Carl Elliott and Matt Lamkin
JAMA Psychiatry
Published online February 10, 2016. doi:10.1001/jamapsychiatry.2015.3117
Can an involuntarily committed psychiatric patient give truly voluntary consent for medical research? This question has been fiercely debated in Minnesota since 2008, when the St Paul Pioneer Press reported the death of Dan Markingson, a mentally ill young man who had been recruited into an antipsychotic study at the University of Minnesota while under a civil commitment order. Along with many others, we have argued that the circumstances of Markingson’s commitment order compromised the voluntariness of his consent to the study. Although federal guidelines are silent on the issue, we believe the Markingson case serves as a powerful argument for serious restrictions on the recruitment of involuntarily committed patients into psychiatric research studies.
The article is here.
Showing posts with label Medication Trials. Show all posts
Showing posts with label Medication Trials. Show all posts
Friday, April 1, 2016
Thursday, August 28, 2014
What We Need to Learn From the Ebola Epidemic
By Robert Klitzman
The Huffington Post
Originally posted August 9, 2014
Here is an excerpt:
Still, even if the medication works and is provided abroad, obstacles will remain to educate patients adequately about it and obtain appropriate informed consent. The fact that the drug is experimental and may still fail or make patients sicker -- even if it seems to offer benefit to a few patients -- needs to be explained in a way that patients in Africa, many of whom have little education, can understand. Barriers exist in part for cultural and linguistic reasons. In some African languages, for instance, there is no word for "placebo" or "experimental treatment," only for "cure. Questions remain regarding whether the drug should first be tested against a placebo or simply given to everyone. Use of a placebo will help scientists understand the drug's effectiveness. But if the medication turns out to work, patients who were randomized not to receive it will have lost out. These quandaries are complex, and WHO needs to explore and address them very carefully.
The entire article is here.
The Huffington Post
Originally posted August 9, 2014
Here is an excerpt:
Still, even if the medication works and is provided abroad, obstacles will remain to educate patients adequately about it and obtain appropriate informed consent. The fact that the drug is experimental and may still fail or make patients sicker -- even if it seems to offer benefit to a few patients -- needs to be explained in a way that patients in Africa, many of whom have little education, can understand. Barriers exist in part for cultural and linguistic reasons. In some African languages, for instance, there is no word for "placebo" or "experimental treatment," only for "cure. Questions remain regarding whether the drug should first be tested against a placebo or simply given to everyone. Use of a placebo will help scientists understand the drug's effectiveness. But if the medication turns out to work, patients who were randomized not to receive it will have lost out. These quandaries are complex, and WHO needs to explore and address them very carefully.
The entire article is here.
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