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Revised Draft 2nd Edition of the TCPS (December 2009)

Chapter 3

CONSENT

This chapter sets out the ethical requirements for consent in research involving humans. Throughout this Policy, the term “consent” means “free, informed and ongoing consent.” In general, participation should be based on consent that is voluntary, informed, and ongoing throughout the duration of the research. For the purpose of this Policy, “free” and “voluntary” are used interchangeably.

Respect for persons implies that individuals who participate in research should do so voluntarily, understanding the purpose of the research and its risks and potential benefits as fully as reasonably possible. Where a person has the capacity to understand this information, and the ability to act on it voluntarily, the decision to participate is generally seen as an expression of autonomy.

Equally, respect for persons implies that those who lack the capacity to decide for themselves should nevertheless have the opportunity to participate in research that may benefit themselves or others, through the intervention of authorized third parties who decide whether participation would be appropriate. For the purposes of this Policy, the term “authorized third party,” (also known as “authorized third party decision makers”) refers to any person with the necessary legal authority to make decisions on behalf of an individual who lacks the capacity to consent to participate or to continue to participate in a particular research project. These decisions involve considerations of welfare and justice.

Certain types of research require alternate processes for consent. These are also described in this chapter. Where elements of the consent process may need to be adapted to the requirements of a particular research project, the research ethics board (REB) can play an educational and consultative role in determining the appropriate process for seeking and maintaining consent.

The principal researcher is responsible for ensuring that the consent process is respected. This includes responsibility for the actions of the research team who are involved in the consent process.

In addition to this Policy, researchers are responsible for ensuring that all applicable legal and regulatory requirements with respect to consent are met. In some circumstances, researchers may have further legal obligations that may be determined in part by the nature of the research and the jurisdiction in which the research is being conducted.1

A.    General Principles

Consent Shall Be Given Voluntary

Article 3.1

(a) Consent shall be given voluntarily.

(b) Consent may be withdrawn at any time.

(c) If a participant withdraws consent, he or she can also request the withdrawal of his or her data or biological materials.

Application (a) The voluntariness of consent is important because it means that an individual has chosen to participate in research according to his or her own values, preferences and wishes.

The approach to recruitment is an important element in assuring voluntariness. In particular, how, when and where participants are approached and who recruits them are important elements in assuring (or undermining) voluntariness. In considering the voluntariness of consent, REBs and researchers should be cognizant of situations where undue influence, coercion, or the offer of incentives may undermine a participant’s voluntariness to consent to participate in research.

Undue Influence

Undue influence and manipulation may arise when potential participants are recruited by individuals in a position of authority. The influence of power relationships on the voluntariness of consent should be judged from the perspective of prospective participants, since the individuals being recruited may feel constrained to follow the wishes of those who have some form of control over them (e.g. employer and employees, teachers and students, commanding officers and members of the military or correctional officers and prisoners). This control may be physical, psychological, financial, or professional, for example, and may involve offering some form of inducement or threatening some form of deprivation. In such situations, the control may place undue pressure on the prospective participants. At the extreme, there can be no voluntariness if consent is secured by the order of authorities.

REBs should also pay particular attention to elements of trust and dependency in relationship (e.g. between physician and patient or between professor and student). These relationships can impose undue influence on the individual in the position of dependence to participate in research projects. Any relationship of dependency, even a nurturing one, may give rise to undue influence, even if it is not applied overtly. There may be a greater risk of undue influence in situations of ongoing or significant dependency.

Pre-existing entitlements to care, education and other services should not be prejudiced by the decision of whether or not to participate in or to withdraw from a research project. Accordingly, for example, a physician should ensure that continued clinical care is not linked to research participation.

Coercion

Coercion is a more extreme form of undue influence, involving a threat of harm or punishment for failure to participate. Coercion would negate the voluntariness of a decision to participate or to remain in a research study.

