Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
TCPS: Appendix 1: Scope
of Research Requiring Ethics Review (PDF, 20 KB)
2: Articles Included in the Tri-Council Policy Statement: Ethical Conduct
for Research Involving Humans (TCPS) (PDF, 37 KB)
Appendix 1: Scope of Research
Appendix 2: Articles Included
in the Tri-Council Policy Statement: Ethical Conduct for Research Involving
Appendix 1 - Scope of Research Requiring Ethics Review
The following, which is adapted from the University of Alberta, General
Faculty Council Policy Manual, indicates the range of research projects
or instances that should be reviewed by the REB.
- Whether the research is funded or not;
- Whether the funding is internal or external;
- Whether the subjects are from inside or outside the institution;
- Whether the subjects are paid or unpaid;
- Whether the research is conducted inside or outside Canada;
- Whether the research is conducted inside or outside the institution;
- Whether the research is conducted by staff or by students;
- Whether the research is conducted in person or remotely (e.g., by
mail, e-mail, fax or telephone);
- Whether the information is collected directly from subjects or from
existing records not in the public domain;
- Whether the research is to be published or not;
- Whether the focus of the research is the subject;
- Whether the research is observational, experimental, correlational
- Whether a similar project has been approved elsewhere or not;
- Whether the research is a pilot study or a fully developed project;
- Whether the research is to acquire basic or applied knowledge; and
- Whether the research is primarily for teaching or training purposes
or whether the primary purpose is the acquisition of knowledge.
Appendix 2: Articles Included in the Tri-Council Policy Statement: Ethical
Conduct for Research Involving Humans
For easy reference, the following is a comprehensive
listing of all articles included in this document.
- All research that involves living human subjects requires review and
approval by an REB in accordance with this Policy Statement, before
the research is started, except as stipulated below.
- Research involving human remains, cadavers, tissues, biological fluids,
embryos or fetuses should also be reviewed by the REB.
- Research about a living individual involved in the public arena, or
about an artist, based exclusively on publicly available information,
documents, records, works, performances, archival materials or third-party
interviews, is not required to undergo ethics review. Such research
only requires ethics review if the subject is approached directly for
interviews or for access to private papers, and then only to ensure
that such approaches are conducted according to professional protocols
and to Article 2.3 of this Policy.
- Quality assurance studies, performance reviews or testing within normal
educational requirements should also not be subject to REB review.
The institution in which research involving human subjects is carried out
shall mandate the REB to approve, reject, propose modifications to, or terminate
any proposed or ongoing research involving human subjects that is conducted
within, or by members of, the institution, using the considerations set
forth in this Policy as the minimum standard.
The REB shall consist of at least five members, including both men and women,
- At least two members have broad expertise in the methods or in the
areas of research that are covered by the REB;
- At least one member is knowledgeable in ethics;
- For biomedical research, at least one member is knowledgeable in the
relevant law; this is advisable but not mandatory for other areas of
- At least one member has no affiliation with the institution, but is
recruited from the community served by the institution.
- REBs shall be established by the highest levels of the institution,
and cover as broad a range of research as is consistent with manageable
workloads. Departmental REBs normally are not acceptable (except as
discussed below for review of undergraduate research within course requirements).
A multiplicity of REBs with small workloads within the same institution
should be avoided.
- Large institutions may find it necessary to create more than one REB,
usually to cover different areas of research. The jurisdiction of each
REB should be clearly defined by the normal processes of governance
within the institution, and a mechanism should be established to coordinate
the practices of all REBs within the institution.
- Small institutions may wish to explore regional cooperation or alliances,
including the sharing of REBs.
- The REB shall satisfy itself that the design of a research project
that poses more than minimal risk is capable of addressing the questions
being asked in the research.
- The extent of the review for scholarly standards that is required
for biomedical research that does not involve more than minimal risk
will vary according to the research being carried out.
- Research in the humanities and the social sciences that poses, at
most, minimal risk shall not normally be required by the REB to be peer
- Certain types of research, particularly in the social sciences and
the humanities, may legitimately have a negative effect on public figures
in politics, business, labour, the arts or other walks of life, or on
organisations. Such research should not be blocked through the use of
harms-benefits analysis or because of the potentially negative nature
of the findings. The safeguard for those in the public arena is through
public debate and discourse and, in extremis, through action
in the courts for libel.
The REB should adopt a proportionate approach based on the general principle
that the more invasive the research, the greater should be the care in
assessing the research.
REBs shall meet regularly to discharge their responsibilities.
Minutes of all REB meetings shall be prepared and maintained by the REB.
The minutes shall clearly document the REB's decisions and any dissents,
and the reasons for them. In order to assist internal and external audits
or research monitoring, and to facilitate reconsideration or appeals,
the minutes must be accessible to authorized representatives of the institution,
researchers and funding agencies.
REBs shall meet face-to-face to review proposed research that is not delegated
to expedited review. REB review shall be based upon fully detailed research
proposals or, where applicable, progress reports. The REB shall function
impartially, provide a fair hearing to those involved and provide reasoned
and appropriately documented opinions and decisions. The REB shall accommodate
reasonable requests from researchers to participate in discussions about
their proposals, but those researchers may not be present when the REB is making its decision.
