中新网3月7日电 卫生部今日在其官方网站就干细胞临床研究和应用规范征求意见，《干细胞临床试验研究管理办法(试行)》明确规定，I期、II期和III期干细胞临床试验研究均属于在人体的试验研究阶段，不得向受试者收取费用。

Beijing, March 7 (xinhua) the ministry of health on its official website today for stem cell research and clinical application specification for advice,[Stem cell research measures for the administration of clinical trials(On a trial basis)]Make clear a regulation,Phase I/Phase II and phase III studies stem cell clinical trials are in experimental study stage of the body,May not charge fees from the subjects.

　　为进一步规范干细胞临床试验研究活动，加强干细胞临床试验研究管理，卫生部、国家食品药品监督管理局日前组织制定了《干细胞临床试验研究管理办法(试行)》、《干细胞临床试验研究基地管理办法(试行)》和《干细胞制剂质量控制和临床前研究指导原则(试行)》征求意见稿，正在广泛征求各方意见。

In order to further regulate stem cell clinical trials research activities,Strengthen the management of stem cell clinical trials,The ministry of health/The state food and drug administration has to make[Stem cell research measures for the administration of clinical trials(On a trial basis)]/[Stem cell clinical trials for management research base(On a trial basis)]and[Before stem cell preparations, quality control and clinical research guiding principle(On a trial basis)]draft,Is to solicit opinions from all sides.

　　《干细胞临床试验研究管理办法(试行)》适用于干细胞临床试验研究项目的申报和备案，以及临床试验研究的开展和监管，已有规定的造血干细胞移植和以产品注册为目的的临床试验除外。

[Stem cell research measures for the administration of clinical trials(On a trial basis)]Is suitable for the stem cell clinical trials research project declaration and for the record,Experimental study and clinical development and regulation,Regulation of hematopoietic stem cell transplantation and except for the purpose of product registration of clinical trials.

　　从适用对象上看，《干细胞临床试验研究管理办法(试行)》规定了干细胞临床试验研究申报单位、伦理委员会、专家委员会，以及国家和省级卫生行政和食品药品监管部门的主要职责。

Look from the applicable objects,[Stem cell research measures for the administration of clinical trials(On a trial basis)]Rules for stem cell clinical trials reporting unit/Ethics committee/Committee of experts,As well as the national and provincial health administration and the food and drug regulatory responsibilities.

　　《干细胞临床试验研究管理办法(试行)》明确规定，I期、II期和III期干细胞临床试验研究均属于在人体的试验研究阶段，不得向受试者收取费用。在提交干细胞临床试验研究申请前，必须将干细胞制品的相关材料、供者和受试者的筛选标准和知情同意书样稿、临床研究的安全性评估及相应处理措施、临床试验研究方案、研究者手册、主要研究者简历等提交相应的伦理委员会审查，对项目做出伦理审查意见，以保障供者和受试者的合法权益。

[Stem cell research measures for the administration of clinical trials(On a trial basis)]Make clear a regulation,Phase I/Phase II and phase III studies stem cell clinical trials are in experimental study stage of the body,May not charge fees from the subjects.Before submitting your application for stem cell clinical trials,Stem cells must be products related material/Donor screening standard and the informed consent form materials and subjects/Clinical research of safety assessment and the corresponding treatment measures/Clinical trials research plan/The manual/Lead researcher resume and submit the corresponding ethics committee review,The project to make ethical review,To safeguard the lawful rights and interests of the donor and subjects.