Ethics & Health Law News

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Archive for category Informed Consent

Cadaver shows stir controversy

Sep 8

Posted by Edwina Light in Case Law, Death, Informed Consent, Regulatory Compliance | Comments off

CMAJ, early release online, 7 September 2010, doi: 10.1503/cmaj.109-3351
Author: Roger Collier
“Coating skinless human cadavers in liquid plastic and charging humans still living in their skin an admission fee to take a look has become a lucrative business. But all is not well in the land of corporate corpse display. Critics say some human cadaver exhibits do not obtain consent from either the deceased people on display or their families. These criticisms are getting noticed, and some areas are banning these very popular shows. …One of the latest bans was instituted in July by the city council of Seattle, Washington. The Seattle ban stems from a complaint filed in United States District Court in 2006 by Charlette LeFevre and Philip Lipson, who run the Seattle Museum of the Mysteries. …Contemplating having a cutting-edge educational display for his museum,  Lipson researched the “Bodies” show and was dismayed to discover that the cadavers come from unclaimed bodies in China.”
Find article here.

A patient and relative centred evaluation of treatment escalation plans: a replacement for the do-not-resuscitate process

Sep 6

Posted by Edwina Light in Advance Care Planning and Advance Directives, Competence and Capacity, Informed Consent, UK Health Services | Comments off

J Med Ethics 2010;36:518-520 doi:10.1136/jme.2009.033977
Authors: L Obolensky, T Clark, G Matthew, M Mercer
“The Treatment Escalation Plan (TEP) was introduced into our trust in an attempt to improve patient involvement and experience of their treatment in hospital and to embrace and clarify a wider remit of treatment options than the Do Not Resuscitate (DNR) order currently offers. Our experience suggests that the patient and family are rarely engaged in DNR discussions. This is acutely relevant considering that the Mental Capacity Act (MCA) now obliges these discussions to take place. The TEP is a form that the doctor completes, ideally with the competent patient or close relative, documenting what treatment options would be appropriate if that patient were to become acutely unwell. Ventilation of the lungs, cardiac resuscitation, renal replacement therapy, intravenous fluids and antibiotics are all discussed. The study evaluated patient and relative experiences with the TEP…”
Find abstract here.

Help for Women Who Are Forced to Get Pregnant

Sep 1

Posted by Sabina Bhate in Human Rights, Informed Consent, Pregnancy | Comments off

Time.com-31 August, 2010.

Author: Belinda Luscombe

“Reproductive coercion, as it’s known, takes several forms. Partners may verbally or physically threaten women if they use birth control or seek abortions, or they may throw away or damage birth control and remove condoms during sex.”

Read article here.

$100,000 penalty for surgeon over death of bypass patient

Aug 21

Posted by Nancy Lentz in Death, Disciplinary Tribunals, Informed Consent | Comments off

NZ Herald, By Lincon Tran, 20 August 2010

“A surgeon who has been the subject of several complaints about failing to properly inform patients has been ordered to pay more than $100,000 in fines and costs after the death of a patient. Richard Stubbs, a specialist treating liver cancer and obesity, was found guilty by the Health Practitioners Disciplinary Tribunal of professional misconduct over the care he provided to a gastric bypass surgery patient, who died in February 2006.”

Find article here.

Severe Substance Dependence Treatment Act 2010 (Vic)

Aug 17

Posted by Edwina Light in Addictions, Competence and Capacity, Health Law, Human Rights, Illegal drug use, Informed Consent, Refusing Treatment, Victorian Health Services | Comments off

Parliament of Victoria, assented to 10 August 2010
“(1) The objectives of this Act are—
(a) to provide for the detention and treatment of persons with a severe substance dependence where this is necessary as a matter of urgency to save the person’s life or prevent serious damage to the person’s health; and
(b) to enhance the capacity of those persons to make decisions about their substance use and personal health, welfare and safety.
(2) This Act must be interpreted, and every function conferred or imposed by this Act must be performed or exercised, so that—
(a) detention and treatment is a consideration of last resort; and
(b) any limitations on the human rights and any interference with the dignity and self-respect of a person who is the subject of any actions authorised under this Act are kept to the minimum necessary to achieve the objectives specified in subsection (1).”
Find Act here.

