Continuing Review Form for Nonexempt Studies Involving Human

UW Oshkosh Office of Sponsored Programs and Faculty Development INSTITUTIONAL REVIEW BOARD (IRB) CONTINUING REVIEW FORM FOR NONEXEMPT STUDIES

Federal law requires that all nonexempt research projects approved by the IRB be monitored annually. Please complete this form and submit to: [email protected] . If you have completed your project, please indicate below. Projects not updated by the project anniversary date will be closed administratively. All data collection must stop until you receive IRB approval to continue beyond the original project approval period.

Principal Investigator (PI): ______Co-PI (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.

Last updated: 10/24/17 CONTINUING REVIEW FORM Page 1 of 3 UW Oshkosh Office of Sponsored Programs and Faculty Development 2. Have any new or additional risks to participants been identified since the last IRB review? If yes, please explain:

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 (Part I) * Please attach training certificate for new PI. Please submit a Research Personnel Addition Form for all additional research personnel not serving as PI or Co-PI for administrative review. 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. How will the proposed changes have an impact on the risks or benefits to research participants? ______

5. I agree to conduct the project in accordance with federal IRB regulations and all relevant institutional policies. I will not implement the above changes until IRB approval is granted. Signature: An electronic signature is acceptable when submitting to [email protected] from a UW Oshkosh email account.

Signature of Principal Investigator Date

Signature of Faculty Advisor (if applicable) Date IRB Use Only Below IRB Office Use Only:

Last updated: 10/24/17 CONTINUING REVIEW FORM Page 2 of 3 UW Oshkosh Office of Sponsored Programs and Faculty Development Date: Status: Closed Project Extension Requested Modification Requested Original type of Protocol Review: IRB Staff (Exempt) Expedited (Non-exempt) Full Board (Non-exempt)

Comments:

Last updated: 10/24/17 CONTINUING REVIEW FORM Page 3 of 3