A Primer on the ACT Ethics Protocol for Candidates and Supervisors The right hand column of the tables below indicate questions the HREC will ask that you need to demonstrate you’ve considered and have responded to in your Ethics Protocol submission. The questions are keyed to the National Statement on Ethical Conduct in Human Research (updated May 2013). NS1.1 (a) means National Statement Paragraph 1.1 sub paragraph (a). RESEARCH MERIT Research merit (NS 1.1-1.3 p.12) Research justifiable by potential benefit NS 1.1(a) Uses appropriate methods to achieve aims NS 1.1(b) Based on current knowledge in literature NS 1.1 (c) Respect for participants not compromised by aims, methods or results NS 1.1 (d) Conducted / supervised by those with appropriate experience, qualifications & competence. NS 1.1 (e) Use appropriate facilities & resources NS 1.1 (f) RESEARCH(ER) INTEGRITY Research(er) Integrity (NS 1.3, p.12) Researchers with integrity have commitment to: Searching for knowledge and understanding NS 1.3(a) Following recognized principles of research conduct NS 1.3(b) Conducting research honestly; and NS 1.3 (c) Disseminating / communicating results, to permit public scrutiny & add to public knowledge / understanding NS 1.3 (d) Questions HREC will want to see you have addressed in your Ethics Protocol What is the benefit, to whom, & why does it justify research? Why are the methods appropriate? What is the current knowledge? What specific gap in the literature are you addressing? How do you demonstrate you have not compromised respect for participants? Explain why the experience, qualification and competence of yourself, your supervisor, or any third parties, who might participate in the study, are appropriate to use the methods proposed? Why are the facilities and resources you propose to utilise appropriate to the research? Questions HREC will want to see you have addressed in your Ethics Protocol What is the knowledge and understanding that the researchers are seeking? What are the recognised principles of research conduct that the researchers will use? How will the research be conducted honestly? How will the results be disseminated to permit scrutiny and contribute to public knowledge and understanding? 1 A Primer on the ACT Ethics Protocol for Candidates and Supervisors JUSTICE Justice (fair recruitment etc) (NS 1.4, 1.5 p.12) Within the scope and objectives of research, selection, exclusion, inclusion of research participants is fair, and accurately described NS 1.4(a) Process of recruiting participants is fair NS 1.4(b) No unfair burden of participation in research on groups NS 1.4 (c) Fair distribution of benefits of participation in research NS 1.4 (d) No exploitation of participants NS 1.4 (e) Fair access to the benefits of research NS 1.4 (f) Outcomes accessible to participants in timely and clear manner NS 1.5 BENEFICENCE Beneficence (NS 1.6-1.9 p.13) Likely benefit to participants or community, must justify risks of harm / discomfort to participants (NS 1.6, p.13) Researchers responsible: To design research to minimize risks of harm and discomfort NS 1.7(a) To clarify potential benefits & risks; and NS 1.7(b) For welfare of participants in research NS 1.7 (c) Where no likely benefits to participants, risk to participants lower than where likely benefits NS 1.8 p.13 Questions HREC will want to see you have addressed in your Ethics Protocol Why are the selection, inclusion and exclusion criteria for the research fair? How will they be accurately described in the results? Why is the recruitment process fair? Why is there no unfair burden of participation on particular groups? How is the distribution of benefits of participation fair? Why is there no exploitation of participants? How is access to the benefits of the research fair? How will timely and clear access to the outcomes of the research be provided to participants? Questions HREC will want to see you have addressed in your Ethics Protocol Why do likely benefits of the research justify any risks of harm or discomfort to participants? What constitutes harm or discomfort? (NS 2.1, p. 16) How does the design minimize the risk of harm / discomfort? How are potential benefits and risks clarified for participants? How will researchers fulfil responsibility for welfare of participants? How have risks to participants been reduced where participants will not benefit? 2 A Primer on the ACT Ethics Protocol for Candidates and Supervisors RESPECT Respect (NS 1.10, - 1.13, p.13) Requires due regard for the welfare, beliefs, perceptions, customs & cultural heritage of individuals and collectives NS 1.10 Respect for privacy, confidentiality & cultural sensitivities NS 1.11 Give due scope to capacity of human beings to make own decisions NS 1.12 Consent (NS2.2.2 p.19) Where participants are unable to make own decisions / have diminished capacity, respect involves empowering and providing protection Voluntary participation based on Sufficient information about the research Adequate understanding of the purpose, methods, demands Risks and potential benefits of the research Questions HREC will want to see you have addressed in your Ethics Protocol How does the research give due respect for welfare, beliefs, perceptions, customs & cultural heritage of participants? How will researchers respect privacy, confidentiality, customs & cultural sensitivities of participants? How will the research give due scope to the capacity of participants to make their own decisions? Why is there sufficient information on which participants can give informed consent? Why will there be adequate understanding? 3