Proposes in China medical device trial participants should select the non-vulnerable groups | | object | test _ for medical devices news

Beijing times hearing, according to the State Council Legislative Affairs Office Web site, the State food and drug supervision and administration of medical device clinical trials quality control standard hours Kok exposure drafts for public comment. Soliciting opinions on the medical device clinical trial subjects ' interests protection requirements, saying the subject is generally chosen should be selected in the non-vulnerable groups, cannot be selected except in non-vulnerable groups.

Draft noted that the sponsors of subjects should be avoided, institutions and researchers, clinical trials oversight or other participation or adversely affect the parties in relation to clinical trials or to mislead. Clinical trials and research on the subjects should also be avoided, sponsor, supervisor or other participation or adversely affect the parties in relation to clinical trials or misleading. Sponsors, clinical trials, and the researchers should not exaggerate the compensation measures of participation in clinical trials in order to mislead, encourage subject participation in clinical trials.

Draft said the subject is generally chosen should be selected in the non-vulnerable groups, cannot be selected except in non-vulnerable groups. Targeting vulnerable groups as participants shall abide by the Ethics Committee about the proposed additional requirement, in clinical trials specifically designed for their health problems, and good for their health. In front of the subjects participating in clinical trials, researchers should be sufficient to the subject or his or her immediate family members, guardians or legal representatives note details of clinical trials, including known and foreseeable risks and adverse events that may occur. According to the new agency

(Original title: medical device trial participants should select non-vulnerable groups)

(Edit: SN048)
November 17, 2013 The Beijing times
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我国拟规定医疗器械试验对象应选择非弱势群体|医疗器械|试验|对象_新闻资讯

　　京华时报讯 据国务院法制办网站消息，国家食品药品监督管理总局就《医疗器械临床试验质量管理规范﹙征求意见稿﹚》公开征求意见。意见稿就医疗器械临床试验受试者权益保护作出要求，称受试者的选择一般应当在非弱势群体中选取，不能在非弱势群体中选取的除外。

　　意见稿指出，申办者应当避免对受试者、临床试验机构和研究者、监督者或者其他参与或与临床试验有关的各方有不良影响或者误导。临床试验机构和研究者也应当避免对受试者、申办者、监督者或者其他参与或与临床试验有关的各方有不良影响或者误导。申办者、临床试验机构和研究者不应当夸大参与临床试验的补偿措施，以误导、怂恿受试者参与临床试验。

　　意见稿称，受试者的选择一般应当在非弱势群体中选取，不能在非弱势群体中选取的除外。以弱势群体为受试者，应当遵守伦理委员会提出的有关附加要求，在临床试验中针对其健康问题进行专门设计，并有益于其健康。在受试者参与临床试验前，研究者应当充分向受试者或者其直系亲属、监护人或法定代理人说明临床试验的详细情况，包括已知的、可预见的风险和可能发生的不良事件等。据中新社

(原标题：医疗器械试验对象应选择非弱势群体)

（编辑：SN048）
2013年11月17日02:24
京华时报
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