Section 2. Free and Informed Consent (PDF, 50 KB)
A. Requirement for Free and Informed
C. Naturalistic Observation
D. Informing Potential Subjects
F. Research in Emergency Health Situations
Free and informed consent lies at the heart of ethical research involving
human subjects. It encompasses a process that begins with the initial contact
and carries through to the end of the involvement of research subjects in
the project. As used in this Policy, the process of free and informed consent
refers to the dialogue, information sharing and general process through
which prospective subjects choose to participate in research involving themselves.
- 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).
- 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.
- The REB may approve a consent procedure
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:
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration is unlikely to adversely affect the
rights and welfare of the subjects;
- The research could not practicably be carried out without the
waiver or alteration;
- Whenever possible and appropriate, the subjects will be provided
with additional pertinent information after participation; and
- The waived or altered consent does not involve a therapeutic
- 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.
Article 2.1(a) states the requirement in both ethics and law: to protect
and promote human dignity. Ethical research involving humans requires free
and informed consent. As elaborated more fully below, free and informed
consent is exercised by an authorized third party for those who lack legal
Article 2.1(b) states the preference for written evidence of free and informed
consent. The article acknowledges that written consent is not always appropriate.
For most people in our society, a signed statement is the normal evidence
of 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. Nonetheless, in most cases a written statement of the
information conveyed in the consent process, signed or not, should be left
with the subject. 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. When in doubt
about an issue involving free and informed consent, researchers should consult
The requirement for free and informed consent should not disqualify research
subjects who are not proficient in the language used by the researchers
from the opportunity to participate in potential research. Such individuals
may give consent, provided that one or more of the following are observed
to the extent deemed necessary by the REB, in the context of a proportionate
approach to the harms envisaged in the research and the consent processes
that are to be used:
- 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
- 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
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
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.
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.
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
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.
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:
Under the normal process of obtaining written consent, the prospective subject
should be given a copy of the consent form and any relevant written information.
The consent of the participants shall not be conditional upon, or include
any statement to the effect that, by consenting, subjects waive any legal
- Information that the individual is being invited to participate
in a research project;
- 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;
- 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;
- 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
- 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.
In light of (b) and (c), REBs may require researchers to provide prospective
subjects with additional information, such as that detailed in Table 1, below.
Article 2.4 indicates the requirement to give prospective subjects the information
they need to give free and informed consent on whether to be involved in
the research project. In a research team, the principal researcher is ultimately
responsible for the actions of those acting with delegated authority.
Research subjects, whether inside or outside Canada, may have cultural values
different from those of the researcher. Thus, as Articles 2.4(a-c) indicate,
researchers must clearly explain the nature and goals of the research and
other essential information, in a manner appropriate for the prospective
subjects' cultural settings. With some cross-cultural research projects,
it may not be possible to offer an adequate translation of the researcher's
understanding to prospective subjects. REBs should proceed cautiously in
such cases and require stringent protection for the interests of subjects,
such as appointing an individual to act in an independent advocacy role.
On the other hand, REBs should not assume an unnecessarily protective role
that suggests that those who do not share the culture of the researchers,
particularly those in foreign countries, are incapable of making rational
decisions in their own interest.
Articles 2.2 and 2.4(d) help to ensure that a prospective subject's choice
to participate is voluntary. Pre-existing entitlements to care, education
and other services shall not be prejudiced by the decision on whether to
participate. Accordingly, a physician should ensure that continued clinical
care is not linked to research participation, and teachers should not recruit
prospective subjects 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 require REB approval. Article
2.4(d) also requires that researchers specifically ascertain continuing
consent from subjects on the basis of new information.
- An assurance that new information will be provided to the subjects
in a timely manner whenever such information is relevant to a
subject's decision to continue or withdraw from participation;
- The identity of the qualified designated representative who
can explain scientific or scholarly aspects of the research;
- Information on the appropriate resources outside the research
team to contact regarding possible ethical issues in the research;
- An indication of who will have access to information collected
on the identity of subjects, descriptions of how confidentiality
will be protected, and anticipated uses of data;
- An explanation of the responsibilities of the subject;
- Information on the circumstances under which the researcher
may terminate the subject's participation in the research;
- Information on any costs, payments, reimbursement for expenses
or compensation for injury;
- In the case of randomized trials, the probability of assignment
to each option;
- For research on biomedical procedures, including health care
interventions: information about (a) foregoing alternative procedures
that might be advantageous to the subject, (b) which aspects of
the research involve the use of procedures that are not generally
recognized or accepted; and, (c) particularly in trials of therapeutic
interventions, the care provided if the potential subject decides
not to consent to participation in the study;
- The ways in which the research results will be published, and
how the subjects will be informed of the results of the research.
