伦理审查申请报告

    一、 项目名称：_____________________________________________                                                                

    ______________________________________________________ ______________________________________________________                                                                

    二、 项目分类：                                                                

    □ 药物     □ 医疗器械      □ 课题      □ 其他                                                                

    三、 项目性质： （可多选）                                                                

    □ 国际多中心临床试验         □ 国内多中心临床试验   □ 国内临床试验               □ 研究者发起                                                                

    □ 牵头                       □ 参加                                                                

    四、 项目分期：                                                                

    □ⅰ期    □ⅱ期    □ ⅲ期    □  ⅳ期    □ 其他                                                                

    五、研究设计                                                                

    □ 病例对照研究     □ 队列研究     □ 横断面研究                                                                

    □ 非随机对照研究   □ 随机对照研究  □ 应用盲法                                                                

    □ 其它                                                                

    六、研究背景和目的概要: ____________________________________                                                                

    ______________________________________________________ ______________________________________________________                                                                

    七、申办方: ___________________  sfda批件号: ____________                                                                

    八、项目负责人:___________ 项目负责单位：__________________                                                                                                                                    

    九、                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            

    十、 项目相关材料:（院内基金及课题只需准备研究方案及知情同意                                                                

    书）                                                                

    1．□ 递交信及sfda批件                                                                

    2. □ 有cro公司的需递交申办者委托书                                                                

    3. □ （药物/医疗器械/试剂盒）检验合格报告                                                                

    4. □ 临床试验方案（注明版本号及日期）                                                                

    5. □ 知情同意书（注明版本号及日期）                                                                

    6. □ 研究者手册                                                                

    7. □ 病例报告表                                                                

    8. □ 研究者简历（研究者签名）                                                                

    9. □ 多中心临床试验需提供所有参加单位的名单及负责人                                                                                        篇二：伦理审查申请报告                                                                            

    伦理审查申请人关于                                                                

    伦理审查申请报告模板                                                                

    尊敬的伦理委员会主任，各位委员：                                                                

    现就有关××药×期临床试验方案的伦理问题报告如下，请伦理委员会审查。                                                                

    一、研究人员资格与经验，试验机构条件与设备                                                                

    1. 各中心主要研究者履历：专业，学历与学位，技术职称，gcp培训                                                                

    2. 本院主要研究者的简历（包括临床药理培训）、发表与试验专业相关的论文、同时承担的其他新药临床试验、科研课题、医疗教学工作、行政管理等工作，以说明其是否具备与本项临床试验相关的专业经验、是否有充分的时间承担本项临床试验任务。                                                                

    3. 本院研究者、研究协助人员、研究护士名单，及其职称、专业、研究分工                                                                

    4. 试验主要指标的仪器设备条件，以及相关检验人员的资格和经验，不良事件处理抢救设备与条件。                                                                

    二、研究总体设计的伦理问题                                                                

    1. 研究依据                                                                

    试验药物药效、毒理实验的结果，包括量效、毒效关系。                                                                

    处方组成（药物、剂量、每日服用量相当于生药量），及组成药物中已知的不良反应。 研究目的是否符合公认的科学原理并有充分的相关科学文献作为依据。                                                                

    2. 研究对象                                                                

    受试者的纳入与排除标准与试验干预措施的效应相符。                                                                

    3. 样本量                                                                

    样本量计算和用最少的受试者人数获得可靠结论的可能性。                                                                

    4. 随机                                                                

    随机分配可能使受试者被剥夺已知的有效疗法而受到损害，特别是随机化对照试验中的试验干预措施是用于防止或推迟致命的、或残疾的后果。参见"风险最小化设计"制订相应的对策。                                                                

    5. 对照的选择                                                                

    通常从安全、有效的治疗方法中选择当前最好的方法。                                                                

    安慰剂对照是基于：①目前缺乏有效的替代治疗措施；②安慰剂治疗仅伴随较小的风险，仅在生理测量上产生一个小的差别，如血清胆固醇轻度增加；或延迟治疗或不治疗仅导致暂时的不适，并没有严重不良后果。③当阳性对照不能产生可靠结果时，使用安慰剂不会增加受试者任何严重的、或不可逆损害的风险。                                                                

