Research Participant Protections in Rural America

美国农村地区的研究参与者保护

• 批准号: 8146013
• 负责人: Ann Freeman Cook
• 金额: $ 24.85万
• 依托单位: UNIVERSITY OF MONTANA
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-14 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8146013
• 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' 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

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）：这项定性研究旨在检查农村医疗保健环境中临床研究的道德行为，包括临床试验的行为。这项研究具有重要意义，因为在美国进行的超过一半的临床研究（包括药物基因组研究）是在医师办公室，诊所和医院进行的。（1-8）遇到农村医生，，不寻常在临床研究企业中以各种身份订婚的护士，研究协调员和医院管理员。药品和其他生物技术公司在农村地区招募的许多员工在负责研究，研究伦理和研究参与者的保护方面的教育，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）或为指导其研究活动的政策，因此依靠中央或独立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协议和政策，以确保对居住在农村社区的人类研究参与者的充分保护。在多个PIS 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，利用关键的知情人士访谈来研究如何研究四个主要利益相关者群体，包括医师，护士，护士如何，研究协调员和医院管理人员 - 在农村医疗保健环境中进行临床研究或从事这些研究伦理问题，尤其是对研究参与者的适当保护。这项研究有两个目标：具体目标1：确定面临四个农村利益相关者群体的道德问题，他们从事农村私人实践，诊所和医院的临床研究。具体目标2：探索农村环境的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完整性的能力。 为期三年的研究将在有众多农村人口的12个州进行。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。对科学以及公众的健康和福祉的潜在影响是双重的。这项拟议的研究的结果将阐明：（1）现有的政策和指导足以确保对农村研究参与者的最佳保护； （2）在进行农村医疗保健环境中进行临床研究时，可以确保遵守研究完整性原则的保障措施。 公共卫生相关性：由于农村临床医生，协调员，护士和管理人员越来越多地参与临床研究企业，因此在农村环境中进行此类研究时，确定伴随该研究的道德问题很重要。该研究对科学的潜在影响以及公众的健康和福祉是双重的。这项拟议的研究的结果将阐明：（1）现有的政策和指导足以确保对农村研究参与者的最佳保护； （2）在进行农村医疗保健环境中进行临床研究时，可以确保遵守研究完整性原则的保障措施。