Skip to main content

A framework for ethics review of applications to store, reuse and share tissue samples

Abstract

The practice of biobank networking—where biobanks are linked together, and researchers share human tissue samples—is an increasingly common practice both domestically and internationally. The benefits from networking in this way are well established. However, there is a need for ethical oversight in the sharing of human tissue. Ethics committees will increasingly be called upon to approve the sharing of tissue and data with other researchers, often via biobanks, and little guidance currently exists for such committees. In this paper, we provide a structured approach to the ethical review of on-sharing of data and tissue for research purposes.

This is a preview of subscription content, access via your institution.

References

  1. Caulfield, T., Burningham, S., Joly, Y., Master, Z., Shabani, M., Borry, P., Becker, A., Burgess, M., Calder, K., Critchley, C., Edwards, K., Fullerton, S. M., Gottweis, H., Hyde-Lay, R., Illes, J., Isasi, R., Kato, K., Kaye, J., Knoppers, B., … Zawati, M. H. 2014. A review of the key issues associated with the commercialization of biobanks. Journal of Law and the Biosciences, 1(1), 94–110. https://doi.org/https://doi.org/10.1093/jlb/lst004

  2. Caulfield, T., and J. Kaye. 2009. Broad Consent in Biobanking: Reflections on seemingly Insurmountable Dilemmas. Medical Law International. https://doi.org/10.1177/096853320901000201.

    Article  Google Scholar 

  3. Chadwick, R., O’Connor, A., & O’Connor, A. 2016. Biobanking Across Borders. In B. Parry, B. Greenhough, & I. Dyck (Eds.), Bodies Across Borders: The Global Circulation of Body Parts, Medical Tourists and Professionals (pp. 15–28). Routledge. https://doi.org/https://doi.org/10.4324/9781315569598-2

  4. Chalmers, D., D. Nicol, P. Nicolás, and N. Zeps. 2014. A Role for Research Ethics Committees in Exchanges of Human Biospecimens Through Material Transfer Agreements. Journal of Bioethical Inquiry 11 (3): 301–306. https://doi.org/10.1007/s11673-014-9552-1.

    Article  Google Scholar 

  5. Coppola, L., A. Cianflone, A.M. Grimaldi, M. Incoronato, P. Bevilacqua, F. Messina, S. Baselice, A. Soricelli, P. Mirabelli, and M. Salvatore. 2019. Biobanking in Health Care: Evolution and Future Directions. Journal of Translational Medicine 17 (1): 172. https://doi.org/10.1186/s12967-019-1922-3.

    Article  Google Scholar 

  6. Domaradzki, J., and J. Pawlikowski. 2019. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. International Journal of Environmental Research and Public Health. https://doi.org/10.3390/ijerph16122209.

    Article  Google Scholar 

  7. Gille, F., E. Vayena, and A. Blasimme. 2020. Future-Proofing Biobanks’ Governance. European Journal of Human Genetics. https://doi.org/10.1038/s41431-020-0646-4.

    Article  Google Scholar 

  8. Grady, C., L. Eckstein, B. Berkman, D. Brock, R. Cook-Deegan, S.M. Fullerton, H. Greely, M.G. Hansson, S. Hull, S. Kim, B. Lo, R. Pentz, L. Rodriguez, C. Weil, B.S. Wilfond, and D. Wendler. 2015. Broad Consent For Research with Biological Samples: Workshop Conclusions. The American Journal of Bioethics 15 (9): 34–42. https://doi.org/10.1080/15265161.2015.1062162.

