Public titles of clinical trials should have ethics review.
A key aspect to guarantee that research with human subjects is ethical is being overlooked. Ethics review committees invest great effort examining the informed consent documents of research protocols to ensure that potential participants can provide consent validly and are not deluded into thinking that the experimental intervention they may sign up for is already known to be therapeutic. However, these efforts to avoid what is called the "therapeutic misconception" might be in vain if the title with which the studies are being introduced to the potential participants escapes ethics review. Research participants might be deceived by clinical trials entitled "novel therapy" when the point of the trial is precisely to find out whether the intervention at stake is therapeutic or not. Providing potential research participants with such misleading information hampers their ability to make informed decisions. The well-established scrutiny that ethics review committees exercise with regard to consent forms is limited if the registration of clinical trials, for which a public title is chosen, constitutes a process that is independent from the ethics review. In this article, we examine this problem, assess recent measures to integrate clinical trial registration with ethics review processes, and provide specific recommendations to solve the problem and ultimately enhance the accountability, transparency, and ethics of research with human subjects.
Department of Knowledge Management, Bioethics and Research, Pan American Health Organization/World Health Organization, 525 23rd St NW, Washington, DC 20037, USA. Electronic address: saenzcar@paho.org.
Carla
C
Saenz
Department of Knowledge Management, Bioethics and Research, Pan American Health Organization/World Health Organization, 525 23rd Street NW, Washington, DC 20037, USA.
Ludovic
L
Reveiz
Molecular and Clinical Hematology Branch, National Heart, Lung and Blood Institute, National Institutes of Health, Building 10, Room 9N112, 9000 Rockville Pike, Bethesda, MD 20892, USA.
John F
JF
Tisdale
D002986:Clinical Trials as Topic / Q000941:ethics*; D028744:Ethics Committees, Research; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007258:Informed Consent; D012107:Research Design; D014481:United States
Bias; Bioethics; Clinical trial registration; IRB review; Marketing; Research ethics