The Significance of Biobanking in the Sustainability of Biomedical Research: A Review.

Biobank, defined as a functional unit for facilitating and improving research by storing biospecimen and their accompanying data, is a key resource for advancement in life science. The history of biobanking goes back to the time of archiving pathology samples. Nowadays, biobanks have considerably improved and are classified into two categories: diseased-oriented and population-based biobanks. UK biobank as a population-based biobank with about half a million samples, Biobank Graz as one of the largest biobanks in terms of sample size, and The International Agency for Research on Cancer biobank as a specialized the World Health Organization cancer agency are few examples of successful biobanks worldwide. The present review provides a history of biobanking, and after presenting different biobanks, we discuss in detail the challenges in the field of biobanking and its future, as well. In the end, ICR biobank, as the first cancer biobank in Iran established in 1998, is thoroughly described.

Frederik Ruysch (1638-1731): Historical perspective and contemporary analysis of his teratological legacy.

The Peter the Great Museum of Anthropology and Ethnography (Kunstkamera) in Saint Petersburg is the oldest museum in Russia. It keeps the remains of the anatomical collection of the world-famous 17th century Dutch anatomist Frederik Ruysch. This unique collection was bought and shipped in 1717 by Czar Peter the Great, and presently still comprises more than 900 specimens, a modest number of which concerns specimens with congenital anomalies. We searched for teratological clues in the existing collection and in all his descriptions and correspondence regarding specimens and cases he encountered during his career as doctor anatomiae and chief instructor of the surgeons and midwives in Amsterdam. A total of 63 teratological specimens and case descriptions were identified in this legacy, including some exceedingly rare anomalies. As it turns out, Ruysch was the first to describe several of the conditions we encountered, including intracranial teratoma, enchondromatosis, and Majewski syndrome. Although his comments pose an interesting view on how congenital anomalies were scientifically perceived in early 18th century Europe, Ruysch mostly refrained from explaining the causes of the conditions he encountered. Instead, he dedicated himself to careful descriptions of his specimens. Almost 300 years after his demise, Ruysch's legacy still impresses and inspires both scientists and lay men. © 2016 The Authors. American Journal of Medical Genetics Part A Published by Wiley Periodicals, Inc.

The role of biobanks in elucidating prevalent genetic diseases in Saudi Arabia.

Biobanking entails large-scale collection of human biological specimens that are linked to the donors' health and personal information, and has several applications in clinical research. Human biological specimens, such as blood, urine and tissue, have become immensely important to medical research: they offer a valuable source of genetic material that researchers can use to identify disease-associated genetic variation and to determine interactions between genes and environmental factors. Identification of genetic contributions to disease can lead to the development of new diagnostic tests and targeted treatments. Over the last decade, both common diseases and rare genetic disorders have been reported in Saudi Arabia. The need to generate extensive genetic data on these diseases has led to the establishment of several Saudi Arabian biobanks. Fortunately, these vital efforts have the support of the Saudi Government and researchers. However, the success of any biobank also requires public support and the willingness of the population to donate their biological material along with information on their medical records. Thus, the Saudi public needs to be informed of the benefits of maintaining biobanks, their participation needs to be encouraged through donation of biological material, and any public concerns regarding the confidential treatment of medical data need to be addressed. This article reviews the most common genetic diseases identified in the Saudi population, it describes biobanks and it examines how biobanks can support biomedical research in the area. Moreover, this article proposes measures that might help to increase public awareness of biobanks and the preparedness of the Saudi Arabian population to donate biological material.

A Troubled Past? Reassessing Ethics in the History of Tissue Culture.

Recent books, articles and plays about the 'immortal' HeLa cell line have prompted renewed interest in the history of tissue culture methods that were first employed in 1907 and became common experimental tools during the twentieth century. Many of these sources claim tissue cultures like HeLa had a "troubled past" because medical researchers did not seek informed consent before using tissues in research, contravening a long held desire for self-determination on the part of patients and the public. In this article, I argue these claims are unfair and misleading. No professional guidelines required informed consent for tissue culture during the early and mid twentieth century, and popular sources expressed no concern at the widespread use of human tissues in research. When calls for informed consent did emerge in the 1970s and 1980s, moreover, they reflected specific political changes and often emanated from medical researchers themselves. I conclude by arguing that more balanced histories of tissue culture can make a decisive contribution to public debates today: by refuting a false dichotomy between science and its publics, and showing how ethical concepts such as informed consent arise from a historically specific engagement between professional and social groups.

