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Collecting and Storing Specimens for a Single Research Protocol at a For-profit Company

You should refer to this page if you are storing at a pharmaceutical company or at their associated reference laboratory.

Requirements for Specimen Storage at a For-profit Institution

The following requirements apply for storage at a non-academic, for-profit site or in any case where a for-profit company is in control of the specimens:

• Only the specific analyses/tests listed in the protocol and informed consent may be performed. (The specimens may not be used for future studies.)
• All specimens and associated data must be de-identified. (They must be labeled with a code that does not contain any of the 18 HIPAA identifiers.)
• The key linking the code on the specimens and data to the subjects' identity must be maintained at the VAMC.
• DNA and RNA may not be analyzed unless it is for a specific gene or gene expression product. Genome-wide association studies and DNA or RNA profiling studies are not permitted. (This will be evaluated on a case-by-case basis).v
• The company must inform the PI in writing when samples are destroyed.
• Specimens must be destroyed within 1 year of the study completion date.

The protocol must state that human biological specimens will be stored, where they will be stored, and for how long.

How to Apply for an Off-site Specimen Storage Waiver

Please click the for-profit application link at the bottom of the page in order to access the form. Please complete all fields in the form unless directed to skip a section. The form is a fillable pdf which should be saved to your computer before entering any information. It can be completed using Adobe reader version 7.0 or higher. The following documents, which are also listed on page 3 of the application form, must be submitted when applying:

• Informed Consent (For-profit informed Consent Guidance 24 KB, PDF)
• HIPAA authorization document (Must be a separate, stand-alone document)
• Research protocol
• Information regarding the storage facility's policies, mechanisms of specimen acquisition, and all oversight mechanisms in place (lab manual or SOP's)

*We encourage you to submit your application before you have IRB approval because often elements are missing, and we can point this out before you request IRB review. In addition, we can provide approval of your application that is contingent on IRB approval of the consent form. The approval of your application would also be contingent on the final study approval by the IRB committee and R&D committee, or ACOS of R&D. Please email all materials to the offsite tissue banking mailbox (link below) or Kristina Hill (kristina.hill@va.gov). If emailing is not possible there is a fax number and mailing address on the last page of the application. Emailing does ensure quicker review.

• Application for Biospecimen Storage at a For-Profit Institution (229 KB, PDF)- VA FORM 10-0474, Last revised 8/09
• VHACO Offsite Tissue Banking Mailbox