Request for Determination of Exempt Status, or No Human Subjects Designation:

Existing Data or Research Records

Title of Study:
A. Will any information from this project be submitted to the FDA or held for inspectionby the FDA? No Yes If Yes, STOPand contact the IRBat .
B. How will information be recorded? (check all that apply)
  1. Information is publically available
  2. Information is recorded WITHOUT identifiers or linkage codes by the investigator;
  3. An independent individual, not associated with this research study, will de-identify data prior to providing it to the investigator and will not assign linkage codes;
  4. An independent individual, not associated with this research study, will de-identify data prior to providing it to the investigator and will assign linkage codes; but will not provide the investigator with access to those linkage codes:
  5. The following person or group, who is independent of the research team, has agreed
to serve in that capacity:
  1. Information electronically de-identified by a computerized system to which
research team has no access (e.g., Pitt De-ID program; other program (name):
  1. Other; describe:

C. Are all data in existence as of the date the protocol is submitted to the IRB?
No If No, over what time period will these be collected, from what source, and who will collect the data?
If No, this form should not be used unless this project qualifies for a “no human subjects” determination (see section D). Otherwise, this project must be submitted for expedited review.
If Yes, List the date range of records to be studied:
D. Are you explicitly requesting a ‘no human subjects’ determination [46.102(f)]? No Yes
If Yes, does your study meet both of the following requirements? No Yes
1.No member of the research team has interacted, for research purposes, with the individuals whose information will be studied and;
2.No identifiable private information can be reviewed or recorded.
Note: If this project is NIH-funded, the grant application must explicitly indicate that at least a component of the study does not involve human subjects. For additional information, e-mail Chris Ryan, IRB Director, at .
Note: If data will come from, or will be sent to, another institution, please consult with the University of Pittsburgh Office of Research regarding any necessary agreements?
  1. Records to be studied
  2. Describe the records that will be accessed, including the source and/or the purpose for which they were originally collected.
  3. Are personal identifiers associated with the original data? Note: Unless data are publically available, investigators cannot record subject identifiers with data. No Yes
    If Yes, address the following questions:
  4. Who will access the records?
  5. What is their right to do so? (e.g., specify their right to access to the records; clarify that they will only have access to de-identified records, etc.):
  6. Describe the process of obtaining the data:
  7. Describe how data will be de-identified prior to being provided to the investigators (if applicable):
  8. Methods
  9. Describe or list variables that will be extracted from records:
  10. If data are from a previous research study, attach copy of consent form(OSIRIS question E 2.0).
  1. Analysis
  2. How will results be analyzed to determine that study aims have been met?
  3. Additional Information, Clarification, or Comments for the IRB Reviewer:

Request for Determination of Exempt Status, or No Human Subjects Designation:

Existing Data or Research Records

Assurance of Individual Who is De-identifying Data to be Used in this Study

By signing below, I agree / certify that:

  1. I have reviewed this project with the Principal Investigator and agree to de-identify and, if applicable, to maintain linkage code information for data that will subsequently be accessed by the research team.
  1. I will, under no circumstance, provide the PI or any member of the research team with information that would permit the identification of research subjects.
  1. I will not intervene or interact with identified human subjects during the conduct of THIS research project.
  1. I will maintain complete confidentiality of research subjects’ private information.

Title of Study:

Principal Investigator:

Name: / Signature: / Date:
Position: / E-mail: / Phone:

Please scan or digitize (if needed) file – to include signature and upload in question E 2.0

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