Incentives

Incentives are anything offered to participants, monetary or otherwise, for participation in research (incentives differ from reimbursements and compensation for injury, which are discussed in Article 3.2[j] below). Because incentives are used to encourage participation in a research project, they are an important consideration in assessing voluntariness. Where incentives are offered to participants, they should not be so large or attractive as to constitute an inducement to take risks that one would otherwise not take. This is a particular consideration in the case of healthy volunteers for the early phases of clinical trials, as discussed in Article 11.6. The offer of incentives in some contexts may be perceived by potential participants as a way to gain favour or improve their situation. This may amount to undue inducement and thus negate the voluntary aspect of the consent of participants.

This policy neither recommends nor discourages the use of incentives. The onus is on the researcher to justify to the REB the use of a particular model and the level of incentives. In considering the possibility of undue influence in research involving financial or other incentives, researchers and REBs should be sensitive to issues such as the economic circumstances of those in the pool of prospective participants, the age and capacity of participants, the customs and practices of the community and the magnitude and probability of harms. (See Chapter 4, Section D). Guardians and authorized third parties should not receive incentives.

(b) To maintain the element of voluntariness, the participant shall be free to withdraw their consent to participate from the research at any time and need not offer any reason for doing so. In some cases, however, the physical practicalities of the study may prevent the actual withdrawal of the participant partway through for example, if the study involves only a single intervention or the termination of the research procedure may compromise the safety of the participant.

The participant should not suffer any disadvantage or reprisal for withdrawing nor should any payment due prior to the point of withdrawal be withheld. If the study used a lump-sum incentive for participation, the participant is entitled to the entire amount. If a payment schedule is used, the participant should be paid in proportion to his or her participation.

(c) Once they have withdrawn their consent to participate, participants may request the withdrawal of their data or biological materials2. In some research studies, the withdrawal of data or biological materials may not be feasible – for example, when personal information is de-identified and added to a data pool. As part of the consent process, participants should be informed when they are entering a study that it may not be feasible to withdraw data or biological materials.

Consent Shall Be Informed

Article 3.2 Researchers shall provide to prospective participants or authorized third parties full disclosure of all information necessary for making an informed decision to participate in a research project.

Application At the commencement of any process of consent, researchers or their qualified designated representatives shall provide prospective participants with the information set out in the following list, as appropriate to the particular research project. Not all the listed elements are required for all research. However, additional information may be required in particular types of research or under particular circumstances.

It is up to the researcher to explain to the REB why, in a particular project, some of the listed disclosure requirements do not apply. It is also up to the REB to consider whether all elements listed or additional elements are necessary in a given research project.

The information generally required for informed consent includes:

(a) information that the individual is being invited to participate in a research project;

(b) a statement of the research purpose in plain language – the identity of the researcher, the identity of the funder or sponsor, the expected duration and nature of participation, a description of research procedures, and an explanation of the responsibilities of the participant;

(c) a plain language description of reasonably foreseeable risks and potential benefits, both to the participants and in general, that may arise from research participation;

(d) an assurance that prospective participants:

  • are under no obligation to participate; are free to withdraw at any time without prejudice to pre-existing entitlements;
  • will be given, throughout the course of the research, in a timely manner, information that is relevant to their decision to continue or withdraw from participation; and
  • will be given information on the participant’s right to request the withdrawal of data or biological materials including any limitations on the feasibility of that withdrawal;

(e) information concerning the possibility of commercialization of research findings, and the presence of any real or potential conflict of interests on the part of researchers, their institutions or sponsors;

(f) the measures to be undertaken for dissemination of research results and whether participants will be identified directly or indirectly;

(g) the identity of the qualified designated representative with contact information who can explain scientific or scholarly aspects of the research;

(h) information identifying the appropriate individual(s) with contact information outside the research team to contact regarding possible ethical issues in the research;

(i) an indication of who will have access to information collected on the identity of participants, descriptions of how confidentiality will be protected, and anticipated uses of data; and information on who may have a duty to disclose information collected and to whom;

(j) information on any payments, including incentives for participants, reimbursement for participation-related expenses and compensation for injury;

(k) a statement to the effect that, by consenting, participants have not waived any rights to legal recourse in the event of research-related harm; and

(l) in clinical trials, information on stopping rules and when researchers may withdraw participants.

