Documents reviewed organized by review-type

Type of Review	IRB staff provide primary reviewers (and reviewers using the expedited procedure) with the following materials either electronically or in paper form.Primary reviewers are expected to review these materials in depth in advance of the IRB meeting.	IRB staff provide all IRB members who are not primary reviewers with the following materials either electronically or in paper form.All IRB members are expected to review these materials in advance of the meeting in enough depth to be familiar with them and able to discuss them at the IRB meeting.
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Initial	o The Initial IRB Application form o Proposed consent document. o Recruitment materials. o The full protocol. o Any relevant grant applications. o The investigator’s brochure (when one existed). o The DHHS-approved sample informed consent document (when one exists). o The complete DHHS-approved protocol (when one exists).	o The Initial IRB Application form o Proposed consent document. o Recruitment materials.
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Continuing	o The Initial IRB Application form o The Continuing Review IRB Application form o The current consent document. o Any newly proposed consent document. o The complete protocol including any protocol modifications previously approved by the IRB.	o The Initial IRB Application form o The Continuing Review IRB Application form o The current consent document. o Any newly proposed consent document.
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Amendments	o Amendment application o All modified documents	o Amendment application o All modified documents

Source: Office for Human Research Protections (OHRP), Department of Health and Human Services, Guidance on Written IRB Procedures, July 11, 2002