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IRB Review Tools

Please note: The review guides posted on this page are for informational purposes only -- they are internal forms used by OPRS. These forms do not need to be completed by researchers.

UPDATED!(10/14/09) Review guides are tools used by IRB members and/or OPRS staff in the evaluation of each submission to the IRB. Each application form submitted by a PI to OPRS has a corresponding review guide.

UPDATED!(9/29/09) Tip sheets are reference materials used by IRB members and/or OPRS staff during review for regulatory guidance, as appropriate.

Review Guides

To access the review guides, open the PDF document and use the bookmarks to navigate through the document.
  • Health & Biomedical Sciences – Initial and Continuing Review
  • Social & Behavioral – Initial and Continuing Review
  • JBVAMC Health & Biomedical Sciences – Initial and Continuing Review
  • JBVAMC Social & Behavioral – Initial and Continuing Review
  • Expedited Addendum
  • Facilitated NCI CIRB – Initial and Continuing Review
  • Development Only Addendum
  • Amendment
  • JBVAMC Amendment
  • Exemption Eligibility
  • Determination of Whether an Activity Represents Human Research
  • Review of Modifications Required by the IRB
  • Protocol Exception to Previously Approved Research
  • Adults Unable to Consent
  • Pregnant Women Neonates Fetuses
  • Prisoners
  • Children
  • Wards
  • Humanitarian Use Device
  • Prompt Reporting (3)
  • Emergency Use of a Test Article (2)
  • Final Report

Tip Sheets

To access the tip sheets, open the PDF document and use the bookmarks to navigate through the document.
  • #1 Approval Criteria
  • #2 Data Monitoring
  • #3 Recruitment
  • #4 Reimbursement
  • #5 Informed Consent Document Elements
  • #6 Waiver/ Alteration of Informed Consent
  • #7 Waiver of Documentation of Informed Consent- OHRP
  • #8 Informed Consent Process
  • #9 FDA Exception to General Consent Requirements
  • #10 FDA Consent Requirements for Emergency Research
  • #11 Research Involving Children
  • #12 Pregnant, Fetuses, Neonates
  • #13 Prisoners
  • #14 Human Subjects Research Determination
  • #15 Exempt Criteria
  • #16 Expedited
  • #17 Prompt Reporting
  • #18 Non-Compliance
  • #19 VA Tissue Bank FAQs
  • #20 VA Approved Tissue Banking Sites
  • #21 VA Tissue Bank Informed Consent
  • #22 VA Consent Template Language
  • #23 Key Definitions Glossary
 

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