A RESEARCHER`S LEGAL LIABILITY : ETHICAL AND

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A RESEARCHER’S LEGAL LIABILITY : ETHICAL AND LEGAL CONSIDERATIONS
Catherine Bergeron*
LEGER ROBIC RICHARD, L.L.P.
Lawyers, Patent and Trademark Agents
Centre CDP Capital
1001 Square-Victoria – Bloc E – 8th Floor
Montreal, Quebec, Canada H2Z 2B7
Tel. (514) 987 6242 – Fax (514) 845 7874
www.robic.ca – [email protected]
Medical law, more specifically the area of doctors’ liability, is a field which has
known many developments during the last few years in Quebec. But what
about researchers’ liability, that is to say the liability of those specialists
devoted to medical research on human beings? This article will provide a
brief overview of different aspects of a researcher’s liability from a legal
standpoint and also from an ethical point of view.
1.
Legal Aspects: Main Duties of the Researcher
The duties imposed on medical researchers towards their subjects are largely
inspired by a doctor'
s duties towards his patients. Since there are very few
differences between the duties of a doctor and those of a researcher, we
can say that these duties originate from a common source: an individual'
s
rights to the inviolability and integrity of his or her person. Moreover, it is
important to note that duties imposed on researchers are at least equal if not
superior to those imposed on doctors and surgeons towards their patients
(Halushka v. University of Saskatchewan (1965), 53 D.L.R. (2d) 436 (Sask. C.A.,
J. Hall)).
Firstly, the researcher has a duty to inform his subject. In order to fulfil this duty,
the researcher has to meet four main requirements : he has to clearly set out
to the subject the purpose of his experiment and make sure that the subject
understands the meaning and the impact of this purpose; he must set out to
the subject what the benefits of the experiment are for him or her and for
society; he must inform the subject of the risks related to the experiment
keeping in mind that "the duty to inform in matters relating to purely scientific
experimentation is the most exacting possible. This duty includes the
revelation of all risks, including those which are rare or remote and especially
© CIPS, 2001.
* Of LEGER ROBIC RICHARD, L.L.P., a multidisciplinary firm of lawyers, and patent and
trademark agents. Published in the Fall 2001 issue (Vol. 5, No. 4) issue of our Newsletter.
Publication 068.042E.
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those risks which may entail serious consequences." (Weiss c. Solomon, [1989]
R.J.Q. 731 (S.C.Que., J. De Blois at p. 743), and finally, in the case of
therapeutic research, the researcher has to inform his subject about all
possible research alternatives.
Secondly, the researcher has to obtain a written, free and clear consent from
his subject. This second obligation is unquestionably the corollary of the first
one as the subject to an experiment must have received all the relevant
information in order to give a clear consent.
Thirdly, owing a duty of care to his subject, the researcher has to respect a
certain “code of conduct”. Throughout the course of the experiment, the
researcher’s behaviour must be objective and the research must be carried
out with reasonable care. Any failure to respect these pre-set standards
could lead to the researcher'
s liability, whether professional liability, or civil or
contractual responsibility.
Finally, the researcher has an obligation of confidentiality towards his subject.
This obligation, which is directly related to professional secrecy, finds its source
in the trust which must be found between the researcher and the subject and
also in the right to privacy and dignity, two rights provided for in sections 4
and 5 of the Quebec Charter of Human Rights and Freedoms.
2. Ethical aspects
2.1 History of
experiments
the
development
of
ethical
considerations
regarding
The Nuremberg Code (1948) and the Declaration of Helsinki (1964), which are
still today considered as guidelines intended for doctors and other medical
researchers interacting with human beings, have inspired recent ethical
developments concerning experiments with human subjects. The legal
considerations mentioned above put aside, these medical researches must
also meet ethical criteria.
2.2 Ethical approval criteria of research protocols
In order to evaluate the “ethical content” of research protocols, the main
objective of which is to give a detailed description of the researches to be
carried out, ethical committees have established ethical approval criteria.
Even though the nature and the number of these criteria can vary from one
research to another, some criteria are essential in evaluating a research
protocol.
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Since experimental research on human beings is only ethical if it is
acceptable on a scientific basis, the first criterion concerns the determination
of the scientific value of the research protocol. It is up to the researcher to
justify the performance of research on his subject by demonstrating that such
research is necessary for the advancement of scientific knowledge and the
enhancement of the quality of human life. Secondly, an ethical committee
has to balance the risks and benefits of the experimental research and such
research will only be ethical if the benefits outweigh the risks for the subject or
for society at large. Thirdly, in order to be ethically acceptable, a research
protocol has to ensure the confidentiality of the facts collected for the
purpose of the experiment. Among other things, the researcher has to
establish measures which will guarantee that the subject'
s anonymity will be
protected and determine in advance, as precisely as possible, the instances
where the researcher will be exempted from the duty of confidentiality
towards his subject. Finally, the researcher will also have to make sure that
the subject gives a free and clear consent by asking him or her to sign a
consent form which he or she fully understands and to which he or she
liberally adheres to.
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