OAR 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.

Source: Rule 333-025-0110 — Institutional Review Boards (IRBs) and Approval for Research, https://secure.sos.state.or.us/oard/view.action?ruleNumber=333-025-0110.

333‑025‑0100
Definitions 333‑025‑0105
Scope 333‑025‑0110
Institutional Review Boards (IRBs) and Approval for Research 333‑025‑0115
Informed Consent for Non-Exempt Genetic Research 333‑025‑0120
Anonymous, Coded, or Exempt Genetic Research 333‑025‑0125
IRB Registry 333‑025‑0130
Recontact 333‑025‑0135
Information Concerning Deceased Individuals 333‑025‑0140
Informed Consent Procedures for Obtaining Genetic Information 333‑025‑0145
Retention of Genetic Information for the Purpose of Identification of Deceased Individuals 333‑025‑0150
Retention of Genetic Information for the Purpose of Testing to Benefit Blood Relatives of Deceased Individuals 333‑025‑0155
Retention of Genetic Information for the Purpose of Newborn Screening Procedures 333‑025‑0160
Disclosure of Genetic Information: Procedure for Authorization of Disclosure by the Tested Individual or the Tested Individual’s Representative 333‑025‑0165
Disclosure of Genetic Information: Provider Notification and Opt Out

Last Updated

Jun. 8, 2021

Rule 333-025-0110’s source at or.us

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Location: https://oregon.public.law/rules/oar_333-025-0110

Original Source: Rule 333-025-0110 — Institutional Review Boards (IRBs) and Approval for Research, https://secure.sos.state.or.us/oard/view.action?ruleNumber=333-025-0110 (last accessed Jun. 8, 2021).