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

Chapter 3

CONSENT

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Respect for human dignity 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. The decision to participate is therefore generally seen as an expression of autonomy - the result of an individual’s weighing the risks and potential benefits of a research study prior to agreeing to participate.

These are not, however, the only circumstances under which research takes place. Some potential participants, such as young children, lack the capacity to decide for themselves whether to participate. Consent in these cases requires the intervention of third parties to decide whether participation would be appropriate, based on considerations of well-being and welfare. These circumstances also involve considerations of equal moral status: it is important that those who lack capacity have the opportunity to participate in research that may benefit themselves or others.

The circumstances of the research itself may not allow for full disclosure of all relevant information prior to its commencement. This is the case, for example, with research in individual medical emergencies. It is also the case with certain research methodologies, where partial disclosure or an element of deception may be necessary in order for the research to be valid. In these cases, consent is still important, but it may have to be addressed, at least in part, following the research rather than preceding it.

These variations in the approach to consent raise a number of ethical issues. For example, what constitutes coercion or undue influence? When is partial or late disclosure ethically acceptable? What are the appropriate limits on the types of research in which individuals who lack the capacity to decide for themselves may participate?

In assessing consent, much emphasis has been placed on the signing of a consent form. Consent, however, may be evidenced in many equally legitimate ways. The primary focus of ethical concern should be on the quality of the consent, and not on how it is documented.

A. General Principles

Consent Must Be Voluntary

Article 3.1 Consent must be given voluntarily and, where feasible, may be withdrawn at any time.

Application The element of voluntariness is important, because it means that an individual has chosen to participate in research according to his or her own values, preferences and wishes. To maintain the element of voluntariness, the participant should be free to withdraw from the research at any time.

Researchers and research ethics boards (REBs) must be aware of the approach to recruitment as an important element in assuring voluntariness. In particular, who recruits participants, and how and when they are approached, are important elements in assuring (or undermining) voluntariness.

Undue influence and manipulation may arise when potential participants are approached by individuals in a position of authority over them. The influence of power relationships on voluntary choice should be judged according to the particular context of prospective participants. For example, the voluntariness of prisoners, members of organizations with authoritarian structures (such as the military, police, some religious groups, or street gangs), or of employees or students, may be restricted because their institutional context implies that the individuals being recruited may feel constrained to follow the wishes of those who have some form of control over them. This control may be physical, financial, or professional, for example. It 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. There can be no voluntariness if consent is secured by the order of authorities - the most explicit exercise of undue influence.

REBs should also pay particular attention to the elements of trust and dependency - for example, within doctor-patient or professor-student relationships - because these can impose undue influence on the individual in the position of dependence to participate in research projects. Undue influence is particularly likely in situations of ongoing or significant dependency.

Voluntariness is especially relevant in research involving restricted or dependent participants. Any relationship of dependency, even a nurturing one - as, for example, between an individual with a debilitating chronic condition and his or her caregiver - may give rise to undue influence, even if it is not applied overtly.

Beyond undue influence, potential participants may be subjected to coercion, which involves a threat of harm or punishment for failure to participate. This more extreme form of influence would, of course, negate the voluntariness of a decision to participate or to remain in a research study.

The offer of benefits in some contexts may amount to undue inducement and thus negate the voluntary aspect of the consent of participants, who may perceive such offers as a way to gain favour or improve their situation. The issue of reasonable versus excessive compensation for participation in research is an important consideration in assessing voluntariness. Compensation for participation is intended to ensure that participants are not put at a financial disadvantage for the time and inconvenience of participation in research. In some cultures, the giving and receiving of gifts symbolizes the establishment of a relationship comparable to consent. Compensation or gifts should not be so 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 11.1 of Chapter 11 (“Clinical Trials”).

In considering the possibility of undue inducement in research projects where participants will be compensated, REBs should be sensitive to issues such as the economic circumstances of those in the pool of prospective participants, and to the magnitude and probability of harms.

Participants should be able to change their mind, for any reason or even for no reason, and decide to withdraw from a research study. In some cases, however, the physical practicalities of the study may prevent withdrawal partway through - for example, if the study involves only a single intervention or personal information is de-identified and added to a data pool.

Consent Must Be Informed

Article 3.2 Subject to the exceptions in Articles 3.8 and 3.9, researchers shall provide, to prospective participants or authorized third parties, full and frank disclosure of all information relevant to free and informed consent.

Application Researchers should ensure that prospective participants are given adequate opportunities to pose any questions they may have, and to discuss and consider whether they will participate. For the purposes of this Policy, “authorized third party” refers to an individual with the necessary legal authority to make decisions on behalf of an individual who lacks the capacity to decide whether to participate in a particular research project.

