Ethical Issues in Maintaining a Rapid Tissue Donation Program

 描述（由申请人提供）：基因组学和蛋白质组学的最新进展允许有针对性的精确医学方法来诊断和治疗癌症。对于精准医学，血液和组织样本的储存库与个人信息相结合，通常在手术过程中收集，以揭示与治疗反应，进展和总生存期相关的因素。然而，难治性疾病患者的组织很少被收集，因此对化疗药物失败的原因知之甚少。快速组织捐献（RTD）的过程和目标是在患者死亡后24小时内从原发肿瘤和转移部位获得高数量和质量的肿瘤组织，该组织可以储存并用于未来的基因组和蛋白质组学研究。招募癌症患者参与RTD计划具有伦理挑战。参加RTD计划的提议可以被视为即将死亡的迹象。医生和工作人员可能会不舒服招募病人，担心提供代表失去希望。家属和亲人可能不愿意遵守患者的同意参加，因为在死亡后不久移动尸体涉及后勤工作。与近亲共享基因组结果的政策和协议已经开始出现，但针对肺癌人群的研究很少。在一个试点项目中，我们进行了多个利益相关者的评估，以确定RTD的看法。利益相关者包括：病人和亲人，临终关怀，病理学家，殡仪馆和卫生保健提供者。总的来说，RTD方案得到了大力支持。基于我们的研究结果显示支持假设的RTD计划，我们获得了IRB批准实施RTD计划。该应用程序的目标是评估Moffitt胸部肿瘤RTD计划的实时利益相关者感知。具体而言，我们将从多个利益相关者的角度探讨参与我们既定RTD计划的障碍和促进因素，这些利益相关者包括：IV期肺癌患者，家属/近亲（NOK）;医疗保健提供者和团队;参与组织收集的科学工作人员和病理学家。我们的目标是：通过对NOK、临终关怀机构、殡仪馆、救护车、医生和工作人员的定性半结构化访谈，检查同意RTD计划的过程，并确定重新同意、运输、组织收集和归还尸体过程中每个阶段的障碍和促进因素。最终目标是监测和改善RTD计划的伦理和心理社会方面，并将这些知识传播给其他计划和科学界。

 DESCRIPTION (provided by applicant): Recent advances in genomics and proteomics are allowing for a targeted, precision medicine approach to the diagnosis and treatment of cancer. For precision medicine, repositories of blood and tissue samples combined with personal information are normally collected at the time of surgical procedures to reveal factors associated with treatment response, progression, and overall survival. However, tissue from patients with refractory disease is rarely collected so less is known about why chemotherapy drugs failed. The process and goal of rapid tissue donation (RTD) is to procure high quantity and quality tumor tissue from both the primary tumor and site(s) of metastasis within 24 hours after patient death this tissue can be stored and used for future genomic and proteomic research. Recruiting cancer patients to participate in RTD programs has ethical challenges. The offer of participation in the RTD program can be seen as a sign of impending death. Physicians and staff may be uncomfortable recruiting patients, fearing the offer represents a loss of hope. Family and loved ones may be unwilling to comply with the patient's consent to participate due to the logistics involved in moving the body soon after death. Policies and protocols for sharing genomic results with next of kin have begun to emerge, yet there are sparse studies specific to lung cancer populations. In a pilot project, we conducted multiple stakeholder assessments to identify perceptions of RTD. The stakeholders included: patients and loved ones, hospice, pathologists, funeral homes, and health care providers. Overall, there was strong support for the RTD program. Based on our findings showing support for the hypothetical RTD program, we obtained IRB approval to implement an RTD program. The goal of this application is to evaluate real-time stakeholder perceptions of Moffitt's Thoracic Oncology RTD program. Specifically, we will explore barriers and facilitators to participating in our established RTD program from multiple stakeholder perspectives which includes: Stage IV lung cancer patients, families/Next of Kin (NOK); health care providers and team; scientific staff involved in tissue collection, and pathologists. Our aims were created to: examine the process of consent to the RTD program and identify barriers and facilitators of each phase of the process of the re-consent, transportation, tissue collection and return of the body through qualitative semi-structured interviews with NOK, hospice, funeral home, ambulance, physicians and staff. The ultimate goal is to monitor and improve upon the ethical and psychosocial aspects of the RTD program and to disseminate this knowledge to other programs and the scientific community.