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Policy recommendations for addressing privacy challenges associated with cell-based research and interventions Ogbogu, Ubaka; Burningham, Sarah; Ollenberger, Adam; Calder, Kathryn; Du, Li; El Emam, Khaled; Hyde-Lay, Robyn; Isasi, Rosario; Joly, Yann; Kerr, Ian; Malin, Bradley; McDonald, Michael; Penney, Steven; Piat, Gayle; Roy, Denis-Claude; Sugarman, Jeremy; Vercauteren, Suzanne; Verhenneman, Griet; West, Lori; Caulfield, Timothy Feb 3, 2014

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DEBATE Open AccessPolicy recommendations for addressing privacychallenges associated with cell-based researchand interventionsUbaka Ogbogu1,2*, Sarah Burningham2, Adam Ollenberger2, Kathryn Calder3, Li Du2, Khaled El Emam4,Robyn Hyde-Lay2, Rosario Isasi5, Yann Joly6, Ian Kerr7, Bradley Malin8, Michael McDonald9, Steven Penney2,10,Gayle Piat11, Denis-Claude Roy12, Jeremy Sugarman13, Suzanne Vercauteren14, Griet Verhenneman15, Lori West16and Timothy Caulfield2,17AbstractBackground: The increased use of human biological material for cell-based research and clinical interventionsposes risks to the privacy of patients and donors, including the possibility of re-identification of individuals fromanonymized cell lines and associated genetic data. These risks will increase as technologies and databases used forre-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’ abilityto control what is done with their genetic data, amplify the privacy concerns.Discussion: To date, the privacy issues associated with cell-based research and interventions have not received muchattention in the academic and policymaking contexts. This paper, arising out of a multi-disciplinary workshop, aims torectify this by outlining the issues, proposing novel governance strategies and policy recommendations, and identifyingareas where further evidence is required to make sound policy decisions. The authors of this paper take the positionthat existing rules and norms can be reasonably extended to address privacy risks in this context without compromisingemerging developments in the research environment, and that exceptions from such rules should be justified using acase-by-case approach. In developing new policies, the broader framework of regulations governing cell-based researchand related areas must be taken into account, as well as the views of impacted groups, including scientists, researchparticipants and the general public.Summary: This paper outlines deliberations at a policy development workshop focusing on privacy challengesassociated 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. Thepaper concludes that privacy risks associated with cell-based research and interventions should be addressed throughevidence-based policy reforms that account for both well-established legal and ethical norms and current knowledgeabout actual or anticipated harms. The authors also call for research studies that identify and address gaps inunderstanding of privacy risks.* Correspondence: uogbogu@ualberta.ca1Faculties of Law and Pharmacy & Pharmaceutical Sciences, University ofAlberta, 116 Street and 85 Avenue, Edmonton T6G 2R3, Canada2Health Law Institute, Faculty of Law, University of Alberta, 116 Street and 85Avenue, Edmonton T6G 2R3, CanadaFull list of author information is available at the end of the article© 2014 Ogbogu et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the original work is properly cited.Ogbogu et al. BMC Medical Ethics 2014, 15:7http://www.biomedcentral.com/1472-6939/15/7BackgroundUses of human biological materials for cell-based researchand interventions have re-ignited persistent worries re-garding the protection of genetic privacy in an era whereopenness, sharing, and access to affordable and accessiblegenetic testing technologies are increasingly commonplace.While the privacy challenges associated with cell-based re-search and interventions are by no means unique, theyhave become more evident in light of the considerablepublic interest and scientific excitement surroundingground-breaking recent discoveries in the field, such asinduced pluripotent stem cells (iPSCs) [1,2], somatic-cellnuclear transfer (SCNT) derived human embryonic stemcells (hESCs) [3] and triploid human embryonic stem cells(hESCs) [4]. In this article, we examine and offer recom-mendations for addressing these privacy challenges throughthe lens of cell-based research and interventions, whilerecognizing that the derivation and sharing of stem celllines are a critical part of good scientific practice [5], andthat the privacy challenges discussed here are engagedequally (or perhaps more markedly) in other contexts,such as in relation to genetic research and biobank datasets.Indeed, our discussion of the stem cell context will ne-cessarily canvass and draw upon the academic literatureon privacy issues facing genetic research.In the context of cell-based research and interventions, aspecific concern relates to potential privacy risks surround-ing research uses of iPSCs. There is emerging