For consent to be informed, prospective participants should have adequate time and opportunity to assimilate the information provided, pose any questions they may have and discuss and consider whether they will participate. The time required for this initial phase of the consent process will depend on such factors as the magnitude and probability of harms, the complexity of the information conveyed and the setting where the information is given.

The key to informed consent is that potential participants understand the information being conveyed to them by researchers. Researchers and REBs should consider how best to convey that information to facilitate understanding. For example, written documentation may be supplemented with visual aids or accompanied by video presentations.

When language barriers necessitate the use of an intermediary for communication between the research team and participants the researcher should use an intermediary who has the necessary language skills to ensure effective communication. (See Article 4.1).

Paragraphs (a) to (c) require researchers to clearly explain the nature and goals of the research and other essential information, in a manner that best promotes understanding on the part of potential participants.

Paragraph (b) requires disclosure of those who support a particular research project, through funding or sponsorship. It is unethical for researchers to engage in covert activities for intelligence, police or military purposes under the guise of research. Conducting clandestine research or deliberately misrepresenting one’s research goals and impact to research participants is a clear violation of this policy. There are circumstances where deception may be a legitimate part of the research. (See Article 3.7 and its application, Research Involving Partial Disclosure or Deception).

Paragraph (c) requires researchers to consider all reasonably foreseeable risks that may result from participation. For example, when research is conducted on an organization or a community, researchers should inform potential participants within that organization or community the extent to which the organization or community is collaborating with the research and any risk this may pose to the participant.

Paragraph (d) helps to ensure the effectiveness of Article 3.1 – that a prospective participant’s choice to participate is voluntary. Paragraph (d) also supports the requirement that the consent process continue throughout the research.

Paragraph (e) aims at managing real or potential conflicts of interests. Researchers should separate, to the extent possible, their role as researcher from their roles as therapists, caregivers, teachers, advisors, consultants, supervisors, employers or the like. If a researcher is acting in dual roles, this fact must always be disclosed to the participant. Conflict of interests matters are further elaborated in Chapter 7.

Paragraph (f) requires that researchers provide a reasonable explanation of the measures to be undertaken to publish and otherwise disseminate the results of the research, to the extent that it is feasible and in a manner that is appropriate. Beyond the ethical obligation to do so in such areas as clinical trials, this requirement is grounded on the reasonable expectation of participants in research that the results will be published or otherwise disseminated in the public domain to advance societal knowledge (addressed further inArticles 11.12 and 11.13).

Paragraph (h) acknowledges that some institutions may decide either to name an ombudsman for research participants, or designate a resource person to handle queries, receive complaints, and transmit those complaints to the REB. This is a matter for institutions to determine.

Paragraph (i) touches on issues of privacy and confidentiality, and secondary use of data, which are addressed in Chapter 5.

Paragraph (j) ensures that participants are informed of the payments they will receive, if any, for their participation. Reimbursement for participation-related expenses is intended to ensure that participants are not put at a direct or indirect financial disadvantage for the time and inconvenience of participation in research. Direct expenses are costs incurred because of research participation (e.g. paying for transportation to or parking at the research site) while indirect expense refers to losses that arise from participation (e.g. taking unpaid leave from work). Participants should also be informed about any compensation they may be entitled to for research-related injuries.

Paragraph (l) is intended to inform the prospective participant in clinical trials of circumstances under which the researcher may end the participant’s involvement in a research project. Clinical trials have stopping rules – statistical points determined in advance, which, once reached, dictate that the trial must be terminated. As well, researchers may withdraw participants when the participants are not following the procedures of the clinical trial. These are discussed further in Chapter 11.

Consent Shall be an Ongoing Process

Article 3.3 Consent shall be maintained throughout participation in the research.

