How Democracy Can Inform Consent: Cases of the Internet and Bioethics
Carol C. Gould
Journal of Applied Philosophy, 22 March 2019; Special Issue 
Abstract
Traditional conceptions of informed consent seem difficult or even impossible to apply to new technologies like biobanks, big data, or GMOs, where vast numbers of people are potentially affected, and where consequences and risks are indeterminate or even unforeseeable. Likewise, the principle has come under strain with the appropriation and monetisation of personal information on digital platforms. Over time, it has largely been reduced to bare assent to formalistic legal agreements. To address the current ineffectiveness of the norm of informed consent, I suggest that we need a notion of structural injustice (on a distinctive interpretation, elaborated here, which takes account of unequal power and property relations). I then argue that in order to protect and enhance people’s freedom, we have to go beyond traditional applied ethics and introduce perspectives from democratic theory and social philosophy. I attempt to show how applications of the ‘all‐affected principle’, together with new forms of democratic participation, deliberation, and representation can helpfully frame the narrower principle of informed consent. There is an important role for what we could call collective consent, and informed consent can only succeed in increasing individual agency if it is situated within enhanced forms of democratic decision‐making.

Democracy as Uninformed Non‐Consent
Jason Brennan
Journal of Applied Philosophy, 14 March 2019; Special Issue
Abstract
Carol Gould argues that democratic institutions can serve as mechanisms of informed consent or could at least facilitate creating regulations and other structures which facilitate informed consent in bioethics, medicine, and elsewhere. I am sceptical. I argue that democracies cannot serve as vehicles of consent, let alone informed consent. Further, the problems of democratic ignorance and irrationality created significant barriers to democratic deliberation helping to produce better regulations or conditions for informed consent. Democracy is not a good surrogate for consent.

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’
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)
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.