Informed Consent: A Monthly Review
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March 2019

This digest is intended to aggregate and distill key content around informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the GE2P2 Global Foundation’s Center for Informed Consent Integrity, which is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Fellow
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org

Publisher
David R. Curry
President & CEO
GE2P2 Global Foundation
david.r.curry@ge2p2global.org

PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_March 2019

A Survey on Including Risks in the New “Key Information” Section of an Informed Consent Form
Katelyn Le, Stacy Kopka, Doreen Chaitt, Jerome Pierson, Martha Nason, Tracey Miller
Clinical Research (Alex), December 2018; 32(10) pp 18–29
Abstract
Informed consent forms (ICFs) are growing longer and more complex.{1–4} The forces behind this trend may be well-intentioned, such as the desire to disclose more accurate and complete information{1}; however, it raises questions about whether important information is buried in lengthy documents, as well as whether ICFs can be structured to better emphasize the information that is most relevant to a study participant.

Recent updates to what is generally known as the Common Rule for protection of human subjects in research are in part meant to respond to this trend. Among these updates is the introduction of a new section called “Key Information”—every ICF now must open with the most important information that potential subjects would want to know when deciding to join a study. But what exactly should this new section contain?

This question is crucial to us, a group of writers and reviewers who work with investigators to develop ICFs (the program was described in a 2013 issue of the ACRP Monitor{5}). For groups like ours, it is important to explore how best to implement the new regulations in a way that promotes consistency across different ICFs.

As an initial step, we wanted to understand how to objectively decide which risks to provide as Key Information. A survey was conducted to investigate how institutional review board (IRB) members, medical monitors, and principal investigators (PIs) view which risks should be considered Key Information. The hypothesis was that cohorts would have differing viewpoints on selecting these risks.

While the findings of this exploratory study demonstrate variability in viewpoints, they also suggest a number of points of consensus to consider when writing Key Information.

The ethics of consent
Peter Ellis
Journal of Kidney Care, 13 February 2019; 4(1)
Abstract
As healthcare professionals, we come into contact with patients on a daily basis, and it is important that the professional relationship we develop with our patients is one built on respect and trust. One important element of this is gaining consent. In this article, Peter Ellis explores what consent is, why it is important and when and how it should be gained.

The Ever-Changing Landscape of Informed Consent and Whether the Obligation to Explain a Procedure to the Patient May Be Delegated
Samuel D. Hodge, Maria Zambrano Steinhaus
Arkansas Law Review, January 2019; 71(3)
Abstract
Informed consent is an integral part of the shared decision making process and requires a patient be informed of the benefits, risks and alternatives to a medical procedure. This information, which requirement has been codified into the law and practice of every healthcare provider, helps a patient decide whether to proceed with the recommended treatment plan. Informed consent has its foundation in the ethical notion of patient autonomy and fundamental human rights. After all, it is the patient’s decision to determine what may be done to his or her body and to ascertain the risks and benefits before undertaking a procedure. On the other hand, a physician’s role is to act as a facilitator in the patient’s decision making process by providing information about the planned treatment and to answer questions. While the roles of the patient and physician seem clearly defined, a number of barriers present challenges in creating a process that guarantees a patient understands a test or procedure. This includes ineffective communication between the doctor and patient. The first part of this article will explore the liability of various health care providers who participate in the informed consent process, such as the physician, nurse, physician assistant and hospital. The second section will examine whether the treating physician may delegate the duty to explain the risks and alternatives of a procedure to another. The controversial decision of Shinal v. Toms, which mandates that the doctor must have a one-on–one exchange with the patient in order to secure a valid informed consent, will also be explored. This recent ruling has sent shock waves throughout the medical community causing a reexamination of their informed consent policies.

Editor’s Note: Information on the Shinal v. Toms case can be found here

Autonomy Challenges in Epigenetic Risk-Stratified Cancer Screening: How Can Patient Decision Aids Support Informed Consent?
Maaike Alblas, Maartje Schermer, Yvonne Vergouwe, Ineke Bolt
Journal of Personalized Medicine, 18 February 2019; 9(1)
Abstract
Information of an individual’s epigenome can be useful in cancer screening to enable personalised decision making on participation, treatment options and further screening strategies. However, adding this information might result in complex risk predictions on multiple diseases, unsolicited findings and information on (past) environmental exposure and behaviour. This complicates informed consent procedures and may impede autonomous decision-making. In this article we investigate and identify the specific features of epigenetic risk-stratified cancer screening that challenge the current informed consent doctrine. Subsequently we describe current and new informed consent models and the principle of respect for autonomy and argue for a specific informed consent model for epigenetic risk-stratified screening programmes. Next, we propose a framework that guides the development of Patient Decision Aids (PDAs) to support informed consent and promote autonomous choices in the specific context of epigenetic cancer screening programmes.