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.
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.
Definition: This refers to the practice of storing information about people for the purposes of contacting them about specific research opportunities in the future. These are often set up by departments or research groups who have ongoing recruitment initiatives for many different studies and find it useful to have a pool of potential subjects who may be eligible for them. Information collected and stored in the registry varies and can be limited to name and contact information, or can include additional information, such as health history, disease status (if for example, it is a registry only for asthma studies), and even some preliminary screening information.
Maintaining a one-time list of subjects who participated in a particular research study and are willing to be contacted for future research does not typically constitute a recruitment registry. Rather, this should be reflected in the IRB application and consent form of the particular research study. However, if this list of subjects is going to be added to over time, used by more than one researcher and/or subjects are specifically recruited to be included on the list, then this likely constitutes a recruitment registry that requires IRB review and oversight. In addition, under VA regulations, retaining a subject list is considered a recruitment registry.
IRB Review Requirements: 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. The IRB would expect informed consent be obtained to include an individual’s information in a recruitment registry and to be contacted about future research opportunities. For tips on submitting a recruitment registry application to the IRB, please see the guidance.
HIPAA Requirements: Under the HIPAA Privacy Rule, permission is required for use of individually identifiable health information (aka protected health information). The IRB would expect authorization be obtained from subjects for storage and use of their protected health information in the recruitment registry.
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.’
Research Data Repository Definition: These repositories typically involve the collection and long-term storage of data to be used primarily for future research projects. Data to be entered into the repository can be collected retrospectively, prospectively, or both. Data repositories can include data collected from other research protocols or clinical data. In addition, images can be included as part of the data.
In contrast to Research Data Repositories, some repositories (or databases) involve collating information within an institution with the primary intent to improve system performance at a clinic or department level. Although data from these repositories may be used for research, their creation does not constitute a research activity when the primary intent is clinical use. Generally, IRB review is not required for the creation and maintenance of clinical Quality Improvement/Quality Assurance (QI/QA) data repositories. See the Guidance on Research vs. Quality Improvement and Program Evaluation for additional guidance on this topic. However, the subsequent use of data from these repositories for research purposes requires IRB review. In addition, a clinical database that contains PHI should be registered with the HIPAA Privacy Officer using the Database Registration and Preparatory to Research Certification for Database Custodian form.
IRB Review Requirements: If the primary intent of the repository is for use in future research projects, IRB approval is required. The IRB would typically expect informed consent be obtained to include an individual’s information in the research repository prospectively. The IRB may waive informed consent in certain situations in which the data are being collected retrospectively. For tips on submitting a data repository application to the IRB, please see the guidance. In addition, VA regulations include additional requirements for maintaining a research repository.
HIPAA Requirements: Under the HIPAA Privacy Rule, permission is required for use of individually identifiable health information. The IRB would expect written authorization be obtained from subjects for storage and use of their protected health information in the research repository. The IRB may waive authorization in certain situations in which data is being collected retrospectively.
Use of Data from Repository: IRB approval is generally required both for the creation of a research repository, as well as any future projects that wish to access the repository. The latter must be submitted separately from the Research Repository application for IRB review and approval. The IRB reviews subsequent research involving banked data to determine whether the use of the data raises any ethical concerns and whether explicit consent and HIPAA authorization was obtained from the individuals for the use of their data in research and the particular research that is proposed. Study teams who wish to incorporate specific analysis and/or aims into their repository application should consult with the HS IRBs Office prior to submission.
A tissue repository (also known as a tissue bank) is a mechanism for maintaining tissue, blood, and other biological specimens for unspecified future use.
Research Tissue Repository Definition: 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: Specific IRB approval is required for banking of specimens. An investigator can obtain IRB review of a tissue repository either through a stand-alone application (e.g. for the creation and maintenance of a tissue bank) or, if the specimen collection occurs in conjunction with a specific research project, by explicitly building into the IRB application the intent to store tissue for future use. Researchers are typically expected to obtain informed consent from subjects for the inclusion of their specimen(s) in a bank for future use. For tips on submitting a specimen repository application to the IRB, please see the guidance. In addition, VA regulations include additional requirements for maintaining a research repository.
HIPAA Requirements: Under the HIPAA Privacy Rule permission is required for use of any corresponding individually identifiable health information (aka protected health information). Authorization from subjects for each new use of their protected health information for research purposes in conjunction with the tissue must be obtained or a waiver of such authorization sought from the IRB for a use for which written authorization was not previously obtained.
Use of Tissue from a Repository: The IRB reviews subsequent research involving banked specimens to determine whether the source of the samples raises any ethical concerns and whether explicit consent and HIPAA authorization was obtained from the individuals for the use of their specimens in research and the particular research that is proposed.
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