TCPS 2 (2014)
Updates to guidance re: Privacy,
Secondary Use of Data/Biological Materials
and Alterations to Consent Requirements
Laura-Lee Balkwill, Policy Analyst
Wendy Burgess, Policy Analyst
Susan Zimmerman, Executive Director
CAREB - Vancouver
April 2015
Agenda
• Evolution of TCPS 2
• Consultation overview
• Updates to guidance
– Privacy
– Secondary use of data/biological materials
– Alterations to consent requirements
• Questions
Evolution of TCPS 2
Tri-Council Policy Statement: Ethical Conduct
for Research Involving Humans created in 1998 by:
– Canadian Institutes of Health Research
– Natural Sciences and Engineering Research Council
– Social Sciences and Humanities Research Council
Updates:
December 2010: 2nd edition released
December 2014: TCPS 2 (2014) released
Recent changes to TCPS 2
• PRE is committed to ongoing Policy evolution
• Your interpretation requests and SRCR/PRE policy analysis led
to revisions that:
– filled policy gaps
– clarified guidance and/or definitions
– addressed emerging issues
• Public consultation - Fall, 2013 to January, 2014
• Comments reviewed, revisions drafted, vetted
• TCPS 2 (2014) released December 2014
http://pre.ethics.gc.ca/eng/resources-ressources/news-nouvelles/nr-cp/2014-12-18/
Privacy
Identifiable information*
• Information is identifiable if it may reasonably be expected to
identify an individual, when used alone or combined with other
available information.
• Information is non-identifiable if it does not identify an
individual, for all practical purposes, when used alone or
combined with other available information.
* Definitions are the same for human biological materials
Privacy
• Identifiability is an assessment that is made in the context of a
specific research project.
• Example: a research project that relies solely on the secondary
use of coded information:
• If the researcher has access to the code, the information is identifiable
• If the researcher does not have access to the code, the information is
non-identifiable
• Consider aspects of the research that may make the
information identifiable
• E.g., size of population, unique characteristics
Privacy
Anonymous information is information that has never had
identifiers associated with it*
For the purposes of TCPS 2, ‘non-identifiable’ is not the same as
‘anonymous’
• Identifiability is an assessment made in the context of the research
project
• Anonymous information is anonymous irrespective of the research
project
* Definition is the same for human biological materials
Why do we care?
There is an exemption from REB review for the secondary use of
anonymous information/human biological materials (Article 2.4).
There is an exception to the general requirement to seek consent
for the secondary use of non-identifiable information/human
biological materials (Articles 5.5B, 12.3B).
research involves secondary use of information
Information
anonymous?
Y
REB review not required
N
Information
non-identifiable?
Y
REB review required
Consent not required
Y
REB review required
Consent may not be
required if REB approves
N
Research meet
conditions of
Art. 5.5A?
N
Consent required
Alterations to consent requirements
Article 3.7 (2010)
Article 3.7A (2014):
Criteria for REB approval:
Criteria for REB approval:
a) no more than minimal risk;
a)no more than minimal risk;
b) unlikely to adversely affect welfare;
b)unlikely to adversely affect welfare;
c) it is impossible or impracticable to do
the research with prior consent;
c)it is impossible or impracticable to do
the research with prior consent;
d) participants will be debriefed if
possible and appropriate; and
d)the precise nature and extent of any
proposed alteration is defined; and
e) the research does not involve a
therapeutic intervention, or other
clinical or diagnostic interventions
e)any debriefing plan shall be in
accordance with Article 3.7B and may
allow withdrawal of data and/or human
biological materials
Alterations to consent requirements
Rationale for removal of 3.7(e)
 Posed an unnecessary barrier to research based on methodology rather than on
ethical issues
 The other criteria – including no more than minimal risk and unlikely to affect
welfare – are sufficient to prevent the use of deception and/or lack of consent in
higher risk research
 Consistent with other international guidance such as:
-
The U.S. Common Rule
-
Australian National Statement on Ethical Conduct in Human Research
-
Council for International Organizations of Medical Sciences: International Ethical
Guidelines for Biomedical Research Involving Human Subjects (CIOMS)
Alterations to consent requirements
Article 3.7B (New):
Criteria for REB approval:
a) Debriefing must be part of all research involving an alteration to consent
requirements (see Article 3.7A) whenever it is possible, practicable and
appropriate;
b) Participants in such research must have the opportunity to refuse consent and
request the withdrawal of their data and/or human biological materials
whenever possible, practicable and appropriate
Debriefing is the default requirement
Alterations to consent requirements
New glossary entries for:
Possible/impossible:
• If an action can be done, regardless of the level of difficulty required to
do it, it is possible.
• If an action cannot be done under any circumstances, it is impossible.
Practicable/impracticable:
• If an action is possible and it is reasonable to expect it to be done, it is
practicable.
• An action is possible but not practicable when it is unreasonably difficult
to do, or, the action will jeopardize the ability of the researcher to
address the research question.
Research Ethics Education Resources
•
•
•
•
TCPS 2: Course on Research Ethics (CORE)
Interpretation service
Posted interpretations
Webinars
www.pre.ethics.gc.ca
Questions?
Please get in touch
PANEL ON RESEARCH ETHICS
350 Albert Street, Ottawa, ON K1A 1H5
613-996-0072
www.pre.ethics.gc.ca
[email protected]