Chapter 3 Tri-Council Policy Statement (TCPS) - First standard Canadian ethics code to research 1. Respecting autonomy: enable people to choose participation freely i. Informed consent: provided with all information that might influence (purpose, risk and benefits) 1. Assent: agreement by minor ii. Eliminate Coercion: procedure that limits freedom to consent 1. Threat/ pressure/ embarrassment E.g. a poor person offered 100 dollars to participate 2. Concern for welfare: minimize risk for participants, maximize benefits to participants and society a. Benefits to participants and society i. Education about scientific process ii. Acquisition of new skill iii. Treatment for a psychological or medical problem b. Risk i. Physical Harm ii. Losing privacy and confidentiality Psychological Stress iii. 1. Anonymous 2. Concealed observation 3. Show justice: treat people and distribute benefits/burdens fairly. Withholding Information - Providing too much information could potentially invalidate results of study - Withhold information about the hypothesis/ particular condition *Acceptable when the information would not affect decision to participate Deception is used when fully informed consent may affect who agrees to participate or how they behave once the study begins. - Role Playing: ask participants to predict how real participants in a situation would behave - Simulation Studies - Honest Studies
3 Categories of Risk 1. Exempt - Does not require REB review - Uses publicly available information - Involves observing people in public places without intervention, no individuals identified 2. Minimal Risk - Approved by REB - Risk of harm to participants are no greater than risks in daily life - Using questionnaires or interviews with competent adults on non-sensitive topics 3. Greater than Minimal risk - Thorough review by full REB committee - Safeguards may be required - Using questionnaires of interview with sensitive nature (e.g. sexual practice) or intended participants are vulnerable populations - In cases where it is ambiguous b/t minimal and greater than minimal, will be classified as greater Assess potential BENEFITS · to participants · to science · to society Assess potential RISKS to participants Do the potential benefits of the study outweigh the risks involved with the procedure? NO Study cannot be conducted in its current form; alternative procedures must be found. YES Research may be carried out. Canadian Council on Animal Care (CCAC) The Three R's of "Good Animal Practice in Science:
1. Replacement: replacing use of animals or avoiding use altogether (e.g. use mathematical modeling, humans or meta-analyses on past research) 2. Reduction: minimizing number of animals used 3. Refinement: modifying procedures to minimize pain and distress Scientific Misconduct and Publication Ethics 1. Fabricating Data and Altering Data 2. Plagarism 3. Ethical Data Analysis 4. Improving Science through publication reform: improve trustworthiness of published research Chapter 8