Ethical Issues in Maintaining a Rapid Tissue Donation Program

维持快速组织捐赠计划的道德问题

• 批准号: 9059055
• 负责人: Matthew B. Schabath
• 金额: $ 18.32万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-01 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9059055
• 关键词: Ambulances; Bioethics; Blood specimen; Cancer Patient; Cessation of life; Chest; Communities; Consent; Diagnosis; Disease Resistance; Distant Metastasis; Drug resistance; Enrollment; Ethical Issues; Ethics; Family; Family member; Freezing; Fright; Future; Gene Expression; Genome; Genomics; Goals; Health; Health Personnel; Histocompatibility Testing; Home Care Services; Home environment; Hour; Individual; Institutional Review Boards; Interview; Knowledge; Logistics; Malignant neoplasm of lung; Molecular Profiling; Monitor; Neoplasm Metastasis; Nurses; Operative Surgical Procedures; Outcome; Pamphlets; Paraffin Embedding; Participant; Pathologist; Pathology; Patient Education; Patients; Perception; Pharmaceutical Preparations; Phase; Physicians; Pilot Projects; Policies; Population; Primary Neoplasm; Procedures; Process; Proteomics; Protocols documentation; Recruitment Activity; Refractory Disease; Research; Resources; Retrieval; Sampling; Site; Social Workers; Staging; Structure; Thoracic Oncology; Time; Tissue Banks; Tissue Donations; Tissue Sample; Tissues; Transcript; Transportation; Tumor Tissue; base; cancer therapy; chemotherapy; experience; hospice environment; improved; loved ones; mortality; oncology; precision medicine; programs; psychosocial; repository; theories; treatment response

 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.

 描述（由适用提供）：基因组学和蛋白质组学的最新进展允许采用针对性的精确医学方法来诊断和治疗癌症。对于精确的医学，通常在手术程序时收集血液和组织样本的存储库，与个人信息相结合，以揭示与治疗反应，进展和整体生存有关的因素。然而，来自难治性疾病患者的组织很少收集，因此对化学疗法药物失败的原因少得多。快速组织捐赠（RTD）的过程和目标是在患者死亡后的24小时内从原发性肿瘤和转移的原发性肿瘤和部位（S）采购高量和质量肿瘤组织，可以存储该组织并用于未来的基因组和蛋白质组学研究。招募癌症患者参加RTD计划有道德挑战。参与RTD计划的提议可以看作是即将死亡的标志。医生和员工可能会感到不舒服招募患者，担心要约是失去希望的。由于死后不久涉及的后勤工作，家庭和亲人可能不愿遵守患者同意参加。与亲属的下一家共享基因组结果的政策和方案已经开始出现，但是有针对肺癌种群的稀疏研究。在一个试点项目中，我们进行了多次利益相关者评估，以确定对RTD的看法。利益相关者包括：患者和亲人，临终关怀医生，fun仪馆和卫生保健提供者。总体而言，对RTD计划有强有力的支持。根据我们对假设RTD计划的支持的发现，我们获得了IRB批准以实施RTD计划。该应用程序的目的是评估对莫菲特胸部肿瘤RTD计划的实时利益相关者的看法。具体来说，我们将探索障碍和促进者，以从多个利益相关者的角度参与我们已建立的RTD计划，其中包括：IV期肺癌患者，家庭/Kin（Nok）的下一家（NOK）；医疗保健提供者和团队；参与组织收集的科学人员和病理学家。我们的目标是为了：检查RTD计划的同意过程，并通过与诺克，临终关怀，Funeral Home，Funeral Home，Funeral Home，Ambulance，Physicians，Physicians和Chere的定性半结构化访谈来确定重新融合，运输，组织收集，组织收集，组织收集和返回的障碍和促进者。最终目标是监视和改进RTD计划的道德和社会心理方面，并将这些知识传播给其他计划和科学界。