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Grace Kelly Ethics Officer
Office of Research EthicsThe University of Western Ontario
[email protected] x84692
An Introduction to Research Ethics at Western
Ethics Considerations for Teachers’ Research with
Students in their own Classroom
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Guiding Principles ofResearch Ethics
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Policy Framework
Nuremberg Code, 1949 (end of 2nd world war)
Declaration of Helsinki, 1964 – cornerstone document of human research ethics.
Belmont Report, 1979
PHIPA section 44 -disclosure for research/REB
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TCPS
**Tri-Council Policy Statement (TCPS):
Ethical Conduct for Research Involving Humans, 1998
-Federal Granting Agencies – SSHRC; CIHR; NSERC
-Funding is only given to individuals at institutions that comply with this policy
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TCPSCore PrinciplesWelfare (assess risks and benefits)
Autonomy and Decision Making (informed consent and voluntary participation)
Equal Moral Status of All (inclusive, everyone treated the same)
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How does the TCPS fit into the ORE?
• Based on the Core Principles of the TCPS the ORE’s main goals are as follows:– Protection of human subjects– Assess risks and benefits– Assess research design to ensure minimal
risk and meet objectives– Review subject recruitment to ensure
informed consent– Protect vulnerable groups of individuals
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What Research Goes Where?
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Research Ethics at Western
HSREBFull Board(high risk)
HSREBDelegated Board
(lower risk)Level 1 & Level 2
NMREBNon-MedicalHigher andLower Risk
UWOOffice of Research
Ethics
UWO is the Board of Record for all London Hospitals
UWO Faculty, Staff and Students & institutions
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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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ALL research involving human subjects and their data must be reviewed by a UWO REB.
This includes all research conducted on campus by UWO Faculty, Staff and Students Research conducted on campus.
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Determining if REB Review is Necessary can be Tricky!
• You wish to conduct a study of the ways in which space and resources are used in the Library– Goal #1: to improve service, see what areas
are used, how could physical space be improved?
– Goal #2: to interview students and staff to understand their perceptions of the library, how important access to materials is to their work, what their demographics are, etc.
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If you’re not sure, please ask.
Everyone’s research is different and unique.
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• If my research requires REB approval• Factor time in as part of research
process– Back and forth process with the ORE
and REB.• Are you the PI of a study? Using UWO
staff, faculty, students or facilities.
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How does the Board Review my Research Proposal?
(From the Guiding Principles)
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What the REB Reviews
• UWO Research Submission (HSREB or NMREB)– Objectives, rationale, hypotheses– Methods, including surveys/instruments– Participants– Confidentiality
• Letter of Information & Consent
• Scripts & Advertisements
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The REB also Reviews…
• 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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Additionally…The REB Reviews
• All Revisions to already approved research
• FYIs• Adverse Events• Updated Approvals• Protocol Violations• Protocol Deviations
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Sound Methodology• Have you provided support, in the form of
references for your current research question?
• Sample size? Does it work?• Are human participants really necessary to
answer the question?• Clear explanation of steps – also to letter of
information• Do the benefits of the research outweigh the
risks?
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Coercion or Inducements to Participate
• 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 recognized as fundamental human rights.
• What counts as loss of privacy may vary from individual to individual and society to society.
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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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Assessing Identifiability & Risk
• Identifying information: identifies a specific research participant directly (e.g., name, address, SIN or PIN)
• Identifiable information: could be used to re-identify a participant through a combination of indirect
• De-identified/coded information: Identifiers are removed/replaced with a code. Those with access to the code and the data (or those working directly with those with the code) have identifiable information.
• Anonymized information: Information is irrevocably stripped of identifiers, and a code is not kept
• Anonymous information: Information never had identifiers
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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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Waiver of Consent
• Not to be confused with other forms of consent. – Explicit Consent (eg. Completion of Survey)– Explicit Verbal Consent (eg. Telephone
Survey)– Passive Consent (Opt-Out)– Previous Consent
You still need a Letter of Information or script for these forms of consent.
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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
• Consent Form
• Assent Form
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Informed Consent Guidance
HSREB & NMREB GUIDELINEShttp://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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Teachers’ Research with Students in their own Classroom
The main issue that exists when a teacher wants to conduct research in their own classroom is the power relationship that exists between a teacher and her/his own students and even further – the issue of coercion.
However…..
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Teachers’ Research with Students in their own Classroom
• …with proper planning and consideration a teacher may be able to use the students within his/her own class as study participants provided (s)he is able to avoid both the reality and appearance of coercion and coercion itself.
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Step 1
• When thinking about your research, distinguish between activities that constitute ‘research’ and those that fall under ‘professional development’. – Look back at our examples of whether or not
ethics is needed. • If not publishing and only examining the teacher’s
pedagogical practices then no ethics is needed.• If publishing best to get ethics approval
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Step 2
• Decide how you will avoid both the reality and perception of coercion– A potential ‘risk’ in these studies is being
coerced into participating in a study in which one does not want to participate.
• (eg. Parents or students feel obligated to participate to avoid offending teacher or so that the child’s marks are not affected).
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Step 3• Create a plausible plan for avoiding
coercion in your submissions. – Alternatives forms of data collection should be
made to avoid coercion. • Anonymous online questionnaire
• Study students in a different classroom
• Use another researcher to do the research for you (3rd party) – they collect consent and keep results until final grades submitted, therefore teacher doesn’t know who participated and can’t base grades on that
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Summary• Careful consideration must be taken to
avoid any undue influence on the participant which will undermine the voluntary character of the consent.
• Where possible, the approach to the participant inviting to participation in a research project should be made by someone not in a position of authority over the subject.
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Summary
• Students must be assured that withdrawal will not result in any academic penalty.
• Similarly students should not be promised academic reward.