Phase I Clinical Trials and the Informed Consent of Healthy Subjects

项目描述（由申请人提供）：本项目将开展健康人体受试者参与一期药物临床试验知情同意的探索性研究。私营的、以营利为目的的第一阶段研究诊所，专门从事快速招募人类受试者进行住院研究，在过去十年中激增。这些诊所往往设在该国经济落后的地区，向健康的志愿人员提供大笔资金（例如7 000美元），鼓励他们参加研究。尽管大多数学者认为，健康志愿者参与第一阶段试验的主要动机是经济诱因，但尚未对经济诱因和知情同意对受试者决策的影响进行评估。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经验空白。通过两年的探索性研究，采用定性方法（观察性研究和半结构化访谈），本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I期研究的因素是什么？2. 在I期试验中，哪些程序促进和/或阻碍知情同意？3. 健康受试者与研究人员之间的相互作用如何因受试者的性别、种族和阶级而异？研究将在美国的6个I期诊所进行（5个商业诊所和1个学术诊所）。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。定性研究非常适合于更全面地记录影响人类受试者参与I期临床试验决策的背景和因素。这项研究将为迄今为止很少受到学术关注的知情同意领域提供重要数据。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药物研究和开发过程至关重要。因此，有必要优化知情同意程序，以保护参与这些试验的受试者。该研究项目将产生政策建议，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。

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.