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published in(发表于) 2013/11/15 12:56:28
Medical device trial participants proposed provisions should normally be for non-vulnerable groups

November 15, according to the State Council Legislative Affairs Office Web site news, the State food and Drug Administration on the clinical trials of medical devices quality management norm Kok hours draft 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 notes that informed consent and ethics review the key measures is to protect the interests of participants. Participation in a clinical trial test of each Party shall, in accordance with their respective mandates and corresponding ethical responsibility.

Draft requirements, sponsors should avoid the subject, clinical trials, institutions and researchers, supervisors 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.

Draft stressed that 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.

Requests made to the draft, before the subject participation 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.

(Original title: official proposes: medical test subjects shall normally be for non-vulnerable groups)

　　中新网11月15日电 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，伦理审查与知情同意是保障受试者权益的主要措施。参与临床试验的各方应当按照试验中各自的职责承担相应的伦理责任。

　　意见稿要求，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。

　　意见稿强调，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。

　　意见稿要求，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。

（原标题：官方拟规定：医疗器械试验对象一般应为非弱势群体）

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