Studies Using In Vitro Diagnostic Devices with Specimens that are NOT Individually Identifiable: Request for an Exception to Informed Consent Requirements and Exempt Determination

Principal Investigator:
Study Title:


  1. This project meets the IDE exemption criteria at 21 CFR 812.2(c)(3): No Yes

NOTE: 21 CFR 812.2(c)(3) states that Part 812 does not apply to investigations of a diagnostic device if the sponsor complies with applicable requirements in 809.10(c) and if the testing meets ALL of the following criteria:

  • Is noninvasive;
  • Does not require an invasive sampling procedure that presents significant risk;
  • Does not, by design or intention, introduce energy into a subject; and
  • Is not used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure.
  1. The study uses leftover specimens: No Yes

NOTE: ‘Leftover specimens’ refers to remnants of specimens collected for routine clinical care or analysis that would have been discarded, OR specimens previously collected for other research purposes or were obtained from specimen repositories.

  1. Specimens are not individually identifiable: No Yes

NOTE: This means that the identity of the subject is not known to, and may not readily be ascertained by this study team or any other individual associated with the study, including the sponsor. Further, if the specimen is coded, neither this study team nor other individuals associated with the study, including the sponsor, can link the specimen to the person from whom the specimen was collected, either directly or indirectly through coding systems.

  1. Identify the IVD that will be used in this study and upload relevant product information in the Other Attachmentsitem in OSIRIS:
  1. How will the study be conducted?
  2. How will results be analyzed to determine the study aims have been met?

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  1. What specimens will be accessed (e.g., tissue, blood, bodily fluids)?

a.Where are the specimens currently stored?

b.How and where were the specimens collected originally?

c.If the specimens used in this study are still being collected for clinical purposes, who will be responsible for obtaining the specimens?

  1. Is that person a member of this research team? No Yes

d.Describe the PI’s right to access these specimens:

  1. If applicable, provide a list of data variables that will be collected (e.g., diagnosis, age, lab results):
  1. How will confidentiality of data/specimens be maintained?
  1. Describe how the specimens and corresponding clinical data will be de-identified prior to being provided to this study team (if applicable):
  1. If data and/or specimens 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 and/or specimens, 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