Vulnerable Populations and Special Protections in ACTUs

申请者描述(由申请者提供)：科学家发展指导奖(PAR-01-144)申请将支持候选人在拉里·丘吉尔博士与健康伦理与政策中心的初级指导下，以及南希·金博士与北卡罗来纳大学教堂山分校社会医学系的二级指导下，在与弱势研究人群有关的研究伦理相关问题上的职业发展。该奖项将为候选人提供所需的指导和培训，以a)发展她在研究伦理方面的知识，特别是在临床研究方面，b)发展她在临床研究中定量方法方面的技能，以及c)成为一名更有能力和更有地位的研究伦理研究者。该研究计划将以国家生物伦理咨询委员会(NBAC)提出的建议为指导，以便更好地概念化艾滋病临床试验中的脆弱性，并评估同意监测协议作为改进艾滋病临床试验中知情同意程序的手段的有效性。拟议的培训计划旨在解决该奖项的主要目标，它将有助于一个尚未得到很好探索的研究伦理领域：研究中的脆弱性概念，以及在设计具体保护措施以保护那些被视为脆弱者时涉及的伦理考虑。研究计划将涉及两项研究。研究1将是一项试验性研究，旨在收集有关艾滋病临床试验研究人员如何将他们的研究人群视为脆弱的信息，以及他们目前正在采取什么措施来保护他们的研究人群。研究2将由两部分组成。研究1的信息将通过探索受试者在艾滋病临床试验中经历了哪些类型的特殊保护来为研究2提供信息。其次，研究2还将检验同意监测作为一种特殊保护的有效性，以改进艾滋病临床试验中的知情同意程序。这项研究计划的试点工作将产生申请RO1的初步结果，该RO1将探索不同研究环境和不同研究人群中的脆弱性和特殊保护的概念。其他拟议的职业发展活动将是参加研究伦理方面的短期课程和研讨会/会议，以进一步加深对临床研究伦理中知情同意和脆弱性问题的了解。

DESCRIPTION (provided by applicant): The Mentored Scientist Developmental Award in Research Ethics (PAR-01-144) application will support the career development of the candidate in research ethics-related issues pertaining to vulnerable study populations under the primary mentorship of Dr. Larry Churchill with the Center for Health Ethics and Policy, and secondary mentorship of Dr. Nancy King with the Department of Social Medicine, The University of North Carolina at Chapel Hill. This award will provide the needed mentoring and training for the candidate to a) develop her knowledge in research ethics, particularly with respect to clinical research, b) develop her skills in quantitative methods in clinical research, and c) become a more competent and established investigator in research ethics. The research plan will be guided by recommendations made by the National Bioethics Advisory Board (NBAC) to better conceptualize what is meant by vulnerability in the context of AIDS clinical trials and to evaluate the effectiveness of a consent monitoring protocol as a means to improve the informed consent process in AIDS clinical trials. The proposed training program to address the main objective of this award will contribute to an area of research ethics that has not been well explored: The concept of vulnerability in research, and the ethical considerations involved in devising specific protections to safeguard those who are seen as vulnerable. The research plan will involve two studies. Study 1 will be a pilot study to gather information on how AIDS Clinical Trial investigators see their study populations as vulnerable, and what they currently are doing to protect their study populations. Study 2 will have two components. Information from Study 1 will inform Study 2 by exploring what types of special protections subjects have experienced in AIDS Clinical Trials. Secondly, Study 2 also will examine the effectiveness of consent monitoring as one type of special protection to improve the informed consent process in AIDS Clinical Trials. The pilot work in this research plan will engender preliminary findings to apply for an RO1 that will explore the concept of vulnerability and special protections in different research settings and with different study populations. Other career development activities proposed will be to take short courses and attend seminars/meetings in research ethics to further advance understanding of issues concerning informed consent and vulnerability in clinical research ethics.