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Factors Affecting the Use of Human Tissues in Biomedical Research: Implications in the Design and Operation of a Biorepository

  • Daniel S. Atherton
  • Katherine C. Sexton
  • Dennis Otali
  • Walter C. Bell
  • William E. GrizzleEmail author
Part of the Methods in Molecular Biology book series (MIMB, volume 1381)

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.

Key words

Research Human tissue Biorepository Prospective tissuecollection Tissue banking IRB HIPAA Limitations 

Notes

Acknowledgement

This work was supported in part by the Cooperative Human Tissue Network (NCI 5U01CA044968-23), the Tissue Procurement Shared Facility of the UAB Comprehensive Cancer Center (P30CA13148), the Breast SPORE at UAB (NCI 5P50CA89019), the Pancreatic SPORE at UAB (NCI P50CA101955-05), the U54 MSM/TU/UAB Comprehensive Cancer Center Partnership (2U54CA118948), and the Pulmonary Hypertension Breakthrough Initiative (1R24HL123767-01 together with a grant from the Cardiovascular Medical Research and Education Fund). The authors report no conflict of interest.

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Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  • Daniel S. Atherton
    • 1
    • 2
  • Katherine C. Sexton
    • 1
    • 2
  • Dennis Otali
    • 1
  • Walter C. Bell
    • 1
  • William E. Grizzle
    • 2
    • 3
    Email author
  1. 1.Department of PathologyUniversity of Alabama at BirminghamBirminghamUSA
  2. 2.Comprehensive Cancer CenterUniversity of Alabama at BirminghamBirminghamUSA
  3. 3.Department of PathologyUniversity of Alabama at BirminghamBirminghamUSA

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