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

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.

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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.

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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:

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Section 3 :

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.

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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.

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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.

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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.

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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.

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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.

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Sample Consent Forms and Checklist

The requirements for adequate disclosure are summarized below under specific sub-headings. The subheadings in italics should appear in the Research Consent Form to ensure complete information and to further comprehension. To be precise, use of these subheadings helps to:

1. ensure that relevant information is not inadvertently excluded; and
   
2. encourage researchers to present the information in a manner that is more accessible to the average prospective research participant.

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Research Consent Form

The form must be properly titled to ensure that the prospective research participant clearly understands that the proposed intervention is for research rather than treatment purposes.

• Name of the institution
  
• Date

The form should be dated on the upper right-hand corner of each page. This should be the date of REB approval of the protocol. The objective is to ensure that any subsequent amended version of the research consent form can be easily identified. For example, it is possible that new information regarding the potential harms and benefits of research might require a revision to the original research consent form. It follows that the date of any revision after the original approval should be placed in the upper right-hand corner.

Title of the Research

The research consent form should include the exact title of the research protocol (i.e., the title under which the research was approved and funded). When the title is particularly cumbersome, a short simplified title may be added.

Researcher(s)

The name(s), degree(s), department (and affiliation, if other than the institution where the research is being conducted), and contact telephone number(s) of all researchers should appear immediately below the title of the research project.

Care must be taken not to mislead or misrepresent facts. For example, if a researcher is a student, this must be explicitly stated and the name(s), degree(s), department (and affiliation, if other than the institution where the research is being conducted), and telephone number(s) of the supervisor must also appear on the form.

A prospective research participant might also be misled if it is not clear that Dr. Smith (M.D.) is a physician, while Dr. Jones (Ph.D.) is not. The difference and its relevant implications must be made clear.

Also, it is imperative that the contact person (usually the principal researcher) be explicitly identified and an invitation offered to the prospective research participant to call with any questions. Time of availability should be clearly indicated (e.g., Monday to Friday, 9:00 to 5:00).

Sponsor(s)

The name of the company(ies) and/or the granting agency(ies) that is (are) sponsoring the research must appear on the form. As well, it is appropriate to indicate if the research is being done at a single site or whether the research is part of a multi-centre trial.

Purpose of the Research

A brief description of the purpose of the research should explain what hypothesis is being tested and what the research is supposed to demonstrate. If there are specific inclusion and exclusion criteria for research participation, these should be noted here.

Description of the Research

A step-by-step description of the research as it will be experienced by the research participant must be provided, and it must clearly explain the expected length of her or his participation in the research. The objective is to provide the prospective research participant with a clear understanding of how she or he will be involved in the research (e.g., completion of a questionnaire, studies in behaviour modification, testing of equipment, testing of a new drug, or surgical intervention). In providing this description it is important to explain:

1. whether any specific testing is required to determine eligibility for research participation (e.g., HIV testing, psychological testing);
   
2. whether the research design involves specific research techniques such as randomization, sequential assignment, blinding, or placebo control;
   
3. whether the person's health record will be reviewed;
   
4. whether radiation is involved and, if so, the level of radiation to which the participant will be exposed;
   
5. whether blood testing is involved and, if so, the amount of blood that will be taken;
   
6. whether research participation will result in missed school or work;
   
7. whether future use of the research data (e.g., subsequent use of photographs, videos, sound recordings, DNA information, permanent cell lines) is or is not anticipated. If future use of the data/samples is anticipated, this must be explained and the prospective participant must be assured that the data/samples will be maintained in a manner that ensures confidentiality. If future use of the data/ samples is not anticipated, the participant should be told that the data/samples will be destroyed once the research is complete;
   
8. rules for stopping the research and/or removing a participant from the research.

As well, if the prospective research participants are patients, it is important to explain:

1. which interventions are part of standard therapy and which interventions are purely research;
   
2. whether any therapy that is being received will be altered or discontinued as a result of research participation;
   
3. whether research participation will require additional visits to the hospital or lengthen hospital stay;
   
4. whether the service/drug/intervention/device will or will not be available to the participant once the research is complete, assuming that the service/drug/ intervention/device was found to be beneficial. (It is expected that, where appropriate, the researcher will attempt to secure agreement from the sponsor to continue to provide the service/drug/intervention/device to research participants beyond the original research time frame, until it is available in a therapeutic context).