Application Consent encompasses a process that begins with the initial contact and carries through to the end of – and sometimes beyond – the involvement of research participants in the project. Throughout the process, researchers have a continuing duty to provide participants and REBs information relevant to the participant’s consent to participate in the research. The researcher has an ongoing ethical and legal obligation to bring to the participant’s attention changes that have ethical implications or that may be germane to their continued participation in the research or to the particular circumstances of the participant. In particular, researchers should disclose changes to risks or potential benefits of the research. This gives the participant the opportunity to reconsider the basis for his or her consent in light of the new information.

Incidental Findings

Article 3.4 Researchers have an obligation to disclose to the participant any material incidental findings discovered in the course of research.

Application “Incidental findings” is a term that describes unanticipated discoveries made in the course of research but that are outside the scope of the research. Material incidental findings are findings that have been interpreted as having significant welfare implications for the participant, whether health-related, psychological or social. If, in the course of research, material incidental findings are discovered, researchers have an obligation to inform the participant.

In some areas of research, such as medical and genetic research, there is a greater likelihood of material incidental findings. For research where material incidental findings are likely, researchers should develop a plan indicating how they will disclose such findings to participants and submit this plan to the REB. If there is uncertainty as to whether a research project warrants a plan, the researcher and REB can make such a determination on a case-by-case basis.

If researchers are unsure of how to interpret findings, or uncertain whether findings are material, they should consult with colleagues or refer to standards in the discipline. If researchers are unsure of the most appropriate method for disclosing material incidental findings to participants, they should consult with their REB or with colleagues. In some cases, incidental findings may trigger legal reporting obligations – researchers should be aware of these obligations. (See Article 5.1).

Consent Should Precede Collection of or Access to Research Data

Article 3.5 In general, research should begin only after the participants or their authorized third parties have provided their consent.

Application  In keeping with the principle of respect for persons, participants should provide their consent prior to engaging in research. This is the clearest demonstration that their participation is based on consideration of the risks and potential benefits of the research and other principles in this Policy. There are exceptions to this general ethical requirement, however, set out below in Articles 3.7 and 3.8.

This article does not apply to conversations that researchers may have with potential participants as part of the development of the design of their research. These preliminary conversations – including, for example, negotiations concerning the terms on which a researcher may engage with a particular community or group – do not in themselves constitute research and therefore do not require consent. (See Chapter 2, Article 6.11, Articles 9.3 to 9.6, and 10.1).

Critical Inquiry

Article 3.6 Permission is not required from an organization in order to conduct research on that organization.

Application Research in the form of critical inquiry, that is, the analysis of social structures or activities, public policies or other social phenomena, requires an adjustment in the assessment of consent. Where the goal of the research is to adopt a critical perspective with respect to an institution, organization or other entity, the fact that the object of the research may not endorse the research should not be a bar to the research receiving ethics approval. Where social sciences or humanities researchers seek knowledge that critiques or challenges the policies and practices of institutions, governments, interest groups or corporations may require that researchers not seek the organization’s permission to proceed with the proposed research. If institutional approval were required, it is unlikely that research could be conducted effectively on such matters as institutional sexual abuse or a government’s silencing of dissident scientists. Important knowledge and insights from research would be forgone. Specific requirements pertain to Aboriginal organizations, the details of which are discussed in detail in Articles 9.4 - 9.8.

REBs should not prohibit research simply because the research is unpopular or looked upon with disfavour by a community or organization, in Canada or abroad. Similarly, REBs should not veto research on the grounds that the government in place or its agents have not given approval for the research project or have expressed a dislike of the researchers.

However, individuals who are approached to participate in a research project about their organization should be fully informed about the views of the organization regarding the research, if these are known, and of the possible consequences of participation. Researchers engaging in critical inquiry need to be attentive to risks, both of stigmatization or breach of privacy, to those who participate in research about their organization. In particular, potential participants should be fully informed of the possible consequences of participation.

