Research Ethics Applications

D. Gordon E. Robertson, PhDSchool 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/policy-politique/initiatives/tcps

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• 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

• 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