scientificconsensus that these stem cell lines retain substantialgenetic characteristics of the parent/donor somatic cellor tissue [6,7]. Accordingly, an individual could be re-identified from anonymized or anonymous genetic dataderived from such cell lines. Moreover, in most cases, celllines will be linked to the donor’s clinical information forboth research and regulatory purposes [8]. Insecure hand-ling or misuse of these lines and associated clinical informa-tion could also result in disclosure of personal informationto unauthorized parties. The highly collaborative nature ofcell therapy research and the transnational movement ofstem cell lines and associated health information reinforceprivacy concerns, and have generated calls for policy inter-vention [9-11]. Privacy concerns, among other ethical andlegal issues associated with cross-jurisdictional transfer ofstem cell lines, also suggest a need for harmonization ofpolicy responses across jurisdictions [12-15]. Indeed, it hasbeen observed that conceptual and logistical impedimentsto international sharing of biological resources can beovercome by harmonizing privacy standards through acontinuing process that fosters the interplay of differentnational viewpoints [16].Furthermore, recent studies have demonstrated thepossibility of re-identifying research participants fromanonymized genetic data [17-19] by linking such datawith freely available information in the public domain,such as familial database records, and demographic infor-mation obtained through Internet searches [10,18,20-22].However, these re-identification studies currently requirehighly sophisticated technical ability and technologicalresources, and involve complex and specialized processes,with very limited success rates [23]. Also, institutional datause policies may preclude or impose stringent conditionson re-identification of research participants from anon-ymized genetic data or other health information. While itis possible that re-identification could become easier ormore successful with advances in data linkage technologies,and proliferation of reference databases (including geneal-ogy websites, genome-phenome data banks, and linkedelectronic medical records) [18,22,24,25], the potential risksof re-identification are presently neither manifest norpressing in magnitude or feasibility [26]. That said, thepotential for re-identification has generated significantpolicy and media attention and scrutiny [27-34].It has been suggested that re-identification may causea variety of harms, including harms to donors’ privacyinterests [9,10], the possibility of genetic discriminationin the context of employment, health care, and life andmedical insurance [35-37], and inappropriate disclosure ofstigmatizing, embarrassing or incriminating genetic infor-mation [10,35,38]. Also, unauthorized re-identification ofanonymous research participants could undermine publictrust in genetic research and result in public reluctance todonate biological material for genomics research [39,40].However, there is presently little evidence to support fearsthat these harms will materialize [21,41,42]. Geneticdiscrimination in insurance, for example, is uncommonbecause the predictive ability of genetic testing is limited,and most of the information that would arise is alreadydisclosed through evaluation of family and medical history[36,42-44].The foregoing privacy concerns are made more sensitiveby emerging practices that challenge well-established legaland ethical norms. For instance, consent models, suchas broad consent—which enable donors to consent toprospective, as-yet-unknown research uses of their donatedmaterials—are increasingly common in genomics and re-lated research contexts [45-47]. Likewise, an increasingnumber of policy instruments limit the right to withdrawconsent to the use of donated biological materials to atime before the materials are used for research or a stemcell line is created [45,48-53]. These practices remain con-troversial and have generated significant discussion in theacademic community [52-56]. In many jurisdictions, in-cluding Canada, Australia, the U.S. and the E.U., voluntaryinformed consent to identified or specific research studiesis required by applicable policies [57-62]. However, re-search ethics committees (RECs) can approve studies thatdepart from this rule, on a case-by-case basis, but only ifthere is minimal risk to participants and the failure toOgbogu et al. BMC Medical Ethics 2014, 15:7 Page 2 of 7http://www.biomedcentral.com/1472-6939/15/7obtain consent will not adversely affect participant welfare,or if it would be impossible or impractical to carry out theresearch without prior consent from participants [57-59].Given the significant public interest in cell-based re-search and interventions, privacy is likely to be a hot areaof policy debate. However, to date, there have been few,if any, attempts to examine the privacy issues arising inthis context, or to formulate proactive evidence-basedpolicy guidance to address associated risks. To this end,and under the