Abstract
Data gathered by investigators are used to test the validity of a specific scientific hypothesis. When the hypothesis relates to the biology of a disease or its treatment, then data sets may contain specific and identifiable medical information. Since the information in a clinical data set was gathered to test a specific hypothesis and there is usually a sponsor interested in the outcome, the issue of who owns the data is a critical one. In my opinion, data from both publicly and privately funded research should be made available, in a format that protects confidentiality and intellectual property rights, to interested and responsible parties within a reasonable period of time after publication.
Similar content being viewed by others
References
Kulynych J., Korn D. (2002) The effect of the new federal medical-privacy rule on research. N Engl J Med 346(3): 201–204.
Carney P.A., Geller B.M., Moffett H., Ganger M., Sewell M., Barlow W.E., et al. (2000) Current medicolegal and confidentiality issues in large, multicenter research programs. American Journal of Epidemiology 152(4): 371–378.
Davidoff F., DeAngelis C.D., Drazen J.M., Nicholls M.G., Hoey J., Hojgaard L., et al. (2001) Sponsorship, Authorship, and Accountability. N Engl J Med 345: 825–826.
Miller H.G., Baldwin W.H. (2001) A terse amendment produces broad change in data access. American Journal of Public Health 91(5): 824–825.
Marshall E. (2002) Clear-cut publication rules prove elusive. Science 295(5560): 1625.
Author information
Authors and Affiliations
Corresponding author
Additional information
J. M. Drazen is Editor-in-Chief of The New England Journal of Medicine and Professor of Medicine at Harvard Medical School.
Rights and permissions
About this article
Cite this article
Drazen, J.M. Who owns the data in a clinical trial?. SCI ENG ETHICS 8, 407–411 (2002). https://doi.org/10.1007/s11948-002-0062-x
Issue Date:
DOI: https://doi.org/10.1007/s11948-002-0062-x