乌克兰卫生部
中央道德委员会
国家药理中心
得到正式认可的
乌克兰卫生部副部长
_______________ AP古琴科
保险药物临床试验
乌克兰产品 (如果患者的生命和健康受到损害，则客户的责任)
(指南)
“得到正式认可的”
中央委员会主席
乌克兰卫生部道德规范
_______d.m.n. 科学. VM科纳茨基 “得到正式认可的”
国企副主任 “国家药理中心” 乌克兰卫生部
_______d.m.n. 科学. 莫罗佐夫
基辅 2010
乌克兰卫生部
中央道德委员会
国家药理中心
得到正式认可的
乌克兰卫生部副部长
_______________ AP古琴科
保险药物临床试验
乌克兰产品 (如果患者的生命和健康受到损害，则客户的责任)
(指南)
“同意”
中央委员会主席
乌克兰卫生部道德规范
医学博士, 教授. VM科纳茨基
«____» ___________ 2010 “同意”
国企副主任 “国家药理中心” 乌克兰卫生部
医学博士, 教授. 莫罗佐夫
«____» ___________ 2010
基辅 2010
开发商的:
乌克兰卫生部中央道德委员会
国企 “国家药理中心” 乌克兰卫生部
编译者
医学博士, 教授. 塔拉耶娃·塔蒂亚娜, 乌克兰卫生部中央伦理委员会副主席;
奥尔加五世博士. 西兰季耶夫, 乌克兰卫生部中央伦理委员会执行秘书;
斯卡琳娜·奥尔加, 乌克兰保护权利和患者安全委员会法律部负责人;
蒂特·玛丽娜·亚历山德罗芙娜, 乌克兰患者权利与安全委员会法律部负责人;
科夫通博士, 柳德米拉·伊万诺芙娜, SE临床试验及临床前测试部负责人 “国家药理中心” 乌克兰健康;
莫斯卡连科·达里娅·彼得罗芙娜, SE临床及临床前检测部不良反应监测负责人 “国家药理中心” 乌克兰健康.
审稿人:
尤里·伊里奇·昆季耶夫, 乌克兰 NAS 和 AMS, 乌克兰医学科学院副院长, 医学博士, 教授, 乌克兰AMS职业医学研究所所长, 乌克兰国家科学院生物伦理委员会主席;
Grevtsova Radmila Yuriyevna 事务专家, 乌克兰宣传科学院医学与药学法与生物伦理学研究所所长, 乌克兰医学和法律协会主席.
编者向乌克兰医学法协会表示诚挚的谢意 (总统 – k.yu.n. 右. J. 格列夫佐娃) 个人及协会第一副会长, 医学博士, Alla Stepanenko V.教授, 编制者在制定数据指南时广泛使用的研究项目和出版物.
建议召开第四次全国生命伦理学大会 (九月 2010).
内容
缩略词列表
方法建议中使用的关键术语的解释 … … … … … .. … … … … … … … … … … … .. … … … … … … ..
介绍 … … … … … … … … … … … … … … … … … … … … … … … … … …. …
1. 乌克兰临床试验秩序和安全立法机构 … … … … … … … … …
2. 保险患者的道德问题 (健康志愿者), 参加临床试验 … …
3. 对参与客户试验保险责任的保险公司的要求 … … … … … … … … … … … … … … … … … … … … … … … …
4. 责任保险客户试验合同的一般要求和特殊要求 … … … … … … … … … … … … … … … … … … … … … … … …
4.1. 合同签订事实证明 … … … … … … … … … … … … … … … … … … … … … … … … ..
4.2. 责任保险合同客户向第三方试用的要求 (患者, 健康志愿者) … … … … … … … … … … … ..
5. 保险赔付条款 … … … … … … … … … … ..
6. 拒绝领取保险金的原因 … … … … … … … … … …
来源 … … … … … … … … … … … … … … … … … … … … ..
缩略词列表
药品
心力衰竭临床试验
民法典 乌克兰民法典
GCP 良好临床实践
方法建议中使用的关键术语的解释
保险 – 此类民事法律关系是为了在发生某些事件时保护公民、法人的财产利益 (保险索赔), 由保险合同或适用法律定义, 以公民和法人缴纳保险费形成的基金为费用 (保险缴款, 保险费) 以及这些资金的安置收益.
