All initial submissions are submitted in the RAMS-IRB electronic system. RAMS-IRB is available here. For guidance on navigating the RAMS-IRB system, see the RAMS-IRB guide for researchers. For general guidance on getting started with an IRB submission, see the Getting Started Guide.
See below for information pertinent to specific study types.
Exempt research studies are reviewed to ensure that all research activities of the study fit into one or more of the exempt research categories. Research that is determined to be exempt is not regulated by the DHHS or FDA regulations for conducing human subject research. However, all exempt studies should be conducted in accordance with the Belmont Principles for ethical research.
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:
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 and are no greater than minimal risk. Expedited review does not necessarily mean the review will occur more quickly than other types of 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.