Research Ethics
Applications
D. Gordon E. Robertson, PhD
School of Human Kinetics
Faculty of Health Sciences
Structure
• Parliament of Canada funds research councils
– principally CIHR, NSERC, SSHRC
• These agencies created the Interagency Advisory Panel on
Research Ethics
• This agency produced the Tri-council Policy Statement: Ethical
Conduct for Research Involving Humans (TCPS)
• TCPS-2 (2010) is the current policy
– http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/
• Canadian universities require ALL research (not just those funded
by the three councils or unfunded) to follow the TCPS-2
• Each university has one or more Research Ethics Boards
Research Ethics Boards (REB)
• uOttawa has 2 REBs:
http://www.research.uottawa.ca/ethics/boards.html
– Social Sciences and Humanities (including Education, excluding
School of Psychology)
– Health Science and Science (including Engineering and School
of Psychology) [this is our REB]
• Faculty of Medicine is reviewed by Ottawa Health Network REB,
includes Ottawa Hospital Research Institute and Heart Institute
• Funds for research involving humans are not released until an REB
application is approved!
• Research on animals is reviewed by the Animal Care Committee
• Other REBs are necessary if research is conducted elsewhere
REB structure
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Appointments by Vice-President, Research
Chair (Dr. Daniel Legarec, retired professor of Geography)
Co-chair (Mr. Marc Audcent, member at large, legal council)
At least one member-at-large not affiliated with the university
At least one legal expert
At least one member with ethics expertise
Members from various faculties and schools with at least two
having “expertise in relevant research disciplines, fields, and
methodologies covered by the REB
• One student member, usually graduate student
• One protocol officer (non-voting) serves as secretary, other
protocol officers may attend (non-voting)
Pillars of Research Ethics
• Respect for human dignity is the underlying principle of research
involving living humans
• “Respect for human dignity requires that research involving
humans be conducted in a manner that is sensitive to the
inherent worth of all human beings and the respect and
consideration that they are due.”
• There are three core principles:
1. Respect for Persons
2. Concern for Welfare
3. Justice
Respect for Persons
• Especially important, when participants are considered to be “at
risk”, e.g., persons with ‘’developing (i.e., young), impaired, or
diminished autonomy’’
– diminished autonomy includes participants that are
supervised, taught, or treated by the researcher
• Persons under 18 years are considered at risk unless they are
attending university otherwise their “assent” is required as well
as “consent” from a third person, usually a parent.
• Autonomy is maintained by the requirement to seek their free,
informed, and ongoing consent
• When research involves persons at risk, the application usually
receives a full-board review
Concern for Welfare
• Welfare consists of the impact of the research on individuals and
associated groups of factors such as their physical, mental, and
spiritual health, as well as their physical, economic, and social
circumstances
• Harm to any of these factors must be divulged to the REB and the
participant, through a information sheet and/or a consent form
• Researchers “should attempt to achieve the most favourable
balance of risks and potential benefits in a research proposal”
Justice
• “Justice refers to the obligation to treat people fairly and
equitably. Fairness entails treating all people with equal respect
and concern. Equity requires distributing the benefits and
burdens of research participation in such a way that no segment
of the population is unduly burdened by the harms of research
or denied the benefits of the knowledge generated from it.”
TCPS-2
• This means excluding groups from a project needs to be
justified, e.g., gender, age, language, ethnicity, etc. exclusions
should be avoided
Confidentiality and Anonymity
• One element of the concern for welfare is confidentiality, which
must be preserved if possible, and must be disclosed to
participant if it cannot, e.g., in group discussions, etc.
Participants can choose whether or not to be anonymous.
• Anonymity is not possible if video or audio recordings are made
• Aliases may be used to preserve anonymity if quotations or
photographs are used
• Participant data and consent forms need to be protected and
their methods of protection disclosed to the REB and participant
• If sensitive information is collected it may be advisable to
disconnect data from the participant’s name. That way no
authority will be able to access the information, but neither can
the researcher identify a particular participant’s information.
Harm
• First, do no harm (Primum non nocere), a medical dictum related
to Hippocratic Oath
Harm
• First, do no harm (Primum non nocere), a medical dictum related
to Hippocratic Oath
• This is not a research ethics regulation
• Some harm or risk of harm is permissible when the benefits
outweigh the harm or risk
• It is the responsibility of the researcher to:
– Inform the participant of any harm, risk of harm, or discomfort
that may occur during the research
– Minimize any harm, prevent unnecessary harm
– Alleviate harm done and provide sources to mitigate any harm
– Report any inadvertent harm to the Research Ethics Board
• By Unanticipated Issues / Adverse Events Form
Types of Reviews
1. Full-board Review
- for any study that has “at risk” participants or has potentially
harmful procedures, or cannot pass minimal review criteria
- will be reviewed at a monthly meeting (excepting July) of the
full board, principally by two members but all members view
the application (must be submitted at beginning of month)
2. Minimal Risk Review
- just meet minimal risk guidelines: form
- reviewed by two members (can be submitted any time)
3. Expedited Review
- for secondary analysis of data or follow-up studies
- reviewed by chairs only and protocol officers
Checklist of Forms (mandatory)
 Ethics Application Checklist: pdf
 Eligibility for ethics review – Initial ethics review: pdf
 Application Form for Ethics Approval: pdf
 Information and/or Consent Form(s), Assent Form Recruitment
poster and/or telephone dialog
 If thesis: thesis committee’s approval letter
 If student project: letter from supervisor
 All signatures and contact information
Checklist of Forms (optional)
 Confidentiality agreement for assistants
 If designated acts are used by researchers, letter from Office of
Risk Management, and delegating authority
• designated acts are acts that are usually carried out by
nurses, doctors, etc. Some acts are permissible during
research, e.g., surface electromyography, others will need
approval form ORM. Some acts may be done by the
participant, e.g., rectal probe).
 Copies of questionnaires, surveys, interview guides, etc.
 Letters from participation organizations (universities, hospitals,
school boards, community centres, sports organizations, etc.)
 Debriefing text especially if purpose was hidden from participant
Common errors
• Consent form in both official languages unless rationale given
for a single language
• Specific and definite date at which data conservation will end
• Details of REB form and consent form must agree
• Consent form must be on letterhead
• Statement in consent form:
If I have any questions regarding the ethical conduct of this study, I
may contact the Protocol Officer for Ethics in Research, University of
Ottawa, Tabaret Hall, 550 Cumberland Street, Room 159, Ottawa, ON
K1N 6N5, Tel.: (613) 562-5841, Email: ethics@uottawa.ca
• Clear statement of the benefits to participant, e.g., advancement of
knowledge, free physical test
Heads-up
• Be sure to distinguish between confidentiality and anonymity
• Proof-read the documents
• Cut-and-paste is OK and often advisable but the text must be
consistent throughout
• Modify existing documents that have been recently approved
but make sure the new documents match your study
• Justify use of one language but unless justified, consent forms
must be in both official languages
• Use of a single gender needs to be justified
– Risks that are part of normally daily like don’t need to be
declared as a risks (e.g., tripping while walking on level
surfaces, falling during normal activities)
• All stated risks must have a means of mitigation