Research Enhancements and Administration Project

该项目的广泛目标是，通过最大限度地提高对匹兹堡大学、玛吉妇女医院和区域机构从事人类研究的个人进行教育和培训的机构能力，加强对人类研究对象的保护。该项目的具体目标是：1)发展多媒体社区外展和参与者教育活动；2)为研究人员、协调员和学生开发关于人类研究伦理的示范互动研讨会；以及3)建立 临床研究资源中心。 匹兹堡大学和玛吉妇女医院的这项合作努力建立在每个机构现有的人类主体保护倡议的基础上。该项目面向当地研究界的成员，包括但不限于机构审查委员会(IRB)成员、调查人员、管理人员、研究人员、学生和潜在的研究参与者。 在具体目标1中，一个由专家教员和工作人员组成的多学科小组将针对当地社区和研究参与者开展多媒体教育活动。这些材料的设计将提供对临床研究过程的基本了解，临床研究的价值，以及作为研究参与者的期望。重点将放在风险和利益、参与者权利、保密性和知情等问题上 同意。 在具体目标2中，将举办一个关于人类研究伦理的三节、六小时的互动研讨会。研讨会将涵盖核心伦理价值观，并包括互动会议，参与者参加模拟的IRB会议，并在知情同意过程中进行角色扮演对话。 在具体目标3中，将在匹兹堡大学临床研究办公室教育计划的赞助下创建一个临床研究资源中心。该中心将作为与临床研究相关的教育和培训材料的集中协调储存库。书面、视听和 计算机资源将存放在这个中心。其他院校如有需要，亦可索取社区外展服务及参与教育材料。伦理学研讨会和资源中心将向来自加州大学的教职员工和学生开放 匹兹堡和Maee--妇女医院，以及来自外部机构的个人。

The broad objective of this project is to enhance the protection of human research subjects by maximizing the institutional capacity for the education and training of individuals who are involved in human subject research at the University of Pittsburgh, Magee-Womens Hospital and regional institutions. The specific aims of the project are: 1) to develop a multimedia community outreach and participant education campaign, 2) to develop a model interactive seminar on human research ethics for investigators, coordinators and students, and 3) to establish a clinical research resource center. This collaborative effort involving the University of Pittsburgh and Magee-Womens Hospital builds upon existing human subject protection initiatives at each institution. The project targets members of the local research community including, but not limited to, institutional review board (IRB) members, investigators, administrators, research staff, students and potential research participants. In Specific Aim 1, a multidisciplinary team of expert faculty and staff will develop a multimedia educational campaign targeting local communities and research participants. The material will be designed to provide a basic understanding of the clinical research process, the value of clinical research, and what to expect as a research participant. Emphasis will be given to issues such as risks and benefits, participant rights, confidentiality and informed consent. In Specific Aim 2, a three-session, 6-hour interactive seminar on human research ethics will be developed. The seminar will cover core ethical values and include interactive sessions wherein participants participate in a mock IRB meeting and role play conversations in an informed consent process. In Specific Aim 3, a clinical research resource center will be created under the auspices of the University of Pittsburgh Office of Clinical Research's Education Program. This center will serve as a centralized, coordinated repository of education and training materials related to the conduct of clinical research. Written, audiovisual and computer resources will be housed in this center. Copies of community outreach and participant education material will be available to other institutions on request. The ethics seminar and resource center will be accessible to faculty, staff and students from the University of Pittsburgh and Ma_ee-Womens Hospital, as well as individuals from outside institutions.