Contributory factors to the evolution of the concept and practice of informed consent in clinical research: A narrative review

Abstract

Informed consent can be defined as a freely-given decision or agreement following disclosure of relevant information. This review explores how legislation surrounding informed consent has impacted upon clinical research practices, with a focus on clinical trials involving individuals with the capacity to give consent in the non-emergency setting. We also highlight the challenges which remain with the informed consent process, including those which exist in the era of data protection legislation and genetic research. Modern ethicists agree that informed consent encompasses three principal factors: disclosure of information, capacity for decision making, and voluntariness. In the context of clinical research, informed consent is now required by regulatory and ethical frameworks as well as by law, and various guidelines govern the practice of informed consent, including the Declaration of Helsinki and the Good Clinical Practice Guidelines. Historically, however, researchers acted paternalistically and included participants in research without their knowledge or consent. Following societal and political revolution, an autonomy model of consent became prevalent, and individuals became free to make individual choices about whether to participate. Despite this, it is also recognized that an individual's community has a role in supporting their decision making, and this may be a strong influence, particularly within some societies. Research scandals and controversies and whistle-blowers which exposed unethical practices in the area of informed consent also contributed to changes in societal attitudes and legislation changed as a result. Medical journals also have an established, although indirect, role in strengthening good practices surrounding informed consent.

Foundations for Meaningful Consent in Canada’s Digital Health Ecosystem: Retrospective Study

“…Future public and stakeholder engagement activities will require a greater in-depth investigation in co-designing consent management for patient access channels. Recognizing the ethical transgressions in trust in health care and research of marginalized and vulnerable communities [ 58 ], future research must include more diversity in perspectives to understand how to equitably strengthen meaningful consent and consent management practices.…”

Equipoise, placebo in clinical trials and Brazilian Code of Medical Ethics

“…Patients' informed consent is a prima facie obligation for RCTs and patients' right to self-determination must always take precedence. Nonetheless, full autonomy in decision-making, to provide the relevant information in an understandable way and check whether patients in fact understood it, is necessary to obtain a valid consent 20 .…”

Community-engaged training in informed consent

“…3 However, inconsistent or sometimes nonexistent training in the practical interpersonal skills of conducting informed consent conversations has long been noted as a challenge for clinical research. [4][5][6][7][8] Experiential learning and hands-on, practical experience in Good Clinical Practice (GCP) is highly valued by research coordinators, and years of experience as a research coordinator is a better predictor of GCP knowledge than hours of training. 9 Educational techniques such as simulations and role-plays can help bridge that gap by including experiential components in a more formalized training setting.…”

“…However, informed consent is more than the document; it is a process, and a critical part of that process is the conversation [3]. However, inconsistent or sometimes nonexistent training in the practical interpersonal skills of conducting informed consent conversations has long been noted as a challenge for clinical research [4][5][6][7][8].…”