Application for Biospecimen Collection

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Application for Biospecimen Collection

  1. Decide if you want to obtain human biospecimens from the BTRF as anonymous, coded-linked or identified specimens. This will dictate the type of IRB approval under which the research is conducted. If you receive anonymous (fully de-identified) samples, this is not considered human subjects research, and UVA policy is that you do not need to apply for any IRB review (skip to Step 4). Please understand that for anonymous (fully de-identified) samples you cannot get additional clinical information once you receive the samples, you cannot get additional material from the same subject, and you cannot be assured that other samples you receive from the BTRF do not belong to the same individual, because the BTRF keeps no records of the donors' identities for anonymous specimens. Anonymization is also not recommended for fresh tissue requests, because the BTRF will not be able to provide you with any pathology information or perform QA on the specimen. Whole Genome Sequencing, Whole Exome Sequencing, and GWAS studies, as well as creation of stable cell lines, are not categorized as minimal risk research and may have specific requirements for subject Informed Consent and for data sharing in public databases. Please consult with the Biorepository Manager or the BTRF Faculty Director for guidance if you plan to conduct these types of activities using specimens obtained from the Biorepository.
  2. If you wish to receive coded-linked specimens, our IRB will usually determine this is non-Human Subjects Research. For coded specimens, the BTRF maintains a link to subject identity in our records, and the code key is not disclosed to you. You receive specimens and data identified by a BTRF specific code only, and any clinical information you request is abstracted by BTRF staff from available records and conforms to a HIPAA Limited Data Set. For this, you must submit a coded research application for your research project to the Institutional Review Board for Health Sciences Research . This is a really easy submission which takes just a few minutes to prepare and has a very quick turnaround with the IRB. Code-linking is highly recommended when requesting fresh tissue so final pathology diagnosis and QA information is available. Code-linking is necessary if you need to avoid receiving duplicate samples or may want additional samples or clinical data from the same subject in the future. For detailed instructions on how to file a Coded Research application with the UVA IRB-HSR, click here. Separately, you will need to download and completed a BTRF Coded Research Agreement (click here) and bring it to the Biorepository Manager or Faculty Director for signature. Send a copy of the IRB determination letter with your completed BTRF application to the address given below. Collection or distribution of tissue will not occur until this documentation is provided!
  3. If you wish to receive human biospecimens and data with HIPAA identifiers, if you wish have the code key for coded specimens released to you, or if you will be requesting BTRF services on specimens from research subjects whose identity is known to you (e.g. your clinical trial participants), this requires Informed Consent of the subject, a Waiver of Consent, or a determination that the research activities are Exempt from review. You must obtain an approved protocol for your research project from the Institutional Review Board for Health Sciences Research. The BTRF will not collect, distribute, or initiate processing of any specimens until this documentation is provided. 
  4. Obtain the appropriate training, approval, equipment and supplies to work with human tissue and or fluids. See the Biosafety Committee web-page for more information.
  5. Complete the application form. Please consider your needs carefully. The larger the specimen aliquot that you request, and the more strict the conditions that you specify, the greater the difficulty we have in fulfilling your request. Please feel free to discuss your requirements with the the Biorepository Manager or the Faculty Director (see Contacts ). Send the form to the Biorepository Manager:

                            Craig Rumpel
                            Dept. of Pathology
                            P.O. Box 800904 
                            Ph. 982-6453 PIC#6551 email:  

Mr. Rumpel's office is in the basement of the Carter-Harrison Medical Research Building (MR6), Rm. B705A

By completing the application and initiating your request, you indicate that you understand and will comply with the following conditions:

  1. You will comply with the provisions of the IRB approval regarding human subjects research.
  2. The Biorepository does not screen samples or subjects for any type of infections, and therefore the researchers and all laboratory personnel should observe universal precautions. You must understand that in receiving anonymous or coded-linked samples, subject identity cannot or will not be disclosed even in the event of exposure of laboratory personnel to potentially infectious material. It is assumed the investigator adheres to all University of Virginia policies and procedures regulations regarding biohazardous materials, including the appropriate training of, and notification of risk to, all personnel exposed to these materials.
  3. All University of Virginia policies and procedures regarding transfer of material to a third party apply to these biospecimens. The transfer of coded-linked and/or identified human materials to individuals or entities not authorized by the IRB-HSR is a violation of Federal Law.
  4. You will reimburse the BTRF according to the published fee structure for materials and services that you receive.
  5. To justify the investment by UVA in this facility, you must agree to acknowledge the contribution of the Biorepository and Tissue Research Facility in any publications arising from the use of these samples. We also request that a copy of the manuscript(s) be sent to us upon publication.