ACCESS TO BIOSPECIMENS

Investigator Requirements & Priority
Policies & Procedures for the Protection of Human Subjects
IRB Policy
HIPAA Compliance Policy
Use by Third Parties
Application Form

INVESTIGATOR REQUIREMENTS & PRIORITY

Access to the CHTN is provided to any investigator who signs the agreements regarding biohazards and commercial use (refer to the CHTN Application) provides a summary of the project for which the tissue is requested, and whose request and summary are subsequently approved by the CHTN. Patient identity or other identifying information cannot be provided to investigators. This ensures complete confidentiality regarding medical information of patients. In addition, a copy of a review from the investigator's local institutional review board (IRB or human use) of the investigator’s proposed research is required for all projects. Click here to download the CHTN Application in PDF.

Investigators are obligated to acknowledge the CHTN in any publications that result from their use of specimens received through the CHTN. Recommended wording to the methods or acknowledgement section is as follows: Tissue samples were provided by the Cooperative Human Tissue Network which is funded by the National Cancer Institute. Other investigators may have received samples from these same tissues.

Tissues are provided on a rotating basis and given a priority as follows:

First priority is assigned to peer-reviewed funded investigators, including investigators from Federal and National laboratories.
Second priority is assigned to developmental and new investigators and investigators developing new projects in academic centers or non-profit research institutions.
Third priority is assigned to other investigators including those who are associated with for-profit research institutions.

The CHTN seeks to provide tissues to the widest group of investigators practicable. In this regard no investigator should expect to have access to unlimited numbers of malignant specimens of one type. If you require large numbers of specimens and/or extensive patient data, you may need to contact the NCI Tissue Expediter (e-mail tissexp@mail.nih.gov), consult the NCI Specimen Resource Locator, or identify local sources for your specimens and data. The CHTN attempts to provide each investigator with as many specimens as equitable. Investigator access to increased numbers of specimens is improved by requesting as small a specimen as possible. For example, investigators requesting a minimum of 10 grams of one tumor would have access to only a very limited number of specimens, while investigators requesting a minimum of .5 gm. of tumor would have access to many more samples. Access to specimens varies according to the surgical schedules and autopsy rates and is thus, not predictable. Therefore, investigators requesting fresh specimens should make every effort to use these specimens when they are made available. Investigators may be charged a processing fee for specimens collected according to their protocol that are refused.

POLICIES & PROCEDURES FOR THE PROTECTION OF HUMAN SUBJECTS

The CHTN has established operating policies and procedures that protect the subjects from whom CHTN specimens are obtained. These policies and procedures are consistent with current regulations and guidance for repositories from the Office of Human Research Protections (OHRP, DHHS), http://www.hhs.gov/ohrp/humansubjects/guidance/reposit.htm. All divisions of the CHTN have full IRB reviews and approvals by their local IRB. The following policies and procedures govern collection of specimens and their distribution to researchers:

CHTN specimens are derived from material that is removed as part of routine medical care or autopsy specimens collected in accordance with operative state and local law. Only residual material not needed for patient care is distributed for research.
Every CHTN institution has obtained human subjects assurance from the Office of Human Research Protections, DHHS. The Assurance document provides agreement that the institution will comply with Federal human subjects regulations (The "Common Rule;" 45CFR46).
Each Division of the CHTN has received approval for collection and distribution of specimens from its local Institutional Review Board (IRB). The IRBs review the procedures in place to ensure adequate protection of human subjects and protection of patient privacy and confidentiality. The approvals are reviewed by the IRB every year.
Donor identities or other identifying information is never provided to researchers; thus, tissue is provided as either anonymized, de-identified, or as a limited data set. All CHTN investigators are required to complete a Data Use Agreement. Specimens are assigned a unique code and every CHTN employee has signed an agreement to protect patient privacy and confidentiality.
Each researcher must document review by his/her Institutional Review Board of the specific research proposed. It is up to the local IRB to determine whether or not the proposed research requires IRB approval. The researcher and his or her institutional official must also sign an agreement form indicating that they agree not to attempt to obtain information identifying the individuals providing tissue to the CHTN and that they will not share the tissue with third parties. This approach is consistent with current OHRP guidance for tissue repositories. Investigators at institutions that DO NOT have an institutional review board (IRB) may submit a fully executed copy of the CHTN Human Subjects Agreement with their application instead of IRB approval. This form is NOT intended to be utilized by investigators who do have access to a local IRB.

