TCPS: Section 2. Free and Informed Consent (PDF, 50 KB)

1. Research governed by this Policy (see Article 1.1) may begin only if (1) prospective subjects, or authorized third parties, have been given the opportunity to give free and informed consent about participation, and (2) their free and informed consent has been given and is maintained throughout their participation in the research. Articles 2.1(c), 2.3 and 2.8 provide exceptions to Article 2.1(a).
   
   
2. Evidence of free and informed consent by the subject or authorized third party should ordinarily be obtained in writing. Where written consent is culturally unacceptable, or where there are good reasons for not recording consent in writing, the procedures used to seek free and informed consent shall be documented.
   
   
3. The REB may approve a consent procedure¹ that does not include, or that alters, some or all of the elements of informed consent set forth above, or 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 subjects;
      
      
   2. The waiver or alteration is unlikely to adversely affect the rights and welfare of the subjects;
      
      
   3. The research could not practicably be carried out without the waiver or alteration;
      
      
   4. Whenever possible and appropriate, the subjects will be provided with additional pertinent information after participation; and
      
      
   5. The waived or altered consent does not involve a therapeutic intervention.
      
      
4. In studies including randomization and blinding in clinical trials, neither the research subjects nor those responsible for their care know which treatment the subjects are receiving before the project commences. Such research is not regarded as a waiver or alteration of the requirements for consent if subjects are informed of the probability of being randomly assigned to one arm of the study or another.

• An intermediary not involved in the research study, who is competent in the language used by the researchers as well as that chosen by the research subject, is involved in the consent process.
  
  
• The intermediary has translated the consent document or approved an existing translation of the information relevant to the prospective subject.
  
  
• The intermediary has assisted the research subject in the discussion of the research study.
  
  
• The research subject has acknowledged, in his or her own language, that he or she understands the research study, the nature and extent of his or her participation, including the risks involved, and freely gives consent (see exception in Article 2.1(c)).

Consent is not required from organizations such as corporations or governments for research about their institutions. However, individuals who are approached to participate in a research project about their organization have the right to give free and informed consent. In particular, they should be fully informed about the views of the organization's authorities, if these are known, and of the possible consequences of participation. In this context, researchers should pay special attention to confidentiality. Private corporations and organizations have the right as institutions to refuse to cooperate with researchers or to deny them access to their private records if they so wish, and may have rules governing the conduct of their employees. However, such organizations need not be approached for consent, and REBs should not require such an approach. Nor should institutions be given the right to veto research projects.

Under Article 2.1(c), the REB should exercise judgement on whether the needs for research justify limited and/or temporary exception to the general requirements for full disclosure of information relevant for a research subject's meaningful exercise of free and informed consent. In such cases, subjects may be given only partial information or may be temporarily led to believe that the research has some other purpose because full disclosure would be likely to colour the responses of the subjects and thus invalidate the research. For example, social science research that critically probes the inner workings of publicly accountable institutions might never be conducted without limited recourse to partial disclosure. Also, some research in psychology seeks to learn about human responses to situations that have been created experimentally. Such research can only be carried out if the subjects do not know in advance the true purpose of the research. In some research, therefore, subjects may be told in advance about the task that they will be asked to perform, yet given additional information, perhaps as part of the consent process or as part of the manipulated experimental conditions, that provides subjects with a different perspective on some aspect of the task or experiment and/or its purpose. Another scenario, in questionnaire research, embeds questions that are central to the researcher's hypothesis within distracter questions, decreasing the likelihood that subjects will adapt their responses to their perceptions of the true objective of the research. 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 2.1(c).

The debriefing referred to in Article 2.1(c)(iv) 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 subjects were temporarily led to believe that the research or some aspect of it had a different purpose, or 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, and their concern about the welfare of the subject. They should seek to remove any misconceptions that may have arisen, and to reestablish any trust that might have been lost, assuring the research subject during debriefing that these research procedures were neither arbitrary nor capricious, but necessary for scientifically valid findings. Debriefing is an important mechanism in maintaining the subject's trust in the research community.

Immediate, full debriefing of all persons 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 subjects 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 subject's needs and feelings.

In studies in which a waiver of informed consent has been allowed, it may still be practicable for subjects to exercise their consent at the conclusion of the study, following debriefing. In cases where a subject expresses concerns about a study, the researcher may give the subject the option of removing his or her data from the project. This approach should be used only when the elimination of the subject's data will not compromise the validity of the research design, and hence diminish the ethical value of participation by other subjects.

When subjects express significant concern about being temporarily misled or about the use of partial disclosure in the research, the researcher should report those concerns to the REB.


B. Voluntariness

Article 2.2

Free and informed consent must be voluntarily given, without manipulation, undue influence or coercion.

The element of voluntariness has important implications. Consent must be freely given and may be withdrawn at any time. Undue influence may take the form of inducement, deprivation, or the exercise of control, or authority over prospective subjects.