An Overview of Biorepositories-Past, Present, and Future.

The collection, storage, and distribution of biological materials for research and improving health have been employed for more than a century. Biorepositories have been used to maintain and reallocate these specimens. Historically, the Department of Defense (DoD) has been maintaining biorepositories and using the materials stored to expand our understanding of diseases and for developing medical countermeasures since the Civil War. Other U.S. Government and nongovernmental organizations are also engaged in curating human and other samples for future studies, as are organizations in other countries. The reasons for collection and the possible uses of specimens maintained within repositories have changed with the advent of novel technologies and the genomics discipline. However, over the years, many of the issues faced by repositories have remained largely the same, although of increased importance more recently because of limited funding and enhanced ethical concerns. These issues include what samples to collect; how to collect, transport, and store the samples; legal and ethical matters relating to sample collection and use; durability of analytes of interest in stored specimens; assessing the quality of stored specimens and providing researchers with statements of specimen quality; costs; maintenance and sustainability of the repository; and, implementing and maintaining laboratory quality programs and possibly accreditation. National and international scientific groups are working to identify and define best practices, but universal standards and practices remain challenges for the future. To begin addressing the above issues, the DoD implemented several initiatives, which are described elsewhere in this Military Medicine Supplement. Additionally, staff members working on the issues saw potential value in identifying other biorepository groups and similar work being done by these groups with the expectation of developing lines of communication and, eventually, even collaboration in establishing universal standards and practices. The repositories identified are briefly discussed in this report.

The Denver Serum Bank.

At the University of Colorado, Dr. Gordon Meiklejohn pursed the study of influenza and other respiratory pathogens for an unbroken period of 40 years, under the auspices of the Commission on Influenza of the Armed Forces Epidemiological Board through a series of contracts with the U.S. Army Medical Research and Development Command. Sera, throat washings, and other specimens for diagnosis were sent to Dr. Meiklejohn's laboratory. After serologic and virologic studies were carried out, aliquots of sera and virus samples were logged in and frozen. Sera were stored at -20°C and virus specimens at -70°C. These specimens became known as the Denver Serum Bank. The Bank supported military research programs and other researchers nationally and internationally until the 1990s when lacking of funding and considerations of administration, space, and cost resulted in the destruction of all specimens.

The DoD Joint Pathology Center as a Resource for Researchers.

The Department of Defense's Joint Pathology Center (JPC) is the world's largest collection of human pathology specimens, comprising some 7.4 million accessions. The biorepository, which began during the Civil War as a collection of materials obtained from medical and surgical procedures performed by Army physicians, houses specimens and associated data obtained for diagnostic purposes. It also holds several collections of specimens from military personnel who shared a common, service-related exposure or medical condition. This article, which is excerpted and adapted from the 2012 Institute of Medicine report "Future Uses of the Department of Defense JPC Biorepository,"1 summarizes information on the repository, its past uses, and the future operational issues and challenges that the JPC faces as it develops a concept of operations that will allow it to move forward as a resource for researchers.

Chinese biobanking initiatives.

Due to the requirement for comprehensive clinical research efforts in China, the importance of biobanking in modern clinical research is outlined in this overview. Hospitals, universities, and research institutes have been well organized as fundamental resources for Chinese biobanking initiatives and the resulting bio-sample collections. Here, a brief history and time line of development of biobanking in China will be introduced, as well as strategic designs for future biobanking development.

The challenge of establishing, growing and sustaining a large biobank: a personal perspective.

