The Oregon Legislature enacted genetic privacy laws in response to concern about genetic privacy in the areas of insurance, employment and research. The laws were amended in 2003. Genetic research can be of two kinds: either anonymous research (or research otherwise exempt from Institutional Review Board approval), or non-exempt research. Any researcher who proposes to conduct genetic research, including anonymous research, must submit the research to an IRB for a determination that the research is anonymous or for approval if the research is not exempt.
The Administrative Rules enacted by DHS to implement the statutes on Genetic Privacy require all genetic research, whether anonymous, exempt or otherwise, to be submitted to an IRB for explicit approval or explicit determination that the research is exempt. The researcher is responsible for obtaining informed consent for non-exempt genetic research and for assuring the IRB that the requirements of the genetic research rules have been met. If the genetic information or biological sample is obtained after June 25, 2001, it may only be used by the researcher with the specific informed consent of the research subject.
See our Genetic Privacy Definitions page for more information about terminology.
The statutes include specific previsions for:
- Anonymous or Exempt Research
- Non-Exempt Research
- Recontact of Research Subjects
- Retention, Inspection, and Disclosure of Genetic Information
- Remedies for Violation
If your human subjects research project will involve genetic testing or genetic information, include Appendix E with your submission. If your project is otherwise not human subjects research but it involve genetic information and testing, a submission will be required in the RAP to ensure state law requirements are met. We have a separate human subjects determination form for projects involving genetic testing or genetic information. See our Applications, Forms and Guidance website for submission materials.