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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A Federal Ban on Making Lethal Viruses Is Lifted

NYT, 19 December 2017
Author: Donald G McNeil Jr
“Federal officials on Tuesday ended a moratorium imposed three years ago on funding research that alters germs to make them more lethal. Such work can now proceed, said Dr. Francis S. Collins, the head of the National Institutes of Health, but only if a scientific panel decides that the benefits justify the risks.”
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Rules on reporting trials must be better enforced, say health integrity groups

BMJ 2017; 359: j5786
Author: Deborah Cohen
“Unregulated reporting of clinical trials opens the door to fraud and corruption, undermining medical advances and public health objectives, a report has warned. The report, by a consortium of “health integrity organisations,” urges governments to enforce current rules to ensure that patients, doctors, and scientists can access the full results of all clinical trials.”
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Why a Lot of Important Research Is Not Being Done

NYT, 4 December 2017
Author: Aaron E Carroll
“We have a dispiriting shortage of high-quality health research for many reasons, including the fact that it’s expensive, difficult and time-intensive. But one reason is more insidious: Sometimes groups seek to intimidate and threaten scientists, scaring them off promising work. Lawsuits have an intimidating effect on an already difficult enterprise.”
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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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Insurers discriminating against people who get genetic test results could hobble research, bioethicists warn

SMH, 8 November 2017
Author: Kate Aubusson
“Insurers are able to discriminate against individuals who undergo genetic testing, and that threatens to hobble genomic research, bioethics and law experts have warned in a recent paper published in Public Health Genomics. Anyone who receives their results of genetic testing as part of a research project needs to disclose them to insurers if asked, despite the Human Genetics Society of Australasia calling for research findings to be excluded. Insurers can deny cover or hike up premiums for healthy individuals who discover they carry a mutation for a condition they may never develop based on the testing results, the authors warned.”
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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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Pathogenic variants in the healthy elderly: unique ethical and practical challenges

Journal of Medical Ethics 2017; 43: 714-722.
Author: Paul Lacaze, Joanne Ryan, Robyn Woods, Ingrid Winship, John McNeil
“Genetic research into ageing, longevity and late-onset disease is becoming increasingly common. Yet, there is a paucity of knowledge related to clinical actionability and the return of pathogenic variants to otherwise healthy elderly individuals. Whether or not genetic research in the elderly should be managed differently from standard practices adapted for younger populations has not yet been defined. In this article, we provide an overview of ethical and practical challenges in preparing for a genetic study of over 14?000 healthy Australians aged 70?years or older enrolled in the ASPirin in Reducing Events in the Elderly (ASPREE) Healthy Ageing Biobank.”
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Why health services research needs bioethics

Journal of Medical Ethics 2017; 43: 655-656.
Author: Lucy Frith
“Health services research brings together a wide variety of disciplines and would seem ideally placed to include ethics. However, if you search health services research journals and conference programmes there is very little consideration of ethics as a substantive topic and often scant attention paid to the ethical issues that might be raised by an intervention or policy. Ethics and ethical issues are generally confined to discussions over priority setting, and occasionally health technology assessment, with other areas of health service research seldom engaging in ethical debate.”
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