保险公司是公认的金融机构, 以股票形式创建, 满的, 乌克兰法律规定的有限合伙企业或额外责任 “论商业协会” 考虑到本法设想的具体情况, 并按规定方式取得保险活动许可证. 保险人成员不少于三人. 乌克兰的保险活动完全由保险公司管理 – 乌克兰居民.
保险公司认可的法人实体以及与保险公司或保险机构签订合同的有能力的公民根据乌克兰立法受保.
自愿保险 – 是基于被保险人和保险公司之间协议的保险. 自愿保险的一般条件和程序由保险人根据本法独立制定的保险法规确定. 具体保险条款应在合同签订时依法确定.
保险风险 – 一个事件, 已投保并具有特征和偶然发生概率的事件.
保险事件 – 一个事件, 提供保险合同或法律, 保险人有义务支付保险金额时发生的情况 (保险) 给被保险人, 被保险人或其他第三方.
保险金额 – 保险人根据保险条款应在保险案件中赔偿的金额.
保险金 – 保险事故发生时，保险人根据保险合同支付的金额.
保障 – 保险金, 是该保险案件中财产保险、责任保险合同保险金额范围内的保险人.
保险费 (优质的, 优质的) – 保险费, 保险人根据保险合同有义务作出的.
保险费率 – 一定保险期间内每单位保险金额的费率保险费.
责任限额 – 保险合同规定的限额 (最大限度) 由于一个原因而导致的每起保险事故或一系列案件的赔付金额.
保险 – 保险人和保险人之间的书面协议，根据该协议，保险人在保险案件中承诺向保险合同中指定的第三方支付保险金 (提供帮助, 执行服务等), 保险人承诺按时支付保险金, 以及合同的其他条件.
近亲 – 个人, 他们之间基于彼此起源或共同祖先的自然关系，并在法律规定的情况下具有法律意义. 近亲是丈夫 / 妻子, 父母, 孩子们, 兄弟姐妹;
研究药物 – 正在研究或用于临床试验比较的活性物质或安慰剂的药物形式, 包括已取得注册证的药品, 但它们被使用或生产 (制作或包装) 与注册剂型相比，方式不同, 或用于未注册适应症或用途有关产品注册形式的更多信息;
法定代表人 – 父母, 养父母, 养父母, 监护人, 受托人和监护人及受托人的代表;
临床试验申请人 – 个人或法人实体 (例如, 赞助, 合同研究组织) 向卫生部门或其授权机构提交临床试验申请. 申请人只有在申办者发出命令的情况下才可以申请临床试验, 有明确的授权;
知情同意 – 参加临床试验的决定, 必须以书面形式作出, 注明日期并签名, 在适当了解临床试验的性质后自愿进行, 它的重要性, 影响和风险, 正式签署的文件应由有协议能力的人或其法定代表人制作, 在特殊情况下，该人不能写, 它可以在至少一名证人在场的情况下给予口头同意，该证人在研究中证明受试者的同意书面知情同意书;
临床试验 (研究) 产品 – 旨在识别或确认临床研究的任何涉及人类受试者的研究工作, 药理和 / 或一种或多种研究药品的其他药效学作用, 和 / 或检测一种或多种研究药品的不良反应, 和 / 或研究吸收, 分配, 一种或多种药物的代谢和排泄，以验证其 (他们的) 安全和 / 或功效;
合同研究组织 – 与赞助商签订协议并具有其一项或多项职能的自然人或法人 (权力) 在临床试验中, 并根据保荐人发出的命令行事，并具有明确的授权;
病人 (健康志愿者) – 可能参与临床试验研究的人;
主要病历 – 原始文件, 数据和记录 (例如, 病史, 医院卡, 实验室笔记, 备忘录, 日记或问卷, 配药, 打印设备, 经核实和认证的录音制品副本或抄本, 缩微胶片, 照相底片 , 缩微胶片或磁性介质, X光片, 行政文件, 药房保存的记录, 参与临床试验的实验室和仪器诊断部门, ETC。);
不良反应 – PRE 试验中的新药或新用途研究, 特别是如果安装了产品的治疗剂量, 药物的不良反应必须将所有负面和意外的反应归因于任何剂量的产品. 期限 “对药品的反应” 意味着使用药物 ZASO ‐bu 与不良反应之间至少存在允许的因果关系概率, 即不能排除这种关系.
