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Expert knowledge about the multiple regulations and guidance documents pertaining to clinical and translational research, including stem cell and other novel research, and regulatory support to investigators has been previously available at Northwestern University and its clinical affiliates. However, these resources have resided in multiple distinct units, and limited coordination and communication has occured between these units.
Recognizing that the such a system may result in conflicting advice and inefficiency, under the auspices of the NUCATS Institute, Northwestern University is creating a new model of regulatory knowledge and support. In this model, a new Regulatory Support Program (RSP) will subsume many of the relevant functions and services that are now decentralized. In addition, stronger, better-defined links are planned between the RSP and those units whose functions remain outside the RSP and the NUCATS Institute. Establish a central resource to provide regulatory knowledge and support for the clinical and translational research community; Improve the quality and timeliness of regulatory support; Create a culture and structure that supports novel research methods, technologies and studies; and Ensure that the services meet investigator needs and are compliant with all federal, state and local regulations.
The Regulatory Support Program (RSP) is central to expanding regulatory knowledge and support of clinical and translational research at Northwestern University, its hospital affiliates, and the community. This office provides a range of services and expertise to meet the institutional and external needs of investigators, scholars, and trainees. An experienced faculty leader ensures that an appropriate balance is achieved between advocating for and supporting the clinical and translational research teams and advocating for and protecting the research participants who are so vital to the advancement of science. At an institutional level, the RSP will expand existing programs (such as participant and research subject advocacy, data and safety monitoring, quality assurance/site audit), create several new programs (e.g., internship and certificate program for regulatory support staff, single common proposal application, Institutional Review Board panel that meets weekly to review new time-sensitive clinical trials, development and dissemination of research best practices), integrate existing and new programs, and improve the communication with related programs and offices located outside the NUCATS Institute. These actions will help transform the clinical and translational research environment at Northwestern. In addition, the RSP will contribute to the nationwide National Institutes of Health (NIH) Clinical and Translational Science Awards (CTSA) program by sharing its innovative programs and its knowledge about new information technology platforms, and taking the lead in developing regional and national institutional review boards.  |
The director of the RSP is Lewis J. Smith, MD, a senior NU faculty member with extensive experience as a clinical investigator (leader and participant in NIH, foundation, and industry-sponsored patient-oriented research projects), IRB panel member and chair, speaker at national and regional forums on human subject protections, holder of two investigator INDs, developer and director of the Master of Science in Clinical Investigation (MSCI) program at NU and research subject advocate for the GCRC. He has worked with foundations (e.g., chair of the Research Grant review committee [study section] and Scientific Advisory Committee of the American Lung Association), industry (consultant, advisory board member, chair and member of data and safety monitoring committees) and the federal government on issues related to clinical and translational research. Dr. Smith will be assisted by two associate directors, an administrative assistant and a staff experienced in regulatory support functions (e.g., Institutional Review Board, Lurie Comprehensive Cancer Center at NU, General Clinical Research Center submissions; Investigational New Drug (IND) and Investigational Device Exemption(IDE) preparation and submission); budget preparation and contract negotiation; Good Clinical Practices (GCP) training and quality assurance/site audits; participant and research subject advocacy; and data and safety monitoring. The associate directors will have extensive experience in two or more of the above areas and serve the investigator advocacy function. One of the associate directors will lead the new program which will cross-train individuals to function in one or more of the RSP staff and leadership positions. | |
