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

Posted by Social Science Research Network

Facilitating Medical Product Development Through Voluntary Data Sharing: A Look at the Legal Issues – Aliza Y. Glasner (Georgetown University – The O’Neill Institute for National and Global Health Law), Erin E. Wilhelm (Georgetown University Medical Center), Lawrence O. Gostin (Georgetown University – Law Center – O’Neill Institute for National and Global Health Law) and Ira Shoulson (Georgetown University)

ABSTRACT: 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. To date, the subject has received considerable attention in the media and scientific literature, however focused mainly on philosophical arguments. 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.

This report examines the legal issues that may pose barriers to data sharing. The report provides a helpful guide to those in the biomedical community who wish to engage in data sharing. In each section, the authors provide an overview of the legal issue, including the statutes and other background, and suggest approaches for surmounting legal issues.

Note: The report was researched and written by collaborators from the O’Neill Institute for National and Global Health Law at Georgetown University Law Center, and the Georgetown University Medical Center. The effort was supported by the Georgetown University Center of Excellence in Regulatory Science and Innovation (CERSI), a cooperative agreement (FD U01004319) funded by the U.S. Food and Drug Administration.