At the commencement of the process of free and informed consent, researchers or their qualified designated representatives should provide prospective participants with the following, as appropriate to the particular research:

  1. Information that the individual is being invited to participate in a research project;
  2. A comprehensible statement of the research purpose, 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;
  3. A comprehensible description of reasonably foreseeable harms and benefits, both to the participants and in general, that may arise from research participation, as well as the likely consequences of non-action, particularly in research related to treatment, or where invasive methodologies are involved, or where there is a potential for physical or psychological harm;
  4. An assurance that prospective participants are under no obligation to participate; have the right to withdraw at any time without prejudice to pre-existing entitlements; and throughout the course of the research will be given, in a timely manner, information that is relevant to their decision to continue or withdraw from participation;
  5. Information concerning the possibility of commercialization of research findings, and the presence of any apparent or actual or potential conflict of interest on the part of researchers, their institutions or sponsors;
  6. The measures to be undertaken for dissemination of research results, and whether participants will be identified directly or indirectly;
  7. The identity of the qualified designated representative who can explain scientific or scholarly aspects of the research;
  8. Information on the appropriate resources outside the research team to contact regarding possible ethical issues in the research;
  9. 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;
  10. Information on the circumstances under which the researcher may terminate the participant’s participation in the research;
  11. Information on any costs, payments, reimbursement for expenses or compensation for injury; and
  12. A statement to the effect that, by consenting, participants have not waived any legal rights.

Once research results have been compiled, researchers should make them readily available to participants, to the extent that it is feasible and in a manner that is appropriate.

Where there is a research team, the principal researcher is ultimately responsible for the actions of those acting with delegated authority. This includes responsibility for ensuring that the consent process has been respected.

Article 3.2 states the requirement to provide prospective participants with the information they need to give free and informed consent to their involvement in the research project. While the list of required information in Article 3.2 is extensive, additional information may be required in particular types of research or under particular circumstances.

Rushing the process of free and informed consent, or treating it as a perfunctory routine, violates the principles of autonomy and welfare, inasmuch as it may not allow for the assimilation of information for the participant, nor allow adequate time for the participant to make a considered judgment. The time required for providing an initial free and informed consent will depend on such factors as the magnitude and probability of harms, the complexity of the information conveyed, the setting where the information is given, and the participant’s situation (for example, his or her level of apprehension or curiosity about the research, or the importance to the participant of the potential benefit).

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. REBs must disallow any such research.

Article 3.1 and paragraph (d) in the Application of Article 3.2 help to ensure that a prospective participant’s choice to participate is voluntary. Pre-existing entitlements to care, education and other services should not be prejudiced by the decision of whether to participate. Accordingly, for example, a physician should ensure that continued clinical care is not linked to research participation, and teachers should not recruit prospective participants from their classes, or students under their supervision, without REB approval. Nothing in this section should be interpreted as meaning that normal classroom assessments of course work or other comparable performance evaluation undertakings require REB approval.

Paragraph (d) also requires that researchers provide all the new information pertaining to the risks of the research and any new ethical implications as that information becomes available, in order to ensure that, throughout the research, participants have all the information that could affect their consent. It is equally important that prospective participants be made aware of their right to withdraw from a research study at any time.

Paragraph (e) aims at managing potential or actual conflicts of interest. 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 interest matters are further elaborated in Chapter 7 (“Conflict of Interest”).

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. Beyond the ethical obligation to do so in such areas as clinical trials (see Articles 11.11 and 11.12 in Chapter 11 [“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.

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 (j) is intended to inform the prospective participant of circumstances under which the researcher may end the participant’s involvement in a research project. While participants need no reason to justify withdrawing from a research project, researchers must establish the basis on which they terminate the research or end the participation of a particular individual. For example, clinical trials have stopping rules - statistical points determined in advance, which, once reached, dictate that the trial must be terminated. These are discussed further in Chapter 11 (“Clinical Trials”).

Paragraph (k) is intended to prevent the development of a payment structure for research participation that might place undue pressure on research participants, either to join or remain within a research project. It also ensures that participants receive information regarding inducements for those who recruit participants. It should not be taken to mean that participants should be paid for their participation in research.

The list of information to be disclosed to potential participants is extensive. Not all of it may be applicable to all forms of research. 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 are necessary in a given research project.

