Must Consent Be Informed? Patient rights, state authority, and the moral basis of the physician’s duties of disclosure

Must Consent Be Informed? Patient rights, state authority, and the moral basis of the physician’s duties of disclosure
Robert MacDougall
Kennedy Institute of Ethics Journal, September 2021; 31(3) pp 247-270
Abstract
    Legal standards of disclosure in a variety of jurisdictions require physicians to inform patients about the likely consequences of treatment, as a condition for obtaining the patient’s consent. Such a duty to inform is special insofar as extensive disclosure of risks and potential benefits is not usually a condition for obtaining consent in non-medical transactions.

What could morally justify the physician’s special legal duty to inform? I argue that existing justifications have tried but failed to ground such special duties directly in basic and general rights, such as autonomy rights. As an alternative to such direct justifications, I develop an indirect justification of physicians’ special duties from an argument in Kant’s political philosophy. Kant argues that pre-legal rights to freedom are the source of a duty to form a state. The state has the authority to conclusively determine what counts as “consent” in various kinds of transactions. The Kantian account can subsequently indirectly justify at least one legal standard imposing a duty to inform, the reasonable person standard, but rules out one interpretation of a competitor, the subjective standard.

The Rise of the French Doctrine of Informed Consent: Criminal Responsibility for an Unauthorised Medical Experiment – The Case of the Antiquaille Hospital and Subsequent Notable Judgments

The Rise of the French Doctrine of Informed Consent: Criminal Responsibility for an Unauthorised Medical Experiment – The Case of the Antiquaille Hospital and Subsequent Notable Judgments
Anatoliy A. Lytvynenko
Athens Journal of Law, 2021; 7 pp 1-14
Open Access
Abstract
The French doctrine regarding a patient’s informed consent has a long and very rich history, dating back at least to the mid-nineteenth century. Medical malpractice had become a frequent subject of criminal trials and civil litigation against physicians and surgeons in the nineteenth and early twentieth centuries, resulting in French medical case law and its academic scholarship becoming one of the most prominent throughout all the civil law jurisdictions. Simultaneously, medical malpractice lawsuits were not rare in civil or common law jurisdictions. The uniqueness of French jurisprudence lies in the development of a robust body of case law, which formed the basis for patients’ rights, and specifically informed consent and the right to medical data confidentiality. The right to informed consent is a reflection of the patient’s right to their own bodily integrity, which may not be violated for the purpose of treatment, except in an emergency. Moreover, the rule of consent is even stricter if physicians are administering experimental treatment (which is not generally banned, as it may benefit the patient), or conducting certain methods of treatment for purely scientific purposes – as was in the case of the Antiquaille Hospital in Lyon, where a dangerous and experimental method of treatment was used to treat a ten-year-old minor suffering from dermatophytosis, which was not authorised by his guardians. The case, which was adjudicated by the criminal court of Lyon, is historically one of the first legal cases to deal with unconsented treatment conducted for the purpose of a scientific experiment. Over the twentieth century, similar legal cases became more frequent in France.

Implementing Informed Consent with Knowledge Graphs

Implementing Informed Consent with Knowledge Graphs
Anelia Kurteva
European Semantic Web Conference, ESWC 2021 Satellite Events, 21 July 2021; pp 155-164
Abstract
The GDPR legislation has brought to light one’s rights and has highlighted the importance of consent, which has caused a major shift in how data processing and sharing are handled. Data sharing has been a popular research topic for many years, however, a unified solution for the transparent implementation of consent, in compliance with GDPR that could be used as a standard, has not been presented yet. This research proposes a solution for implementing informed consent for sensor data sharing in compliance with GDPR with semantic technology, namely knowledge graphs. The main objectives are to model the life cycle of informed consent (i.e. the request, comprehension, decision and use of consent) with knowledge graphs so that it is easily interpretable by machines, and to graphically visualise it to individuals in order to raise legal awareness of what it means to consent and the implications that follow.

Recent Judgement of the Italian Judiciary about medical assisted procreation (MAP): is informed consent valid after parents separation?

