Ethical Legal and Social Implications Issues in Comparative Effectiveness Researc

描述（由申请人提供）：临床医学中即将出现的两股主要力量有望改变临床护理的范式。一种是个性化基因组医学（PGM），它寻求利用有关个体遗传禀赋的知识，为个体量身定制特定的医疗疗法。当今医疗保健的第二个驱动力是进行比较有效性研究（CER），直接比较针对同一疾病或病症的替代疗法或诊断方式的有效性，有时还比较成本。由于CER是在PGM的替代方法上进行的，因此重要的是要适当地解决基因组研究引起的伦理、法律和社会问题，这些问题已经由ELSI项目阐明。然而，到目前为止，还没有重大的尝试来确定如何设计和实施关于PGM的CER研究应该由ELSI计划的教训来塑造。本项目旨在通过全面考察个性化基因组医学（CER/PGM）比较有效性研究所引发的具体伦理、法律和社会问题来弥补这一差距，并提出一套在设计和开展这项研究时需要考虑的要点，以便以伦理、法律和社会适当的方式开展这项研究。

DESCRIPTION (provided by applicant): Two major forces in clinical medicine on the horizon are expected to change the paradigm of clinical care. One is personalized genomic medicine (PGM), which seeks to harness knowledge about the genetic endowment of the individual to individually tailor specific medical therapies. The second driving force in healthcare today is to conduct comparative effectiveness research (CER) to directly compare the effectiveness, and sometimes the cost, of alternative therapies or diagnostic modalities for the same disease or condition. As CER is conducted on alternative approaches to PGM, it is important for it to appropriately address the ethical, legal, and social concerns raised by genomic research, which have been elucidated by the ELSI program. To date, however, there has been no significant attempt to determine how the design and conduct of CER research on PGM should be shaped by the lessons from the ELSI program. This project aims to respond to this gap by comprehensively examining the specific ethical, legal, and social issues raised by comparative effectiveness research on personalized genomic medicine (CER/PGM), and to propose a set of points to consider in designing and conducting this research so that it can be carried out in an ethical, legal, and socially appropriate manner.