title: Factors Affecting the Use of Human Tissues in Biomedical Research: Implications in the Design and Operation of a Biorepository.
abstract: The availability of high-quality human tissues is necessary to advance medical research. Although there are inherent and induced limitations on the use of human tissues in research, biorepositories play critical roles in minimizing the effects of such limitations. Specifically, the optimal utilization of tissues in research requires tissues to be diagnosed accurately, and the actual specimens provided to investigators must be carefully described (i.e., there must be quality control of each aliquot of the tissue provided for research, including a description of any damage to tissues). Tissues also should be collected, processed, stored, and distributed (i.e., handled) uniformly under a rigorous quality management system (QMS). Frequently, tissues are distributed to investigators by tissue banks which have collected, processed, and stored them by standard operating procedures (SOPs). Alternatively, tissues for research may be handled via SOPs that are modified to the specific requirements of investigators (i.e., using a prospective biorepository model). The primary goal of any type of biorepository should be to ensure its specimens are of high quality and are utilized appropriately in research; however, approaches may vary based on the tissues available and requested. For example, extraction of specific molecules (e.g., microRNA) to study molecular characteristics of a tissue may require less clinical annotation than tissues that are utilized to identify how the molecular expression might be used to clarify a clinical outcome of a disease or the response to a specific therapy. This review focuses on the limitations of the use of tissues in research and how the design and operations of a tissue biorepository can minimize some of these limitations.
authors.affiliation: Department of Pathology, University of Alabama at Birmingham, Birmingham, AL, USA.|Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Atherton
authors.affiliation: Department of Pathology, University of Alabama at Birmingham, Birmingham, AL, USA.|Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Katherine C
authors.initials: KC
authors.lastname: Sexton
authors.affiliation: Department of Pathology, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Dennis
authors.initials: D
authors.lastname: Otali
authors.affiliation: Department of Pathology, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Walter C
authors.initials: WC
authors.lastname: Bell
authors.affiliation: Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA. wgrizzle@uabmc.edu.|Department of Pathology, University of Alabama at Birmingham, Zeigler Research Building, Room ZRB 408, 703 South 19th Street, Birmingham, AL, 35294-0007, USA. wgrizzle@uabmc.edu.
authors.forename: William E
authors.initials: WE
authors.lastname: Grizzle
mesh_terms: D035843:Biomedical Research / Q000379:methods / Q000458:organization & administration; D006801:Humans; D011786:Quality Control; D013048:Specimen Handling; D014015:Tissue Banks / Q000458:organization & administration; D016707:Tissue Fixation / Q000379:methods; D014021:Tissue Preservation / Q000379:methods
keywords: Biorepository; HIPAA; Human tissue; IRB; Limitations; Prospective tissue collection; Research; Tissue banking