Version 03/01/08
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No change will be made to the approved protocol or methodology.
I request a change to the approved protocol or methodology (see attached IRB Addendum/Modification
Request Form)
Participant risk has not increased during the current IRB approval period and is not expected to increase
during the continuation period.
Participant risk has increased during the current IRB approval period and is now being reported to the
IRB on the attached IRB Adverse Event/Unanticipated Problem/Increased Risk Report Form.
No adverse affects or unanticipated outcomes occurred during the current IRB approval period.
Adverse affects or unanticipated outcomes occurred during the current IRB approval period as previously
reported to the IRB on the IRB Adverse Event/Unanticipated Problem/Increased Risk Report Form.
Adverse affects or unanticipated outcomes occurred during the current IRB approval period and are now
being reported to the IRB on the attached IRB Adverse Event/Unanticipated Problem/Increased Risk
Report Form.
Participants withdrew and/or complaints were received about the research during the current IRB
approval period (see attached Participant Withdrawal/Complaint Report Form).
Participants were informed of project findings during the current IRB approval period and no re-consent
was needed.
Participants were informed of project findings during the current IRB approval period and re-consent was
needed because the findings may have affected their decision to participate.
I request a change to the informed consent process (see attached Participant Informed Consent Form)
Submission instructions:
• This form and any applicable forms and documents should be completed and submitted to the IRB Chair
both electronically (attached to an email) and in hard copy.
• The subject line for the email should say “IRB continuing review [insert last name of PI].”
• The form must be submitted electronically in Microsoft Word or Adobe Acrobat (pdf) format; additional
documents may be submitted electronically in Word, Excel, or Adobe Acrobat (pdf) format.
• Signatures are not required on the electronic version of this form, however the review process will not begin
until the signed hard copy and all appropriate additional documents are received.
Allow a minimum of three weeks for the review and approval process. A form will be mailed to the PI indicating one of
the following determinations:
• The research is exempt from IRB review.
• The research is eligible for expedited review and has been approved.
• The research is eligible for expedited review and has been disapproved.
• The research is eligible for expedited review but requires modifications before approval can be given.
• The research is subject to full review and will be discussed at the next scheduled IRB meeting.
If you have any remaining questions about Valencia’s IRB process, contact the IRB Chair at
irb@valenciacc.edu .
THANKS!
______________ ___________________ ________________ ________________
Date Received Date Distributed to IRB Date of IRB Vote IRB Determination
by IRB Chair or (if applicable) (if applicable)
Designated Rep ________________
IRB #