auspices of the Office of the Privacy Com-missioner of Canada Contributions Program, we conveneda workshop to facilitate focused scholarly and policy reflec-tion and analysis on the privacy risks and issues associatedwith cell-based research and interventions. Workshop par-ticipants consisted of the authors of this paper, and repre-sent a multi-institutional, multidisciplinary group of legalscholars, bioethicists, privacy experts, data security experts,bioinformaticians, stem cell scientists, and trainees in allthese areas. Using a workshop format we have successfullyemployed in the past to generate debate and consensus onpolicy recommendations [8,63,64], participants presentedon and discussed the following topics: cell-based researchand interventions, current governance regimes and associ-ated challenges, data security and re-identification studies,privacy and open access, and consent requirements.Following the presentations, recommendations formu-lated by the workshop conveners (Ogbogu, Caulfield andBurningham) were presented for deliberation and revision.In the next section, we outline key themes and specificpolicy recommendations that emerged from the discus-sions at the workshop.DiscussionTheme 1: Re-identification risk is a moving targetRecent research studies have demonstrated the possibilityof successful re-identification of de-identified genetic data[18,19]. While these studies raise serious questions aboutwhether de-identification-based privacy guarantees areadequate to protect research participants against unlawfuluse and disclosure of their genetic information, it shouldbe borne in mind that re-identification attacks are presentlytechnologically rigorous and expensive, have limited suc-cess rates, and require specialized equipment and accessto other health data. Re-identification attacks therefore donot currently raise a level of risk that should be met withrestrictive policies, such as restrictions on open access andon sharing of genetic research data. Open access policiesshould be combined with acceptable use or data use agree-ments that prohibit re-identification and/or misuse.The risk of re-identification may increase as technologyimproves and/or publicly accessible databases containinggenetic information linkable to identifiable individualsbecome more widespread. Policies designed to preventunauthorized re-identification should be based on evidenceof actual or anticipated harm, and incorporate processes forongoing evaluation of anticipated risk or harm.Theme 2: Informed consent: “The devil is in the defaults”aAs previously stated, many jurisdictions require researchersto inform research participants about and obtain their con-sent to specific research uses of their biological materialsand associated genetic or other health information. Thisrequirement is typically subject to limited exceptions andmust be complied with prior to commencement of re-search. Participants must also be made aware of any legallyor ethically sanctioned limits to exercising meaningfulcontrol over their personal health or genetic informationonce the research has commenced.To ensure “a consistent floor of privacy protections” [34],p. 5, these policies should be maintained as the default inrelation to uses and disclosure of genetic information andassociated health data. Departure from the default rulesmay be warranted, but only where the public interest in thedeparture clearly outweighs a corresponding public interestin protecting and preserving individual privacy and auton-omy. The rationale for setting aside the default rules mustbe clearly and specifically demonstrated, and balancedagainst actual evidence of consequent benefits and risks.This approach is necessarily case-specific, and should beimplemented by a body or institution that is familiar with,or structured to obtain and incorporate into its deliberativeand decision-making process, multiple perspectives on theresearch context, associated privacy challenges, participantpreferences, and the risks and benefits of proposed excep-tions. While it remains an open question whether or notRECs can fulfill these roles within the scope of theirpresent mandates [65], an emerging alternative is theestablishment of data access committees that are chargedwith the responsibility of overseeing requests or applica-tions for research use and disclosure of personal healthdata, and with monitoring and responding to privacy chal-lenges resulting from innovations in health research [26,65].Theme 3: Beyond re-identification risk and consent:grounding the default in a “big picture” view of policydevelopment and analysisThere is a need to move scholarly reflection beyonddiscussion of re-identification risks and consent issuessurrounding research involving human biological materials.To encourage a shift in focus, researchers should prioritizetwo other relevant areas: the broader framework of policiesand regulations applicable to privacy issues in this context(such as the impact of access to information law on partici-pant rights and researcher responsibilities), and studies