Anonymous Genetic Research

The law generally requires informed consent to obtain genetic information, subject to certain exceptions. One of the exceptions is for anonymous genetic research, which requires notification to or consent from the research subject.

Subsequent statutes direct the Department of Human Services to adopt rules to implement a notification requirement for anonymous research subjects. Anonymous research must be determined by an Institutional Review Board to be exempt from review requirements.

Under the Administrative Rules, the researcher must demonstrate that the research subject was notified that anonymous research might take place in the future and, at the time of notification, did not request that the sample be withheld from the anonymous research. Multiple notifications are permitted, but at least one notification is required. Any notification must include a general description of the type of sample intended to be used, a general explanation of the meaning of anonymous research, and an opportunity for the subject to withhold the sample from the anonymous research (OAR 333-025-0120(3 & 4)).