What is knowledge/understanding being sought? What are recognised principles of research conduct used? Why is research conducted honestly? How are results disseminated to permit scrutiny, contribute to public knowledge/understanding? Why are facilities appropriate? 3. Project Funding: adequacy & Why are resources adequate? (Funding, Conflicts conflict of interest of Interest) Research conducted honestly? Effect of funding on results disseminated to permit scrutiny, contribute to public knowledge/understanding? 4. Prior scientific and/or ethical Can the duplication of ethical review reviews (Multi-centre, Scientific be avoided? merit) Why do likely benefits to participants 5. Risks and Benefits to Participants and/or community justify to (Risks and Benefits) participants? How does design minimise risks to participants? How are potential benefits & risks of research sufficiently clarified (see PICF)? How will researchers fulfil responsibility for welfare of participants? How are risks reduced where participants no benefit? Why is selection, inclusion/exclusion 6. Recruitment (and Justice) criteria fair? (Participants) Why is recruitment process fair? Why is there no unfair burden of participation on particular groups? Why is there no exploitation of participants How is access to benefits of research fair? How will there be timely & clear access to outcomes to participants? How do research give due respect for 7. Participants, Consent & participants’ welfare, beliefs, Participation (and Respect) perceptions, customs, culture (Participants, PICF) How does research give due scope to capacity of participants to make own decisions? How do researchers empower/protect participants not able to make own decisions? Why will participation be voluntary, with sufficient information & adequate understanding of purposes, methods,
What is knowledge/understanding being sought? What are recognised principles of research conduct used? Why is research conducted honestly? How are results disseminated to permit scrutiny, contribute to public knowledge/understanding? 3. Project Funding: adequacy & conflict of interest (Funding, Conflicts of Interest) Why are facilities appropriate? Why are resources adequate? Research conducted honestly? Effect of funding on results disseminated to permit scrutiny, contribute to public knowledge/understanding? 4. Prior scientific and/or ethical reviews (Multi-centre, Scientific merit) Can the duplication of ethical review be avoided? 5. Risks and Benefits to Participants (Risks and Benefits) Why do likely benefits to participants and/or community justify to participants? How does design minimise risks to participants? How are potential benefits & risks of research sufficiently clarified (see PICF)? How will researchers fulfil responsibility for welfare of participants? How are risks reduced where participants no benefit? 6. Recruitment (and Justice) (Participants) Why is selection, inclusion/exclusion criteria fair? Why is recruitment process fair? Why is there no unfair burden of participation on particular groups? Why is there no exploitation of participants How is access to benefits of research fair? How will there be timely & clear access to outcomes to participants? 7. Participants, Consent & Participation (and Respect) (Participants, PICF) How do research give due respect for participants’ welfare, beliefs, perceptions, customs, culture How does research give due scope to capacity of participants to make own decisions? How do researchers empower/protect participants not able to make own decisions? Why will participation be voluntary, with sufficient information & adequate understanding of purposes, methods,
a_structured_approach_to_ethical_review_of_human_research_11.07.2017.docx