Oregon Oregon Health Authority, Public Health Division

Rule Rule 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 (Informed Consent for Non-Exempt Genetic Research) and 333-025-0120 (Anonymous, Coded, or Exempt Genetic Research) and provide assurances to the IRB that these requirements have been met.
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Last accessed
Jun. 8, 2021