Phase I Clinical Trials and the Informed Consent of Healthy Subjects

I期临床试验和健康受试者的知情同意

• 批准号: 7589336
• 负责人: JILL A FISHER
• 金额: $ 20.88万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-05-01 至 2011-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7589336
• 关键词: Address; Advertising; Area; Attention; Clinic; Clinical Trials; Comprehension; Consent Forms; Country; Data; Decision Making; Enrollment; Gender; Goals; Housing; Human Subject Research; Incentives; Informed Consent; Intervention; Intervention Studies; Interview; Lead; Literature; Location; Malignant Neoplasms; Nurse Administrator; Observational Study; Patients; Perception; Pharmacologic Substance; Phase; Phase I Clinical Trials; Physicians; Policies; Private Sector; Procedures; Process; Proliferating; Publishing; Qualitative Methods; Qualitative Research; Race; Recommendation; Research; Research Contracts; Research Project Grants; Risk; Scholarship; Services; Shapes; Site; Speed; Structure; Sum; Testing; Time; Uncertainty; United States; clinical research site; depressed; design; drug development; healthy volunteer; human subject; improved; innovation; public health relevance; research and development; therapeutic misconception; volunteer

DESCRIPTION (provided by applicant): This project will initiate exploratory research on the informed consent of healthy human subjects participating in Phase I pharmaceutical clinical trials. Private-sector, for-profit Phase I research clinics, specializing in the rapid recruitment of human subjects for in-patient studies, have proliferated in the last decade. These clinics tend to be located in economically depressed areas of the country and offer healthy volunteers large sums (e.g., $7,000) for their participation in studies. Although most scholars assume that healthy volunteers are motivated largely by financial inducements to participate in Phase I trials, there has been no assessment of the effects of financial inducements and informed consent upon subjects' decision-making. The proposed project will fill this empirical gap on informed consent of healthy volunteers in Phase I pharmaceutical research. Through a two-year exploratory study employing qualitative methods (observational studies and semi-structured interviews), this project will address three research questions: 1. what are the factors influencing healthy human subjects' decisions to participate in Phase I studies? 2. What procedures facilitate and/or impede informed consent in Phase I trials? 3. How do the interactions between healthy human subjects and research staff vary by subjects' gender, race, and class? Research will be conducted at 6 Phase I clinics (five commercial and one academic) in the United States. A minimum of 246 interviews will be conducted with human subject volunteers and research staff (i.e., physicians, nurses, administrators, and other research staff). Qualitative research is ideally suited to documenting more fully the context of and factors influencing human subjects' decision-making regarding participation in Phase I clinical trials. This research will provide important data on an area of informed consent that has received little scholarly attention to date. PUBLIC HEALTH RELEVANCE: Although many Phase I studies involve considerable risk and uncertainty, these early clinical trials are critical to the process of pharmaceutical research and development. Thus, it is necessary to optimize the informed consent process to protect subjects who participate in these trials. This research project will lead to policy recommendations detailing innovative interventions to improve informed consent in Phase I research clinics.

描述（由申请人提供）：该项目将启动关于参与I期药物临床试验的健康人类受试者的知情同意的探索性研究。私营部门的营利性一期研究诊所在过去十年中激增，专门从事快速招募人类受试者进行住院研究。这些诊所往往位于该国经济不景气的地区，并为健康志愿者参与研究提供大笔资金（例如 7,000 美元）。尽管大多数学者认为健康志愿者主要是受到经济诱因参与第一阶段试验的动机，但尚未评估经济诱因和知情同意对受试者决策的影响。拟议的项目将填补第一阶段药物研究中健康志愿者知情同意的实证空白。通过采用定性方法（观察性研究和半结构化访谈）的为期两年的探索性研究，该项目将解决三个研究问题： 1. 影响健康人类受试者决定参加第一阶段研究的因素有哪些？ 2. 哪些程序有助于和/或阻碍 I 期试验的知情同意？ 3. 健康人类受试者和研究人员之间的互动如何因受试者的性别、种族和阶层而异？研究将在美国的 6 家一期临床诊所（5 家商业诊所和 1 家学术诊所）进行。将与人类受试者志愿者和研究人员（即医生、护士、管理人员和其他研究人员）进行至少 246 次访谈。定性研究非常适合更全面地记录人类受试者参与第一阶段临床试验的决策的背景和影响因素。这项研究将提供迄今为止很少受到学术关注的知情同意领域的重要数据。公共卫生相关性：尽管许多 I 期研究涉及相当大的风险和不确定性，但这些早期临床试验对于药物研发过程至关重要。因此，有必要优化知情同意流程以保护参与这些试验的受试者。该研究项目将提出政策建议，详细说明创新干预措施，以改善第一阶段研究诊所的知情同意。