The Department of Health and Human Services federal regulations (45 CFR 46) define three types of IRB review levels. When submitting to the IRB, the VCU investigator makes the initial determination of what type of review a study may qualify for. Upon review of the research, the IRB makes the final determination.
All initial submissions are submitted in the VIRBs (VCU IRB system). VIRBs is available here. For guidance on navigating the VIRBs system, see the New IRB review system: VIRBs (VCU IRB system) page, or check out the VIRBs demos and training videos. For general guidance on getting started with an IRB submission, see our Getting started page.
See below for information pertinent to specific study types.
Exempt review
The HHS and FDA regulations identify categories of research that are exempt from the regulations, although the ethical principles of study conduct still apply. Even though the research may be exempt, at VCU the determination of exemption must be made by the IRB.
The IRB refers to the HRP-312 - WORKSHEET - Exemption determination when making determinations of exemption. The HRP-103 - Investigator manual outlines expectations related to exempt studies, including consent information for exempt research. At this time, VCU is NOT implementing exemption categories 7 and 8.
OHRP decision charts: Does my study qualify for exemption/which exempt category applies?
Exempt research studies are reviewed to ensure that all research activities of the study fit into one or more of the exempt research categories (see above) and are no greater than minimal risk. Research that is determined to be exempt is not regulated by the DHHS or FDA regulations for conducting human subject research. However, all exempt studies should be conducted in accordance with the Belmont Principles for ethical research, and in accordance with institutional standards and requirements.
- Upload all supporting study documents such as:
- Information sheets to inform participants about the research activity
- Recruitment materials
- Survey instruments and interview questions
- Principal Investigator CV/Biosketch (and, if applicable, CVs/Biosketches for lead student investigators)
- Be sure all submitted documents include version numbers and/or dates in the footer. When documents are changed, a new version number and/or date should be applied. This helps the IRB track approved versions most efficiently.
Because exempt research is not regulated by federal requirements, informed consent is not required. VCU does, however, require some sort of information sheet be shared with prospective research participants. The information sheet may be brief and may or may not include all of the consent elements. At minimum, it should address:
- The activity involves research
- Participation is voluntary
- Brief description of what participants will be doing
- Whom to contact with questions (generally the principal investigator)
- Note any compensation to participants
Expedited review
Expedited review means that the review can be done by a single qualified IRB member rather than at a convened IRB meeting. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When reviewers cannot approve the research under expedited review, the study is referred for full board review.
To qualify for expedited review, research must be no greater than minimal risk and involve only procedures described by specific categories identified in the federal regulations.
The IRB refers to the HRP-313 - WORKSHEET - Expedited review when using the expedited review pathway. The HRP-103 - Investigator manual outlines expectations related to expedited studies.
Expedited research means a study may be reviewed by a single IRB member, rather than by the convened IRB, if all research activities of the study fit into one or more of the expedited research categories (see above) and are no greater than minimal risk. Expedited review does not necessarily mean the review will occur more quickly than other types of review.
- Upload all supporting study documents such as:
- Informed consent form(s)
- Recruitment materials
- Survey instruments and interview questions
- Grant proposal, if applicable
- Principal Investigator CV/Biosketch (and, if applicable, CVs/Biosketches for lead student investigators and/or medically/psychologically responsible investigators)
- Be sure all submitted documents include version numbers and/or dates in the footer. When documents are changed, a new version number and/or date should be applied. This helps the IRB track approved versions most efficiently.
Full board review
Full board review means that the research is reviewed at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. This type of review applies to studies that are greater than minimal risk, or minimal risk but do not qualify for exempt or expedited review.
Full board review is conducted by the convened IRB. Studies that require full board review are those that are greater than minimal risk and/or do not qualify for an exempt or expedited research category.
Full board studies undergo an administrative pre-review process prior to IRB review. Following completion of pre-review, studies are forwarded to a convened panel for IRB review.
- Upload all supporting study documents such as:
- Informed consent form(s)
- Recruitment materials
- Survey instruments and interview questions
- Multi-center study protocol
- Grant proposal, if applicable
- FDA regulatory documents, if applicable
- Principal Investigator CV/Biosketch (and, if applicable, CVs/Biosketches for lead student investigators and/or medically/psychologically responsible investigators)
- Be sure all submitted documents include version numbers and/or dates in the footer. When documents are changed, a new version number and/or date should be applied. This helps the IRB track approved versions most efficiently.
Contact us
Please use the following contact information for:
- Reporting for single patient access and emergency uses of FDA regulated products, or
- General questions and questions related to IRB submissions
Questions related to single IRB, reliance agreements and/or external IRBs:
For individual staff email addresses, please see Contact us page for staff directory