    Article  Google Scholar 

  9. Harris, J. R., Burton, P., Knoppers, B. M., Lindpaintner, K., Bledsoe, M., Brookes, A. J., Budin-Ljøsne, I., Chisholm, R., Cox, D., Deschênes, M., Fortier, I., Hainaut, P., Hewitt, R., Kaye, J., Litton, J.-E., Metspalu, A., Ollier, B., Palmer, L. J., Palotie, A., … Zatloukal, K. 2012. Toward a roadmap in global biobanking for health. European Journal of Human Genetics, 20(11), 1105–1111. https://doi.org/https://doi.org/10.1038/ejhg.2012.96

  10. Hudson (Chairperson), T. J., Anderson, W., Aretz, A., Barker, A. D., Bell, C., Bernabé, R. R., Bhan, M. K., Calvo, F., Eerola, I., Gerhard, D. S., Guttmacher, A., Guyer, M., Hemsley, F. M., Jennings, J. L., Kerr, D., Klatt, P., Kolar, P., Kusuda, J., Lane, D. P., … Liver cancer (hepatocellular carcinoma; secondary to alcohol and adiposity) (France). 2010. International network of cancer genome projects. Nature, 464(7291), 993–998. https://doi.org/https://doi.org/10.1038/nature08987.

  11. ISBER. 2018. BEST PRACTICES: Recommendations for Repositories Fourth Edition.

  12. Kaye, J. 2011. From Single Biobanks to International Networks: Developing e-Governance. Human Genetics 130: 377–382.

    Article  Google Scholar 

  13. Kaye, J., E.A. Whitley, D. Lund, M. Morrison, H. Teare, and K. Melham. 2015. Dynamic Consent: A Patient Interface for Twenty-First Century Research Networks. European Journal of Human Genetics 23 (2): 141–146. https://doi.org/10.1038/ejhg.2014.71.

    Article  Google Scholar 

  14. Langhof, H., H. Kahrass, T. Illig, R. Jahns, and D. Strech. 2018. Current Practices for Access, Compensation, and Prioritization in Biobanks: Results from an Interview Study. European Journal of Human Genetics 26 (11): 1572–1581. https://doi.org/10.1038/s41431-018-0228-x.

    Article  Google Scholar 

  15. Langhof, H., J. Schwietering, and D. Strech. 2019. Practice Evaluation of Biobank Ethics and Governance: Current Needs and Future Perspectives. Journal of Medical Genetics 56 (3): 176–185. https://doi.org/10.1136/jmedgenet-2018-105617.

    Article  Google Scholar 

  16. Lemrow, S.M., G.A. Colditz, J.B. Vaught, and P. Hartge. 2007. Key Elements of Access Policies for Biorepositories Associated with Population Science Research. Cancer Epidemiology and Prevention Biomarkers 16 (8): 1533–1535. https://doi.org/10.1158/1055-9965.EPI-07-0101.

    Article  Google Scholar 

  17. Litton, J.-E. 2018. Launch of an Infrastructure for Health Research: BBMRI-ERIC. Biopreservation and Biobanking 16 (3): 233–241. https://doi.org/10.1089/bio.2018.0027.

    Article  Google Scholar 

  18. Mascalzoni, D., E.S. Dove, Y. Rubinstein, H.J.S. Dawkins, A. Kole, P. McCormack, S. Woods, O. Riess, F. Schaefer, H. Lochmüller, B.M. Knoppers, and M. Hansson. 2015. International Charter of Principles for Sharing Bio-specimens and Data. European Journal of Human Genetics 23 (6): 721–728. https://doi.org/10.1038/ejhg.2014.197.

    Article  Google Scholar 

  19. McHale, J.V. 2011. Accountability, Governance and Biobanks: The Ethics and Governance Committee as Guardian or as Toothless Tiger? Health Care Analysis 19 (3): 231–246. https://doi.org/10.1007/s10728-011-0195-7.

    Article  Google Scholar 

  20. Mee, B., Gaffney, E., Glynn, S. A., Donatello, S., Carroll, P., Connolly, E., Garrigle, S. M., Boyle, T., Flannery, D., Sullivan, F. J., McCormick, P., Griffin, M., Muldoon, C., Fay, J., O’Grady, T., Kay, E., Eustace, J., Burke, L., Sheikh, A. A., … Giles, F. J. 2013. Development and Progress of Ireland’s Biobank Network: Ethical, Legal, and Social Implications (ELSI), Standardized Documentation, Sample and Data Release, and International Perspective. Biopreservation and Biobanking, 11(1), 3–11. https://doi.org/https://doi.org/10.1089/bio.2012.0028.

