FACILITATING ETHICAL RESEARCH:
PROMOTING INFORMED CHOICE

Discussion Document

National Council on Ethics in Human Research
(NCEHR)

774, Promenade Echo Drive
Ottawa, Canada

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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

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 documents.

Many individuals 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 on:

1. Key Elements of Informed Choice;
2. Competence;
3. Disclosure; and
4. Voluntariness.

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.