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2012 Best Practices for Repositories Collection,Storage,Retrieval,and Distribution of Biological Materials for Research International Society for Biological and Environmental Repositories
These Best Practices are reviewed periodically and revised to incorporate improved application and research findings that would affect repository work. The reader is advised to check the ISBER web site (www.isber.org) to ensure that the most recent version is available for use.
Printed with permission from the International Society for Biological and Environmental Repositories (ISBER)
Jonas Astrin, Susan Baker, Thomas J. Barr, Erica Benson, Mark Cada, Lori Campbell, Antonio Hugo Jose Froes Marques Campos, David Carpentieri, Omoshile Clement, Domenico Coppola, Yvonne De Souza, Paul Fearn, Kelly Feil, Debra Garcia, Judith Giri, William E. Grizzle, Kathleen Groover, Keith Harding, Edward Kaercher, Joseph Kessler, Sarah Loud, Hannah Maynor, Kevin McCluskey, Kevin Meagher, Cheryl Michels, Lisa Miranda, Judy Muller-Cohn, Rolf Muller, James O'Sullivan, Karen Pitt, Rebecca Pugh, Rivka Ravid, Katherine Sexton, Ricardo Luis A. Silva, Frank Simione, Amy Skubitz, Stella Somiari, Frans van der Horst, Gavin Welch, Andy Zaayenga
2012 Best Practices for Repositories: Collection, Storage, Retrieval and Distribution of Biological Materials for Research
INTERNATIONAL SOCIETY FOR BIOLOGICAL AND ENVIRONMENTAL REPOSITORIES (ISBER)
INTRODUCTION
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. Sharing successful strategies for accomplishing this goal is one of the driving forces for the International Society for Biological and Environmental Repositories (ISBER). For more information about ISBER see www.isber.org.
ISBER's Best Practices for Repositories (Best Practices) reflect the collective experience of its members and has received broad input from other repository professionals. Throughout this document effective practices are presented for the management of specimen collections and repositories. The term “Best Practice” is used in cases where a level of operation is indicated that is above the basic recommended practice or more specifically designates the most effective practice. It is understood that repositories in certain locations or with particular financial constraints may not be able to adhere to each of the items designated as “Best Practices”. Repositories fitting into either of these categories will need to decide how they might best adhere to these recommendations within their particular circumstances. While adherence to ISBER Best Practices is strictly on a voluntary basis, it is important to note that some aspects of specimen management are governed by national/federal, regional and local regulations. The reader should refer directly to regulations for their national/federal, regional and local requirements, as appropriate.
ISBER has strived to include terminology appropriate to the various specimen types covered under these practices, but here too, the reader should take steps to ensure the appropriateness of the recommendations to their particular repository type prior to the implementation of any new approaches. Important terms within the document are italicized when first used in a section and defined in the glossary.
The ISBER Best Practices are periodically reviewed and revised to reflect advances in research and technology. The third edition of the Best Practices builds on the foundation established in the first and second editions which were published in 2005 and 2008, respectively.
American Academy of Pediatrics Committee on Bioethics. Informed consent, parental permission, and assent in pediatric practice. Pediatrics, 1995; 95,2:314–317.
2.
American Neurological Association Council on Ethical and Judicial Affairs. 1999. Medical futility in end-of-life care: report of the Council on Ethical and Judicial Affairs. JAMA, 281:937–941.
3.
BelgraderP, DelRioSA, TurnerKA, MarinoMA, WeaverKA, WilliamsPE. Automated DNA purification and amplification from bloodstain cards using a robotic workstation. BioTechniques, 1995; 19:426–432.
4.
BensonEE. Crit. Rev Plant Sci., 2008; 27:141–219.
5.
BetsouF, LuzerguesA, CarterA, GearyP, RiegmanP, ClarkB, MorenteM, VaughtJ, DhirrR, Druez-VéritéC. the Marble Arch Working Group on International Biobanking. Towards norms for accreditation of biobanks for human health and medical research: compilation of existing guidelines into an ISO certification/accreditation norm-compatible format. The Quality Assurance Journal, 2008; 11,3–4:221–294.
6.
BetsouF, BarnesR, BurkeT, CoppolaD, DeSouzaY, EliasonJ, GlazerB, HorsfallD, KleebergerC, LehmannS, PrasadA, SkubitzA, SomiariS, GunterE. the ISBER Working Group on Biospecimen Science. Human Biospecimen research: Experimental Protocol and Quality Control Tools. Cancer Epidemiol Biomarkers Prevention, 2009; 18:1017–1025.
