Tri-Council Policy Statement 2
2010
Ethical Conduct for Research
Involving Humans
The TCPS 2
• First version of TCPS released in 1998
• Updates in 2000, 2002, 2005 and now
replaced by TCPS 2 (2010)
• Changing ethical and social context
• Three councils:
– CIHR Canadian Institutes of Health Research
– NSERC Natural Sciences and Engineering
Research Council of Canada
– SSHRC Social Sciences and Humanities
Research Council of Canada
Core Principles (Ch. 1)
• “Respect for human dignity requires that
research involving humans be conducted in a
manner that is sensitive to the inherent worth
of all human beings and the respect and
consideration that they are due.” (Ch. 1)
• Involves:
– • Respect for Persons
– • Concern for Welfare
– • Justice
Scope of the Policy
• The policy applies to all…
– “(a) research involving living human
participants;
– (b) research involving human biological
materials, as well as human embryos,
fetuses, fetal tissue, reproductive materials
and stem cells. This applies to materials
derived from living and deceased
individuals.” (Article 2.1)
Exemptions
• “Research that relies exclusively on
publicly available information does not
require REB review when:
– (a) the information is legally accessible to
the public and appropriately protected by
law; or
– (b) the information is publicly
accessible and there is no reasonable
expectation of privacy.” (Article 2.2)
Observation in Public Places
• REB review not required when
– (a) it does not involve any intervention
staged by the researcher, or direct
interaction with the individuals or groups;
– (b) individuals or groups targeted for
observation have no reasonable
expectation of privacy; and
– (c) any dissemination of research results does
not allow identification of specific individuals.
(Article 2.3)
Secondary Analysis
• “REB review is not required for research
that relies exclusively on secondary use of
anonymous information, or anonymous
human biological materials, so long as the
process of data linkage or recording or
dissemination of results does not generate
identifiable information.” (Article 2.4)
Balancing Potential Benefits and
Risks of Harm
• Researchers must seek a balance between the
benefits…
– “that positively affect the welfare of society as
a whole through the advancement of
knowledge for future generations, for
participants themselves or for other
individuals”
• And the risk of harm…
– “anything that has a negative effect on the
welfare of participants, and the nature of the
harm may be social, behavioural,
psychological, physical or economic.”
(Ch. 2 B)
Consent (Ch. 3)
• Related to “Respect for persons”
• Documentation required
• Consent = “free, informed and ongoing
consent”
– “(a) Consent shall be given voluntarily.
– (b) Consent can be withdrawn at any time.
– (c) If a participant withdraws consent, the
participant can also request the withdrawal of
their data or human biological materials.”
(Article 3.1)
Issues related to Consent
• Must be voluntary and informed
(disclosure of potential risks and benefits)
• No undue influence or coercion
• If incentives are used should not be overly
large
• The burden is on the researcher to ensure
that participants understand fully
• Incidental findings must be disclosed
• Debriefing may be needed
• Medical emergencies
Justice (Ch. 4)
• Justice = “Fairness and equity in research
participation” (Ch. 4)
• Exclusion by gender, age, ethnicity,
language, disability, sexual orientation etc.
may compromise equity
Privacy and Confidentiality (Ch. 5)
• “Privacy refers to an individual’s right to be
free from intrusion or interference by others.
It is a fundamental right in a free and
democratic society.”
• “confidentiality refers to the obligation of an
individual or organization to safeguard
entrusted information.”
• Related issues: security = “measures used
to protect information” and identifiability of
individuals (Ch. 5 A)
Research Ethics Boards (REBs)
• Every institution responsible for setting up
an independent REB appropriate to the
range of research done at that institution
• At least 5 members
– Both male and female
– 2 with expertise in area
– 1 ethics expert
– 1 law expert
– 1 unaffiliated community member
Conflict of Interest (Ch. 7)
•
•
•
•
Conflict of interest may involve
The institution
REB members
The researcher (i.e. dual role,
interpersonal, financial or other affiliations)
First Nations, Inuit, and Metis
Peoples (Ch. 9)
• Much research in this area has been
carried out by non-aboriginals
• Must respect history, culture and tradition
• Safeguard against imbalance of power
• May require different interpretation of
ethical principles
• Read this chapter carefully if doing
research in this area!
Qualitative Research (Ch. 10)
• READ CHAPTER 10 THOROUGHLY
BEFORE STARTING YOUR PROJECT!!
• Qualitative research is a special case
– Involves inductive understanding, diversity of
approaches, ongoing reflexivity, takes place in
multiple, evolving contexts, involves
partnerships with research participants
• Qualitative approaches are “inherently
dynamic” and “grounded in different
assumptions” than quantitative research
Aspects Of Qualitative Research
(from Introduction to Ch. 10)
•
•
•
•
•
•
•
•
•
Inductive understanding
Diversity of approaches
Dynamic and continuous process
Multiple and evolving contexts
Limited sample sizes
Diversity of research aims/goals
Negotiated and ongoing consent
Collaborative process
Limited generalizability of results
Research Ethics Board Review
• Overall, qualitative subject to same general
guidelines as quantitative (above)
– i.e. consent, confidentiality, privacy
• No REB required for exploratory phase (unless
pilot study undertaken – Article 6.11)
• But also special ethical issues involved
– Related to gaining access, building rapport etc.
