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HIS Breast Cancer Awareness is a 501(C)3 non-profit organization supporting the awareness and education of male breast cancer survival rate and support, breast cancer in men risk factors, male breast cancer statistics, male breast cancer symptoms, male breast cancer treatment, signs and symptoms of male breast cancer lump, causes, survival, ribbon, ICD 10, BRCA, BRCA2 and breast cancer genetics in men. HISbreastcancer.org is an educational website supporting male breast cancer coalition. All information contained herein is not a substitute for medical advice and/or treatment. We are not physicians. Please consult your physician for any medical concerns as our information is not intended for any diagnoses. We do not assume any liability for the accuracy or usefulness of any information on this web site.

 

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September 28, 2016

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Biorepository-Human Tissue Samples for Research

 

A biorepository is a laboratory facility devoted to the processing and storing of human tissue samples and other animal samples for use by third party institutions. The purpose of a biorepository is to maintain the biological samples and related information for future use in research. They assure the quality of the specimens and manage the distribution and accessibility of the samples in its inventory.

There are four main operations that a biorepository conducts: collection, processing, storage, and distribution of human tissue samples (or other animals depending on the facility). 

 

Biorepositories are a crucial part of our modern-day cancer research efforts. They continue to aid in the advancement of the complex diseases cure.

They can help in such things as, but not limited to:

·      disease prevention

·      disease control

·      the personalization of cancer therapy

 

The establishment of a biorepository is no easy task, it requires multiple parties and a variety of assets, including, inter alia:

·      strict consent from participants

·      the preparation of equipment necessary for tissue sample collection

·      a strict adherence to specimen processing protocols

·      ensure accurate specimen storage conditions are met

·      maintaining the anonymity of participants 

 

The operational requirements of establishing a biorepository are as follows:

·      the correct collection, processing, and storage of specimens

·      retrieval and distribution of biospecimens

·      collection and management of clinical data

·      the quality assurance and control of biospecimens

·      the adherence to the system of biosafety and bioinformatics

 

Biorepositories have been the subject of many legal and ethical debates, some of these include issues surrounding:

·      custodianship

·      informed consent from participants

·      protection of privacy from donors

·      access for researchers to biospecimens

·      access for researchers to intellectual property

·      resource sharing between researchers

 

The business aspects of a biorepository will include:

·      the development of a business model that has a proper rate user fee structure

·      having procedures and tools that monitor funding

·      having business plans and performance reviews that ensures that the core facility is effectively managed

 

USE OF THE BIOREPOSITORY

Biorepositories play a vital role in cancer research. Their role within cancer centers is crucial, new cancer therapies are being discovered and tested all the time, and their presence guides these efforts. They help improve patients’ prognosis. Researchers have discovered various ways to identify genes and their roles in the progression and origin of many diseases. Biorepositories have helped scientists achieve some of the following:

·      the analysis of a vast amount of clinical data pertaining to a patient’s health and their diseases

·      Identifying and validating new methods for drug delivery

·      monitoring the progression of diseases

·      Determining how different population groups respond to therapy

 

There are many examples of the successful use of biospecimens in the acceleration of cancer research. High quality and well-preserved specimens were used to develop a drug called Trastuzumab. This drug has been used for the treatment of a form of genetically linked breast cancer. Another example of its successful use was in the development of a drug known as Gleevec that was developed for chronic lymphocytic leukemia that was also discovered to be successful in the treatment of gastrointestinal stromal tumors.

 

As more biorepositories are established, an increase for institutional collaboration is required, so to continue the building of national databases. The need for centralization, locally and nationally, of these vastly large databases is very important for the progress of cancer research. New next-generation biorepositories are being developed worldwide to aid the medical community, but ethical issues remain prevalent, these include:

·      Privacy

·      Institutional review

·      Informed consent

·      Data stewardship

 

Extreme measures and innovative approaches are now required for data security and research oversight. Alternative methods in obtaining consent for participation in biorepositories will enable an ongoing involvement of participants if ways of re-contacting participants are developed. Data stewardship should be observed while institutions should be mandated to adopt research governance mechanisms. A centralized Institutional Review Board approval is also required to ensure the consistency and expedited access to samples. Institutions are required to protect their participants and to establish a way to maintain, monitor, and use donated samples in the most efficient way.

 

CHALLENGES FACED BY BIOREPOSITORIES

Setting up a successful biorepository has many challenges such as:

·      Establishing a quality management program

·      Standardizing and maintaining high-quality biospecimens

·      Ensuring quality assurance, control, informed consent, protection of privacy, access, and ownership of biospecimens

·      Setting up of administration and management of the biorepository

·      Finding the right personnel with the proper experience and certification

·      Finding equipment for the biorepository to reduce risks that may jeopardize biospecimens

·      Establishing regulatory considerations for shipping biospecimens that adhere to domestic and international transport regulations

·      Difficulty associated with the acquisition of participant samples

·      Securing continued financial support to sustain the operations of the biorepository

 

EVALUATION OF THE SUCCESS OF THE BIOREPOSITORY

It’s important that biorepositories and their procedures are continually evaluated, this can be achieved through:

·      Examining the number of users

·      Determining the number of publications that cite the biorepository

·      Examining the dollar volume of business

·      Looking at user satisfaction surveys

·      Analyzing the overall results of research and operations that stem from biorepositories

If the biorepository can provide high-quality biospecimens while meeting institutional guidelines on legal, operational, and ethical matters a biorepository can be considered successful.

Opportunities are offered to researchers to expand the treatment and management of cancers via personalized medicine. Biorepositories are changing how clinicians and physicians think about cancer and delivery of treatment to patients. Instead of focusing on getting the diagnosis right, researchers are now also looking to further characterize the tumor specifically, so treatments can be tailored to specific patients. The success of biorepositories is measured through their role and contribution. This is done by examining evidence in reports that cite biospecimens. The ultimate goal is for the furthering of treatment options for patients.

 

CONCLUSION

Biorepositories play a significant and crucial role in the field of biomedical research, especially in that of cancer research. Although establishing and managing biorepositories comes with many challenges, but results show that their role has led to enhanced and improved diagnosis, treatment, and prognosis for many patients.

 

 

This article was provided by Geneticist Inc., a next-generation biorepository based in Los Angeles that plays a pivotal role in the discovery of cancer treatment options. Follow us on LinkedIn or check out our website.

 

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