    6. 中止试验                                                                

    在试验过程中如果发现风险超过潜在的益处，或者获得阳性有益结果的确凿证据，应中止试验。                                                                

    三、受益与风险                                                                

    1. 预期的受益                                                                

    受试者在研究期间将获得医生特别的监护和免费的医疗。                                                                

    将提前获得有临床应用前景的、将来可能被药品监督管理部门正式批准上市的新药治疗，特别是试验药物具有已上市药品不具备的某些治疗特点。                                                                                                                                    

    ⅰ期、ⅱ期临床试验，一般认为试验药物没有把握给受试者提供直接受益的前景。                                                                

    2. 可能的风险                                                                

    ①治疗风险与试验风险。                                                                

    ②试验药物已知或未知的不良反应。                                                                

    ③安慰剂对照伴随的风险。                                                                

    ④随机对照试验的受试者被分配至接受已被证明疗效较差的治疗。                                                                

    3. 不便                                                                

    参加试验所花费的时间，交通，饮食控制与活动受限等。                                                                

    4. 风险最小化设计                                                                

    ①建立不良事件的监测系统：指定专人或成立的数据和安全监查委员会，负责监控研究数据，保护受试者避免以往未知的不良反应，避免不必要地长时间接受疗效较差的治疗。                                                                

    ②针对可能的风险制订医疗对策，如对可能发生的不良反应的处理方案与程序，允许在无法忍受的症状发生时改用阳性治疗，研究者有权根据自己的判断中止该病例的临床试验等措施。                                                                

    ③当研究性治疗的作用机理与标准治疗不同时，可在标准治疗基础上，加上试验治疗和安慰剂。这类研究的特定场合是：已知标准治疗可以减少死亡率或不可逆损害的发病率，停止一个公认有效的治疗可能导致进行性的残疾，难以忍受的不适，或两者皆有，但试验采用标准治疗作阳性对照则难以实施，或难以做出解释时。                                                                

    四、招募受试者                                                                

    1. 受试者的人群特征                                                                

    选择受试者人群应遵循负担和利益公平分配的准则。                                                                

    邀请弱势个体（老人，儿童，妊娠期妇女，智力或行为障碍，以及等级群体中处于下级或从属地位的成员等）作为受试者的特殊理由，以及保护他们权力和健康的措施。                                                                

    2. 招募受试者的方式与程序                                                                

    招募受试者可通过广告，或布告的方式发布有关信息→有意向者报名→阅读"研究简介"→志愿者体检筛选→合格者签署知情同意书→入选受试者随机分组→临床试验。                                                                

    "招募受试者布告"和"研究简介"见附件，并提交伦理委员会审查。                                                                

    五、受试者的医疗和保护                                                                

    1. 受试者可获得的医疗服务的说明                                                                

    研究者负责受试者的医疗服务，作出与临床试验相关医疗决定的措施。是否有保证受试者能够随时找到研究者的措施（研究者留手机给受试者，保证受试者能够在需要时随时找到研究者）。ⅰ期临床试验期间受试者必须住在ⅰ期病房，由临床药理室医师、ⅰ期病房医师和护士负责受试者的医疗护理。                                                                

    受试者参加临床试验可得到免费医疗的安排（如试验药物、理化检查，门诊挂号，额外或延长的住院，不良事件的医疗等）。ⅰ期临床试验将免费提供全部住院医疗护理费用和每天××元标准的伙食补助。                                                                

    研究结束后若继续为受试者免费提供研究性治疗的方式与时间。如果试验治疗无效，将免费获得的标准治疗。受试者自愿退出时，可供选择的治疗措施。                                                                

    严重不良事件应急处理预案。                                                                

    2. 补偿                                                                                                                                    

    向受试者提供的因参与研究而给予的任何补偿的说明，如因参加临床试验的交通费、检验营养费、误工费的补偿，以及医疗保健，必要的科普读物或教育等。ⅰ期、ⅱa期等探索性临床试验将给予受试者的酬劳费。                                                                

    受试者因与研究有关的原因，如研究药品不能接受的副作用，或因健康原因退出研究，应作为完成全部研究而获报酬或补偿。受试者因其他理由退出研究，应按参加工作量的比例而付给报酬。因受试者故意不依从而必须从研究中淘汰，研究者有权扣除其部分或全部报酬。                                                                

    3. 保险与赔偿                                                                

    与研究有关的伤害、致残或死亡的赔偿的安排，研究者和临床试验机构负责提供医疗，申办者负责承担治疗的费用及赔偿。                                                                

    申办者应对参加临床试验的受试者提供保险，应向研究者提供法律上与经济上的担保（由医疗事故所致者除外）的安排。                                                                

    六、受试者隐私的保护                                                                

    1. 只有参与临床试验的研究人员和监查员才可能接触到受试者的个人医疗记录，他们将签署研究者声明或保密承诺中包括保密内容。伦理委员会与药品监督管理部门有权视查临床试验记录。                                                                

