Oregon Health Authority
Public Health Division - Chapter 333
Division 25
GENETIC INFORMATION AND PRIVACY
333-025-0110
Institutional Review Boards (IRBs) and Approval for Research
(1) An IRB must conform to the organizational and operational standards contained in the Federal Common Rule.
(2) All proposed genetic research, including anonymous research, or research otherwise exempt from IRB approval, must first be submitted to an IRB for explicit prior approval or an explicit determination that the research is anonymous or otherwise exempt.
(3) A researcher must disclose to the IRB the intended use of human DNA samples, genetic tests or other genetic information for every proposed research project, including anonymous or otherwise exempt research.
(4) A researcher must follow the requirements of OAR 333-025-0115 and 333-025-0120 and provide assurances to the IRB that these requirements have been met.
Statutory/Other Authority: ORS 192.547
Statutes/Other Implemented: ORS 192.533 & 192.547
History:
PH 21-2005, f. 12-30-05, cert. ef. 1-1-06
PH 9-2004, f. & cert. ef 3-23-04
PH 16-2003(Temp), f. & cert. ef. 10-27-03 thru 4-16-04
OHD 14-2002, f. & cert. ef. 9-27-02