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

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Ottawa, Canada

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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


Presumption of Competence


Chronological Age


Legal Incompetence


Determining Competence to Participate in Research


Research Involving Persons with Disabilities


Family Support


Protocol Duration


Substitute Decision-Makers


Participant Selection

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 2 :

Competence and Informed Choice

Because only a competent person can make a morally (and legally) valid choice, it is important to ensure that any prospective research participant is capable of making a valid choice to participate in a research protocol. Thus a key question is: what specifically constitutes competence?

The terms "competence" and "capacity" are often used interchangeably. In law, capacity refers to the recognition that certain rights may be exercised by designated persons, and is frequently defined by characteristics of status such as age or civil status, as well as by the mental ability to understand. This latter characteristic is often referred to as mental competence or mental capacity. Because the variability in the definitions of competence or capacity is extremely wide, this may be cause for confusion. However, at the core, competence/capacity is the measure of the "fitness" of an individual to act or behave in certain situations. In the context of research, it means the mental ability to understand the nature and consequences of one's acts, so as to be "fit" to make informed choices concerning participation in research protocols.

Since the important question is whether the individual is fit to function in a particular situation, such fitness is in fact determined by both the situation and the person's understanding of it. Therefore, incompetence in one area does not necessarily imply incompetence in another. A prospective research participant may be incompetent to enter into a contract or write a will, for instance, without necessarily being incompetent to make other choices.

A. Presumption of Competence

Adults are presumed to be competent unless evidence to the contrary is produced and accepted by an appropriate authority. Competence or incompetence is not a particular "diagnosis" in a medical or psychiatric sense. A diagnosis of cerebral palsy, mental illness, or dementia, for example, should not automatically be accepted by health professionals as evidence of incompetence per se. Many individuals with such diagnoses are able to make a competent choice regarding participation in research. Caution should be exercised in making such determinations.

However, circumstances in which an individual lacks sufficient cognitive ability to perform any, or almost any, task requiring understanding do warrant a presumption of general incompetence to make valid choices, regardless of the protocol in question. Extreme examples of general incompetence would be unconscious individuals, or those completely unaware of their surroundings. Persons in the later stages of Alzheimer's disease would also fall into this category, given the nature of their condition.

Determinations of general incompetence are often made in less extreme circumstances. For example, an individual whose overall functioning is impaired by a permanent condition such as severe mental retardation, or a temporary condition such as being under the influence of alcohol or drugs (prescribed or unprescribed) could be viewed as incompetent. Persons suffering serious cognitive impairment as the result of a stroke, who may later recover some or all of the lost functions, also fall within this category of prospective research participants. Other conditions, such as certain severe psychiatric illnesses or symptoms, might also critically impair overall functioning so that prospective participants would be unable to make informed choices in almost all situations, including participation in research.

B. Chronological Age

Chronological age may be a relevant factor in making a legally valid choice; for example, some provinces have established a statutory minimum age for consent to one's own medical treatment. Chronological age to consent to participate in research, however, may differ from the age for consent to medical treatment. Other provinces operating under common law allow all those who have the mental ability to understand and appreciate the nature and consequences of their acts to make their own choices regardless of age.

Aside from fulfilling any statutory requirement, chronological age alone should not be a consideration for participation in research. Chronological age is relevant, however, to the ability to act as a substitute decision-maker for an incompetent person. Only a competent person of legal majority may act on behalf of an incompetent person.

When a child is unable to make a legally valid choice regarding research participation, ordinarily his or her parents would be the legal representatives and they would be responsible for authorizing the research on the child's behalf.

C. Legal Incompetence

Legal incompetence results when a court issues an order declaring an adult person incompetent in accordance with relevant provincial statutes, at which time a legal representative is appointed for the person. This representative may be a private individual or an official such as the Public Trustee, a guardian, or a curator. Researchers should be familiar with the requirements of their own provinces concerning the authority of legal representatives to authorize the participation of legally incompetent individuals in research protocols.

All legal representatives are charged with the responsibility for the welfare of those they represent. Research that is clearly intended to benefit participants is uncontroversial. However, the degree of discomfort or risk of harm legal representatives may authorize without corresponding benefit remains the subject of discussion in jurisdictions that have no legislation clarifying the matter.

D. Determining Competence to Participate in Research

Causes of incompetence are varied. There are differences in:

  1. the onset of a debilitating condition;
  2. the duration; and
  3. the effect on an individual’s ability to make an informed choice or to continue to make informed choices over the course of a protocol. Some conditions are life-long while others have onset late in life.

