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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Center Core Grants (P30)
Project #
5P30AR053503-07
Application #
8380936
Study Section
Special Emphasis Panel (ZAR1-MLB)
Project Start
Project End
Budget Start
2012-08-01
Budget End
2013-07-31
Support Year
7
Fiscal Year
2012
Total Cost
$269,896
Indirect Cost
$105,608
Name
Johns Hopkins University
Department
Type
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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Cappelli, Laura C; Gutierrez, Anna Kristina; Baer, Alan N et al. (2017) Inflammatory arthritis and sicca syndrome induced by nivolumab and ipilimumab. Ann Rheum Dis 76:43-50
Albayda, Jemima; Pinal-Fernandez, Iago; Huang, Wilson et al. (2017) Antinuclear Matrix Protein 2 Autoantibodies and Edema, Muscle Disease, and Malignancy Risk in Dermatomyositis Patients. Arthritis Care Res (Hoboken) 69:1771-1776
Cappelli, Laura C; Shah, Ami A; Bingham 3rd, Clifton O (2017) Immune-Related Adverse Effects of Cancer Immunotherapy- Implications for Rheumatology. Rheum Dis Clin North Am 43:65-78
Turnbull, Alison E; Sepulveda, Kristin A; Dinglas, Victor D et al. (2017) Core Domains for Clinical Research in Acute Respiratory Failure Survivors: An International Modified Delphi Consensus Study. Crit Care Med 45:1001-1010

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