  21. Mikkelsen, R.B., M. Gjerris, G. Waldemar, and P. Sandøe. 2019. Broad Consent for Biobanks is Best—Provided It is Also Deep. BMC Medical Ethics 20 (1): 71. https://doi.org/10.1186/s12910-019-0414-6.

    Article  Google Scholar 

  22. Morente, M.M., L. Cereceda, F. Luna-Crespo, and M.J. Artiga. 2011. Managing a Biobank Network. Biopreservation and Biobanking 9 (2): 187–190. https://doi.org/10.1089/bio.2011.0005.

    Article  Google Scholar 

  23. NHMRC. 2010. Biobanks information paper | NHMRC. https://www.nhmrc.gov.au/about-us/publications/biobanks-information-paper.

  24. NHMRC. 2018. National Statement on Ethical Conduct in Human Research (2007)—Updated 2018 | NHMRC. https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#toc__725.

  25. Nicol, D., C. Critchley, R. McWhirter, and T. Whitton. 2016. Understanding Public Reactions to Commercialization of Biobanks and Use of Biobank Resources. Social Science & Medicine 162: 79–87. https://doi.org/10.1016/j.socscimed.2016.06.028.

    Article  Google Scholar 

  26. Nielsen, J., T. Bubela, D.R.C. Chalmers, A. Johns, L. Kahl, J. Kamens, C. Lawson, J. Liddicoat, R. McWhirter, A. Monotti, J. Scheibner, T. Whitton, and D. Nicol. 2018. Provenance and Risk in Transfer of Biological Materials. PLOS Biology 16 (8): e2006031. https://doi.org/10.1371/journal.pbio.2006031.

    Article  Google Scholar 

  27. Ploug, T., and S. Holm. 2015. Meta Consent: A Flexible and Autonomous Way of Obtaining Informed Consent for Secondary Research. BMJ. https://doi.org/10.1136/bmj.h2146.

    Article  Google Scholar 

  28. Strech, D. 2015. Ethical Review of Biobank Research: Should RECs Review Each Release of Material from Biobanks Operating Under an Already-Approved Broad Consent and Data Protection Model? European Journal of Medical Genetics 58 (10): 545–549. https://doi.org/10.1016/j.ejmg.2015.09.008.

    Article  Google Scholar 

  29. Verlinden, M., H. Nys, N. Ectors, and I. Huys. 2016. Qualitative Study on Custodianship of Human Biological Material and Data Stored in Biobanks. BMC Medical Ethics 17 (1): 15. https://doi.org/10.1186/s12910-016-0098-0.

    Article  Google Scholar 

  30. Wolf, L.E., and B. Lo. 2004. Untapped Potential: IRB Guidance for the Ethical Research Use of Stored Biological Materials. IRB 26 (4): 1–8.

    Article  Google Scholar 

  31. World Medical Association. 2016. WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks. https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/.

  32. World Medical Association. 2013. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/.

Download references

Acknowledgements

The authors would like to acknowledge the research assistance of Kristina Chelberg, funded by the Australian Centre for Health Law Research, Queensland University of Technology.

Author information

Affiliations

Authors

Corresponding author

Correspondence to Shih-Ning Then.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Then, SN., Lipworth, W., Stewart, C. et al. A framework for ethics review of applications to store, reuse and share tissue samples. Monash Bioeth. Rev. 39, 115–124 (2021). https://doi.org/10.1007/s40592-021-00126-4

Download citation

Keywords

  • Biobanks
  • Ethics review
  • Human tissue
  • Research
  • Biobank networks