Recent Judgement of the Italian Judiciary about medical assisted procreation (MAP): is informed consent valid after parents separation?
N Di Fazio, B Fineschi, M Caporale, Z Del Fante, G Volonnino, P Santoro, R La Russa
La Clinica Terapeutica, 1 July 2021, 172(4) pp 253-255
Open Access
Abstract
Law No 40/2004 regulates in Italy the matter of medically assisted procreation (MAP). Recently, the Tribunal of Capua Vetere expressed its position on the subject of informed consent in a case of MAP. In the specific case, a couple entered the preliminary stages of the PMA procedures, carrying out the fertilization of the ovum and the embryo production. Afterwards, the couple separated and the man denied consent to the continuation of the MAP. The woman, willing to proceed with the implantation, the woman made an urgent judicial appeal, obtaining the judge’s permission to transfer the embryo to the uterus. This paper analyses the different bioethical positions on MAP’s informed consent. In fact, on the one hand, the paper highlight what is set out in Law 219/2017 which provides for the possibility of the patient to revoke at any time the consent to the treatment given. On the other hand, it should be noted that Law 40/2004, willing to protect the embryo, establishes the irrevocability of the position of parental consent after fertilization. The judgment in question seems to favour this latter position, placing itself in the protection of the cryopreserved embryo and recall-ing the principle of entrustment following the fertilization of the egg. Nevertheless, the matter is controversial a consistent amount of legal developments are expected to arise in the next future.

The History and Policy Evolution of Waivers of Informed Consent in Research

The History and Policy Evolution of Waivers of Informed Consent in Research
Austin Connor Kassels, Jon F Merz
The Journal of Legal Medicine, January-June 2021; 41(1-2) pp 1-28
Abstract
We examine the evolution of policies permitting exceptions to or waivers of informed consent for research in the United States. This review reveals that (1) exceptions to the duty to secure informed consent were originally quite narrow; (2) there were two alternative approaches to allowing research on human subjects without their prospective consent: (i) exceptions in which individual capacity to consent is to be assessed and consent tailored to each person’s abilities and (ii) waivers of the general requirement for a population of potential subjects, where securing prospective consent would “destroy or invalidate” critically important research; (3) waivers only appeared in the final rulemakings for research regulations issued by the National Institute of Education in 1974 and the Department of Health and Human Services in 1981, limiting the opportunity for the public to weigh in on the scope and use of waivers; and (4) rules adopted since 1981 have almost uniformly added extra requirements to justify waivers. Examples drawn from recent research show expansion of the use of waivers far beyond the bounds originally envisioned. Greater transparency about the use of waivers is needed for the public to weigh in on the standards for foregoing informed consent in human research.

Consent for withholding life-sustaining treatment in cancer patients: a retrospective comparative analysis before and after the enforcement of the Life Extension Medical Decision law

Consent for withholding life-sustaining treatment in cancer patients: a retrospective comparative analysis before and after the enforcement of the Life Extension Medical Decision law
Yu Jin Chung, Incheol Park, Junho Cho, Jin Ho Beom, Ji Eun Lee
BMC Medical Ethics, 17 June 2021; 22(72)
Open Access
Abstract
Background
The Life Extension Medical Decision law enacted on February 4, 2018 in South Korea was the first to consider the suspension of futile life-sustaining treatment, and its enactment caused a big controversy in Korean society. However, no study has evaluated whether the actual implementation of life-sustaining treatment has decreased after the enforcement of this law. This study aimed to compare the provision of patient consent before and after the enforcement of this law among cancer patients who visited a tertiary university hospital’s emergency room to understand the effects of this law on the clinical care of cancer patients.
Methods
This retrospective single cohort study included advanced cancer patients aged over 19 years who visited the emergency room of a tertiary university hospital. The two study periods were as follows: from February 2017 to January 2018 (before) and from May 2018 to April 2019 (after). The primary outcome was the length of hospital stay. The consent rates to perform cardiopulmonary resuscitation (CPR), intubation, continuous renal replacement therapy (CRRT), and intensive care unit (ICU) admission were the secondary outcomes.
Results
The length of hospital stay decreased after the law was enforced from 4 to 2 days (p = 0.001). The rates of direct transfers to secondary hospitals and nursing hospitals increased from 8.2 to 21.2% (p = 0.001) and from 1.0 to 9.7%, respectively (p < 0.001). The consent rate for admission to the ICU decreased from 6.7 to 2.3% (p = 0.032). For CPR and CRRT, the consent rates decreased from 1.0 to 0.0% and from 13.9 to 8.8%, respectively, but the differences were not significant (p = 0.226 and p = 0.109, respectively).
Conclusion
After the enforcement of the Life Extension Medical Decision law, the length of stay in the tertiary university hospital decreased in patients who established their life-sustaining treatment plans in the emergency room. Moreover, the rate of consent for ICU admission decreased.

(Un)informed Consent: To What Degree are Research Participants ‘Informed’ by Common Consent Procedures in Psychology under EU Data Protection Law?

