14 - 22 Years of Meeting Learning Objectives and Satisfying Learners: Report of a Training Program in Human Research Protection

Background: : Since 2000, the National Institutes of Health has required education on the protection of human research participants for all investigators and key study personnel. In addition to Collaborative Institutional Training Initiative (CITI) courses, our institution has required principal investigators and research fellows to attend a synchronous, in-person or virtual, course.

Program

Description: : From 2003 to 2010, we offered a multi-faceted course that included online training, in-person lectures and video, and small group workshops. The in-person portion was a half-day for principal investigators and a full-day for fellows. Other research personnel were welcome to attend the course but fulfilled their training requirement through online education. From 2011 to present, we have offered a full-day course on average five times per year; new principal investigators (PIs) and fellows must attend 2 workshops to fulfill their training requirements. Human Subjects Research (HSR) recertification training is required for all PIs and study team members every 3 years; this is fulfilled through online courses and one in-person activity (e.g., one workshop in the day-long course). Workshops address a variety of topics including the Belmont Report, informed consent, pediatric research, global health research, stored tissue research, clinical study design and reporting, and the responsible conduct of research.

Program

Assessment: : Evaluation results from Course 1 and Course 2 have been combined to assess impact of the synchronous HSR training. Course 1 had 3,439 attendees (for available data, 55% faculty, 40% fellows, 4% students, 1% other). Course 2 had 3,240 attendees (64% principal investigators, 8% co-investigators, 4% research coordinators or staff, 22% fellows or residents, 4% students). For Course 1, 48% had previously submitted a protocol to the IRB, whereas for Course 2, it was 71%. Overall evaluation of the combined courses was excellent (37%), very good (44%), and good (17%). The majority of evaluation respondents agreed or strongly agreed that learning objectives were met: 83% could recognize ethical aspects of study design; 89% could describe key concepts of informed consent; 91% could recognize key concepts of responsible conduct of research. Respondents also agreed or strongly agreed that the course improved their ability to conduct HSR (84%) and interact with the IRB (84%). 84% of respondents indicated they had learned from other researchers attending the small group session. 84% would recommend the course to a colleague.

Limitations:: Learner satisfaction with the course does not measure their actual research behavior. Another concern is testing effect--whether learners tended to pick the same rating throughout the evaluation, although ratings in different domains showed variability. Evaluations were anonymous and results were available in aggregate, limiting the ability to generate explanatory models linking learner demographic characteristics with their ratings.

Discussion: : Training in research ethics is one aspect of an overall human research protection program. The evaluation data demonstrate that a course designed for adult learners ranging in research experience from novice to senior investigator can be well received. Small group workshops are effective methods for delivery of HSR content and have secondary benefits of researchers learning from each other and fostering collegiality with the IRB. Our institution has found post-pandemic that this training can be delivered in a virtual platform that can connect geographically diverse learners. This model can be adopted by other institutions wishing to enhance their online training.