Ethical failings of CPSO policy and the health care consent act: case review
Joshua T. Landry, Rakesh Patel, David Neilipovitz, Kwadwo Kyeremanteng, Gianni D’Egidio
BioMed Central Medical Ethics, 19 March 2019; 20(20)
Abstract
End-of-life disputes in Ontario are currently overwhelmingly assessed through the singular lens of patient autonomy. The current dispute resolution mechanism(s) does not adequately consider evidence-based medical guidelines, standards of care, the patient’s best interests, expert opinion, or distributive justice. We discuss two cases adjudicated by the Consent and Capacity board of Ontario that demonstrate the over emphasis on patient autonomy. Current health care policy and the Health Care Consent Act also place emphasis on patient autonomy without considering other ethically defensible factors. We argue that current policy and legislation require amendment, and unless there are measures undertaken to modify them, both the quality of care provided and the long-term capabilities of the health care system to remain publicly-funded, comprehensive and equitable, are at stake.
A review and analysis of new Italian law 219/2017: ‘provisions for informed consent and advance directives treatment’
A review and analysis of new Italian law 219/2017: ‘provisions for informed consent and advance directives treatment’
Marco Di Paolo, Federica Gori, Luigi Papi, Emanuela Turillazzi
BioMed Central Medical Ethics, 4 March 2019; 20(17)
Background
In December 2017, Law 219/2017, ‘Provisions for informed consent and advance directives’, was approved in Italy. The law is the culmination of a year-long process and the subject of heated debate throughout Italian society. Contentious issues (advance directives, the possibility to refuse medical treatment, the withdrawal of medical treatment, nutrition and hydration) are addressed in the law.
Main text
What emerges clearly are concepts such as quality of life, autonomy, and the right to accept or refuse any medical treatment – concepts that should be part of an optimal relationship between the patient and healthcare professionals. The law maximizes the value of the patient’s time to decide. Every patient is allowed to make choices for the present (consenting to or refusing current treatment) as well as for the future, conceived as a continuation of the present, and to decide what comes next, based on what he/she already knows. The law identifies three distinct but converging paths towards the affirmation of a care relationship based on reciprocal trust and respect: the possibility to consent to or refuse treatment, the shared care planning, and advance directives.
Conclusions
The fundamental point to emerge from the new Italian law is that consensus is an essential connotation of the treatment relationship. Consensus is not limited to the acceptance/rejection of medical treatment but is ongoing. It is projected into the future through shared care planning and advance directives which act as tools for self-determination and the manifestation of the beliefs and preferences of persons unable to express their will. These principles are in line with the idea of appropriate care as evaluated from two different perspectives, one of scientific adequacy and the other commensurate with the individual’s resources, fragility, values, and beliefs. Surely, however, the new law is not the end of the matter on issues such as conscientious objection, which is deeply rooted within the Italian cultural and political debate. In this regard, healthcare institutions and policymakers will be called upon to develop and implement organizational policies aimed at the management of foreseeable conscientious objection in this field.
Ethical governance of the medical research: clinical investigation and informed consent under the new EU Medical Devices Regulation (2017∕745)
Ethical governance of the medical research: clinical investigation and informed consent under the new EU Medical Devices Regulation (2017∕745)
Olimid DA, Olimid AP, Ifrim Chen F
Romanian Journal of Morphology and Embryology, 1 Jan 2018, 59(4):1305-1310
Purpose
The paper focuses on the ethical appraisal of the clinical investigations (CIs) and the informed consent within the new European Union (EU) legislation on medical devices (MDs). The Regulation (EU) 2017∕745 of the European Parliament and of the Council was adopted on 5 April 2017 and entered into force on 25 May 2017, repealing the Council Directives concerning Medical Devices 93∕42∕EEC and the Active Implantable Medical Devices 90∕385∕EEC.
Background
For the past thirty years, the EU legislation on MDs has been updated by several directives: Council Directive 90∕385∕EEC on Active Medical Devices (1990); Council Directive 93∕42∕EEC on Medical Devices (1993) and Council Directive 98∕79∕EC on In vitro Medical Devices (1998) aiming to frame the MDs market development.
Content
From the ethical perspective, the present article investigates the new rules concerning the CIs of the MDs for human use and accessories for such devices conducted in the EU by highlighting new regulatory aspects: (1) the framework of the clinical evaluation and CI; (2) the relevant definitions; (3) the ethical principles related to CIs; (4) the informed consent; (5) the role of the national ethics committees.
Conclusions
Although the new guidelines enable an extension of the definition of “medical device” and the harmonization of the rules for “the placing on market and putting into service of the medical devices”, it also regulates the MDs industry to ensure clinical benefits for patients and high standards of quality and safety.
Analysis of Privacy Policies to Enhance Informed Consent (Extended Version)
Analysis of Privacy Policies to Enhance Informed Consent (Extended Version)
Raúl Pardo, Daniel Le Métayer
Hyper Articles en Ligne, 15 Mar 2019
Abstract
In this report, we present an approach to enhance informed consent for the processing of personal data. The approach relies on a privacy policy language used to express, compare and analyze privacy policies. We describe a tool that automatically reports the privacy risks associated with a given privacy policy in order to enhance data subjects’ awareness and to allow them to make more informed choices. The risk analysis of privacy policies is illustrated with an IoT example.
