Critical Care Research危重医学研究1109.docx

1、Critical Care Research危重医学研究1109危重病人医疗研究和调控顺应性Critical Care Researchand Regulatory ComplianceCHAPTER 12学习目标LEARNING OBJECTIVES学习本章后，你应该能：After studying this chapter, you should be able to:讨论研究目的的概念 Discuss the concept of research intent.辨别在美国负责研究的调控机构 Identify the regulatory authorities who are resp

2、onsiblefor research conducted in the United States.描述机构评审组织的责任 Describe the responsibilities of the institutional reviewboard (IRB). 列举IRB评审研究的种类范畴List the categories available to the IRB for review ofresearch. 举实例IRB需要的材料以恰当评估研究计划Give examples of the materials the IRB will need to adequately review

3、 a research proposal. 描述知情同意过程Describe the informed consent process. 描述知情同意的例外原则怎样影响急危症研究Discuss how the exception from informed consent (EFIC) impacts emergency and critical care research.本章概况CHAPTER OUTLINE学习目标Learning Objectives个案研究：Case Study: The Pad Trial绪论Introduction研究目的Research Intent研究和研究调

4、节的伦理学指导Ethical Conduct of Research and Research RegulationsIRB 责任 Irb Responsibilities评审的分类Categories of ReviewIRB 评审的研究免除 Research Exempted from IRB Review快速评审 Expedited Review全机构评审 Full Board Review要提交什么IRB评审 What to Submit for Irb Review机构特异的申请表格Institution-Specific Submission Form研究方案The Researc

5、h Protocol知情同意文件和健康医疗保险账号机构Informed Consent Document and HIPAA Authorization增补材料Supplemental MaterialsIRB同意研究的需求Requirements of Irb Approval of Research知情同意过程The Informed Consent Process知情同意的四点要求The Four Requirements of Informed Consent关于危重医疗研究的知情同意的特别问题Special Issues Regarding Informed Consent in C

6、ritical Care Research使用生物标本的知情同意Informed Consent for the Use of Biological Samples总结Summary复习问题Review Questions答案Answers参考文献References进一步阅读Additional Reading绪论INTRODUCTION有良好的临床实践指导的进行医学研究活动对有经验的研究者是有挑战性的，对进行首次进行临床研究的个体是压倒性的极大的。Conducting medical research activities in compliance with Good Clinical

7、Practice guidelinesis challenging for experienced investigators and may be overwhelming for the individualmaking a first attempt to perform a clinical study. 研究规则是广泛的，许多会导致发布指导文件便于适用合理的解释和研究组织所有成员能够顺从。Research regulations are extensive andmany have resulted in the issuance of guidance documents to f

8、acilitate appropriate interpretationand compliance by all members of the research enterprise. 对规则不顺从的可能性是很高的，尽管实际的发生率的估计很困难。The potential for noncompliancewith regulations is high, although the actual prevalence is difficult to estimate. 而不强调调节不顺从性的广度问题，分析从FDA来信的警告分析对研究者和IRB表明确实有严重违反规则的事情发生。Whilenot

9、 addressing the issue of the extent of regulatory noncompliance, an analysis of warningletters from the Food and Drug Administration (FDA) to investigators 6 and institutionalreview boards (IRBs) 7 shows that serious violations of the regulations do occur. 例证表明有研究者偏离了研究计划、没有获得法律有效的知情同意，未及时报告出现的不良事件。

10、Investigatorshave been cited for deviating from the investigational plan, failing to obtain legally effectiveinformed consent, and not reporting adverse events in a timely manner. IRB被发现没有或未遵守适当的评审研究的书面程序，会议活动的记录很差，不适当的继续评估规程等。IRBs have been citedfor not having (or not following) adequate written pr

11、ocedures for reviewing research, poordocumentation of meeting activities, and inadequate continuing review procedures.在危重医学研究呈现了特殊的环境可能进一步影响执行研究的临床和道德标准。Research in the critical care setting presents unique circumstances that may further strainthe clinical and ethical standards for performing resear

12、ch. 在这些高危发病和死亡率的病人人群中，窄时间床开始干预以最大化疗效，从病人和监护人取得知情同意的困难，这些问题在多数其他人体研究中不常遇到。Among these are patient populations at high risk for morbidity or mortality, narrow time frames for initiating an interventionto maximize effectiveness, and diffi culties in obtaining informed consent from patients ortheir surr

13、ogates. 8 These issues are infrequently encountered in most other human researchsituations. 尽管如此，进行危重病医学研究对在危重病人中的发展、评估、新治疗方法的有效性是基本的，也是应该被鼓励的。Even so, the conduct of critical care research is essential to the development,evaluation, and effective use of new therapeutic approaches in the critically

14、ill patients andshould be encouraged. 本章节的目的是提供一个关于ICU人体研究的调节要求的总揽并提供医师书写研究方案达到IRB标准。The objectives of this chapter are to provide a general overview of theregulatory requirements of human subjects research in the ICU and to assist clinicians inwriting research protocols that measure up to IRB stand

15、ards.研究目的RESEARCH INTENT进行人体研究必须与政府的规矩一致。在开始资料收集的很久以前，甚至是开始写实验方案，就应该问一个问题“这是关于人体的研究吗？”，Human research must be conducted in compliance with governmental regulations. Longbefore the initiation of data collection, or even the writing of the protocol, the questionshould be asked, “Is this human research

16、?” 很多医院的进程和规程都是为诊断改善和资源利用的目的详察。Many hospital processes and procedures arescrutinized for the purposes of quality improvement or resource utilization. 她们常依赖使用医疗记录和可能前瞻性地收集信息。然而，这些活动常不被认为是研究。They frequentlyrely on the use of medical records and may collect information prospectively. Yet, theseactiviti

