Iafrate R Peter, Lipori Gloria P, Harle Christopher A, Nelson David R, Barnash Timothy J, Leebove Patricia T, Adams Kathleen A, Montgomery Debbi
Institutional Review Board, University of Florida, Gainesville, Florida, United States.
Operational Planning & Analysis, University of Florida Health and University of Florida Health Sciences Center, Gainesville, Florida, United States.
J Clin Transl Res. 2016 Oct 10;2(4):113-122. eCollection 2017 Jan 4.
Obtaining sufficient subjects into research studies is an ongoing barrier to conducting clinical research. Privacy rules add to the complexity of identifying qualified study subjects. The process described facilitates consent of patients coming to their clinically scheduled appointments who are asked to consent to having researchers review their electronic medical records (EHR), and if they meet study criteria for future research, being contacted by those researchers and asked if they wish to be involved in a research project. An interdisciplinary group representing the Institutional Review Board (IRB), Information Technology (IT), Hospital, University and Research developed an initial paper then electronic method to consent all patients attending a medical subspecialty clinic. All consent data are integrated to the EHR to facilitate linking to clinical information. Although the paper consenting method resulted in over an 80% "yes" rate of consent, it was complicated by significant procedural challenges which prevented scalability. Revising the process has resulted in nearly 28,000 patients consenting in a 3 year period and in 20 IRB approved protocols using subjects who agreed to Consent2Share. A multi-disciplinary effort is essential to develop a successful electronic based, integrated process to assist investigators and patients to facilitate study subject accrual. Consent2Share more efficiently assists researchers in identifying and contacting potential study subjects that meet entrance criteria. The process provides a model to comply with the proposed Notice of Public Rule Making (NPRM) where institutions will be strongly encouraged to develop broad research consent procedures.
在临床研究中，招募到足够数量的受试者一直是个障碍。隐私规定增加了确定合格研究受试者的复杂性。所描述的流程有助于让按临床预约前来就诊的患者同意研究人员查阅其电子病历（EHR），并且如果他们符合未来研究的标准，研究人员会联系他们，询问他们是否愿意参与研究项目。一个由机构审查委员会（IRB）、信息技术（IT）、医院、大学和研究机构代表组成的跨学科小组制定了一种最初的纸质然后电子化的方法，以征得所有在医学专科诊所就诊的患者的同意。所有同意数据都整合到电子病历中，以便与临床信息相链接。尽管纸质同意方法的同意率超过80%，但由于重大的程序挑战而变得复杂，这阻碍了其推广。对流程进行修订后，在三年时间里有近28000名患者同意，并且有20个IRB批准的方案使用了同意参与“同意共享”的受试者。开展一项多学科的工作对于开发一个成功的基于电子的综合流程至关重要，该流程可协助研究人员和患者促进研究受试者的招募。“同意共享”更有效地帮助研究人员识别和联系符合入选标准的潜在研究受试者。该流程提供了一个模型，以符合拟议的《公共规则制定通知》（NPRM），在该通知中，将大力鼓励各机构制定广泛的研究同意程序。
