J.M. DuBois is Steven J. Bander Professor of Medical Ethics and Professionalism and director, Center for Clinical and Research Ethics, Washington University School of Medicine, St. Louis, Missouri. J.T. Chibnall is professor of psychiatry and behavioral neuroscience and director, Statistics & Design Section, Grants Development Office, Saint Louis University School of Medicine, St. Louis, Missouri. R. Tait is professor of psychiatry and interim director of research, Cancer Center at Saint Louis University School of Medicine, St. Louis, Missouri. J.S. Vander Wal is professor of psychology and director, Clinical Psychology Graduate Program, Saint Louis University, St. Louis, Missouri.
Acad Med. 2018 Apr;93(4):586-592. doi: 10.1097/ACM.0000000000001804.
Violations of rules and regulations in research can cause significant problems for human participants, animal subjects, data integrity, institutions, and investigators. The Professionalism and Integrity in Research Program (PI Program) provides remediation training that addresses the root causes of violations of rules and regulations in research. Through assessments, a three-day workshop, and follow-up coaching calls, the PI Program teaches evidence-based decision-making strategies designed to help researchers to compensate for bias, uncertainty, and work-related stress, and foster the skills needed to oversee research projects in today's complex regulatory environments. Across its first three years (2013-2015), the program trained 39 researchers from 24 different institutions in the United States. Participant evaluations of the program's faculty and workshop content were highly positive (4.7-4.8 and 4.5-4.6, respectively, on a 5-point scale). Preliminary program outcome assessment using validated measures of professional decision making and cognitive distortions in a pre- and postworkshop design indicated significant improvements. A follow-up survey of participants found statistically significant increases in a variety of target behaviors, including training research staff members to foster compliance and research quality, using standard operating procedures to support compliance and research integrity, performing self-audits of research operations, reducing job stressors, actively overseeing the work of the research team, and seeking help when experiencing uncertainty. Assessment of the PI Program was conducted with modest sample sizes, yet evaluation, outcome assessment, and self-reported survey data provided statistically significant evidence of effectiveness in achieving program goals.
研究中的违规行为可能会给人类参与者、动物实验对象、数据完整性、机构和研究人员带来重大问题。专业精神和研究诚信计划（PI 计划）提供补救培训，旨在解决研究中违规行为的根本原因。通过评估、为期三天的研讨会和后续辅导电话，PI 计划教授基于证据的决策策略，旨在帮助研究人员弥补偏见、不确定性和与工作相关的压力，并培养在当今复杂监管环境中监督研究项目所需的技能。在最初的三年（2013-2015 年）中，该计划培训了来自美国 24 个不同机构的 39 名研究人员。参与者对该计划的教师和研讨会内容的评价非常高（分别为 5 分制中的 4.7-4.8 分和 4.5-4.6 分）。使用预先和研讨会后的验证性专业决策和认知扭曲措施对初步计划结果进行评估表明，有显著的改善。对参与者的后续调查发现，各种目标行为都有统计学上的显著增加，包括培训研究人员促进合规和研究质量、使用标准操作规程支持合规和研究诚信、对研究操作进行自我审核、减少工作压力源、积极监督研究团队的工作以及在遇到不确定性时寻求帮助。PI 计划的评估采用了适度的样本量，但评估、结果评估和自我报告的调查数据提供了统计学上的证据，证明该计划在实现其目标方面是有效的。
