Request for Determination of Exempt Status, or No Human Subjects Designation:
Research with Biological Specimens
Title of Study:A. 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 .
B. Will this study use residual specimens (and if applicable, data) that were obtained originally for clinical treatment or pathology purposes – independent of this research project? No Yes
If Yes, answer the following questions:
1. Will the specimens and/or data (e.g., medical record information) be provided to this research team without personal identifiers or linkage codes? No Yes If No, explain:
2. Will an Honest Broker be used to de-identify these specimens and/or data? No Yes
If No, describe how the research team will receive specimens and/or data without identifiers:
3. If paraffin tissue blocks from UPMC will be studied, provide the name of the pathologist who has reviewed this project and approved the allocation of tissue: Name: E-mail:
C. Will this study use specimens (and if applicable, data) obtained from a tissue bank or repository?
No Yes
If Yes, answer the following questions:
1. Identify bank/repository by name, and provide IRB number or attach bank/repository consent form or description.
2. Will specimens (and if applicable, data) be provided to the research team without identifiers?
No Yes If No, explain:
3. If paraffin tissue blocks from UPMC will be studied, provide the name of the pathologist who has reviewed this project and approved the allocation of tissue: Name: E-mail:
D. Will this study use specimens (and if applicable, data) obtained from a prior research study?
No Yes
If Yes, answer the following questions:
1. Did the consent form signed by the subjects restrict the use of their samples in any way?
No Yes If Yes, describe restrictions:
2. Is copy of initial consent form attached? No Yes If No, explain why not:
3. Information from the prior research study:
a. Study Title:
b. PI name:
c. IRB number:
E. Will this study use specimens (and if applicable, data) obtained directly from a commercial vendor?
No Yes If Yes, identify the vendor by name:
F. Address each of the following questions:
1. Will the investigator(s) access (look at) identifiable private information? No Yes
If Yes, explain:
2. Will the investigator collect or receive specimens and/or data with identifiable private information?
No Yes If Yes, explain:
3. Will the investigator record subject identifiers and link them to the specimens and/or data?
No Yes If Yes, STOP – this is not an exempt study. Submit an expedited application.
4. Do the specimens and/or data have a numerical code such that a link exists that could allow the specimens and/or data to be re-identified? No Yes
If Yes, is there a written agreement that prohibits the PI and the research staff from accessing the link? No Yes If No, explain:
G. Are all specimens and/or data in existence as of the date the protocol is submitted to the IRB?
No: Over what time period will these be collected, from what source, and who will collect the specimens and/or data?
If No, this form should not be used unless this project qualifies for a “no human subjects” determination (see section H). Otherwise, this project must be submitted for expedited review.
Yes - List the date range of records/specimens to be studied:
H. 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 and specimens 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 .
I. If specimens and/or data will come from, or will be sent to, another institution, have the necessary material transfer agreements been initiated with the University of Pittsburgh Office of Research?
No Yes N/A
If No, why not? If Yes, describe:
Information about Material Transfer Agreement (MTA) can be obtained at: http://www.pitt.edu/~offres/
J. If applicable, in what format will medical record information be provided to the investigators of this research study?
1. De-identified (HIPAA “safe harbor”; none of the 18 HIPAA identifiers will be included)
2. Limited Data Set (includes dates and certain geographic information)
a. Justify why dates and/or geographical information from medical record are needed to perform this study:
b. Justify the need for each of the requested medical record data elements that are specified under item 2d below:
c. A completed Data Use Agreement Form must be uploaded and submitted with this form. Note that this IRB submission cannot be processed without this form, signed by recipient.
Note: Information about the HIPAA requirement and the Data Use Agreement is available from the IRB website: http://www.irb.pitt.edu/hipaa
1. Research Design and Methods
a. How will the study be conducted?
2. Types of specimens (e.g., tissue, blood, bodily fluids) to be studied:
a. What specimens will be accessed?
b. Describe the original collection of the specimens and/or data (how, where, and by whom):
c. If specimens are still being collected, who will be responsible for obtaining the specimens?
i. Is that person a member of this research team? No Yes
d. If applicable, provide a list of data variables that will be collected (e.g., diagnosis, age, laboratory results, etc.):
e. How will confidentiality be maintained?
f. Are personal identifiers associated with the original specimen? No Yes
If Yes, address the following questions:
i. Who will access the specimens and/or data?
ii. What is their right to do so? (e.g., specify their right to access to the materials; clarify that they will only have access to de-identified materials, etc.).
iii. Describe the process of obtaining specimens and/or data?
iv. Describe how the specimens and/or data will be de-identified prior to being provided to investigators (if applicable).
1. If specimens and/or data will be obtained from the University and/or UPMC, specify the identity of the IRB-approved Honest Broker System/Process that will be used in obtaining the specimens and/or data. If multiple systems are used, include all below:
a. Honest Broker System or Process:
b. UPMC/IRB Honest Broker Approval Number:
c. Name of individual who has agreed to provide Honest Broker service to this project:
d. If applicable, the specified Honest Broker must complete and sign the Assurance Form (next page). One copy should be retained by Honest Broker, and one copy should be uploaded into OSIRIS
OR
2. If a non-approved Honest Broker is used, provide a justification:
a. Name the person or group, independent of this research team, who has agreed to serve as the honest broker and has completed the honest broker assurance form:
3. Additional Information, Clarification, or Comments for the IRB Reviewer:
Independent “Honest Broker” Assurance (If Applicable)
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 (including specimens) that will subsequently be accessed by the research team.
2. 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.
3. I will not intervene or interact with identified human subjects during the conduct of this research project.
4. I will maintain complete confidentiality of research subjects’ private information.
Title of Study:
Principal Investigator:
Name: / Signature: / Date:Position: / E-mail: / Phone:
Additional optional comments of Honest Broker:
Name of Honest Broker System or Process: / UPMC/IRB Honest Broker Approval Number: HB
Please scan or digitize (if needed) file – to include signature and upload into OSIRIS.
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