Continuing Review of IRB Approved Expedited or Full Board Research

Expedited and full board research must be re-reviewed by the IRB at least annually through a continuing review process. Exempt research does not require continuing review. Well in advance of an expiration date, reminders are sent to investigators prompting preparation and submission of a continuing review package.

Studies expiring before April X, 2013 will undergo continuing review in a paper system. After that date, all currently approved research will submit continuing review documentation in RAMS-IRB. In order to be able to submit a continuing review in RAMS-IRB, a study must have gone through the conversion process to populate the electronic research plan with current protocol information.

Paper Submissions

  • IRB approval prior to expiration cannot be guaranteed if submissions are not received by stated deadlines.
  • Complete the Continuing Review Form. Occasionally the forms change. Make sure you are using the most up to date form by downloading directly from the forms page. A grace period of 30 days is allowed when forms are updated.
  • Include in the submission the latest approved version of:
    • Research Plan Template
    • Informed Consent/Assent form(s)
    • Study Personnel Roster
  • Include version numbers and/or dates in the footer of all documents. When documents are changed, a new version number and/or date should be applied. This helps the IRB track approved versions most efficiently.
  • When requesting changes to documents, submit A) the track changes version showing revisions, B) a clean copy of revised version, and C) the last approved version of the document.
  • Include a Summary of Progress with the continuing review submission. The Summary should address:
    • The number of subjects accrued
    • Adverse events and adverse outcomes experienced by subjects
    • Unanticipated problems involving risks to subjects or others
    • Explanation of any subject withdrawals
    • Complaints about the research
    • Any relevant recent literature
    • Any interim findings
    • Any relevant multi-center trial reports
    • Any change in risk-benefit assessment based on study results
  • Follow instructions on the continuing review form for other instructions about required submission information and documentation.
  • Signatures: The PI or a designee must sign the continuing review form
  • Number of Copies:
    • Expedited Review: 4 copies of all submission forms and supporting documents
    • Full Board Review: 25 copies of all submission forms and supporting documents; 4 copies of all documents if the research has not yet begun and no changes are being submitted with the continuing review
  • Submit all forms to:
  • VCU Office of Research Subjects Protection
  • BioTech Building One
  • 800 East Leigh Street, Suite 3000
  • Box 980568
  • Richmond, VA 23298

RAMS-IRB Continuing Review

  • Login to RAMS-IRB and open the workspace for the study needing continuing review
  • Complete a continuing review activity and upload relevant documentation such as DSMB reports.