INSTITUTIONAL REVIEW BOARD (IRB)
CONTINUING REVIEW FORM FOR NONEXEMPT STUDIES INVOLVING HUMAN PARTICIPANTS
Federal law requires that all nonexempt research projects approved by the IRB be monitored at least annually. Please
complete this form and submit to: irb@uwosh.edu or Office of Grants and Faculty Development, 214 Dempsey Hall. If
you have completed your project, please indicate this so that we can designate your project as closed.
Please return this completed form prior to your project anniversary date:
Projects not updated by the project anniversary date will be designated as inactive and approval will be suspended. All
data collection must stop until you receive IRB approval to continue beyond the original project approval period.
Principal Investigator (PI):
Faculty Advisor (if applicable):
Protocol #:
Project Title:
Protocol Approval Period:
Start Date:
End Date:
Please check one of the following:
Study was never conducted. Please close the file. (Sign form)
Study is completed. Data analysis is complete or limited to non-identifiable human subject’s data. Please close the
file. (Answer questions in Section A and sign form)
Study has been closed to enrollment of participants and all research interventions have been completed. I would like
to request a (1) year extension for
long term follow up of participants OR
data analysis of identifiable human
subjects data. (Answer questions in section A & B and sign form)
Study is still in operation, and I would like to request a (1) year extension for this study with no revisions to the
approved protocol. (Answer questions in Section A & B and sign form )
Study is still in operation, and I would like to request a (1) year extension and modification for this study. (Answer
questions in Section A, B, & C and sign form)
Section A: Study Summary (This section is required for ongoing and completed projects)
1. How many participants have been enrolled in the study to date?
2. How many participants were indicated in the original intended
sample size (Part III.2.e IRB application)?
3. Were there any complaints by study participants? If yes, explain:
4. Were there any adverse or unanticipated events? If yes, explain:
(Note: All adverse or unanticipated events must be reported to the IRB within 72 hours of the event. Please submit an
Adverse Event or Unanticipated Problem Form found at www.uwosh.edu/grants/forms )
5. Where are the data stored?
Section B: Extension Request (Please fill this section out if you wish to request an extension of IRB approval)
1. Please provide a narrative summary of the study progress to date. Please attach all current study documents
(protocol, consent forms, questionnaires, surveys, etc.) approved by the IRB when submitting this form.
2. Have any new or additional risks to participants been identified since the last IRB review? If yes, please explain:
Last updated: 07/16/14
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Section C: Modification Request (Please fill this section out if you wish to request any changes to your protocol)
1. Please review your approved protocol and check ALL of the categories of amendments you are requesting:
Change in Study Title (Part I)
Change in Principal Investigator or research personnel (Part I) * Please attach training certificate for new personnel
Change to research design, methods, or procedures (Part II. 1-4, Part V. 1-6) *Please attach revised instruments
Change in research site(s) (Part II. 5) *Please attach letters of support from each new site
Addition of or change to study population (Part III. 1-5) *Please attach any revised instruments
Addition of or change to recruitment (Part IV. 1-4) * Please attach copy of recruiting materials or script
Change in deception (Part VI.) * Please attach debriefing form
Change to benefits, incentives, or compensation procedures (Part VII. 1-4) *Attach any revised documents
Addition of or change in risks to participants (Part VIII. 5-7) *Attach any revised documents
Addition of or change to informed consent/assent procedure and documents (Part VIII) *Please attach documents
Addition of or change to the identifiers collected in the study, or any other information that would impact the
privacy and confidentiality of the study participants (Part IX)
Addition of or change to survey(s), questionnaire(s), or other research instruments *Please attach revised instruments
2. Please describe the change(s) that you are proposing. Please address all of the questions in each
Part/section of your current application, as checked above, to provide sufficient information for the IRB to
review the request.
3. Please justify the reasons you are requesting the changes.
4. Are any of the proposed changes the result of something that occurred during human participant interaction
or an unanticipated event?
Yes
No
If yes, please explain:
(Note: All adverse events or unanticipated events must be reported to the IRB within 72 hours of the event. Please submit an Adverse Event or
Unanticipated Problem Form found at www.uwosh.edu/grants/forms)
5. How will the proposed changes have an impact on the risks or benefits to research participants?
6. Do these changes involve information that might relate to a subject’s willingness to continue to take part in
the research?
Yes
No
I agree to conduct the project in accordance with federal IRB regulations and all relevant institutional
7.
policies. I will not implement the above changes until IRB approval is granted.
Signature: An electronic signature is acceptable when submitting to irb@uwosh.edu from a UW Oshkosh email account.
The
Faculty Advisor is the person ultimately responsible for student projects and may complete the form if a student is unreachable.
Signature of Principal Investigator
Date:
Date
Signature of Faculty Advisor (if applicable)
IRB Use Only Below This Line
Status:
Closed
Project Extension Requested
Original type of Protocol Review:
IRB Staff (Exempt)
Expedited (Non-exempt)
Date
Modification Requested
Full Board (Non-exempt)
Comments:
Last updated: 07/16/14
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