The Importance of Physician Directed Informed Consent
Neena Oza
Journal of Health Care Finance, 2020
Open Access
Abstract
The process and scope of procedural/surgical informed consent has changed dramatically with emerging technologies, expanding medical knowledge, updated outcomes data and increased recognition of patient autonomy.  With the paradigm shifting towards ethical considerations of patient care and active involvement of patient’s in their treatment, medical practices and laws have evolved to guide communication standards between the patient and physician.  The delivery of all relevant information should enable the patient to make an informed decision regarding the procedure, while preserving the core principles of patient understanding and free consent, devoid of coercion or manipulation.[1],3  Additionally, education and counseling delivered during the informed consent should relieve the patient’s safety concerns related to procedures and to address patient knowledge deficiencies, present other alternative plans or procedures, as well as any possible perceived coercion related to noninvasive and invasive procedures.  The intent of this article will be to further explain the rationale for the performing provider, attending physician or surgeon, to be the sole person ultimately responsible for providing the patient with the goals, risks and benefits of the proposed treatment or intervention; and for the words and actions of any other medical team member (such as medical students or residents) that may assisting during the informed consent process.

Reconsidering the Process of Informed Consent in Assisted Reproductive Technology: Experiences and Implications for Practice
Reflections
Fabiola Fedele, Barbara Cordella, Viviana Langher
Psychological Studies, 28 March 2020
Abstract
A patient’s conscious decision to voluntarily undergo a therapeutic treatment is called informed consent (IC). The aim of IC is to provide information about health and treatment options and increase patient’s participation in healthcare decision-making. IC therefore honors the ethical principles of human autonomy and self-determination. In the field of assisted reproductive technology (ART), the process of communication and mutual understanding between patient and doctor (the IC process) is a current and relevant issue due to its medical, ethical and psychological implications. This exploratory research aims to understand how couples with infertility problems relate to the ART IC, and it proposes the innovative experience of IC conversations with a psychologist. It also provides practical advice on a better use of IC process in ART centers.

Systematic Review of Preoperative Risk Discussion in Practice
Original Reports
Davis M. Aasen, Brett M. Wiesen, Abhinav B. Singh, Christi Piper, Ben Harnke, Allan V. Prochazka, Aaron S. Fink, Karl E. Hammermeister, Robert A. Meguid
Journal of Surgical Education, 16 March 2020
Abstract
Background
Informed consent is an ethical imperative of surgical practice. This requires effective communication of procedural risks to patients and is learned during residency. No systematic review has yet examined current risk disclosure. This systematic review aims to use existing published information to assess preoperative provision of risk information by surgeons.
Methods
Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses as a guide, a standardized search in Ovid MEDLINE, Embase, CINHAL, and PubMed was performed. Three reviewers performed the study screening, with 2-reviewer consensus required at each stage. Studies containing objective information concerning preoperative risk provision in adult surgical patients were selected for inclusion. Studies exclusively addressing interventions for pediatric patients or trauma were excluded, as were studies addressing risks of anesthesia.
Results
The initial search returned 12,988 papers after deduplication, 33 of which met inclusion criteria. These studies primarily evaluated consent through surveys of providers, record reviews and consent recordings. The most ubiquitous finding of all study types was high levels of intra-surgeon variation in what risk information is provided to patients preoperatively. Studies recording consents found the lowest rates of risk disclosure. Studies using multiple forms of investigation corroborated this, finding disparity between verbally provided information vs chart documentation.
Conclusions
The wide variance in what information is provided to patients preoperatively inhibits the realization of the ethical and practical components of informed consent. The findings of this review indicate that significant opportunities exist for practice improvement. Future development of surgical communication tools and techniques should emphasize standardizing what risks are shared with patients.

