Transcript General - University of Western Ontario

Research Ethics
Research Methods
Grace Kelly
Ethics Officer
Health Sciences Research Ethics Board
http://www.uwo.ca/research/services/ethics/
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
http://www.uwo.ca/research/services/ethics/
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
http://www.uwo.ca/research/services/ethics/
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.
http://www.uwo.ca/research/services/ethics/
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.
http://www.uwo.ca/research/services/ethics/
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)
http://www.uwo.ca/research/services/ethics/
The Tri-Council Policy Statement 2
(TCPS2)
•When do you need ethics approval?
•What is informed consent and when
is it needed?
http://www.uwo.ca/research/services/ethics/
• 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.
http://www.uwo.ca/research/services/ethics/
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.
http://www.uwo.ca/research/services/ethics/
The Informed Consent Process
(a) Consent shall be given voluntarily and informed.
(b) 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.
http://www.uwo.ca/research/services/ethics/
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.
http://www.uwo.ca/research/services/ethics/
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
http://www.uwo.ca/research/services/ethics/
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.
http://www.uwo.ca/research/services/ethics/
Waivers of Informed Consent
The REB may approve low risk (Level 1) research without requiring
that the researcher obtain the participant’s consent.
http://www.uwo.ca/research/services/ethics/
The University of Western Ontario
Research Ethics Board (REB) and Office
of Research Ethics (ORE)
•
•
•
•
Deadlines
Timelines
Forms
Romeo
http://www.uwo.ca/research/services/ethics/
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
http://www.uwo.ca/research/services/ethics/
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
http://www.uwo.ca/research/services/ethics/
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
http://www.uwo.ca/research/services/ethics/
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.
http://www.uwo.ca/research/services/ethics/
Romeo
New 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.
http://www.uwo.ca/research/services/ethics/
Thank you!
We are always here to help.
If you have any questions please contact:
Grace Kelly at 519-661-2111 ext. 84692 or
[email protected]
http://www.uwo.ca/research/services/ethics/
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/
http://www.uwo.ca/research/services/ethics/