In the last several years, the complexity of human subjects research has increased substantially, with a greater appreciation of the need for privacy protection, ethical conduct of research, careful, systematic data acquisition, quality control, and enhanced security. Investigators face a number of additional requirements to initiate studies, often leading to excessive delays that impair progress on projects. Moreover, as datasets become more complex and are frequently linked with the acquisition of biological specimens from patients, there are increasing demands for improved data collection, biospecimen acquisition, and sample linkage to clinical data. Recognizing the great complexity of human subject research and the barriers faced by individual investigators, we have developed a central core within the Rheumatic Diseases Research Core Center (RDRCC) to facilitate human subject research. The overall goal of the Human Subjects Research and Analytical Core is to streamline and centralize the process for the initiation and operationalization of human subject research for RDRCC investigators. We will achieve this goal through the following Four Specific Aims:
- Provide assistance for the regulatory and operational process of human subject research beginning at the study inception phase, through various approval steps, study initiation, and maintenance. These include ethical and regulatory concerns, informed consent development, and patient recruitment.
- Provide a central resource to investigators for clinical and translational study design so that appropriate statistical considerations are taken into account. Services provided include initial consultation, ongoing support for analysis, and identification of additional expertise.
- Provide a system for database development and maintenance, and the creation of data forms and their linkage with databases using a Teleform-based platform and direct data acquisition via secure Web-based and tablet computer platforms.
- Provide a single platform and central resources for specimen coding, archiving, tracking and retrieval, and linkage with clinical data using a common barcoding system that integrates with other cores.
The Human Subjects Research and Analytical Core (HSRAC) is led by Clifton Bingham MD and Sharon Ghazarian PhD, bringing together two seasoned clinical and translational researchers with experience in various aspects of human subjects research, ranging from longitudinal cohort studies, biomarker analysis, studies of human pathological tissues, interventional studies, clinical outcome measurements, and interdisciplinary investigations of human disease. The Core will integrate with other RDRCC cores and Rheumatology Centers of Excellence. This Core will interface with other resources including the Institute for Clinical and Translational Research (ICTR) at Johns Hopkins to provide additional consultation and guidance to investigators.
The HSRAC provides key personnel and infrastructure to facilitate planning, initiation, and conduct of clinical and translational studies. This core will establish central oversight and education for human subject protections, and will utilize a common platform of efficient, secure data collection, quality assurance procedures and analysis, and a standardized method to link biological materials with clinical data. At all stages of consultation with investigators using the HSRAC, faculty and staff will provide recommendations for further training in research methods related to the goals of the Core. This Core will realize significant economies of scale and provide services that individual investigators could not otherwise easily access.