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

本项目由科学与社会计划的科学、工程和技术伦理与价值观部分资助。目前保护人类研究对象的系统需要伦理委员会或机构审查委员会（IRB）批准研究者提议的研究。由于联邦法规解释的不确定性，该系统可能会对研究施加程序化的要求，损害人类受试者和科学，特别是在实地研究中，如签署知情同意书等标准做法在文化上对研究人群是不可接受的，因此不可能进行有效抽样。尽管管理人类研究的联邦法规是灵活的，但研究人员和内部审查委员会通常都不知道是否有合法的方法通过创新的解决方案来解决这些问题。这种混乱阻碍了创造性的努力，即开发和测试创新程序，以了解它们在某些情况下是否在伦理和科学上优于传统程序。“创造性地解决人类研究中的伦理问题：研究人员和伦理委员会面临的挑战和解决方案”会议探讨了如何克服官僚主义障碍，进行表面上安全、伦理和至关重要的研究。在尝试创新研究过程中受挫的研究人员和伦理委员会委员将提出申诉。每个案例将包括一个创新程序，其明显的科学和伦理理由，对创新的反对意见，以及对创新优点进行实证评估的一种或多种建议方法。一个在伦理、规章和方法领域广受尊敬的专家小组将根据科学、伦理、规章和风险/效益标准对这些程序进行评价。将提供具体的解决方案和一般指导方针。这次会议更广泛的影响将是鼓励研究者和内部审查委员会之间在真正解决伦理问题方面的合作，而不是在传统做法不适合特定情况时试图遵守传统做法。研究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.