Cooperative Human Tissue Network (CHTN)
Encyclopedia
The Cooperative Human Tissue Network (the CHTN) was established in 1987 by the National Cancer Institute
in response to an increase in the demand for high quality biospecimens for cancer research
. The purpose of the CHTN is to stimulate, for the good of the public, cooperative efforts to collect and distribute human biospecimens and to thereby facilitate research utilizing those specimens. These activities are expected to encourage basic and developmental studies in many areas of cancer research
, including molecular biology
, immunology
and genetics
. The CHTN is not intended to be a human tissue bank
but may use limited banking as needed to meet specific requests and longer-term banking of targeted specimens to assure availability of rare and hard to obtain materials.
The CHTN has six divisions, five adult divisions and one pediatric division. These divisions are located at the following institutions:
s and autopsies
, which otherwise would be discarded. Malignant, benign, diseased and normal biospecimens are collected and distributed to both national and international investigators. In addition, remnant body fluids are available on some patients and limited histological services can be obtained by special arrangement. Requests for large sample sizes, large numbers of biospecimens, rare biospecimens or biospecimens in high demand may be served if they do not negatively impact the availability of biospecimens for other researchers.
(IRB) approval or exemption.
, 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.”
in the Department of Human and Health Services (DHHS)
, http://www.hhs.gov/ohrp/humansubjects/guidance/reposit.htm. The following policies and procedures govern collection of biospecimens and their distribution to researchers:
The CHTN is aware of and actively participates in national discussions of the legal and ethical issues relating to the research use of human specimens. The CHTN continues to review its procedures for compliance with applicable regulations and for consistency with any emerging consensus about the ethical collection and use of specimens for research.
National Cancer Institute
The National Cancer Institute is part of the National Institutes of Health , which is one of 11 agencies that are part of the U.S. Department of Health and Human Services. The NCI coordinates the U.S...
in response to an increase in the demand for high quality biospecimens for cancer research
Cancer research
Cancer research is basic research into cancer in order to identify causes and develop strategies for prevention, diagnosis, treatments and cure....
. The purpose of the CHTN is to stimulate, for the good of the public, cooperative efforts to collect and distribute human biospecimens and to thereby facilitate research utilizing those specimens. These activities are expected to encourage basic and developmental studies in many areas of cancer research
Cancer research
Cancer research is basic research into cancer in order to identify causes and develop strategies for prevention, diagnosis, treatments and cure....
, including molecular biology
Molecular biology
Molecular biology is the branch of biology that deals with the molecular basis of biological activity. This field overlaps with other areas of biology and chemistry, particularly genetics and biochemistry...
, immunology
Immunology
Immunology is a broad branch of biomedical science that covers the study of all aspects of the immune system in all organisms. It deals with the physiological functioning of the immune system in states of both health and diseases; malfunctions of the immune system in immunological disorders ; the...
and genetics
Genetics
Genetics , a discipline of biology, is the science of genes, heredity, and variation in living organisms....
. The CHTN is not intended to be a human tissue bank
Tissue bank
A Tissue Bank, as used in this article, is a term most commonly used to describe an establishment that collects and harvests human cadaver tissue for the purposes of medical research and education....
but may use limited banking as needed to meet specific requests and longer-term banking of targeted specimens to assure availability of rare and hard to obtain materials.
The CHTN has six divisions, five adult divisions and one pediatric division. These divisions are located at the following institutions:
- Hospital of the University of PennsylvaniaHospital of the University of PennsylvaniaThe Hospital of the University of Pennsylvania is a hospital affiliated with the University of Pennsylvania Health System located in the University City section of West Philadelphia. The hospital was founded at its current location in 1874 by the University of Pennsylvania School of Medicine,...
- CHTN Eastern Division - University of VirginiaUniversity of VirginiaThe University of Virginia is a public research university located in Charlottesville, Virginia, United States, founded by Thomas Jefferson...
- CHTN Mid-Atlantic Division - Ohio State UniversityOhio State UniversityThe Ohio State University, commonly referred to as Ohio State, is a public research university located in Columbus, Ohio. It was originally founded in 1870 as a land-grant university and is currently the third largest university campus in the United States...
- CHTN Midwestern Division - Nationwide Children's HospitalNationwide Children's Hospital (Columbus)Nationwide Children’s Hospital is a primary pediatric hospital in Columbus, Ohio, with more than 950 medical staff members and over 6,800 total employees. In recent years, the hospital has been ranked as one the best hospitals in the United States by US News & World Report...
- CHTN Pediatric Division - University of Alabama at BirminghamUniversity of Alabama at BirminghamThe University of Alabama at Birmingham is a public university in Birmingham in the U.S. state of Alabama. Developing from an extension center established in 1936, the institution became an autonomous institution in 1969 and is today one of three institutions in the University of Alabama System...
- CHTN Southern Division - Vanderbilt UniversityVanderbilt UniversityVanderbilt University is a private research university located in Nashville, Tennessee, United States. Founded in 1873, the university is named for shipping and rail magnate "Commodore" Cornelius Vanderbilt, who provided Vanderbilt its initial $1 million endowment despite having never been to the...
