Resources, Policies, and Procedural Documents
The CHTN's operating policies and procedures 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).
All divisions of the CHTN operate with the review and approval of their local Institutional Review Board (IRB).
CHTN Biofluids Policy
When an Investigator's request is for required tissue and biofluids, please review the rules for acceptance and payment of these specimens.
Investigators requesting tissue and biofluids are required to accept all specimens procured on their behalf. The fees paid by investigators cover the time and resources involved in identifying donors, obtaining consent, tracking, and collecting biospecimens and biofluids.
CHTN divisions work diligently to identify donors with a high probability of successfully procuring both tissue and biofluids.Biofluids may be collected during a clinic visit or in the pre-operative holding area beforesurgical resection. Once the patient is in surgery, tissue collection will proceed if there is sufficient remnant tissue available.
However, if the amount of tissue is inadequate for research purposes, collection will not be permitted. Additional circumstances that may prevent tissue collection include the presence of metastatic disease, the surgery being terminated, the tumor being necrotic and unsuitable for research, or the patient's death during surgery.
In cases where matching solid tissue cannot be collected, but biofluids have already been collected for a selected request, investigators have the option to either accept the charges and have CHTN discard the biofluids or have the biofluids shipped to them.
CHTN Division's Data Retention Plans
Each CHTN Division operates under its institutional data retention policies and plans. Please see their attached plans below.
- Eastern Division - University of Pennsylvania
- Mid-Atlantic Division - University of Virginia
- Midwestern Division - The Ohio State University
- Pediatric Division - Nationwide Children's Hospital
- Southern Division - Duke University
- Western Division - Vanderbilt University Medical Center
All divisions of the CHTN operate with the review and approval of their local Institutional Review Board (IRB).
Code of Conduct
The rules and guidelines that all CHTN personnel abide by.
The CHTN is committed to treating all individuals, including investigators, patients, coworkers and all staff with courtesy, respect and dignity. CHTN personnel will conduct themselves in a professional and collegial manner at all times. Personnel should be fair and principled in business transactions and other related professional activities, acting in good faith when dealing with both internal constituents and external entities. All CHTN personnel have every reasonable expectation to receive a similar and respectful standard of conduct in return from CHTN investigators and their staff. Interactions that are inconsistent with this code of conduct will not be tolerated, and services from the CHTN may be terminated.
Unprofessional or inappropriate behavior will be brought to the attention of a CHTN Principal Investigator (PI)* and actions will be administered consistent and appropriate to the level of the offense. The CHTN PI will apply local institutional codes of conduct as applicable to the situation.
*This may be done in the setting of a committee call, email or personal communication.
The CHTN requires payment within 60 days from the original invoice date and after 90 days an investigators account will be considered delinquent. Payment must be made to the division which provided the specific services and while the CHTN makes reasonable efforts to assist investigators with billing issues, the CHTN reserves the right to suspend services to any investigator or institution with delinquent accounts.
Demographic Descriptor Document
The guidelines that all CHTN divisions follow when providing samples with clinical and demographic data.
For more than thirty-five years the Cooperative Human Tissue Network has provided high-quality biospecimens and associated data, including clinical and demographic data, to investigators in support of their research.This includes race and ethnicity, which are predominantly self-reported and obtained from the medical records of the participating institutions. Currently,federal law and NIH policies require the collection of gender, race,and ethnicity data where appropriate.
The CHTN is aware of and continues to learn about evolving scientific rationales and methodologies for describing the attributes and group labels of research participants. The National Academies' publication on using population descriptors in genetics and genomics research provides a thorough review of the current state and recommendations/suggestions for improving genetic and genomic science in the future. (Using Population Descriptors in Genetics and Genomics Research: A New Framework for an Evolving Field |The National Academies Press) Investigators should carefully consider the appropriateness of existing population descriptors and the possible need for multiple descriptors to represent the participants best.
Currently, the CHTN cannot recontact our sample donors to obtain additional demographic or other data not available in the medical record. Investigators can consult with CHTN Principal Investigators and/or Program Leadership if they have specific questionsabout how we can best support their clinical data annotation needs.
HIPAA Compliance
The rules defining how the CHTN is regulated by HIPAA compliance due to providing human specimens.
The Department of Health and Human Services (DHHS) issued the HIPAA "Privacy Rule" on August 14, 2002. 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.
HIPAA applies to allthe CHTN institutions that supply tissues and patient information to you as an investigator, and all CHTN divisions must follow their institutional policies. 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 for providing specimens with associated data, the CHTN implemented a Data Use Agreement. 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.
IRB Policy
The CHTN requires investigators to obtain Institutional Review Board (IRB) review and approval (if deemed necessary by their local IRB) before receiving specimens for their research. For commercial companies, this may not apply; see Human Subjects Agreement below.
IRB review can be achieved by one of the following:
- Utilization of the established IRB at their institution/commercial organization.
- Utilization of a local institution/organization if the investigator does not have an established IRB at his/her institution/organization.
- Utilization of 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 who do not have access to an IRB should contact CHTN.
All investigators 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.
Safety and Security of CHTN Investigator Data
The Cooperative Human Tissue Network (CHTN) takes the responsibility to protect the safety and security of an Investigator's research and personal data, such as applications, projects, tissue requests and data. The CHTN will not release Investigator's information to other CHTN Investigators or resources that are not directly related to the operations of the network. CHTN operates as a network and shares Investigator information only among the CHTN sites for the purpose of fulfilling an Investigator's request. For the evaluation of our program the CHTN also must disclose research abstracts to our funding resource, the National Cancer Institute (NCI).
Third-Party Transfers
Any transfer of samples, aliquots, derivatives, or associated clinical data to collaborating personnel or laboratories that are not under the direct supervision of the requesting PI requires approval by the CHTN. Download the instructions.
CHTN policy is that samples provided are to be used only by the laboratory and/or personnel under the direct control of the Principal Investigator listed on the application. As stated in the Investigator Agreement, any transfers or sharing of samples requires prior approval of the CHTN.
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 benefits 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 investigators should be encouraged to apply to the CHTN directly. Patient identity or other identifying information cannot be provided to investigators. This ensures complete confidentiality regarding the medical information of patients.
Other CHTN Resources
Agreement for Use of Tissue
The agreement between the CHTN division(s) and the Investigator regarding the appropriate use of the biospecimens.
Biohazard & Infection Control
Optimize your scientific operations with this guide, covering best practices for sample handling and storage
CHTN Biomarker Policy
The CHTN has set a policy that all five adult divisions will provide the following biomarkers free of charge to investigators upon request if they are not already a part of the pathology report. These biomarker methods conform to CAP CLIA standards.
Biospecimen Preservation and Collection Options
The attached document shows the biopreservation options that are available at the CHTN.
CHTN Acknowledgement Slide for Researchers
Example of how to appropriately acknowledge the CHTN in your research.
CHTN Bibliography
The CHTN Bibliography through February 2019.
Data Use Agreement
The Data Use Agreement is designed to permit the use of a Limited Data Set for research according to the Standards for Privacy of Individually Identifiable Health Information (Privacy Rule) 45 CFR Parts 160 and 164. All terms used in this agreement are as defined in the Privacy Rule.
Human Subjects Agreement
The recipient of CHTN tissue acknowledges that the conditions for the receipt of tissues are governed by the Institutional Review Boards (IRBs) of the CHTN, by the Department of Health and Human Services regulations for the protection of human subjects (45 CFR Part 46).