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.
Year: 2020
Systematic Review of Preoperative Risk Discussion in Practice
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
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
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]
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.
A Human-centric Perspective on Digital Consenting: The Case of GAFAM [CONFERENCE PAPER]
A Human-centric Perspective on Digital Consenting: The Case of GAFAM [CONFERENCE PAPER]
Human Soheil, Cech Florian
Human Centred Intelligent Systems, 17 June 2020 – 19 June 2020; Split, Croatia
Open Access
Abstract
According to different legal frameworks such as the European General Data Protection Regulation (GDPR), an end-user’s consent constitutes one of the well-known legal bases for personal data processing. However, research has indicated that the majority of end-users have difficulty in understanding what they are consenting to in the digital world. Moreover, it has been demonstrated that marginalized people are confronted with even more difficulties when dealing with their own digital privacy. In this research, we use an enactivist perspective from cognitive science to develop a basic human-centric framework for digital consenting. We argue that the action of consenting is a sociocognitive action and includes cognitive, collective, and contextual aspects. Based on the developed theoretical framework, we present our qualitative evaluation of the consent-obtaining mechanisms implemented and used by the five big tech companies, i.e. Google, Amazon, Facebook, Apple, and Microsoft (GAFAM). The evaluation shows that these companies have failed in their efforts to empower end-users by considering the human-centric aspects of the action of consenting. We use this approach to argue that their consent-obtaining mechanisms violate principles of fairness, accountability and transparency. We then suggest that our approach may raise doubts about the lawfulness of the obtained consent—particularly considering the basic requirements of lawful consent within the legal framework of the GDPR.
Informed Consent: A Monthly Review
___________________________
March 2020
This digest aggregates and distills 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 Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation 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 2020
Germline Genome Editing Research: What Are Gamete Donors (Not) Informed About in Consent Forms?
Germline Genome Editing Research: What Are Gamete Donors (Not) Informed About in Consent Forms?
Research Article
Emilia Niemiec, Heidi Carmen Howard
The CRISPR Journal, February 2020; 3(1) 2020
Open Access
Abstract
The potential for using germline genome editing (GGE) in humans has garnered a lot of attention, both for its scientific possibilities as well as for the ethical, legal, and social challenges it ignites. The ethical debate has focused primarily on the suggestions of using GGE to establish a pregnancy (i.e., to offer it in a clinical setting), which is, to date, illegal in many jurisdictions. The use of GGE in research (where a pregnancy would not be established) has received much less attention, despite the fact that it raises serious ethical and social issues as well. Herein, we report on the analysis of informed consent forms for egg and sperm donation used in a widely publicized study where genome editing was used to correct a disease-causing genetic mutation in human embryos. Importantly, embryos were created using eggs and sperm obtained specifically for these experiments. The analysis indicates deficiencies in how the forms addressed various issues, including limited and potentially misleading information about the sensitive nature of the study, the lack of an explicit mention of genomic sequencing, as well as the poor readability of the forms. Furthermore, the arguably high compensation of U.S.$5,000 for egg donors raises questions about undue inducement to participate in research. Moreover, since the procurement of eggs involves serious health risks, it may be questioned whether research requiring such a procedure should be pursued. If such experiments are continued, donors should be informed about all relevant aspects in order to make informed decisions about participating.
Informed Consent for Genetic Testing in Autopsy
Informed Consent for Genetic Testing in Autopsy
Editorial
Ken Gatter
Archives of Pathology & Laboratory Medicine, 2020
Open Access
Excerpt
As next generation sequencing, whole exome sequencing, and other genetic tests become cheaper and more prevalent, pathologists will likely incorporate genetic testing into routine autopsies. Such testing has great promise for helping diagnose and treat living and future family members, but also raises questions about whether current consenting practices for autopsy are adequate. How is informed consent in the autopsy context different from informed consent in the typical clinical setting? Should we require specific consent for genetic autopsy testing?…
Trust and consent: a prospective study on parents’ perspective during a neonatal trial
Trust and consent: a prospective study on parents’ perspective during a neonatal trial
Original Research
Sonia Dahan, Camille Jung, Gilles Dassieu, Xavier Durrmeyer, Laurence Caeymaex
Journal of Medical Ethics, 20 February 2020
Abstract
Objective
This study aimed to describe how parents and physicians experienced the informed consent interview and to investigate the aspects of the relationship that influenced parents’ decision during the consent process for a randomised clinical trial in a tertiary neonatal intensive care unit (NICU). The secondary objective was to describe the perspectives of parents and physicians in the specific situation of prenatal informed consent.
Setting
Single centre study in NICU of the Centre Hospitalier Intercommunal de Créteil, France, using a convenience period from February to May 2016.
Design
Ancillary study to a randomised clinical trial: Prettineo. Records of interviews for consent. Population: parents and physicians. Mixed study including qualitative and quantitative interview data about participants’ recall and feelings about the consent process. Interviews were reviewed using thematic discourse analysis.
Results
Parents’ recall and understanding of the study’s main goal and design was good. Parents and physicians had a positive experience, and trust was one of the main reasons for parents to consent. Misunderstanding (bad comprehension) was the main reason for refusal. Before birth, three situations can compromise parents’ consent: the mother already consented to participate in other studies, the absence of the father during the interview and the feeling that the baby’s birth is not an imminent possibility.
Conclusions
Confronting parents and physicians’ perspectives in research can help us reach answers to sensitive issues such as content and timing of information. Each different types of study raises different ethical dilemmas for consent that might be discussed in a more individual way.