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涉及人的生物医学研究中保护受试者权益问题研究随着现代医学科学技术的发展和生物医学技术的广泛应用,任何一种新药在研制过程中或者一种新的医疗技术在应用试验中,都要经过人体试验...
涉及人的生物医学研究中保护受试者权益问题研究
随着现代医学科学技术的发展和生物医学技术的广泛应用,任何一种新药在研制过程中或者一种新的医疗技术在应用试验中,都要经过人体试验后才能推广应用。这样就产生了“受试者”这一特殊群体和以此为职业的所谓“职业受试者”。有资料显示,目前我国仅年申报的新药就达万种,新的医疗技术试验更加广泛。涉及人的生物医学研究愈来愈多,侵犯受试者权益时有发生,受试者权益问题倍受人们担忧和关注。
在涉及到人的生物医学研究中,侵害受试者合法权益的例子屡见不鲜。虽然《纽伦堡法典》,《赫尔辛基宣言》以及CIOMS提出的《涉及人的生物医学研究国际伦理准则》构成了人类社会对人体实验进行保护的立法和伦理准则。但是许多保护受试者权益深层次的问题有待进一步研究。笔者以受试者应享有的合法权益为切入口,结合受试者的现状与存在的问题,从法律规范,伦理道德,管理制度等面对保护受试者权益的相关问题进行探讨。
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随着现代医学科学技术的发展和生物医学技术的广泛应用,任何一种新药在研制过程中或者一种新的医疗技术在应用试验中,都要经过人体试验后才能推广应用。这样就产生了“受试者”这一特殊群体和以此为职业的所谓“职业受试者”。有资料显示,目前我国仅年申报的新药就达万种,新的医疗技术试验更加广泛。涉及人的生物医学研究愈来愈多,侵犯受试者权益时有发生,受试者权益问题倍受人们担忧和关注。
在涉及到人的生物医学研究中,侵害受试者合法权益的例子屡见不鲜。虽然《纽伦堡法典》,《赫尔辛基宣言》以及CIOMS提出的《涉及人的生物医学研究国际伦理准则》构成了人类社会对人体实验进行保护的立法和伦理准则。但是许多保护受试者权益深层次的问题有待进一步研究。笔者以受试者应享有的合法权益为切入口,结合受试者的现状与存在的问题,从法律规范,伦理道德,管理制度等面对保护受试者权益的相关问题进行探讨。
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Biomedical research involving human subjects in the protection of the rights and interests of the subjects of study
With the development of modern medical science and technology the development of science and technology widespread application, any new drug in the process of development or a new medical technology in the application of test, must pass through human trials before the popularization and application of. This produces a" subjects " this special groups and the occupation of the so-called " occupation subjects". The data shows, at present our country only year declare on10000 kinds of new drugs, new medical technology test more widely. Biomedical research involving human subjects more and more, violations of the rights and interests of the subjects have occurred, the rights and interests of the subjects of much concern and attention.
The people involved in biomedical research, enroach on the legitimate rights and interests of the subjects. It is often seen. Although the" Nuremberg Codex"," Helsinki declaration" and the" CIOMS involving human international ethical guidelines for biomedical research" made human society on human subjects protection legislation and codes of ethics. But a lot of protecting the rights and interests of the subjects of deep-seated problems to be further studied. The author subjects shall enjoy the legal rights for the entrance, with subjects of the present situation and the existence question, from the legal norms, ethics, management system facing the protection of the rights and interests of the subjects of the related issues.
With the development of modern medical science and technology the development of science and technology widespread application, any new drug in the process of development or a new medical technology in the application of test, must pass through human trials before the popularization and application of. This produces a" subjects " this special groups and the occupation of the so-called " occupation subjects". The data shows, at present our country only year declare on10000 kinds of new drugs, new medical technology test more widely. Biomedical research involving human subjects more and more, violations of the rights and interests of the subjects have occurred, the rights and interests of the subjects of much concern and attention.
The people involved in biomedical research, enroach on the legitimate rights and interests of the subjects. It is often seen. Although the" Nuremberg Codex"," Helsinki declaration" and the" CIOMS involving human international ethical guidelines for biomedical research" made human society on human subjects protection legislation and codes of ethics. But a lot of protecting the rights and interests of the subjects of deep-seated problems to be further studied. The author subjects shall enjoy the legal rights for the entrance, with subjects of the present situation and the existence question, from the legal norms, ethics, management system facing the protection of the rights and interests of the subjects of the related issues.
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Involves people of biomedical research subjects rights protection in the study of the problem
With modern medical science and technology development and biomedical technology extensive application, a kind of any new drugs in the developing process or a new medical technology application in trial, are through the human body after test to application. This created "subjects" this special group and make a career of so-called "vocational subjects". The data shows, at present our country in the new drug declare only reached ten thousand kinds, new medical technology test more extensive. The biomedical research involves people more and more, infringe upon the rights were to happen from time to tome, subjects were rights concern that and attention.
When it comes to human biological in medical research, infringe upon the lawful rights and interests of the common subjects example. Although the nuremberg code ", "the declaration of Helsinki, and put forward CIOMS" involves people of biomedical research international ethics guidelines form the human society on the human body for the protection of legislation and ethical standards. But many participants rights protection deep problems to be studied further. The author shall enjoy the legal rights of subjects related, combined with the subjects of the current situation and problems, from the legal standard, ethics, management system so as to protect the rights and interests of participants with relevant issues are discussed.
With modern medical science and technology development and biomedical technology extensive application, a kind of any new drugs in the developing process or a new medical technology application in trial, are through the human body after test to application. This created "subjects" this special group and make a career of so-called "vocational subjects". The data shows, at present our country in the new drug declare only reached ten thousand kinds, new medical technology test more extensive. The biomedical research involves people more and more, infringe upon the rights were to happen from time to tome, subjects were rights concern that and attention.
When it comes to human biological in medical research, infringe upon the lawful rights and interests of the common subjects example. Although the nuremberg code ", "the declaration of Helsinki, and put forward CIOMS" involves people of biomedical research international ethics guidelines form the human society on the human body for the protection of legislation and ethical standards. But many participants rights protection deep problems to be studied further. The author shall enjoy the legal rights of subjects related, combined with the subjects of the current situation and problems, from the legal standard, ethics, management system so as to protect the rights and interests of participants with relevant issues are discussed.
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Involves people of biomedical research subjects rights protection in the study of the problem With modern medical science and technology development and biomedical technology extensive application, a kind of any new drugs in the developing process or a new medical technology application in trial, are through the human body after test to application. This created "subjects" this special group and make a career of so-called "vocational subjects". The data shows, at present our country in the new drug declare only reached ten thousand kinds, new medical technology test more extensive. The biomedical research involves people more and more, infringe upon the rights were to happen from time to tome, subjects were rights concern that and attention. When it comes to human biological in medical research, infringe upon the lawful rights and interests of the common subjects example. Although the nuremberg code ", "the declaration of Helsinki, and put forward CIOMS" involves people of biomedical research international ethics guidelines form the human society to the human body for the protection of the legislation
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