Research Participant Protections in Rural America

美国农村地区的研究参与者保护

基本信息

批准号：
8303369
负责人：
Ann Freeman Cook
金额：
$ 24.76万
依托单位：
UNIVERSITY OF MONTANA
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-14 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8303369
关键词：
Academic Medical Centers Address Adherence Administrator American Heart Association Americas Anatomy Area Attention Award Awareness Behavioral Research Biomedical Research Biotechnology Cancer Patient Censuses Characteristics Clinic Clinical Investigator Clinical Research Clinical Trials Clinics and Hospitals Communities Conduct Clinical Trials Development Disease Doctor of Philosophy Educational process of instructing Enrollment Ensure Environment Equilibrium Ethical Issues Ethics Face Familiarity Foundations Funding Future Genetic Genome Glean Goals Grant Health Personnel Health Professional Healthcare Hospital Administrators Human Human Subject Research Income Industry Institution Institutional Review Boards Interview Leadership Life Light Logistics Mission Montana Moral Obligations National Center for Research Resources National Comprehensive Cancer Network Nurse Administrator Nurses Nursing Research Participant Patients Personal Satisfaction Pharmacogenomics Pharmacologic Substance Phase Physicians Physicians&apos Offices Policies Population Density Principal Investigator Privacy Private Practice Professional Organizations Protocols documentation Psychology Public Health Qualifying Recruitment Activity Regulation Reporting Research Research Activity Research Contracts Research Design Research Ethics Research Methodology Research Personnel Research Subjects Resources Role Rural Rural Community Rural Population Science Site Staging Training Training and Education United States National Institutes of Health Universities Writing biobank cooking data sharing design experience human subject informant meetings member professor programs public health relevance research study responsible research conduct rural area trend

项目摘要

DESCRIPTION (provided by applicant): This qualitative study is designed to examine the ethical conduct of clinical research, including the conduct of clinical trials, in rural healthcare settings. This study is of great significance since more than half of the clinical research, including pharmacogenomic studies, conducted in the U.S. takes place in physicians' offices, clinics, and hospitals.(1-8) It is no longer unusual to encounter rural physicians, nurses, research coordinators, and hospital administrators who are engaged, in various capacities, in the clinical research enterprise. Many of the staff recruited in rural areas by pharmaceutical and other biotechnology companies have limited education, training, or experience in the responsible conduct of research, research ethics, and the protection of research participants. In addition, many rural institutions do not have their own Institutional Review Board (IRB) or policies in place to guide their research activities and so rely on oversight provided by central or independent IRBs. As rural healthcare professionals enter the research arena, it is important to ensure that adequate protocols and policies are in place so as to assure adequate protection of the human research participants who live in rural communities. Under the leadership of Multiple PIs Ann Cook, Ph.D., and Hoas, Ph.D., researchers at The University of Montana (UM) propose a qualitative study using key informant interviews to examine how four key stakeholder groups - physicians, nurses, research coordinators, and hospital administrators - who conduct or engage in clinical research in rural healthcare settings address these research ethics issues, especially the adequate protection of research participants. The study has two aims: Specific Aim 1: Identify the ethical issues that face four rural stakeholder groups who engage in clinical research in rural private practices, clinics, and hospitals. Specific Aim 2: Explore how features of the rural environment may influence stakeholders' abilities to maintain research integrity when engaging in clinical research activities. The three year study will be conducted in12 states with large rural populations; 11 of these states meet the criteria for the NIH Institutional Development Award (IDeA) program of the National Center for Research Resources (NCRR). The potential impact on science and the public's health and well-being is twofold. Findings from this proposed study will shed light on whether: (1) existing policies and guidance are sufficient to ensure optimal protection of rural research participants; (2) the safeguards are in place to assure adherence to the principles of research integrity when conducting clinical research in rural healthcare settings. PUBLIC HEALTH RELEVANCE: As rural clinicians, coordinators, nurses, and administrators increasingly participate in the clinical research enterprise, it is important to identify ethical issues that accompany such research when it is conducted in rural settings. The study's potential impact on science and the public's health and well-being is twofold. Findings from this proposed study will shed light on whether: (1) existing policies and guidance are sufficient to ensure optimal protection of rural research participants; (2) the safeguards are in place to assure adherence to the principles of research integrity when conducting clinical research in rural healthcare settings.

描述（由申请人提供）：本定性研究旨在检查农村医疗机构中临床研究的道德行为，包括临床试验的进行。这项研究具有重要意义，因为在美国进行的临床研究，包括药物基因组学研究，有一半以上是在医生办公室、诊所和医院进行的。(1-8) 遇到乡村医生已不再罕见，以各种身份从事临床研究事业的护士、研究协调员和医院管理人员。制药公司和其他生物技术公司在农村地区招聘的许多员工在负责任的研究行为、研究道德和保护研究参与者方面的教育、培训或经验有限。此外，许多农村机构没有自己的机构审查委员会（IRB）或指导其研究活动的政策，因此依赖中央或独立IRB 提供的监督。随着农村医疗保健专业人员进入研究领域，重要的是要确保制定适当的方案和政策，以确保生活在农村社区的人类研究参与者得到充分的保护。在多位 PI Ann Cook 博士和 Hoas 博士的领导下，蒙大拿大学 (UM) 的研究人员提出了一项定性研究，使用关键知情人访谈来研究四个关键利益相关群体（医生、护士）如何在农村医疗机构中进行或参与临床研究的研究协调员和医院管理人员负责解决这些研究伦理问题，特别是对研究参与者的充分保护。该研究有两个目标：具体目标 1：确定在农村私人诊所、诊所和医院从事临床研究的四个农村利益相关者群体面临的伦理问题。具体目标 2：探索农村环境特征如何影响利益相关者在从事临床研究活动时保持研究诚信的能力。这项为期三年的研究将在 12 个拥有大量农村人口的州进行；其中 11 个州符合国家研究资源中心 (NCRR) 的 NIH 机构发展奖 (IDeA) 计划的标准。对科学以及公众健康和福祉的潜在影响是双重的。这项拟议研究的结果将揭示：（1）现有政策和指导是否足以确保对农村研究参与者的最佳保护； (2) 保障措施到位，确保在农村医疗机构进行临床研究时遵守研究诚信原则。公共卫生相关性：随着农村临床医生、协调员、护士和管理人员越来越多地参与临床研究事业，确定在农村环境中进行此类研究时伴随的伦理问题非常重要。该研究对科学以及公众健康和福祉的潜在影响是双重的。这项拟议研究的结果将揭示：（1）现有政策和指导是否足以确保对农村研究参与者的最佳保护； (2) 保障措施到位，确保在农村医疗机构进行临床研究时遵守研究诚信原则。