The Duty To Inform Is Ongoing

Article 3.3 Free and informed consent must 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 free and informed consent to participate in the research. The researcher has the obligation to bring to the participant’s attention changes in circumstances germane to the research or to the particular circumstances of the participant. The participant is, of course, free to withdraw consent at any time for any reason. The ongoing obligation to provide new information that may be relevant to the participant’s consent, however, provides the participant with the opportunity to reconsider the basis for his or her consent in light of the new information. As used in this Policy, the process of free and informed consent refers to the dialogue, information sharing, and general process through which prospective participants choose to participate in research.

Incidental Findings

Incidental findings is a term that describes unanticipated discoveries made in the course of research (or care). This policy is concerned only with incidental findings in the context of research. They are findings that may have important psychological, social, health-related or other implications for the participant, but they are not the focus of the research itself. For example, a sociologist doing research on early childhood education may receive information that a child is suffering abuse, or a health-care worker doing research on one disease may discover evidence that a participant suffers from an entirely different and perhaps more serious disease. In a research setting, this raises particular ethical issues, because the consent process did not anticipate (and perhaps could not have anticipated) that such information would surface. Incidental findings frequently arise in the course of genetic research. This is addressed more specifically in Chapter 13 (“Human Genetic Research”).

Article 3.4 In their research proposal, researchers must:

  1. Develop a plan for handling incidental findings that their research may reveal and submit their plan to the research ethics board; and
  2. Advise potential participants of the plan for handling incidental findings in order to obtain free and informed consent.

Application It is not always possible to anticipate with any specificity the nature of the incidental findings that may surface in the course of research. It is therefore not possible to inform prospective participants in anything but the most general terms of what the research may reveal, beyond the realm of the research question itself.

So, for example, social science researchers embarking on questions of a personal nature should inform prospective participants of the legal obligations they are under to reveal information concerning certain types of abuse. Clinical researchers should disclose the possibility that they may come across evidence of other diagnoses beyond the particular condition they are studying. To the extent that certain types of incidental findings are foreseeable, however, researchers should consider these possibilities when engaging in the consent process. The complexity of disclosing serious incidental findings may be mitigated to some extent by how well researchers have prepared participants for at least the possibility of discovering such information.

Incidental findings should be considered part of the obligation of ongoing disclosure to participants of information that may be germane to their continued participation in the research. The withholding or transmission of such information, particularly when it may have implications for the health or safety of the participant, may have legal consequences for the researcher. These are outside the scope of this Policy.

Consent Should Precede Research

Article 3.5 In general, research with human participants should begin only after the participants or their authorized third-party decision-makers have provided their free and informed consent.

Application In keeping with the principle of autonomy, participants should provide their free and informed consent prior to engaging in research. This is the clearest demonstration that their participation is based on consideration of the risks and benefits of the research and other principles in this Policy.

This article does not apply to conversations that researchers, particularly those in the social sciences and humanities, 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 [“Scope and Approach”], Articles 9.3 to 9.6 in Chapter 9 [“Research Involving Aboriginal Peoples”] and Article 10.6 in Chapter 10 [“Qualitative Research”]).

There are exceptions to this general ethical requirement, however, set out below in Articles 3.8 and 3.9.

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

Application Much, but not all, of the research undertaken concerning organizations such as corporations and governments across Canada is likely conducted with the explicit or implicit authorization, acquiescence or cooperation of the organization. Collaboration is often essential to the effective conduct of research - for example, to facilitate recruitment of participants, to enable organizations to fulfil their ethical duties, to coordinate logistical and operational aspects of research, and to respect applicable laws. When individual participants are involved, the ethical principle of respect for autonomy generally requires their voluntary and informed consent.

In other instances, when the goals of the research are to undertake the form of research known as critical inquiry (which analyzes social structures or activities, public policies or other social phenomena), community or organizational authorization may be overridden by the potential benefits for society to conduct research on organizations such as corporations or governments. The exception is tailored to the needs of different kinds of research undertaken by social science or humanities researchers whose methods may include seeking knowledge that critiques or challenges the policies and practices of institutions, governments, interest groups or corporations. 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.

Such an exception and its application requires due consideration to context, as outlined in Chapter 1 (“Ethics Framework”). Since this Policy does not define “organization,” REBs and researchers need to evaluate the goal, kind and methodology of any research involving particular organizations, groups or settings. Different considerations may apply to, for example, corporations or governments, in contrast to community centres, schools, hospitals, churches or Aboriginal organizations.

Article 3.7 When conducting research on an organization, researchers should inform potential participants who work within that organization of the extent to which the organization is or is not collaborating with the research. Risk to participants from the organization should be evaluated in relation to the participants’ position of power within the organization.

Application Individuals who are approached to participate in a research project about their organization must have the opportunity to give free and informed consent. In particular, they should be fully informed about the views of the organization’s authorities regarding the research, if these are known, and of the possible consequences of participation. In this context, researchers should pay special attention to confidentiality, to ensure that they do not jeopardize the participant’s employment or status in the organization.

