34 - Learning the Ropes: Advancing Ethical Conduct of New Student Researchers Through Research Compliance Educational Outreach Initiative

Background: An IRB at a teaching college works with student researchers new to the Common Rule and IRB protocol submission process. CITI training provides new researchers with basic human subjects protections training. However, federal regulations, local policies, and institutional requirements create challenging layers of compliance for novice researchers to navigate.

Program

Description: The IRB developed a four-armed Research Compliance Educational Outreach Initiative to support student researchers in developing quality research protocols. This program included (1) student-centered comprehensive and responsive online guidance, (2) demystifying the IRB presentations and workshops tailored to student needs, (3) weekly open office hours, and (4) the Interdepartmental Research Writing & Ethics Internship (citation will be included, but removed for identification purposes). College-wide online education initiatives contained detailed instructions on IRB processes, guidance on institutional, local, and state policies, and timely articles responsive to the current climate and needs of researchers. Presentations were hosted at New Student Orientation and classroom, targeting new students who are specifically entering into the research development phase and tailored to the program’s specific needs and interests. Weekly office hours provided 1:1 support and were managed by administrative staff trained in institutional processes. We developed a dynamic walk-in and online scheduling program to accommodate students’ changing schedules.

Program

Assessment: The IRB conducts regular assessments of the program so that it is responsive to researchers’ evolving needs. The success of IRB’s online guidance is primarily measured via student and faculty feedback through the submission of queries. Additionally, IRB reviewers identified common stop-gaps or revisions required in the review process. These metrics were reviewed for questions that were not readily addressed in the website, but that were general enough to be shared with the research community. From there, further guides and resources were published.Feedback on educational presentations was produced by attending advisors and faculty sponsors who identified areas needing further clarification. Student follow-up questions based on presentation materials were also taken into account. Metrics of success for presentations and office hours included ease of pre-review on student-submitted protocols, improved quality of submissions, and improved postapproval reporting. Finally, individual interviews with work-study students provided detailed insight into areas for improvement across all education initiatives. A full assessment of the RWE Internship is provided in a poster presented last year (citation will be included, but removed for identification purposes).

Limitations: Despite responsive feedback from the research community at the teachers college, the Educational Outreach Initiative has yet to be reviewed by a random selection of users. Currently, program changes are only informed by those who self-select to provide the IRB with feedback. Random sampling would provide a more representative sampling of researcher needs and experiences across the college. Additionally, the program’s generalizability is limited to those institutions interfacing primarily with a student and faculty population.

Discussion: Initially, educational outreach initiatives focused on the IRB submission process, in response to researcher confusion over the submission platform. TheIRB also addressed the doctoral dissertation submission requirements such that they reflected doctoral requirements for graduation. The initiative then shifted to request topical guidance for common obstacles to research initiatives, such as collaborating with departments of education. During the COVID-19 shutdown, the initiative provided researchers with timely guidance and assistance in shutting down, and later restarting, their studies. The most common inquiries are that students have difficulty finding published guidance, which has led the IRB to consider restructuring the guidance.