FAQs for Investigators

1. Do I need IRB approval to use these specimens?

   You will need to submit your proposal to an IRB and provide documentation that they have reviewed the submission and the outcome of that review. IRB review is required even if the specimens you are receiving have had patient identifiers removed. We have developed some templates to help you submit your proposals. Please go to CGB Forms to view and download these tools or ask the Cooperative Group for additional materials.

2. Why don’t you have specimens from every patient who registered?

   Many Cooperative Group clinical trials have a tissue collection component. In most cases, especially in older studies, tissues were collected for clinical trial-specific correlative studies. After conducting these studies, some specimens may have been depleted, with no leftover material available for future studies. Additionally, collection of these tissues may or may not have been mandatory for participation, and thus specimens were not collected or may be unavailable because of patient choice. Patients' choices for use of their specimens as well as institutional resources also may have an impact on availability of specimens. Some examples of situations that may contribute to lack of adequate specimens include failure of a procedure to provide adequate material for both patient treatment and future study, patient's refusal to undergo a procedure, or inability of the Group or institution to adequately fund the performance of a special procedure required to collect the material. Also, local institutional policies may affect their ability to share specimens.

3. Can these specimens be used for Genome-Wide Association Studies (GWAS)?

   This will depend on several factors, including the policies and procedures in place for the Group or Groups providing the materials for study. Relevant issues to consider are whether the patient signed a consent form that indicated future research might include genetic testing; whether the research requires submission of data to a central database *(for some Groups, the patient must have been notified of this in the consent process.) Finally, if outcome data are to be supplied to a central database as a part of the research, the Group may need to approve this or arrange a data sharing agreement. Because of the potential complexity of the question, it is best to consult with the Group (or Groups) about relevant policies and the details of the specific clinical trial(s) from which the specimens of interest were collected. See the contacts page for group contact information.

   *The NCI has issued guidelines outlining updated informed consent language that meets these criteria.

   For additional information about GWAS, go to the NHGRI Genome-Wide Association Studies Fact Sheet or the NIH Genome-Wide Association Studies Web site.

4. I only want a few specimens; does my proposal really require NCI review?

   It depends on the number of specimens that you request and the type of clinical trial under which the specimens were collected. Currently, the NCI reviews all proposals meeting any of the following criteria:

   1. 100 or more specimens are requested, including requests for multiple specimens from 100 unique patients (e.g., requests for 1 slide from 100 patients, or 2 vials of serum from 50 patients would both require review);
   2. any specimens from a study accruing 100 or more patients;
   3. any Phase III study or study involving multiple Cooperative Groups.

   Although requests for a small number of specimens would seem to be insignificant, over time there is a risk that without careful monitoring, the overall resource will be depleted and unusable for the well-powered biomarker studies, which the Cooperative Group translational research program is designed to support. The GBC is committed to working with the NCI to establish the most rapid and appropriate review process possible.

   We have developed some templates to help you submit your proposals. Please go to CGB Forms page to view and download these tools.

5. How do I contact a cooperative group to request their specimens?

   The cooperative group bank should be contacted to inquire about available sample inventory and the needs of your study. You should also contact a representative from the cooperative group regarding that group’s request process. Typically your first contact will give you the contact information of others relevant to your request. Cooperative group contact information is available on the Contacts page.

   A more detailed description of the request process is described on the Access Process page.

6. How is the CHTN different from the Cancer Cooperative Group Banks?

   The Cooperative Human Tissue Network (CHTN) is a group of six academic institutions (five adult divisions and one pediatric division) funded by the NCI to work together (as a network) to provide remnant human tissue and fluids from routine procedures to investigators who utilize human biospecimens throughout the U.S. and elsewhere.

   The CHTN provides malignant, benign, diseased, normal and fluid biospecimens from routine surgical resections and autopsies. Unlike tissue banks, the CHTN works prospectively with each investigator to tailor specimen acquisition and processing to meet their specific project requirements. Biospecimens can be provided to the investigator fresh, frozen or as paraffin blocks and/or slides. Although the CHTN is not a bank, some biospecimens are banked for a limited time. Banked biospecimens that meet an investigator's request will be made available for distribution. Each of the adult divisions (University of Pennsylvania, Vanderbilt University, Ohio State University, University of Alabama-Birmingham, University of Virginia) coordinates investigator applications/requests based upon the investigator's geographic location within North America. The pediatric division (Nationwide Children’s Hospital) manages all investigators who request pediatric specimens only. The CHTN divisions share coordination for requests from outside North America.

   In addition to procuring and distributing biospecimens following the usual CHTN procedures, the pediatric division of the CHTN (pCHTN) also has a unique and longstanding relationship with the Children’s Oncology Group (COG). This relationship allows the pCHTN to distribute COG banked biospecimens once all clinical trial-specific correlative science studies/projects are completed. In this setting the applications for these precious clinically-annotated biospecimens are handled by the pCHTN, but the availability of the biospecimens is determined by the COG’s specific Disease Committees following detailed evaluation of the scientific value of each application.

General FAQs

1. If I was on one of these clinical trials and consented to have my specimens donated, how can I check to make sure that it happened?

   You would check with the investigator/study staff who enrolled you in the clinical trial.

   The biobanks do not talk to patients directly, and many have strict policies that do not allow them to have direct contact with the patients who agreed to provide their tissue specimens. Also, most banks receive or store the tissues using codes that are designed so that they cannot link the specimens directly to you, so the banks would not know whether they received tissue specifically from you. This coding of the specimens is done to protect your confidentiality.