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Biobank information sites

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A compliation of external resources on biobanks

A biobank, also known as a biorepository, is a place that collects, stores, processes and distributes biological materials and the data associated with those materials. Typically, those “biological materials” are human biospecimens – such as tissue or blood - and the “data” are the clinical information pertaining to the donor of that biospecimen. A biobank can also include tissues from other animals, cell and bacterial cultures, and even environmental samples.


Professional organizations

International Society for Biological and Environmental Repositories; A Division of the American Society for Investigative Pathology (ASIP)

ISBER is the leading international forum that addresses the technical, legal, ethical, and managerial issues relevant to repositories of biological and environmental specimens.  ISBER educational resources and meetings focus on technical issues such as quality assurance and control, regulations, human subject privacy and confidentiality issues, and provide information about sources of equipment and expertise. ISBER assists vendors in recognizing the needs of repositories for the development of new products and services, and provides information about existing repositories and their specimen collections.

Related publications and articles

Issues in Contamination and Temperature Variation in the Cryopreservation of Animal Cells and Tissues

David W. Burden, Ph.D.

The cryopreservation of animal cells and tissues has traditionally been accomplished using liquid nitrogen based storage vessels and freezers. With changing technologies in the life sciences, two major problems have surfaced from this approach, the first being contamination of submersed samples, and second, the observation that vapor phase storage systems may have temperature gradients which rise above the glass transition temperature of water. To remedy these problems, auto-cascade mechanical freezers can be used for the storage of animal cells at temperatures below -130°C, i.e., the glass transition temperature of water. Data shows that the chamber temperature of the Revco cryofreezer is below -130°C as compared to liquid nitrogen vapor which has been documented to be as high as -72°C. Since storage tubes are not submersed in mechanical freezers, contamination concerns are lessened as well. The consistent storage of samples below -130°C without cross-contamination is allowing for the novel application of the cryofreezer to the preservation of cells in microwell plates.

2008 Best Practices for Repositories: Collection, Storage, Retrieval and Distribution of Biological Materials for Research

International Society for Biological and Environmental Repositories

Excerpt: The availability of high quality biological and environmental specimens for research purposes requires the development of standardized methods for collection, long-term storage, retrieval and distribution of specimens that will enable their future use.  ISBER’s Best Practices for Repositories (Best Practices) reflect the collective experience of its members and provide repository professionals with a comprehensive tool to guide them in all their repository activities.  The focus of the second edition of the ISBER Best Practices has been expanded to include best practices for environmental specimen collections in addition to human specimen collections and to more effectively represent international best practices.

Cell Preservation Technology

CPT is the official journal of the International Society for Biological and Environmental Repositories (ISBER) and addresses research in biological tissues preservation and specimen handling.

Cell and Tissue Banking

This international journal covers the complete spectrum of cell and tissue banking and provides a forum for disseminating information to scientists and clinicians involved in the banking and transplantation of cells and tissues.

Information sites

Biobank Central

As science and technology leaders work to address the many challenges facing U.S. biobanks – logistical, technical, ethical, financial, intellectual property, and IT – BioBank Central will serve as an accurate and timely source of knowledge and news about biorepositories and their role in research and drug development. The Web site, built in partnership with Feinstein Kean Healthcare, based in Cambridge, Massachusetts, also provides a working group venue, patient and public education programs, and a forum for international collaboration and harmonization of best practices. The project is sponsored by IBM, Affymetrix, Bioaccelerate, and Invitrogen.

P3G Observatory

Public Population Project in Genomics.

Excerpt: The Observatory is a central Internet repository of scientific information and tools aimed at facilitating the development, realization and harmonization of research projects. It includes a series of Catalogues documenting large population-based biobanks worldwide and allows the rapid overview of the similarities and differences, and potential for harmonization between participant biobanks.

Government - United States

NIH Guidelines for Human Tissue Repository

National Heart, Lung, and Blood Institute, National Institutes of Health, Revised: April 14, 2000

Excerpt: The concept of a tissue repository may include two kinds of samples: a) those collected with the expressed purpose of distribution to investigators, and b) those collected by individual investigators, and not originally intended to be shared with others, but which are subsequently shared as part of a repository. Any identifiable tissue (included coded tissue) that is collected requires IRB review at the site of collection (even if different from the site of the repository) and, under most circumstances, written informed consent from the subject. Any tissue repository that distributes materials requires an IRB, convened under an OPRR-approved assurance, that lays out the conditions under which the tissue will be shared.The above Operating Principles will be broadly disseminated to the research community, including to investigators who do not currently distribute tissue samples, but might do so in the future.