作为注册药品, 该术语是指与使用常规剂量的药品进行预防相关的任何负面或意外反应, 疾病的诊断或治疗, 恢复, 矫正或对生理功能的影响;
临床试验方案 – 描述目标的文件, 方法论, 程序, 临床试验的组织和统计方面, 通常是先前获得的有关研究产品的数据和临床试验的理由;
赞助 – 负责发起和组织临床试验的法人或自然人 / 或资助;
第三人称 – 在临床试验中倾向于 – 病人, 健康志愿者.
良好临床实践 (GCP) – 标准规划, 执行, 执行, 监控, 审核和记录临床试验, 以及结果的处理和呈现, 该协会致力于保证数据的可靠性并保护人类健康和受试者的匿名性.
介绍
乌克兰药物临床试验, 国际国内均按照药品临床试验质量管理规范的原则进行 (良好临床实践), 手册中指定的 42-7.0:2005 经乌克兰卫生部批准 22.07.2005, 数量 373 并根据 “进行药品临床试验的程序以及临床试验的专业知识和示范法规伦理委员会” 乌克兰卫生部自 2009 年 9 月 23 日起批准。, ○ 690.
在乌克兰, 药物临床试验, 根据其法律规定, 进行与 90 上世纪以来，他们的数量逐年增加 (在 1996 同意 79 测试在 2006. – 仅322, 2008年. – 208 多- 和 67 odnotsetrovyh 临床试验.
患者人数 (健康志愿者), 谁作为药物测试对象发言 2008. 总计 27,961 代表人 5.14% 患者和健康志愿者总数 (544,116 人们) 各国参加CR的人.
乌克兰 HF 程序与国际要求的协调, 根据GCP原则 – 主体权利的保障 – 患者和健康志愿者受到保护, 保密并获得的研究数据是可靠的信息. 遵循既定惯例, 标准责任保险客户kV.
乌克兰的保险活动完全由保险公司管理 – 乌克兰居民和受监管的一般保险法.
鉴于保险参与者临床试验药物的特殊性, 这是一项涉及人的生物医学研究 (患者, 健康志愿者, 包括儿童, 未成年人), 客观确定临床药物研究风险的需要, 这需要对保险公司的专家进行适当的培训 , 保险赔偿研究参与者的道德和伦理方面 – 需要支持此类保险方法论方向的文件, 知识库权利保护指南.
致为临床试验风险提供保险的保险公司及其专家, 药物, 除一般保险立法外, 有一些道德, 合法的, 资质要求, 其实施是为参与者的kV提供有效的保险保障以及对可能发生的情况进行赔付的保证.
1. 乌克兰临床试验秩序和安全立法机构
在乌克兰, 研究参与者的兴趣 (患者, 健康志愿者) 发生保险事故时获得赔偿的权利受法律保护 (当对患者造成伤害时).
药物临床试验保险以乌克兰保险立法为基础. 乌克兰法律提及的基本原则和概念 “关于乌克兰法律修正案” 关于保险 “(2001). 在文章中 7 该法列出了强制保险的类型, 但此列表不包括责任保险客户对第三方的试用 (患者 (志愿者) 在药品临床试验期间对其生命和健康造成损害.
本规定按照乌克兰其他法律执行 – “关于药物” (文章 8) – “药品的客户试验必须在开始临床试验之前签订人寿保险和患者健康的合同 (志愿者) 按照法律规定的顺序 “, 即保险KB不是强制保险类型, 但对其持有至关重要.
根据药品注册技术要求国际协调会议《药物临床试验质量管理规范指南》的国际要求 (我的GCP): “标准程序申办者应根据监管要求考虑对因研究程序造成伤害的临床试验参与者的治疗费用进行补偿) (§ 5.8.2 我E6).