When an REB is considering a negative decision, it shall provide the researcher
with all the reasons for doing so and give the researcher an opportunity
to reply before making a final decision.
Researchers have the right to request, and REBs have an obligation to
provide, reconsideration of decisions affecting a research project.
- In cases when researchers and REBs can not reach agreement through
discussion and reconsideration, an institution should permit review of
an REB decision by an appeal board, provided that the board's membership
and procedures meet the requirements of this Policy. No ad hoc appeal boards are permitted.
- Small institutions may wish to explore regional cooperation or alliances,
including the sharing of appeal boards. If two institutions decide to
use each other's REB as an appeal board, a formal letter of agreement
- The Agencies will not entertain any appeals of REB decisions.
If an REB is reviewing research in which a member of the REB has a personal
interest in the research under review (e.g., as a researcher or as an
entrepreneur), conflict of interest principles require that the member
not be present when the REB is discussing or making its decision. The
REB member may disclose and explain the conflict of interest and offer
evidence to the REB, provided the conflict is fully explained to the REB,
and the proposer of the research has the right to hear the evidence and
to offer a rebuttal.
- Ongoing research shall be subject to continuing ethics review. The
rigour of the review should be in accordance with a proportionate approach
to ethics assessment.
- As part of each research proposal submitted for REB review, the researcher
shall propose to the REB the continuing review process deemed appropriate
for that project.
- Normally, continuing review shall consist of at least the submission
of a succinct annual status report to the REB. The REB shall be promptly
notified when the project concludes.
Research to be performed outside the jurisdiction or country of the institution
that employs the researcher shall undergo prospective ethics review both
(a) by the REB within the researcher's institution; and (b) by the appropriate
REB, where such exists, which has authority in the country or jurisdiction
where the research is to be done.
- 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 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:
- 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.
Free and informed consent must be voluntarily given, without manipulation,
undue influence or coercion.
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
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:
- 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 below:
that may be required for some projects
- 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, and 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.
Subject to applicable legal requirements, individuals who are not legally
competent shall only be asked to become research subjects when:
- the research question can only be addressed using the identified group(s);
- free and informed consent will be sought from their authorized representative(s);
- the research does not expose them to more than minimal risk without
the potential for direct benefits for them.
For research involving incompetent individuals, the REB shall ensure that,
as a minimum, the following conditions are met:
- 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 participation.
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.
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:
- A serious threat to the prospective subject requires immediate intervention;
- 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.
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.
Subject to the exceptions in Article 1.1(c), researchers who intend to interview
a human subject to secure identifiable personal information shall secure
REB approval for the interview procedure used and shall ensure the free
and informed consent of the interviewee as required in Article 2.4. As indicated
in Article 1.1c, REB approval is not required for access to publicly available
information or materials, including archival documents and records of public
interviews or performances.
Subject to Article 3.1 above, researchers shall secure REB approval for
obtaining identifiable personal information about subjects. Approval for
such research shall include such considerations as:
- The type of data to be collected;
- The purpose for which the data will be used;
- Limits on the use, disclosure, and retention of the data;
- Appropriate safeguards for security and confidentiality;
- Any modes of observation (e.g., photographs or videos) or access to
information (e.g., sound recordings) in the research that allow identification
of particular subjects;
- Any anticipated secondary uses of identifiable data from the research;
- Any anticipated linkage of data gathered in the research with other
data about subjects, whether those data are contained in public or personal
- Provisions for confidentiality of data resulting from the research.
If identifying information is involved, REB approval shall be sought for
secondary uses of data. Researchers may gain access to identifying information
if they have demonstrated to the satisfaction of the REB that:
- Identifying information is essential to the research;
- They will take appropriate measures to protect the privacy of the
individuals, to ensure the confidentiality of the data, and to minimize
harms to subjects; and
- Individuals to whom the data refer have not objected to secondary
The REB may also require that a researcher's access to secondary use of
data involving identifying information be dependent on:
- The informed consent of those who contributed data or of authorized
third parties; or
- An appropriate strategy for informing the subjects; or
- Consultation with representatives of those who contributed data.
Researchers who wish to contact individuals to whom data refer shall seek
the authorization of the REB prior to contact.
The implications of approved data linkage in which research subjects may
be identifiable shall be approved by the REB.
Researchers and REB members shall disclose actual, perceived or potential
conflicts of interest to the REB. REBs should develop mechanisms to address
and resolve conflicts of interest.
- Where research is designed to survey a number of living research subjects
because of their involvement in generic activities (e.g., in many areas
of health research, or in some social science research such as studies
of child poverty or of access to legal clinics) that are not specific
to particular identifiable groups, researchers shall not exclude prospective
or actual research subjects on the basis of such attributes as culture,
religion, race, mental or physical disability, sexual orientation, ethnicity,
sex or age, unless there is a valid reason for doing so.
