund research involving humans, may require compliance with ethical standards or other contractual terms as a condition of funding.

   * The imposition of ethical standards or rules of conduct as a condition of funding means that the public body may suspend or withdraw...