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Grace Kelly

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An Introduction to Research Ethics at Western Grace Kelly Ethics Officer Office of Research Ethics The University of Western Ontario – PowerPoint PPT presentation

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Title: Grace Kelly


1

An Introduction to Research Ethics at Western
  • Grace Kelly
  • Ethics Officer
  • Office of Research Ethics
  • The University of Western Ontario

2
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.

3
Why We Exist
  • To protect the research participants and make
    sure that theyre not exposed to any unnecessary
    harms, risks or discomforts.

4
Tri-Council Policy Statement 2http//www.pre.et
hics.gc.ca/eng/policy-politique/initiatives/tcps2-
eptc2/Default/
5
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)

6
What Research Goes Where?
7
Research Ethics at Western
Western Faculty, Staff and Students institutions
Western is the Board of Record for all London
Hospitals
8
Which REB do I use?
9
Delegated Review?
10
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

11
When Do You Need to Apply?
12
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
13
Please remember
  • this includes ALL research.
  • If youre not sure, please contact us and ask.

14
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,
    Co-received own REB approval and will be doing
    analyses only - not direct interaction

15
Examples of When Ethics is Needed and When it is
Not
16
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)

17
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!

18
How does the Board Review my Research
Proposal?(From the Guiding Principles)
19
What the REB Reviews
  • Western Research Submission Form (HSREB or
    NMREB)
  • Objectives, rationale, hypotheses
  • Methods, including surveys/instruments
  • Participants
  • Confidentiality
  • Letter of Information Consent

20
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)

21
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

22
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

23
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).

24
What Constitutes Identifiers?
  • Name, initials
  • Date of birth or death (partial)
  • Initials and DOB together
  • PINs, OHIP numbers, SIN, others
  • Postal code
  • Mapping of data

25
If I need REB Review, do I also always need to
obtain consent?
26
Waiver 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

27
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

28
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

29
Letter 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

30
Ongoing 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

31
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

32
ContactsGrace 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
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