Phase I Clinical Trials and the Informed Consent of Healthy Subjects

说明（申请人提供）：本项目将对参与I期药物临床试验的健康人体受试者的知情同意进行探索性研究。在过去的十年里，专门从事住院研究的快速招募人类受试者的私营营利性I期研究诊所激增。这些诊所往往位于该国经济不景气的地区，并为健康的志愿者提供大量资金（例如，7,000元），用于研究。虽然大多数学者认为健康志愿者参与I期试验的动机主要是经济诱因，但尚未评估经济诱因和知情同意对受试者决策的影响。拟议的项目将填补这一经验空白的知情同意的健康志愿者在第一阶段的药物研究。本研究透过为期两年的探索性研究，以质性研究（观察性研究及半结构式访谈），探讨三个研究问题：1。影响健康受试者决定参加I期研究的因素是什么？2.在I期试验中，哪些程序有助于和/或妨碍知情同意？3.健康受试者和研究人员之间的互动如何因受试者的性别、种族和阶级而异？研究将在美国的6个I期诊所（5个商业诊所和1个学术诊所）进行。将对人类受试者志愿者和研究人员进行至少246次访谈（即，医生、护士、管理人员和其他研究人员）。定性研究非常适合更充分地记录人类受试者参与I期临床试验的决策背景和影响因素。这项研究将提供重要的数据，在一个领域的知情同意，已收到很少的学术关注日期。公共卫生相关性：虽然许多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发过程至关重要。因此，有必要优化知情同意过程，以保护参与这些试验的受试者。该研究项目将导致政策建议，详细说明创新的干预措施，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.