Conference Support: Improving the Success of Proposals for Research on Issues in Human Research Ethics; Oakland, CA; July 28, 2006

该项目由科学与社会计划的科学，工程和技术组成部分的伦理和价值观资助。 目前保护人类研究受试者的制度要求研究者提出的研究得到伦理委员会或机构审查委员会（IRB）的批准。由于对联邦法规解释的不确定性，这一制度可能对研究施加强制性要求，损害人类受试者和科学，特别是在实地研究中，标准做法，如签署的知情同意书，在文化上不被研究人群接受，因此不可能进行有效的采样。尽管管理人类研究的联邦法规是灵活的，但通常研究人员和IRB都不知道是否有法律的方法通过研究创新解决方案来解决这些问题。这种混乱阻碍了开发和测试创新程序的创造性努力，以了解在某些情况下，这些程序在道德和科学上是否优于传统程序。“人类研究中的创造性伦理问题解决：研究人员和伦理委员会的挑战和解决方案”会议探讨了如何克服官僚主义障碍，进行表面上安全，道德和至关重要的研究。在尝试创新研究程序的努力中受挫的研究人员和IRB成员将提交案例。每个案例将包括一个创新的程序，其明显的科学和伦理理由，对创新的反对意见，以及一个或多个建议的方法来经验评估创新的优点。一个在伦理、法规和方法领域广受尊重的专家小组将根据科学、伦理、法规和风险/获益标准对这些程序进行评估。将提供具体的解决方案和一般性指导方针。会议的更广泛的影响将是鼓励研究者和IRB之间的合作，真正解决伦理问题，而不是试图遵守不适合特定情况的传统做法。调查结果将通过科学出版物、会议和网上广泛传播。

This project is funded by the Ethics and Values in Science, Engineering, and Technology component of the Science and Society Program. The current system for protecting human subjects of research requires approval of investigators' proposed research by an ethics committee or Institutional Review Board (IRB). Due to uncertainty about interpretation of Federal Regulations, this system may impose procrustean requirements on research, to the detriment of human subjects and science, particularly in field research where standard practices, such as signed informed consent forms are culturally unacceptable to the research population and thus valid sampling is rendered impossible. Although Federal Regulations governing human research are flexible, often neither researchers nor IRBs know if there are legal ways to solve such problems through research with innovative solutions. This confusion stymies creative efforts to develop and test innovative procedures to learn whether they are ethically and scientifically superior to customary procedures in certain settings. The conference "Creative Ethical Problem Solving in Human Research: Challenges and Solutions for Researchers and Ethics Committees," asks how to surmount bureaucratic barriers to apparently safe, ethical and vitally important research. Researchers and IRB members who have been frustrated in their efforts to try innovative research procedures will submit cases. Each case will consist of an innovative procedure, its apparent scientific and ethical justifications, objections to the innovation, and one or more proposed approaches to empirical evaluation of the merits of the innovation. A panel of experts, widely respected in areas of ethics, regulations and methodology, will evaluate these procedures in relation to scientific, ethical, regulatory and risk/benefit criteria. Specific solutions and general guidelines will be offered. The broader impact of the conference will be encouragement of collaboration between investigators and IRBs in genuine ethical problem solving rather than attempts to comply with traditional practices when they do not fit the particular circumstances. Findings will be widely disseminated via scientific publications, at meetings, and online.