ofaffected groups’ views, such as the views of research partici-pants, the public, and researchers working in this area.Some work has been done in both areas, including studiesof public and stakeholder opinions [66-68] and a recentOgbogu et al. BMC Medical Ethics 2014, 15:7 Page 3 of 7http://www.biomedcentral.com/1472-6939/15/7analysis of Canadian judicial doctrine and its implicationsfor participants’ rights of continued access to and controlover genetic and other health information [69]. However,de-identification is still an important tool in the privacy“tool-box”. Even though de-identification of cell lines maynot guarantee privacy, it is one tool to employ in theconstruction of a privacy framework and will work inconjunction with other approaches, such as educationand strengthening of governance mechanisms.In accordance with this “big picture” approach to policydevelopment, default rules should be broadly based onexisting policy rules and norms, including privacy andaccess to information laws, research ethics guidelines,government reports and white papers, and non-bindingpolicy statements issued by influential scientific or researchethics organizations [34,70-80]. Gaps and warranted excep-tions should be addressed through governance mechanismsdesigned to balance competing public interests that arise inthis research context. To facilitate cross-border researchcollaborations, national policies should be designed toallow for harmonization with other jurisdictions.Lastly, affected groups’ perspectives must be taken intoaccount in designing policy, including the views of scien-tists, clinicians, institutional managers and research partic-ipants. Research on missing or incomplete perspectivesshould be encouraged and prioritized. Specifically, thesegroups should be included in policy deliberations and inthe actual policy-making process, in addition to moretraditional “top down” approaches to public consultationsuch as public opinion surveys, focus groups and publiccommentary.Recommendation #1: Changes to existing policiesExisting legal and ethical policies (including privacy andaccess to information laws and research ethics policies)should be extended to cover research involving humanbiological material that contains identifiable genetic infor-mation about a research participant. No special rules orexceptions need apply. Specifically:i. research participants must be informed of knownrisks of re-identification of de-identified genetic dataat the time of donation and consent;ii. researchers and research institutions shouldinform research participants about new risks ofre-identification as they emerge;iii. researchers and institutions seeking to use or sharehuman biological material and/or de-identified geneticdata must have policies and processes in place tomonitor and respond to re-identification risks, includingbut not limited to controlled access mechanisms;biv. legal definitions of “personal information”, “personalhealth information” and similar terms should beexpanded to include “human biological material”;v. the term “information custodian” and other similarterms in privacy and access to informationlegislation should be defined to include “persons orinstitutions that collect, use, share or disclosehuman biological material or genetic informationderived from such samples”;vi. institutional sharing policies should address privacyprotections for associated clinical health informationcollected with human biological material;vii. policymakers should seek to harmonize policiesacross jurisdictions, and to coordinate monitoringand enforcement processes;viii. institutions should work out inter-institutionalarrangements to deal with privacy issues eitherthrough delegated or centralized review; andix. privacy regulators should establish mechanisms tomonitor technological developments and review andupdate best practices in relation to privacy risksattending to research uses of human biologicalmaterials.Recommendation #2: Changes to governance mechanismsThe role of RECs in privacy governance in the context ofcell-based research should be clarified. At the moment,some hurdles may stand in the way of effective oversight,including the fact that RECs may lack experience inprivacy matters or may exchange rigorous ethics reviewfor bureaucratic box checking [65,81,82]. Accordingly,legislation and relevant policies should set out dedicatedgovernance frameworks to monitor and respond to privacychallenges in the context of cell-based research. Options toconsider include:i. revising membership requirements to includemandatory representation by a privacy expert or ITsecurity specialist; orii. establishing an independent “data access committee”to review research protocols that raise significantprivacy concerns (perhaps on a referral basis fromRECs) and to provide general guidance in responseto anticipated or existing privacy challenges.SummaryAddressing privacy challenges and issues facing cell-basedresearch and interventions requires collaborative reflectionamong and response from multiple interested parties,including