IRB Submission Guide (352 KB)

CITI Training Registration Guide

VCOM IRB Forms (Word Docs)

• IRB Application Form
• Assent Form
• Form A, Full Review Request
• Form B, Expedited Review Request
• Form C, Exemption Request
• Form D, Progress/Final Report Form
• Form E, Adverse Event/Unanticipated Problem Report
• Form F, Application for Waiver/Alteration of Informed Consent
• Post Approval Monitoring Form

Consent Guidelines (Word Docs)

• Informed Consent Guidelines
• Sample Consent Outline
• Informed Consent Checklist

OHRP Charts & Guidance

• Expedited Categories of Review
• OHRP Guidance on Expedited Review
• Exempt Categories (see 101.b)
• OHRP Human Subject Decision Charts
• OHRP Policy and Guidance (Help Topics)
• OHRP Human Subjects Guidebook

Other Resources

• NIH’s Page on Human Subjects
• Human Subjects in NIH Research Plan
• Ethical Guidlines for Health Services Research
• Human Subjects Research Brochure

The VCOM Institutional Review Board (IRB) is responsible for protecting the rights and welfare of the human subjects in research conducted by faculty at the Institution. The VCOM IRB reviews all human subjects research projects conducted by VCOM faculty and staff.

VCOM is committed to protecting the rights and ensuring the safety of human subjects participating in research at the College.  This commitment is guided by the ethical principles described in the Protection of Human Subjects of Biomedical and Behavioral Research entitled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, often referred to as the Belmont Report. Furthermore, VCOM’s commitment is also guided by the federal regulations 45 CFR 46, 21 CFR 50, and 21 CFR 56.

This commitment is vested in the VCOM IRB for Research Involving Human Subjects, which operates under a Federalwide Assurance on file with the OHRP, a subdivision of the DHHS.  All research at the College involving human subjects, regardless of funding source, is under the authority of the VCOM IRB.  VCOM’s IRB is also registered at OHRP.  More information on federal regulations can be found at the Office of Human Research Protections (OHRP) website: http://www.hhs.gov/ohrp/.

To fulfill the agreement underlying the assurances, and to satisfy institutional policy, all faculty and staff at the Institutions must submit for VCOM IRB review any human subject research project, regardless of funding source and/or location at which the research will be conducted.