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

A.

Competence

B.

Disclosure

C.

Voluntariness

D.

Responsibility of the Research Team

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 1

Consent as an Ethical Imperative:
Key Elements of Informed Choice

  Amorally valid choice concerning research participation is a choice made:

  1. by a competent person;
  2. on the basis of adequate information concerning the nature and foreseeable consequences of the research (as these are known at the time the request is made) and all available alternatives; and
  3. without controlling influences such as "force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion" (Nuremberg Code).

A morally valid choice is an ongoing dialogue; it is not a form signed by the prospective research participant or substitute decision-maker. It is the culmination of an educational process involving a responsible member of the research team (or contracted person), and the prospective research participant and/or others such as family members. It requires an affirmative action being taken by the prospective research participant or substitute decision-maker, not silent acquiescence. Moreover, if the prospective research participant or substitute decision-maker chooses to consent, then confirmation of continuing consent may be required, as appropriate, in recognition of the ongoing nature of the process. A morally valid choice also includes assent, in cases where the prospective research participant is deemed legally incompetent.

As much as it values the concept of consent, however, a morally valid choice places equal value on the concept of refusal: thus, it is as valid to refuse to participate in research or to withdraw from participation in research, as it is to agree to participate or to continue participating.

The key elements necessary for ensuring that a choice is morally valid include the following:

A. Competence

Usually, a person invited to participate in research must be competent. This means that she or he must be capable of making a morally (and legally) valid choice to participate in research. Any assessment of the prospective research participant's ability to make a valid choice must take into account that prospective participant's personal life goals and values. If the prospective participant is deemed competent to make a choice, it is appropriate to proceed with full disclosure of the information necessary for that person to make an informed choice about whether or not to participate in the specific research in question. In cases where the prospective research participant is deemed incompetent to make a valid choice (e.g., by virtue of insufficient age, mental illness, dementia, or being unconsciousness), a competent substitute decision-maker must be identified (while parents often serve in this role for their children, this is not always the case).

The substitute decision-maker is responsible for safeguarding the interests of the prospective research participant in any decision to be made regarding that person's participation in a research project. In the case of a person who is now unable to make her or his wishes known in this regard, but who has made those wishes known previously (whether directly or as inferred from behaviour), the substitute decision-maker acts for that person's interests in making a decision consistent with her or his understood wishes (no matter what the personal inclination of the substitute decision-maker might be).

In the case of a person who is now unable to make her or his wishes known in this regard, and who has never been able to do so, the standard for decision-making with regard to participation in health care interventions has been protection of the incompetent person's "best interests" (usually interpreted as protection of life, as well as physical and psychological integrity). With reference to a never-competent person's participation in research endeavours, however, there is a question as to whether the "best interests" standard as narrowly interpreted above should prevail. Consistent with its statement in Reflections on Research Involving Children (1993), NCEHR has argued that, in matters of research, the substitute decision-maker may authorize such participation provided there is a favourable harm/benefit ratio. In particular cases, no more than the potential for negligible or minimal harm to the person would be allowed (such harm to be judged in terms of both magnitude and probability). Any such potential harm must have a positive balancing of potential benefit for the group of which the person is a member, if not directly for the person herself or himself.

As a general proposition, incompetent persons should not be invited to participate in protocols if competent persons would be sufficiently suitable.

Hereafter, for the purposes of this document, the phrase "prospective research participant" when used in the context of choice should be understood to include the additional phrase: "and her or his substitute decision-maker", unless otherwise stated.

B. Disclosure

In order for a choice to be valid, it must be based upon all relevant information concerning the proposed research. Deciding what is relevant involves weighing alternatives. On the one hand, the researcher must provide information concerning the purpose and nature of the research, the potential harms and benefits of the research, and the process of research participation. On the other hand, the prospective research participant should not be overwhelmed with minutiae. In addition, the prospective research participant must be provided with specific information concerning confidentiality, reimbursement, the right not to participate, and the right to withdraw. Specific questions from the prospective participant should be encouraged and must be answered. Researchers will find guidance as to what might and what might not be considered relevant in the accompanying checklist which forms part of this document.

C. Voluntariness

It is imperative that the choice made by the prospective research participant be a free choice or, in other words, a choice that is not subject to undue pressure or coercion. The stricture applies not only to overt attempts at persuasion and force, but also to situations where subtle forms of pressure and coercion may be endemic to the environment. Examples of such potentially coercive situations arise in dealing with captive populations (e.g., institutionalized persons), or with patients and their friends or family in certain hospital settings (e.g., neonatal ICUs or emergency rooms). Researchers in these environments should be particularly aware of indirect application of pressure and coercion that may occur.

Researchers who also act in the role of the prospective research participant's physician bear an added responsibility to ensure that any consent given is unencumbered by feelings of patient loyalty to the physician. Another special case is one in which limitations in research design do not easily accommodate withdrawals from research (e.g., when a patient is under anaesthetic, when a research participant develops worsening dementia, when stopping the research participant’s treatment could mean an increased morbidity rate, or when somatic cell gene transfer is underway).

Other situations involving a differential in authority, such as professors recruiting their own students, or employers recruiting their employees, also require careful attention to issues regarding the potential exertion of undue influence.

Situations such as those described above require particular consideration by an REB as a standard part of its review so that opportunities for either subtle pressure or coercion to participate will be minimized.

D. Responsibility of the Research Team

The role of the research team in soliciting an informed choice from a prospective research participant is complex, as all three key elements of a morally valid choice must be addressed. The competence of the prospective research participant must be assessed, a full disclosure of relevant information must be undertaken, and the absence of coercion or inappropriate inducement must be assured.

Of concern is the locus of responsibility for the accomplishment of these tasks. Ultimately, the principal investigator is responsible for ensuring that prospective research participants have an opportunity to exercise a morally valid choice. It does not follow, however, that the principal investigator must personally execute all or any of these tasks. These may be delegated to the individuals who are most capable with respect to each of the specific tasks. For example, in cases where competence assessments are difficult, the assessment may be delegated to a qualified member of the research team (or contracted individual). However, the principal investigator does maintain overall moral responsibility for the results of delegated acts.

As regards disclosure, when the research is relatively simple and innocuous, the principal investigator may delegate this responsibility to another member of the research team. However, when the proposed research is particularly complex, the principal investigator should be particularly careful to ensure that a very knowledgeable member of the team (and, as appropriate, himself or herself) assumes responsibility for this task.

Further complications arise when the principal investigator is also the treating physician, health professional or therapist, as this may give rise to some concern regarding the potential for subtle coercion. The most important or overriding consideration, however, is that the prospective research participant be well informed. When the best person to explain the proposed research is both the principal investigator and the treating health professional, a colleague should participate in the process of obtaining the prospective research participant's informed choice.

A separate point worthy of note is that when the research proposal is very complex, or extends over a long period of time, it may be appropriate to think of the informed choice process as ongoing, in which case the research participant periodically would be asked to confirm her or his continuing choice regarding research participation. This task might be appropriately assigned to a delegate. In especially complex situations, or when the participant may become incompetent, it may be valuable to appoint a representative, advocate, or ombudsperson to deal with the re-affirmation process.

Given the above, it follows that more than one person may be involved in soliciting an informed choice to research participation. When one or more of those individuals involved in the process is in a position of possible conflict of interest (e.g., has a commercial interest in a company sponsoring a trial), this should be disclosed and discussed with the prospective research participant.

As a follow-up to this overview of informed choice as an ethical imperative, its key elements (competence, disclosure and voluntariness) are discussed more fully below.