National health and family planning commission is involved in the body of the medical science and technology research management measures for public comment

National health and family planning commission of the People's Republic of China: www.moh.gov.cn2013-07-15

        To strengthen human research management of medicine science and technology, guide and standardize research, promoting the healthy development of medical science and technology research by commission to make a "relating to the human medical science and technology research management method", is open for advice. About answering questions as follows:

        A, what is the purpose of "method" for?

        Due to the part relating to the human medical science and technology research such as surgical technique, such as food safety risk assessment is not standard, the lack of effective management, brings to the subjects of health risk, even in charge service way infringing the subjects' rights and interests. Many institutions to carry out research in medical science and technology, has not yet formed in view of the medical science and technology research project, the ethical review, technical evaluation, registration, publishing and so on each link more perfect management system, has affected the healthy development of medical science and technology research. , in order to strengthen the medical science and technology research involving human management, establish and improve the medical science and technology research management system and mechanism, standardize medical and health, public health intervention, family planning, food safety risk assessment and so on medical clinical trials involving human behavior, by organization of experts involved in view of the current in the conduct of human medical science and technology research, problems that exist in the drafting of the "relating to the human medical science and technology research management method" (hereinafter referred to as the "method").

        Second, the methods formulated in compliance with the basic principle is what?

        The methods formulated in compliance with the principles: one is through the norms of medical science and technology research to promote the development of medical technology innovation; 2 it is through the establishment of sound rules and regulations, effectively regulating the conduct of scientific research to improve the quality and level; 3 it is to clear the responsibility, adhere to the fair, just and open, the government supervision, social supervision and industry self-discipline combination; Four is the effective protection of rights and interests of the subjects.

        3, what are the main content of "method"?

        "Method" article 51, seven chapters focus on project management is established, register put on record, process management, the research results, the basic management system of evaluation and supervision and management, etc.

        4, documents applicable scope is what?

        All the methods used in China to carry out the involving human medical science research, technology development and application of science and technology activities of independent legal person units, including medical and health institutions, medical institutions, research institutes, the institution of disease prevention and control, food safety risk assessment system, family planning and other enterprises and institutions and nongovernmental organizations (ngos).

        Five, the main responsibility of the problem

        "Method" has been clear about the conduct involving human medical science and technology research institution (or group) is the first responsibility main body, scientific research and project implementation main body and shall provide necessary conditions for scientific research, establish and improve the scientific research project examination and approval, registration and filing, process management, acceptance, and evaluation and other rules and regulations, take effective measures to safeguard the rights and interests of the subjects. The family planning administrative department of health at or above the county level should be through the registration and filing system in a timely manner to understand medical information on the development of science and technology research projects within their respective jurisdictions, and to perform regulatory responsibilities.

        6, regarding the registration for the record

        "Method" regulation conducted relating to the human medical science and technology research institutions (or organization) to have an approval of research project before into the first participants shall, in accordance with the relevant procedures and regulatory requirements in the national medical science and technology research register put on record information system for registration for the record. Register put on record information should organize regular analysis and evaluation, to understand the research progress in time and to supervision and management of scientific research work.

        Seven, about the results of the study evaluation

        Involving human medical science and technology research in the basic completed, before the formal application, should be systematic, comprehensive, scientific, standardized research result assessment, evaluation content mainly includes the technology of safety, effectiveness, ethical compliance, as well as economic, social, suitability, evaluation results can be used as medical science and technology to promote the basis for management decisions.

        Eight, about the supervision and management

        Does not perform this "method" regulation of medical science and technology research behavior is not standard, shall be investigated for corresponding responsibility. Include: without registration and filing of involving human medical science and technology research report, published in any form, and shall not participate in the selection of all kinds of science and technology award, Without the agency (or organization) project audit and network registration and filing of do STH without authorization to carry out the medical science and technology research involving human, directly responsible shall be investigated for legal and liability; Agency (or organization) to carry out the medical science and technology research involving human don't abide by the "method" relevant provisions, the competent administrative departments shall supervise the immediately stop the technology research, and on the basis of the "regulations on the administration of medical institutions" to give corresponding punishment. Has entered the application, the competent administrative department shall timely cancel the technology admittance qualification, and announced to the public.

Related links: the involving human medical science and technology research management method"