da HORTA -v- PODIATRY BOARD OF AUSTRALIA [2017] WASC 82

Delivered: 24 March 2017
“On about 30 November 2016, the Board notified the applicant that it had decided under s 178 and s 179 of the Health Practitioner Regulation National Law to caution him. The Board gave brief reasons for its action, finding certain failings in the applicant’s treatment of a named patient, including that he should have communicated risks and likely success or failure rates of any proposed treatment more clearly, should have conducted a more through ‘consenting process’, and that his clinical records were inadequate. It stated his professional performance ‘is or may be unsatisfactory’.”
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Pelvic mesh devices hit by allegations of research fraud, experimental surgery on thousands of women

SMH, 14 March 2017
Author: Joanne McCarthy
“Pelvic devices developed in Australia from the 1980s and 1990s are at the centre of a global medical scandal that includes regulatory failure, and allegations of research fraud and experimental surgery on women in multiple countries.”
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Presumed consent: licenses and limits inferred from the case of geriatric hip fractures

BMC Medical Ethics 2017 18:17
Authors: Joseph Bernstein, Drake LeBrun, Duncan MacCourt, Jaimo Ahn
“Hip fractures are common and serious injuries in the geriatric population. Obtaining informed consent for surgery in geriatric patients can be difficult due to the high prevalence of comorbid cognitive impairment. Given that virtually all patients with hip fractures eventually undergo surgery, and given that delays in surgery are associated with increased mortality, we argue that there are select instances in which it may be ethically permissible, and indeed clinically preferable, to initiate surgical treatment in cognitively impaired patients under the doctrine of presumed consent.”
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Donation after brain circulation determination of death

BMC Medical Ethics 2017 18:15
Authors: Anne L. Dalle Ave, James L. Bernat
“In DBCDD, death is determined when the cessation of circulatory function is permanent but before it is irreversible, consistent with medical standards of death determination outside the context of organ donation. Safeguards to prevent error include that: 1] the possibility of auto-resuscitation has elapsed; 2] no brain circulation may resume after the determination of death; 3] complete circulatory cessation is verified; and 4] the cessation of brain function is permanent and complete. Death should be determined by the confirmation of the cessation of systemic circulation; the use of brain death tests is invalid and unnecessary. Because this concept differs from current standards, consensus should be sought among stakeholders. The patient or surrogate should provide informed consent for organ donation by understanding the basis of the declaration of death.”
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Ethics panel blocks proposed Zika vaccine research

Statnews, 28 February 2017
Author: Helen Branswell
“A federally appointed ethics panel has rejected an application from a team of scientists to deliberately infect people with the Zika virus, a decision that threatens to further slow the search for an effective vaccine. The panel’s report said it would not currently be ethical to conduct the study because of the risk to potential volunteers and their sexual partners and because there are other possible study approaches.”
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Informed Consent

N Engl J Med 2017; 376:856-867
Authors: Jeffrey M. Drazen, David P. Harrington, et al
“In the classic interaction in which informed consent is obtained for research, an investigator presents the potential participant with information regarding a new therapeutic, diagnostic, or prophylactic intervention and then asks the participant to read and sign a detailed written consent document. This traditional prototype is becoming outdated. Informed consent, which is ethically essential in most clinical research, respects persons’ rights to decide whether participation in the research is compatible with their interests, including their interests in protection from exploitation and harm. Required by ethical guidelines and regulations unless explicitly waived by institutional review boards, informed consent is thus a means of protecting the rights and welfare of participants while they contribute to the advancement of knowledge.”
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Chemical restraint or lethal injection?

MJA Insight, 6 March 2017
Author: Minh Le Cong
“The implicit goal of chemical restraint at the hands of health care providers is to ensure the safety of the patient and those trying to care for them during a period of acute agitation that makes informed consent and adequate assessment difficult, if not impossible.”
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When organ donation isn’t a donation

BMJ 2017;356: j1028
Author: Margaret McCartney
“The rest of the UK requires consent for organ donation, either by the dead person having pre-empted the decision by joining the donor register or by family consent. Wales uses a “soft” opt-out, meaning that it’s not intended to be legally enforced and that potential situations where doctors remove organs for transplant directly against the surviving family’s wishes will not occur.”
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