    2. 数据处理时将采用数据匿名的方式，省略可识别受试者个体身份的信息。若参加临床试验（如艾滋病、阳痿等）可能使受试者受到社会歧视，医疗记录应采取安全编码等措施，保守可识别病人身份的信息。                                                                

    3. 负责保存受试者试验记录的临床试验机构与申办者的资料档案室应建立严格的安全保密措施。                                                                

    七、知情同意                                                                

    1. 知情同意的过程                                                                

    研究者应采用受试者或其合法代表能理解的语言和文字，说明有关临床试验的详细情况，包括试验目的、试验程序、可能的受益和风险、受试者的权利和义务等，使受试者充分理解并有充分的时间考虑、所提问题均得到满意答复后表示同意，并签署知情同意书。每一例病人签署知情同意书时医生要将自己的联系电话留给病人，以便病人在出现病情变化时能够随时找到医生。签署知情同意书的责任人是研究者。                                                                

    "知情同意书"见附件，并提交伦理委员会审查。                                                                

    2. 重新获取知情同意                                                                

    研究的条件或程序发生了显著的变化，或得到了可能影响受试者继续参加研究意愿的新信息，应重新获取受试者的知情同意。                                                                

    长期研究项目，即使该研究的设计或目标没有变化，也要按事先确定的时间间隔重新获取知情同意。                                                                

    3. 避免胁迫和不正当影响                                                                

    患者担心拒绝参加研究可能损害医患关系，医生/研究者必须保证不论他们决定参加研究与否，都不会影响医患关系，必要时应由一个中立的第三方来获取知情同意。                                                                

    4. 知情同意的例外情况                                                                

    因急诊情况无法取得本人及其合法代表知情同意书，如缺乏已被证实有效的治疗方法，而试验干预措施有望挽救生命，恢复健康，或减轻病痛，应在试验方案中确定符合研究条件疾病的人群，说明接受这些对象的方法，并事先取得伦理委员会批准。                                                                                                                                    

    八、伦理审查                                                                

    1. 多中心研究可通过各中心间达成的协议，各中心均接受组长单位伦理委员会的审查结论开始试验。                                                                

    2. 对研究方案或知情同意书的任何修改，可能影响受试者的权益或研究的实施，需再次报请伦理委员会批准后实施。                                                                

    3. 临床试验中发生任何严重不良事件，各中心伦理委员会应及时审查，提出书面修改意见，包括有充分的权力中止试验，并通报组长单位和申办者，供其考虑和做出相应的行动，以确保所有其他受试者都能得到保护，各中心的研究都将有效。                                                                

    九、研究结果的报告                                                                

    1. 合同规定谁拥有发表研究结果的权力，并强制规定报告研究结果的文稿要与主要研究者一起准备、并服从主要研究者的意见。                                                                

    2. 在阴性结果的情况下，通过公开发表或向药品注册当局报告的途径，以保证可以得到这类结果。                                                                

    3. 可能被认为不适合发表研究发现的情况，如流行病学、社会学或遗传学研究的发现可能对社会、或人群、或以种族或民族定义的群体的利益带来风险。                                                                

    4. 每位受试者将被告知与他们自身健康状态有关的任何发现。研究完成后，受试者将被告知研究发现的方式。篇三：医学伦理委员会审查申请表                                                                                                                                            

    医学伦理委员会审查申请表                                                                                                                                                                                                                                                                

    申请者签字：                                                                                                                                

    日期：篇四：药物临床试验伦理审查申请书(初审)                                                                                                                                            

