his issue of Communiqué is the first one under our new name
—the National Council on Ethics in Human Research (NCEHR). The change to Ethics
from Bioethics (NCBHR) reflects the broadened mandate of Council to encompass the
ethics, not just of medical research, but of all research on humans in Canada. The
composition and sponsorship of NCEHR has changed to reflect its wider community. Unchanged
is our central mission to be a national resource for Research Ethics Boards (REBs) and the
ethics review process.
A challenging development, which parallels NCEHR’s broadened activities, is the
Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans. This
initiative by the three federal research-funding councils began over three years ago. It
has involved a cast of hard-working authors and editors. The first draft in 1996 evoked
250 responses from a wide variety of sources, totalling over 3000 pages. As we go to
press, the latest version of the Tri-Council document has received endorsement by the
Natural Sciences and Engineering Research Council, the Social Sciences and Humanities
Research Council and the Medical Research Council.
The Tri-Council document describes the context
for an ethics framework, outlines standards, procedures and practices for ethics review,
and addresses selected topics such as research involving aboriginal peoples and human
genetic research. It begins by stating that Councils’ decision to adopt a unified
approach was based "fundamentally on the special responsibilities owed to research
subjects and the public".
An accountable, effective and efficient process of ethics review must
accompany such professional responsibility. A major educational effort and resources are
needed to implement, maintain and monitor such a process.
Since the beginning of the Tri-Council initiatives, attention and debate
in the Canadian research community have been directed to challenges posed by creating a
document with guidelines applicable to all research disciplines, ranging from medicine to
psychology, education and history. Of greater concern is whether guidelines are soon to be
threatened by those who would replace them with government legislation and regulations.
The issue of guidelines versus legislation was reviewed succinctly in the
1987 MRC Guidelines on Research Involving Human Subjects. That document expressed
the opinion that "Guidelines can accommodate more easily than the law the shifting
social evaluations that affect research, and can influence responses in subtle ways rather
than with the rigidity found in legislation. Indeed, the truly ethical quality of
assessments to be made may atrophy when judgments are directed by the law"1.
Guidelines can be abused. The NCBHR report of site visits to Canadian
universities with medical faculties revealed considerable variation in ethics review
procedures and minimal monitoring2. Initial visits to universities without
medical faculties reveal a wider range of problems. If guidelines are to survive, they
need public trust, local commitment and administrative structures to administer and
monitor them. Therein lie the real challenges.
