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Or. Admin. R. 333-025-0120 - Anonymous, Coded, or Exempt Genetic Research

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A human biological sample or clinical individually identifiable health information may be used in anonymous or coded genetic research only if, prior to the time the research is conducted, one of the following occurred:

  • The subject gave informed consent for the project;
  • The subject gave consent for general genetic research;
  • The subject was informed that his information could be used for such research and did not request that it be withheld; or
  • An Institutional Review Board waived/altered the consent or authorization requirements

In addition to the above requirements, genetic research in which the DNA sample or genetic information is coded must satisfy the following requirements:

  • The research has been approved by an Institutional Review Board
  • The code is not derived from individual identifiers, is kept securely and separately from the DNA samples and genetic information and is not accessible to the investigator, unless specifically authorized by the IRB;
  • The data is stored securely in password protected electronic files, or by another means with access limited to necessary personnel;
  • The data is limited to elements required for analysis and is a limited data set; and
  • The investigator is a party to a data use agreement with any limited data set recipient

Current as of June 2015