Article 2.4(e) reminds researchers of relevant ethical duties that govern
potential or actual conflicts of interest, as they relate to the free and
informed consent of subjects. To preserve and not abuse the trust on which
many professional relations reside, researchers should separate their role
as researcher from their roles as therapists, caregivers, teachers, advisors,
consultants, supervisors, students, employers and the like. If a researcher
is acting in dual roles, this fact must always be disclosed to the subject.
Researchers should disassociate their role as researcher from other roles,
in the recruitment process and throughout the project. Conflict of interest
matters are further elaborated below in Section 4.
Table 1 also indicates other information that researchers may be required
to provide in some areas of research for the purpose of obtaining free and
informed consent. Item 2 refers to the qualified designated representative
who is usually someone on the research team. When the research poses more
than minimal risk, it may be advisable to have a person who is independent
of the research team in this role. Item 3 acknowledges that some institutions
may decide either to name an ombudsman for research subjects, or designate,
with the agreement of the researcher, a resource person to handle queries,
receive complaints, and transmit them to the REB. Item 7 is intended to
prevent the development of a payment structure for research participation
that might place undue pressure on research subjects either to join or remain
within a research project. It does not imply that subjects should be paid
for their participation in research. In research projects where subjects
will be compensated, REBs should be sensitive to the possibility of undue
inducement for participation, such as payments that would lead subjects
to undertake actions that they would not ordinarily accept. REBs should
pay attention to issues such as the economic circumstances of those in the
pool of prospective subjects, and to the magnitude and probability of harms.
Item 10 in Table 1 indicates that subjects have the right to know whether
they will be identified directly or indirectly in publications resulting
from the research.
Rushing the process of free and informed consent, or treating it as a perfunctory
routine, violates the principle of respect for persons, and may cause difficulty
for potential subjects. The time required for the process of free and informed consent
can be expected to depend on such factors as the magnitude and probability
of harms, the setting where the information is given (e.g., hospital or
home) and the subject's situation (e.g., level of anxiety, maturity or seriousness
In some circumstances, witnessing the signatures on the consent form may
be felt to be appropriate. In law, the role of a witness is only to attest
that the person actually signed the form; a witness is not responsible for
certifying such factors as the signature being obtained under defined conditions
or that the signers were competent. However, a court might subsequently
seek the opinions of the witness on such issues.
Competence refers to the ability of prospective subjects to give informed
consent in accord with their own fundamental values. It involves the ability
to understand the information presented, to appreciate the potential consequences
of a decision, and to provide free and informed consent. This ability may
vary according to the choice being made, the circumstances surrounding the
decision, or the time in question. Competence to participate in research,
then, is not an all-or-nothing condition. It does not require prospective
subjects to have the capacity to make every kind of decision. It requires
that they be competent to make an informed decision about participation
in particular research. Competence is neither a global condition nor a static
one; it may be temporary or permanent.
The law on competence varies between jurisdictions. Researchers must comply
with all applicable legislative requirements.
Ethical considerations around research involving those who are not competent
to give a free and informed consent on their own behalf must seek to balance
(1) the vulnerability that arises from their incompetence with (2) the injustice
that would arise from their exclusion from the benefits of research.
As indicated in the Ethics Framework of this Policy, the principle of
respect for human dignity entails high ethical obligations to the vulnerable
populations. Such obligations often translate into special procedures to
promote and protect their interests and dignity. The articles that follow
detail the special procedures for research involving individuals with diminished
decision making capacity.
