Establishing and Maintaining an Academic Biorepository

By Ashley, Mas Sonia; Goodman, Cra Ira | Journal of Research Administration, Fall 2015 | Go to article overview

Establishing and Maintaining an Academic Biorepository


Ashley, Mas Sonia, Goodman, Cra Ira, Journal of Research Administration


Introduction

Bio repositories are essential to research in order to advance the treatment of many diseases. Their products can assist researchers in the areas ofprevention and control and in providing personalized medicine to patients. Establishing the infrastructure for a biorepository requires significant efforts in strategic planning to effectively identify and request consent from participants as well as prepare for the proper collection, processing and storage of specimens while maintaining participant privacy rights (Ambrosone, Nesline, & Davis, 2006).

There are many aspects to a biorepository system. The operational aspects include the collection, processing, storage, retrieval and distribution of bio specimens; collection and management of clinical data; quality assurance and control; and biosafety and bio informatics system. The legal and ethical aspects include custodianship; informed consent from human subjects; privacy protections for individuals who donate biospecimens; researchers access to biospecimens and intellectual property and resource sharing ( National Cancer Institute, 2011). The business aspects involve the development of a business model that adequately incorporates building a recharge facility with proper rate user fee structure, procedures and tools to appropriately monitor funding, business plans and performance review to ensure effective management of the core facility. This article will highlight the role of biorepositories in cancer research and the practical steps taken at the Moores Cancer Center to administer and enhance the procurement, storage and distribution of human tissue samples as well as the business aspects including the rate setting, billing, financial monitoring, annual business plans and performance reviews.

Use of the Biorepository

It is now well known that biorepositories are a key resource for cancer research. It is therefore vital to have bio repositories in the Cancer Center as new therapies are developed and made available to patients to save and prolong lives. Their products can assist researchers in the areas ofprevention and control and in providing personalized medicine to patients.

Scientists have developed many ways to identify genes and their functions and have learned a great deal about the role they play in the origin and progression of diseases. With the help of biorepositories, scientists are able to analyze vast amounts ofclinical information about a patients health and diseases. Biorepositories can assist researchers to identify and validate ways to deliver drugs, identify how diseases progress and vary, and determine how different groups of patients respond to drugs. There are examples of how biospecimens can accelerate cancer research. Through the use of well-characterized and well-preserved tissue samples, a drug called trastuzumab (Herceptin®) was developed for the treatment of a genetically linked form of breast cancer Another drug called Gleevec®was originally developed for the treatment of Chronic Lymphocytic Leukemia, a form of blood cancer, but researchers found through the analysis of biospecimens collected from different tumor types that it also can be used for treatment of gastrointestinal stromal tumors and is now FDA approved forthat purpose (National Cancer Institute, 2015).

As the use of bio repositories increased, it created more collaboration among institutions and the establishment of large national databases. The existence of these large dispersed databases prompted the need for centralization at both the local institutional as well as the national level (Ginsburg, Burke, & Febbo, 2008). This ledto the creation ofthe "next generation" bio repositories (Fullerton, Anderson, Guzauskas, Freeman, & Fryer-Edwards, 2010). The next generation biorepository will provide great scientific benefits to the medical community but there are many challenges associated with its implementation. The new initiatives and research governance can make the establishment and maintenance of biorepositories ver)' difficult. …

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