Site Archives Informed Consent

31 Keio University Hospital patients had bone marrow harvested without knowing


[Mainichi News] Two Keio University researchers took bone marrow from a total of 31 patients without permission, it was revealed at a March 19 press conference on the ongoing case of illicit marrow harvesting at the prestigious university.The two researchers, a professor and a lecturer of Keio University Hospital’s respiratory surgery section, harvested the marrow [...]

President’s Bioethics Commission Releases Report on Human Subjects Protection: Current regulations are robust, but should be improved


WASHINGTON, D.C. – The Presidential Commission for the Study of Bioethical Issues today issued its report concerning federally-sponsored research involving human volunteers, concluding that current rules and regulations provide adequate safeguards to mitigate risk.  In its report, “Moral Science: Protecting Participants in Human Subjects Research,” the Commission also recommended 14 changes to current practices to [...]

Experimental therapies for Parkinson’s disease: Why fake it?


How ’sham’ brain surgery could be killing off valuable therapies for Parkinson’s disease.
[Nature] Peggy Willocks was 44 when she was diagnosed with Parkinson’s disease. It progressed quickly, forcing her to retire four years later from her job as a primary-school principal in Elizabethton, Tennessee. Soon, her condition had deteriorated so much that she was often [...]

Could another Guatemala case happen?


[Blog.Bioethics.gov]- The question was simple, the answers not.
At the Presidential Commission for the Study of Bioethical Issues today, Commission Chair Dr. Amy Gutmann, president of the University of Pennsylvania, asked a panel of international experts on bioethics whether the so-called Guatemala incident could happen again. In Guatemala, from 1946 to 1948, a U.S.-funded research experiment [...]

Dying with Your Rights On: Mental Illness, Civil Rights and Saving Lives


[Huffington Post]- I am a psychiatrist who has treated patients for over 35 years, run all varieties of psychiatric services and worked in city and state government. But I still cannot bear to read or hear a story of a fatal outcome for a person with a serious mental illness who dies from neglect or [...]

Uninformed Consent: Tech Solutions for Faulty Permissions in Health Care


[Scientific American]- Technology can help individuals weigh the risks and benefits of an invasive medical procedure, experts say, but only if doctors and patients keep talking.
Much of what happens to you in the hospital in the name of diagnosing and healing is invasive. Depending on what ails you, a doctor may need to ream out [...]

Bioethics Panel Told No Guarantee Against Unethical Research


[Huffington Post]— Experts say that the kind of unethical medical studies that occurred half a century ago could still happen again despite more than 1,000 rules and regulations that should prevent such abuses.
Bioethicists and researchers spoke Tuesday before a presidential panel in Washington. The meeting was triggered by the government’s apology last fall for federal [...]

Deadly Medicine


[VanityFair] Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves? The authors investigate the globalization of the pharmaceutical industry, [...]

Pa. firm admits crimes in human bone-cement trial


[BusinessWeek] A medical device company near Philadelphia pleaded guilty to dozens of crimes Tuesday for conducting unauthorized tests of its bone cement on about 200 spinal surgery patients, three of whom died on the operating table.
Synthes Inc. and its subsidiary, Norian Corp., performed the tests from 2002 to 2004.  The product was approved for use [...]

‘Doctor, Are You Telling Me the Truth?’ Exclusive Ethics Survey Results


[Medscape] “Honesty is the best policy” and “the patient always comes first.”
As absolute and correct as those aphorisms may be, they can be hard for doctors to apply in the complex world of modern medicine.
A recent Medscape medical ethics survey of over 10,000 physicians found that when it comes to patient treatment, a significant number [...]