Editor’s Note: “IoT” refers to the “internet of things” as explained in this article.
Performing informed consent in transgender medicine
Performing informed consent in transgender medicine
Shuster SM
Social Science and Medicine, 3 March 2019; 226 pp 190-197
Abstract
Using in-depth interviews with 23 physical and mental healthcare providers and observations at transgender-specific healthcare conferences between 2012 and 2015, I examine how medical providers negotiate informed consent processes in their clinical encounters with trans patients. While a growing body of scholarship has examined informed consent in scientific research from the patient’s perspective, a gap remains in how informed consent is understood in clinical encounters, and from providers’ perspectives. I use the case of trans medicine, an emergent field of medicine that has not yet implemented standardized procedures or policies that shape providers’ decision-making. I demonstrate how many providers of trans medicine give voice to following informed consent, but fail to actually practice it in their work with trans patients. In performing informed consent, providers revert to a paternalistic model of care, which amplifies their medical authority while veiling power differentials in their clinical encounters and decision-making in trans medicine.
Predicting major mental illness: ethical and practical considerations
Predicting major mental illness: ethical and practical considerations
Stephen M. Lawrie, Sue Fletcher-Watson, Heather C. Whalley and Andrew M. McIntosh
British Journal of Psychiatry, 2019; 5(e30) pp 1–5
Summary
An increasing body of genetic and imaging research shows that it is becoming possible to forecast the onset of major psychiatric disorders such as depression and schizophrenia before people become ill with ever improving accuracy. Practical issues such as the optimal combination of clinical and biological variables are being addressed, but the application of predictive algorithms to individuals or in routine clinical settings have yet to be tested. The development of predictive methods in mental health comes with substantial ethical questions, including whether people wish to know their level of risk, as well as individual and societal attitudes to the potential adverse effects of data sharing, early diagnosis and treatment, which so far have been largely ignored. Preliminary data suggests that at least some people think predictive research is valuable and would take part in such studies, and some would welcome knowing the results. Future initiatives should systematically assess opinions and attitudes in conjunction with scientific and technical advances.
Crisis at the Pregnancy Center: Regulating PseudoClinics and Reclaiming Informed Consent
Crisis at the Pregnancy Center: Regulating PseudoClinics and Reclaiming Informed Consent
Teneille R. Brown
Yale Journal of Law & Feminism, 2019; 30(2)
Abstract
Crisis Pregnancy Centers (CPCs) adopt the look of medical practices-complete with workers in scrubs, ultrasound machines, and invasive physical exams-to deceive pregnant women into thinking they are being treated by licensed medical professionals. In reality, CPCs offer exclusively Bible- based, non-objective counseling. Numerous attempts to regulate CPCs have faced political roadblocks. Most recently, in NIFLA v. Becerra, the Supreme Court held that state efforts to require CPCs to disclose that they are not medically licensed are unconstitutional violations of CPCs’ First Amendment right to free speech. In the wake of that decision, pregnant women in crisis-a disproportionate percentage of whom are low-income women, minority women, or women in vulnerable or dangerous situations-continue to be subject to CPCs’ ideological marketing, masquerading as medical advice.
Informed Consent: A Monthly Review
___________________________
March 2019
This digest is intended to aggregate and distill 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_March 2019
A Survey on Including Risks in the New “Key Information” Section of an Informed Consent Form
A Survey on Including Risks in the New “Key Information” Section of an Informed Consent Form
Katelyn Le, Stacy Kopka, Doreen Chaitt, Jerome Pierson, Martha Nason, Tracey Miller
Clinical Research (Alex), December 2018; 32(10) pp 18–29
Abstract
Informed consent forms (ICFs) are growing longer and more complex.{1–4} The forces behind this trend may be well-intentioned, such as the desire to disclose more accurate and complete information{1}; however, it raises questions about whether important information is buried in lengthy documents, as well as whether ICFs can be structured to better emphasize the information that is most relevant to a study participant.
Recent updates to what is generally known as the Common Rule for protection of human subjects in research are in part meant to respond to this trend. Among these updates is the introduction of a new section called “Key Information”—every ICF now must open with the most important information that potential subjects would want to know when deciding to join a study. But what exactly should this new section contain?
This question is crucial to us, a group of writers and reviewers who work with investigators to develop ICFs (the program was described in a 2013 issue of the ACRP Monitor{5}). For groups like ours, it is important to explore how best to implement the new regulations in a way that promotes consistency across different ICFs.
As an initial step, we wanted to understand how to objectively decide which risks to provide as Key Information. A survey was conducted to investigate how institutional review board (IRB) members, medical monitors, and principal investigators (PIs) view which risks should be considered Key Information. The hypothesis was that cohorts would have differing viewpoints on selecting these risks.
While the findings of this exploratory study demonstrate variability in viewpoints, they also suggest a number of points of consensus to consider when writing Key Information.
The ethics of consent
The ethics of consent
Peter Ellis
Journal of Kidney Care, 13 February 2019; 4(1)
Abstract
As healthcare professionals, we come into contact with patients on a daily basis, and it is important that the professional relationship we develop with our patients is one built on respect and trust. One important element of this is gaining consent. In this article, Peter Ellis explores what consent is, why it is important and when and how it should be gained.
Center for Informed Consent Integrity 