<< Previous Section | < Previous Page | Next Page > | Next Section >> Introduction Since we published, "Teaching the Responsible Conduct of Research utilizing a Case Study Approach" in 1994 (AAMC Publications), the scientific community has addressed research integrity issues with energy and, I believe, with considerable success. Trainees routinely receive instruction in responsible conduct of research (RCR) and their mentors have become much more sensitive to the issues, partly because of their prior education and surely because of heightened public interest, regulation and accountability. Institutions have developed and updated policies regarding data, patent and licensure, collaboration, sharing, conflict of interest and misconduct. Faculty committing malfeasance or misconduct are no longer sacrosanct and problems are less likely to be whitewashed. Institutional managers, in their fiduciary roles have made great efforts to prevent expensive and embarrassing misadventures from taking place, with substantial but incomplete success. Research involving human beings remains particularly challenging to the scientific community. Studying people, their tissues and their data raises ethical complexities not seen with basic research, including responsibility for the safety and privacy of study participants. Investigators must also help participants learn before, during and after a study the rationale, procedures and results of the study. Both international and domestic research require sensitivity to the cultural background and preferences of participants. Unlike molecular, cellular or animal studies, human subjects require fairness in participation, respect for their autonomy and protection from harm. While every scientist needs to become well versed in the ethical issues surrounding basic research, clinical investigators have the additional responsibility to fully appreciate the ethical dilemmas characteristic of clinical investigation. But clinicians who do human research rarely have the time or inclination to study and teach the responsible conduct of research with humans (RCRH). The development of national initiatives to facilitate translational medicine including the Clinical Translational Science Award (CTSA) makes it imperative for the scientific teams that assemble to be fully cognizant of the issues surrounding human research. This E-book is designed to help them. In this book we employ problem-based learning to address ethical questions involving research in humans. Each chapter contains an introduction, a glossary of terms, problem scenarios for discussion and annotated bibliographical references to help readers find the sources they need. Needless to say, the policies, guidelines and regulations involving research with humans continue to evolve. Our society regularly upgrades its demands for accountability as social mores steadily evolve. Therefore, the literature must be updated regularly and new scenarios developed with the evolution of important ethical issues. A section on writing scenarios is thus included. << Previous Section | < Previous Page | Next Page > | Next Section >> Quick Links Introduction Scenarios Bibliography Introduction Download (PDF)