- 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.
- 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.
- 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.