指令 2001/20/ES (st.3.2.f) 指出 “可以进行临床研究, 假如 … 提供担保人责任提供的保险或赔偿。”
根据章程 7, 8 乌克兰法律 “关于药物”, 欧洲议会和理事会 2001/20/EC “关于定律的近似, 成员国关于在人类消费药品临床试验中实施良好临床实践的法规和行政规定 “的 4 四月 2001, 并进一步协调乌克兰批准的药物临床试验国际规则” 进行药品临床试验的程序和临床试验的专业知识以及道德委员会的示范条例 “(乌克兰卫生部自 2009 年 9 月 23 日起。, ○ 690). IY对保险参与者参与临床研究的条件和原则的特殊要求, 这, Ⅲ期, 本文第九节.
2. 保险患者的道德问题 (健康志愿者), 参加临床试验
参与药物临床试验可能会给患者的健康和福祉带来风险 (健康志愿者). 所以, 权利作为主体受到法律和道德规范监管的 CR.
补救措施之一是确保参与者KO其自愿参与, 及时告知患者与研究药物相关的所有风险 (知情同意程序). 第二个重要因素是通过保险机制确保参与者KV生命和健康受到损害时得到可能的损失补偿.
现在, 通过自愿合同责任保险客户试验向第三方承担临床试验的保险风险 (患者, 健康志愿者) 在药品临床试验期间对其生命和健康造成损害.
所以, 获得乌克兰中央伦理委员会和卫生部报告的批准乌克兰主管当局进行药品临床试验申请人的临床研究 (赞助, 合同研究组织) 连同其他文件, 必须向每个结构提交一份上述合同副本以及证书副本.
3. 对参与客户试验保险责任的保险公司的要求
保险活动受乌克兰立法监管, 以及高度的社会重要性, 涉及人体的临床研究的保险风险的医学和伦理方面, 对此类保险提出额外要求和建议条款.
必需的, 受法律监管, 的规定:
1.斯特拉霍维克 (保险组织, 保险公司) 必须注册为金融机构，并获得根据乌克兰国家金融服务监管委员会现行立法颁发的此类保险开展保险业务的许可.
2. 对第三方的保险责任 (除段落中规定的以外 12-14 文章数量 6 乌克兰法律 “关于保险” 保险公司应该开发它并在乌克兰国家金融服务市场监管委员会注册 (授权机构) 保险的.
3. 根据文章 17 乌克兰法律 “关于保险” 保险法规规定的特殊保险条件也在主管当局登记.
推荐位置: 为保证保险机构的适当水平, 保险合同的专业方法和考虑可能的保险索赔 – 保险公司负责人, 保险风险评估和检查被保险人生命和健康受到损害的事件 参加者KB应具有较高的医学教育水平并应熟悉GCP的要求, 应提供适当的证书.
4. 合同责任保险客户试用的一般要求和具体建议
4.1. 合同签订事实证明.
书面形式的保险合同 (文章 16 乌克兰法律 “关于保险”).
保险合同可以由保险证书证明的事实 (政策, 证书), 这是保险合同的一种形式 “(文章 18 乌克兰法律” 关于保险).
由于法律上本文件的形式缺乏单一标题，因此对合同的解释存在一些法律模糊性. 然而, 不管叫什么名字, 这些要求意味着所需的文件 (合同或保险证书或保险单或证书 – 所有同义词) 必须以书面形式提交，并且必须符合法律规定的形式和内容 .
保险公司必须提供额外文件才能完成合同, 通常带有证书名称 (不适用法律规定的合同形式和内容要求). 他具有任意含义，表明合同的主要项目可以通过某种设计注册来制造.
需要说明的是，本文件只能作为合同的补充，并不能替代合同. 立法规定本文件作为单一文件存在, 确认合同.
因此, 乌克兰中央伦理委员会和国家药理中心卫生部已提交完整的书面保险合同 (保险单, 证书), 其形式和内容符合乌克兰法律 “关于保险”.
4.2. 责任保险合同客户向第三方试用的要求 (患者, 健康志愿者)
根据艺术. 980 乌克兰民法典是合同的主题 – 财产权益不违反法律并与: 对被保险人造成的损害进行赔偿 (责任保险), 这是被保险人对第三方生命或健康造成的损害的责任 (病人 , 健康志愿者), 作为临床试验的结果，该事件是由属于非故意描述范围内的事件引起的, 偶然, 意外, 大概是这样.
