ah yes...the wonderful world of mental health research...
"According to a DPPC report, patients' medications were switched without informed consent and without a clear medical need, the changes were made more than two months before the human-studies review boards approved the research protocol, and the patients involved were clearly not eligible under the criteria for the study, which specified that subjects be outpatients.
One of the four patients whose medication was switched, a man who had been stable for 10 years on the drug Clozaril, became so ill and acutely psychotic that he spent months in and out of hospital wards. He was diagnosed with neuroleptic malignant syndrome, a rare, sometimes lethal side effect of medication changes, according to the commission's report.
Institutionalized patients, like prisoners, may feel pressure to become subjects, and researchers, as well as their institutions, could benefit financially from recruiting subjects, Lurie said. As soon as medication changes were made, the clinical trial was effectively underway, without oversight to protect subjects' rights -- "a flagrant violation of clinical ethics," he said."
Drugs of 4 patients subbed without OK
Switch at Fuller mental health clinic aimed at research
By Ellen Barry, Globe Staff, 11/10/2003
"According to a DPPC report, patients' medications were switched without informed consent and without a clear medical need, the changes were made more than two months before the human-studies review boards approved the research protocol, and the patients involved were clearly not eligible under the criteria for the study, which specified that subjects be outpatients.
One of the four patients whose medication was switched, a man who had been stable for 10 years on the drug Clozaril, became so ill and acutely psychotic that he spent months in and out of hospital wards. He was diagnosed with neuroleptic malignant syndrome, a rare, sometimes lethal side effect of medication changes, according to the commission's report.
Institutionalized patients, like prisoners, may feel pressure to become subjects, and researchers, as well as their institutions, could benefit financially from recruiting subjects, Lurie said. As soon as medication changes were made, the clinical trial was effectively underway, without oversight to protect subjects' rights -- "a flagrant violation of clinical ethics," he said."
Drugs of 4 patients subbed without OK
Switch at Fuller mental health clinic aimed at research
By Ellen Barry, Globe Staff, 11/10/2003
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