Title: Grace Kelly
1An Introduction to Research Ethics at Western
- Grace Kelly
- Ethics Officer
- Office of Research Ethics
- The University of Western Ontario
2Who 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.
3Why We Exist
- To protect the research participants and make
sure that theyre not exposed to any unnecessary
harms, risks or discomforts.
4Tri-Council Policy Statement 2http//www.pre.et
hics.gc.ca/eng/policy-politique/initiatives/tcps2-
eptc2/Default/
5What 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)
6What Research Goes Where?
7Research Ethics at Western
Western Faculty, Staff and Students institutions
Western is the Board of Record for all London
Hospitals
8Which REB do I use?
9Delegated Review?
10Assessment 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
11 When Do You Need to Apply?
12Do 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
13Please remember
- this includes ALL research.
- If youre not sure, please contact us and ask.
14When 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,
Co-received own REB approval and will be doing
analyses only - not direct interaction
15Examples of When Ethics is Needed and When it is
Not
16Ethics 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)
17Ethics 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!
18How does the Board Review my Research
Proposal?(From the Guiding Principles)
19What the REB Reviews
- Western Research Submission Form (HSREB or
NMREB) - Objectives, rationale, hypotheses
- Methods, including surveys/instruments
- Participants
- Confidentiality
- Letter of Information Consent
20The 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)
21Sound 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
22Coercion 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
23Privacy 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).
24What Constitutes Identifiers?
- Name, initials
- Date of birth or death (partial)
- Initials and DOB together
- PINs, OHIP numbers, SIN, others
- Postal code
- Mapping of data
25If I need REB Review, do I also always need to
obtain consent?
26Waiver of Consent
- Principle of Beneficence
- Sheer size
- Proportion of individuals relocated or died
- Creation of privacy risk by linking ID to
de-identified data - Risk of psychological, social or other harm
- Difficulty in contacting individuals
- Identifiability
27Informed 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
28Informed 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
29Letter of Information Consent
- grammatically correct
- no spelling mistakes
- use of lay language
- grade 8 level
- easy to read - type, titles
- consent form not always required
30Ongoing Ethics Review
- REBs 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
31We 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
32ContactsGrace Kellygrace.kelly_at_uwo.caethics_at_u
wo.cahttp//www.uwo.ca/research/ethics/Helpful
LinksInteragency Panel on Research Ethics (PRE)
http//www.pre.ethics.gc.ca/english/index.cfmCI
HR Privacy Best Practices Guidelineshttp//www.ci
hr-irsc.gc.ca/e/29138.html