让研究对象得益于知情同意

1、1Informed Consent in Research: Making Sense to Subjects让研究对象得益于知情同意让研究对象得益于知情同意Nancy M. P. King, JDProfessor of Social MedicineUniversity of North Carolina, Chapel Hill北卡罗来纳大学社会医学教授2Some Things to Remember需要记住需要记住 Subjects need to understand what research is 对象需要了解是什么研究 Subjects need to know the ris

2、ks of harm, the possible benefits, and confidentiality protections 对象需要知道受伤害的风险、可能的利益、以及隐私保护 Investigators and IRBs need to work together to present information clearly 研究人员和伦理审查委员会需要一道努力以清楚地表达信息3Informed Consent Explains:知情同意解释：知情同意解释： How subjects can help contribute to science and/or public healt

3、h 对象如何能够对科学和公共卫生做出贡献 How researchers will work to protect subjects and their data 研究人员如何能够保护研究对象和其资料4Explaining Research解释研究解释研究 How research is different from treatment depends on each study 研究为何与治疗不同取决于每一个研究 Researchers should discuss: 研究者应当讨论： Goals 目的 Procedures and tests 程序和检测 Uncertainty 不确定性5

4、Explaining Risks of Harm解释伤害的风险解释伤害的风险 Nature of Harm 伤害的性质 Physical harms 身体伤害 Psychological harms 精神伤害 Discrimination from loss of confidentiality 泄漏隐私而导致的歧视 Probable Size (Severity) and Duration of Harm 伤害可能的程度和期限 Likelihood of Harm 伤害的可能性 How common or frequent or likely to happen is each harm?

5、每一种伤害发生的可能性? Good ways to explain likelihood 解释可能性的好方法6Explaining Possible Benefits解释可能的利益解释可能的利益 Direct Benefits 直接利益 Come from the experimental intervention itself 来自于试验干预本身 May not be expected or possible at all 也许根本不可能 May be very limited in much clinical research 也许在许多临床研究中非常有限 Collateral or In

6、clusion Benefits 附属或内含利益 Come from being in the study 来自于参加研究 Offered as inducements to participate 作为参加研究的刺激 Must be carefully examined and described; examples 必须仔细检查和描述； 举例 Benefit to Society 对社会的利益 Future benefits only; altruism 仅仅是未来的利益；利他主义 Contributions to knowledge 对知识的贡献 Benefit to other pat

7、ients through use of study data 通过使用研究资料对其他病人的利益7Explaining Direct Benefits解释直接利益解释直接利益 Nature of Benefit 利益的性质 Specific description of something subject can feel 详细描述对象可以感觉到的事物 Improvement in a laboratory measure is not a benefit 实验室指标的改善不是利益 Probable Size and Duration of Benefit 利益的可能程度和期限 Improve

8、ment or cure? 改善或治愈？ Temporary or permanent? 短暂或长久？ Likelihood of Benefit 利益的可能性 How common or frequent or likely to happen is direct benefit? 直接利益发生的可能性 Good ways to explain likelihood 解释可能性的好方法8Explaining Collateral Benefits解释附属利益解释附属利益 Nature of Benefit 利益的性质 Something offered by researcher, such

9、 as free check-up or vitamins 研究者提供的一些好处，如免费体检或维生素 Closer monitoring of condition or better treatment from research team 研究小组更好的监护或治疗 Free Health Benefits are Inducements 免费的健康保健利益是诱导物 Look closely, describe carefully 认真描述 Be sure they are not offered to get subjects to take more risks 要肯定不要使研究对象因此而

10、承担更多的风险 Likelihood of Inclusion Benefit 内含利益的可能性 More monitoring is not always a good thing 更多的监督不总是一件好事 “Better treatment” claims may be unsupported 声称“更好的治疗”可能得不到支持9Explaining Benefit to Society解释对社会的利益解释对社会的利益 Discuss Goals of Research 讨论研究的目标 Distinguish benefit to subjects from benefit to society 区分对研究对象的利益与对社会的利益 Nature of Benefit 利益的性质 Avoid describing benefit to others as immediate 避免将对他人的利益描述为立即可得 Likelihood of Benefit 利益的可能性 Avoid describing benefit to others as certain 避免将对他人的利益描述为肯定10Use All Your Tools:使用所有的工具使用所有的工具