Psychiatric patients used for drugs research, breaking clinic protocol
Patients at a Dutch psychiatric hospital have been used for drugs research even though they were incapable of giving permission, according to research by current affairs programme Zembla.
In total, 22 of the 52 patients used in the research should not have taken part because they could not give informed consent, according to the programme, which will be broadcast on Wednesday evening.
The claims are based on the clinic’s documents and interviews with family and staff, including a whistleblower who was sacked for raising the issue with the local health board. The clinic is in Heiloo in Noord-Holland.
The local medical ethics board in Alkmaar had approved the research on patients who did not live in residential care and who were capable of giving informed consent for the research. The research involved giving patients two drugs to assess the safety of the combination.
Whistleblower
Nevertheless, 22 of the patients lived in the clinic and eight of them received round the clock care, Zembla says.
The issue was raised by a nurse who was concerned about the involvement of a paranoid schizophrenic man in the research. Both the nurse and the patient’s relations say he is not capable of making an informed decision.
Only then did the researcher attempt to have the terms of the research altered, Zembla reports. However, by that time it was too late because the experiment had been completed, Gavin ten Tusscher of the ethics committee told the programme.
Crime
Health law professor Frans van Wijmen told the show that using patients without informed consent breaks research protocols and can be considered a crime ‘which could result in legal action’.
The psychiatrist at the centre of the experiments, Selene Veerman, has refused to comment on the case. The research supervisor Lieuwe de Haan told the programme a mistake had been made in including patients who were not capable of independent living.
The health board also refused to comment apart from to say the research had been properly carried out.
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