REBs should, however, legitimately concern themselves with the welfare of research participants and the security of research materials in such circumstances. When copies of field material are provided to participants in situations in which participants are vulnerable to risks from third parties on account of their participation, or in countries with authoritarian regimes, researchers should concern themselves with commitments concerning anonymity and confidentiality of participants to ensure that the human rights of participants and the ethical principles set out in this Policy are not compromised. In general, regardless of where the researchers conduct their research, researchers and REBs should concern themselves with safeguarding information while in transit. (See Articles 5.1 through 5.4).

B.    Departures from General Principles of Consent

Alteration and Waiver of Consent in Minimal Risk Research

Article 3.7 The REB may approve a consent procedure that does not include or that alters some or all of the elements of consent or may waive the requirement to seek informed consent, provided that the REB finds and documents that all of the following apply:

(a) the research involves no more than minimal risk to the participants;

(b) the alteration or waiver is unlikely to adversely affect the welfare of the participants;

(c) it is impossible to carry out the research and to answer the research question properly, given the research design, without the alteration or waiver;

(d) whenever possible and appropriate, the participants will be debriefed and provided with additional pertinent information after participation or at a later time during the study; and

(e) the altered or waived consent does not involve a therapeutic intervention, or other clinical or diagnostic interventions.

Application In the circumstances described under Article 3.7, the nature of the research may justify a limited or temporary departure from the general requirement for consent prior to participation in research. It is the responsibility of researchers to justify the need for such a departure. It is the responsibility of REBs, however, to understand that certain research methodologies necessitate a different approach to consent and to exercise judgment on whether the need for the research justifies a limited or temporary exception to the general requirements in a particular case.

It should be noted that in cases of randomization and blinding in clinical trials, neither the research participants nor the researchers know which treatment arm the participant will be receiving before the research commences. This is not regarded as a waiver or alteration of the requirements for consent, however, so long as the research participants or their authorized third parties are informed of the probability of being randomly assigned to one arm of the study or another.

Research Involving Partial Disclosure or Deception

Some social science research, particularly in psychology, seeks to learn about human responses to situations that have been created experimentally. Some types of research can be carried out only if the participants do not know in advance the true purpose of the research. For example, some social science research that critically probes the inner workings of publicly accountable institutions might never be conducted without limited recourse to partial disclosure. In some research, therefore, participants may not know that they are part of a research project until it is over, or they may be told in advance about the task that they will be asked to perform, yet given additional information that provides them with a different perspective on some aspect of the task or research and/or its purpose. For such techniques to fall within the exception to the general requirement of full disclosure for consent, the research must meet the requirements of Article 3.7.

Where partial disclosure or deception has been used, debriefing is an important mechanism in maintaining the participant’s trust in the research community. The debriefing referred to in Article 3.7(d) should be proportionate to the sensitivity of the issue. Often, debriefing can be quite simple and straightforward. In sensitive cases, researchers should provide, in addition to candid disclosure, a full explanation of why participants were temporarily led to believe that the research, or some aspect of it, had a different purpose, or why participants received less than full disclosure. The researchers should give details about the importance of the research, the necessity of having to resort to partial disclosure or deception, and their concern about the welfare of the participants. They should seek to remove any misconceptions that may have arisen and to re-establish any trust that might have been lost, by explaining why these research procedures were necessary to obtain scientifically valid findings.

Immediate, full debriefing of all individuals who have contributed data may not be feasible in all cases. In studies with data collection over a longer term, debriefing may have to be deferred until the end of the project. In some cases – for example, in research involving children – it may be more appropriate to debrief the parents, guardians or authorized third parties rather than the participants themselves. In other cases, it may be more appropriate to debrief the entire family or community. It may sometimes be appropriate to modify the debriefing to be sensitive to the participant’s needs and feelings.

