Research repositories are used to store data and/or biospecimens for future research use, either by the research team who collected them or to share with other researchers. 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.

The purpose of establishing a formal research repository is to give the investigator the authority and responsibility for distributing data and/or specimens from the repository, to minimize the regulatory paperwork burden and to define future uses in a fashion that protects participants’ rights yet supports scientific inquiry.

This guidance applies to human subject research repositories established by UW-Madison investigators for the purpose of storing data and/or specimens for future research purposes.

Generally, the creation and maintenance of a research registry or repository requires IRB review and approval. Please see the submission requirements below. IRB review is not required for the development of a Quality Improvement or Quality Assurance database. However, if an investigator later wants to access the QI/QA database for research, IRB approval should be sought.

Data and biospecimen repositories may utilize retrospective or prospective data or specimens. For IRB purposes, data and specimens are collected “prospectively” if they do not exist at the time of the IRB’s initial review, even if the study team is collecting them weeks or months after they were created or obtained clinically. The IRB expects participant consent for prospective collection of data or biospecimens absent a very strong justification for a waiver.

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General Repository/Registry Guidelines

  1. The collection and storage of specimens/data becomes a research repository when there is a specific intention for the data/specimens to be used repeatedly for research purposes or stored for future research or shared with other investigators.
  2. The operation of any research repository requires standard continued oversight by the IRB.
  3. Revisions to a repository protocol must be approved by the IRB prior to implementation.
  4. Requests by a recipient investigator to access identifiable or coded data and/or specimens from any existing research repository require IRB approval. Secondary uses must be submitted to the IRB for review and comply with all requirements of the repository and terms of any usage.

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Submitting an Application for IRB Approval of a Research Repository

  1. Registry/Repository is Maintained at UW-Madison – When the database/repository is maintained at UW-Madison, a repository protocol must be submitted for review and approval by the IRB. The IRB has created HRP 503a-TEMPLATE PROTOCOL-Registries and Repositories to assist study teams. You should use this protocol template when submitting a repository application. In addition to checking applicable boxes within the template, you will need to modify template language to fit your procedures.
  2. Registry/Repository is Maintained Outside of UW-Madison – When an investigator is contributing data/specimens to a repository not held by UW-Madison, the UW-Madison IRB must approve at a minimum the collection protocol and consent process, unless the UW-Madison is ceding review to another site.
  3. General Repository Protocol Requirements – All repository protocols must include information regarding the following (see HRP 503a-TEMPLATE PROTOCOL-Registries and Repositories):
    • Purpose and Significance of the Repository
    • Governance and Oversight – The role of key personnel. Describe whether there will be a designated steering committee or custodian (e.g, who will decide what data may be shared; who will curate data for sharing), and the plan for sustaining the repository over time.
    • Data and/or Specimen Collection – Data/specimens to be included. Describe the source(s) of the data/specimens and the process of acquisition.
      • External sites – If some of the data/specimens have been or are to be collected at sites outside of UW-Madison for storage at UW-Madison, include a collection plan and, when appropriate, a consent document. Indicate conditions under which data/specimens may be accepted.
      • Consent – Describe how consent has been or will be obtained from subjects, or why a waiver of consent is justified.
        • Keep in mind that data collected and stored under a waiver may have more limitations on future use.
    • Security, Storage, and Management – How and where data/specimens will be stored and how the privacy of subjects and the confidentiality of data will be protected, including if a Certificate of Confidentiality will be obtained. The following minimum measures must be described in the repository protocol:
      • Coding – a method to code the data/specimens, including a process to protect/maintain the key to the code and limit access to the key. The coding system must be adequate to reduce the possibility of re-identification.
      • Data transfer security – methods to ensure confidentiality during the collection and release of data and specimens.
      • Location and housing of data/specimens.
    • Data/Specimen Access and Release – Mechanisms for release of data/specimens and what data elements will be shared. A complete description of the process for requesting and releasing data must be included. A statement should be made in the repository protocol that separate IRB approval/determination will be required for each specific human subject research activity that uses coded or identifiable data/specimens from the repository. Each study is considered to be a research activity that is separate from the repository itself.
    • Operating Procedures – How the repository will perform the following required activities:
      • Inclusion Criteria: identifying when and what material (data or/or identifiable specimens) is originally received.
      • Informed Consent: Documenting whether the person from whom the material was obtained provided consent or there was an IRB approved waiver of consent.
      • Withdrawal: Identifying data/samples for which consent has been withdrawn and how the repository will ensure no future use.
      • Prohibitions on Uses: Identifying data/samples which have limitations on future uses and ensuring that future uses are not contrary to those limits.
      • Transfer of Data or Specimens: If some of the data/specimens have been or are to be collected at sites outside of UW-Madison for storage at UW-Madison:
        • Certifying that the material collection protocol had IRB approval from the home institution. A copy of the approval letter should be submitted.
        • Any IRB approved consent forms for the collection of the material being submitted to the repository should be included with data/specimen submissions.
        • Securing submittal agreements from investigators placing data/specimens in the repository (e.g., MTAs, DUAs).
      • Release/Sharing: Securing data usage agreements from recipient investigators and
      • Ensuring that material transfer agreements are used when necessary for the transfer of biological materials.
    • Special Populations – justifications and safeguards for including vulnerable populations must be provided. Repositories/registries enrolling children should have a plan for reconsenting when they reach the age of 18.

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How to Avoid Repository Application Delays

The IRB frequently receives repository applications that lack sufficient detail for approval. This causes significant delays. Applications lacking sufficient details will be returned to pre-submission status without review.

Creation of a repository study requires a careful, detailed presentation of the study design. Below is a list of common problems that lengthen review time:

  1. Informed consent not addressed, including requests for waivers of informed consent for use of retrospective records;
  2. Misunderstanding the meaning of “prospective data” (see above for details);
  3. Sources of data/specimens are not clearly identified;
  4. Process for dissemination is not addressed.

Attempts to create both a repository and an umbrella application within one protocol frequently result in significant delays due to the complexity of both application types, along with missing and conflicting information. An umbrella application to conduct research using data from the repository should generally be submitted as a separate application from the repository.

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Defining Types of Repositories

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.

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Terminating a Repository

  1. When there is no intent to continue to operate a repository for future research or if the data/specimens are being transferred to another repository, the repository should be terminated via a study closure report.
  2. The study closure report must include the disposition of the data and samples, including details on transfer, donation or destruction of specimens or data in a secure way.

When applicable, a description of any communications with research participants regarding disposition of data and samples should be submitted for approval.

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