TCPS 2 Guidance:
Interpretations R Us
Laura-Lee Balkwill, PhD, Policy Analyst
Secretariat on Responsible Conduct of Research
CAREB Atlantic - Fredericton
November, 2013
Agenda
• TCPS 2 interpretation service
• Hot topics
• Q&A
TCPS 2 Interpretation Service
• SRCR responds to individual interpretation questions
 135 so far in 2013
 144 in 2012
• Questions that raise new issues or suggest policy
revisions are discussed by PRE
• Responses to questions of general interest vetted by
PRE and published on PRE website
 35 entries and growing
Note: PRE/SRCR cannot serve as an appeal body for specific REB decisions
Objectives of Interpretation Service
• To enhance understanding and consistency in
applying TCPS 2
• To inform the need for revisions to TCPS 2
 interpretation requests help identify recurrent issues or
gaps in guidance
• To better direct TCPS 2 educational initiatives to
issues of relevance to the research community
Hot Topic: Multi-jurisdictional Research
• What is multi-jurisdictional research?
– Involves multiple REBs and/or institutions with jurisdiction over
the research
• Question 5 posted under Governance
If a researcher obtains REB approval at his/her own institution to
gather data from participants who are members of other institutions,
is it necessary to obtain REB approval at each of the other
institutions that employ the participating members?
Hot Topic: Multi-jurisdictional Research
Considerations for each institution:
1 or more
researchers
affiliated with
the institution
Institution
resources
needed for
recruitment
Institution
resources
needed for
data collection
The research
is within the
jurisdiction of
the institution
= REB Review
Research
approved by an
REB covered by
a reciprocal or
delegated review
agreement
Delegated or
reciprocal review
is possible
(but consider
local participant
issues)
Hot Topic: Research vs Non-research activities
• Is it research?
– an undertaking intended to extend knowledge through a disciplined
inquiry or systematic investigation
• Does it involve human participants?
– individuals whose data, or responses to interventions, stimuli … are
relevant to answering the research question
• Research and non-research activities confusion:
– When activities and research employ similar methods and techniques
– When participants are recruited for a dual purpose
Hot Topic: Research vs Non-research activities
• Is it research?
– an undertaking intended to extend knowledge through a disciplined
inquiry or systematic investigation
• Does it involve human participants?
– individuals whose data, or responses to interventions, stimuli … are
relevant to answering the research question
• Research and non-research activities confusion:
– When activities and research employ similar methods and techniques
– When participants are recruited for a dual purpose
Hot Topic: Research vs Non-research activities
Posted interpretations – under ‘Scope’
7. Does publishing the results of a quality assurance study in a
journal determine whether it is research, and whether it requires
REB review?
Example:
• An evaluation of an administrative approach to improving
hospital staff morale following a series of challenging events.
– The hospital administration publishes the results in a quality assurance
journal to show how the approach helped improve staff morale
Hot Topic: Research vs Non-research activities
Posted interpretations – under ‘Scope’
8.Is it ethically acceptable to recruit participants for a dual purpose: a
quality improvement study and research?
Example
•An independent survey company asks post-secondary
institutions to administer a student well-being questionnaire to
their student population.
– The institutions intend to use the results for quality assurance and
evaluation of their student outreach programs.
– The company intends to pool the data from all of the institutions to
answer specific research questions about factors that affect student
well-being.
Hot Topic: Community Engagement
Most frequent question:
Why does the guidance in chapter 9 (particularly the guidance on
community engagement) apply only to First Nations, Inuit, and Métis
communities?
2nd most frequent question:
When is community engagement required and to what extent?
Hot Topic: Community Engagement
Question 1 posted under Research Involving FNIM
1. Can guidance in Chapter 9 for research involving FNIM peoples also apply
to other communities? (March 2012)
Chapter 9:
- acknowledges the unique status of the Aboriginal peoples of Canada
- was designed to guide research involving those communities
- may also be an important source of guidance for research involving other
distinct communities.
Therefore:
• Research ethics boards and researchers can apply the articles of Chapter 9
that are relevant to the particular community involved in the research.
Questions & Answers
Education resources
• On-line tutorial
• Webinars
• Interpretation service
Please get in touch
PANEL ON RESEARCH
ETHICS
350 Albert Street
Ottawa, ON K1A 1H5
Tel.: 613 996-0072
[email protected]
www.pre.ethics.gc.ca