Subject to applicable legal requirements, individuals who are not legally
competent shall only be asked to become research subjects when:
Article 2.5(a) expresses the general requirement to restrict research involving
incompetent subjects to questions that cannot be addressed with competent
subjects. It also expresses the general moral preference for involving competent
rather than incompetent research subjects, and the need to avoid selecting
prospective subjects merely because of convenience. Article 2.5(b) provides
a means of protecting their interests and dignity through the free and informed
consent of authorized representatives (see also Articles 2.6 and 2.7), who
are acting in the interests of the potential subjects and are not influenced
by conflict of interest. Article 2.5(c) restricts the extent to which their
authorized representatives can consent on their behalf.
- The research question can only be addressed using individuals within
the identified group(s); and
- Free and informed consent will be sought from their authorized
- The research does not expose them to more than minimal risk without
the potential for direct benefits for them.
Sound ethical reasoning and the subject-centred perspective require attention
to context. In this instance, the notion of harm applied to children should
be understood differently from harm in adults. Harm induced in children
may have longer-term consequences to their growth and development. Furthermore,
harms and benefits for children with chronic disabilities and terminal illnesses
require special consideration. Every researcher working with child subjects
must consider the possibility of the children suffering pain, anxiety or injury,
and must develop and implement suitable precautions and ameliorating measures.
Cumulative physical, moral, psychological and social consequences (relevant
to pain, anxiety and injury) should be reviewed by REBs when assessing the
probability, magnitude and character of any harmful impact the research
may have on the child.
For research involving incompetent individuals, the REB shall ensure
that, as a minimum, the following conditions are met:
Article 2.6 outlines other safeguards to protect the dignity, interests
and integrity of those who lack competence 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 subjects. In some cases, the REB will have to determine
from whom the free and informed consent should be sought.
- 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.
- The authorized third party may not be the researcher or any other
member of the research team.
- 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.
- 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
Where free and informed consent has been obtained from an authorized
third party, and in those circumstances where the 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 subject's dissent will preclude his or her participation.
Many individuals who are not legally competent are still able to express
their wishes in a meaningful way, even if such expression may not fulfil
the requirements for free and informed consent. Prospective subjects 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 competence is in the process of development, such
as children whose capacity for judgement and self-direction is maturing;
(b) those who once were capable of making an informed decision about informed
consent, but whose competence is now considerably, but not completely, diminished,
such as individuals with early Alzheimer's disease; and (c) those whose
competence remains only partially developed, such as those suffering from
permanent cognitive impairment.
Subject to all applicable legislative and regulatory requirements, research
involving emergency health situations 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 health emergencies to be carried out without
the free and informed consent of the subject or of his or her authorized
third party if ALL of the following apply:
When a previously incapacitated subject 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.
- A serious threat to the prospective subject requires immediate
- 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
- 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
- The prospective subject is unconscious or lacks capacity to understand
risks, methods and purposes of the research; and
- Third-party authorization cannot be secured in sufficient time,
despite diligent and documented efforts to do so; and
- No relevant prior directive by the subject is known to exist.
For purposes of studying potential improvement in the treatment of life-threatening
conditions, Article 2.8 outlines an exception, in addition to that in Article
2.1(c), to the general obligation of obtaining the 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 subjects is not possible due to loss of consciousness or competence,
and 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.
Researchers must justify to the REB recourse to the provisions of this exception.
The underlying assumption of Article 2.8 is that direct research benefits
to the subject could not be secured without forgoing the free and informed
consent of the subject or of his or her authorized third party. Article
2.8 indicates that research in emergency medicine must be reviewed by the
REB, be restricted to the emergency needs of the subjects, and be conducted
under criteria designated by the REB. Article 2.8 outlines the minimal conditions
necessary for the REB to authorize research without free and informed
It is unethical to expose subjects 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 subject's condition. Accordingly, Articles 2.8 (b) and (c)
indicate that researchers and REBs must assess the potential risk of harms
and benefits of proposed research against existing standard efficacious
care. Together, Articles 2.8(b) and (c) require that the therapeutic aspects
of the trial satisfy the requirements of clinical equipoise. To respect
the autonomy of the research subject, Article 2.8(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 subject and for the monitoring or continuing review functions
of the REB. The article also requires that research subjects who become
competent 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 judgement.
Because their incapacity to exercise free and informed consent makes them
vulnerable, prospective subjects 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
which should include, where feasible and appropriate, one or more of the
- 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
- Careful review by the REB of the relative harms and benefits of participation.
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]