Attitudes About Informed Consent: An Exploratory Qualitative Analysis of UK Psychotherapy Trainees
Original Research Article
Charlotte R. Blease, Tim Arnott, John M. Kelley, Gillian Proctor, Tobias Kube, Jens Gaab, Cosima Locher
Frontiers in Psychiatry, 13 March 2020
Open Access
Abstract
Background
Ethical informed consent to psychotherapy has recently been the subject of in-depth analysis among healthcare ethicists.
Objective
This study aimed to explore counseling and psychotherapy students’ views and understanding about informed consent to psychological treatments.
Methods
Two focus groups were conducted with a total of 10 students enrolled in a Masters course in counseling and psychotherapy at a British university. Questions concerned participants’ understanding of informed consent including judgments about client capacity; the kinds of information that should be disclosed; how consent might be obtained; and their experiences of informed consent, both as a client and as a therapist. Focus groups were audio-recorded, transcribed, and analyzed using qualitative content analysis. Coding was conducted independently by three authors.
Results
Comments were classified into three main themes: (1) the reasons and justifications for informed consent; (2) informed consent processes; and (3) the hidden ethics curriculum. Some trainees expressed significant doubts about the importance of informed consent. However, participants also identified the need to establish the clients’ voluntariness and their right to be informed about confidentiality issues. In general, the format and processes pertaining to informed consent raised considerable questions and uncertainties. Participants were unsure about rules surrounding client capacity; expressed misgivings about describing treatment techniques; and strikingly, most trainees were skeptical about the clinical relevance of the evidence-base in psychotherapy. Finally, trainees’ experiences as clients within obligatory psychotherapy sessions were suggestive of a “hidden ethics curriculum”—referring to the unintended transmission of norms and practices within training that undermine the explicit guidance expressed in formal professional ethics codes. Some students felt coerced into therapy, and some reported not undergoing informed consent processes. Reflecting on work placements, trainees expressed mixed views, with some unclear about who was responsible for informed consent.
Conclusions
This qualitative study presents timely information on psychotherapy students’ views about informed consent to psychotherapy. Major gaps in students’ ethical, conceptual, and procedural knowledge were identified, and comments suggested the influence of a hidden curriculum in shaping norms of practice.
Implications
This exploratory study raises important questions about the preparedness of psychotherapy students to fulfill their ethical obligations.

On shared decision-making and informed consent
Editorial
James L. Bernat, Michael P. McQuillen
Neurology Clinical Practice, 11 March 2020
Excerpt
In the idealized concept of shared decision-making, the physician and patient comprise a collaborative clinical decision-making dyad. The physician contributes medical knowledge, training, experience, and judgment, whereas the patient contributes personal values and health care goals through which to evaluate how each treatment option could fulfill those goals. As partners, the patient and physician collaboratively achieve a mutually agreeable medical decision through an ongoing communication process that creates informed consent…

Informed Consent in Fetal Hypoplastic Left Heart Syndrome [BOOK CHAPTER]
Constantine Mavroudis, Angira Patel, Rupali Gandhi
Bioethical Controversies in Pediatric Cardiology and Cardiac Surgery
Springer, 29 February 2020; pp 163-177
Abstract
Informed Consent in the setting of complex fetal congenital heart disease such as hypoplastic left heart syndrome involves many concerned individuals who include: the mother, the father, the obstetrician, the pediatric cardiologist, the pediatric cardiac surgeon, and many others. It is the duty of the physician to administer and perform informed consent under high risk pre- and postnatal circumstances that require high risk surgical options without which the newborn baby would most certainly die. We explore the intricate roll that physicians play in the informed consent process from prenatal to post-natal circumstances which include making decisions about pregnancy termination, comfort care, and staged palliation. Important considerations such as the importance of the woman’s bodily integrity, autonomy, and the ethics of comfort care are discussed with reference to other complex congenital heart lesions. We conclude that informed consent for HLHS decisions is best practiced by a multi-disciplinary organized approach that will allow comprehensive counseling by multiple care-givers in a timely fashion. Ultimately, the obstetrician/pediatric cardiologist team continue to be the primary physicians that assist with shared decision-making.