Potential Harms

Potential harms and potential benefits of research must be described separately from one another. Moreover, to further the goal of voluntariness, potential harms must be listed prior to potential benefits.

If there are no known or anticipated harms associated with the proposed research, this should be stated explicitly. If there are known potential harms to the research participant, these should be described as accurately as possible. This description should include relevant information about the nature of the potential harm(s) (how serious is the potential harm?), and the probability of occurrence (how likely is it that the potential harm will occur?). As well, information concerning the possibility of reversibility should be included along with a description of any precautions that will be taken to minimize the probability of occurrence. In either case, there should be a statement acknowledging the possibility of unforeseen harms.

Potential Benefits

If there are no potential benefits to the prospective research participant, this must be stated explicitly. If there are potential benefits to the participant, these should be described as accurately as possible. This description should include relevant information about the nature of the potential benefit(s) (how important are these benefits?) and the probability of occurrence (how likely is it that the potential benefits will occur?).

In research projects where there may be anticipated benefits to society or to a specific group within society (e.g., persons with a particular disease/disorder), these potential benefits must be explained in a separate paragraph so as not to confuse potential benefits to others wa particular disease/disorder), these potential benefits must be explained in a separate paragraph so as not to confuse potential benefits to others with potential benefits to the research participant.

Alternatives

If the research does not include patients as research participants, this section may be deleted. If the prospective research participant is not a patient, the alternative to research participation is non-participation and this is explained under the subheading "participation".

If the research does include patients as participants, it is important that the prospective research participant know whether there are any "treatment" alternatives. If there are no such alternatives (i.e., no available therapy), this should be stated. If there are treatment alternatives, the alternatives should be described and this description should include a summary of the nature of the alternative intervention(s), as well as the potential harms and benefits.

Confidentiality

It is important for the prospective research participant to know who will have access to the research data/samples, and how such data/samples will be stored.

Usually, it is possible to assure the prospective research participant that confidentiality will be respected and that no information that discloses the participant's identity will be released or published without the proper consent. It is important to note, however, that certain agencies may legitimately require access to research files to monitor ongoing research. When applicable, this should be explained in the research consent form and the name(s) of the agency(ies) to whom identifying information will be available should be provided (e.g., the research sponsor, Health Protection Branch, the U.S. Food and Drug Administration).

When there are separate plans to use identifying information (e.g., the use of photographs, videos, or sound recordings) for subsequent research or for teaching purposes, this must be disclosed in the research consent form and there should be a separate consent form for the subsequent use of the identifying information. In most cases, this separate consent form should only be presented to the prospective research participant once she or he has had an opportunity to review the identifying information and, on this basis, to decide whether to consent or refuse to allow the data to be used for future research or teaching.

As a separate matter, the research consent form should explain that if the participant is a patient in the institution where the research is being conducted, information regarding her or his participation will be added to her or his health record. At the very least, the signed research consent form will be part of the health record. As well, test results (e.g., HIV test, genetic tests) and other research findings (particularly when these may directly impact on treatment) may be included in the health record. If this is the intention or a likely consequence of the research, it must be disclosed.

Finally, in rare instances it will not be possible to ensure confidentiality (e.g., suspected child abuse, reportable communicable diseases). When this is the case, the prospective research participant should be aware of this limitation.

Reimbursement

When reimbursement is available for lost wages (minimum wage) and out-of-pocket expenses (transportation costs, meals, baby-sitters, etc.), this should be disclosed in the research consent form. As well, it should be explained that a decision to withdraw from the research will not affect any reimbursement costs that may have been incurred prior to withdrawal.

Participation

The prospective research participant must be told very explicitly that she or he has the right to refuse to participate in the proposed research and, moreover, that a decision to participate in the research is not binding. It is important to make it clear that participant withdrawal may be made at any time without negative consequences.

In those rare instances where it will not be possible for the participant to withdraw from the research, this should be explained (e.g., research on somatic cell gene transfer). It is equally important to advise participants that withdrawal of their participation does not necessarily include withdrawal of any data compiled up to that point.

