Who owns the data in clinical trial?

Sci Eng Ethics. 2002 Jul;8(3):407-11. doi: 10.1007/s11948-002-0062-x.


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.

MeSH terms

  • Clinical Protocols*
  • Confidentiality*
  • Humans
  • Informed Consent*
  • Intellectual Property*