Issues to Consider in the Research Use of Stored Data or Tissues

OFFICE FOR PROTECTION FROM RESEARCH RISKS

Excerpt: OPRR offers the following guidance concerning operation of human cell repositories under Department of Health and Human Services (HHS) regulations for the protection of human subjects (45 CFR 46). The guidance assumes that repository activities include nonexempt humansubjects research as defined under HHS regulations.  The operation of any HHS-supported human cell repository and its data management center should be subject to oversight by an Institutional Review Board (IRB) convened under an applicable OPRR-approved Assurance of Compliance.  Where human genetic research is anticipated, informed consent information should include information about the consequences of DNA typing.  OPRR recommends that the cell repository develop a sample collection protocol and informed consent document for distribution to collector-investigators and their local IRBs.

Guidance on Research Involving Coded Private Information or Biological Specimens

Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS) October 16, 2008

Excerpt: This document applies to research involving coded private information or human biological specimens (hereafter referred to as “specimens”) that is conducted or supported by HHS.  Provides guidance as to when research involving coded private information or specimens is or is not research involving human subjects, as defined under HHS regulations for the protection of human research subjects (45 CFR part 46).

Case Studies of Existing Human Tissue Repositories

Prepared for the National Cancer Institute National Dialogue on Cancer by Rand Science and Technology

Excerpt: Over the last year, the National Biospecimen Network (NBN) Design Team, a subset of the Tissue Access Working Group (TAWG) convened by the National Dialogue on Cancer (NDC) to address “access to appropriately collected, consented, and annotated tissue,” has been drafting a blueprint for a national biospecimen network.  To assist in its examination of existing tissue resources, the NBN Design Team requested that the RAND Corporation conduct case studies of existing human tissue resources to evaluate their utility for genomics- and proteomics-based cancer research and that RAND identify “best practices” at these institutions.

Statement on Storage and Use of Genetic Materials

American College of Medical Genetics Storage of Genetics Materials Committee

Excerpt: The sensitivities of DNA analytic methods have increased dramatically in the past several years.  Many health professionals as well as lay people may not appreciate how frequently biological samples are stored and how easily samples that have been stored for an unrelated reason could be used for genetic analysis in the future. The potential problems posed by such uses were explored at length in a Workshop sponsored by the National Center for Human Genome Research and the Centers for Disease Control and Prevention (Clayton et al., in press). ACMG members, recognizing these issues, may have concerns about access by insurers, employers, and others to samples or test results.

Research Repositories, Databases, and the HIPAA Privacy Rule

Department of Health and Human Services

Excerpt:  This fact sheet discusses the Privacy Rule and its potential to affect the creation of research databases and repositories, and research that uses identifiable health information in repositories
and databases.  The Privacy Rule was not intended to impede research using records within databases and repositories that include individuals’ health information, but the Privacy Rule does place new conditions on the use and disclosure of PHI by covered entities for research.

Human Specimens for Research > Legal and Ethical Issues

National Cancer Institute

Excerpt: Ethical issues related to the collection and use of human specimens for research purposes have been the subject of considerable discussion. Although the human subjects regulations detailed in the “Common Rule” (45CFR46) have not changed, application of the regulations are complicated by a variety of legal and social implications. The National Bioethics Advisory Commission’s report entitled “Research Involving Human Biological Materials: Ethical Issues and Policy Guidance” addresses many of the issues currently under discussion. The National Cancer Institute has worked with other NIH institutes and centers and with a variety of other groups to help clarify these issues and to provide education and models to assist the research community.

NCI Best Practices for Specimen Resources

National Cancer Institute

NCI, through the Office of Biorepositories and Biospecimen Research (OBBR), has assembled guiding principles for biospecimen resources to ensure specimen and data quality and adherence to ethical and legal requirements.

RAND ISE: Human Biospecimen Database

Rand ISE and the NIH office of rare disease research

Excerpt: Welcome to the Human Biospecimen Database. This Web site contains a searchable database of human biospecimens collected, stored, and distributed by biorepositories in the United States for research use. The Web site was developed under contract with the National Institutes of Health (NIH) Office of Rare Diseases Research (ORDR). The purpose of this project is to facilitate research leading to treatments and cures for rare diseases, as well as more common diseases, by improving researchers' access to needed human biospecimens by providing a system that enables them to access information about biorepositories and their collections.




Keywords

Biobank, repository, collection, biological, archive


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