Skip to main content

Standardization and Quality Assurance in Life-Science Research - Crucially Needed or Unnecessary and Annoying Regulation?

  • Conference paper
  • First Online:
ICT Innovations 2018. Engineering and Life Sciences (ICT 2018)

Abstract

Open Science describes the ongoing transitions in the way research is performed, i.e. researchers collaborate, knowledge is shared, and science is organized. It is driven by digital technologies and by the enormous growth of data, globalization, enlargement of the scientific community and the need to address societal challenges [23]. It has now widely been recognized that making research results more accessible to all societal actors contributes to better and more efficient science, as well as to innovation in the public and private sectors [1, 17]. However, the reuse of research results can only be achieved reliably and efficiently, if these data are valorized in a specific manner. Data are to be generated, formatted and stored according to Standard Operating Procedures (SOPs) and according to sophisticated Data Management Plans [23]. Hence, to generate accurate and reproducible data sets, to allow interlaboratory comparisons as well as further and future use of research data it is mandatory to work in line with good laboratory practices and well-defined and validated methodologies. Within this article, members of the Cost Action CHARME [10] will discuss aspects of quality management and standardization in context with Open Access (OA) efforts. We will address the question: Are Standardization and Quality Management measures in life-science research crucially needed or introduce further unwanted means of regulation?

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 39.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 54.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Editorial: Benefits of sharing. Nature 530(7589), 129 (2016). https://doi.org/10.1038/530129a

  2. Berman, H., Henrick, K., Nakamura, H.: Announcing the worldwide protein data bank. Nat. Struct. Mol. Biol. 10(12), 980 (2003). https://doi.org/10.1038/nsb1203-980

    Article  Google Scholar 

  3. Directorate-General for Research and Innovation. ISBN 978-92-79-65567-8, https://doi.org/10.2777/380389

  4. Understanding Science. University of California, Museum of Paleontology, 3 January 2018. http://www.understandingscience.org

  5. Ellingsen, G., Monteiro, E.: Seamless integration: standardisation across multiple local settings. Comput. Support. Coop. Work CSCW 15(5–6), 443–466 (2006). https://doi.org/10.1007/s10606-006-9033-0

    Article  Google Scholar 

  6. Endrullat, C., Glöckler, J., Franke, P., Frohme, M.: Standardization and quality management in next-generation sequencing. Appl. Transl. Genom. 10, 2–9 (2016). https://doi.org/10.1016/j.atg.2016.06.001

    Article  Google Scholar 

  7. European Commission EUR 22836 - Improving knowledge transfer between research institutions and industry across Europe: embracing open innovation (2007). ISBN 978-92-79-05521, http://ec.europa.eu/invest-in-research/pdf/download_en/knowledge_transfe_07.pdf

  8. Freedman, L.P., Venugopalan, G., Wisman, R.: Reproducibility 2020: progress and priorities. F1000Research 6, 604 (2017). https://doi.org/10.12688/f1000research.11334.1. [version 1; referees: 2 approved]

    Article  Google Scholar 

  9. Gargis, A.S., et al.: Assuring the quality of next-generation sequencing in clinical laboratory practice. Nat. Biotechnol. 30(11), 1033–1036 (2012). https://doi.org/10.1038/nbt.2403

    Article  Google Scholar 

  10. Harmonising standardisation strategies to increase efficiency and competitiveness of European life-science research (CHARME) Cost Action CA15110. https://www.cost-charme.eu/the-action/about-charme

  11. Impact of Emerging Technologies on the Biological Sciences, Report of a Workshop, 26–27 June 1995. https://nsf.gov/bio/pubs/reports/stctechn/stcmain.htm

  12. Monya, B.: How quality control could save your science. Nat. News 529, 456–458 (2016)

    Article  Google Scholar 

  13. Wilkinson, M.D., et al.: The FAIR guiding principles for scientific data management and stewardship. Sci. Data 3, Article no. 160018 (2016). Winkler-News. http://www.ariadne.ac.uk/issue64/datacite-2010-rpt

  14. Nickerson, D., et al.: The Human Physiome: how standards, software and innovative service infrastructures are providing the building blocks to make it achievable. Interface Focus 6(2), 20150103 (2016). https://doi.org/10.1098/rsfs.2015.0103

  15. OECD: Frascati Manual 2015: Guidelines for Collecting and Reporting Data on Research and Experimental Development. The Measurement of Scientific, Technological and Innovation Activities. OECD Publishing, Paris (2015). Accessed 27 Oct 2017

    Google Scholar 

  16. OECD Principles and guidelines for access to research data from public funding – OECD (2007). http://www.oecd.org/sti/sci-tech/38500813.pdf

  17. Open Access in Deutschland. https://www.bmbf.de/pub/Open_Access_in_Deutschland.pdf

  18. Rehm, H.L., et al.: ACMG clinical laboratory standards for next-generation sequencing. Genet. Med. 15(11), 733–747 (2013). https://doi.org/10.1038/gim.2013.92. Working Group of the American College of Medical Genetics and Genomics Laboratory Quality Assurance Committee

    Article  Google Scholar 

  19. Sansone, S., et al.: FAIRsharing: working with and for the community to describe and link data standards, repositories and policies. bioRxiv No. 1, 0–9 (2018)

    Google Scholar 

  20. Smalter Hall, A., Shan, Y., Lushington, G., Visvanathan, M.: An overview of computational life science databases & exchange formats of relevance to chemical biology research. Comb. Chem. High Throughput Screen. 16(3), 189–198 (2013)

    Article  Google Scholar 

  21. Source: Definition of ‘science’. https://www.collinsdictionary.com/dictionary/english/science

  22. Stuart, D., et al.: Practical challenges for researchers in data sharing. Springer Nature (2018). https://doi.org/10.6084/m9.figshare.5975011.v1

  23. The transition towards an Open Science system - Council conclusions, 8791/16 RECH 133 TELECOM 74. http://data.consilium.europa.eu/doc/document/ST-9526-2016-INIT/en/pdf. Accessed 27 May 2016

Download references

Acknowledgement

This publication is based upon work from COST Action CHARME (CA15110) supported by COST (European Cooperation in Science and Technology). www.cost.eu.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Susanne Hollmann .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2018 Springer Nature Switzerland AG

About this paper

Check for updates. Verify currency and authenticity via CrossMark

Cite this paper

Hollmann, S. et al. (2018). Standardization and Quality Assurance in Life-Science Research - Crucially Needed or Unnecessary and Annoying Regulation?. In: Kalajdziski, S., Ackovska, N. (eds) ICT Innovations 2018. Engineering and Life Sciences. ICT 2018. Communications in Computer and Information Science, vol 940. Springer, Cham. https://doi.org/10.1007/978-3-030-00825-3_2

Download citation

  • DOI: https://doi.org/10.1007/978-3-030-00825-3_2

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-00824-6

  • Online ISBN: 978-3-030-00825-3

  • eBook Packages: Computer ScienceComputer Science (R0)

Publish with us

Policies and ethics