Vulnerable Populations and Special Protections in ACTUs

ACTU 中的弱势群体和特殊保护

• 批准号: 7101120
• 负责人: Sohini Sengupta
• 金额: $ 9.85万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7101120
• 关键词: HIV infections; behavioral /social science research tag; clinical research; ethics; health education; human subject; informed consent; interview; medically underserved population; questionnaires; social perception

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.

描述（由申请人提供）：研究伦理学的指导科学家发展奖（PAR-01-144）的申请将支持候选人在研究伦理相关的问题中与弱势研究人群有关的研究人群在Larry Churchill博士的主要指导下与健康伦理和政策中心与Nancy King Chapel Chart of North Medicine的二级导师，并在Chapel Hill Social of North Carcar of North Carcar of North Carcar of North Carcar of North Carcar，该奖项将为候选人提供所需的指导和培训a）a）发展她在研究伦理方面的知识，尤其是在临床研究方面，b）发展她在临床研究中的定量方法方面的技能，c）成为更有能力和既定的研究伦理研究者。该研究计划将由国家生物伦理学咨询委员会（NBAC）提出的建议指导，以更好地概念化艾滋病临床试验中脆弱性的含义，并评估同意监测方案的有效性，以此作为改善艾滋病临床试验中知情同意程序的手段。旨在解决该奖项主要目标的拟议培训计划将有助于研究道德领域，这些领域尚未得到充分探讨：研究中的脆弱性概念以及为保护特定的保护措施保护以维护被视为脆弱的人所涉及的伦理考虑因素。研究计划将涉及两项研究。研究1将是一项试点研究，旨在收集有关艾滋病临床试验研究者如何将其研究人群视为脆弱的信息，以及他们目前在保护其研究人群中所做的事情。研究2将有两个组成部分。研究1中的信息将通过探索AIDS临床试验中经历了哪些类型的特殊保护受试者来告知研究2。其次，研究2还将研究同意监控的有效性，作为一种特殊保护，以改善艾滋病临床试验中知情同意过程。该研究计划中的试点工作将引起初步发现，以申请RO1，该发现将在不同的研究环境中探索脆弱性和特殊保护的概念，并具有不同的研究人群。提出的其他职业发展活动将是参加简短的课程并参加研究伦理的研讨会/会议，以进一步进一步了解有关知情同意和临床研究伦理中脆弱性的问题。