Mental Disorders

Expert Forum on Medical Ethics Association recently held in Shanghai, the Shanghai Mental Health Center president Xu Yifeng throw a series of studies of mental illness in the "Ethical question mark", triggering concern.
 
Xu Yifeng says that as of now, our patients with mental disorders are about 100 million people, including patients with serious mental disorders about 16 million people, but the field of mental health clinical trial registration carried out quite small, for this area is the ethical concern rare.Xu Yifeng said that there was an international multi-center clinical trials, hope in the country conducted by the Shanghai Mental Health Center lead, but the hospital ethics committee review found that the informed consent translation was very simple, does not comply with the relevant regulations, they did not carry out This research.

"A standardized informed consent must meet two requirements: inform the full details of the content, the language is straightaway inform the international standard is in line with the reading ability of junior high school graduates," Xu Yifeng said, "In the medical practice, Because of professional knowledge, skills and other resources, unequal, patients and their families in a relatively weak one, mental illness is more specific, it must be considered for such special groups, in order to protect their rights and interests, based on the informed consent requirement more stringent. "Xu Yifeng introduced, if found in patients with associated impaired and unable to customize the implementation of informed consent, it is necessary to let the legal guardians together."In our hospital, patients and their families after reading the informed consent form, but also to answer a 'paper', there are multiple-choice questions about the content of the above-consent by the answer, it is determined whether or not they fully understand this informed consent, and further decides whether they can sign. "Xu Yifeng said.

Guardian can sign it on behalf of a patient?

 Clinical trials often involve financial rewards, so easily lead to conflicts of interest. For patients with mental illness, the problem becomes more complex.Xu Yifeng, for example, the hospital has been carried out clinical trials of Alzheimer's disease in recruiting subjects, medical personnel will face this problem: elderly patients with no self-awareness, can not make decisions on behalf of their children can decide it?"If the patient is a child, the parents took the signature, usually no problem; but if the parents are patient, signed on behalf of their children, the hospital will need to be treated with caution, for example, an Alzheimer's patients have three children, we need to elect them as one. representatives signed, but the premise is that the three children must agree, as long as there is an objection, we will not let the patient in a clinical trial. "Xu Yifeng said," in the study of mental illness, because of the special nature of the patient, informed consent process often requires additional protection. "At present, the field of mental health and informed consent ethical review standards and the lack of relevant instructions. In this regard, Xu Yifeng said the hospital ethics committee of the Shanghai Cooperative Medical Ethics Association, is preparing to review the operation of mental health ethics guidelines, published this year is expected.
 
Xu Yifeng introduction, the development of the ethics committee began in the 1990s, a great number of medical institutions established the Ethics Committee. In Shanghai, for example, three hospitals have ethics committees, nearly six two general hospitals have ethics committees.Shanghai Mental Health Center told the Beijing, Shanghai, Guangzhou three cities on the "clinical trials ethical attitude" survey, 1177 medical personnel, 3454 mental illness and their families to participate. It was found that 87.8% do not have mental health hospital ethics committee, most of district level health institutions. At the same time, the negative attitude of both doctors and patients in clinical trials is also worthy of attention. Survey, 78.6% of people in clinical trials uncertain whether help patients; 50% of people believe that clinical trials of pharmaceutical companies in the equivalent study; most people do not want to participate in clinical trials of the informed consent, stems from the efficacy of new medicines uncertainty and fear of side effects.Xu Yifeng said, our mental health workers should receive ethics training and learning, rich ethical knowledge, and universal mental health knowledge and ethical awareness to the public. Establish a mature system of ethical review is imperative.