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.
and Informed Choice
Respect for persons requires
that we recognize the autonomy of those able to make their
own decisions, and protect from harm those who are not.
Exercising autonomy in an informed way requires an adequate
disclosure of information. Ideally, this occurs in the
research context when participation is viewed as a partnership
between investigators and those considering entering a
protocol. This model of shared and rational decision-making
requires an exchange of essential information that fosters
informed and prudent choices by both parties. Under this
view of the research partnership, an individual informed
of the harms and benefits of participation is most likely
to make reasoned, self-protective judgements about the
assumption of risk. To do so requires the sharing of detailed
information. This attitude is supported in law, where,
because the presumed benefits of research participation
are unproven, or no benefit is intended for the participant,
the highest standard of disclosure is required. Information
provided should include what a reasonable person contemplating
participation would want to know about the consequences
and conditions of participation, including information
about the nature and probability of the potential harms
Information about research participation
must be provided both verbally and in writing. As well,
as much time as is necessary must be taken to ensure effective
understanding and appreciation. If the information to
be conveyed is particularly complex, audio-visual aids
and user-friendly information pamphlets may also be helpful.
If required, provision must be made for qualified interpretation
To further the goal of understanding,
it is imperative that relevant information be provided:
- in the prospective research
participant's preferred language. Care should be taken
so that any interpretation or translation does not bias
the informed choice process;
- in lay terms that avoid
the overuse of medical or technical jargon (e.g. "bruise"
rather than "haematoma");
- in the first or second person
(e.g., "you" or "your child");
- at an appropriate level
for the person's age and educational level (a computer
program does exist which identifies the language used
in documents by grade level);
- with simple explanations
of clinical terms (e.g.,"a placebo is an inactive
substitute for a drug"); and
- with descriptive accounts
of relevant information (e.g., an explanation of the
level of exposure to radiation in terms of chest X-ray
equivalents, not just roentgens; a description of blood
volume required in terms of teaspoons, not just cc's).
In general, the research consent
form should not exceed three pages and should contain
both the relevant information and the actual consent form.
This combined form is preferable to separate information
and consent forms because it effectively ensures that
the prospective research participant receives the relevant
written research information.
In all cases, the individual
who consents to research must be provided with a copy
of the signed research consent form. When the research
participant is also a patient in the institution in which
the research is being conducted, the original signed form
should generally be included in the patient's record;
the researcher may only keep a copy of the signed form.
Otherwise, the original signed form should be kept on
file by the researcher.