    药物临床试验伦理审查申请书（初审）                                                                                                                                

    试验药名称（inn）：                                      药理学分类：                                                                                                                                

    试验药类别：                                                                

    □中药、天然药物       类                                                                

    □化药      类                                                                

    □生物制品     类                                                                

    □进口注册                                                                

    □上市药                                                                                                                                

    临床试验所在专业：                                                                                                                                

    填表日期：         年    月      日                                                                                                                                                                                                    

    填写说明                                                                                                                                

    一、 此表适用于药物临床研究方案初次在我院申请伦理评审。                                                                

    二、 请用电脑打印此表，字迹要清楚、工整、不得涂改。                                                                

    三、 请按要求在相应的□栏内划√。                                                                

    四、 第1页，试验目的栏：1=i期耐受性试验；2=i期药代动力学试验；3=ii期临床试验；                                                                

    4=iii期临床试验；5= iv期临床试验； 6=生物利用度试验；7=上市药临床试验                                                                

    五、 表中如某些栏目内容不能完整填写时，请用a4纸附页。                                                                

    六、 初次报送伦理委员会时需报送以下文件：                                                                

    1. 递交信(含所递交文件清单，注明所有递交文件的版本号或日期)；                                                                

    2. 国家食品药品监督管理局临床试验批件或注册批件（适合上市药物临床研究）；                                                                

    3. 伦理审查申请书；                                                                

    4. 临床试验药品及对照药品合格检验报告（某些特殊药品需要中国药品生物制品检定所组织实施的合格质检报告）；                                                                

    5. 申办者资质证明及临床试验药品生产的gmp证书复印件；                                                                

    6. 研究方案 (含版本号、研究方案提纲)；                                                                

    7. 知情同意书 (含版本号)；                                                                

    8. 研究者手册(含版本号)或药品说明书；                                                                

    9. 研究病例和病例报告表(含版本号)；                                                                

    10. 主要研究者简历及gcp培训证书复印件；                                                                

    11. 其他单位对该临床试验的伦理审查批件；                                                                

    12. 上市药临床试验须提交申办者的委托函及赠药证明；                                                                

    13. 申办者对cro的委托函（如有cro）；                                                                

    14. 临床研究的申办者与临床试验批件的申办者不一致时，提供相关证明文件；                                                                

    15. 其他资料(如受试者须知、受试者日记、招募广告、保险声明等)。                                                                                                                                                                                                    

    一、 项目名称：                                                                

    方案编号：                   版本号：                                                                

    二、 试验目的：1 □  2 □  3 □   4 □   5 □   6 □   7 □                                                                

    三、 申办者：                                                      申办者联系人：              联系电话：                                                                

    四、 国家食品药品监督管理局临床试验批件号：                                                                

    五、 临床试验机构专业名称：            是□ 否□ 批准专业                                                                

    六、 主要研究者：          职称：       有□ 无□ gcp证书                                                                

    科室：           联系电话：                                                                

    项目负责人：          职称：       有□ 无□ gcp证书                                                                

    科室：           联系电话：                                                                

    主要参加者           职称         分工        有□ 无□ 证书                      职称         分工        有□ 无□ 证书                      职称         分工        有□ 无□ 证书                              职称         分工        有□ 无□ 证书                                                                

    七、项目参加单位： 1                               是□ 否□ 批准的专业                                                                

    负责人        职务       职称        有□ 无□ gcp证书 2                               是□ 否□ 批准的专业                                                                

    负责人        职务       职称        有□ 无□ gcp证书 3                               是□ 否□ 批准的专业                                                                

    负责人        职务       职称        有□ 无□ gcp证书                                                                

    八、该研究方案是否被其他伦理委员会拒绝或否决过?  是□ 否□                                                                

    九、该研究方案是否曾被暂停或者终止过?  是□ 否□                                                                

    十、科室是否有同类药物临床试验项目？是□ 否□                                                                

    十一、科室目前在研药物临床试验项目：     项，其中与本试验药物的目标适                                                                

    应症患者相同的在研药物临床试验项目：     项。                                                                

    十二、试验药品：                                                                

    1、 受试药品：                                                                                                                                    

    名称                   剂型及规格                                                                

    批号                         有效期                                                                

    合格药检报告：有□ 无□    gmp证书：有□  无□                                                                

    剂量：      疗程：        本中心受试者数/本研究受试者总数：    /         剂量：      疗程：        本中心受试者数/本研究受试者总数：    /      剂量：疗程：本中心受试者数/本研究受试者总数：剂量：      疗程：        本中心受试者数/本研究受试者总数：    /                                                                

    2、 对照药品：  无 □    有 □                                                                

    名称                   剂型及规格                                                                

    批号                         有效期                                                                

    合格药检报告：有□ 无□    gmp证书：有□  无□                                                                

    剂量：      疗程：        本中心受试者数/本研究受试者总数：    /      剂量：      疗程：        本中心受试者数/本研究受试者总数：    /      剂量：      疗程：        本中心受试者数/本研究受试者总数：    /      十三、试验方法                                                                

    随机双盲□  随机单盲□  随机开放□  其他□，描述：                                                                

    十四、研究对象：                                                                

    正常人□     病人□，请描述：         受试者年龄范围：            受试者性别：                                                                

    受试者是□否□ 有弱势群体：精神疾病、病入膏肓者、孕妇、文盲、穷人/                                                                

    无医保者、未成年人、认知损伤者、pi或研究人员的下属、研究单                                                                

    位或申办者的员工。