Research Regulations for the Residual Tissue Repository Program
On this page:
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Institutional Review Board (IRB) Procedures
- Material Transfer Agreement (MTA) Procedures
- Confidentiality and Privacy
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Because repositories include protected health information, access to and maintenance of specimen-associated information must comply with relevant HIPAA provisions. Relevant issues should be addressed in the application submission.
NIH has developed the following guide regarding the HIPAA Privacy rule on research repositories: Research Repositories, Databases, and the HIPAA Privacy Rule (PDF).Institutional Review Board (IRB) Procedures
Because the Residual Tissue Repository (RTR) Program maintains biospecimens of human subjects, it is necessary for an IRB to examine and review all research proposals that require the use of samples from the RTR database. When a proposal is submitted to the RTR Program for review, NCI personnel will schedule an IRB to consider the study and ensure that it abides by the various federal regulations, state laws, institutional policies, and rules of confidentiality that govern and protect research that involves the use of biospecimens. NCI’S IRB will work with researchers to protect the rights and welfare of human research subjects recruited to participate in research activities conducted. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction.
The US Department of Health and Human Services Office for Human Research Protections (OHRP) has detailed instructions on the required elements of written IRB procedures and the regulations for the protection of human subjects. This information can be found in Guidance for Written IRB Procedures.
In addition to IRB Procedures and regulations for the protection of human subjects, OHRP has also developed Guidance on Research Involving Coded Private Information or Biological Specimens.
Material Transfer Agreement (MTA) Procedures
Definition and Purpose
Material Transfer Agreements (MTAs) are contractual documents used for the acquisition of various biological and research materials, and occasionally data, developed by nonprofit, government and private industry. In order to ensure that MTAs meet NIH/NCI policies, MTAs will be reviewed to ensure compliance with policies on sharing of research tools. MTAs have been developed for transfer of specimens from registries and for distribution of TMA slides.
Procedure for Incoming MTA – For Materials Received by SEER Registries
- Complete the incoming submission form and sign it.
- Attach signed submission form to MTA with any pertinent compliance letters and supporting documentation and send to below address.
Procedure for Outgoing MTA – For Materials Provided by SEER Registries
- Complete the outgoing submission form and sign it.
- Complete our MTA and sign it. Signatures should also include all collaborators. No one who has not signed the MTA should handle specimens and/or data.
- Attach signed submission form to MTA and forward all documents to us for counter signature.
Confidentiality and Privacy
All confidentiality and privacy procedures used by the SEER Program will be followed in generation and use of these TMAs. Specifically, no personal identifying information will be sent by the SEER Program cancer registries to the NCI TARP Laboratory. Similarly, if due to small numbers of cases with particular characteristics providing non personal identifying information on these characteristics could facilitate identification of the cancer case, the information will be aggregated for all cases so as to make this improbable, or the information will not be provided for cases in question. Similarly, no personal identifiers will be made available to recipients of TMA slides. In the case where information associated with a TMA requires updating to facilitate research such updating will be performed by a contractor. All identifiers will be removed and relevant cell sizes (with respect to total SEER data for the three participating registries) will be checked before de-identified information is supplied to the recipient of the TMA slides. Aggregated socio-economic status (SES) data will be made available at the census tract level.