New guidelines for genetic tests are welcome but insufficient

Aug 16

Posted by Edwina Light in Genetics, Health information and education, Informed Consent, Privacy & Health Information | Comments off

The Lancet,  Volume 376, Issue 9740, doi:10.1016/S0140-6736(10)61234-2
Editorial: “A common framework of principles for direct-to-consumer genetic testing, published on Aug 4 by the UK’s Human Genetics Commission (HGC), is a commendably clear and detailed guideline about what constitutes good practice for commercial genetic testing. The guidelines cover the full range of genetic tests currently available—from diagnosis to ancestry tests—and set out minimum standards for consent, data protection, marketing, scientific rigour, and interpretation. Less clear, however, is what practical value the guidelines will have in the context of an international industry that crosses regulatory jurisdictions.”
Find editorial here.

IOM Advises FDA on Ethics in Postmarket Safety Trials

Aug 11

Posted by Edwina Light in Bioethics, Health information and education, Informed Consent, Regulatory Compliance, Safety, The Pharmaceutical Industry | Comments off

JAMA. 2010;304(6):627. doi:10.1001/jama.2010.1080
Author: Bridget M. Kuehn
“To ensure that FDA-mandated postmarket safety trials of medications meet appropriate ethical standards, the Institute of Medicine (IOM) has developed a framework to guide the agency in its decisions regarding such trials.  The IOM published the framework July 9, in advance of a larger report on postmarket drug safety due to be published in 2011 (http://www.nap.edu/catalog.php?record_id=12948). The Food and Drug Administration Amendments Act of 2007 (FDAAA) expanded the FDA authority to monitor postmarket safety of approved drugs, including requiring manufacturers to conduct postmarket safety trials. To guide such regulatory actions, the FDA asked the IOM in April 2010 to evaluate the ethics, including informed consent, and scientific issues unique to postmarket safety evaluations of medications.”
Find extract here.

An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents

Aug 11

Posted by Edwina Light in Bioethics, Biomedical Research, Health information and education, Informed Consent | Comments off

Journal of Bioethical Inquiry, Vol. 7, Issue 3 / September 2010
Authors: Laura D. Buccini, Donald Iverson, Peter Caputi and Caroline Jones
“The aims of this study were to measure the readability of Australian based informed consent documents and determine whether informed consent readability guidelines have been established by Australian human research ethics committees (HRECs). …Based on Australian literacy data, the majority of informed consent documents were written well beyond the reading ability of many Australians. Unreadable informed consent documents may result in patients rejecting trial participation altogether or conversely may result in their participating in a trial with inadequate consent. Therefore, a step toward reducing the complexity of informed consent documents may be to implement objective readability assessments into the human research ethics application and review process.”
Find abstract here.

Kin agree to donate brain-dead man’s organs

Aug 10

Posted by Sabina Bhate in Global and International Health, Informed Consent, New Legislation, Organs and Tissue | Comments off

Japan Times- 10 August, 2010

Author: Natsuko Fukue

“The family of a man left brain dead from a traffic accident agrees to donate his organs in the first such case under the revised transplant law, saying that although he hadn’t consented in writing, he had voiced such wishes.”

Read article here. 

Patient Willingness to Be Seen by Physician Assistants, Nurse Practitioners, and Residents in the Emergency Department: Does the Presumption of Assent Have an Empirical Basis?

Aug 9

Posted by Edwina Light in Bioethics, Health Services, Informed Consent, Resource Allocation | Comments off

The American Journal of Bioethics, Volume 10, Issue 8 August 2010
Authors: Gregory L. Larkin; Roderick S. Hooker
“Physician assistants (PAs), nurse practitioners (NPs), and medical residents constitute an increasingly significant part of the American health care workforce, yet patient assent to be seen by nonphysicians is only presumed and seldom sought. In order to assess the willingness of patients to receive medical care provided by nonphysicians, we administered provider preference surveys to a random sample of patients …Despite presumptions to the contrary, ED patients are generally unwilling to be seen by PAs, NPs, and residents. While seldom asked in practice, 79.5% of patients fully expect to see a physician regardless of acuity or potential for cost savings by seeing another provider. Patients are more willing to see residents than nonphysicians.”
Find abstract here and related peer commentaries here.