– May not be able to identify during design phase
– Preliminary and exploratory activities like note-taking,
passive observation or diary writing common and do not
require REB consent
– Review and consent becomes necessary later when
relationships are established or need for
privacy/confidentiality is identified (Article 10.1)
Consent in Qualitative Research
(Article 10.2)
• Same general guidelines for consent as in Ch. 3
• But in qualitative, signed written consent not
always feasible
• Attempts to obtain consent, whether written or
oral should be documented via field notes, etc. or
completed questionnaires
• Participants in positions of power or who regularly
interact with the public can be assumed to have
signified consent by virtue of having agreed to
speak to researcher
– Should also be documented
Observational Studies (10.2)
• Non-participant (naturalistic) studies
– Need to be careful
– If observation in public space where participants
have expectation of privacy, then REB review
and consent may become necessary
• Participant (ethnographic) studies
– Covert may not require consent
• Natural or virtual environments vary in
expectations of privacy
• Observational studies in public places where
no expectation of privacy are exempt
Privacy (Article 10.3)
• Breach of privacy may arise from identification of
individuals, groups or communities when research
is published or disseminated
• But if no identification of individuals made, then is
regarded as minimal risk
• If consent is not sought, researcher must
demonstrate to REB that precautions to protect
privacy and confidentiality taken
• You may not violate the privacy of individuals who
had a reasonable expectation of privacy or
confidentiality when acting or interacting
• Consent not needed when personal or identifying
information is not collected
Other Issues
• Dissemination of results (Article 10.4)
– Need permission to identify participant
– Need to respect participant’s contribution i.e.
oral histories
• Waiver of anonymity must not compromise
other individuals involved in the research
• Emergent research designs (Article 10.5)
– Provide all possible info to REB and consult
regularly as design evolves
Ch. 11 – 13 of TCPS2
• These chapters relevant for research in
health, medical and biological sciences
• Cover:
– Clinical trials
– Human biological materials
– Human genetic research
TCPS 2: CORE — Tutorial
• The TCPS 2: CORE (Course on Research
Ethics) is an online tutorial with an overview
and introduction to the TCPS 2.
• Has 8 modules with quizzes, progress reports
and a certificate of completion at the end.
• Please click this link to register and
access the CORE tutorial
• Please review also:
– Brescia University Policy
– Queen’s University Digital Data Policy
Queen’s Digital Data Policy, 2012
• One relevant criterion that determines whether
naturalistic observation research needs ethics
review is whether or not the people being
observed are seeking to be observed. Similarly,
when a user posts material on a site widely
known to be viewable by the general public this
may be taken as evidence that this user expects
their material to have public visibility. In contrast,
when a user posts material in a members-only
chat room or discussion venue, or to a forum
that is focused on a small sub-set of the
population, this is to be taken as evidence that
users do not anticipate that their material will be
viewed by people outside this “community”.
Eight Criteria for Exemption
(source: Queen’s Digital Data Policy)
• Criterion #1. The researcher can freely
see the information online without having
to register as a member of the discussion
venue (e.g. chat room, discussion forum,
listserv, etc.)
• Criterion #2. The discussion venue has
no policy prohibiting research, or the
reproduction, redistribution, and/or
reprinting of its content.
Criteria (cont.)
• Criterion #3. The owner/moderator of the
discussion venue does not indicate in any
way that messages posted on the site are
private, confidential, or meant to be
viewed only by people matching the
characteristics of a particular interest
group.
Criteria (cont.)
• Criterion #4. The researcher will not be
engaging in any deception of the users,
such as ‘posing’ as a member of a group
or suddenly becoming a regular
contributor to the discussion venue.
Similarly, the researcher, or anyone
working on behalf of the researcher, was
not already a member of the discussion
venue for their own interest and is now
making use of their membership for
research purposes.
Criteria (cont.)
• Criterion #5. The researcher will not
directly contact any human sources of
digital content.
• Criterion #6. Websites that are frequented
by minors (persons under the age of 18)
must not be part of the research project.
Similarly, digital communication in any
form that can be identified as being from a
minor must not be included in the data
collection.
Criteria (cont.)
• Criterion #7. The research plan must
indicate that the identities of users
(including nicknames and pseudonyms)
will be disguised in any presentations or
publications of the research works.
• Criterion #8. The research plan must
indicate that verbatim quotes will not be
used in any presentations or publications.
Paraphrasing and coded categorization of
content are acceptable.