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

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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.

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Why We Exist

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

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

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

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When Do You Need to Apply?
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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
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Please remember

• this includes ALL research.
• If youre not sure, please contact us and ask.

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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

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

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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!

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How does the Board Review my Research
Proposal?(From the Guiding Principles)
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What the REB Reviews

• Western Research Submission Form (HSREB or
  NMREB)
• Objectives, rationale, hypotheses
• Methods, including surveys/instruments
• Participants
• Confidentiality
• Letter of Information Consent

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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)

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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

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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

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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).

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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

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

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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

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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

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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

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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

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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

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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