The broad objective of this project is to strengthen oversight of human subjects and enhance the protection of research subjects at the University of Pittsburgh and its affiliated institutions, Children's Hospital of Pittsburgh and Magee-Womens Hospital.
The specific aims of the project are: 1) to develop and implement Web-based education and certification on vulnerable subject populations, IRB board member education and good clinical practices and 2) to develop an electronic IRB protocol submission process. This collaborative effort involving the University of Pittsburgh, Children's Hospital of Pittsburgh and Magee-Womens Hospital builds upon existing human subject protection initiatives at each institution. The project targets members of the research communities of the participating institutions including, but not limited to, institutional review board (IRB) members, investigators, administrators, research staff and students.
In Specific Aim 1, a multidisciplinary team of expert faculty and staff will develop educational objectives, content and quizzes on each topic. This material will be evaluated and assigned continuing education credit hours. Content and quizzes will be programmed into a Web-based delivery package, and a database will be established to track certification for administrative and evaluation purposes. Certification requirements for personnel will be determined at the institutional level.
In Specific Aim 2, an outline incorporating the issues and requirements relevant to the ethical and regulatory compliant conduct of human subject research will be developed in a question/answer format. An algorithm based on responses will further refine the question/answer outline. In addition, educational flags will be built into the program. The content for protocol submission will be programmed into a Web-based delivery package. Alpha and beta testing will be at the user level, and content and programmatic enhancements will be made based on the results of the evaluations. The project team will continue to meet after the project period to ensure successful implementation of the electronic protocol submission program. It is anticipated that the system will be live by December 2003. This electronic process will strengthen human subject oversight by streamlining IRB processes and ensuring consistency in the review process between and within the participating institutions.
| Barnes, Barbara E; Friedman, Charles P; Rosenberg, Jerome L et al. (2006) Creating an infrastructure for training in the responsible conduct of research: the University of Pittsburgh's experience. Acad Med 81:119-27 |
