Data Sharing

An area of innovative research sponsored by the Georgetown CERSI explores the issues around voluntary sharing of biomedical research data.

Georgetown University conducted research to examine voluntary arrangements for sharing of research data created by medical product developers. There are many types of voluntary data sharing arrangements to share data, usually in response to specific needs within a community. For example, safety data are shared among the airline and auto industries, and clinicians voluntarily report near miss or adverse event data.

Voluntary sharing of research data may provide benefits to medical product developers, in a number of ways, such as (1) reduced waste of resources by following already failed paths, (2) third-party data review to confirm findings, (3) minimized negative publicity associated with unsafe products, and (4) enhanced collective good for industry and health care practice.

Led by CERSI Principal Investigator, Ira Shoulson, MD, the Georgetown research team studies the benefits and barriers to data sharing among industry and academia.


Approaches and Costs for Sharing Clinical Research Data

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Approaches and Costs for Sharing Clinical Research Data 
Released: March 26, 2014

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. 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.


Facilitating Medical Product Development Through Volunatry Data Sharing: A Look at the Legal Issues

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Facilitating Medical Product Development Through Voluntary Data Sharing: A Look at the Legal Issues
Released: October 1, 2014

Data sharing has been lauded as a promising approach to facilitate the development of medical products and attendant benefits to public health. The subject has focused mainly on philosophical arguments and has received considerable attention in the media and scientific literature. Of the empirical research that exists, much of it has focused on data sharing among academic investigators in the field of life science, including biomedical research, medicine, and genetics. A number of commentaries and editorials have dealt with the ethical repercussions when researchers choose not to share data; others have discussed real or perceived legal barriers to data sharing. These barriers include (1) compromised intellectual property rights and unfair advantages to competitors, (2) risk of increased product liability, (3) issues of collusion under antitrust laws, and (4) risks to research participant privacy. In this report, we dissect the legal issues that may pose barriers to data sharing and identify solutions to overcome these barriers. 


Identifying and Examining Voluntary Sharing of Research Data Among Sponsors of Medical Products

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Data Sharing for Public Health: A Qualitative Study of Industry and Academia
Released: August 19, 2015

Our research examined the institutional positions and policies, experiences, and concerns regarding data sharing of small- to medium-sized for-profit companies and academic research centers that generate data in the development of medical products regulated by the FDA. Our approach included conducting qualitative, semi-structured interviews with people working in industry and academia. The purpose of these interviews was to identify and understand the attitudes and beliefs about data sharing as well as experiences sharing data (i.e., toxicological data, clinical or human subject data, or both). Based on results from this pilot study, we developed a survey to gather data from a broader group of participants among industry and academia.