- The first step to request human specimens from the BTRF is to determine if you can utilize coded specimens (de-identified) or will require identifiable specimens and data. This will dictate whether your study requires approval of the UVA Institutional Review Board for Health Sciences Research (IRB-HSR).
Coded specimens are standard for the majority of basic and translational research supported by the BTRF. The BTRF identifies the specimens/donors, and the specimens and accompanying clinical data provided are identified only by a BTRF-specific code. Any clinical data requested is abstracted by the BTRF staff and will conform to a HIPAA Limited Data Set. The BTRF functions as an Honest Broker and will maintain the key to the code. The researcher cannot access the key to the code without proper IRB-HSR authorization. With coded specimens, researchers are able to request additional clinical information or material (if available) after receipt of the samples. The BTRF can also ensure that other samples provided in the future do not come from the same individual, if that is important. Per IRB-HSR policy, this is considered non-human subjects research and does not require review or approval. This can be initiated without an IRB submission, and the documentation takes just a few minutes to prepare. Click here to download a detailed Quick Start Guide to applying for Coded Specimens. Alternatively, you may have an existing Coded Specimens protocol approved by the UVA IRB-HSR. Documentation for either option must be submitted with your BTRF Application.
Identifiable specimens can be provided by the BTRF to researchers with proper IRB-HSR authorization. Specimens and accompanying clinical data are still provided with a BTRF-specific code, but the researcher receives the key to the code. Data abstraction performed by the BTRF is limited to items readily accessible in the Electronic Medical Record (EMR) and easily abstracted. Interpretation or in-depth clinical correlation is outside the scope of the BTRF, and the investigator will need require IRB-HSR approval to access the EMR for this purpose. Specimens are also considered identifiable if a member of the study team, such as a physician, has direct knowledge of the patients from whom they are obtained or if the researcher requests materials from a specific patient or procedure. These require IRB-HSR approval. Low-risk, retrospective studies usually qualify for expedited review by the IRB-HSR and may be granted a Waiver of Consent. Please note that a subset of BTRF patients are directly consented for specimen collection, and a Waiver of Consent does not cover these patients. If you wish to receive identifiable human biospecimens or clinical data, documentation of IRB approval and what type of approval (Informed Consent or Waiver of Consent) must be provided with your BTRF application.
For higher-risk studies involving GWAS (whole genome/whole exome sequencing), specific consent of the patient for genetic research and sharing of genomic data is required. A limited subset of available specimens meet this criteria. If you are planning to conduct these types of studies, please consult with the Biorepository Manager prior to submitting a request for specimens.
- 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.
- Complete a Biorepository User Agreements Form and a Biorepository Specimen Request 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:
Dept. of Pathology
P.O. Box 800904
Ph. 982-6453 PIC#6551 email: firstname.lastname@example.org
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:
- You will comply with the provisions of the IRB approval regarding human subjects research.
- 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.
- 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.
- You will reimburse the BTRF according to the published fee structure for materials and services that you receive.
- 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.