Issues in collecting, processing and storing human tissues and associated information to support biomedical research.

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  • Additional Information
    • Author-Supplied Keywords:
      annotation
      audits
      bias
      biohazards
      caBIG
      chemical hazards
      clinical information
      clinical trials
      common data elements
      cost recovery
      demographics
      difficult requests
      epidemiology
      good manufacturing practice
      HIPAA
      informatics
      informed consent
      material transfer agreement
      prospective collections
      quality assurance
      quality control
      repository science
      safety
      security
      services
      shipping
      specimen identification
      storage
      tissue banking
      Tissue repositories
      training
      vocabulary
    • NAICS/Industry Codes:
      541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
      621991 Blood and Organ Banks
    • Abstract:
      The availability of human tissues to support biomedical research is critical to advance translational research focused on identifying and characterizing approaches to individualized (personalized) medical care. Providing such tissues relies on three acceptable models - a tissue banking model, a prospective collection model and a combination of these two models. An unacceptable model is the "catch as catch can" model in which tissues are collected, processed and stored without goals or a plan or without standard operating procedures, i.e., portions of tissues are collected as available and processed and stored when time permits. In the tissue banking model, aliquots of tissues are collected according to SOPs. Usually specific sizes and types of tissues are collected and processed (e.g., 0.1 gm of breast cancer frozen in OCT). Using the banking model, tissues may be collected that may not be used and/or do not meet specific needs of investigators; however, at the time of an investigator request, tissues are readily available as is clinical information including clinical outcomes. In the model of prospective collection, tissues are collected based upon investigator requests including specific requirements of investigators. For example, the investigator may request that two 0.15 gm matching aliquots of breast cancer be minced while fresh, put in RPMI media with and without fetal calf serum, cooled to 4°C and shipped to the investigator on wet ice. Thus, the tissues collected prospectively meet investigator needs, all collected specimens are utilized and storage of specimens is minimized; however, investigators must wait until specimens are collected, and if needed, for clinical outcome. The operation of any tissue repository requires well trained and dedicated personnel. A quality assurance program is required which provides quality control information on the diagnosis of a specimen that is matched specifically to the specimen provided to an investigator instead of an overall diagnosis of the specimen via a surgical pathology report. This is necessary because a specific specimen may not match the diagnosis of the case due to many factors such as necrosis, unsuspected tumor invasion of apparently normal tissue, and areas of fibrosis which are mistaken grossly for tumor. Aliquots for quality control (QC) may or may not be collected at the time of collection and in some cases, QC may not occur until specimens are distributed to investigators. In establishing a tumor repository, multiple issues need to be considered. These include the available resources, long term support, space and equipment. The needs of the potential users need to be identified as to the types of tissues and services needed and the annotation expected. Other specific issues to be considered include collection of specimens potentially infected with blood borne pathogens (e.g., hepatitis B), charge back mechanisms, informatics needs and support, and investigator requirements (e.g., recognition of repository contributions in publications). In general, the repository should not perform the research of the investigators, but should provide the infrastructure necessary to support the research of the investigator. Thus, the goals of the repository must be established. Similarly, ethical and regulatory issues must be evaluated. In general, tissue repositories need ethical (e.g., IRB) and privacy (e.g., HIPAA) review. Also, safety issues need to be considered as well as how biohazards will be addressed by investigator-users. Considerations involving the transfer of specimens to other organization usually require a material transfer agreement (MTA). A MTA should address biohazards as well as indemnification. Thus, many issues must be considered and addressed in order to establish and operate successfully a biorepository. [ABSTRACT FROM AUTHOR]
    • Abstract:
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    • Author Affiliations:
      1Cancer Biomarkers Research Group, Division of Cancer Prevention, National Cancer Institute, Rockville, MD, USA
      2Department of Pathology, Division of Anatomic Pathology, University of Alabama at Birmingham, Birmingham, AL, USA
      3Division of Anatomic Pathology, Department of Pathology, University of Alabama at Birmingham, Birmingham, AL, USA
      4Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA
    • ISSN:
      1574-0153
    • Accession Number:
      67467490
  • Citations
    • ABNT:
      SRIVASTAVA, S. et al. Issues in collecting, processing and storing human tissues and associated information to support biomedical research. Cancer Biomarkers, [s. l.], v. 9, n. 1–6, p. 531–549, 2011. Disponível em: . Acesso em: 20 ago. 2019.
    • AMA:
      Srivastava S, Grizzle WE, Bell WC, Sexton KC. Issues in collecting, processing and storing human tissues and associated information to support biomedical research. Cancer Biomarkers. 2011;9(1-6):531-549. http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=asn&AN=67467490&custid=s8280428. Accessed August 20, 2019.
    • APA:
      Srivastava, S., Grizzle, W. E., Bell, W. C., & Sexton, K. C. (2011). Issues in collecting, processing and storing human tissues and associated information to support biomedical research. Cancer Biomarkers, 9(1–6), 531–549. Retrieved from http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=asn&AN=67467490&custid=s8280428
    • Chicago/Turabian: Author-Date:
      Srivastava, Sudhir, William E. Grizzle, Walter C. Bell, and Katherine C. Sexton. 2011. “Issues in Collecting, Processing and Storing Human Tissues and Associated Information to Support Biomedical Research.” Cancer Biomarkers 9 (1–6): 531–49. http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=asn&AN=67467490&custid=s8280428.
    • Harvard:
      Srivastava, S. et al. (2011) ‘Issues in collecting, processing and storing human tissues and associated information to support biomedical research’, Cancer Biomarkers, 9(1–6), pp. 531–549. Available at: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=asn&AN=67467490&custid=s8280428 (Accessed: 20 August 2019).
    • Harvard: Australian:
      Srivastava, S, Grizzle, WE, Bell, WC & Sexton, KC 2011, ‘Issues in collecting, processing and storing human tissues and associated information to support biomedical research’, Cancer Biomarkers, vol. 9, no. 1–6, pp. 531–549, viewed 20 August 2019, .
    • MLA:
      Srivastava, Sudhir, et al. “Issues in Collecting, Processing and Storing Human Tissues and Associated Information to Support Biomedical Research.” Cancer Biomarkers, vol. 9, no. 1–6, Dec. 2011, pp. 531–549. EBSCOhost, search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=asn&AN=67467490&custid=s8280428.
    • Chicago/Turabian: Humanities:
      Srivastava, Sudhir, William E. Grizzle, Walter C. Bell, and Katherine C. Sexton. “Issues in Collecting, Processing and Storing Human Tissues and Associated Information to Support Biomedical Research.” Cancer Biomarkers 9, no. 1–6 (December 20, 2011): 531–49. http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=asn&AN=67467490&custid=s8280428.
    • Vancouver/ICMJE:
      Srivastava S, Grizzle WE, Bell WC, Sexton KC. Issues in collecting, processing and storing human tissues and associated information to support biomedical research. Cancer Biomarkers [Internet]. 2011 Dec 20 [cited 2019 Aug 20];9(1–6):531–49. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=asn&AN=67467490&custid=s8280428