Research Ethics

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Research Ethics
Research Methods Grace Kelly Ethics
Officer Health Sciences Research Ethics Board
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The main Health Sciences Research Ethics Board
has been broken up into three boards Full
Board Delegated Level 1 (chart review /
databases, etc.) Delegated Level 2
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Full Board Review Research which may include but
is not limited to clinical trials, medical
intervention or therapy. Research that is
deemed minimal-risk to patients and participants
or is a chart review is eligible for delegated
review. All other research should be submitted to
the full board for review
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Delegated Review Level 1 (Chart Review) 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.
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Tri-Council Policy Statement 2 (TCPS2)

• 2010 replaces 1998 version
• The TCPS2 is a policy that has been created as a
  benchmark for the ethical conduct of research
  involving humans.

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Tri-Council Policy Statement 2 (TCPS2)

• New Sections
• Multi-Jurisdictional Research (Chapter 8)
• Research Involving First Nations, Inuit and
  Métis Peoples of Canada (Chapter 9)
• Qualitative Research (Chapter 10)

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The Tri-Council Policy Statement 2 (TCPS2)

• When do you need ethics approval?
• What is informed consent and when is it needed?

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• 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 if you are unsure.

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The following MAY NOT require approval by an REB
before the research commences Research that
relies exclusively on publicly available
information. Research involving the observation
of people in public places. Research that
relies exclusively on secondary use of data
(fully anonymous). Quality assurance work /
program evaluation.
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• The Informed Consent Process
• Consent shall be given voluntarily and informed.
• 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.

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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.
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• 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

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• 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.

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Waivers of Informed Consent The REB may
approve low risk (Level 1) research without
requiring that the researcher obtain the
participants consent.
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The University of Western Ontario Research Ethics
Board (REB) and Office of Research Ethics (ORE)

• Deadlines
• Timelines
• Forms
• Romeo

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• Deadlines
• The ORE sets deadlines for each of its major
  boards
• Please see our website for these deadline dates
  if applicable to the board you are submitting to.
• HSREB Full Board Deadlines
• Delegated Level 1 No deadlines
• Delegated Level 2 Deadlines the same as HSREB
  Full Board

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• Timelines
• Full Board
• Protocols are submitted on the deadline date
• Reviewed at the meeting date indicated online
• Recommendations sent out within 5 days of review

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• 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 date indicated online
• Recommendations sent out within 5 days of review

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• Forms
• All new forms due to the fact that we have
  switched over to an electronic database /
  submission system - Romeo
• 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.
• Full Board moving toward fully electronic,
  Delegated already there.

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RomeoNew electronic database has been used
in-house for some time and for submissions
starting this past May, 2012. Training and
education sessions have now begun institution
wide and will continue as we continue to roll out
new modules of the program.
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• Thank you!
• We are always here to help.
• If you have any questions please contact
• Grace Kelly at 519-661-2111 ext. 84692 or
  grace.kelly_at_uwo.ca

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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/