In studies in which a waiver of prior consent has been allowed, it may still be possible for participants to express their consent or refusal at the conclusion of the study, following debriefing. In cases where a participant expresses concerns about participation in a study, the researcher may give the participant the option of removing his or her data from the project. Researchers should be required, as part of their research proposal, to set out the conditions under which they would not be able to remove a participant’s data from the study even if the participant requested such a withdrawal, and justify why these conditions are essential for conducting the research. Where under the terms of the research proposal the participants are not permitted to withdraw their data, the identity of the participant shall be protected. Participants who express concern about the conduct of the study at the time of debriefing or who contest the limits imposed on withdrawing their data should be given contact information for the REB that approved the research.

Consent in Individual Medical Emergencies

This section addresses the exception to consent in situations where an individual who requires urgent medical care is unable to provide consent due to loss of consciousness or capacity, and the delay to seek authorized third party consent could seriously compromise that individual’s health. Certain types of medical emergency practices can be evaluated only when they occur, hence the need for this exception.

This section is to be distinguished, however, from situations where there is a publicly declared emergency (such as the SARS crisis or a major flood) that disrupts the ordinary system for obtaining REB approval for research. For guidance on research ethics review during a publicly declared emergency see Articles 6.21 and 6.22.

Article 3.8 Subject to all applicable legal and regulatory requirements, research involving medical emergencies shall be conducted only if it addresses the emergency needs of individuals involved, and then only in accordance with criteria established in advance of such research by the REB. The REB may allow research that involves medical emergencies to be carried out without the consent of the participant or of his or her authorized third party if all of the following apply:

(a)     a serious threat to the prospective participant requires immediate intervention;

(b)     either no standard efficacious care exists or the research offers a real possibility of direct benefit to the participant in comparison with standard care;

(c)     either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the direct benefits to the participant;

(d)     the prospective participant is unconscious or lacks capacity to understand the risks, methods and purposes of the research;

(e)     third-party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so; and

(f)     no relevant prior directive by the participant is known to exist.

When a previously incapacitated participant regains capacity, or when an authorized third party is found, consent shall be sought promptly for continuation in the project and for subsequent examinations or tests related to the study.

Application  For purposes of studying potential improvement in the treatment of life-threatening conditions, Article 3.8 outlines an exception, in addition to that in Article 3.7, to the general obligation of seeking consent from those participating in research.

It is the responsibility of researchers to justify to the REB the need for recourse to this exception. The underlying assumption of Article 3.8 is that the participant could not receive the direct benefits of the research without foregoing the consent of the participant or of his or her authorized third party. Article 3.8 indicates that research in emergency medicine must be reviewed by the REB, be restricted to the emergency needs of the participants, and be conducted under criteria designated by the REB.

It is unethical to expose participants to any additional risk without their consent if standard efficacious care exists, unless it can clearly be shown that there is a realistic possibility of significantly improving the participant’s condition. Accordingly, paragraphs (b) and (c) of Article 3.8 indicate that researchers and REBs must satisfy the requirements of clinical equipoise and assess the risks and potential benefits of proposed research against existing standard efficacious care.

To respect the autonomy of the research participant, Article 3.8(e) requires researchers to undertake diligent efforts to contact authorized third parties, if reasonably feasible, and to document such efforts for the benefit of both the participant and for the continuing review functions of the REB. The article also requires that research participants who regain capacity be promptly afforded the opportunity to consent concerning continued participation. Concern for the patient’s welfare is paramount and should be informed by ethical and professional judgment.

Because their incapacity to exercise consent makes them vulnerable, prospective participants for emergency research are owed special ethical obligations and protection commensurate with the risks involved. Their welfare should be protected by additional safeguards, where feasible and appropriate. These might include: additional scientific, medical or REB consultation; procedures to identify potential participants in advance to seek consent prior to the occurrence of the emergency situation; consultation with former and potential participants; and special monitoring procedures to be followed by data safety and monitoring boards.

