Version Date 01/22/2013 1 INSTITUTIONAL REVIEW BOARD 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. Do not change the margins of this form. All margins are set to 0.75 inches. 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 IRB # Date of Original IRB Approval Title Investigator(s) 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 review.) 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 review. 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 2 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 research. 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 begun. Recruitment is open. Procedures involving interaction or intervention with participants have begun. Recruitment is closed. Procedures involving interaction or intervention with participants have begun. 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 above. 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 3 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. Ethnicity Native American or Pacific Gender Asian Black Hispanic Alaskan Islander White Other Total Male Female Transgender 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 immediately.