Research ethics

Practitioners involved in designing, organising, conducting or reporting human health research: (a) give participants due respect and protection; (b) are honest and act with integrity; (c) make sure a human research ethics committee has approved the protocol under the NHMRC National Statement on Ethical Conduct in Human Research (which covers privacy and relevant privacy law); (d) disclose funding sources and amounts to that committee; (e) declare to it any actual or potential conflict of interest; (f) make sure participants join freely and with informed consent, understanding enough about the aims, methods, demands, risks and possible benefits; (g) take account of any dependent relationship when recruiting their own patients; (h) seek advice where research involves children or adults unable to consent, so that safeguards are in place, including consent from an empowered decision-maker or other lawful authority; (i) follow the approved protocol; (j) monitor the study and report adverse events or unexpected results quickly; (k) respect participants' right to withdraw at any time without reasons; (l) follow the rules on publishing, authorship and peer review; and (m) report suspected research fraud or misconduct as the Australian Code for the Responsible Conduct of Research requires.

• Human research ethics committee approval letter for each study
• Funding and conflict of interest declarations lodged with the committee
• Signed participant information and consent forms
• Adverse event and protocol deviation reports sent to the committee

• Data collected before ethics approval
• Practitioner's own patients recruited without addressing the dependent relationship
• Adverse events not reported to the committee