Situations may arise in which an organization, such as a corporation, government, political party or criminal organization, that has been approached about a research project, wishes to prevent that research. 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.

B. Departures from General Principles of Consent

Article 3.8 The research ethics board (REB) may approve a research proposal and may waive the requirement to obtain informed consent, provided that the REB finds and documents that:

  1. The research involves no more than minimal risk to the participants;
  2. The waiver is unlikely to adversely affect the well-being and welfare of the participants;
  3. The research could not practicably be carried out without the waiver;
  4. Whenever possible and appropriate, the participants will be provided with additional pertinent information after participation; and
  5. The waived consent does not involve a therapeutic intervention.

Application In some circumstances, the nature of the research may justify a limited or temporary departure from the general requirement for free and fully informed 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. (See discussion of different approaches to consent in Article 10.1 in Chapter 10 [“Qualitative Research”]).

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 representatives 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. Such research can be carried out only if the participants do not know in advance the true purpose of the research. 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 experiment and/or its purpose. For example, in questionnaire research, questions that are central to the researcher’s hypothesis may be embedded within distracter questions, decreasing the likelihood that participants will adapt their responses to their perceptions of the true objective of the research. Similarly, social science research that critically probes the inner workings of publicly accountable institutions might require limited recourse to partial disclosure or deception in order to be effective. For such techniques to fall within the exception to the general requirement of full disclosure for free and informed consent, the research must meet the requirements of Article 3.8.

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 3.8(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 informed consent has been allowed, it may still be practicable for participants to exercise their consent at the conclusion of the study, following debriefing. In cases where a participant expresses concerns about a study, the researcher may give the participant the option of removing his or her data from the project. This approach should be used only when the elimination of the participant’s data will not compromise the validity of the research design.

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. Once the deception is revealed, participants should be given a contact on the REB if they have any concerns about the conduct of the research.

Consent in Individual Medical Emergencies

This section addresses the exception to free and informed consent in situations where an individual who requires urgent medical care is unable to provide consent, and the delay to obtain 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. The process for research ethics review during a publicly declared emergency is addressed in Articles 6.21 - 6.23 in Chapter 6 (“Governance of Research Ethics Review”).

Article 3.9 Subject to all applicable legislative 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 research ethics board (REB). The REB may allow research that involves medical emergencies to be carried out without the free and informed consent of the participant or of his or her authorized third party if all of the following apply:

  1. A serious threat to the prospective participant requires immediate intervention;
  2. Either no standard efficacious care exists or the research offers a real possibility of direct benefit to the participant in comparison with standard care;
  3. Either the risk of harm is not greater than that involved in standard efficacious care, or it is clearly justified by the direct benefits to the participant;
  4. The prospective participant is unconscious or lacks capacity to understand risks, methods and purposes of the research;
  5. Third-party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so; and
  6. 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, free and informed 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 3.9 outlines an exception, in addition to that in Article 3.8, to the general obligation of obtaining free and informed consent from those participating in research.

The exception is intended for a limited class of health research: that which takes place in emergency situations where obtaining free and informed consent from the participants is not possible due to loss of consciousness or capacity, and where free and informed consent from an authorized third party is not possible due to the urgent time constraints for effective intervention. Seeking consent in advance is often impossible due to the unforeseeable nature of the causes of the medical emergency. However, individuals and those in comparable future situations should not be denied potential benefits of research because of the inability to consent.

It is the responsibility of researchers to justify to the REB the need for recourse to this exception. The underlying assumption of Article 3.9 is that direct research benefits to the participant could not be secured without forgoing the free and informed consent of the participant or of his or her authorized third party. Article 3.9 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. Article 3.9 outlines the minimal conditions necessary for the REB to authorize research without free and informed consent in individual medical emergencies.

It is unethical to expose participants to any additional risk of harm without their free and informed 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 3.9 indicate that researchers and REBs must assess the potential risk of harms and benefits of proposed research against existing standard efficacious care.

To respect the autonomy of the research participant, Article 3.9(e) requires researchers to undertake diligent efforts to contact family members or authorized third parties, if reasonably feasible, and to document such efforts for the benefit of both the participant and for the monitoring or continuing review functions of the REB. The article also requires that research participants who regain capacity be promptly afforded the opportunity to give free and informed consent concerning continued participation. Concern for the patient’s well-being is paramount and should be informed by ethical and professional judgment.

