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Submission Process

All research projects that involve human subjects must have approval from the Institutional Review Board (IRB). Examples of research are surveys, interviews, observations of activities or behaviors, exercise tests, blood or other tissue collections, psychological or medical measurements or intervention and sensory responses. In addition, any research involving responses from people or access to records about people must be reviewed.  Research studies involving human subjects are reviewed in one of three ways:  exempt review, expedited review and full board review.

The process for applying for IRB approval begins with a request for application materials. This request is made by contacting the IRB Coordinator, who will send instructions to the principal investigator on completing the required forms.  In addition, the principal investigator may also download all application materials online from the IRB Forms page. Once the principal investigator has assembled the application paperwork, it should be submitted electronically to the IRB Coordinator.

  • The VCOM Institutional Review Board has plans to begin accepting electronic protocol submisions via IRBNet's electronic protocol management system. More information about this new submission process will be made available soon.

The IRB Chair, not the principal investigator, is charged with reviewing the application to determine the appropriate level of review for the research as well as assuring that all necessary documents are included.  The Coordinator will work closely with the principal investigator to ensure the appropriate forms are completed, and will assist with the preparation of other items that may be needed.

Step 1:  Prepare Research Protocol

In many cases, this can be the research plan of a grant application. Literature reviews, reference lists, etc are not required, but be sure that the protocol includes the following requirements:

  • A clear research hypothesis or study aims
  • Demonstration that the study design is appropriate to test the hypothesis or meet the aims
  • Explanation of the risks to the subjects and how they are reasonable in relations to benefits
  • Description of inclusion and exclusion criteria as well as protections in place for any subjects considered vulnerable
  • Procedure outlining informed consent process
  • Description of safeguards in place to ensure subject privacy and confidentiality

Step 2: Complete the IRB Application Form

The IRB Application Form requires summary information from the research protocol, and lists supplemental documents that may be required for submission. In addition to the IRB Application Form, one of the following forms must be completed depending upon the level of review required:

  • Form A:  Full-board review request, or
  • Form B:  Expedited review request or
  • Form C: Exemption request.

Questions on what level of review a protocol requires can be directed to the IRB Coordinator.  Information on what constitutes expedited review or exemptions from research can be found on the Resources for Investigators page.

Step 3:  Review Requirements and Develop Informed Consent Form

The Resources for Investigators page includes guidelines on developing a consent form, as well as components of informed consent, information on assent determination and sample consent forms. 

Under certain circumstances, a waiver of informed consent is justified. Form F: Application for Waiver/Alteration of Informed Consent form should be completed and included should this be applicable to the study.

Step 4:  Complete Additional Documents as Required

Additional forms and information that may be required include:

  • Surveys / data collection instruments
  • Brochure / recruitment materials
  • Approval letters from cooperative IRBs at other sites

Step 5:  Complete Training Requirements

All personnel involved in the research, including data analysts, lab assistants, etc., must complete and pass all CITI Protection of Human Research Subjects course.  This course is comprised of different modules each with a separate test that must be taken. Once all modules have been taken and tests passed, a completion report can be printed.  This report must be submitted as part of the application packet. A step by step presentation on registering on CITI is available on the Required Education page. VCOM IRB also currently accepts certifications from the NIH’s Protecting Human Research Participants course in lieu of CITI certification.

Once all steps are complete, the application packet should be sent to the IRB Coordinator via email: dgeiger [at] vcom.vt.edu. For further information, please call 540-232-8425.