A qualitative study of participants’ views on re-consent in a longitudinal biobank

BMC Medical Ethics 2017 18:22
Authors: Mary Dixon-Woods, David Kocman, Liz Brewster, Janet Willars, Graeme Laurie, Carolyn Tarrant
“Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or ‘biobanks’ over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank.”
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Dynamic Consent: a potential solution to some of the challenges of modern biomedical research

BMC Medical Ethics 2017 18:4
Authors: Isabelle Budin-Ljøsne, Harriet J. A. Teare, Jane Kaye, Stephan Beck, Heidi Beate Bentzen et al
“Innovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment.”
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Navigating social and ethical challenges of biobanking for human microbiome research

BMC Medical Ethics, 11 January 2017
Authors: Kim H. Chuong, David M. Hwang, D. Elizabeth Tullis, Valerie J. Waters, Yvonne C. W. Yau, David S. Guttman, Kieran C. O’Doherty
“Biobanks are considered to be key infrastructures for research development and have generated a lot of debate about their ethical, legal and social implications (ELSI). While the focus has been on human genomic research, rapid advances in human microbiome research further complicate the debate.”
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Is Mitochondrial Donation Germ-Line Gene Therapy? Classifications and Ethical Implications

Bioethics, Volume 31, Issue 1, January 2017, p55–67
Authors: Ainsley J. Newson, Anthony Wrigley
“The classification of techniques used in mitochondrial donation, including their role as purported germ-line gene therapies, is far from clear. These techniques exhibit characteristics typical of a variety of classifications that have been used in both scientific and bioethics scholarship. This raises two connected questions, which we address in this paper: (i) how should we classify mitochondrial donation techniques?; and (ii) what ethical implications surround such a classification? First, we outline how methods of genetic intervention, such as germ-line gene therapy, are typically defined or classified. We then consider whether techniques of mitochondrial donation fit into these, whether they might do so with some refinement of these categories, or whether they require some other approach to classification.”
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Scientists Battle In Court Over Lucrative Patents For Gene-Editing Tool

NPR, 5 December 2016
Author: Richard Harris
“A gene-editing technology called CRISPR-cas9 could be worth billions of dollars. But it’s not clear who owns the idea. U.S. patent judges will hear oral arguments to help untangle this issue, which has far more at stake than your garden-variety patent dispute. “This is arguably the biggest biotechnology breakthrough in the past 30 or 40 years, and controlling who owns the foundational intellectual property behind that is consequentially pretty important,” says Jacob Sherkow, a professor at the New York Law College.”
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“It’s all about trust”: reflections of researchers on the complexity and controversy surrounding biobanking in South Africa

BMC Medical Ethics 2016 17:57
Authors: Keymanthri Moodley, Shenuka Singh
“Biobanks are precariously situated at the intersection of science, genetics, genomics, society, ethics, the law and politics. This multi-disciplinarity has given rise to a new discourse in health research involving diverse stakeholders. Each stakeholder is embedded in a unique context and articulates his/her biobanking activities differently. To researchers, biobanks carry enormous transformative potential in terms of advancing scientific discovery and knowledge. However, in the context of power asymmetries in Africa and a distrust in science born out of historical exploitation, researchers must balance the scientific imperative of collecting, storing and sharing high quality biological samples with obligations to donors/participants, communities, international collaborators, regulatory and ethics authorities. To date, researcher perspectives on biobanking in South Africa have not been explored and documented.”
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Personalized assent for pediatric biobanks

BMC Medical Ethics 2016 17:59
Authors: Noor A. A. Giesbertz,Karen Melham, Jane Kaye, Johannes J. M. van Delden, Annelien L. Bredenoord
“Pediatric biobanking is considered important for generating biomedical knowledge and improving (pediatric) health care. However, the inclusion of children’s samples in biobanks involves specific ethical issues. One of the main concerns is how to appropriately engage children in the consent procedure. We suggest that children should be involved through a personalized assent procedure, which means that both the content and the process of assent are adjusted to the individual child. In this paper we provide guidance on how to put personalized assent into pediatric biobanking practice and consider both the content and process of personalized assent. In the discussion we argue that the assent procedure itself is formative. Investing in the procedure should be a requirement for pediatric biobank research.”
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National ethics guidance in Sub-Saharan Africa on the collection and use of human biological specimens: a systematic review

BMC Medical Ethics 2016 17:64
Authors: Francis Barchi, Madison T. Little
“Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks.”
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National ethics guidance in Sub-Saharan Africa on the collection and use of human biological specimens: a systematic review

BMC Medical Ethics 2016 17:64
Authors: Francis Barchi, Madison T. Little
“Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks.”
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Personalized assent for pediatric biobanks

BMC Medical Ethics 2016 17:59
Authors: Noor A. A. Giesbertz, Karen Melham, Jane Kaye, Johannes J. M. van Delden, Annelien L. Bredenoord
“Pediatric biobanking is considered important for generating biomedical knowledge and improving (pediatric) health care. However, the inclusion of children’s samples in biobanks involves specific ethical issues. One of the main concerns is how to appropriately engage children in the consent procedure.”
Find article here.