7.
BetsouF, LehmannS, AshtonG, BarnesM, BensonE, CoppolaD, DeSouzaY, EliasonJ, GlazerB, GuadagniF, HardingK, HorsfallD, KleebergerC, NanniU, PrasadA, SheaK, SkubitzA, SomiariS, GunterE. the ISBER Working Group on Biospecimen Science. Standard Preanalytical Coding for Biospecimens: Defining the Sample PREanalytical Code (SPREC)Cancer Epidemiol Biomarkers Prevention, 2010; 19:1004–11.
8.
British Medical Association. 1996. BMA guidelines on treatment decisions for patients in persistent vegetative states. British Medical Association: London.
9.
Budapest Treaty Regulations. 1977. Budapest treaty on the international recognition of the deposit of microorganisms for the purposes of patent procedure. World Intellectual Property Organization: Geneva, Switzerland.
10.
DayJG, LorenzM, WildingTA, FriedlT, HardingK, PröscholdT, BrennanD, MüllerJ, SantosLMA, SantosMF, OsorioHC, AmaralR, LukesovaA, HrouzekP, LukesM, ElsterJ, LukavskyJR, ProbertI, RyanMJ, BensonEE. The use of physical and virtual infrastructure for the validation of algal cryopreservation methods in international culture collections. Cryoletters, 2007; 28:359–376.
11.
DayJG, StaceyG. Methods in Molecular Biology. 38Cryopreservation and Freeze Drying Protocols. Humana Press, 20072nd. Totowa, Inc. NJ.
12.
Dey-HazraE, HertelB, KirschT, WoywodtA, lovricS, HallerH, HaubitzM, ErdbrueggerU. Detection of circulating microparticles by flow cytometry: influence of centrifugation, filtration of buffer, and freezing. Vasc Health Risk Manag, 2010; 6; 6:1125–1133.
13.
DoedtT, KistR, HeckleD, de RozieresS, MullerR, Muller-CohnJ. QIAsafe DNA tubes for room-temperature archiving of purified DNA samples. International Society for Biological and Environmental Repositories (ISBER) Conference, 2009Portland, OR.
14.
DyerWB, PettSL, SullivanJS, EmeryS, CooperDA, KelleherAD, LloydA, LewinSR. Substantial Improvements in Performance Indicators Achieved in a Peripheral Blood Mononuclear Cell Cryopreservation Quality Assurance Program using Single Donor Samples. Clinical Vaccine Immunology, 2007; 14:52–59.
15.
EngelKB, MooreHM. Effects of preanalytical variables on the detection of proteins by immunohistochemistry in formalin-fixed, paraffin-embedded tissue. Arch Pathol Lab Med, 2011; 135,5:537–543.
16.
FAO. Global Plan of Action, for the Conservation and Sustainable Utilization of Plant Genetic Resources for Food and Agriculture. FAO of the UN, 1996Rome, Italy.
17.
FAWC. 1979. The Five Freedoms. London: Farm Animal Welfare Council.
18.
FlemingDO, HuntDL. Biological Safety, Principles and Practices, 4thAugust2006.
19.
FullerBJ, DiijkS. Low temperature organ preservation, blood vessels, and the human tissue act 2007: Impact and Implications. CryoLetters, 2008; 29:175–179.
20.
GrizzleWE, PoltSS. Guidelines to avoid personnel contamination by infective agents in research laboratories that use human tissues. J Tissue Culture Method, 1988; 86,2:217–21.
21.
GrizzleWE, FredenburghJ. Avoiding biohazards in medical, veterinary and research laboratories. Biotech Histochem, 2001; 76,4:183–206.
22.
GrizzleWE, BellW, FredenburghJ. Safety in biomedical and other laboratories. Molecular Diagnostics, 2005; 33:421–428.
23.
GrizzleWE, BellWC, FredenburghJ. General considerations concerning safety in biomedical research laboratories. Molecular Diagnostics, 2010; 39:563–72.
24.
GuderWG, NarayananS, WisserH, ZawtaB. Diagnostic samples: from the patient to the laboratory. The impact of preanalytical variables on the quality of laboratory results. Wiley: Blackwell4th.
25.
HartleyP, LloydM, BurtonN. 2004. Obstacles to the refinement of scientific procedures using living animals. Poster presentation. Proceedings of the UFAW International Symposium ‘Science in the Service of Animal Welfare’KirkwoodJK, RobertsEA, VickeryS. Edinburgh, 2–4.
