Transcript Ethics_for_MClSc - University of Western Ontario

An Introduction to Research
Ethics at Western
Grace Kelly
Ethics Officer
Office of Research Ethics
The University of Western Ontario
Who We Are
• 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.
Why We Exist
• To protect the research
participants and make sure that
they’re not exposed to any
unnecessary harms, risks or
discomforts.
Tri-Council Policy Statement 2
http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/
What is the TCPS2?
• Tri-Council Policy Statement2: Ethical Conduct
for Research Involving Humans
– standard for ethical conduct for research involving
human subjects
– condition of funding for researchers and their
institutions
Core Principles
Welfare (assess risks and benefits)
Autonomy and Decision Making (informed consent)
Equal Moral Status of All (inclusive, vulnerable)
What Research Goes Where?
Research Ethics at Western
UWO
Office of Research
Ethics
HSREB
Full Board
(high risk)
HSREB
Delegated Board
(lower risk)
Level 1 & Level 2
NMREB
Non-Medical
Higher and
Lower Risk
Western Faculty, Staff and Students & institutions
Western is the Board of Record for all London Hospitals
Which REB do I use?
Delegated Review?
Assessment of Risk
• Greater scrutiny and expertise required for
research that is potentially more invasive
or harmful
• REB is responsible for assessing
magnitude and probability of potential
harms and benefits
When Do You
Need to Apply?
Do I Need to Obtain Ethics
Approval?
ALL research involving human subjects and
their data must be reviewed by a University
of Western Ontario REB.
Research conducted on campus by Western
Faculty, Staff and Students Research
conducted on campus involving the same
Please remember…
• this includes ALL research.
If you’re not sure, please
contact us and ask.
When do I apply?
• If my research requires REB approval
• Factor time in as part of research process
• Are you the PI of a study? Using Western
staff, faculty, students or facilities
• Do you work at the hospital, using hospital
staff, facilities or patients (CRIC)
– You designed a study taking place off-site, Coreceived own REB approval and will be doing
analyses only - not direct interaction
Examples of When Ethics is
Needed and When it is Not
Ethics Approval Required?
• YES - All Research using human subjects
including tissues, cadavers, remains,
discarded, etc. unless de-identified and
belonging to bank.
• YES - If personally identifiable information
is accessible through any linkage with the
data sample (Secondary Use of Data)
Ethics Approval Required?
• NO - Research of personal information originally
collected for a purpose other than the current purpose
– e.g. Census, etc.
– Not “research”
– Living individual - public arena
– Publicly available information, documents
– Secondary Uses of de-identified data
– Performance or quality assurance studies
(organization, employees or students), pedagogical
processes - always check first!
How does the Board Review
my Research Proposal?
(From the Guiding Principles)
What the REB Reviews
• Western Research Submission Form
(HSREB or NMREB)
– Objectives, rationale, hypotheses
– Methods, including surveys/instruments
– Participants
– Confidentiality
• Letter of Information & Consent
The REB also reviews…
• Recruitment Items
• - Any ‘item’ used to solicit participation in
a study including:
– Telephone scripts
– Recruitment scripts (for on-the-spot surveys)
– Cover letters
– Email messages
– Follow-up/reminder notices (a la Dillman
Method)
Sound Methodology
• Support provided re: current research
question requires answering (e.g.
references)
• Will your methods answer the questions
you want answered, and do so reliably?
• Sample size?
• Are human participants really necessary to
answer the question?
• Clear explanation of steps – also to letter
of information
• Benefits outweigh the risks
Coercion or Inducements
to Participate
• Participants should NOT:
– overwhelmed by institutional approval
– fear of loss of health benefits,
employment or educational status
– obligation to participate
– financial gain
Privacy &
Confidentiality Issues
• Privacy and confidentiality are basic
human rights and need to be
maintained throughout your project.
• What counts as loss of privacy may
vary from individual to individual and
society to society.
• CIHR Privacy Best Practices, PHIPA,
FIPPA (resources).
What Constitutes
“Identifiers”?
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Name, initials
Date of birth or death (partial)
Initials and DOB together
PINs, OHIP numbers, SIN, others
Postal code
Mapping of data
If I need REB Review, do I
also always need to obtain
consent?
Waiver of Consent
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Principle of Beneficence
Sheer size
Proportion of individuals relocated or died
Creation of privacy risk by linking ID to deidentified data
• Risk of psychological, social or other harm
• Difficulty in contacting individuals
• Identifiability
Informed Consent
• Subjects must be told exactly what is
going to happen to them
• Subjects must agree to participate
– Letter of Information
– Other forms of providing information
(scripts)
– Consent Form
– Assent Form
Informed Consent Guidance
HSREB & NMREB GUIDELINES
http://www.uwo.ca/research/ethics/
•Required Wording
•Letter explains clearly the study methods
•What will be done with the data
•Participant confidentiality/anonymity
•Participant contact information
•Grammar & Spelling
Letter of Information & Consent
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grammatically correct
no spelling mistakes
use of lay language
grade 8 level
easy to read - type, titles
consent form not always
required
Ongoing Ethics Review
• REB’s responsibility does not end
with initial ethics approval
• approve all revisions and changes
• ongoing monitoring of study progress
(surveillance report)
• processing and assessment of
unexpected adverse events
We are here to help!
• It may be difficult to piece together at first subsequent submissions get easier
• We work with you to facilitate your research
• Journals now do not typically accept research
without proof of REB review
– We offer ‘proxy’ proof for those studies not requiring
review
Contacts:
Grace Kelly
[email protected]
[email protected]
http://www.uwo.ca/research/ethics/
Helpful Links:
Interagency Panel on Research Ethics (PRE)
http://www.pre.ethics.gc.ca/english/index.cfm
CIHR Privacy Best Practices Guidelines
http://www.cihr-irsc.gc.ca/e/29138.html