(Un)informed Consent: To What Degree are Research Participants ‘Informed’ by Common Consent Procedures in Psychology under EU Data Protection Law?
Malte Elsonab, Dara Hallinanc, Annika Külpmanna, Franziska Boehmc
PsychArchives, 31 May 2021
Open Access
Abstract
There is reason to believe that consent forms may routinely do not fulfill the requirements for consent outlined in EU data protection law. Where this is the case, the legitimacy of the conduct of research may be undermined and could result in restrictions on the subsequent conduct of research, obligations to delete data, or obligations to limit the sharing of psychological research data. However, so far, there are no empirical data to support the proposition that compliance may not be the norm. We propose a study design in which we draw a random sample of psychological research reports and systematically compare the research practices (i.e., reported data collection procedures, sharing practices) with the details provided in the respective participant information and consent form and compare each of these with the legal requirements outlined in EU data protection law.

Presumed Consent for Organ Donation: An Incoherent Justification

Presumed Consent for Organ Donation: An Incoherent Justification
Vicente Formoso, Sílvia Marina, Miguel Ricou
Acta Bioethica, 2021; 27(1) pp 27-35
Open Access
Abstract
The difference between supply and demand of transplantable organs is a global problem, and one of the most discussed measures aiming to solve it is the implementation of a presumed consent (opt-out) policy in cadaveric organ donation. This type of system is controversial when it comes to its direct effects on organ donation rates as well as its ethical base. We aim to present the latest perspectives concerning the ethical implications of the policy, especially regarding consent: its need, the coherence of presuming it and the policy’s capacity to fulfill its requirements. From a community perspective, we advocate a default change in societies with an opt-out system, with a strong population education in that direction. The potential rights of family objection are also approached as well as the differences between theoretical discussion and concrete application of public policy.

Will EU’s GDPR Act as an Effective Enforcer to Gain Consent?

Will EU’s GDPR Act as an Effective Enforcer to Gain Consent?
Junhyoung Oh, Jinhyoung Hong, Changsoo Lee, Jemin Justin Lee, Simon S.Woo, Kyungho Lee
IEEE, 26 May 2021
Open Access
Abstract
Since the GDPR was implemented in 2018, organizations that collect data from the EU residents are required to receive the user’s consent. Organizational measures to ensure that the organizations are compliant to the recently enacted GDPR are still abstract and ambiguous. Moreover, data subjects and controllers have demanded the practice of obtaining consent from organizations. By observing the case law and guidelines related to the GDPR provisions, we deduced four consent conditions. Then, we examined how online service provider’s websites are making efforts to implement the GDPR framework. For this, we identified key characteristics of these websites, such as the existence of consent buttons. In order to help the data subjects obtain consent, we proposed an automatic tool that can check the consent conditions by checking the websites. Our study examined 10,000 websites for 26 days using the Python libraries with the tool automatically crawling the website information and analyzes the HTML structure according to the specified conditions. In addition, this tool crawls the privacy policy of each website. Moreover, it automatically determines whether it meets the four consent conditions by calculating it according to the formula defined in the consent condition. To evaluate the tool’s accuracy, the researchers manually analyzed 500 websites and compared the manual analysis with the results of the tool’s automatic analysis. We found that this tool differentiates itself through qualitative comparisons with other GDPR meters.

How Has ‘Montgomery’ Changed the Way We Document Risks on Consent Forms for Deceased Donor Kidney Transplantation? A Single-Centre Audit and Re-Audit

How Has ‘Montgomery’ Changed the Way We Document Risks on Consent Forms for Deceased Donor Kidney Transplantation? A Single-Centre Audit and Re-Audit
A M Hussein, C J Callaghan
British Journal of Surgery, 4 May 2021; 108(Supplement 2)
Abstract
Introduction
The 2015 Montgomery case changed the remit of risk discussions required during the consent process. This audit reviewed single kidney transplant (SKT) consent forms to establish which risks are documented, and whether this legal case affected discussions. Following the audit, we introduced a pre-printed consent form and closed the audit loop by assessing its uptake.
Method
Trust paper consent forms for all patients aged 50+ who received a deceased donor SKT in our centre in 2014 (n = 58; pre-Montgomery) and 2017 (n = 70; post-Montgomery) were reviewed to see if 20 perceived ‘gold standard’ risks were documented. A pre-printed procedure-specific consent form including all gold standard risks was then introduced in July 2019. A re-audit reviewed the case-notes of every alternate recipient aged 50+ of a deceased donor SKT from 01/08/19 to 29/02/20 to check if the pre-printed form was used.
Results
Overall, 53% of the 20 ‘gold standard’ risks were documented in 2014 versus 59% in 2017 (p = 0.55). There was a 91% uptake of the pre-printed consent form.
Discussion
This audit established the importance of using a pre-printed consent form to standardise risk discussions We propose that pre-printed procedure-specific forms should be encouraged throughout the NHS to support ‘Montgomery-appropriate’ consent discussions.