The Nuremberg Code and Informed Consent for Research

JAMA. 2018; 319(1): 85-86
Author: Jon F Merz
“The Viewpoint by Dr Moreno and colleagues understated the precedential value of the International Medical Tribunal’s decision in the trial of Nazi doctors accused of war crimes that established the Nuremberg Code and the code’s influence on common law development of the legal duty of researchers to secure informed consent from their research participants.”
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The UK Mental Capacity Act and consent to research participation: asking the right question

Journal of Medical Ethics 2018;44:44-46.
Author: P Willner
“This paper considers the meaning of the term ‘intrusive research’, as used in the UK Mental Capacity Act 2005 (MCA), in relation to studies in which an informant is asked to provide information about or on behalf of a person who lacks capacity to consent, and who is not otherwise involved in the study. The MCA defines ‘intrusive research’ as research that would legally require consent if it involved people with capacity. The relevant ethical principles are that consent should be sought from people who would be affected by a piece of research and that this requirement should be implemented proportionately.”
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Ethical considerations in forensic genetics research on tissue samples collected post-mortem in Cape Town, South Africa

BMC Medical Ethics 2017 18:66
Authors: Laura J. Heathfield, Sairita Maistry et al.
“The use of tissue collected at a forensic post-mortem for forensic genetics research purposes remains of ethical concern as the process involves obtaining informed consent from grieving family members. Two forensic genetics research studies using tissue collected from a forensic post-mortem were recently initiated at our institution and were the first of their kind to be conducted in Cape Town, South Africa.”
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Woman who rejected breast cancer diagnosis may undergo surgery without her consent

BMJ 2017; 359: j5358
Author: Clare Dyer
“A 66 year old woman with paranoid schizophrenia may be put under general anaesthetic and have surgery for breast cancer without her consent, a High Court judge has ruled. Mr Justice Keehan declared that the woman, referred to as JT, who denied that she had cancer, lacked the capacity to decide for herself whether to have the treatment.”
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Does section 63 of the Mental Health Act 1983 disempower patients with mental illness? Analysis of the case law

Medico-Legal Journal, 2 November 2017
Author: Bhanuka Senasinghe
“In England and Wales, detained psychiatric inpatients are treated under section 63 of the Mental Health Act 1983. This paper critically analyses the relevant law and considers the arbitrary distinctions between consent for treatments for mental illnesses and physical conditions, which may disempower patients with mental illness. Section 63 states that (for detained psychiatric patients) consent for medical treatment for patients’ mental disorder is not required. The treating clinician responsible for a patient decides what this medical treatment entails. This article focuses on three main legal cases: B v Croydon Health Authority, Tameside and Glossop v CH and Nottinghamshire Healthcare NHS Trust v RC and considers whether s 63 disempowers patients with mental illnesses.”
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Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011

JAMA Intern Med. 2017;177(10):1-8.
Authors: Peter Doshi, Peter Hur, Mark Jones, et al.
“Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use “noninferiority” hypotheses allowing a degree of inferior efficacy deemed “clinically acceptable” compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials.”
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Dealing with treatment and transfer requests: how PGD-professionals discuss ethical challenges arising in everyday practice

Med Health Care and Philos, 2017, pp1-12
Authors: Soto-Lafontaine, M., Dondorp, W., Provoost, V. et al.
“How do professionals working in pre-implantation genetic diagnosis (PGD) reflect upon their decision making with regard to ethical challenges arising in everyday practice? Two focus group discussions were held with staff of reproductive genetic clinics: one in Utrecht (The Netherlands) with PGD-professionals from Dutch PGD-centres and one in Prague (Czech Republic) with PGD-professionals working in centres in different European countries. Both meetings consisted of two parts, exploring participants’ views regarding (1) treatment requests for conditions that may not fulfill traditional indications criteria for PGD, and (2) treatment and transfer requests involving welfare-of-the-child considerations.”
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Pere v Central Queensland Hospital and Health Service [2017] QCA 225

Decision date: 6 October 2017
“PROFESSIONS AND TRADES – HEALTH CARE PROFESSIONALS – MEDICAL PRACTITIONERS – LIABILITY IN TORT – GENERAL PRINCIPLES – where the applicant was employed by the respondent – where the applicant was acting unusually while at work – where a co-worker escorted the applicant to the Emergency Department – where medical staff believed the applicant to be either under the influence of alcohol or illicit drugs, or suffering from a medical condition that would require urgent attention – where a doctor discussed the taking of blood and urine samples with the applicant – where the hospital staff reported the applicant was calm and co-operative and that consent was obtained prior to the taking of the samples – where the applicant claims no consent was given…’.
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Misdirections in Informed Consent — Impediments to Health Care Innovation

N Engl J Med 2017; 377:1412-1414
Authors: David A. Asch, Tracy A. Ziolek, Shivan J. Mehta
“A large literature on research consent aims to prevent these problems, offering ethical analyses that are more forgiving of waivers of consent than what many investigators hear from their IRBs. Indeed, so many ethicists may have weighed in on this issue not because the ethics are disputed, but because overgeneralizations of research conventions persist despite the published literature. The QRS plan is instructive in part because it seems so obviously acceptable; yet IRBs are left to define “practicability” and “adverse effects on rights and welfare.” In doing so, they are susceptible to predictable sources of misdirection. Trials of substantially greater consequence — for example, those focused on critically ill patients — face greater obstacles.”
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Dutch geriatrician faces charges over euthanasia case

BMJ 2017; 359: j4639
Author: Tony Sheldon
“A specialist in elderly care medicine could face prosecution under the Netherlands’ euthanasia laws after ending the life of a 74 year old nursing home patient with advanced dementia. The woman was considered no longer competent to consent but had previously signed a living will requesting euthanasia. Yet Dutch public prosecutors have launched a criminal investigation, claiming a “serious suspicion” that a criminal offence had been committed. This is the Netherlands’ first such investigation under the reporting arrangements established in the 2002 euthanasia law.”
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