Stem Cell Research Ethics: Consensus Statement on Emerging Issues

Caulfield, Timothy; Ogbogu, Ubaka; Nelson, Erin; Einsiedel, Edna F.; Knoppers, Bartha Maria; McDonald, Michael; Brunger, Fern; Downey, Robin; Fernando, Kanchana; Galipeau, Jacques; Geransar, Rose; Grenier, Glenn; Hyun, Insoo; Isasi, Rosario; Kardel, Melanie; Knowles, Lori P.; Kucic, Terrence; Lötjönen, Salla; Lyall, Drew; Magnus, David; Mathews, Debra J. H.; Nisbet, Matthew C.; Nisker, Jeffrey A.; Paré, Guillaume; Pattinson, Shaun D.; Pullman, Daryl; Rudnicki, Michael A.; Williams‐Jones, Bryn; Zimmerman, Susan V.

doi:10.1016/s1701-2163(16)32632-9

Cited by 20 publications

(10 citation statements)

References 15 publications

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“…There are jurisdictional differences in clinical trial regulations including the use of biologics, privacy rules, informed consent and assessment of risk. Research ethics norms associated with donation of embryos and tissues vary between jurisdictions and at times are undefined, influx or developing within given jurisdictions [27,28]. Relevant research practice standards, including both research conduct and technical standards relating to cell line derivation and maintenance, are not universal.…”

Section: A Complex Patchworkmentioning

confidence: 99%

The Stem Cell Research Environment: A Patchwork of Patchworks

Caulfield

Zarzeczny

McCormick

et al. 2009

Stem Cell Rev and Rep

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Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the enormous variation that exists among the environments in which stem cell research is conducted throughout the world. This variation is layered upon intra-jurisdictional policies that are also often complex and in flux, resulting in what we term a 'patchwork of patchworks'. This patchwork of patchworks and its implications will become increasingly important as we enter this new era of stem cell research. The current progression towards translational and clinical research among international collaborators serves as a catalyst for identifying potential policy conflict and makes it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in contemporary stem cell research environments provide a valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application.

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Section: A Complex Patchworkmentioning

confidence: 99%

The Stem Cell Research Environment: A Patchwork of Patchworks

Caulfield

Zarzeczny

McCormick

et al. 2009

Stem Cell Rev and Rep

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“…This includes the relevance of public opinion research to policy making. 75 Despite a large amount of public debate, many of the issues remain, including concern that human gene/cell patents may harm the research environment, lead to an inappropriate commodification of life, and adversely affect public access to useful healthcare procedures. 76 …”

Section: New Challengesmentioning

confidence: 99%

Ethical Issues in Cardiovascular Research Involving Humans

Frye

Simari²,

Gersh³

et al. 2009

Circulation

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“…Workshop participants consisted of the authors of this paper, and represent a multi-institutional, multidisciplinary group of legal scholars, bioethicists, privacy experts, data security experts, bioinformaticians, stem cell scientists, and trainees in all these areas. Using a workshop format we have successfully employed in the past to generate debate and consensus on policy recommendations [8,63,64], participants presented on and discussed the following topics: cell-based research and interventions, current governance regimes and associated challenges, data security and re-identification studies, privacy and open access, and consent requirements. Following the presentations, recommendations formulated by the workshop conveners (Ogbogu, Caulfield and Burningham) were presented for deliberation and revision.…”

Section: Introductionmentioning

confidence: 99%

Policy recommendations for addressing privacy challenges associated with cell-based research and interventions

et al. 2014

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BackgroundThe increased use of human biological material for cell-based research and clinical interventions poses risks to the privacy of patients and donors, including the possibility of re-identification of individuals from anonymized cell lines and associated genetic data. These risks will increase as technologies and databases used for re-identification become affordable and more sophisticated. Policies that require ongoing linkage of cell lines to donors’ clinical information for research and regulatory purposes, and existing practices that limit research participants’ ability to control what is done with their genetic data, amplify the privacy concerns.DiscussionTo date, the privacy issues associated with cell-based research and interventions have not received much attention in the academic and policymaking contexts. This paper, arising out of a multi-disciplinary workshop, aims to rectify this by outlining the issues, proposing novel governance strategies and policy recommendations, and identifying areas where further evidence is required to make sound policy decisions. The authors of this paper take the position that existing rules and norms can be reasonably extended to address privacy risks in this context without compromising emerging developments in the research environment, and that exceptions from such rules should be justified using a case-by-case approach. In developing new policies, the broader framework of regulations governing cell-based research and related areas must be taken into account, as well as the views of impacted groups, including scientists, research participants and the general public.SummaryThis paper outlines deliberations at a policy development workshop focusing on privacy challenges associated with cell-based research and interventions. The paper provides an overview of these challenges, followed by a discussion of key themes and recommendations that emerged from discussions at the workshop. The paper concludes that privacy risks associated with cell-based research and interventions should be addressed through evidence-based policy reforms that account for both well-established legal and ethical norms and current knowledge about actual or anticipated harms. The authors also call for research studies that identify and address gaps in understanding of privacy risks.

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Stem Cell Research Ethics: Consensus Statement on Emerging Issues

Cited by 20 publications

References 15 publications

The Stem Cell Research Environment: A Patchwork of Patchworks

The Stem Cell Research Environment: A Patchwork of Patchworks

Ethical Issues in Cardiovascular Research Involving Humans

Policy recommendations for addressing privacy challenges associated with cell-based research and interventions

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