Recruitment Registry, Data Repository, and Tissue Repository Guidance

Version date: October 3, 2016

The purpose of this document is to classify various research models for storing data, specimens and images for future use. The HS IRBs use the terms recruitment registry, data repository, and tissue repository for these different models, although terminology can vary widely across institutions. Whether or not a repository or registry requires IRB review depends on what information will be collected and the purpose of storing this data.

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 Health Sciences (HS) IRBs prefer 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.

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 HS IRBs prefer use of the term ‘data repository’ over terms such as ‘databases’ and ‘registries.’

Tissue/Specimen Repository

A tissue repository (also known as a tissue bank) is a mechanism for maintaining tissue, blood, and other biological specimens for unspecified future use.

Registry-Repository Overview Table

The purpose of the table is to provide examples of scenarios in which study teams are creating, maintaining, sharing and/or using data, images, or tissues and the subsequent IRB requirements for these various scenarios. The table should be used in conjunction with this guidance information.

HIPAA Database Registration

Database Registration and Preparatory to Research Certification for Database Custodian is a form used by study teams to register a database with the UW-Madison Privacy Officer and, when applicable, for the database custodian to certify use of the database in preparation of a research protocol. If you are unsure whether your data repository required registration, please contact the UW-Madison HIPAA Privacy Officer.

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