Informed Consent, the Ethical Cornerstone of Medical Intervention, Especially within the Conduct of Clinical Trials

Abstract

Introduction: This paper outlines and explains a new approach to informed consent, especially within clinical trials. Background: Autonomy implies the patient has control for what happens to his/her body. There is a problem with lack of equipoise between clinician and patient, especially when the clinician, conducting a trial, is also the patient’s physician. Beran et al adopted a novel approach to informed consent, especially within clinical trials. The patient is introduced to the trial coordinator who assumes responsibility of discussing the nature, risks and benefits of the trial. If the patient accepts and signs the informed consent document, with the coordinator, the doctor counter-signs it, offering the opportunity to ask further questions, criticize the process and feel confident that the decision was correct. Discussion: Where the investigator is also the patient’s treating clinician, it must be recognized that there might be a perception of potential coercion, asking a patient to join a trial. The practice employed a trial coordinator, a recent university, science graduate, a young person with less influence over the patient. Patients completed the bulk of the informed consent with the trial coordinator, given every opportunity to decline inclusion into a trial. With the trial coordinator, being responsible for discussing the elements of the trial, there is a reduced potential for undue influence, with ultimate respect for autonomy and selfdetermination. This procedure offers a novel approach to gain informed consent for inclusion in clinical trials with the doctor retaining ultimate responsibility, for informed consent, and countersigning the consent document.