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.
Category: General/Other
[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
Opt-in consent policies: potential barriers to hospital health information exchange
Opt-in consent policies: potential barriers to hospital health information exchange
Apathy NC, Holmgren AJ
The American Journal of Managed Care, 1 January 2020; 26(1) e14-e20
Abstract
Objectives
To (1) assess whether hospitals in states requiring explicit patient consent (“opt-in”) for health information exchange (HIE) are more likely to report regulatory barriers to HIE and (2) analyze whether these policies correlate with hospital volume of HIE.
Study Design
Cross-sectional analysis of US nonfederal acute care hospitals in 2016.
Methods
We combined legal scholarship surveying HIE-relevant state laws with the American Hospital Association Annual Information Technology Supplement for regulatory barriers and hospital characteristics. Data from CMS reports for hospitals attesting to Meaningful Use stage 2 (MU2; renamed “Promoting Interoperability” in 2018) in 2016 captured hospital HIE volume. We used multivariate logistic regression and linear regression to estimate the association of opt-in state consent policies with reported regulatory barriers and HIE volume, respectively.
Results
Hospitals in states with opt-in consent policies were 7.8 percentage points more likely than hospitals in opt-out states to report regulatory barriers to HIE (P = .03). In subgroup analyses, this finding held among hospitals that did not attest to MU2 (7.7 percentage points; P = .02). Among hospitals attesting, we did not find a relationship between opt-in policies and regulatory barriers (8.0 percentage points; P = .13) or evidence of a relationship between opt-in policies and HIE volume (β = 0.56; P = .76).
Conclusions
Our findings suggest that opt-in consent laws may carry greater administrative burdens compared with opt-out policies. However, less technologically advanced hospitals may bear more of this burden. Furthermore, opt-in policies may not affect HIE volume for hospitals that have already achieved a degree of technological sophistication. Policy makers should carefully consider the incidence of administrative burdens when crafting laws pertaining to HIE.
Researcher Views and Practices around Informing, Getting Consent, and Sharing Research Outputs with Social Media Users When Using Their Public Data
Researcher Views and Practices around Informing, Getting Consent, and Sharing Research Outputs with Social Media Users When Using Their Public Data
Nicholas Proferes, Shawn Walker
Proceedings of the 53rd Hawaii International Conference on System Sciences, 2020
Open Access
Abstract
Publicly accessible social media data is frequently used for scientific research. However, numerous questions remain regarding what ethical obligations researchers have in regard to using such content. We report on researchers’ own views and practices regarding informing, getting consent from, and sharing research outputs with users when using publicly accessible social media data. Findings reveal both diverging current practices and views on what researchers ought to do in the future. Some researchers view the ethics of public data use as merely requiring compliance with the requirements of their ethics board, while others’ ethical practices go beyond what is minimally required. Some researchers worry about the effects of contacting users to inform, seek consent, or share outputs with users. Yet others note that they want to build bridges with online communities through these mechanisms, but struggle with a lack of precedent and tools to do so at scale.
The role of authentic choices in medical consent [PhD Thesis]
The role of authentic choices in medical consent [PhD Thesis]
Alexander Villafranca
University of Manitoba Electronic Thesis, 23 December 2019
Open Access
Abstract
This dissertation investigates whether the “authenticity” of a patient’s choice (i.e. its correspondence with important markers of the patient’s identity), should be part of a model of valid medical consent. This research question was addressed across three manuscripts using philosophical and empirical methods. Manuscript one is a philosophical manuscript defending my thesis that the standard model of valid consent may be improved by including the “authenticity” of a patient’s choice as an additive condition, thereby forming what I call the “authenticity-informed model of valid consent”. In this manuscript, I present seven procedural practices stemming from this new model. I argue that these practices should be considered for inclusion in the existing procedural recommendations of the Canadian Medical Protective Association (CMPA), which draw heavily from the standard model. The new practices could help physicians to i) more accurately evaluate the decisional capacity of patients; ii) more accurately evaluate the autonomy of patient choices, and iii) better support the psychological and physical well-being of patients. I also created vignettes to assess empirically whether the end goal of promoting authentic and autonomous patient choices would have instrumental value above choices that are solely autonomous. In manuscript two, I introduce the use of pretesting to evaluate and enhance the rigor of vignettes studies used in empirical ethics research. This manuscript includes an illustrative example of how data collected through a respondent debriefing procedure can be used to measure numerous desirable vignette characteristics. Manuscript three uses the vignettes to evaluate the instrumental value of shifting from a choice that is solely autonomous to one that is both authentic and autonomous in a single, but consequential, clinical scenario. This study confirms that shifting from a solely autonomous choice to an authentic and autonomous choice can substantially decrease anticipated decisional regret and increase both anticipated decisional satisfaction and compliance with postoperative instructions. In conclusion, there are plausible reasons to believe that adding authenticity may improve the standard model of valid consent and its associated procedural practices. Consequently, consideration should be given to modifying the procedural recommendations of the CMPA to reflect the addition of authenticity.
Rethinking Informed Consent in a Relational Perspective
Rethinking Informed Consent in a Relational Perspective
Fabio Macioce
notizie di POLITEIA, 2019; pp. 111-128 111
Open Access
Abstract
The article takes the interplay between autonomy and vulnerability into consideration, arguing that the informed consent procedures should be rethought in a relational perspective, so as to improve patients’ right to self-determination. The article aims to demonstrate that communicative contexts and power relations are as relevant as the quantity or the quality of information provided, as well as their form, modality, and effects. In order to discuss this topic, the recent Italian Act No. 219/2017 is analysed: more than other legal instruments, it explicitly asks to take the specific condition of every person into account, and to adapt the informative process to the needs of the patient. The precondition of a free and informed consent, besides the information received, is the relationship of trust between the parties involved, and the consistency between their modes of interaction and the necessity to keep a mutual trust. In that sense, the information is adequate and relevant as a function of the kind of relationship between the parties. The article argues that even if such a goal is largely outside the reach of the legislator, the legal system can settle the condition to make the relationship of trust possible.
Informed Consent: A Monthly Review
___________________________
January 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 GE2P2 Global Foundation’s Center for Informed Consent Integrity, which 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_January 2020
Informed about Informed Consent: A Qualitative Study of Ethics Education
Informed about Informed Consent: A Qualitative Study of Ethics Education
Rocksheng Zhong, John K. Northrop, Puneet K.C. Sahota, Anthony L. Rostain
Online Journal of Health Ethics, January 2019 ;15(2)
Open Access
Abstract
Iformed consent is a foundational concept in modern medicine. Despite physicians’ ethical and legal obligations to obtain informed consent, no standard curriculum exists to teach residents relevant knowledge and skills. This paper presents a qualitative study of residents at one academic medical center. The authors conducted focus groups with trainees in the Departments of Internal Medicine, Emergency Medicine, and Ob/Gyn and analyzed their responses using rigorous qualitative methods. Four themes emerged: First, participants agreed that informed consent and decision-making capacity were relevant in many clinical situations. Second, participants varied widely in their understandings of consent. Third, current resident training was insufficient. Fourth, more training was needed. These results add to the growing literature that ethics education in residency is desired and useful. The findings will help educators craft instruments assessing the prevalence and degree of deficiencies related to informed consent competencies and aid in the development of a model curriculum.
Center for Informed Consent Integrity 