保险合同必须包含:
(依法 “关于保险” (文章 16))
• 文档标题;
评论. 保险合同名称, 它的数量, 签署日期.
• 保险公司的名称和地址;
评论. 对于保险合同责任客户试用必须参照保险公司规则和第三方责任保险客户试用特殊条件进行登记 (患者, 健康志愿者) 在药品临床试验期间对其生命和健康造成损害 (并标明主管当局的注册号及其日期).
• 姓, 保险公司和被保险人的姓名或名称, 他们的地址和出生日期;
评论. 在保险合同责任客户试验中注明被保险人的全名 (sponsored research or contract research organization (if appropriate delegation of authority), or other authorized agency sponsor.
Mandatory is the presence of an individual’s name on whose behalf the paper is concluded and shall include the authority (原因) that entitles a contract (through statutory documents such as statutes, power of attorney, or other acts of civil law).
When insuring “liability” insurer enters into a contract with the insurer in favor of a third party to whom the insurer is required to make an insurance payment when an insured event that is defined
法律 (Civil Code Art. 985). At the conclusion of the contract, “third person” (病人, 健康志愿者) does not require identification (specifying name, 地址, ETC。). This is due to the established procedures of coordination and conduct of clinical research, 哪个 – set of patients (健康志愿者) performed after the conclusion of the contract and obtain a permit for a KO.
所以, in the insurance contract liability of the customer trials to third parties (患者, 健康志愿者) for damage to their life and health during clinical trials of drugs to the insured insures his liability to third parties that do not require identification at the conclusion of the contract shall indicate only the number of third parties.
The third person is identified when an insurer’s obligation to make an insurance payment for damage by means of documents that provides the insurer under the insurance contract. An important document with a written informed consent of the patient (健康志愿者).
Also in the insurance contract may not indicate the place of clinical research, because at the time of signing the contract they have not agreed competent authority ofUkraine. 如果需要的话, this information may be submitted to the insurance company separately (as a project), and the final list for a clinical trial – upon approval by a regulator.
• 姓, 姓名, date of birth or name and address of beneficiary;
评论. Beneficiary under the contract established a third party, with faceless; as in connection with the foregoing, during the contract it can not be determined exactly. 通常, under such agreement, the beneficiary (第三者) may also represent the right to receive compensation – legal representative (父母, 养父母, 养父母, 监护人, 受托人和监护人及受托人的代表) or successor under the law.
• sum insured under a contract of insurance other than life insurance contract;
评论. Individual insurance is determined by one person – 病人 (健康志愿者), ie the limit of liability for one person – the limit set by the insurance contract (最大限度) amount of money payments for each insured event.
For this type of insurance, given the individual sums insured, legally defined in the Ukraine for compulsory insurance, the decision of the Central Ethics Committee of the Ministry of Health of Ukraine № 18 从 09.12.2009, the Section 5 (with the consent of the State Pharmacological Center MoH Ukraine ) recommended the following: “the minimum amount of insurance can not be less than the sum of the minimum wage for 10 年, ie approximately not less than 10 千美元,” which corresponds to regulations, since the order MZ of Ukraine from 23.09.2009r., ○ 690 假如 “in setting the amount of compensation per person is taken into account best international practices and possible real costs for study.”
Total insured amount is the amount of money to all persons – 患者 (健康志愿者), within which the insurer under the terms of insurance shall make compensation.
In this type of insurance is available a limited liability aggregate limit – set by the insurance contract limit (最大限度) amount of money to pay all insurance claims for the period of the contract. Because this amount of money calculated on a number of insurance claims (例如, 10 for participation in CR 100) is in contradiction with the Law of Ukraine “关于药物” (文章 8) and the Order of the Ministry of Health of Ukraine from 23.09.2009r., ○ 690, which regulate what insurance protection subject to all patients (健康志愿者) who intend to participate in clinical trials and that in due course signed informed consent.