C. Capacity

Capacity refers to the ability of prospective or actual participants to understand relevant information presented and to appreciate the potential consequences of any given decision. This ability may vary according to the complexity of the choice being made, the circumstances surrounding the decision, or the time in question. The determination of capacity to participate in research, then, is not a static determination but a process that may change over time, depending on the nature of the decision the potential participant needs to make and changes in the participant’s condition. Assessing capacity is a question of determining, at a particular point in time, whether a research participant (or potential participant) meets the bar for understanding the nature and consequences, risks and potential benefits, of a particular research project.

One may therefore have diminished capacity and still be able to decide whether to participate in certain types of research. Researchers should be aware of all applicable legal and regulatory requirements with respect to capacity. These vary among jurisdictions. Authorized third parties should also be aware of their legal responsibilities.

In keeping with the principle of justice, ethical considerations around research involving those who lack the capacity to consent on their own behalf must seek to balance the vulnerability that arises from their lack of capacity with the injustice that would arise from their exclusion from the potential benefits of research. (See Chapter 4).

As indicated in Chapter 1, respect for persons and concern for welfare entails high ethical obligations to vulnerable individuals. Such obligations often translate into special procedures to promote and protect their interests. The articles that follow detail the special procedures for research involving individuals who lack the capacity to consent to participate in particular research projects.

Article 3.9 For research involving individuals who lack the capacity, either permanently or temporarily, to decide for themselves whether to participate, the REB shall ensure that, as a minimum, the following conditions are met:

(a) the researcher should seek consent from the authorized third party and shall show how that consent will be sought from the authorized third party, as well as how the participants’ welfare will be protected;

(b) the authorized third party shall not be the researcher or any other member of the research team;

(c) the consent of an authorized third party will be required throughout the participation in research of a participant who lacks capacity to consent on his/her own behalf; and

(d) when authorization for participation was granted by an authorized third party, and the participant acquires or regains capacity during the course of the research, the researcher shall promptly seek the participant’s consent as a condition of continuing participation.

Application  The decision of authorized third parties should be based on their knowledge of the potential participants and on a consideration of the potential participants’ welfare. The third parties should not be in a position of conflict of interests when making their decision.

Article 3.9 outlines other safeguards to protect those who lack the capacity to consent to participation in research. The article details various considerations relevant to the use of third-party authorization. Beyond the legal and regulatory requirements for seeking consent from authorized third parties, family members and friends may provide information to the authorized third party about the interests and previous wishes of prospective participants.

Article 3.10 Where an authorized third party has consented on behalf of a person who lacks legal capacity, but that person has some ability to understand the significance of the research, the researcher shall ascertain the wishes of that person with respect to participation. The potential participant's dissent will preclude his or her participation.

Application  Many individuals who lack legal capacity to make decisions may still be able to express their wishes in a meaningful way, even if such expression may not fulfil the requirements for consent. Prospective participants may thus be capable of verbally or physically assenting to, or dissenting from, participation in research. Those who may be capable of assent or dissent include:

(a) those whose capacity is in the process of development, such as children whose capacity for judgment and self-direction is maturing;

(b) those who once were capable of making an autonomous decision regarding consent but whose capacity is diminishing or fluctuating; and

(c) those whose capacity remains only partially developed, such as those suffering from permanent cognitive impairment.

While their assent would not be sufficient to permit them to participate in the absence of consent by an authorized third party, their expression of dissent or signs suggesting dissent must be respected.

Research Directives For Individuals Who Lack Capacity

Although advance directives for treatment are recognized as a legitimate tool in health care, the use of directives in the context of research is not well developed and have no legal status. For the purposes of this Policy, research directives should be understood to express an individual’s preferences for participation in future research in the event that the individual loses capacity. Research directives are written instructions to be used by the authorized third party as information on a potential participant’s preferences when the third party is asked to provide substitute consent.

The efficacy of research directives is unknown and their legal status has not yet been recognized or tested. Research directives, nevertheless, are congruent with this Policy’s core principle of respect for persons. The use of research directives respects the right of individuals to express their preference regarding participation in research and respects privacy by allowing individuals to control information about themselves and materials from their bodies. Authorized third parties should consult with an individual’s research directive when making decisions about their involvement in research.

