Obligations under human trials the researchers explain the criteria.docVIP

 PAGE \* MERGEFORMAT 12 Obligations under human trials the researchers explain the criteria [Abstract] perfect in human trials informed consent system is an important basis for protection of the interests of subjects, and researchers to do experiments to fully explain the obligations of the premise is to improve the elements of informed consent, so do the researchers explain how to determine scope of the obligation and the standard is very important. At present, the researchers note in the issue of obligations of the provisions of the standard is very simple, the author tries to specific criteria and standards for both the abstract description of the obligations of researchers to improve standards. [Keywords:] human trials the researchers note obligations Abstract: It is an essential foundation to improve the system of informed consent in order to protect the rights and interests of experimenter in human experiment, and the researchers full description of all obligations in the experiment is a prerequisite for improving the informed consent.Therefore how reseachers explain the scope and stadnard of the obligation seems to very important.At present, the standard provisions of reseachers description obligations are very simple.The author will try to improve the standard of researcher s description obligation through, the specific scope and the abstract standard. Keywords:: human experiment, researcher, description obligation Human trials is different from the conventional treatment, the immaturity of the technology more easily to the subjects of physical and health damage, so in human beings, in order to better protect the rights of the individual subjects, they are guaranteed full the right to self-determination, the researchers need to do more to fully explain the obligations. However, there are though in the “lt;PRC Drug Administration Law of the People’s Republic gt;gt;,lt;lt; Medical Practitioners Regulations for the Implementationgt;gt;