Guidelines on the ethics of clinical research in anaesthesia

Abstract

This review will identify ethical issues arising from conflicts of interest in sponsored clinical trials, and the need for compliance with recent privacy legislation. It will guide investigators facing ethical dilemmas that compromise the integrity of their research because of conflicts of interest or a flawed consent process. Authors will learn about changes in journal editorial policies that will require registration of clinical trials and consent for publication of case reports. Recently, ethics review committees and clinical investigators have violated research ethical guidelines and authors have ignored journal policies on disclosure of data in multicentre clinical trials. Published reports show selective reporting of data from clinical trials that biases the body of evidence available for clinical decision-making. Privacy laws legislate that patient consent for the use of their health information, other than for their clinical care, must be obtained explicitly. Clinical trial registration and the need for consent for publication of case reports aim to restore and improve the integrity of biomedical publication. Journal policies that incorporate these changes may be persuasive in interpreting privacy laws, in a practical way, to protect patients from harm. It is difficult to eliminate all ethical problems with sponsored trials and government regulatory drug-approval processes may require review.