Cooperative Human Tissue Network Application

PLEASE READ THE INFORMATION BELOW BEFORE COMPETING THIS FORM

The Principal Investigator (PI) responsible for overseeing the project and controlling the laboratory and personnel who will receive, use and process the requested specimens should complete this application. Any transfer of samples, aliquots, derivatives or associated clinical data to collaborating personnel or laboratories that are not under the direct supervision of the indicated PI requires the following:

1. A written justification of the need to transfer the materials and benefit to the applicant's research.
2. Copies of the Agreement for Use of Tissue and Data Use Agreement signed by the collaborator.
3. Documentation of the collaborator's IRB approval, exemption or documentation of IRB review unless the collaborator is covered under the IRB approval/review granted for the project proposed in this application.

The CHTN does not supply samples to specimen banks whose purpose is distribution to third-party researchers; those researchers should be encouraged to apply to the CHTN directly. 

The information in this form is necessary in order to document correctly your request for tissue and other services and to ensure that the CHTN operates within the guidelines of the National Cancer Institute.

Please note:

1. If requesting specimens from more than one specific anatomic site or disease, please complete separate copies of the Request Information Form (biospecimen, donor and preparation details) as necessary. Please be specific about your requirements, including those for storing and handling tissue samples from the time the specimens are collected until they are delivered to your lab (i.e. transport media, refrigeration status, etc.).
2. The CHTN maintains patient confidentiality. Samples and accompanying clinical data will be identified by a code, which will not be released under any circumstances.
3. The PI is responsible for remission of processing fees to the originating CHTN division for each specimen provided, including fees for any additional services performed and any shipping costs not directly billed to the applicant’s courier account. Please refer to the CHTN website for the current processing fees.
4. PIs must obtain human subjects review from their institution in order to receive specimens from the CHTN. Full or expedited approval or an exemption for your project can be obtained from your Institutional Review Board (IRB) (Human Use Committee). Documentation of annual review of non-exempt protocols by the PI’s institution must be forwarded to the CHTN in order to maintain eligibility to receive tissue. This is not necessary for exempt protocols.  If your institution does not have internal review, contact your divisional coordinator. 
5. Please provide a signed copy of the Agreement for Use of Tissue and Data Use Agreement. The language in both agreements is NOT to be altered.

The following policy applies to providing tissue to commercial organizations. The CHTN strongly supports providing tissue to support the goals of commercial (for-profit) companies because these organizations are the source of important advances in biomedical research and in medicinal care. Because many medical advances are based upon products developed and research performed by commercial companies, the CHTN readily provides human tissues to for-profit companies to support their basic and discovery research even if the research is for the development of commercial products. Similarly, the CHTN provides human tissues if the commercial company is characterizing the early stages of product development, testing a product and/or if the company is investing significant intellectual input into developing a product. For example, the CHTN provides human tissues if the company’s goal is to develop cell lines or to identify novel proteins or other biomarkers by antibody reactions. 

The CHTN encourages research using human biospecimens for the good of the public, including providing specimens to commercial companies. The CHTN Agreement for Use of Tissue, which must be signed by all CHTN investigators, states “The recipient agrees that it shall not sell any portion of the tissues provided by the CHTN, or products directly extracted from these tissues (e.g. protein, mRNA or DNA).  The recipient agrees that it shall not transfer tissue (or any portion thereof) supplied by the CHTN to third parties without the prior written permission of the CHTN.”

All CHTN biospecimens are provided to commercial companies as de-identified samples without restrictions as to intellectual property and based on complete recovery of collection, processing and storage costs.  There is no profit for “tissues”; selling human tissue is illegal in the United States based on the Uniform Anatomical Gift Act. 

Specific guidance on the many different uses of biospecimens in product research, from early basic studies to direct product development is complex.  In general, discovery, translational and quality control studies may use CHTN biospecimens.  The use of CHTN provided biospecimens in the final or production stages of product development would rarely be permitted.  The following criteria identify appropriate commercial use of biospecimens:

• A value-added research component is present in the proposed biospecimen use.
• Developed monoclonal antibodies and DNA microarrays can be marketed commercially.
• Cell lines and cDNA libraries may be developed and marketed.
• Tissue microarrays (TMAs) can be provided for basic, discovery and translational phase research use but cannot be sold as commercial products.
• Direct sale of CHTN provided biospecimens or their directly extracted products is never acceptable (e.g. DNA)
• CHTN biospecimens cannot be used directly in a commercial product.  

The CHTN does not provide tissues to anyone to establish a bank of tissues for further use. The CHTN does not provide tissues or sample tissue derivatives (e.g., tissue microarrays, molecular extracts [proteins, mRNA, microRNA, DNA, lipids, etc.]) to commercial companies for direct sale or commercial transfer to third parties.

The CHTN does not permit the transfer of biospecimens to third party collaborators, tissue banks or multiple investigators without prior written permission of the CHTN. This policy does not apply to services provided by a core facility or a laboratory performing assays specifically for the applicant PI. (See details provided in first paragraph of page 1).

If there is any question about whether the proposed use is appropriate, please contact the divisional coordinator of the division to which you are applying.

All CHTN investigators must identify the requirement for genomic DNA sequencing in their application so samples can be suitably screened for appropriate consent status. The human biospecimens collected from the CHTN come from a wide range of academic hospitals and allied health care entities. While all specimens are collected under local human subjects research institutional review board (IRB)-approved protocols that approve minimal-risk research to be performed on the collected specimens, not all specimens have received informed consent for genomic DNA sequencing, or to be involved in studies of genetic inheritance. The CHTN does not re-contact subjects donating biospecimens for specific studies. Therefore, the CHTN will not give blanket assurance that tissue or biofluid specimens provided to our investigators can be used for genetic/genomic studies. All CHTN specimens are either fully anonymized or coded-linked but considered permanently de-identified to recipient investigators. CHTN investigators are responsible for the use of the specimens according to the requirements placed on their research by their local IRB and the requirements for publication of any genomic data generated by their studies.

Please select the appropriate tissue type below and complete the details for the biospecimen type requested.

Donor History: The standard information provided with each sample includes the patient's age, race, sex, and the final pathology diagnosis as well as the final pathology report or CHTN QA assessment where applicable. Pathology disease stage, categories pT and pN are provided within the included pathology report. pM may also be provided. However, clinical disease staging will require a subject chart review. Any requests for additional information, including prior therapy questions below, require prior CHTN approval and may incur an additional chart review fee. Availability and completeness of clinical information is not guaranteed. 

PLEASE NOTE: Post times are defined as the time between excision, death or draw and processing to the requested preparation.