Establishing and maintaining an academic biorepository.

Author:Ashley, Sonia
 
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Introduction

Biorepositories are essential to research in order to advance the treatment of many diseases. Their products can assist researchers in the areas of prevention 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 biospecimens; collection and management of clinical data; quality assurance and control; and biosafety and bioinformatics system. The legal and ethical aspects include custodianship; informed consent from human subjects; privacy protections for individuals who donate biospecimens; researcher's 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 biorepositories 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 of prevention 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 of clinical information about a patient's 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[R]) was developed for the treatment of a genetically linked form of breast cancer. Another drug called Gleevec[R] 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 for that purpose (National Cancer Institute, 2015).

As the use of biorepositories 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 led to the creation of the "next generation" biorepositories (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 very difficult. Institutions have to deal with many ethical and regulatory issues in the areas of privacy, institutional review, informed consent and data stewardship. In the area of privacy, anonymization (personal information codification but with the secured retention of information linking the data to the subject) is no longer sufficient to protect the privacy of the participants. As such, institutions are required to provide extreme measures to control and retain coded identifiers with innovative approaches to data security and oversight of the research. Consistent approaches to institutional review across institutions are essential with regard to the cooperative understanding of the use and management of data. It is critical that alternative methods of obtaining consent for biorepository participation allow an on-going involvement of research subjects by developing ways of re-contacting the participants through the use of various communication tools. Stewardship of data should be carefully observed and institutions are mandated to adopt the defined research governance mechanisms. Applying standardized specimen and data collection procedures mitigates the process for obtaining and properly preserving high quality specimens (Hullseik, George, & Brown, 2011). In addition, a centralized Institutional Review Board approval is necessary to ensure consistency and expeditious access to the samples. Institutions have a moral obligation to protect trial participants and to establish a system in which samples that are donated are carefully maintained, monitored and used in the most efficient way.

Major Challenges Facing Biorepositories

Setting up a quality management program is one of the major challenges in creating and maintaining a successful biorepository. It has been shown that the most extensive impediment to the effective use of biorepositories is the lack of standardization in maintaining high-quality biospecimens. Institutions are faced with ethical, legal and policy issues on many different aspects involving quality assurance and control, informed consent and privacy protection, access and ownership of specimens. Providing administration and management structure that can address these major issues is difficult and challenging. The National Cancer Institute (NCI) established the Biorepository Coordinating Committee (BCC) and the Office of Biorepositories and Biospecimen Research (OBBR) which provided standardized procedures addressing the operational, ethical and legal aspects of establishing and maintaining biorepositories. They also provided best practices used by biorepositories around the country.

Some of the operational and research challenges that a biorepository faces are personnel, equipment and shipping of samples. The complex operations of the biorepository require that staff have specialized skills and experience. As such, personnel turnover is a major concern. The cost of losing trained employees is very high in terms of dollars and productivity. The biospecimens are stored under controlled temperature and any equipment breakdown such as a power failure will jeopardize the integrity of the samples. This is also true with the bioinformatics systems that support the databases which maintain the sample records. There are cases when biospecimens are shipped and there are regulatory considerations when shipping biospecimens. A biorepository should follow domestic and international transport regulations imposed by the International Air Transport Association. All biorepository personnel are certified to receive, handle, package and distribute human infectious substances and biohazardous materials. Occupational Safety and Health Administration (OSHA) regulations on toxic and hazardous substances are consulted to determine whether a substance requires a hazardous label. Shipping breakdowns such as mislabeling of samples or improper packaging can cost large amounts of money and the loss of valuable research resources to the institution.

Biorepositories can also face difficulty in acquiring samples from participants. One of the common reasons why a person would want to participate in a study is the lack of generally accepted therapy or the partial effectiveness of the experimental therapy available to patients. Participating in a clinical study might offer the patient a new alternative to standard treatment before it will be available to the public. For example, Chronic Lymphoma Leukemia (CLL) is a type of cancer and although many patients suffer from this disease, patient participation in the study is limited. For some people with CLL the disease grows slowly and they don't seek treatment until the disease is in its advanced stages. This contributes to the limited number of patients willing to participate in the study. Many patients do not know they have CLL. The progress of the research is dependent upon the number of samples collected and the frequency of donation. In addition, the collection of samples at different times is imperative to examine longitudinal changes at the various stages of the disease. Limited resources such as nurses/staffing and scheduling conflicts present difficulties and missed opportunities for patients to participate. Coordination of patient visits can be a challenge as some patients do not live locally and their availability is limited.

The last but not least of the major challenges is securing continued financial support to sustain the long term operations of the biorepository. Managing a biorepository requires infrastructure that usually involves different sources of support. It requires financial flexibility to meet emerging research needs. Institutions need to be creative in finding funding sources to continuously support the infrastructure of its biorepository not just for a limited time but also for the long-term commitment. The funds can come from grants, institutional support...

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