Informed Consent
Adil E. Shamoo, Felix A. Khin-Maung-Gyi in Ethics of the Use of Human Subjects in Research, 2021
An important aspect of the informed consent document is that the research protocol and the informed consent document and process must not contradict one another. The informed consent document may be viewed as a script from which those administering the consent process (typically study coordinators and investigators) work in order to present the consent form fully and clearly to potential volunteers. Some of the more significant controversies surrounding informed consent have to do with potential volunteers who are not or may not appear to be physically, emotionally or mentally capable of understanding what is being presented. The standard for all investigators and their staffs should be to obtain truly informed consent from potential subjects. Typically, the sponsor of the study drafts the informed consent document. Most recently, a range of informed consent-based concerns have been raised in both public and private forums, including issues emerging in relation to the frontiers of scientific research.
Consent and the Treatment of Chronic Illness
Tom Walker in Ethics and Chronic Illness, 2019
Treating patients with chronic illness sometimes requires doing things that would be wrong if done without consent, but not wrong if done with consent. This chapter focuses on the implications of this for healthcare professionals. It looks both at the impact of informed consent regulations on healthcare professionals’ obligations, and at requirements to obtain consent that are independent of those regulations. In doing this three questions are important: when is consent needed?, who is it needed from?, and what is needed for it? Approaching consent in this way reveals the limitations of top-down accounts based on respect for autonomy. These limitations are particularly pressing when considering what consent is needed for, why consent needs to be voluntary, the amount a person must understand in order to consent, and how competence relates to consent.
Enticement, Enrollment, and Engagement
JoAnn Pfeiffer, Cris Wells in A Practical Guide to Managing Clinical Trials, 2017
The informed consent process is one of the most important elements in the conduct of clinical trials. Yet, historically, the compromise of the ethical principles underlying informed consent has been the cause of some of the most troubling and ethically challenged research studies ever conducted. In this chapter, we will discuss the informed consent process from recruitment to screening, enrollment, and throughout the duration of the study.
Psychology of the Informed Consent Process: A Commentary on Three Recent Articles
Published in Ethics & Behavior, 2018
In conducting research on humans, respect for human dignity requires investigators to obtain informed consent. Institutional pressures, however, often reduce the informed consent form to a signature on a document. Unfortunately, people often do not read or understand these documents. In the present effort, we argue that the key problem here arises because investigators often do not take into account the psychology of participants. Based on 3 articles, we argue that informed consent requires investigators to help participants “make sense” of a study, and its implications, for both themselves and others. Informed consent procedures that might encourage participant sensemaking are discussed.
Discussion of Patients’ Right to Informed Consent
Published in Chinese Medical Record English Edition, 2013
The patient's right to informed consent is an important part of doctor-patient communication, and it is also the important reflection of human rights in the medical system. This article summarizes the origin of the right to informed consent, and the legal concept of the right to informed consent has been clarified from the main body and content of rights and obligations. The right to informed consent is discussed from the perspective of manifestation forms and implementation procedures in medical practice. The concepts such as the foundation being that the medical staff informs the patients, the core being that the patients are well informed, and patient's signature being the ultimate embodiment of consent, are put forward. In addition, a new way of thinking is provided, for medical personnel to accurately understand and implement the patients’ right to informed consent.
Twelve tips for teaching the informed consent conversation
Published in Medical Teacher, 2019
Obtaining informed consent has been traditionally viewed as a mundane task, learned on the job and often relegated to an inexperienced member of the healthcare team. In reality, the process of obtaining informed consent is complex, challenging, and warrants focused teaching, observation and feedback. There are few published standards for what should be included in a high-quality informed consent conversation, and little or no guidance regarding how to best teach the process of conducting this type of shared decision-making conversation. The following twelve tips provide a roadmap for teaching the essential components of how to obtain informed consent, including both content and communication skills, with a focus on common pitfalls for trainees, and strategies to address them.