VCU Initial Submissions

All initial submissions are submitted in the RAMS-IRB electronic system. RAMS-IRB is available here.

See below for information pertinent to specific study types.

Exempt Initial Submissions

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.

  • Upload all supporting study documents such as:
    • Information sheets to inform participants about the research activity
    • Recruitment materials
    • Survey instruments and interview questions
  • 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
  • Who to contact with questions (generally the principal investigator)
  • Note any compensation to participants

Expedited Initial Submissions

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.

  • Upload all supporting study documents such as:
    • Informed consent form(s)
    • Recruitment materials
    • Survey instruments and interview questions
    • Grant proposal, if applicable
  • 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 Initial Submissions

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