Bronx Research Review Board

布朗克斯研究审查委员会

• 批准号: 7692178
• 负责人: Joann CasadoJD
• 金额: $ 4.15万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-25 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7692178
• 关键词: Accreditation; Adverse effects; Advocacy; Advocate; African American; Bioethics Consultants; Cessation of life; Clinical; Clinical Investigator; Clinical Research; Communication; Communities; Conflict of Interest; Education; Educational Curriculum; Ethics; Evaluation; Faculty; Failure; Fostering; Funding; Funding Agency; Health; Healthcare Systems; Incentives; Individual; Informed Consent; Institutes; Institution; Latino; Laws; Link; Marketing; Measures; Medical Errors; Medicare; Medicine; Modeling; Names; Oral; Outcomes Research; Patients; Pharmaceutical Preparations; Phase; Policies; Process; Protocols documentation; Provider; Quantitative Evaluations; Recommendation; Recruitment Activity; Reporting; Research; Research Ethics Committees; Research Personnel; Research Proposals; Research Subjects; Scientist; Security; Site; Social Security; Solutions; Structure; Syphilis; System; Testing; Time; Training; Training Programs; Training Support; Translational Research; Trust; United States National Institutes of Health; Writing; base; college; community consultation; demographics; dissemination research; experience; follow-up; health disparity; healthy volunteer; human subject protection; improved; influenza virus vaccine; innovation; meetings; member; next generation; programs; public trust; racial and ethnic; success; volunteer

DESCRIPTION (provided by applicant): The Bronx Community Research Review Board (BxCRRB) is an academic-community partnership between the Institute for Community and Collaborative Health (ICCH) and Bronx Center to Reduce and Eliminate Ethnic and Racial Health Disparities (Bronx CREED) of the Albert Einstein College of Medicine and the Bronx Health Link (TBHL). Our Specific Aims are to collaboratively develop (1) an independent research review board of volunteer community residents and representatives at the Bronx Health Link that pilot tests a model of community consultation, dialogue, and "informed consent" by reviewing community-based research applications; (2) a curriculum in the protection of human subjects and communities for community residents and representatives to become BxCRRB members; (3) appropriate evaluation measures of the BxCRRB's success in promoting community trust, academic-community research partnerships, and public understanding of the clinical research process; and (4) increased understanding of and participation in clinical research in the Bronx. Rather than asking each clinical investigator to create their own unique process for community consultation, we propose to develop an innovative, structural approach to achieve community consultation in research planning, implementation, and reporting that at the same time deeply involves and educates the public in the clinical research process. TBHL will recruit and with two Einstein faculty bioethicists train 30 community residents and representatives in the protection of human subjects and their communities in order to yield a 20 member Board whose membership reflects the demographics of the Bronx (i.e., half Latino and one-third African-American members). The BxCRRB will develop its own by-laws under the direction of TBHL and review research protocols voluntarily from researchers recruiting subjects in the Bronx and from investigators-in-training sponsored by Bronx CREED and Einstein's Institute for Clinical and Translational Research. The BxCRBB will review written and oral presentations, thus, opening a face-to-face dialogue between the investigators and BxCRRB about community perspectives on all phases of the proposed research. Rather than the paperwork-laden IRB regulatory process, the BxCRRB will advise the investigator on recruitment, incentives, sensitivities, and effective communications. Follow-up of revisions and research outcomes will be encouraged. The BxCRRB will communicate with the investigator's IRB and funding agencies about its unique process of community consultation and whether or not the Board's research standards for protecting individuals and communities have been met. Summary-Bronx Community Research Review Board The Bronx Community Research Review Board (BxCRRB) will create a model structure and ethical process for community consultation in clinical research that protects both individuals and communities and promotes more effective, relevant, and community-sensitive research. The BxCRRB will educate community members about clinical research, build community and individual capacity to review and judge research, promote timely and local dissemination of research findings, and strengthen the public's trust in the research process as a whole. BxCRRB will also train the next generation of clinical investigators in an innovative and model approach to community consultation that will ripple far beyond the Bronx.

描述（由申请人提供）：布朗克斯社区研究审查委员会 (BxCRRB) 是社区与协作健康研究所 (ICCH) 和布朗克斯减少和消除民族和种族健康差异中心 (Bronx CREED) 之间的学术界合作伙伴关系阿尔伯特·爱因斯坦医学院和布朗克斯健康链接 (TBHL)。我们的具体目标是合作开发 (1) 一个由志愿者社区居民和布朗克斯健康链接代表组成的独立研究审查委员会，通过审查基于社区的研究应用来试点测试社区咨询、对话和“知情同意”的模式； (2) 为成为 BxCRRB 成员的社区居民和代表提供保护人类主体和社区的课程； (3) 对 BxCRRB 在促进社区信任、学术界研究伙伴关系以及公众对临床研究过程的理解方面所取得的成功采取适当的评估措施； (4) 增加对布朗克斯区临床研究的了解和参与。我们建议开发一种创新的、结构性的方法，在研究规划、实施和报告方面实现社区咨询，同时深入参与和教育公众，而不是要求每个临床研究者创建自己独特的社区咨询流程。临床研究过程。 TBHL 将招募并与两名爱因斯坦系生物伦理学家一起培训 30 名社区居民和代表，以保护人类受试者及其社区，以产生一个由 20 名成员组成的委员会，其成员反映了布朗克斯的人口统计数据（即一半拉丁裔和三分之一非洲裔） -美国会员）。 BxCRRB 将在 TBHL 的指导下制定自己的章程，并自愿审查在布朗克斯招募受试者的研究人员以及由布朗克斯 CREED 和爱因斯坦临床与转化研究所赞助的培训研究人员的研究方案。 BxCRBB 将审查书面和口头陈述，从而在研究人员和 BxCRRB 之间展开面对面对话，讨论社区对拟议研究所有阶段的观点。 BxCRRB 将就招聘、激励、敏感性和有效沟通向调查人员提供建议，而不是繁琐的 IRB 监管流程。将鼓励后续修订和研究成果。 BxCRRB 将与研究者的 IRB 和资助机构就其独特的社区咨询流程以及是否符合委员会保护个人和社区的研究标准进行沟通。摘要-布朗克斯社区研究审查委员会 布朗克斯社区研究审查委员会 (BxCRRB) 将为临床研究中的社区咨询创建一个模型结构和道德流程，以保护个人和社区，并促进更有效、相关和社区敏感的研究。 BxCRRB 将向社区成员提供有关临床研究的教育，培养社区和个人审查和判断研究的能力，促进研究成果的及时和本地传播，并增强公众对整个研究过程的信任。 BxCRRB 还将以创新和模型的社区咨询方法培训下一代临床研究人员，这种方法将波及到布朗克斯以外的地区。