By John Tingle
As the year 2020 closes and another year starts, it is important to reflect on significant patient safety events and trends in the National Health Service (NHS) in England.
To anticipate what might happen in 2021, we need to recognize what may be continuing patient safety issues.
The Health Law Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts.
The workshop is led by Professor I. Glenn Cohen, and presenters come from a wide range of disciplines and departments.
In this video, Valerie Gutmann Koch gives a preview of her paper, “Previvorship and the Legal Doctrine of Informed Consent,” which she will present at the Health Law Policy workshop on November 23, 2020. Watch the full video below:
By Matiangai Sirleaf
Two French doctors recently appeared on television and discussed using African subjects in experimental trials for an antidote to the novel coronavirus (COVID-19).
“Shouldn’t we do this study in Africa, where there are no masks, no treatment, no resuscitation, a bit like some studies on AIDS, where among prostitutes, we try things, because they are exposed, and they don’t protect themselves. What do you think?” asked Jean-Paul Mira, head of the intensive care unit at the Cochin Hospital in Paris on April 1, 2020.
By John Tingle
A new hard-hitting report on medicines and medical device safety published in the U.K. presents controversial proposals that have the potential to improve National Health Service (NHS) patient safety.
The report, The Independent Medicines and Medical Devices Safety Review, was published on July 8th, 2020 after a two year investigation chaired by Baroness Julia Cumberlege. The review investigated two medications — Primodos and sodium valproate — and one medical device — pelvic mesh.
The reviews remit was to examine how the healthcare system in England responded to reports about harmful side effects from medicines and medical devices and how best to respond in the future.
By Beatrice Brown
Human subjects research has long been plagued by racial inequality. While flagrant abuses have been curtailed, disparities have, unfortunately, persisted.
One area ripe for scrutiny is clinical trial enrollment. A 2018 study by William Feldman, Spencer Hey, and Aaron Kesselheim in Health Affairs documents racial disparities in trials that are exempt from typical requirements for informed consent from study participants.
This post is the second in a series about conducting human subjects research in emergencies. These posts are being written in response to a rapidly evolving situation and will reflect the state of knowledge at the time of writing.
In April 2020, Dr. Robin Armstrong, medical director of the Resort, a nursing home in Texas City, Texas, reported “signs of improvement” after he gave hydroxychloroquine, a drug approved by the FDA to treat malaria, to 39 of his nursing home patients who were diagnosed with COVID-19.
At about the same time, information was emerging that now represents the current understanding that hydoxychloroquine isn’t only ineffective in treating COVID-19, but also may cause serious harm to patients. Tensions were raised even higher by the seemingly inexplicable enthusiasm for this treatment by the President and some media outlets.
Informed consent in childbirth is under fire by advocates, who stress that there is a widespread absence of meaningful informed consent during birth. While informed consent in medical settings always poses challenges, informed consent in childbirth raises particular concerns. Labor unfolds in real-time, and people are heavily reliant on their provider for information during birth. Providers may not adequately seek informed consent out of a belief that they should make decisions in the fetal interest, rather than the parent. Furthermore, laboring people make choices that are more than medical: birth is a value-laden process entwined with beliefs about parenting, life-meaning, and fetal interests. A new solution is on the table that could help improve the process of informed consent in childbirth: guided decision-making apps. This year, multiple mobile apps are in the works that would assist laboring people and clinicians in real-time decision-making during labor and birth.
By Adrian Gropper
Google’s semi-secret deal with Ascension is testing the limits of HIPAA as society grapples with the future impact of machine learning and artificial intelligence.
I. Glenn Cohen points out that HIPAA may not be keeping up with our methods of consent by patients and society on the ways personal data is used. Is prior consent, particularly consent from vulnerable patients seeking care, a good way to regulate secret commercial deals with their caregivers? The answer to a question is strongly influenced by how you ask the questions.
NHS Improvement, which supports the NHS (National Health Service) and helps improve care for patients, have just published their latest report on Never Events occurring between April 1, 2018 and February 28 2019.
The report makes for uncomfortable reading, as Never Events are not reducing.
Mental Health Care in the National Health Service in England has always existed in the shadow of physical care in terms of funding and NHS-government health policy priorities.
Many in the past have termed it the “Cinderella” part of the NHS. This neglect has been chronicled in numerous reports over the years pointing to many problems which include chronic under funding, poor patient safety, abuses of patient rights, poor complaint handling, unnecessary restrictive care regimes, poor patient, health carer communication, and poor patient satisfaction. Read More