<p> Request for Determination: Planned Activity Does Not Involve Human Subjects OR is Not Research</p><p>Study Title: </p><p>Answer each of the following questions: 1. Will any information from this project be submitted to the FDA or held for inspection by the FDA? No Yes If Yes, STOP and contact the IRB at [email protected].</p><p>2. Are the data or specimens being studied in this project obtained in a systematic manner? No Yes </p><p>3. Is the intent of this data collection to contribute to ‘generalizable knowledge’ – that is the findings are applicable to sites outside the University of Pittsburgh / UPMC? No Yes </p><p> a. If No, and if this project is being conducted at a UPMC facility, has it been submitted to the UPMC QA/QI committee? No Yes Note: If you are submitting this project to the UPMC QA/QI committee, or a similar review committee, you need not complete this form.</p><p>4. Will the planned activity involve intervention or interaction with living persons (human subjects)? No Yes </p><p>5. Will the planned activity involve accessing (i.e., looking at or reviewing) identifiable private information? No Yes </p><p>6. Are the data coded in such that a link exists that could allow the data to be re-identified? No Yes </p><p>Page 1 of 2 OSIRIS_NHS_11.2011 If Yes, is there a written agreement that prohibits the PI and the research staff access to the link? No Yes </p><p>7. Are all records currently available for study? No Yes ; </p><p>If No, over what time period will they be collected, from what source, and who will collect them? </p><p> Note: If prospective collection occurs, to qualify for a ‘no human subjects’ determination under §46.102f, no member of the research team can interact with the subject whose information is being studied, and no identifiable private information can be reviewed or recorded.</p><p>1. Study Design and Methods: a. Summarize the planned activity for which you are seeking an IRB determination: </p><p> b. How will the project be conducted? </p><p> c. How will results be analyzed to determine that study aims have been met? </p><p>2. Types of information to be studied: a. What data will be accessed? </p><p> b. Describe PI’s right to access this data: </p><p> c. How and where were data collected originally (if applicable)? </p><p>3. Additional Information, Clarification, or Comments for the IRB Reviewer: </p><p>Page 2 of 2 OSIRIS_NHS_11.2011</p>