PROMOTING INFORMED CHOICE
National Council on Ethics in Human Research
774, Promenade Echo Drive
FAX: (613) 730-8251
National Council on
Ethics in Human Research (NCEHR) / Conseil national d'éthique
en recherche chez l'humain (CNÉRH)
The views expressed in this
document are for discussion purposes only.
They do not necessarily reflect those of NCEHR.
Copyright © NCEHR
1996. NCEHR authorizes REBs to photocopy the material.
What follows is the result of
several years work by the Panel on Consent (now known
as the "Working Committee on Consent") of the
National Council on Ethics in Human Research (NCEHR).
This document does not set out guidelines: that mandate
belongs to the Medical Research Council of Canada, the
Social Sciences and Humanities Research Council of Canada,
and the Natural Sciences and Engineering Research Council
of Canada. The issues we deal with here pertain to biomedical
and health research ethics. This work does not address
questions particular to public health, epidemiology, or
medical sociology and medical anthropology.
The idea for such a short compendium
came naturally to the group. Since the late 1980's, we
have been called upon to handle queries, usually from
Research Ethics Boards (REBs), concerning the problematic
ethical aspects of a proper approach to, and interaction
with, prospective participants in health research. We
gradually became aware that many of the queries could
have been handled with reference to a general work. This
document is meant to serve as a basic first document.
It is intended to assist medical investigators in preparing
their proposals for research, and REBs in fulfilling their
duty to review, approve or disapprove, and monitor that
research. For references that contain more detail than
is outlined in this document, we include a basic bibliography
of useful works. The Working Committee on Consent intends
to address additional areas of informed choice in future
associated with NCEHR have been involved in the preparation
of this document. The Panel on Consent which conceived
the idea and drafted the initial work was chaired by Janice
Dickin McGinnis and included Françoise Baylis, Douglas
Biggar, Kathleen Glass and Douglas Kinsella. They were
joined in 1994 by Janet Storch, who took over as Chair,
and Betty Flagler, who replaced outgoing member Douglas
Kinsella. When the initial draft was complete, Council
Members were offered the opportunity to comment on the
draft, and many did. Janet Storch and former NCEHR Director
Derek Jones incorporated their comments, as well as the
comments of three outside peer reviewers, to produce the
final text. Kathleen Glass prepared the document for publication.
The participation of NCEHR staff, and in particular, Louise
Dugas, was indispensable in producing the final published
texts in English and in French. Members of Council are
grateful for all of these contributions.
In working our own way through
the issues that follow, the members of the Panel on Consent
chose respect for persons as their basic value. Respect
for persons recognizes both the right of individuals to
decide for themselves, insofar as they are able, and the
obligation to protect the interests of those who are unable
to make their own decisions. The principles of autonomy,
beneficence, and non-maleficence are therefore key in
the analysis that follows.
The creation of this document
also involved the careful selection and use of language
and terminology. Wherever possible, we have limited ourselves
to the use of the words "choice" or "decision".
The term "consent" appears only in situations
where it can be taken that this particular choice has
been made. Individuals who are approached to participate
in research are being asked to make a choice, not to give
consent. Consent should not be valued over refusal since
both are equally valid choices. We have also elected to
use the phrase "research participant" rather
than subject, and "substitute decision-maker"
rather than proxy. Also, the phrase "prospective
research participant" is used in situations where
the person, or substitute decision-maker has not yet chosen
to participate. Finally, we have decided not to use the
term "patient" except in exceptional circumstances.
While many patients are research participants, many research
participants are not patients.
The following text is intended
as a discussion of factors that investigators and Research
Ethics Boards (REBs) should consider in the context of
participant consent and refusal. Although research is
a matter of great importance to the human community, decisions
to participate in it rest solely with the individual or,
in situations where the research participant is not competent,
with a substitute decision-maker. Thus, we have focused
our attention on how to ensure that the process and the
language function to allow the individual to make a competent,
informed, and voluntary decision. Sections are provided
- Key Elements of Informed
- Disclosure; and
In addition to the discussion
of these key elements, we have provided draft clauses
as examples, and a checklist. Investigators and REBs are
invited to borrow or alter these to suit their purposes.