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, and careful and usable data acquisition. Investigators face a number of additional requirements to initiate studies, often leading to excessive delays and impairment of 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, sample acquisition, and linkage to clinical data. Recognizing the great complexity of human subjects research and the barriers faced by individual investigators, we have developed a Central Core within the RDRCC to navigate and address these concerns. 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 within the RDRCC.
The Specific Aims of the Core are: 1 .)To 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 continuing regulatory requirements;2.)To provide a central resource to investigators for clinical and translational study design so that appropriate statistical considerations are taken into account. 3.) To 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;and 4.)To provide a common platform and central resources for specimen coding, archiving, tracking and retrieval, and linkage with clinical data through an integrated barcoding system. This core is led by Dr. Clifton Bingham and Dr. Jonathan Ellen 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 services provided will integrate with other RDRCC Cores and Rheumatology Disease centers. This Core will interface with other resources at Johns Hopkins to provide additional consultation and training for investigators.

Public Health Relevance

The Human Subjects Research and Analytical Core provides key personnel and infrastructure to facilitate planning, initiation, and conduct of clinical/translational research. This core will establish central oversight for human subjects protections, and will utilize a common platform of efficient, secure data collection, quality assurance, analysis, and standardized methods to link biological samples with clinical data. The Core will provide critical services to improve efficiency and compliance through significant economies of scale.

National Institute of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Center Core Grants (P30)
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Special Emphasis Panel (ZAR1-MLB)
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Johns Hopkins University
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Singer, Benjamin D; Mock, Jason R; Aggarwal, Neil R et al. (2015) Regulatory T cell DNA methyltransferase inhibition accelerates resolution of lung inflammation. Am J Respir Cell Mol Biol 52:641-52
Langdon, Jacqueline M; Barkataki, Sangjucta; Berger, Alan E et al. (2015) RAP-011, an activin receptor ligand trap, increases hemoglobin concentration in hepcidin transgenic mice. Am J Hematol 90:14-Aug
Mock, J R; Garibaldi, B T; Aggarwal, N R et al. (2014) Foxp3+ regulatory T cells promote lung epithelial proliferation. Mucosal Immunol 7:1440-51
Liu, Qing-Rong; Rubio, Francisco J; Bossert, Jennifer M et al. (2014) Detection of molecular alterations in methamphetamine-activated Fos-expressing neurons from a single rat dorsal striatum using fluorescence-activated cell sorting (FACS). J Neurochem 128:173-85
Giles, Jon T; Darrah, Erika; Danoff, Sonye et al. (2014) Association of cross-reactive antibodies targeting peptidyl-arginine deiminase 3 and 4 with rheumatoid arthritis-associated interstitial lung disease. PLoS One 9:e98794
Birnbaum, Julius; Duncan, Trisha; Owoyemi, Kristie et al. (2014) Use of a novel high-resolution magnetic resonance neurography protocol to detect abnormal dorsal root Ganglia in Sjögren patients with neuropathic pain: case series of 10 patients and review of the literature. Medicine (Baltimore) 93:121-34
Aggarwal, Neil R; Tsushima, Kenji; Eto, Yoshiki et al. (2014) Immunological priming requires regulatory T cells and IL-10-producing macrophages to accelerate resolution from severe lung inflammation. J Immunol 192:4453-64
Joseph, Christine G; Darrah, Erika; Shah, Ami A et al. (2014) Association of the autoimmune disease scleroderma with an immunologic response to cancer. Science 343:152-7
McCranor, Bryan J; Kim, Min Jung; Cruz, Nicole M et al. (2014) Interleukin-6 directly impairs the erythroid development of human TF-1 erythroleukemic cells. Blood Cells Mol Dis 52:126-33
Geetha, D; Levine, S M; Manno, R L et al. (2014) BK virus replication in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis. Am J Nephrol 39:20-6

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