17、es are generally not considered research.联邦管理法规定义研究为“一种系统性的调查，包括研究开发、实验和评估、旨在发展和有利于一般性知识”。The Code of Federal Regulations defines research as “a systematic investigation, includingresearch development, testing and evaluation, designed to develop or contribute to generalizableknowledge.” 9当这个概念自身使用来确

18、定一个工程是否是研究的时候就会遇到困难。 There are problems when this definition is used by itself to decide if a projectis a research. 报告单个病例很难被认为是“系统的调查”。相反的，随机对照的实验应该被认为是研究，尽管没有计划通过发表结果来对一般性知识作出贡献。A report of a single case could hardly be considered “a systematic investigation.”Conversely, a randomized controlled tr

19、ial would be considered research even if there was noplan to “contribute to general knowledge” by publishing the results. Amdur and Speers 提供了很好的指南看一项工程是否为符合研究的标准。provideexcellent guidance for determining if a project meets the criteria for research. 10 简言之，他们解释了研究是所做的工作的功能而且最终地激励研究者进行研究，他们称之为研究意图。他

20、们建议研究者和IRB成员问个问题“这项研究能否象申请书的进行，如果项目研究者知道他们的项目可能永远得到任何形式的学术认可，包括在医学杂志上发布结果或在学术会议上交流论文”。如果对这个问题的回答是否定的，提议的活动是科研，应该提交到IRB批准。In short, theyexplain that research is a function of what is being done and what is ultimately motivating theinvestigator to conduct the research, what they term research intent.

21、They suggest that investigatorsand IRB members ask the question, “Would the project be conducted as proposed if theproject investigators knew they would never receive any form of academic recognition for theproject, including publication of results in a medical journal or presentation of the project

22、 at anacademic meeting?” 10 If the answer to this question is no, the proposed activity is research andshould be submitted for IRB approval. 越来越多的，医学杂志需要IRB的统一的证据作为发表研究结果的前提条件。更近一步的，没有调节的允许回归评议和已经进行的研究同意。Increasingly, medical journals require evidence of IRBapproval as a precondition for publication

23、 of research results. Furthermore, there are no regulatoryprovisions that permit retroactive review and approval of research that has already beenconducted. 因此，有适当的IRB同意是在调节一致的很重要的第一步，可促进重要研究结果的发布。Therefore, having appropriate IRB approval is an important first step in regulatorycompliance and facil

24、itates publication of important research results.研究的伦理学行为和研究规则ETHICAL CONDUCT OF RESEARCH AND RESEARCHREGULATIONS参加人体研究的个体是特殊的，尽管参加的人可能是很少侵袭性的、预想很少风险的研究。Individuals who participate in human medical research are special; even those who participate in the least invasive, most minimal risk study imagin

25、able. 为什么？因为每个人花费时间提供信息或进行的程序可能会导致对他人很好的照顾。危重医学研究的进行对危重病人的新治疗方法的有效性验证是必须的。Why? Because each took the time to provide information or engage in a procedure that could lead to better care for The conduct of critical care research is essential to the development, evaluation, and effective use of new the

26、rapeutic approaches in the critically ill patients. IRB批准是调节顺应性和促进重要研究结果的发表。IRB approval is an important first step in regulatory compliance and facilitates publication of important research results. 案例研究：CASE STUDY: THE PAD TRIAL公众可行的除颤实验前瞻性地比较了心肺复苏的有效性和安全性与CPR加适用自动体外除颤仪在发生门诊心脏停搏时由受训练的社区外行志愿者进行。The

27、 Public Access Defibrillation trial prospectively compared the effectiveness and safety of cardiopulmonary resuscitation (CPR) only to CPR plus the use of an automated external defibrillator (AED) in patients experiencing an outpatient cardiac arrest when treated by trained community lay volunteers

28、. 1 初期的结果是出院时的生存。研究设计和规则考虑远超过许多研究者在他们自己研究努力所需要处理的。The primary outcome parameter was survival until hospital discharge . The study design and regulatory considerations of this trial go well beyond what many investigators will need to deal with in their own research endeavors. 尽管这样，它可作为我们产生研究设计的模板，准确定

29、义重要的研究参数，产生一种知情同意实验免责条款的方法、Even so, it can serve as a model for developing a study design, 2 , 3 accurately defining important study parameters, 4 and developing an approach for conducting exceptions from informed consent trials. 5AU1AU2有些人没有相关的知识，常没有补偿。someone they have no knowledge of; often witho

30、ut compensation. 像这样，人类研究参与者和他们可能收获另外的保护的信息在国际解释法规，由一系列的政府机构发布的在联邦和州水平实行的法律。，As such, human research participants and the information they provide appropriately receive additional protections established in internationally accepted codes for research conduct, laws enacted at the federal and state le

31、vels, and regulations promulgated by a variety of governmental agencies.健康和人类服务部维持从分别单位的人类研究的失败。The department of health and human services (DHHS) maintains oversight of human subject research through three separate units. 食品药品管理局监督药物、仪器、疫苗和其他产品市场化疾病的诊断和治疗。The FDA oversees clinical trials of drugs,

32、devices, vaccines, and other products to be marketed for the diagnosis and treatment of disease.她的当局从21标题50、56部分的联邦法规。 Its authority comes from Title 21 Parts 50 and 56 of the Code of Federal Regulations. 人类研究保护的办公室实施相似的45部分46成分由18联邦机构。，The office for human research protections (OHRP) enforces similar regulations from Title 45 Part 46 for research supported by 18 federal agencies (thus being known as the Common Rule). 公民权利办公室负责实施健康医疗保险账号条例。The office for civil rights (OCR) is responsib