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Version Date 01/22/2013
FWA: 00007392 | IRB: 0004173
2043 College Way | UC Box A-133 | Forest Grove, OR 97116
P: 503-352-1478 | F: 503-352-1447 | E: [email protected] | W: www.pacificu.edu/irb
Post-Approval Requests
Please read all information and follow the instructions as precisely as possible. All text in red is
explanatory. Please delete it after filling out this form.
Do not remove or change the heading. Leave the version date as it is. This corresponds to the date
the form was last updated by the IRB.
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Do not change the font (12 point, Times New Roman) used in this form.
Do not remove any section or question from this form. If something does not apply, please state so.
1. File Identifiers
Date of Original IRB Approval
Faculty Advisor(s)*
*A faculty advisor is required for student investigator research.
2. Purpose of Request
Continuing Review
(For use with expedited and full board studies only. Exempt studies do not require continuing
Modification to Approved Protocol
(For use with all studies.)
Project Closure
(For use with all studies. If this option is selected, and plans for additional analyses or reports
based on identifiable or linked (coded) data or specimens collected during this project develop, a
new research proposal requesting the use of this data must be prepared and submitted for IRB
Analyses and reports may continue on all de-identified data or specimens without further IRB
purview. For data to be de-identified, the identity of a subject cannot be readily determined by
an investigator or associated with a subject’s information (45 CFR 46.102(f)). Examples of
individually identifiable information that must not be used include (but are not limited to):
names, birth dates, identification numbers (e.g., Social Security cards, driver’s licenses, etc.),
full-face photographs, street addresses, phone numbers, and email addresses. If you are unsure
of these requirements, contact the IRB. (If you have informed consent and release forms
associated with de-identified data, send them to the IRB. The IRB will archive these forms and
restrict investigator access to them to ensure de-identification.))
Version Date 01/22/2013
All recruitment, procedures, data collection, and follow-up with participants have been
completed, and all data have been cleaned. (Data cleaning refers to identifying incomplete,
incorrect, inaccurate, and irrelevant parts of the data and then replacing, modifying, or
deleting them.)
All recruitment, procedures, and data collection pertaining to this project never began.
3. Campus Location of Signed Forms
Please record the campus location of the signed informed consent and release forms for your study.
Remember that all signed forms must be kept on file for three years beyond the conclusion of your
If submitting a project closure request, Sections 4-7 do not apply. Enter N/A and continue on to
Section 8.
4. Project Status
Recruitment is open. Procedures involving interaction or intervention with participants have not
Recruitment is open. Procedures involving interaction or intervention with participants have
Recruitment is closed. Procedures involving interaction or intervention with participants have
Recruitment is closed. Procedures are complete. Data analysis and reporting are ongoing.
Please describe the status of your ongoing project here in addition to checking the appropriate box
5. Timeline Changes
Please describe any changes to your timeline, especially if they are in relation to your project end
date (month and year). Keep in mind that regardless of your anticipated end date, this project can
only be approved in one-year increments.
6. Personnel Changes
If there have been any additions to personnel working with participants or having access to study
data, provide the name, contact information, relevant credentials, and NIH certificate for each.
7. Brief Outline of Proposed Changes and Influence on Participant Risk Exposure
Using lay language, briefly summarize the purpose of the proposed changes to your project. Identify
specifically whether and how the requested modifications will change participant risk. If some
participants have completed the study procedures, disclose whether the anticipated risks (i.e., the risk
assessment made in the originally-approved proposal) were accurate and whether the original risk
assessment should be changed to reflect the reality.
8. Progress and Findings
Version Date 01/22/2013
Summarize your progress and findings to date. Provide a copy of each report and/or manuscript
disseminated based on these data since the last review. If no data have been gathered and/or
analyzed, state this explicitly.
9. Participants
a. If possible, provide the following demographic information for the study participants.
American or Pacific
Asian Black Hispanic Alaskan
White Other Total
b. State the number of participants who completed the study procedures.
c. Report and provide a brief explanation for any excluded or terminated subjects.
i. Tally and provide a brief explanation for any subjects who withdrew.
Provide a brief explanation here.
ii. Tally and provide a brief explanation of any subject complaints.
Provide a brief explanation here.
State the number of new participants anticipated during the next phase of the
d. study.
e. Disclose any new findings pertinent to the informed consent.
Federal policy requires investigators to inform participants of new findings (from this or other
work) that might affect their willingness to participate in this research. If this consideration is
relevant, submit a brief explanation and the appropriately revised informed consent materials.
10. Incident Reports
If an anticipated, unanticipated, serious, or continuing incident occurred, explain the nature of the
incident and how you handled it. Please reference the “Incident Reports – Adverse Events, Issues of
Noncompliance, and Unanticipated Problems” form you submitted to the IRB at the time the
incident occurred. If you did not submit this form at the time the incident occurred, do so