Voluntariness is especially relevant in research involving restricted or dependent subjects. It is absent if consent is secured by the order of authorities or as a result of coercion or manipulation. The influence of power relationships on voluntary choice should be judged according to the particular context of prospective subjects. 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 undue pressure. Care should be exercised in developing relationships between researchers and authorities, so as not to compromise either the free and informed consent or the privacy and confidentiality of subjects.

Conversely, situations may arise in which an organization, such as a corporation, a government, a political party or a criminal organization that may have been approached about a research project, may wish to prevent the research; however, individuals over whom the organization has some authority may be willing to participate. Researchers and REBs should not prevent such research, but should ensure that potential subjects are fully informed of the views of the organization's authorities and the possible consequences of participation, and pay special attention to confidentiality.

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 constitute undue influence on the patient to participate in research projects, especially those involving residents in long-term care facilities or psychiatric institutions.

Researchers should avoid being put in a position of becoming informants for authorities or leaders of organizations. The offer of benefits in some contexts may amount to undue inducement, and thus negate the voluntary aspect of the consent of subjects who may perceive such offers as a way to gain favour or improve their situation.


C. Naturalistic Observation

Article 2.3

REB review is normally required for research involving naturalistic observation. However, research involving observation of participants in, for example, political rallies, demonstrations or public meetings should not require REB review since it can be expected that the participants are seeking public visibility.

Naturalistic observation is used to study behaviour in a natural environment. Because knowledge of the research can be expected to influence behaviour, naturalistic observation generally implies that the subjects do not know that they are being observed, and hence cannot have given their free and informed consent. Due to the need for respect for privacy, even in public places, naturalistic observation raises concerns of the privacy and dignity of those being observed. These concerns are accentuated if, for example, the research records permit identification of the subjects, or if the research environment is staged.

In considering research involving naturalistic observation, researchers and REBs should pay close attention to the ethical implications of such factors as: the nature of the activities to be observed; the environment in which the activities are to be observed (in particular, whether it is to be staged for the purposes of the research); and the means of recording the observations (in particular, if the records will allow subsequent identification of the subjects). Naturalistic observation that does not allow for the identification of the subjects, and that is not staged, should normally be regarded as of minimal risk.

Researchers and REBs should also be aware that, in some jurisdictions, publication of identifying information—for example a photograph taken in a public place but focused on a private individual who was not expecting this action—may be interpreted in a civil suit as an invasion of privacy.


D. Informing Potential Subjects

D1. General Conditions

Article 2.4

Researchers shall provide, to prospective subjects or authorized third parties, full and frank disclosure of all information relevant to free and informed consent. Throughout the process of free and informed consent, the researcher must ensure that prospective subjects are given adequate opportunities to discuss and contemplate their participation. Subject to the exception in Article 2.1(c), at the commencement of the process of free and informed consent, researchers or their qualified designated representatives shall provide prospective subjects with the following:

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 expected duration and nature of participation, and a description of research procedures;
   
   
3. A comprehensible description of reasonably foreseeable harms and benefits 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 subjects are free not to participate, have the right to withdraw at any time without prejudice to pre-existing entitlements, and will be given continuing and meaningful opportunities for deciding whether or not to continue to participate; and
   
   
5. 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.

1. The research question can only be addressed using individuals within the identified group(s); and
   
   
2. Free and informed consent will be sought from their authorized representative(s); and
   
   
3. The research does not expose them to more than minimal risk without the potential for direct benefits for them.

1. The researcher shall show how the free and informed consent will be sought from the authorized third party, and how the subjects' best interests will be protected.
   
   
2. The authorized third party may not be the researcher or any other member of the research team.
   
   
3. The continued free and informed consent of an appropriately authorized third party will be required to continue the participation of a legally incompetent subject in research, so long as the subject remains incompetent.
   
   
4. When a subject who was entered into a research project through third-party authorization becomes competent during the project, his or her informed consent shall be sought as a condition of continuing participation.

1. A serious threat to the prospective subject requires immediate intervention; and
   
   
2. Either no standard efficacious care exists or the research offers a real possibility of direct benefit to the subject in comparison with standard care; and
   
   
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 subject; and
   
   
4. The prospective subject is unconscious or lacks capacity to understand risks, methods and purposes of the research; and
   
   
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 subject is known to exist.

• Additional scientific, medical or REB consultation;
  
  
• Procedures to identify potential subjects in advance to obtain free and informed consent prior to the occurrence of the emergency situation;
  
  
• Consultation with former and potential subjects;
  
  
• Special monitoring procedures to be followed by safety and monitoring boards; and
  
  
• Careful review by the REB of the relative harms and benefits of participation.

Endnotes

¹ Article 2.1(c) was adapted from the U.S. Department of Health and Human Services, Protection of Human Subjects, Title 45: "Code of Federal Regulations", Part 46.116(d). [Back]