Article 3.11 Research directives allow individuals with capacity to express preferences about their future participation in research should they ever lose capacity. Researchers and authorized third parties should take these directives into account during the consent process, but only if the individual who provided the research directive lacks capacity at the time the research is initiated.

Application  Research directives are useful to individuals who are already participating in research as well as those who are not participating but may wish to participate in research at a later date. They give individuals a range of options regarding future participation in research. The use of research directives is particularly relevant for research involving participants with diminishing capacity, fluctuating capacity, or degenerative conditions and research that collects information or human biological materials.

The use of research directives does not alter the requirements for consent as articulated by the provisions of this Policy. In particular, in accordance with Article 3.9, researchers are required to seek the consent of authorized third parties before individuals who lack capacity can participate in research. If an individual regains capacity the researcher should promptly seek the consent of the individual as a condition of continuing participation.

Researchers, institutions and organizations may suggest the use of research directives in order to give participants an opportunity to express preferences about the use of information or material that has already been collected. Researchers who collect information or human biological materials for a specific research project may anticipate subsequent research uses. Some types of research initiatives (research platforms) involve long-term retention and use of information or human biological materials for research purposes (e.g. longitudinal studies that involve biobanking). These platforms typically cannot specify at the time of initial collection every study that could be carried out using the participants’ information or human biological materials. Research directives may be used in these contexts to give participants the opportunity to express their preference about future research should they lose capacity.

In long-term studies, research directives may be used to allow participants to make choices about other aspects of research participation. For example, participants could specify preferences about receiving findings or continuing use of information or samples if the participant loses capacity or upon death.

Individuals can also use research directives to express preferences concerning participation in future research. For example, individuals in an early stage of dementia may use a research directive to express their preferences for future participation in research that, due to diminishing capacity, they would not otherwise be able to consent to on their own. They also allow existing participants to express their preference to continue to participate in research should they lose capacity. Research directives should be as specific as possible and in the event of ambiguity or imprecision, should be interpreted narrowly.

D.    Consent Shall Be Documented

Article 3.12 Evidence of consent shall be contained either in a signed consent form or in documentation by the researcher of other means of consent.

Application  Written consent through a signed statement from the participant is a common means of demonstrating consent, and in some instances, is mandatory (e.g. Health Canada regulations under the Food and Drugs Act, the Quebec Civil Code). There are other means of providing consent that are equally ethically acceptable however. In some types of research, and for some groups or individuals, written consent may be perceived by some research participants as an attempt to legalize or formalize the consent process and thus may be interpreted as a violation of trust. In these cases, oral consent, a verbal agreement or a handshake may be required, rather than signing a consent form. In some cultures, the giving and receiving of gifts symbolizes the establishment of a relationship comparable to consent.

Where consent is not documented in a signed consent form, researchers use a range of consent procedures, including oral consent, field notes, and other strategies, for documenting the consent process. Consent may also be demonstrated solely by the actions of the participant – for example, through the return of a completed questionnaire. Where there are valid reasons for not recording consent in writing, the procedures used to seek consent must be documented. (See Article 10.2).

Whether or not a consent form is signed, it may be advisable to leave a written statement of the information conveyed in the consent process with the participant. For the participant, it is evidence of the fact that he or she has agreed to participate in a particular research project. It may serve as a reminder to the participant of the terms of the research. It may also facilitate the ability of the participant to consider and re-consider his or her involvement as the research proceeds. However, researchers should not leave any documentation with a participant if it may compromise their safety or confidentiality. Additionally, in some cases it may not be appropriate to leave a written statement, such as in cultural settings where such written documentation is contrary to prevailing norms.

Endnotes

[1] For example, see Article 21 of the Civil Code of Québec, which sets conditions for the conduct of research involving minors or adults who lack the capacity to consent.

[2] The term “human biological materials” may be considered, for the purposes of most of this Policy, to include materials related to human reproduction. The last Section of Chapter 12 discusses ethical issues specific to such materials.