• a list of insurance claims;
评论. In this type of insurance is an insurance company, 确定了由于临床试验期间出现研究药品不良反应而损害他人生命和健康的事实, 导致并发症或死亡 – 属于描述范围内的事件是如何无意的, 随机的.
研究药物引起的不良反应和患者人身伤害的存在 (健康志愿者) 建立赞助研究, 向保险组织提供此信息, 必须在保险合同中注明.
保险, 除因研究药品不良反应造成的损害外，应包括与临床试验和研究方案直接相关的其他负面影响.
按照国际惯例, 监管机构批准将HF纳入临床试验参与者综合保险 (即不仅涉及与研究药物相关的保险风险, 还有与研究人员和临床试验场所相关的风险), 因为患者可能并遭受医务人员的错误或遗漏, 医疗设备故障, ETC。.
• 保险缴款 (付款, 奖金) 和付款条件;
评论. 是按照法律规定进行的.
根据 ICC St.983 保险合同自受保人首次保险付款之日起生效, 除非合同另有规定. 保险生效的时刻很重要, 在通知乌克兰主管当局和中央伦理委员会开始临床试验的同时，申办者或其授权代表必须提交证明，证明在临床研究开始时，导致受试者受伤的责任保险合同已生效并生效 (乌克兰卫生部自 2009 年 9 月 23 日起。, ○ 690).
被保险人居民, 根据适用法律, 有权仅以乌克兰货币付款, 和非居民保险公司 – 在乌克兰立法规定的情况下，以外国可兑换货币或乌克兰货币单位.
• 保险费率 (保险费率是针对没有固定保险金额的保险索赔确定的);
评论. Legislatively determined that insurance rates for this type of insurance the insurer calculated actuarially (mathematically) on the basis of the statistical occurrence of insurance claims and approved as part of the Special Terms and conditions of insurance regulator.
The specific amount of insurance rate is determined in the insurance contract by agreement.
It should be noted that to determine the tariff expert insurance company is qualified to determine the risks of clinical research and investigational drugs, which can lead to negative consequences for the patient. Risk assessment is carried out using the protocol of a clinical study, investigator’s brochure, ETC。. According to this expert should have higher medical education (see rozd.3, p.11), as well as appropriate training for a KO.
• term of the contract;
评论. Sure must not be less than the duration of a clinical trial.
In the Ministry of Health of 23.09.2009r., ○ 690 indicates that this protocol takes into account the peculiarities of the clinical trial and pharmacological characteristics of the investigational product.
对此, 在某些情况下, by agreement, the term of the contract period and may include observation of the patient (通常 1-3 年) after the expiration of a clinical trial.
It should be noted that the Civil Code of Ukraine defined this concept as statute of limitations – “is a period within which a person may
go to court to demand protection of their civil rights or
interest “. The general statute of limitations established by law, is three years. 然而, 这 “statute of limitations does not apply to the request of the insured (insured) 向保险人支付保险金 (保险)” 那个病人 (健康志愿者), 无论进行临床研究的时间如何流逝, 可向法院申请赔偿临床试验期间造成的损失 (国际商会, 艺术. 268).
• 更改订单和合同;
评论. 是按照法律规定进行的, 其中指出: “任何一方有意提前终止合同的，应不迟于 30 合同终止日之前的日历天, 除非另有规定” (法律 “关于保险 “文章 28).
如果提前终止合同, 此类保险的附加条件是提前投保, 官方通知申请人KV乌克兰中央伦理委员会和乌克兰卫生部主管部门终止合同.
When concluding an agreement on early termination of the contract the insurer has the right to request supporting documents in the insured that KO really stops (this may be a copy of the letter of the insured to the regulatory (authorized) body of notice of termination of the clinical trial in Ukraine).
Change certain provisions of the contract, additions to the contract, and breach of contract is in accordance with legislation, namely Art. 654 Civil Code provides that “Change or cancellation of the contract committed in the same form as the agreement that varies or is terminated, unless otherwise provided by contract or by law or implied in customs business turnover,” IE, an additional agreement as a contract termination must be made in writing signed by authorized persons and stamped as required by law.
• rights and obligations of the parties and the responsibility for failure or improper performance of the contract;
评论. Regulated by the Law of Ukraine “关于保险” (文章 20, 文章 21) and the Rules and special conditions of insurance, approved by the regulator.
