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.
- 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.