Research Ethics
Western University
Health Sciences Research Ethics Board
Tri-Council Policy Statement 2
Grace Kelly
Ethics Officer
grace.kelly@uwo.ca
www.uwo.ca/research/ethics
Upcoming Educational Sessions
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Letter of Information and Consent Process
Forms – Initial submission + Post Approval Forms
Surveys and Online Research
Teachers’ Research with their own Students
• ROMEO and electronic submissions
Tri-Council Policy Statement 2 (TCPS2)
TCPS2 is a guideline created by the Interagency Agency
Panel on Research Ethics for the Tri-Council
Agencies(CIHR, NSERC and SSHRC).
To be eligible to receive and administer research funds
from the Agencies, institutions must agree to comply with
Agency policies, the TCPS2 being one of those policies.
Researchers funded by the Agencies are expected to
adhere to the TCPS2.
Today’s Agenda
•When is ethics approval required? (Chapter 2)
•Which Research Ethics Board to use?
•Where are you required to submit? (Chapter 6)
•The Consent Process (Chapter 3)
•Protocol submissions and Review Process
•Question and Answer Period
When is Ethics Approval Required?
Chapter 2
ALL research involving human participants is subject to
ethics review by an REB, even if approval may not be
needed.
Therefore, if you are doing research with humans and are
unsure of whether or not ethics is required, please
contact our office first.
When is Ethics Approval Required?
Chapter 2
The following require ethics review by an REB before
the research commences:
• (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.
When is Ethics Approval NOT Required?
Chapter 2
Research that relies exclusively on publicly available
information MAY 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.
Publicly Available Information - Example
The researcher wanted to record a speech by the Health
Minister of Canada. This speech was to be given publicly
and for all to hear.
Therefore, based on the fact that this information was
presented publicly, no ethics approval was needed.
*Alternatively, the researcher also wanted to interview the
Minister separately after, this is not public information
and ethics approval and consent was needed.
When is Ethics Approval NOT Required?
Chapter 2
• REB review MAY NOT be required for research
involving the observation of people in public places
where:
• (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.
Public Places - Example
The researcher wanted to carry out observations in a public
shopping mall in order to review the use of a certain
guest service in that mall
The shopping mall is a public place, she was not taking any
video or audio recordings, was not going to identify the
participants nor was she going to interact with them.
Therefore, no ethics approval was needed.
*Alternatively, a researcher wanted to go into a long-term
care facility to observe – ethics approval WAS needed
for this.
When is Ethics Approval NOT Required?
Chapter 2
Research that relies exclusively on secondary use of
anonymous information MAY NOT require REB
review when:
• It includes the 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.
Secondary Use - Example
The researcher wanted to write a paper in which they
would use an existing dataset maintained as a database
to collect their information. Neither the PI nor the
researcher were able to link the information from the
database back to the person that the information was
originally collected from.
No linkage possible, completely de-identified and therefore
no ethics approval needed.
When is Ethics Approval NOT Required?
Chapter 2
Research that is to be used for internal purposes only
and will not be published MAY NOT require REB
review when it is:
• Quality assurance and quality improvement studies,
• Program evaluation activities,
• Performance reviews or testing within normal
educational requirements when used exclusively for
assessment, management or improvement purposes,
• Course or program planning or development,
• Development of case studies for teaching purposes
Evaluation - Example
The researcher wanted to assess / evaluate the
performance of her organization by using feedback
through focus groups, interviews and looking at billing
records of this institution.
This did not include any vulnerable populations and there
were no known risks. Although ethics approval was not
needed we still asked that she use our consent process
to consent individuals being interviewed or participating
in the focus group.
Where are you required to submit?
Chapter 6
All Western University students, staff and faculty must
obtain research ethics approval from Western University
to do any research at any location.
If you are doing research at Western and at another
location you may also need to obtain ethics from that
institution. Please contact the institution for confirmation,
based on your particular project.
Research at another institution - Example
A researcher wanted to do focus groups and surveys with all 3rd
year medical students at all medical schools across Ontario.
Therefore, he had to first obtain ethics approval from Western as
this is his home university and then he had to correspond with
all other universities he wished to do his research at to ask
what steps should be taken before he could start.
This would be the same for anyone wishing to do research at
Western that was not from this institution. They would also
need Western approval to do research with Western staff,
faculty or students.
Which Research Ethics Board to Use?
Chapter 6
Western University has two main Research Ethics Boards.
The board being discussed today is the Health Sciences
Research Ethics Board (HSREB). This main board is
divided further, based on the level of risk indicated in the
protocol.
– HSREB
• Full Board, Delegated Board Level 2, Delegated Board Level 1.
Delegated Review
Chapter 6
Research that is deemed minimal risk or lower and
does not use vulnerable participants, children or in
some cases elderly.
Minimal Risk: Research in which the probability and
magnitude of possible harms implied by
participation in the research is no greater than
those encountered by participants in those aspects
of their everyday life that relate to the research.
Delegated Review Level 1
Research which includes for example chart reviews,
database or registry creation, analysis of tissue
samples.
Generally speaking research which does not involve
participant contact.
Delegated Review Level 2
Research which includes contact with patients,
participants in the form of focus groups,
questionnaires, surveys, etc.
Generally low risk patient / participant contact.
The Consent Process
Chapter 3
Letter of Information
The Consent Process should be thought of as a process,
not just a letter and a form that the potential participants
signs.
The Letter of Information should not cause the potential
participant to:
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Feel overwhelmed by institutional approval
Fear loss of benefits, employment or educational status
Feel an obligation to participate
Believe there will be financial gain
The Consent Process
Chapter 3
Obtaining Consent
This can happen in a number of ways:
– Written Consent (Letter of Information + Consent to sign)
– Explicit Consent (Letter of Information + Completion of Survey)
– Explicit Verbal Consent (Telephone Script + Agree to Interview)
You still need a Letter of Information or script for ALL of these
forms of consent.
Subjects must be told exactly what is going to happen to them
(full disclosure)
Protocol Submissions & Review Process
The Office of Research Ethics sets deadlines for each
of its major boards
• http://www.uwo.ca/research/ethics/deadlines.html
HSREB
Full Board – Deadlines
Delegated Level 2 – Deadlines
Delegated Level 1 – No Deadlines
Protocol Submission & Review Process
Timelines
HSREB Delegated Level 1
– Protocols can be submitted at anytime
– Reviewed within 2 weeks of being submitted
– Recommendations sent out within 5 days of review
HSREB Delegated Level 2
– Protocols are submitted on the deadline date
– Reviewed at the meeting date indicated online
– Recommendations sent out within 5 days of review
Protocol Submission & Review Process
Forms
The REB provides initial review and approval to a
research project and the REB and the ORE provide
ongoing post-approval review to research revision,
etc.
We are currently in the process of going electronic with
our submissions - ROMEO
Question & Answer Period
Thank you!
We are always here to help.
If you have any questions please contact
Grace Kelly at 519-661-2111 ext. 84692 or
grace.kelly@uwo.ca
or
Julie Pfeiffer at 519-661-2111 ext. 86811 or
jpfeiff@uwo.ca