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Legacy Institutional Review Board

The Legacy Institutional Review Board (IRB) is responsible for the review and approval of all research involving human subjects that utilize Legacy Health facilities, resources or patients. 

The IRB is a federally mandated board charged with protecting the rights and welfare of human research subjects recruited to participate in research activities and to ensure compliance with applicable Legacy Health policies, and federal and state regulations. It is responsible for reviewing, approving, and monitoring all research projects involving human subjects, and its members always include at least one participant whose primary concerns are in nonscientific areas.

At Legacy Health there are two IRBs, one that meets at Legacy Good Samaritan Medical Center and one that meets at Legacy Emanuel Medical Center; both IRBs can review research at any Legacy facility.

The origins of human subjects protection regulations are based on international standards such as the Nuremberg Code, the Geneva Convention and the Helsinki Accords. In the United States the regulatory framework was created with the drafting of the Belmont Report in 1978. Because of its involvement with the National Institute of Health, Legacy Good Samaritan Medical Center established an IRB in 1981 while Emanuel Medical Center established an IRB in the late 1980s due to its physician’s use of products regulated by the Food and Drug Administration (FDA).

Legacy Health maintains a Federal Wide Assurance with the Department of Health and Human Services’ Office for Human Research Protection (OHRP). This assurance (FWA 00001280) commits Legacy Health to comply with applicable federal regulations governing the conduct of all research involving human subjects and is reiterated at Legacy in administrative policy 100.18.

For additional information, please contact Paul Newton, JD, Senior Research Regulatory Specialist.
Telephone:  (503) 413-5355
Email: pwnewton@lhs.org

Documents:
Legacy IRB Policy
Standard Operating Procedures
Read Me - Investigators
Read Me - Sponsors
Model Consent Form (Word file)
IRB Questionnaire (Word file)
Retrospective Chart Review (Word file)
Adverse Event Form and SOP (Word file)
Amendment Modification (Word file)
Closure Form (Word file)
Registry Questionnaire (Word file)