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 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 the 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 a human subjects Assurance from the Office of Human Research Protections, DHHS. The Assurance documents 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 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 and approval by his/her Institutional Review Board 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 specimens in accordance with the Common Rule, in which 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 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.

For specimens in which clinical outcome or other information is important, the CHTN attempts to obtain informed consent. This informed consent includes permission to use the tissues in studies of inheritable diseases (genetically transmitted), as well as the use of patients’ protected health care information. Thus, a HIPAA authorization is also requested. If patients decline the use of their specimens in research, these specimens are not utilized. If the patient cannot be contacted, the specimens are anonymized. If consent is obtained, the specimens are utilized in accordance with the extent of the consent.

For tissues in which clinical outcome and patient information is not important (e.g. normal tissues such as normal spleen), the CHTN does not attempt to obtain consent and all these specimens are anonymized.

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 will continue 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.

Last updated: 02/01/07. for comments or concerns about this web site please contact: Steve Marroulis at tissueresources@imsweb.com