Westfall John M, Zittleman Linda, Felzien Maret, Ringel Marc, Lakin Alison, Nease Don
High Plains Research Network (HPRN), University of Colorado School of Medicine, Aurora, CO, USA.
Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, USA.
Fam Pract. 2017 Jun 1;34(3):301-304. doi: 10.1093/fampra/cmw112.
Patient engagement efforts often rely on a participatory research approach, which means engaging patients and community members in all aspects of research. As research team members, they require familiarity with the principles of human subject protection, privacy, and institutional review boards (IRB). However, the time required for individual IRB training may be a barrier to engaging community members in participatory research. As more community members participated in research, the State Networks of Colorado Practices and Partners (SNOCAP) was faced with finding a balance between including community members as part of the research team and the significant time commitment and institutional requirements for human subjects research oversight.
Design and implement a community training on human subject protection in research.
The SNOCAP team worked with the leadership from the Colorado Multi-Institutional Review Board (COMIRB) to develop a training programme that included the ethical principles and guidelines for the protection of human subjects.
The final training programme was based on the core principles of the Belmont Report: respect for persons, beneficence and justice. Privacy was taught using the Health Insurance Portability and Accountability Act (HIPAA) national guidelines.
The members of the High Plains Research Network Community Advisory Council were fully engaged in developing the training programme, as well as in the training itself. They were committed to the principles and guidelines for protecting the rights and welfare of human subjects. Patients and community members have become a critical part of our research team. They understand the principles of human subjects protection and privacy and incorporate these principles into their research activities.
患者参与研究的工作通常依赖于参与式研究方法，这意味着让患者和社区成员参与研究的各个方面。作为研究团队成员，他们需要熟悉保护人类受试者、隐私以及机构审查委员会（IRB）的原则。然而，个人接受IRB培训所需的时间可能成为让社区成员参与参与式研究的障碍。随着越来越多的社区成员参与研究，科罗拉多实践与合作伙伴州网络（SNOCAP）面临着在将社区成员纳入研究团队与人类受试者研究监督所需的大量时间投入和机构要求之间找到平衡的问题。
设计并实施一项关于研究中保护人类受试者的社区培训。
SNOCAP团队与科罗拉多多机构审查委员会（COMIRB）的领导层合作，制定了一个培训计划，其中包括保护人类受试者的伦理原则和指导方针。
最终的培训计划基于《贝尔蒙报告》的核心原则：尊重个人、行善和公正。使用《健康保险流通与责任法案》（HIPAA）国家指导方针教授隐私知识。
高平原研究网络社区咨询委员会的成员充分参与了培训计划的制定以及培训本身。他们致力于保护人类受试者权利和福利的原则和指导方针。患者和社区成员已成为我们研究团队的重要组成部分。他们理解保护人类受试者和隐私的原则，并将这些原则纳入他们的研究活动中。
