LEGACY INSTITUTIONAL REVIEW BOARD
Ensuring the safety and ethical treatment of patients taking part in research projects at Legacy.
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.
Send all new studies, modifications, deviations, adverse event reports, other requests and correspondence to email@example.com.
Updated 3/30/2020: New guidance re: COVID-19 effect on new and ongoing research
|Forms||Form Download||Instructions||Version date|
|Form A - Initial Review Application (.docx)||Form A - download||Form A instructions||7/15/2022|
|Form B - Retrospective Chart Review (.docx)||Form B - download||Form B instructions||7/19/2022|
|Form D - Exemption Request Form||Form D - download||7/19/2022|
|Form E - Continuing Review (.docx)||Form E - download||Form E instructions||7/19/2022|
|Form F - Modifications or Changes (.docx)||Form F - download||Form F instructions||8/4/2022|
|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||7/19/2022|
|Form K - Study Closure Form (.docx)||Form K - download||Form K instructions||7/19/2022|
|Protocol Template - with instructions (.docx)||Protocol Template||May 2022|
|Model Consent form (.docx)||Model Consent download|
For additional information, please contact Paul Newton, JD, Senior Research Regulatory Specialist.
Telephone: (503) 413-5355