Office of Clinical Research
The identification of key barriers (outlined below) has led to a plan for centralization and consolidation of research support infrastructure campus-wide throughout Emory University, with a proposal to broaden the scope of the current Clinical Trials Office (CTO) to form an Office of Clinical Research (OCR). In addition, a research ethics resource was developed within the OCR, the Section of Ethics in Research and Participant Advocacy (SERPA). These transformations allow for more efficient campus-wide regulatory, knowledge and ethics programs and ultimately help provide regulatory technology and ethics support to the entire ACTSI. The OCR provides the appropriate leadership and infrastructural support for investigators with the prime goal of accelerating the pace of translational research projects while maintaining the highest quality of safe and ethical clinical research in human subjects. The core features of the OCR include discipline specific protocol navigators and resources for: 1) Regulatory Guidance; 2) Safety Surveillance and Support; 3) Financial and Research Compliance; 4) Quality Assurance; and 5) Ethics Research and Support. Throughout each of these support areas, training and education programs for investigative teams is provided. Critical to future success of OCR and for clinical and translational research is the development of an integrated electronic research record to facilitate studies. In addition, development of research regulatory connectivity with our partner institutions, MSM and GA Tech, is an essential part.
OCR plays a central role in helping investigative teams understand regulatory requirements for the conduct of their research, including the process of writing appropriate informed consent forms (ICF) and relevant documents, the conduct of the highest quality of research that meets safety and financial compliance requirements, the education of trainees about the fundamental basics of regulatory knowledge, and fostering investigation into the ethical components of research and the continued improvement of the regulatory process (Specific Aim 1). The OCR interacts with the Biomedical Informatics to develop NoERR, a standardized, single point of entry electronic research proposal submission process for all institutions; incorporating databases for adverse event tracking at all institutions, billing, IND/IDE tracking, professional development monitoring, alternative methodologies of obtaining informed consent for special populations, ethical dilemmas and their resolutions that are developed as a consultation service and as education and training modules, and provide regulatory information required for career development programs and lay communications (Specific Aim 2). The organization of OCR helps integrate partnering institutions of the ACTSI with regard to safety surveillance, regulatory guidance, quality assurance, education and training for investigators in the Clinical Interaction Network (Specific Aim 3). Through efforts and research performed by the GA Tech Health Services Institute (HSI), research on research infrastructure is done to determine the efficiency and transportation of regulatory and ethical knowledge to the: 1) investigator; 2) research subject; and 3) community across institutions. The OCR provides framework to integrate and broaden the scope of regulatory support and training, assist the academic growth of clinical investigations and support the highest level of ethically conducted clinical and translational investigation across institutions. The newly created OHSR reduces duplication and fragmentation of currently available services. The primary goal of the OCR is to provide the expertise needed to optimize clinical and translational research.