Research Ethics
An Overview of Research Ethics and the
Tri-Council Policy Statement 2
Grace Kelly
Ethics Officer
Health Sciences Delegated Boards - Level 1 & 2
Non-Medical Full Board and Delegated Board
www.uwo.ca/research/ethics
The Office of Research Ethics plays an
administrative role to two main boards here at
Western:
The Health Sciences Research Ethics Board (HSREB)
The Non-Medical Research Ethics Board (NMREB)
www.uwo.ca/research/ethics
Each of these two main boards are divided
further, based on the level of risk indicated in
the protocol.
HSREB
•Full Board, Delegated Level 1, Delegated Level 2
NMREB
•Full Board, Delegated
•Faculty level sub-REBs
www.uwo.ca/research/ethics
Delegated Review
Any 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.
www.uwo.ca/research/ethics
Vulnerability
Often caused by limited capacity, or limited access to social goods, such as
rights, opportunities and power.
Individuals or groups in vulnerable circumstances have historically included
children, the elderly, women, prisoners, those with mental health issues and
those with diminished capacity for self-determination.
Ethnocultural minorities and those who are institutionalized are other examples
of groups who have, at times, been treated unfairly and inequitably in research,
or have been excluded from research opportunities.
People or groups whose circumstances cause them to be vulnerable or
marginalized may need to be afforded special attention in order to be treated
justly in research.
www.uwo.ca/research/ethics
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.
www.uwo.ca/research/ethics
Tri-Council Policy Statement 2
(TCPS2)
The TCPS2 is a policy that has been
created as a benchmark for the
ethical conduct of research involving
humans.
www.uwo.ca/research/ethics
The Tri-Council Policy Statement 2
(TCPS2)
•When do you need ethics approval?
•What is informed consent and when
is it needed?
www.uwo.ca/research/ethics
• ALL research involving human participants is
subject to ethics review by an REB, even if
approval may not be needed.
• If you are doing research with humans please
contact our office first.
www.uwo.ca/research/ethics
The following require ethics review and approval 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.
www.uwo.ca/research/ethics
The following MAY NOT require ethics review and
approval by an REB before the research
commences:
Research that relies exclusively on publicly
available information does 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.
www.uwo.ca/research/ethics
REB review is not 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.
www.uwo.ca/research/ethics
REB review is not required for research that relies
exclusively on secondary 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.
www.uwo.ca/research/ethics
Quality assurance and quality improvement studies,
program evaluation activities, and performance reviews,
or testing within normal educational requirements when
used exclusively for assessment, management or
improvement purposes, do not constitute research for
the purposes of this Policy, and do not fall within the
scope of REB review.
www.uwo.ca/research/ethics
Creative practice activities, in and of themselves, do not
require REB review.
However, research that employs creative practice to
obtain responses from participants that will be analyzed
to answer a research question is subject to REB review.
www.uwo.ca/research/ethics
The Informed Consent Process
(a) Consent shall be given voluntarily and informed.
(b) Consent can be withdrawn at any time.
(c) If a participant withdraws consent, the participant can
also request the withdrawal of their data or human
biological materials.
www.uwo.ca/research/ethics
Alternate forms of Informed Consent
Certain types of research require alternate processes
for seeking consent. Where elements of the consent
process may need to be adapted to the requirements of
a particular research project, the research ethics board
(REB) can play an educational and consultative role in
determining the appropriate process for seeking and
maintaining consent.
www.uwo.ca/research/ethics
It should be noted that you ALWAYS still need to
inform a participant of the research, the risks,
benefits, etc. and they must consent to this.
• Verbal Scripts
• Explicit Consent by completion of a survey
www.uwo.ca/research/ethics
Assent Form
• All children participating in research also need the
consent of their parent unless it is more risky to have the
parents sign also or the child is emancipated.
• Children 7-12 should read and sign the Assent Form
• Children 13-18 can use the same Letter of Information
as their parents but sign a separate consent.
www.uwo.ca/research/ethics
Waivers of Informed Consent
The REB may approve low risk (Level 1) research without requiring
that the researcher obtain the participant’s consent where the REB is
satisfied, and documents, that all of the following apply:
(a)the research involves no more than minimal risk to the
participants;
(b) the lack of the participant’s consent is unlikely to adversely affect
the welfare of the participant;
www.uwo.ca/research/ethics
(c) it is impossible or impracticable to carry out the
research and to answer the research question properly,
given the research design, if prior consent of the
participant is required;
(d) whenever possible and appropriate, after
participation, or at a later time during the study,
participants will be debriefed and provided with
additional pertinent information at which point they will
have the opportunity to refuse consent; and
(e) the research does not involve a therapeutic
intervention, or other clinical or diagnostic interventions.
www.uwo.ca/research/ethics
The University of Western Ontario
Research Ethics Board (REB) and Office
of Research Ethics (ORE)
•
•
•
•
Deadlines
Timelines
Forms
Romeo
www.uwo.ca/research/ethics
Deadlines
– The ORE sets deadlines for each of its major boards
• http://www.uwo.ca/research/ethics/deadlines.html
NMREB Full Board – Deadlines
– Delegated – No deadlines
HSREB Full Board – Deadlines
– Delegated Level 1 – No deadlines
– Delegated Level 2 – Deadlines the same as
HSREB Full Board
www.uwo.ca/research/ethics
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 by the meeting data indicated online
–Recommendations sent out within 5 days of
review
www.uwo.ca/research/ethics
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
www.uwo.ca/research/ethics
ROMEO
New electronic database currently used in-house.
Within the next six months the ORE will be going live with
the new online submission form.
Training and education sessions institution wide.
Hoping that this will cut down on turn around time.
www.uwo.ca/research/ethics
Thank you!
We are always here to help.
If you have any questions please contact
Grace Kelly at 519-661-2111 ext. 84692 or
[email protected]
or
Julie Pfeiffer at 519-661-2111 ext. 86811 or
[email protected]
www.uwo.ca/research/ethics
Acknowledgements:
Canadian Institutes of Health Research, Natural
Sciences and Engineering Research Council of
Canada, and Social Sciences and Humanities
Research Council of Canada, Tri-Council Policy
Statement: Ethical Conduct for Research Involving
Humans, December 2010.
http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/
www.uwo.ca/research/ethics
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Research Ethics & the Tri-Council Policy Statement 2