Consent for Emergency Treatment: Emergency Department Patient Recall and Understanding
Ashley LaFountain
Wright State Univseriity CORE Scholar, Scholarship in Medicine Papers, 2019
Abstract
Informed consent is an important ethical and legal requirement that underlies the concept of patient autonomy. This prospective survey study was conducted to assess patient recall and understanding of consent for treatment in adult emergency department (ED) patients at an urban level 1 trauma center with annual volume of 95,000, Miami Valley Hospital. Out of a total 293 patients, most individuals reported only receiving a verbal explanation of the consent document (45%) or not reading the document at all (36%). About half of the patients recalled consenting to treatment (N=144, 49%) and over one third of patients could not recall anything that they consented to during the consent process. These results demonstrate poor understanding of the informed consent document.
Unethical informed consent caused by overlooking poorly measured nocebo effects
Unethical informed consent caused by overlooking poorly measured nocebo effects
J. Howick
Journal of Medical Ethics, 16 February 2020
Open Access
Abstract
Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to share intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which such risk information is shared. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside the principle of autonomy when obtaining (ethical) informed consent.
Ethical Issues of Informed Consent: Students as Participants in Faculty
Ethical Issues of Informed Consent: Students as Participants in Faculty
Research
Phatcharapon Tulyakul, Soontareeporn Meepring
Global Journal of Health Science, 15 February 2020; 12(3)
Open Access
Abstract
Educators may face an ethical dilemma when they conduct research by using their own students as participants. The dual role conflict, coercion, confidentiality, misconstruction, and unawareness of the informed consent documents have been discussed as ethical issues in such faculty research. The educators as the researchers should be aware of these ethical dilemmas and attempt to implement the informed consent effectively. Thus, this article explores the ethical considerations of informed consent for the educational setting that students are recruited in the faculty research. Furthermore, this article represented recommendations for potentially resolving the ethical dilemmas of informed consent surrounding this phenomenon which consisted of eliminating dual role conflict and coercion, guarding confidentiality, and promoting good construction and awareness of the informed consent documents.
[Consent management and workflows for cross-sectoral patient records and teleconsultations]
[Consent management and workflows for cross-sectoral patient records and teleconsultations]
Bauer J, Rohner-Rojas S, Holderried M
Der Radiologe, 14 February 2020
Abstract
Cross-enterprise electronic patient records are a key element in the design of interoperable medical care networks and process chains. However, the different requirements concerning type, performance and quality assurance of available communication services within the different healthcare sectors still require that the hospitals participate in various secure communication networks which have to be bridged for cross-sectoral communication. Cross-institutional pathways for telemedicine, however, can be mapped both within and across sectoral boundaries via automated process chains using the IHE (Integrating the Healthcare Enterprise) defined integration profile CrossEnterprise Document Sharing (XDS) and associated integration profiles. The provision of medical documents in a cross-institutional patient record outside of defined medical pathways requires differentiated authorization management. In this respect, consent documents according to the IHE APPC (Advanced Patient Privacy Consents) profile enable the documentation of the patient’s consent, including information about planned authorized people, document types, period and type of document access allowed. Providing access control to medical documentation by the patients themselves is an essential part of the required focusing of medical services on patients. New interoperability standards optimized for use on mobile devices, such as FHIR (Fast Healthcare Interoperability Resources), will enable simplified delivery of patient-centered health records and other medical services on mobile platforms in the future.
Editor’s note: This is a German language publication. Der Radiologe is an internationally recognized publication. The journal is devoted to all aspects of radiology and serves to further train radiologists who are resident and who work in the clinic.
The peculiar case of the Standards of Care: Ethical ramifications of deviating from informed consent in transgender-specific healthcare
The peculiar case of the Standards of Care: Ethical ramifications of deviating from informed consent in transgender-specific healthcare
Practices and concepts
Lipshie-Williams
Ethics, Medicine and Public Health, April – June 2020; 13
Summary
In this article, we discuss the alternate model of consent that has become dominant for the provision of transgender-specific health care within the United States, referred to here as the Standards of Care model. This model, which requires medical professionals to provide official opinions on a transgender patient’s readiness to accept and undergo care, stands in contrast to the majority model of medical consent in the US, namely individually provided informed consent. Here, we review the informed consent model, including the basic ethical components of this model and the essential elements of medical decision-making capacity. We then consider the Standards of Care model. We situate its origins in pathological understandings of gender variance and review the current requirements of the model. Consideration is given to logical inconsistencies within the current Standards of Care model, which holds that gender variance is non-pathological and affirming care is medically necessary, but that adult patients requesting such care require psychiatric diagnoses and are unable to consent to their own care. We then consider the bioethical meaning of the Standards of Care model, which others have proposed cedes some of the patient autonomy offered by informed consent for an inflated reliance on nonmaleficence. We align ourselves with this position. We continue this interpretation to suggest that the Standards of Care model ultimately fails to deliver this proffered nonmaleficence.
