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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Mecoli, Christopher A; Delev, Nikolay G; Bingham 3rd, Clifton O (2016) Measuring transaminases in patients with rheumatoid arthritis on weekly methotrexate: does timing of blood testing matter? Clin Rheumatol 35:3053-3056
Bouquet, Jerome; Soloski, Mark J; Swei, Andrea et al. (2016) Longitudinal Transcriptome Analysis Reveals a Sustained Differential Gene Expression Signature in Patients Treated for Acute Lyme Disease. MBio 7:e00100-16
Bingham 3rd, Clifton O; Bartlett, Susan J; Merkel, Peter A et al. (2016) Using patient-reported outcomes and PROMIS in research and clinical applications: experiences from the PCORI pilot projects. Qual Life Res 25:2109-16
McMahan, Zsuzsanna H; Cottrell, Tricia R; Wigley, Fredrick M et al. (2016) Enrichment of Scleroderma Vascular Disease-Associated Autoantigens in Endothelial Lineage Cells. Arthritis Rheumatol 68:2540-9
Cappelli, Laura C; Shah, Ami A; Bingham 3rd, Clifton O (2016) Cancer immunotherapy-induced rheumatic diseases emerge as new clinical entities. RMD Open 2:e000321
Fava, Andrea; Cimbro, Raffaello; Wigley, Fredrick M et al. (2016) Frequency of circulating topoisomerase-I-specific CD4 T cells predicts presence and progression of interstitial lung disease in scleroderma. Arthritis Res Ther 18:99
McMahan, Zsuzsanna H; Wigley, Fredrick M; Casciola-Rosen, Livia (2016) Increased risk of digital vascular events in scleroderma patients who have both anti-centromere and anti-interferon-inducible protein 16 antibodies. Arthritis Care Res (Hoboken) :
Park, Jin Kyun; Fava, Andrea; Carrino, John et al. (2016) Association of Acroosteolysis With Enhanced Osteoclastogenesis and Higher Blood Levels of Vascular Endothelial Growth Factor in Systemic Sclerosis. Arthritis Rheumatol 68:201-9
Xu, George J; Shah, Ami A; Li, Mamie Z et al. (2016) Systematic autoantigen analysis identifies a distinct subtype of scleroderma with coincident cancer. Proc Natl Acad Sci U S A 113:E7526-E7534
Birnbaum, Julius; Atri, Nidhi M; Baer, Alan N et al. (2016) The Relationship Between the Neuromyelitis Optica Spectrum Disorder and Sjögren's Syndrome: Central Nervous System Extraglandular Disease or Unrelated, Co-occurring Autoimmunity? Arthritis Care Res (Hoboken) :

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