- This article is not intended to preclude research focused on a single
living individual (such as in a biography) or on a group of individuals
who share a specific characteristic (as in a study of an identifiable
group of painters who happen to be all of one sex, colour or religion,
or of a religious order that is restricted to one sex).
Women shall not automatically be excluded from research solely on the basis
of sex or reproductive capacity.
Subject to the provisions in Articles 2.6 to 2.8, those who are not competent
to consent for themselves shall not be automatically excluded from research
that is potentially beneficial to them as individuals, or to the group
that they represent.
Phase I non-therapeutic clinical trials shall undergo both stringent review
and continuous monitoring by an REB independent of the clinical trials sponsor.
In combined Phase I/II clinical trials, researchers and REBs shall carefully
examine the integrity of the process of free and informed consent. Where appropriate,
the REB may require an independent monitoring process.
REBs shall examine the budgets of clinical trials to assure that ethical
duties concerning conflict of interest are respected.
The use of placebo controls in clinical trials is generally unacceptable
when standard therapies or interventions are available for a particular
The genetics researcher shall seek free and informed consent from the individual
and report results to that individual if the individual so desires.
The researcher and the REB shall ensure that the results of genetic testing
and genetic counselling records are protected from access by third parties,
unless free and informed consent is given by the subject. Family information
in databanks shall be coded so as to remove the possibility of identification
of subjects within the bank itself.
Researchers and genetic counsellors involving families and groups in genetic
research studies shall reveal potential harms to the REB and outline how
such harms will be dealt with as part of the research project.
Genetics researchers and the REB shall ensure that the research protocol
makes provision for access to genetic counselling for the subjects, where
Gene alteration (including "gene therapy") that involves human
germ-line cells or human embryos is not ethically acceptable. Gene alteration
for therapeutic purposes and involving human somatic cells may be considered
Though the banking of genetic material is expected to yield benefits, it
may also pose potential harms to individuals, their families and the groups
to which they may belong. Accordingly, researchers who propose research
involving the banking of genetic material have a duty to satisfy the REB
and prospective research subjects that they have addressed the associated
ethical issues, including confidentiality, privacy, storage, use of the
data and results, withdrawal by the subject, and future contact of subjects,
families and groups.
At the outset of a research project, the researcher shall discuss with the
REB and the research subject the possibility and/or probability that the
genetic material and the information derived from its use may have potential
Researchers shall obtain free and informed consent from the individual whose
gametes are to be used in research.
In research, it is not ethical to use in research ova or sperm that have
been obtained through commercial transactions, including exchange for service.
It is not ethically acceptable to create, or intend to create, hybrid individuals
by such means as mixing human and animal gametes, or transferring somatic
or germ cell nuclei between cells of humans and other species.
It is not ethically acceptable to create human embryos specifically for
research purposes. However, in those cases where human embryos are created
for reproductive purposes, and subsequently are no longer required for such
purposes, research involving human embryos may be considered to be ethically
acceptable, but only if all of the following apply:
- The ova and sperm from which they were formed are obtained in accordance
with Articles 9.1 and 9.2;
- The research does not involve the genetic alteration of human gametes
- Embryos exposed to manipulations not directed specifically to their
ongoing normal development will not be transferred for continuing pregnancy;
- Research involving human embryos takes place only during the first
14 days after their formation by combination of the gametes.
It is not ethically acceptable to undertake research that involves ectogenesis,
cloning human beings by any means including somatic cell nuclear transfer,
formation of animal/human hybrids, or the transfer of embryos between humans
and other species.
Research proposing the collection and use of human tissues requires ethics
review by an REB. Among other things, the researcher shall demonstrate
the following to the REB:
- That the collection and use of human tissues for research purposes
shall be undertaken with the free and informed consent of competent
- In the case of incompetent donors, free and informed consent shall
be by an authorized third party;
- In the case of deceased donors, free and informed consent shall be
expressed in a prior directive or through the exercise of free and informed
consent by an authorized third party.
For the purpose of obtaining free and informed consent, researchers who
seek to collect human tissue for research shall, as a minimum, provide potential
donors or authorized third parties information about:
- The purpose of the research;
- The type and amount of tissue to be taken, as well as the location
where the tissue is to be taken;
- The manner in which tissue will be taken, the safety and invasiveness
of acquisition, and the duration and conditions of preservation;
- The potential uses for the tissue including any commercial uses;
- The safeguards to protect the individual's privacy and confidentiality;
- Identifying information attached to specific tissue, and its potential
- How the use of the tissue could affect privacy.
- When identification is possible, researchers shall seek to obtain
free and informed consent from individuals, or from their authorized
third parties, for the use of their previously collected tissue. The
provisions of Article 10.2 also apply here.
- When collected tissue has been provided by persons who are not individually
identifiable (anonymous and anonymized tissue), and when there are no
potential harms to them, there is no need to seek donors' permission
to use their tissue for research purposes, unless applicable law so
1 Article 2.1(c) was
adapted from Protection of Human Subjects, U.S. Department of Health and
Human Services, Title 45;Code of Federal Regulations, Part 46.116(d). [Back]
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