依法 “关于保险” the insurer must:
1) inform the insured of the terms and rules of insurance;
2) within two working days, as soon becomes aware of the insured event, to take steps to execute all necessary documents for timely payment of the insurance or insurance compensation insurer;
3) If an insured to an insurance payment or payment of insurance provided in the contract term. The insurer shall bear property liability for late payment of insurance (保险) by paying the insurer a penalty (fine, penalty) an amount determined by the terms of the contract;
4) to reimburse costs incurred by the insured in the insurance case to prevent or reduce losses, if your contract;
5) at the request of the insured in case of his actions that reduced insurance risk, or increase the value of the property to renew the contract of insurance with him;
6) keep secret information about the insured and its financial status except as provided by legislation of Ukraine.
Insurance contract may also provide for other obligations of the insurer, focused on human participants kV.
Insured must:
1) make timely insurance payments;
2) at the conclusion of the contract to provide information about the insurer all known circumstances that are essential for the assessment of insurance risk, and continue to inform it of any change of insurance risk;
3) 告知保险人有关保险标的的任何其他适用的保险合同;
4) 采取措施预防和减少因事件发生而造成的损失;
5) 在保险条件规定的期限内将保险事件通知保险人.
保险合同还可以规定被保险人的其他义务，以执行 HF 的权利并简化健康损失的报销.
• 双方同意的其他条件;
• 各方签名;
评论. Pravochyn 承诺成立一个由授权签署其组成文件的人签署的法律实体, power of attorney,
法律或其他民法法案, 和
密封的 (中央控制单元, 圣207).
合同字体不得小于Times New Roman, 12.
5. 保险赔付条款
保险支付符合法律规定, “of insurance benefits and payment of insurance held by the insurer under the insurance contract or legislation based on the application of the insured (or its successor entities, defined the terms of insurance) and Insurance Act (emergency certificate), which is the insurer or authorized person in a form determined by the insurer “(Law of Ukraine” 关于保险 “, 文章 25).
1. Statement from the insured regarding possible insurance event
Statement from the insured regarding possible insurance event shall be submitted within the specified contract period, but this term must match specified in the order MZ of Ukraine from 23.09.2009, ○ 690, namely the sponsor (contract research organization sponsored by the presence of delegated functions cooperate with the insurance company) 为了 7 calendar days from the time they become aware of any adverse reaction that can be regarded as an insurance case should send a message to the insurance company. Sponsor also learns about the event over two days (in accordance with the above mentioned order of the Ministry of Health ofUkraine).
Suspicion of the damage may be due to other than the adverse reaction, the reasons (see section 4., P.4.2, stor.14).
因此, the insurer shall be governed by the general term applying to the insurance company in 9 days with events that can be treated as insurance in case.
In addition to the insured, a statement about the occurrence of adverse reactions to the insurance company can provide and the patient (健康志愿者) or his legal representative, and in his absence – close relatives, 为了 9 天.
2. Insurance investigation
On receipt of application by the insurer of a possible case of insurance, the insurance organization began to perform specialized insurance investigation insurance case, from the insured must receive all required documents as stipulated in the contract of insurance, the insurer may make a request for him other documents required under the contract and the laws of Ukraine and international agreements on HF.
大多, it documents the medical direction (证书, extracts from the history of the patient-patient or outpatient card vypysnyy epikryz protocol, anatomical and pathological research, ETC。). Provide expertise in these documents upon which the decision about insurance compensation patient (健康志愿者), is an expert insurance company with higher medical education (see rozd.3, p.11), which is the recommended norm for this type of insurance.
Upon receipt of all necessary documents for some time, caused by the Special Conditions and the contract of insurance, the insurer recognizes this is an insurance event and makes the payment of insurance or does not recognize this is an insurance event, specified in the Insurance Act.
In case of refusal to pay insurance, the insurer shall notify its decision to the insured and the third person in writing the reasons for refusal.
3. Statement of the insured and / or third party for payment of insurance
Insurance paid by the insurer based on the application of the insured and / or statements of a third party (or its legal representative, trustee, heir under the law) to pay compensation.
