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.