IRB POLICY

The CHTN requires researchers to obtain Institutional Review Board (IRB) review and approval (if deemed necessary by their local IRB) before receiving specimens for their research. While these regulations currently do not apply to institutions that do not receive federal support, the CHTN policy requires all researchers using CHTN tissue to follow the Common Rule. The CHTN does not provide patient identity or other identifiers to investigators. As described above, all specimens are either anonymized, de-identified, or are part of a limited data set. This ensures complete confidentiality regarding medical information of patients.

Researchers at academic institutions and commercial companies are required to obtain IRB review of their projects before receiving specimens from the CHTN. This may be accomplished in several ways. A researcher can use the established IRB at their institution/commercial organization. If the researcher does not have an established IRB at their institution/organization, the researcher may request that an IRB at another organization (e.g. university, college, hospital, other company) review their research proposal; or, alternatively, a researcher may use the services of the Association for the Accreditation of Human Research Protection Program (AAHRPP). For an accredited list of IRBs refer to AAHRPP's accredited organizations. Investigators at institutions that DO NOT have an institutional review board (IRB) may instead submit a fully executed copy of the CHTN Human Subjects Agreement with their application. This form is NOT intended to be utilized by investigators who do have access to a local IRB. Please click here for a copy of the Human Subjects Agreement.

All researchers should be aware of how the federal human subjects’ regulations apply to the use of human specimens. For example, specifically, the OHRP has indicated that research using anonymized or de-identified specimens does not constitute human research and thus is not regulated by the Code of Federal Regulations (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)

HIPAA COMPLIANCE POLICY

The Department of Health and Human Services (DHHS) issued the HIPAA "Privacy Rule," on August 14, 2002 (http://www.hhs.gov/ocr/). This federal regulation governs the protection of individually identifiable health information. The Rule was enacted to increase the privacy and confidentiality of health information on identified individuals, and to regulate known and unanticipated risks to privacy that may accompany the use and disclosure of such information. The Privacy Rule does not apply to specimens per se, but does apply to some of the health information that may be provided with the specimen. The CHTN has always protected the identity of patients from whom specimens are obtained. However, the Privacy Rule imposes new requirements on the use of information associated with the specimens. In order to meet the requirements of the Privacy Rule, the CHTN has implemented a new requirement, a Data Use Agreement, in order to receive specimens with associated data. HIPAA applies to all of the CHTN institutions that supply tissues and patient information to you as an investigator and all CHTN divisions must follow their institutional policies.

The Data Use Agreement will permit you to receive tissue and associated patient information from any division of the CHTN from which such data is available. Because the CHTN Western Division, based at Vanderbilt University, only supplies anonymized, de-identified patient information, they are not listed in the agreement.

Investigators who require patient information beyond that routinely provided or clinical outcome data must inform the CHTN at the time that tissues are requested. This is necessary because of CHTN operating procedures and local IRB requirements for protecting human subjects and patient privacy and confidentiality. As a result of HIPAA regulations, some Divisions may apply more stringent requirements for obtaining such information. Similarly, local requirements for protecting patient privacy and confidentiality may limit the ability of some CHTN divisions to obtain copies of pathology reports for samples previously shipped.

USE BY THIRD PARTIES

The CHTN Application is intended for the use and processing of samples utilized by the laboratory and/or personnel that fall under the supervision of the PI listed in the application. Any transfer of samples or aliquots to personnel or laboratories that are not under the supervision of the indicated PI requires the following:

An explanation of the need to transfer the materials and benefit to the investigator's research,
A copy of the CHTN agreement page from the CHTN application signed by the collaborator,
A copy of the collaborator's IRB approval unless the collaborator is covered under the IRB approval granted for the project proposed in this application.

The CHTN does not supply samples to banks solely for distribution to third parties; those researchers should be encouraged to apply to the CHTN directly.

APPLICATION FORM

Each investigator is required to submit and complete a CHTN Application, a signed copy of the Data Use Agreement (included in the CHTN Application) along with a copy of his/her IRB approval. The investigator indicates on the tissue request page the type and amount of services, describes the preservation and shipping conditions (e.g. fresh, snap frozen and sterility requirements) and specifies limiting factors (e.g. age, sex, etc...). The CHTN makes every effort to tailor our services to the needs of each investigator. It is advisable to discuss your request(s) with the Coordinator of the appropriate Division of the CHTN. The Coordinator can provide additional information about the availability of services, help to refine requests, ensure access to the greatest number of suitable biospecimens and provide guidance through the application process. (Click here to download the CHTN Application in PDF.)