Because their incapacity to exercise free and informed consent makes them vulnerable, prospective participants for emergency research are owed special ethical obligations and protection commensurate with the harms involved. Their interests, rights and 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 obtain free and informed 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 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 capacity to participate in research, then, may change over time, and depending on the nature of the decision the potential participant needs to make. Assessing capacity is a question of determining, at a particular point in time, whether a potential research 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.

Legislation with respect to capacity varies between jurisdictions. Researchers should be aware of all applicable legislative requirements.

In keeping with the principle of equal moral status, ethical considerations around research involving those who lack the capacity to give free and informed 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 benefits of research. (See Chapter 4 [“Inclusion in Research”], which addresses these issues in more detail.)

As indicated in Chapter 1 (“Ethics Framework”), respect for human dignity 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 participate in particular research projects.

Article 3.10 For research involving individuals who lack the capacity, either permanently or temporarily, to decide for themselves whether to participate, the research ethics board shall ensure that, as a minimum, the following conditions are met:

  1. The researcher should seek free and informed 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’ well-being and welfare will be protected;
  2. The authorized third party should not be the researcher or any other member of the research team;
  3. The ongoing consent of an authorized third party will be required throughout the participation in research of an individual who lacks capacity to consent on his or her own behalf; and
  4. When a participant who was entered into a research project through third-party authorization acquires or regains capacity during the course of the research, his or her informed consent shall be sought as a condition of continuing participation.

Application Article 3.10 provides a means of protecting the interests and dignity of participants who lack adequate capacity, either permanently or temporarily, by having authorized third parties make the decision about participation on their behalf. The decision of the 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 interest when making their decision.

Article 3.10 outlines other safeguards to protect the dignity, interests and integrity of those who lack the capacity to give their free and informed consent to participation in research. The article details various considerations relevant to the use of third-party authorization. Beyond the legal requirements for obtaining free and informed consent from authorized third parties, family members and friends may provide information about the interests and previous wishes of prospective participants.

Article 3.11 Where free and informed consent has been obtained from an authorized third party, and in those circumstances where a legally incompetent individual understands the nature and consequences of the research, the researcher shall seek to ascertain the wishes of the individual concerning participation. The potential participant's dissent will preclude his or her participation.

Application Many individuals who are legally incompetent may still be able to express their wishes in a meaningful way, even if such expression may not fulfil the requirements for free and informed 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 informed decision about informed consent, but whose capacity is now considerably, but not completely, diminished, such as individuals with early Alzheimer’s disease; 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 must be respected.

Consent should be documented

Article 3.12 Evidence of free and informed consent may be contained either in a signed consent form or in documentation by the researcher of other means of consent. Consent may also be demonstrated solely by the actions of the participant - for example, through the return of a completed questionnaire.

Application While it is not necessary for consent itself to be in writing, there should be some written evidence of the process adopted to obtain free and informed consent and that demonstrates that consent has been obtained. Such documentation serves a number of purposes. For the participant, it is evidence of the fact that he or she has agreed to participate in a particular research project. Whether or not a consent form is signed, a written statement of the information conveyed in the consent process, signed or not, should be left with the participant. 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.

For the researcher, it is evidence that he or she has satisfied the ethical obligation of obtaining the free and informed consent of the participant prior to involving that individual in a given research project. In cases where the consent is inferred from the professional responsibilities of the research participant, it is not necessary to provide a written confirmation of this to the research participant. 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.

For the research sponsor, for the REB and for the institution, such evidence demonstrates that the consent obligations have been fulfilled, at least at the outset.

Written consent through a signed statement from the participant is a common means of demonstrating consent. However, for some groups or individuals, a verbal agreement, perhaps with a handshake, is evidence of trust, and a request for a signature may imply distrust. In some types of research, oral consent may be preferable. In others, written consent is mandatory. Where oral consent is appropriate, the researcher may wish to make a contemporaneous journal entry of the event and circumstances. These and like elements may sometimes need to be refined in concert with the REB, which plays an essential educational and consultative role in the process of seeking free and informed consent.

The consent process must reflect trust between the research participants and the researcher. Often this is based on mutual understanding of the project’s intentions. In qualitative research, the nature of the methodology may lead the research participant to sense attempts to legalize or formalize the process as a violation of trust. Hence, written consent is not the norm in qualitative research. Rather, qualitative researchers use a range of consent procedures, including oral consent, field notes, and other strategies, for documenting the consent process. In qualitative research conducted with research participants in positions of authority, trust may be based upon that participant’s confidence in his or her ability to take care of himself or herself or to deter undesirable behaviour on the part of the researcher by denying access to social or professional networks, through the threat of litigation or by other means.

When in doubt about an issue involving free and informed consent, researchers should consult their REB.