scientists, privacy experts, bioethicists, legalscholars and policymakers. This paper outlines the firstattempt at such an endeavour, and provides a summaryof key themes and recommendations to facilitate andguide both future discussions and policymaking activitiesin this context. While the issues canvassed in the paper,chiefly the privacy risks surrounding ongoing linkage ofstem cell lines to research participants’ genetic and clinicalOgbogu et al. BMC Medical Ethics 2014, 15:7 Page 4 of 7http://www.biomedcentral.com/1472-6939/15/7information, deserve scholarly and policy scrutiny, theyare not necessarily unique. They must therefore be metwith measured evidence-based policy reforms that accountfor both well-established legal and ethical norms andcurrent knowledge about actual or anticipated harms.Research on privacy issues in this context should focuson gaps in knowledge, such as canvassing the views ofpersons or groups whose interests are most likely to beaffected. Lastly, policy development in this context mustbe necessarily proactive and aimed primarily at maintain-ing public trust in and support for cell-based research andinterventions.EndnotesaThis phrase is borrowed from Ian Kerr’s presentationat the workshop, and is referenced in his earlier editorialdiscussing Facebook and privacy [83].bIn controlled-access agreements, one party agrees toprovide the other with access to specific data or materialon certain conditions relating to security practices orconfidentiality [84].Competing interestsThe authors declare that they have no competing interests.Authors’ contributionsAll authors contributed to the conception and design of the paper. UO, SBand AO drafted the manuscript. All authors contributed revisions to themanuscript. All authors read and approved the final manuscript.AcknowledgmentsFunding for this paper and authors’ participation in the workshop wasprovided by the Office of the Privacy Commissioner of Canada’sContributions Program, the Canadian Stem Cell Network, the Cancer StemCell Consortium, cbcf Tumor Bank, and the PACE-Omics Project funded byGenome Canada, Genome Alberta, the Canadian Institutes for Health Research,and Alberta Health and Wellness. The authors would like to thank KalinaKamenova for comments on an earlier draft of the paper, Maeghan Toewsfor editorial support, and members of the Health Law Institute team,particularly Robyn Hyde-Lay, for administrative support.Author details1Faculties of Law and Pharmacy & Pharmaceutical Sciences, University ofAlberta, 116 Street and 85 Avenue, Edmonton T6G 2R3, Canada. 2Health LawInstitute, Faculty of Law, University of Alberta, 116 Street and 85 Avenue,Edmonton T6G 2R3, Canada. 3cbcf Tumor Bank/Alberta Cancer ResearchBiorepository, Cross Cancer Institute, Rm 2312, 11560 University Avenue,Edmonton T6G 1Z2, Canada. 4Faculty of Medicine, University of Ottawa,CPCR, 401 Smyth Road, Ottawa K1H 8 L1, Canada. 5Centre of Genomics andPolicy, Faculty of Medicine, and Department of Human Genetics, McGillUniversity, 740, avenue Dr. Penfield, suite 5206, Montreal H3A 0G1, Canada.6Centre of Genomics and Policy, Department of Human Genetics, McGillUniversity, 740, avenue Dr. Penfield, suite 5206, Montreal H3A 0G1, Canada.7Faculties of Law and Medicine, Department of Philosophy and School ofInformation Studies, University of Ottawa, 75 Laurier Avenue East, OttawaK1N 6 N5, Canada. 8Schools of Medicine and Engineering, VanderbiltUniversity, 2525 West End Avenue, Nashville 37203, USA. 9W. Maurice YoungCenter for Applied Ethics, University of British Columbia, 2329 West Mall,Vancouver V6T 1Z4, Canada. 10Faculty of Law, University of Alberta, 116Street and 85 Avenue, Edmonton T6G 2R3, Canada. 11Cell and TissueInnovative Research Centre, University of Alberta, 116 Street and 85 Avenue,Edmonton T6G 2R3, Canada. 12Centre de recherche HôpitalMaisonneuve-Rosemont, and Faculty of Medicine, University of Montreal,5415 L’Assomption blvd, Montreal Quebec H1T 2M4, Canada. 13BermanInstitute of Bioethics and Department of Medicine, John Hopkins University,Baltimore Maryland 21205, USA. 14Faculty of Medicine, University of BritishColumbia, 2329 West Mall, Vancouver V6T 1Z4, Canada. 15University ofLeuven, Oude Markt 13, Leuven 3000, Belgium. 16Alberta Transplant Institute,Faculty of Medicine, University of Alberta, 116 Street and 85 Avenue,Edmonton T6G 2R3, Canada. 17Faculty of Law and School of Public Health,University of Alberta, 116 Street and 85 Avenue, Edmonton T6G 2R3, Canada.Received: 6 August 2013 Accepted: 27 January 2014Published: 3 February 2014References1. 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Hum Genet 2011, 130:441–449.doi:10.1186/1472-6939-15-7Cite this article as: Ogbogu et al.: Policy recommendations foraddressing privacy challenges associated with cell-based research andinterventions. BMC Medical Ethics 2014 15:7.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submitOgbogu et al. BMC Medical Ethics 2014, 15:7 Page 7 of 7http://www.biomedcentral.com/1472-6939/15/7


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