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Sci Eng Ethics. 2002 Jul;8(3):407-11.

Who owns the data in clinical trial?

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Harvard Medical School, Boston, MA, USA.


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.

[Indexed for MEDLINE]

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