Richardson Lynne D, Quest Tammie E, Birnbaum Steven
Department of Emergency Medicine, Mount Sinai School of Medicine, New York, NY 10029, USA.
Acad Emerg Med. 2005 Nov;12(11):1064-70. doi: 10.1197/j.aem.2005.06.018.
The challenge of effectively communicating with communities about research is particularly salient for investigators who are conducting emergency research with an exception from informed consent. The authors discuss the ethical basis for the community consultation requirement and describe the nature and extent of the consultative process required to achieve these ethical purposes. The findings of the consensus conference are summarized as follows. 1) The requirements for community consultation and public disclosure for exception from informed consent studies serve important ethical purposes and should be retained. 2) Community consultation allows investigators and institutional review boards to obtain input from the community regarding planned research. The process serves to facilitate understanding, promote trust, ensure justice, and protect research participants. 3) Community consultation is a process that requires active participation by community members; however, it does not require their approval, consent, or consensus. The practical challenges involved in conducting meaningful community consultation are also discussed: defining the community and its appropriate representatives, methods to actively engage the community, the lack of uniformity among institutional review boards in required community consultation activities, and the lack of measures to evaluate the adequacy and appropriateness of community consultation. The recommendations of the consensus conference regarding future research about community consultation are summarized. Priorities include identifying best practices; defining effectiveness and developing measures to evaluate community consultation; evaluating alternative models and potential infrastructures to facilitate, conduct, and/or oversee effective community consultation processes; and developing educational modules for community members to empower their active participation in discussions about emergency research in their communities.
对于那些正在进行免除知情同意的紧急研究的研究者而言，与社区就研究进行有效沟通是一项尤为突出的挑战。作者们探讨了社区咨询要求的伦理基础，并描述了为实现这些伦理目标所需的咨询过程的性质和范围。共识会议的结果总结如下：1）对于免除知情同意研究的社区咨询和公开披露要求具有重要的伦理目的，应予以保留。2）社区咨询使研究者和机构审查委员会能够获取社区对计划研究的意见。该过程有助于促进理解、增进信任、确保公正并保护研究参与者。3）社区咨询是一个需要社区成员积极参与的过程；然而，并不要求他们批准、同意或达成共识。文中还讨论了进行有意义的社区咨询所涉及的实际挑战：界定社区及其合适的代表、积极吸引社区参与的方法、机构审查委员会在所需社区咨询活动方面缺乏一致性，以及缺乏评估社区咨询充分性和适当性的措施。总结了共识会议关于未来社区咨询研究的建议。优先事项包括确定最佳实践；界定有效性并制定评估社区咨询的措施；评估促进、开展和/或监督有效社区咨询过程的替代模式和潜在基础设施；以及为社区成员开发教育模块，以增强他们积极参与所在社区关于紧急研究讨论的能力。