26.
IsaK, YamauchMS, NagoTT, YamaneN. Quantitative estimation of preanalytical variables which may influence the determinations of prothrombin time (PT) and activated partial thromboplastin (APTT)Rinsho Byori., 2010; 58,10:979–985
27.
JacobMA. 2006. Another look at the presumed-versus informed consent dichotomy in post-mortem organ procurement. Bioethics, 20:293.
28.
JewellSC, SrinivasanM, McCartLM, WilliamsN, GrizzleWE, LiVolsiV, MacLennanG, SedmakDD. Analysis of the molecular quality of human tissues: An experience from the Cooperative Human Tissue Network. Am J Clin Pathol, 2002; 118:733–741.
29.
KarasA. 2006. Barriers to assessment and treatment of pain in laboratory animals. Laboratory Animals Europe, 6:30–9FAWC (1979) The Five FreedomsLondon: Farm Animal Welfare Council.
30.
KaufmanD, GellerG, LeRoyL, MurphyJ, ScottJ, HudsonK. Ethical implications of including children in a large biobank for genetic-epidemiologic research: A qualitative study of public opinion. Am J Med Genet Part C Semin Med Genet, 2008; 148C:31–39.
31.
RamirezNC, BarrTJ, BilliterDM. Utilizing virtual microscopy for quality control review. Dis Markers, 2007; 23:459–466.
32.
RavidR. Standard Operating Procedures, ethical and legal regulations in BTB (Brain/Tissue/Bio) banking: what is still missing?Cell Tissue Bank, 2008; 9:151–67.
33.
RavidR. Biobanks for biomarkers in neurological disorders: The Da Vinci bridge for optimal clinico-pathological connection. J Neurol Sci, 2009; 283:119–26.
34.
ReedBM, DumetDJ, DenomaJM, BensonEE. Validation of cryopreservation protocols for plant germplasm conservation: a pilot study using Ribes. L Biodiver Conser, 2001; 10:939–949.
35.
SchmehlMK, BankHL, CobbL. Evaluation and validation of statistical methods for viability assays. Monte Carlo simulation and power analysis of limiting dilution assay data. Cryobiology, 1989; 26:239–247.
36.
SmithD, RyanMJ. The impact of OECD Best Practices on the validation of cryopreservation techniques for microorganisms. CryoLetters, 2008; 29:63–72.
StaceyGN, DayJG. Long-term ex situ conservation of biological resources and the role of biological resource centres. Methods in Molecular Biology, 2007; 38:1–14.
39.
StaceyGN. Control of contamination in cell and tissue banks. CryoLetters, 1999; 20:141–146.
40.
StaceyGN. Fundamental issues for cell-line banks in biotechnology and regulatory affairs. Life in the Frozen State, 2004; 437–452.
41.
StaceyGN, DoyleA. The biodiversity convention the key role of culture collections. CryoLetters Supplement, 1998; 1:31–38.
42.
TomlinsonM. Risk management in cryopreservation associated with reproduction. CryoLetters, 2008; 29:165–174.
43.
TuckMK, ChanDW, ChiaD, GodwinAK, GrizzleWE, KruegerKE, RomW, SandaM, SorbaraL, StassS, WangW, BrennerDE. Standard Operating Procedures for Serum and Plasma Collection: Early Detection Research Network Consensus Statement Standard Operating Procedure Integration Working Group. J Proteome Res., 2009; 8,1:113–117.
44.
Von VersenR, MönigH-J, SalaiM, BettinD. Quality issues in tissue banking: Quality management systems - A review. Cell Tissue Banking, 2000; 1:181–192.
45.
WanE, AkanaM, PonsJ, ChenJ, MusoneS, KwokP-Y, LiaoW. Green technologies for room temperature nucleic acid storage. Curr Issues Mol Biol., 2010; 12:135–142.
46.
WendlandAE, CamargoJL, PolanczykCA. Effect of preanalytical variables on myeloperoxidase levels. Clin Chim Acta, 2010; 11; 411,21–22:1650–1655.
47.
WilkinsonSP, StassinopoulosS, WhitneyS, ShireenL, OhgiS, MullerR, Muller-CohnJ, ClementO. Gene expression and genomic DNA stabilization in whole blood stored at room temperature. CHI Tri-Molecular Medicine Conference, 2011San Francisco, CA.
