JAMA Network | JAMA | Approaches and Costs for Sharing Clinical Research Data

"The generation, dissemination, and sharing of research data are key ingredients in contributing to scientific progress and the public good. Data sharing has been encouraged to facilitate open science within the clinical research enterprise, improve the development of drugs and devices, and benefit public health.1 But sharing data is complex. Investigators generally tend to guard research data to retain ownership and property rights, avoid competition, protect confidentiality and privacy, or avoid misuse by unqualified persons. Sharing research data also comes at a cost to the sharer. This Viewpoint examines some approaches and cost considerations involved in sharing participant-level clinical research data. Models for data sharing vary based on accessibility of data to researchers who did not originally collect the data, the type and size of data collected, the sophistication of the database, and the design and capabilities of the user interface. As a minimalist approach, a data generator could upload deidentified participant-level data to an Internet-based storage system and provide relatively open access to other researchers. This model typically provides limited or no support to potential users. More expansive models provide extensive and timely sharing of well-characterized data, often drawn from multiple sources, converted to a standardized format, and accompanied by a user-friendly interface and data dictionary. The National Database for Autism Research,2 the Parkinson’s Progression Markers Initiative,3 and the Alzheimer’s Disease Neuroimaging Initiative (ADNI)4 are disease-oriented examples of the expansive model that promotes further research and data sharing. Created in October 2004 and currently funded through 2017 by a combination of government, industry, and foundation sponsors, ADNI is perhaps the best known and most established of these initiatives. ADNI researchers contribute standardized data to a clinical, brain imaging, and biomarker database. At its creation, the ADNI model mandated prospective, timely, and wide sharing of data. After acquisition, clinical research data are entered promptly into a quality-controlled database, monitored to ensure ADNI standards, and, within days of deposit, made accessible via a password-protected website to individuals with research credentials who agree not to attempt to identify research participants. Researchers who access ADNI data also agree to upload new analyses to the ADNI database and cite ADNI in the author line of related publications. More than 4000 investigators have accessed ADNI data, resulting in 411 publications to date (N. Buckholtz, PhD, R. Green, MD, MPH, A. Toga, PhD, J. Trojanowski, MD, PhD, M. Weiner, MD, written communication, August-October 2013). But such an elegant and comprehensive approach to sharing clinical research data comes with substantial costs. Based on interviews with key investigators who orchestrated ADNI (N. Buckholtz, PhD, R. Green, MD, MPH, A. Toga, PhD, J. Trojanowski, MD, PhD, M. Weiner, MD, written communication, August-October 2013),4 4 major categories of costs were identified: (1) infrastructure and administration, (2) standardization, (3) human resources, and (4) opportunity costs.  Infrastructure costs—the costs required to maintain the physical or Internet-based data repository and other facilities—encompass storage, security, and quality-control procedures. Large databases and shared computing environments require firewalls, common 'language' among data sets, compliance monitoring, and ongoing maintenance. A large administration component involves the initial consent, monitoring, and often reconsent of human research participants to share additional or specific data or biospecimens, as well as legal costs to cover management of material transfer agreements, contracts, and risk mitigation. Accessibility to genomic family history data is another complicating and potentially costly obligation when providing adequate protection for research participants ..."