Legacy Research Institute

Transforming medical care through science, technology, and innovation.

LEGACY INSTITUTIONAL REVIEW BOARD

Ensuring the safety and ethical treatment of patients taking part in research projects at Legacy.

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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. Legacy IRB is also available on a contract basis for the review and approval of single-site research involving human subjects for external organizations.

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 three IRBs, one meets at Legacy Good Samaritan Medical Center, one at Legacy Emanuel Medical Center, and one at the Research Institute; all three 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

Updated 3/30/2020: New guidance re: COVID-19 effect on new and ongoing research

COVID-19 Final Guidance 3-30-20

Documents:
Legacy IRB Policy
Standard Operating Procedures
External Researcher Collaboration Policy
Read Me - Investigators
Read Me - Sponsors

 Forms Form Download Instructions Version date
 Form A - Initial Review Application (.docx) Form A - download   2014
 Form B - Retrospective Chart Review (.docx) Form B - download Form B instructions 6/1/2021
 Form E - Continuing Review (.docx) Form E - download Form E instructions 1/1/2021
 Form F - Modifications or Changes (.docx) Form F - download Form F instructions 6/1/2021
 Form H - Protocol Deviation/Violation Report (.docx) Form H - download Form H instructions 6/1/2021
 Form I - Adverse Event/Serious Adverse Event Report (.docx) Form I - download Form I instructions 6/1/2021
 Model Consent form (.docx) Model Consent download    
 Closure Form (.docx) Closure Form download