The IRB uses the terms recruitment registry, data repository, and biospecimen repository for these various research tools/resources, although terminology can vary widely across institutions. Generally, the creation and maintenance of a research registry or repository requires IRB review and approval. A protocol template for the creation and maintenance of research registries and repositories is available for researchers to use when preparing to submit to the IRB (see HRP 503a-TEMPLATE PROTOCOL-Registries and Repositories). IRB review is not required for the development of a Quality Improvement or Quality Assurance database.

Recruitment Registry

Generally, a registry is a tool used to identify and track a group of individuals that have similar characteristics. The characteristics can vary widely (e.g., disease, genetic make-up, health behaviors, surgical procedures), but the intent of the registry is to track and classify these groups of individuals. The IRB prefers the use of the word “registry” to be used to describe lists of people along with limited personal and, when applicable, medical information. The primary use of these lists is to provide investigators with pools of potential study volunteers, as in recruitment registries. Recruitment registries generally require IRB approval, both for the creation and maintenance of the registry itself, as well as for future projects that wish to use a registry as a recruitment method.

Data Repository

A data repository is a tool used to compile a set of individual subject/patient data that will be used for analysis purposes. A data repository generally has data added to it in an on-going manner that is stored long-term. Data in the repository are intended to be distributed to multiple users and subsequently used for ongoing analysis purposes. The IRBs prefer use of the term ‘data repository’ over terms such as ‘databases’ and ‘registries.’ If the primary intent of the repository is for use in future research projects, IRB review and approval is required, and may be required for the subsequent use of the data from the repository.

Biospecimen/Tissue Repository

A biospecimen repository (also known as a tissue bank) is a mechanism for maintaining tissue, blood, and other biological specimens for unspecified future use. These repositories typically involve the collection and long-term storage of tissue and often corresponding data to be used primarily for future research projects. Tissue to be stored in the repository can be collected retrospectively, prospectively, or both. Tissue repositories can include tissue collected from other research protocols or clinical procedures. IRB review and approval is required for banking of biospecimens and may be required for the subsequent use of the specimens from the repository.