Description of the Research
A key contributing factor to the effectiveness of a HRPP is the quality of the education and training provided to faculty and staff conducting research. At our institution, training offered beyond the required basic human subjects training (conducted through the Collaborative Institutional Training Initiative) was largely informal, relying primarily on individual departments and/or mentors to train new study team members. While there were a few formal educational forums, involving knowledge-based seminars and workshops, they were often very role-specific, and some were out of scope for many research personnel. As such, our office sought to design a multifaceted, inclusive education and training framework to address the wide-ranging needs of a diverse research portfolio and research community, which includes both a large academic medical center and a traditional university.
Over approximately six months, from November 1, 2013 to April 9, 2014, a new training framework was designed. Training needs and key attributes were initially identified through: a) informal discussions with the local research community; b) mapping existing training to the Harmonized Core Competencies for the Clinical Research Professionals (Sonstein, et al., 2014); and c) reviewing existing training platforms/frameworks. Based upon the information collected, a draft training framework was developed and presented at various stakeholder meetings within the HRPP. Stakeholders included leadership within the IRB, Grants Administration Office, Clinical & Translational Science Institute, and Privacy Office, as well as other research-related institutional committees. The framework was revised based upon feedback from stakeholders and presented to the Institutional Official.
The resulting framework includes four components: a one-hour Orientation seminar; a half-day Boot Camp workshop; a 10-module Core Training series, and a one-day Advanced Training workshop. To date, Orientation, Boot Camp, and initial Core Training courses have been implemented. Program evaluation is ongoing, with attendees completing evaluations after each course. Future initiatives may include a large-scale evaluation survey after the entire framework is implemented, converting courses (or aspects of each course) to web-based training, conducting pre- and post-training evaluations with new employees, and providing additional outreach to departments wishing to implement formal training requirements.
Sonstein, S., Seltzer, J., Li, R., Silva, H., Jones, C., & Daeman, E. (2014). Moving from Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research Professional. Clinical Researcher, 28(3), 17-23.