Research Regulations for the Residual Tissue Repository Program

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Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Research based on the SEER Residual Tissue Repository must comply with HIPAA provisions.

NIH has developed guidance on HIPAA Privacy rules for repositories: Research Repositories, Databases, and the HIPAA Privacy Rule [PDF - 271 KB].

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Institutional Review Board (IRB) Procedures

Because the Residual Tissue Repository (RTR) Program maintains biospecimens of human subjects, IRB approval is expected for all research proposals involving RTR resources.

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 ProceduresExternal Web Site Policy.

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 SpecimensExternal Web Site Policy.

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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 related data from an institution. In order to ensure that MTAs meet NIH/NCI and SEER registry 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.

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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 case identifying information is provided by the SEER cancer registries. If small numbers of cases have particular characteristics that could enable identification of an individual case, the information is routinely suppressed.

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