International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs involving exchange of biospecimens and data and in monitoring compliance.
This is a preview of subscription content, access via your institution.
Buy single article
Instant access to the full article PDF.
Tax calculation will be finalised during checkout.
Bennett, A., W. Streitz, and R. Gaecel. 2007. Specific issues with material transfer agreements. In Intellectual property management in health and agricultural innovation: A handbook of best practices, ed. A. Krattiger, R. Mahoney, L. Nelsen, et al., 697–706. Oxford and Davis: MIHR and PIPRA.
Bledsoe, M.J., W.E. Grizzle, B.J. Clark, and N. Zeps. 2012. Practical implementation issues and challenges for biobanks in the return of individual research results. Genetics in Medicine 14(4): 478–483. doi:10.1038/gim.2011.67.
Chalmers, D. 2011. Are the research ethics committees working in the best interests of participants in an increasingly globalized research environment? Journal of Internal Medicine 269(4): 392–406.
Chalmers, D., and D. Nicol. 2008. Human genetic research databases and biobanks: Towards uniform terminology and Australian best practice. Journal of Law and Medicine 15(4): 538–555.
Dove, E.S., B.M. Knoppers, and M.H. Zawati. 2013. An ethics safe harbor for international genomics research? Genome Medicine 5(11): 99. doi:10.1186/gm503.
Hansson, M., J. Dillner, C. Bartram, and J. Carlson. 2006. Should donors be allowed to give broad consent to future biobank research? Lancet Oncology 7(3): 266–269.
International Society for Biological and Environmental Repositories [ISBER]. 2012. Best practices for repositories: Collection, storage, retrieval, and distribution of biological materials for research, 3rd ed. Vancouver: ISBER. http://c.ymcdn.com/sites/www.isber.org/resource/resmgr/Files/2012ISBERBestPractices3rdedi.pdf.
Kaye, J., L. Curren, N. Anderson, et al. 2012. From patients to partners: Participant-centric initiatives in biomedical research. Nature Reviews Genetics 13(May): 371–376. doi:10.1038/nrg3218.
Kaye, J., N. Kanellopoulou, N. Hawkins, H. Gowans, L. Curren, and K. Melham. 2013. Can I access my personal genome? The current legal position in the UK. Medical Law Review 22(1): 64–86.
Ministerio de Economía y Competitividad. 2011. Real Decreto 1716/2011, de 18 de noviembre, por el que se establecen los requisitos básicos de autorización y funcionamiento de los biobancos con fines de investigación biomédica y del tratamiento de las muestras biológicas de origen humano, y se regula el funcionamiento y organización del Registro Nacional de Biobancos para investigación biomédica. http://www.boe.es/diario_boe/txt.php?id=BOE-A-2013-8085. Accessed March 10 2014.
National Health and Medical Research Council [NHMRC]. 2007a. National statement on the ethical conduct in human research. Canberra: Australian Government. http://www.nhmrc.gov.au/guidelines/publications/e72.
National Health and Medical Research Council [NHMRC]. 2007b. Australian code for the responsible conduct of research. Canberra: Australian Government. http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/r39.pdf.
National Health and Medical Research Council [NHMRC]. 2010. Biobanks information paper. Canberra: Australian Government. https://www.nhmrc.gov.au/guidelines/publications/e110.
Peel, J. 2005. The precautionary principle in practice: Environmental decision-making and scientific uncertainty. Sydney: Federation Press.
Rodriguez, V. 2007. Merton and Ziman’s mode of science: The case of biological and similar material transfer agreements. Science and Public Policy 34(5): 355–363.
Romeo, C., P. Nicolás, and S. Romeo. 2011. Legal and social implications of creating banks of biological material in Spain. In Latinbanks: Study on the legal and social implications of creating banks of biological materials for biomedical research, ed. C. Romeo and J. Simon, 311–363. Bruxelles: Bruylant.
Steinsbekk, K.S., B. Kåre Myskja, and B. Solberg. 2013. Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem? European Journal of Human Genetics 21(9): 897–902.
Streitz, W.D., and A.B. Bennett. 2003. Material transfer agreements: A university perspective. Plant Physiology 113(1): 10–13.
van Veen, E.-B., P.H.J. Riegman, W.N.M. Dinjens, et al. 2006. TuBaFrost 3: Regulatory and ethical issues on the exchange of residual tissue for research across Europe. European Journal of Cancer 42(17): 2914–2923.
World Health Organization. 2011. Standards and operational guidance for ethics review of health-related research with human participants. Geneva: WHO. http://whqlibdoc.who.int/publications/2011/9789241502948_eng.pdf.
The research for this article was funded by Australian Research Council Discovery Grant DP140100301 and the Chronic Lymphocytic Leukemia (CLL) Genome Project funded by the Spanish Ministry of Economy and Competitiveness through the Instituto de Salud Carlos III (ISCIII).
About this article
Cite this article
Chalmers, D., Nicol, D., Nicolás, P. et al. A Role for Research Ethics Committees in Exchanges of Human Biospecimens Through Material Transfer Agreements. Bioethical Inquiry 11, 301–306 (2014). https://doi.org/10.1007/s11673-014-9552-1
- Material transfer agreements
- Research ethics committees
- International exchange of biological material