Consent in Oral Surgery: a Guide for Clinicians
Mohammed M Dungarwalla, Edmund Bailey
Dental Update, 17 February 2020; 47(2)
Abstract
The consent process remains a pillar of excellent clinical care. The changes in the law after the Montgomery ruling in 2015 has changed the shape of consent, and now, taking adequate consent can be extensive and sometimes confusing for clinicians and patients. Dentists are sometimes faced with the unenvious task of weighing up what patients should know versus what they want to know. This paper aims to describe the consent process for more common oral surgical procedures, helping clinicians to allow their patients to make informed decisions.

Transparent Defaults and Consent for Participation in a Learning Health Care System: An Empirical Study
Research Article
Vilius Dranseika, Jan Piasecki
Journal of Empirical Research on Human Research Ethics, 11 February 2020
Abstract
We report a preregistered study that was designed to answer three questions about using transparent defaults to increase participation in a hypothetical learning health care system. Do default options influence consent to participate in learning activities within a learning health care system? Does transparency about default options decrease the effect of the defaults? Do people reconsider their choice of participation once they are informed about the defaults applied? In our study, application of the defaults did not have influence on rates of consent, nor did transparency about defaults have an effect on the rates of consent. Participants were also not likely to change their choice after being informed that defaults were applied to their previous choice. In general, our study raises doubts that defaults (both covert and transparent) can be used as an effective means in significantly increasing participation in learning health care systems.

How many facts make an “informed patient”? Practical challenges for junior doctors in acquiring surgical informed consent
Josephine de Costa, Alan De Costa, Mandy Shircore
ANZ Journal of Surgery, 6 February 2020; 89 (S1) pp 106-1063
Abstract
Purpose
In addition to technical surgical skills, the complete surgeon requires skills in communication and consenting patients. This protects patients, hospitals, and doctors themselves, but also promotes best practice. However, surgical informed consent (SIC) is commonly acquired by junior doctors (defined as PGY1 until completion of specialist training). Little is known about the quality of SIC that doctors at this level may acquire. This study aimed to synthesize known evidence on challenges faced by junior doctors on this issue.
Methodology
The authors conducted a systematic review of all English-language studies published from 1 January 2007 looking at junior doctors (considered to be from PGY1 to the end of specialist training) and any issues that arose around acquiring SIC. A qualitative synthesis was then conducted.
Results
Junior doctors understanding of the legal standards of consent, including both capacity/competence and the concepts of material risk, varied considerably across studies. Documentation and discussion of possible complications in surgery was found to be highly variable within both trainees and consultants consenting practices. Few junior doctors discussed alternative treatment options, including the possibility of having no treatment; evidence on discussion of benefits and recovery were conflicting. Overall documentation of the SIC process was poor.
Conclusions
While junior doctors are commonly responsible for acquiring SIC, this study shows that there are significant practical deficiencies in how they discharge this duty. As a result, SIC acquired by junior doctors may not always comply with required legal standards, which may open up this cohort, and their hospitals, to legal action.

Montgomery in, Bolam out: are trainee surgeons ‘material risks’ when taking consent for cataract surgery?
Review Article
Omar Qadir, Yusuf Abdallah, Helen Mulholland, Imran Masood, Stephen A. Vernon, Simon N. Madge
Eye, 4 February 2020
Abstract
Trainee involvement in cataract surgery is vital to allow proper training of the next generation of ophthalmic surgeons. However, recent changes in the UK Law, coupled with open publication of National Cataract Dataset results, lead us to conclude that the status of being a trainee is itself a material risk that now needs to be divulged to patients during the consent process. The opinions of current trainee surgeons in the UK were sampled via questionnaire and clinical negligence counsel was involved in the authorship of the paper in order to analyse the legal issues at stake. Attitudes towards consent regarding trainee involvement in UK cataract surgery need to change.