Note that from this moment the injured third party must be identified. Insured (or principal investigator at the request of the insured) must confirm that a patient with a certain number of HF is affected by a person stating his name, first name and patronymic. In the statement of a third party (or its legal representative, guardian, heir under the law) indicates all the necessary passport data for payment of insurance.
6. 拒绝领取保险金的原因
According to the Law of Ukraine “关于保险” sets out common grounds for refusal of the insurer in the insurance payments or insurance among which are:
– An intentional act by the insured or person to whom a contract of insurance aimed at the insured event;
– The insured knowingly submitting false information about the object of insurance or the fact of occurrence;
– Failure to post the insured on the insurance case without a valid reason for this is that an insurer or obstacles in determining the circumstances and the nature and amount of loss;
In the insurance contract may be referred to other cases, the laws ofUkraine.
According to the order MZ of Ukraine from 23.09.2009 ○ 690 “at the conclusion of the contract are not allowed to establish artificial barriers and restrictions in insurance reimbursement: definition unrealistic deadlines notice of the insurance company about the damage his previous confirmation and size of damages the court or the findings of health health, establishing franchises, ETC。. ”
评论. Not allowed, 尤其, specify as exclusion from insurance claims following:
– Adverse reactions to investigational medicinal product to which the patient has been informed in advance (that is mentioned in informed consent form);
– Malfunction of medical equipment used in a clinical trial of medicinal product;
– Blood poisoning, infection with immunodeficiency virus (艾滋病病毒) 和其他人. If during the investigation provided to blood sampling;
– Concealment of information concerning the availability of the Insured, a third person or entity that conducts clinical trials, convictions;
– If the clinical trial was contrary to generally accepted standards of treatment;
– 其他, independent of party HF, but associated with him and led to the deterioration of his health and caused him damage.
7. REQUIREMENTS FOR INFORMING PATIENT (健康志愿者) on the terms of insurance
Each patient (the person who gave consent to participate in a clinical trial) should be as fully informed about the conditions of insurance must be stated in the informed consent.
Informed consent form should be prepared concisely, accurately, easily understandable language without the use of special terms.
Informed consent signed by the patient (legal representative) 和, among other things, shall contain the following provisions regarding insurance coverage:
1) basic data Treaty liability insurance customer clinical trials of medicinal products (full name and address of the insurer, number and date of the contract, individual sum insured);
2) contact details of the insurance company and authorized persons;
3) order the possible application of proactive notification of the occurrence of adverse effects;
In accordance with § 6 (Section IV «The basic requirements for the protection of subjects,” 章 1 “General Provisions on the Protection of subjects’) order MZ of Ukraine from 23.09.2009 ○ 690:
“Investigated (in its sole discretion) or legal representative, and in his absence – close relatives can also initiative (to be specified in the informed consent) 为了 9 天, notify the insurance company that guarantees their rights, the fact of occurrence of adverse reactions to assessment of it as insurance case. ”
来源
1. Constitution ofUkraine.
2.HelsinkiDeclaration (2008).
3. 欧洲议会和理事会 2001/20/EC “关于定律的近似, regulations and administrative provisions of Member States regarding the implementation of good clinical practice in clinical trials of medicinal products for human consumption” 的 4.04. 2001
4. Law of Ukraine ” 关于药物” (1996), as amended.
5. Law of Ukraine ” 关于保险” (1997), as amended.
6. 指南 “药品. 良好临床实践. CT-N 42-7.0:2008 乌克兰卫生部 “, approved by the MOH on 16.02.2009, ○ 95.
7. Order MZ ofUkrainefrom 23.09.2009r., ○ 690 “On approval of the clinical trials of medicinal products and expertise of clinical trials and the Model Regulations on Commission on Ethics.”
8. Standard operating procedures (标准操作程序), the Central Ethics Committee of the Ministry of Health ofUkraine, approved by Order of the Ministry of Health ofUkrainefrom 22.03.2007 ○ 142.
9. The Central Ethics Committee of the Ministry of Health of Ukraine № 1337 从 30.12.2009, 这 “Insurance companies insurance participants in clinical trials in Ukraine.”
