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



Discussion Document

National Council on Ethics in Human Research

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


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

Section 5.

Sample Consent Forms and Checklist

Section 6.

Selected Bibliography on Informed Choice

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Section 3 :

Disclosure 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 and benefits.

Providing Information

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 services.

To further the goal of understanding, it is imperative that relevant information be provided:

  1. 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;
  2. in lay terms that avoid the overuse of medical or technical jargon (e.g. "bruise" rather than "haematoma");
  3. in the first or second person (e.g., "you" or "your child");
  4. 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);
  5. with simple explanations of clinical terms (e.g.,"a placebo is an inactive substitute for a drug"); and
  6. 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.