Some are temporary; others are permanent, with sudden or gradual onset. Only individual evaluation can determine whether a prospective research participant of questionable competence is able to make a voluntary and informed choice to participate in a protocol. As a consequence, when competency is in doubt, individual assessment of the prospective research participant is imperative.

While there is no single standard, method, or formula for competency assessment, researchers should understand that competency is assessed with respect to the particular protocol in question. Consequently, mental status exams or neuro-psychological exams alone will not suffice except as screening tools which may indicate that further assessment is warranted.

To be considered competent to make a valid choice, prospective research participants should be able to understand and appreciate:

  1. the nature and purpose of the research in question;
  2. why they, as opposed to others, are being selected and asked to participate;
  3. the fact that the suggested intervention is for research purposes;
  4. the relevant elements of uncertainty about the protocol;
  5. what participation in the particular research protocol means for the participant;
  6. whether or not the intervention may provide any direct personal benefit to them;
  7. how the consequences of a decision to participate or not to participate will affect their own current and future lives;
  8. that they will be free to withdraw from participation at any time during the course of the protocol;
  9. that a decision not to participate or to withdraw from participation will not adversely affect their care;
  10. any conflict of interest on the part of the person recruiting participants; and
  11. the liability assumed by the investigator.

To understand what participation in a protocol entails, the prospective research participant must be able not only to comprehend the physical risks, such as physical discomforts or threats to life or health, but also to appreciate other implications, such as alterations to familiar routine, the necessity for hospitalization, or restrictions on such things as diet.

In cases where prospective research participants are likely to undergo progressive cognitive deterioration, competence may diminish during the operation of the protocol. It is therefore important that they understand both the short and long range consequences of the participation. If prospective research participants are able to clearly comprehend all of this information, they are competent to make a morally valid choice to participate or refuse to participate.

However, it is possible that an individual who could understand these elements for one protocol may not be able to do so for another; for example, one may be simple or involve procedures with which the person is familiar, while the other may be more complex or threatening. It is up to the investigator to ensure that the research participant understands all aspects of the particular protocol in order to establish that the individual is competent.

E. Research Involving Persons with Disabilities

Many individuals with a disability are competent to make their own choices. Factors such as the loss of vision or hearing, pathologies of speech or slowness of response, should not be confused with mental incompetence.

Other individuals may have a cognitive disability or, because of their young age, may not yet have attained fully mature cognitive capacity. In these cases their ability to make some, but not all decisions, may be impaired. When research protocols involve participants who do not have the necessary cognitive ability, particular care must be taken to ensure that those able to comprehend are presented with information in a manner understandable to them.

In order to fulfil all disclosure requirements for purposes of consent to research, the communication and comprehension barriers of each prospective research participant should be assessed. Methods of communicating should be devised to meet the needs of every individual who is approached to participate. Researchers must draw up a description of their plans for assessing prospective participants of questionable competence. Researchers must also draw up a detailed description of the proposed process of making a choice, including consent forms compatible with the needs of the population from which prospective research participants are to be drawn.

F. Family Support

In many protocols, support of the prospective research participant by an involved and caring family (or other persons close to the individual) may be required to mitigate any psychological risks and anxieties associated with participation in a protocol. Such support may also assist in, or even be vital for, compliance with protocol requirements. However, researchers should be aware of the potential for conflicts of interest between prospective research participants and their families.

G. Protocol Duration

The duration of the protocol is important, not only in consideration of possible inconvenience to the research participant, but also in consideration of the fact that some participants may lose competence during the course of participation, become less competent, or become unable to continue to express willingness to continue participation.

H. Substitute Decision-Makers

When a prospective research participant is unable to make an informed choice, authorization must be given by that person's legal representative. Researchers must pay attention to the appropriateness of substitute decision-makers. The following factors should be taken into account:

  1. Investigators must comply with applicable law(s) regarding the ability of a representative to authorize participation by an incompetent individual in a research protocol.
  2. The protocol must present clear procedures for designation of a substitute decision-maker, when this is necessary.
  3. Researchers must be sensitive to the potential for conflicts of interest (which might entail abuse) between the prospective participant and her or his substitute decision-maker concerning participation in the research protocol.
I. Participant Selection

When researchers propose including incompetent individuals as research participants, they must justify why the research could not be carried out reasonably well with less vulnerable participants. For example, when protocols include young children, researchers must explain why the research could not be done with competent adults.