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
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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.
Dynamic consent management for clinical trials via private blockchain technology
Dynamic consent management for clinical trials via private blockchain technology
Original Research
Giuseppe Albanese, Jean-Paul Calbimonte, Michael Schumacher, Davide Calvaresi
Journal of Ambient Intelligence and Humanized Computing, 14 February 2020
Abstract
Clinical trials (CTs) are essential for the advancement of medical research, paving the way for the development and adoption of new treatments, and contributing to the evolution of healthcare. An essential factor for the success of a CT is the appropriate management of its participants and their personal data. According to the current regulations, collecting and using personal data from participants must comply with rigorous standards. Therefore, healthcare institutes need to obtain freely given, specific, informed, and unambiguous consent before being able to collect the data. Some of the major limitations of the current technological solutions are the lack of control over the granularity of consent grants, as well as the difficulty of handling dynamic changes of consent over time. In this paper, we present SCoDES, an approach for trusted and decentralized management of dynamic consent in clinical trials, based on blockchain technology (BCT). The usage of blockchain provides a set of features that allow maintaining consent information with trust guarantees while avoiding the need for a dedicated or centralized third trusted party. We provide a full implementation of SCoDES, made available as a self-contained infrastructure, with the possibility to interact with external services, and using hyperledger as a blockchain framework.
Editor’s note: The SCoDES project is an applied research project on blockchains involving five Hautes Ecoles from French-speaking Switzerland… Its goal is to develop knowledge within the field of blockchain and smart contracts by studying and developing practical cases of use and transferring the acquired knowledge to the regional economic actors.
Research Consent Models Used in Prospective Studies of Neurologically Deceased Organ Donors: A Systematic Review
Research Consent Models Used in Prospective Studies of Neurologically Deceased Organ Donors: A Systematic Review
Research Article
Frederick D’Aragon, Karen E. A. Burns, Amanda Yaworski, Amanda Lucas, Erika Arseneau, Emilie Belley-Cote, Sonny Dhanani, Anne-Julie Frenette, François Lamontagne, François Lauzier, Aemal Akhtar, Simon Oczkowski, Bram Rochwerg, Maureen O. Meade
Journal of Empirical Research on Human Research Ethics, 13 February 2020
Abstract
Research to inform the care of neurologically deceased organ donors is complicated by a lack of standards for research consent. In this systematic review, we aim to describe current practices of soliciting consent for participation in prospective studies of neurologically deceased donors, including the frequency and justification for these various models of consent. Among the 74 studies included, 14 did not report on any regulatory review, and 13 did not report on the study consent procedures. Of the remaining 47 studies, 24 utilized a waiver of research consent. The most common justification for a waiver of research consent related to the fact that neurologically deceased donors are not considered human subjects. In conclusion, among studies of neurologically deceased donors, research consent models vary and are inconsistently reported. Consensus and standardization in the application of research consent models will help to advance this emerging field of research.
Remote Consent Clinical Research
Remote Consent Clinical Research
Commentary
Sriram Preethi
Clinical Trials and Practice, 30 October 2019; 1(1) pp 39-41
Open Access
Abstract
Recruitment in clinical research trials can be challenging in trials that are time-sensitive and/or are rare disease and critical care trials. One of the hurdles for recruitment in these types of clinical trials is due to the consent process, and the need to have consent of the patient within a certain timeframe, or the patient unable to consent for themselves. This paper will discuss the usage of the utilization of remote consent options for these trials.
An assessment of provider satisfaction with the use of a standardized visual aid for informed consent for appendectomy in children
An assessment of provider satisfaction with the use of a standardized visual aid for informed consent for appendectomy in children
Brittany L. Johnson, Eric H. Rosenfeld, Brittany D. Carter, Monica E. Lopez, Annalyn S. DeMello, David E. Wesson, Mary L. Brandt
Journal of Pediatric Surgery, 1 February 2020
Abstract
Purpose
We previously validated a visual aid for the use in the consent process for an appendectomy showing improved parental satisfaction and understanding. In this study, we evaluated provider satisfaction and perceived value of using the visual aid.
Methods
An IRB approved survey was developed assessing provider experience with use of the visual aid. This was distributed and analyzed via Research Electronic Data Capture (RedCap) Database.
Results
We administered 58 surveys (45% response rate). Participants included faculty (n = 2), fellows (n = 1), residents (n = 6), and physician assistants (n = 17). The visual aid was used > 10 times by 50% of providers. The most common reason for not using the visual aid was not remembering it was available. Nearly half (40%) did not feel the visual aid added any time. 9/20 (45%) felt it added a small amount of time. Slightly over half of providers (52%) felt using the visual aid significantly increased family ability to give informed consent and made the consenting process easier for both providers and families.
Conclusion
Using a visual aid in consenting families for appendectomy does not add significant time and subjectively improves the process for providers and increases provider perception of parental understanding.
Center for Informed Consent Integrity 