In the past year and a half, Rockefeller has undertaken an initiative to comprehensively evaluate and strengthen its human subject protection program. The Physician-in-Chief, Dr. Barry Coller, has led key recruitments and the University Oversight of Protection of Human Subjects Committee. Dr. Rhonda Kost, recruited as the Clinical Research Officer (RSA), has led the Clinical Research Software Committee, a multidisciplinary team for evaluation of software infrastructure to enhance the protection for human subjects. She has also led the Clinical Research Office, providing a core of essential resources for research staff, and a source of educational programs in the protection of human subjects. Within the current educational program, there are additional areas that we would like to address.
The aim of the initiative, undertaken in collaboration with two local hospitals, Lutheran Medical Center and North General Hospital, is to develop a comprehensive educational program that 1) encompasses basic and advanced training in the protection of human subjects and meets the needs of the diverse patient and trainee populations at the collaborating institutions, 2) provides a web-based self-study format that is both flexible and user friendly, and allows for on-line testing and certification, and 3) facilitates conduct of novel research to test the impact of the education on trainee knowledge and behavior toward human subjects. The syllabus will be structured around the six elements described in the NIH Clinical Center's Guidelines and Standards for Clinical Investigative Research: 1) Training and Education, 2) Biostatistics Support, 3) Protocol Review, 4) Clinical Informatics, Data Management, and Protocol Tracking, 5) Quality Assurance and Quality Control, and 6) Human Resources and Physical Plant. Content will be revised collaboratively among the institutions. The teaching tools will be designed and assembled under the direction of Dr. Kost by a full-time staff educator with advanced computer skills, supported by this proposal, and the Rockefeller University Information Technology department. The education program will be customized for the needs of each institution. Questionnaires for researchers and data queries of the educational system will be designed to conduct research describing the impact of the training program on trainees and investigators.
| Kost, Rhonda G; Lee, Laura M; Yessis, Jennifer et al. (2011) Assessing research participants' perceptions of their clinical research experiences. Clin Transl Sci 4:403-13 |