Laboratory medicine professionals have a unique understanding of the wealth that biological samples bring to clinical research, and of the need for quality standards for the collection, transportation, storage and analytical phases. The expertise of laboratory physicians and scientists also adds value to the interpretation and publication of the results of clinical research studies. This is an account of the evolution of over thirty five years of the Biobank/Clinical Research Clinical Trials Laboratory at one Canadian health sciences centre. The logistical, financial, and quality management challenges are presented in growing from a small-scale facility to one that now stores three million well-characterized samples from more than seventy countries, representing five continents and five major ethnic groups. This is an account of a journey, it is not intended as a guide as to how to create an 'ideal' biobank. Collaboration, collegiality, consistency, creativity and clinical collaborators, are the keys to progress, but there must first be a vision, one that can expand to embrace new opportunities.

Half-century archives of occupational medical data on French nuclear workers: a dusty warehouse or gold mine for epidemiological research?

This article discusses the availability and completeness of medical data on workers from the AREVA NC Pierrelatte nuclear plant and their possible use in epidemiological research on cardiovascular and metabolic disorders related to internal exposure to uranium. We created a computer database from files on 394 eligible workers included in an ongoing nested case-control study from a larger cohort of 2897 French nuclear workers. For each worker, we collected records of previous employment, job positions, job descriptions, medical visits, and blood test results from medical history. The dataset counts 9,471 medical examinations and 12,735 blood test results. For almost all of the parameters relevant for research on cardiovascular risk, data completeness and availability is over 90%, but it varies with time and improves in the latest time period. In the absence of biobanks, collecting and computerising available good-quality occupational medicine archive data constitutes a valuable alternative for epidemiological and aetiological research in occupational health. Biobanks rarely contain biological samples over an entire worker's carrier and medical data from nuclear industry archives might make up for unavailable biomarkers that could provide information on cardiovascular and metabolic diseases.

Biobanking past, present and future: responsibilities and benefits.

The review explores the field of biobanking as it has evolved from a simple collection of frozen specimens to the virtual biobank. Biorepository and biospecimen science has evolved in response to the changing landscape of external regulatory pressures, the advances made in the biological sciences, and the advent of the computer chip. Biospecimen banking is a growing enterprise crucial to health science research and other biological sciences. In this review we discuss the history of biobanking, highlight current and emerging issues, discuss demands and responses, and describe an example of a biobank, the University of California, San Francisco AIDS Specimen Bank that has functioned for 30 years.

Human cord blood applications in cell therapy: looking back and look ahead.

INTRODUCTION: Human umbilical cord blood (UCB) has been used as a reliable source of stem cells for blood-borne diseases and disorders. Recent advances in cell reprogramming technology to produce induced pluripotent stem (iPS) cells, which can be differentiated to multiple adult cell types, has further expanded the potential of cord blood cell therapy for treatment of non-blood-borne diseases. However, in order to harness this breakthrough technology and to provide clinical-grade cells for the patient, standardization of iPS production and differentiation, and good manufacturing practice (GMP) need to be employed. AREAS COVERED: UCB is an ethical source of stem cells and has been used to treat diseases including leukemia, cancer and blood disorders. The development of iPS cell technology could potentially greatly increase the application of cord blood cells as a treatment for a broader range of diseases, UCB-iPS banks could, therefore, be a valuable complementary source of clinical-grade cells for cell therapy. The current applicability of GMP to UCB and UCB-iPS cell-based cell therapy will be discussed. EXPERT OPINION: Although cord blood stem cell therapies have been practiced for decades, UCB-iPS cell therapies are a new innovation currently in development. Successful clinical applications of such novel cell therapies will depend on the production of GMP-compliant cells and the establishment of cell banks.

The emergence of biobanks in the legal landscape: towards a new model of governance.

Biobanks are increasingly seen as new tools for medical research. Their main purpose is to collect, store, and distribute human body materials. These activities are regulated by legal instruments which are heterogeneous in source (national and international), and in form (binding and non-binding). We analyse these to underline the need for a new model of governance for modern biobanks. The protection initially ensured by respect for fundamental rights will need to focus on more interactions with society in order to ensure biobanks' sustainability. International regulation is more oriented on ethical principles and traces the limits of the uses of genetics, while European regulation is more concerned with the protection of fundamental rights and the elaboration of standards for biobanks' quality assurance. But is this protection adequate and sufficient? Do we need to move from the biomedical research analogy to new forms of legal protection, and governance systems which involve citizens?