In the past year Rockefeller has undertaken an initiative to comprehensively evaluate and strengthen its human subject protection program including the recruitment of key senior staff, external audits of research conduct and review procedures, and swift implementation of program changes to enhance current practices. The Physician-in-Chief, Dr. Barry Coller, has led the 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 potential software infrastructure to enhance the protection for human subjects.
The aim of the initiative is to develop comprehensive integrated electronic infrastructure to support each element of the clinical research process, and to lead in the advancement of human subject protections. Preliminary software solutions for adverse event tracking and protocol management have been implemented, and existing hospital information systems are being redesigned. The current proposal implements a key component of the infrastructure, electronic IRB functions. The iMedRIS iRIS IRB tracking software, with its IRB and Site Assistant modules, permits electronic filing, facilitates distribution of key safety information and serious adverse event reporting, and permits essential protocol document management. The iRIS system will ultimately link with other applications selected to manage laboratory and research data university wide, including protocol content management; comprehensive adverse event detection, tracking, and reporting; expert systems to mine data and perform interim analyses; and the hospital information and patient scheduling systems, all on the existing University database platform. An IRB Protocol Systems Manager/Programmer will be recruited and dedicated to the execution of this software infrastructure in the coming year, managing aspects of implementation, integration and training.
| 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 |