- CHTN Western Division
CHTN biospecimens
The CHTN obtains biospecimens from routine diagnostic or therapeutic surgical resectionSegmental resection
Segmental resection is a surgical procedure to remove part of an organ or gland. It may also be used to remove a tumor and normal tissue around it. In lung cancer surgery, segmental resection refers to removing a section of a lobe of the lung.- External links :* entry in the public domain NCI...
s and autopsies
Autopsy
An autopsy—also known as a post-mortem examination, necropsy , autopsia cadaverum, or obduction—is a highly specialized surgical procedure that consists of a thorough examination of a corpse to determine the cause and manner of death and to evaluate any disease or injury that may be present...
, which otherwise would be discarded. Malignant, benign, diseased and normal biospecimens are collected and distributed to both national and international investigators. In addition, remnant body fluids are available on some patients and limited histological services can be obtained by special arrangement. Requests for large sample sizes, large numbers of biospecimens, rare biospecimens or biospecimens in high demand may be served if they do not negatively impact the availability of biospecimens for other researchers.
Investigators who wish to receive CHTN biospecimens
Investigators must complete a standard CHTN application which includes a brief description of their research project, funding information, and biospecimen requirements. In addition, a researcher must submit documentation of his/her Institutional Review BoardInstitutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
(IRB) approval or exemption.
Use of CHTN biospecimens
The intent of the CHTN is to encourage research using human biospecimens for the good of the public rather than for private gain. 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. proteinProtein
Proteins are biochemical compounds consisting of one or more polypeptides typically folded into a globular or fibrous form, facilitating a biological function. A polypeptide is a single linear polymer chain of amino acids bonded together by peptide bonds between the carboxyl and amino groups of...
, mRNA or DNA
DNA
Deoxyribonucleic acid is a nucleic acid that contains the genetic instructions used in the development and functioning of all known living organisms . The DNA segments that carry this genetic information are called genes, but other DNA sequences have structural purposes, or are involved in...
). 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.”
Policies and procedures for the protection of human subjects
The CHTN has established operating policies and procedures that protect the subjects from whom CHTN biospecimens are obtained. These policies and procedures are consistent with current regulations and guidance for repositories from the Office of Human Research Protections (OHRP)Office for human research protections
The Office for Human Research Protections is a small office within the United States Department of Health and Human Services that deals with ethical oversight of clinical research conducted by the department, mostly through the National Institutes of Health.The office's primary duty is the...
in the Department of Human and Health Services (DHHS)
United States Department of Health and Human Services
The United States Department of Health and Human Services is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America"...
, http://www.hhs.gov/ohrp/humansubjects/guidance/reposit.htm. The following policies and procedures govern collection of biospecimens and their distribution to researchers:
- CHTN biospecimens are derived from material that is removed as part of routine medical care or collected as autopsy biospecimens; all biospecimens are collected in accordance with state and local laws. Only residual material not needed for patient care is distributed for research.
- Every CHTN institution has obtained a human subjects Assurance from the OHRPOffice for human research protectionsThe Office for Human Research Protections is a small office within the United States Department of Health and Human Services that deals with ethical oversight of clinical research conducted by the department, mostly through the National Institutes of Health.The office's primary duty is the...
of the DHHSUnited States Department of Health and Human ServicesThe United States Department of Health and Human Services is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America"...
. The Assurance documents are an agreement stating that the institution will comply with Federal human subject’s 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 privacyPrivacyPrivacy is the ability of an individual or group to seclude themselves or information about themselves and thereby reveal themselves selectively...
and confidentialityConfidentialityConfidentiality is an ethical principle associated with several professions . In ethics, and in law and alternative forms of legal resolution such as mediation, some types of communication between a person and one of these professionals are "privileged" and may not be discussed or divulged to...
. The approvals are reviewed by the IRB every year. - Donor identities or other identifying information is never provided to researchers. Each biospecimen is assigned a unique code and every CHTN employee has signed an agreement to protect patient privacy and confidentiality. Also each employee is trained in human subjects, IRB and HIPAA issues/regulations.
- Each researcher must document review and approval by his/her IRB of the specific research proposed or submit a signed agreement form stipulating the terms and conditions for the use of the specimens. The researcher and his or her institutional official must also sign an agreement form indicating that they will use biospecimens only for the purposes specified in the application, that they agree not to attempt to obtain information identifying the individuals providing biospecimens to the CHTN and that they will not share the biospecimens with third parties. This approach is consistent with current OHRP guidance for tissue repositories. Investigators at institutions that DO NOT have an 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 or use an external accredited IRB.
The CHTN is aware of and actively participates in national discussions of the legal and ethical issues relating to the research use of human specimens. The CHTN continues to review its procedures for compliance with applicable regulations and for consistency with any emerging consensus about the ethical collection and use of specimens for research.
Sources
- http://www.cancer.gov/search/results.aspx
- http://prostatenbnpilot.nci.nih.gov/blue_app_n.asp
- http://resresources.nci.nih.gov/database.cfm?id=1193