National Council on Ethics in Human Research                        Conseil national d'éthique en recherche chez l'humain
 
 

S U P P L E M E N T   

Volume 7 Number 2
NCEHR Communiqué CNERH
December 1996

S U P P L E M E N T

FACILITATING ETHICAL RESEARCH:
PROMOTING INFORMED CHOICE

Discussion Document


National Council on Ethics in Human Research
(NCEHR)


774, Promenade Echo Drive
Ottawa, Canada

TEL: (613) 730-6225
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.
ISSN 1181-8778

Table of Contents

Introduction

Section 1

Consent as an Ethical Imperative: Key Elements of Informed Choice

Section 2.

Competence and Informed Choice

Section 3.

Disclosure and Informed Choice

Section 4.

Voluntariness and Informed Choice

A.

Dependence

B.

Long Term and Chronic Care

C.

Incentives to Participate in Research

Section 5.

Sample Consent Forms and Checklist

Section 6.

Selected Bibliography on Informed Choice

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Section 4 :

Voluntariness and Informed Choice

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 situations.

A. Dependence

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.

B. 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 upon participation.

Researchers must detail their recruitment plans when approaching such individuals for participation in research protocols.

C. 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 possible terms.