Tissue and Data Repositories in support of WVU Research projects that will be maintained and managed at a WVU facility must be approved prior to the submitting a protocol application and conducting research.
Use of “Big Data” has become increasingly common in research over the past decade. As such, researchers may wish to aggregate data from multiple sources including, but not limited to, other institutions, clinics, or their own research. Researchers may wish to access the aggregate data for use in future research or to share with other colleagues in their field. Likewise, researchers may wish to store biological samples and tissues in a similar way. The information stored in registries or repositories may be used for either current research or future analyses that are yet unknown.
The U.S. Department of Health & Human Services (HHS), Office of Human Research Protections (OHRP) requires operation of data and tissue repositories be overseen by an IRB. The IRB must review and approve a protocol which specifies the methods used in the collection of the data or specimen(s), as well as how the information or samples will be shared. The protocol should also outline adequate provisions for protecting the privacy of subjects and maintaining the confidentiality of the data. OHRP recommends that a Certificate of Confidentiality be obtained to protect the confidentiality of repository contents.
If the tissue bank or database is established entirely or partially for research endeavors, or it will store information or specimens collected purely for research, WVU IRB oversight is required. If researchers plan to de-identify data from multiple protocols and combine them into a single data set or database, this procedure should be followed.
A repository, also known as a tissue bank, is a collection of identifiable, coded, or de-identified biological specimens that support, or will support, research related activities. Repositories are common in clinical practice and, if established and maintained for such purposes, does not require review or registration with the WVU IRB. However, WVU IRB review is required if the contents of the tissue bank will be used in current or future research.
A registry, also known as a database, is a collection of information arranged for ease and speed of search and retrieval. Registries can house either qualitative or quantitative data and do not necessarily need to be clinical in nature. Just like repositories, if a database is established and maintained at WVU for research purposes (current or future), then WVU IRB review and registration is required.