Informed Consent: A Monthly Review
___________________________
February 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_February 2020
Do patients and research subjects have a right to receive their genomic raw data? An ethical and legal analysis
Do patients and research subjects have a right to receive their genomic raw data? An ethical and legal analysis
Research Article
Christoph Schickhardt, Henrike Fleischer & Eva C. Winkler
BMC Medical Ethics volume, 16 January 2020; 21(7)
Open Access
Abstract
Background
As Next Generation Sequencing technologies are increasingly implemented in biomedical research and (translational) care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice.
Methods
In a first step we clarify some central concepts such as “raw data”; in a second step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one’s raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data.
Results
In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom.
Conclusion
Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects’ legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations.
Exploring broad consent in the context of the 100,000 Genomes Project: a mixed methods study
Exploring broad consent in the context of the 100,000 Genomes Project: a mixed methods study
Lisa M. Ballard, Rachel H. Horton, Sandi Dheensa, Angela Fenwick & Anneke M. Lucassen
European Journal of Human Genetics, 9 January 2020
Abstract
The 100,000 Genomes Project (100kGP)—a hybrid clinical-research initiative—was set up to analyse whole-genome sequences (WGS) from patients living with a rare disease or cancer. The project positioned participant consent as being of central importance, but consent in the context of genomic testing raises challenging issues. In this mixed method study, we surveyed 1337 100kGP participants regarding their experiences of taking part in the project and conducted in-depth interviews with 24 survey respondents to explore these findings further. Survey responses were analysed using descriptive statistics and interview data were analysed thematically. The consent approach of the 100kGP resulted in a proportion of our study’s participants not understanding the complexities of the project and what types of results they might receive; for example, 20% of participants who we surveyed from the cancer arm did not recall what decisions they had made regarding additional findings. It is not surprising that a project such as this, with such diverse aims and participant groups, would throw up at least some challenges. However, participants reported being satisfied with their experience of the project to date. Our study highlights that in the context of consent for more complex endeavours, such as the 100kGP, it is important to assess (and document) an agreement to take part, but complicated decisions about what and when to communicate may need revisiting over time in response to changing contexts. We discuss the implications of our findings with reference to participants of the 100kGP and the newly formed NHS Genomic Medicine Service.
The Consent Form in the Chinese CRISPR Study: In Search of Ethical Gene Editing
The Consent Form in the Chinese CRISPR Study: In Search of Ethical Gene Editing
Guest Editorial
David Shaw
Journal of Bioethical Inquiry, 3 January 2020
Open Access
Abstract
This editorial provides an ethical analysis of the consent materials and other documents relating to the recent creation and birth of twin girls who had their genes edited using CRISPR-cas9 in a controversial Chinese research study. It also examines the “draft ethical principles” published by the leader of the research study. The results of the analysis further intensify serious ethical concerns about the conduct of this study.
Would you like to participate in this trial? The practice of informed consent in intrapartum research in the last 30 years
Would you like to participate in this trial? The practice of informed consent in intrapartum research in the last 30 years
Research Article
Mariana Widmer, Mercedes Bonet, Ana Pilar Betrán
PLOS One, 24 January 2020
Open Access
Abstract
Background
Informed consent is the cornerstone of the ethical conduct and protection of the rights and wellbeing of participants in clinical research. Therefore, it is important to identify the most appropriate moments for the participants to be informed and to give consent, so that they are able to make a responsible and autonomous decision. However, the optimal timing of consent in clinical research during the intrapartum period remains controversial, and currently, there is no clear guidance.
Objective
We aimed to describe practices of informed consent in intrapartum care clinical research in the last three decades, as reported in uterotonics for postpartum haemorrhage prevention trials.
Methods
This is a secondary analysis of the studies included in the Cochrane review entitled “Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis” published in 2018. All the reports included in the Cochrane network meta-analysis were eligible for inclusion in this analysis, except for those reported in languages other than English, French or Spanish. We extracted and synthesized data on the time each of the components of the informed consent process occurred.
Results
We assessed data from 192 studies, out of 196 studies included in the Cochrane review. The majority of studies (59.9%, 115 studies) reported that women were informed about the study, without specifying the timing. When reported, most studies informed women at admission to the facility for childbirth. Most of the studies reported that consent was sought, but only 59.9% reported the timing, which in most of the cases, was at admission for childbirth. Among these, 32 studies obtained consent in the active phase of labour, 17 in the latent phase and in 10 studies the labour status was unknown. Women were consented antenatally in 6 studies and in 8 studies the consent was obtained indistinctly during antenatal care or at admission. Most of the studies did not specified who was the person who sought the informed consent.
Conclusion
Practices of informed consent in trials on use of uterotonics for prevention of postpartum haemorrhage showed variability and substandard reporting. Informed consent sought at admission for childbirth was the most frequent approach implemented in these trials.
Center for Informed Consent Integrity 