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.
Not only does valid consent
require that the individual be competent and informed,
it also requires that the choice to participate be made
freely and voluntarily. In order for consent to be voluntary,
free, and genuine, an individual must have the opportunity
to choose between consent and refusal without undue interference,
fear, constraint, compulsion, or undue inducement.
While situations of physical
duress or of fraudulent misrepresentation of facts are
universally recognized as inappropriate, control may be
exerted by more subtle means. Undue influence may take
the guise of: promises of companionship, love, or affection;
economic incentives; emphasis on benefits over risks or
burdens; or, appeals to emotional weaknesses, loyalty
to professional caregivers, or family solidarity.
Researchers must pay special
attention to assessment of voluntariness in the following
Many prospective research participants
live in situations of increased dependence on family and
other caregivers. Such situations should raise sensitivity
to the voluntariness of a prospective research participant's
consent; careful scrutiny is required to assure its authenticity.
Undue influence placed on an individual by family, friends,
health care professionals, or anyone else should be avoided.
At the same time, it is important to recognize diverse
decision-making processes in different families and cultures.
For example, some prospective participants will prefer
full discussion with other family members before making
a choice whether to participate, while others will not.
Long Term and Chronic Care
Individuals in long-term care
facilities are particularly vulnerable due to their level
of dependence, especially on health care professionals,
for fulfilment of basic daily physical, social, and even
emotional needs. This extreme dependence frequently encourages
passivity and a willingness to comply with instructions,
even on the part of those who are mentally competent.
Increased levels of vulnerability also occur in persons
who live outside institutions, but who depend heavily
upon health care establishments for chronic or long-term
care. Such individuals should never be made to feel obliged
to participate in projects for fear that their current
or future care or the esteem of their caregivers may depend
Researchers must detail their
recruitment plans when approaching such individuals for
participation in research protocols.
Incentives to Participate in Research
Payments and other inappropriate
incentives offered for the purpose of inducing participation
on the part of those who would not otherwise participate
in a protocol unduly affect freedom of choice and are
unacceptable. Payment made for any inconvenience to a
participant, or for services that are rendered at a rate
which is appropriate (attractive but not inducing) is
acceptable. Repayment to research participants or their
substitute decision-makers for out-of-pocket expenses
such as babysitting, transportation, or meals is appropriate.
Non-financial incentives such
as promises of modification of care, or early placement
in long-term care facilities, constitute undue influence
when dealing with either or both the prospective research
participant and her or his substitute decision-maker.
Finally, since a strong motivation
for participating may be the offer of treatment, disclosure
of a placebo research design must be made in the clearest