1. 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

2. Agenda Evolution of TCPS 2 Consultation overview Updates to guidance
Privacy
Secondary use of data/biological materials
Alterations to consent requirements
Questions

3. Evolution of TCPS 2 Updates:
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

4. 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

5. Privacy * Definitions are the same for human biological materials
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

6. 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

7. Privacy * Definition is the same for human biological materials
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

8. 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).

9. research involves secondary use of information
REB review not required
REB review required
Consent not required
Consent may not be
required if REB approves
Consent required
Information
anonymous?
non-identifiable?
Research meet
conditions of Art. 5.5A? Y N

10. Alterations to consent requirements
Article 3.7 (2010)
Criteria for REB approval:
no more than minimal risk;
unlikely to adversely affect welfare;
it is impossible or impracticable to do the research with prior consent;
participants will be debriefed if possible and appropriate; and
the research does not involve a therapeutic intervention, or other clinical or diagnostic interventions
Article 3.7A (2014):
Criteria for REB approval:
no more than minimal risk;
unlikely to adversely affect welfare;
it is impossible or impracticable to do the research with prior consent;
the precise nature and extent of any proposed alteration is defined; and
any debriefing plan shall be in accordance with Article 3.7B and may allow withdrawal of data and/or human biological materials

11. 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)

12. Alterations to consent requirements
Article 3.7B (New):
Criteria for REB approval:
Debriefing must be part of all research involving an alteration to consent requirements (see Article 3.7A) whenever it is possible, practicable and appropriate;
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

13. 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.

14. Research Ethics Education Resources
TCPS 2: Course on Research Ethics (CORE)
Interpretation service
Posted interpretations
Webinars

15. Questions?

16. PANEL ON RESEARCH ETHICS
Please get in touch
PANEL ON RESEARCH ETHICS
350 Albert Street, Ottawa, ON K1A 1H5 16