Finally, this section should include an offer to share the research findings with the participant upon completion of the research.

Publication

The investigator must:

1. undertake to alert the participant to publication of results; and
   
2. tell the participant that such publication will not reveal the identity of the participant.

Consent

This section should provide a brief (one paragraph) summary of the research stating that the potential harms, benefits, and alternatives have been explained. There should be a statement to the effect that the prospective research participant:

1. has read and understood the relevant information;
   
2. understands that she or he may ask questions in the future;
   
3. indicates free consent to research participation by signing the research consent form.

When consent is provided by a substitute decision-maker, there should be a record of the prospective research participant's assent to research participation, provided the prospective participant is capable of assent (e.g., this is possible for older children but not for comatose patients). The research participant's assent should be indicated on the form by the researcher who obtained the consent from the substitute decision-maker, not by having the participant sign the form.

The participant's (or substitute decision-maker's) signature should be followed by a signed statement from the researcher who obtained the consent. This statement should indicate that she or he explained the research to the prospective participant or substitute decision-maker and, that to the best of her or his knowledge, the prospective participant or substitute decision-maker understood the proposed research and freely consented to research participation.

Warning

The research consent form should not include any reference to a waiver by the participant of any of the participant's legal rights. The participant should not be asked to release the researcher, the sponsor, or the institution where the research is being conducted, from liability or negligence.

Suggested Wording

Potential Harms

"There are no known harms associated with your participation in this research. However, there may be harms that we don't yet know about."

Potential Benefits

"There are no known benefits to you associated with your participation in this research."
"You will not benefit directly from participation in this research."

Confidentiality

"Confidentiality will be respected. No information that discloses your identity will be released or published without your specific consent to the disclosure."

"Confidentiality will be respected. No information that discloses your identity will be released or published without your specific consent to the disclosure. However, it is important to note that the original signed research consent (and the data which will follow), will be included in your health record."

"Confidentiality will be respected. No information that discloses your identity will be released or published without your specific consent to the disclosure. However, it is important to note that the original signed research consent (and the data which will follow), will be included in your health record. As well, research records identifying you may be inspected by representatives of (at this point name the sponsoring company, the Health Protection Branch, and the U.S. Food and Drug Administration, etc.) for the purpose of monitoring the research."

But

"If we find information we are required by law to disclose (e.g., child abuse, inability to hold a valid driver's licence, etc.), we cannot guarantee confidentiality."

Participation

"Participation in research must be voluntary. If you choose not to participate, you and your family will continue to have access to quality care. If you choose to participate and later decide to change your mind, you can say no and stop the research at any time. Again, you and your family will continue to have access to quality care."

Table of Contents

This form can be used along with the Research Consent Form but not without it.

The following format should be used:

• Title of the Research
• Researcher
• Why are we doing this research?
• What will happen during the research?
• Are there good things and bad things about the research?
• Who will know about what I did in the research?
• Can I decide if I want to be in the research?

The substance of the content listed under these headings should be the same as for the analogous headings outlined for the Annotated Research Consent Form. The information form is meant to be understood by a child seven years of age. Wording should be kept very simple. Sentences should use the active voice at all times. Restrictive clauses should be avoided.

Table of Contents

This checklist is designed to assist researchers in drafting, and REB members in reviewing, research consent forms. The checklist enumerates elements that should be included in the research consent form. Carefully review the draft consent form and check each element that is present.

The consent form clearly identifies:

	the researcher(s), and if the researcher(s) is/are a student(s), the supervisor(s) (the person who is available to answer pertinent questions should be clearly identified);
	the sponsor(s) of the research.

The consent form clearly explains:

	that the proposed intervention is for research (drug, device, procedure, etc., used for research purposes);
	the purpose of the proposed research (why the research is being done);
	the nature of the proposed research (what the research involves; this should include details re: the use of a placebo: the nature of the randomization; the need to discontinue standard therapy);
	the likely duration of participation (how long the research and each intervention will take):
	the potential harms and inconveniences associated with the research (the nature of the harms and inconveniences and the likelihood of their occurrence);