Transcript The Office of Research Ethics September 10, 2012 MClSc Physical Therapy Student Orientation Office of Research Ethics.

The Office of
Research Ethics
September 10, 2012
MClSc Physical Therapy
Student Orientation
Office of Research Ethics
What We Do
The Office of Research Ethics manages the
approval and monitoring process for the use of
humans in research at the University and its
affiliated hospitals and research institutes.
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Why We Exist
To protect the research participants and make
sure that they’re not exposed to any unnecessary
harms, risks or discomforts.
To protect the researchers and students carrying
out the research.
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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.
Is Ethics Approval Needed?
All research involving humans conducted by
faculty, staff or students at Western or its
affiliated hospitals or research institutes must be
reviewed by a University-sanctioned review
board.
At that point the board will decide if approval is
needed, if this is in question.
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Please remember…
This includes ALL research. If you are not
sure, please contact us and ask.
You must obtain ethics approval BEFORE
you begin your research. Retroactive
approval will not be given under any
circumstances.
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Is Ethics Approval
Needed?
Yes…
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.
Is Ethics Approval
Needed?
No…
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 Info - 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.
Is Ethics Approval
Needed?
No…
• 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.
Is Ethics Approval
Needed?
No…
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.
Is Ethics Approval
Needed?
No…
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.
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.
Boards and Review Level
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Boards and Review Levels
HSREB
• Full Board
• Delegated 1 & 2
NMREB
• Delegated
• Sub-boards
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Delegated Review
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.
Deadlines
• The HSREB Full Board and Delegated Level 2 board
have deadlines which must be adhered to. Please see
our website for deadlines.
• The HSREB Delegated Level 1 board does not have
deadlines. The protocols can be submitted at
anytime and are reviewed within 2 weeks.
Ethics Review Process
• Submission of the Protocol and all necessary
documentation by the deadline date.
• Pre-reviewed by the office.
• Reviewed by the board.
• Sent to the researcher for response.
• Response from the researcher.
• Approval.
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ROMEO
• Our online, in-office database and protocol
submission system.
• All protocols are now submitted via ROMEO.
• There are workshops offered or one-on-one training
is also available.
• Please contact us if you would like assistance in
obtaining your username and password.
Consent Process
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The Consent Process
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
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)
Who We Are
ROLE
NAME
PHONE
EMAIL
HSREB FULL BOARD
Janice Sutherland
86764
[email protected]
HSREB FULL BOARD
Shantel Walcott
87437
[email protected]
HSREB Delegated &
NMREB
Grace Kelly
84692
[email protected]
Administrative Assistant
Julie Pfeiffer
86811
[email protected]
Administrative Assistant
Becky Ament
84691
[email protected]
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Where We Are
• We are located in suite 5150, Support Services
Building, University of Western Ontario
• http://www.uwo.ca/research/ethics/
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