Informed Consent for Neurosurgical Innovation [BOOK CHAPTER]
Faith C. Robertson, Tiit Mathiesen, Marike L. D. Broekman
Ethics of Innovation in Neurosurgery, 22 February 2019; pp 11-25
Abstract
While innovation in neurosurgery introduces novel medical devices, lifesaving therapies, and critical advancements in procedural care, it also presents ethical challenges regarding informed consent, particularly as innovative treatment options may provide better patient outcomes, but unprecedented surgical interventions may include unknown risk. The process of informed consent relies on appropriate provision of information to a competent patient in efforts to permit patient autonomy over healthcare decision-making without coercion. Importantly, informed consent is not isolated to a single conversation and document signing but is rather an ongoing process of communication throughout the trajectory of the patient’s care. However, neurosurgical patients are one of the most vulnerable populations, as those eligible for experimental procedures often have illnesses refractory to standard therapies, and alternative treatments may be limited. Furthermore, for disease processes affecting information processing or the ability to participate in high-level cognitive decision-making, an individual’s capacity to partake in informed consent may be hindered. At present, there is limited guidance for how neurosurgeons should approach the informed consent process for novel treatments, and there is controversy over the extent to which a surgeon should discuss the innovative nature of the procedure, the evidence or lack thereof, the associated or unknown risks and benefits, the operating surgeon’s learning curve with respect to experience with the procedure, and the alternative treatment options. This chapter summarizes the importance and difficulties of informed consent within neurosurgery, including patient capacity, content and format of discussion, and coercion—all key factors in the attainment of proper consent and the clinical decision process. We underscore the inherent complexity in balancing scientific evidence, clinical expertise, and patient and family preference when pursuing innovative neurosurgical treatments, in efforts to bring about discussion on improvements we can make within the field. Ultimately, this moral discourse is invaluable in creating a situation where investigators assume a responsibility of ensuring respect for persons, beneficence, and justice as we work to propel the field of neurosurgery forward.

Factors complicating the informed consent process for whole exome sequencing in neonatal and pediatic intensive care units
CJ Diamonstein
Journal of genetic counseling, 8 February 2019; Special Issue
Abstract
Whole exome and whole genome sequencing (WES/WGS) is increasingly utilized in inpatient settings such as neonatal and pediatric intensive care units (ICU), but no research has explored the process of informed consent in this setting. My experience as an inpatient genetic counselor has illuminated factors unique to the ICU that may threaten elements of informed consent such as voluntariness, disclosure, understanding, and capacity. I present three cases that exemplify elements complicating consent counseling for WES/WGS in the ICU, including the emotional state of the parents, involvements of other healthcare providers, environmental distractions and competing clinical priorities. I offer strategies to navigate these factors based on my experience.

Informed Consent and the Ethics of Placebo-Based Interventions in Clinical Practice [BOOK CHAPTER]
Marco Annoni, Franklin G. Miller
Placebos and Nocebos in Headaches, 12 February 2019; pp 135-142
Abstract
In this chapter we explore the ethics of informed consent with respect to the prescription of effective treatments, like acupuncture, that according to evidence-based standards have a prevalent placebo component. First, we review empirical studies demonstrating that placebo effects may significantly modulate symptoms in highly prevalent conditions, taking migraine as our case in point. Next, we chart the ethical implications of prescribing interventions that have been found slightly more effective than placebos and yet significantly better than no treatment—a class of remedies that we label as “placebo-based interventions.” We argue that, provided certain conditions are met, doctors may ethically prescribe placebo-based interventions in nondeceptive ways. By contrast, we contend the prescription of placebo treatments is incompatible with informed consent unless the true nature of the remedy is transparently disclosed to patients.

Clinical Trials Informed Consent: An educational intervention to improve nurses’ knowledge and communications skills
Eileen Regan
Clinical Journal of Oncology Nursing, December 2018; 22(6):E152–E158
Background
Teach-back is an evidence-based tool recommended for use during informed consent (IC) discussions. The nurses’ role in the IC process is important, particularly for patient education and advocacy.
Objectives
The aim was to initiate and evaluate an educational program for nurses to improve knowledge and communication skills used in IC for cancer clinical trials.
Methods
An educational program was presented to nurses. Anonymous pre-, post-, and one-month postprogram surveys measured nurses’ knowledge of research and the importance of and confidence using teach-back during IC discussions.
Findings
Nurses had high research knowledge scores and statistically significant improvement in pre- and post-test scores of conviction and confidence using teach-back. Nurses employed essential elements of teach-back before the program but had greater recognition of elements after the program.