Institutional Review Board (IRB)

An Institutional Review Board (IRB) is charged with protecting the rights and welfare of people involved in research. The IRB reviews plans for research involving human subjects to assure, both in advance and by periodic review, appropriate steps are taken to protect the rights and welfare of human subjects in the research study. To accomplish this purpose, IRBs review research protocols and related materials (e.g., consent forms, recruitment material, investigator brochures) to ensure the rights and welfare of human research subjects are protected.

Institutions that accept research funding from the federal government must have an IRB to review all research involving human subjects (even if a given research project does not involve federal funds). The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) set the guidelines and regulations governing human subjects research and IRBs.

Non-Research Determination

This section includes Quality Improvement Projects, Case Report/Series Projects, and other activities not considered "research".

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Start a New Research Study

This section includes a step-by-step Guide to Starting a Research Study at Virginia Mason.

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Projects with No Human Subjects

This section includes regulations and information about Human Subjects and projects with no Human subjects.

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Use of External IRBs

This section includes information regarding the use of External IRBs, Overarching Cooperative Agreements, Cooperative Guidance and Templates, and more.

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Consent Information

This section includes templates, forms, and guidance information for obtaining informed consent.

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Additional Resources

This section includes additional resources including Guidance, templates, and forms.

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