Request for No Human Subject or Not Research Determination

Principal Investigator:
Study Title:


  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 .
  1. Are the data being studied in this project obtained in a systematic manner? No Yes
  1. 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

If No; explain:

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.

  1. Does your project meet both of the following requirements? No Yes
  • No member of the research team has interacted, for research purposes, with the individuals whose information will be studied (Note: If any member(s) of this study team are/were affiliated with a research project you will obtain data from, you may not qualify for this determination.) AND;
  • No identifiable private information can be reviewed or recorded.

If no, this project does not qualify for a “no human subjects” determination.

  1. Summarize the planned activity for which you are seeking an IRB determination:
  2. How will the project be conducted?
  3. Types of information to be studied:

a.What data will be accessed?

b.Describe study team’s right to access this data:

c.How and where were data collected originally (if applicable)?

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University of Pittsburgh Human Research Protection Office3500 Fifth Avenue  Phone 412-383-1480 
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  1. Will the planned activity involve an intervention or interaction with living persons (human subjects)?
    No Yes
  1. Will the planned activity involve accessing (i.e., looking at or reviewing) identifiable private information?
    No Yes
  2. Are the data coded where a link exists that could allow the data to be re-identified? No Yes

a.If Yes, is there a written agreement that prohibits this study team’s access to the link? No Yes

  1. Are all data in existence as of the date this application was submitted in OSIRIS?

No; Address the following:

  1. Over what time period will the data be collected?
  2. From what source?
  3. Who will collect the data?

If No, this form should not be used unless this project qualifies for a “No Human Subjects determination” (see question 4).

Yes; List the specific date range of records to be studied: Click here to enter start of date range to Click here to enter end of date range

  1. If data will come from, or will be sent to, another institution, you must consult with the University of Pittsburgh Office of Research regarding any necessary transfer agreements ( If you intend to share data, this must be addressed in OSIRIS item 5.8.
  2. Additional information, clarification, or comments for IRB review:

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Final Process: Save this document to your computer and upload into OSIRIS itemE2.0

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University of Pittsburgh Human Research Protection Office3500 Fifth Avenue  Phone 412-383-1480 
v. 1.30.20161of 2