With the announcement by the China Center for Disease Control and Prevention and other three units of the "Golden Rice" incident and the decision to deal with it, the Hunan children who participated in the GM rice research project that had caused the uproar have come to an end. However, the biomedical research issues involving the human body reflected in this incident must not be forgotten because of the end of the case. We should think about how to design a comprehensive, specific, clear and reasonable rules of conduct that incorporate biomedical research into the human body into an orderly and efficient track. Human biomedical research is in urgent need of legislative norms.
Since the 1980s, various biomedical research projects involving human body have been launched in China, and the population has become more widespread. Taking the human body test of drugs as an example, according to statistics, there are more than 800 trials involving new drugs abroad each year; more than 60 multinational companies have nearly 100 clinical trials in China, with direct participation of tens of thousands of people. With a large area sampling, at least 500,000 people.
At the same time as these studies were carried out, many units established an ethics review committee, conducted an ethical review of the research program, and worked hard to adhere to the principle of informed consent. At the same time, the "Practitioner's Law" stipulates that doctors may not conduct experimental clinical care without the consent of the patient or their family members; the Ministry of Health has also issued guidelines such as the "Ethical Review of Human Biomedical Research (Trial)". Despite this, compared with the maintenance of the national medical affairs management order, the social order and good customs, and even the social dignity of the entire human being, as well as the need to effectively protect the health, life, interests and rights of the subjects, there are still obvious deficiencies in China's current legislation.
To this end, the author believes that it is necessary to issue a law or administrative regulation specifically for biomedical research involving human body, and provide more effective legislative support for regulating biomedical research activities involving human body.
In order to do a good job in legislation, the following aspects should be considered.
First, there are two fundamental values ​​that must be measured in terms of biomedical research involving the human body: the benefits of science and medical advancement for society and all its members; the other is the potential rights of potential human subjects and Protection of interests. The author believes that future legislation can encourage members of society to participate in biomedical research that has undergone rigorous scrutiny both scientifically and ethically; at the same time, a more rigorous ethical review mechanism should be established to protect individuals and families participating in biomedical research. When an irreconcilable conflict occurs between the goal of promoting the development of medical science and the principle of protecting human subjects, the subject of protection should be placed first.
Secondly, we must understand how biomedical research involving humans in China currently works, how they affect human subjects and their families, how the ethics review committee works, how the work procedures, and the relevant state departments to researchers and ethics review committees. How to conduct supervision, review, evaluation, what are the existing legislation, and so on.
Finally, we should also study more relevant foreign experience. We should put our eyes wider and deeper, especially to study and learn from other people's practical experience. For example, how advanced countries prepare legislation, what research work has been done, how the basic principles of biomedical research involving the human body are formulated, and how they are implemented, the specific implementation of the law, and the implementation Question, and so on.
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