Principal Investigator:
Study Title:


  1. Will any information from this project be submitted to the FDA? No Yes
    If Yes, STOP and contact us at
  1. Check the types of measures to be used:

Passive observation of public behavior

Educational Tests (cognitive, diagnostic, aptitude)

Survey

Interview

Focus Group

Other (describe):

  1. Describe the participants who will participate in this study:
  1. Will participants under 18 years of age be studied: No Yes If Yes, address the following:
  2. Is this study limited to passive observation of public behavior and/or educational tests? No Yes

If No, STOP. This exempt category is not applicable.

  1. If Yes, describe:
  2. If Yes, also address the following:
  3. Provide a rational for the specific age ranges of children to be studied:
  4. Describe the expertise of the study team for dealing with children of that age range:
  5. Describe the adequacy of the research facilities to accommodate children of that age range:
  6. If applicable, how will parents be informed or involved in this project:
  1. Will you be interacting with non-English speaking participants? No Yes
    If Yes, are you fluent in the language they understand? No Yes If No, indicate how you will communicate with participants (e.g., with interpreter - and if so, who will serve in this role):
  1. Address where the study be conducted and who will collect the data:
  2. How often will participants be contacted and why?
  3. Will information be recorded anonymously (no participant identifiers or codes that can be used to re-identify subjects will be recorded)? No Yes
    If No, provide a justification for recording identifiers:
  4. Will sensitive information be recorded that could damage participants’ reputation or employability, financial standing, or place them at risk for criminal or civil liability? No Yes If ‘Yes, explain:
  1. Upload the introductory script in OSIRIS item 4.1 - a sample script is available on the HRPO website.

If not applicable, explain:

  1. Address how the information will be obtained (e.g., face-to-face, phone, internet) and upload all interview questions, questionnaires, focus group guides, etc. into OSIRIS item 2.8:
  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 then upload into OSIRIS itemE2.0

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