Ethical Legal and Social Implications Issues in Comparative Effectiveness Researc

比较有效性研究中的道德法律和社会影响问题

• 批准号: 8328948
• 负责人: MAXWELL J MEHLMAN
• 金额: $ 35.33万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-07 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8328948
• 关键词: Address; Affect; Alternative Therapies; Clinical Medicine; Communities; Diagnostic; Disease; Endowment; Ethics; Future; Genetic; Genetic Medicine; Genomics; Health Care Costs; Health Insurance Reimbursement; Healthcare; Individual; Intervention; Knowledge; Legal; Literature; Medical; Medicine; Modality; National Human Genome Research Institute; Patients; Play; Policies; Publishing; Reporting; Research; Risk; Role; Shapes; Suggestion; Third-Party Payer; Translating; Translational Research; Translations; clinical care; clinical practice; comparative effectiveness; compare effectiveness; cost; design; driving force; effectiveness research; ethical legal social implication; health care quality; improved; legal implication; programs; research study; social implication; tool

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.

描述(由申请人提供)：临床医学领域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)，它寻求利用关于个人遗传天赋的知识来个性化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)，以直接比较针对相同疾病或状况的替代疗法或诊断方式的有效性，有时甚至是成本。由于CER是在PGM的替代方法上进行的，因此适当地解决基因组研究提出的伦理、法律和社会问题是很重要的，这些问题已经由ELSI计划阐明。然而，到目前为止，还没有重大的尝试来确定CER关于PGM的研究的设计和进行应该如何受到ELSI项目的经验教训的影响。该项目旨在通过全面检查个性化基因组医学(CER/PGM)的比较有效性研究提出的具体伦理、法律和社会问题来应对这一差距，并提出在设计和进行这项研究时需要考虑的一系列要点，以便能够以伦理、法律和社会适当的方式进行。