Heidi Beate Bentzen

• Bentzen, Heidi Beate; Gaillard, Maxence; Nachman, Iftach; Reumann, Daniel; Gadegaard, Nikolaj & David, Laurent [Vis alle 14 forfattere av denne artikkelen] (2026). A guide to using embedded ethics in human stem-cell-based embryo model research. Nature Cell Biology. ISSN 1465-7392. 28(4), s. 665–673. doi: 10.1038/s41556-026-01909-9. Fulltekst i vitenarkiv
• Kloza, Dariusz; Drechsler, Laura; Fernandes, Elora; Birth, Arian; Rossi, Julien & Dewitte, Pierre [Vis alle 10 forfattere av denne artikkelen] (2025). If it ain't broke, don't fix it? Ten improvements for the upcoming tenth anniversary of the General Data Protection Regulation. Computer Law & Security Review. ISSN 2212-473X. 60. doi: 10.1016/j.clsr.2025.106251. Fulltekst i vitenarkiv
• Perry, Julia; Bunnik, Eline; Rietschel, Marcella; Bentzen, Heidi Beate; Malmgren, Charlotta Ingvoldstad & Pawlak, Joanna [Vis alle 23 forfattere av denne artikkelen] (2025). Unresolved ethical issues of genetic counseling and testing in clinical psychiatry. Psychiatric Genetics. ISSN 0955-8829. 35(2), s. 26–36. doi: 10.1097/YPG.0000000000000385. Fulltekst i vitenarkiv Vis sammendrag

  Objective This position article discusses current major ethical and social issues related to genetic counseling and testing in clinical psychiatry (PsyGCT). Methods To address these complex issues in the context of clinical psychiatry relevant to PsyGCT, the interdisciplinary and pan-European expert Network EnGagE (Enhancing Psychiatric Genetic Counseling, Testing, and Training in Europe; CA17130) was established in 2018. We conducted an interdisciplinary, international workshop at which we identified gaps across European healthcare services and research in PsyGCT; the workshop output was summarized and systematized for this position article. Results Four main unresolved ethical topics were identified as most relevant for the implementation of PsyGCT: (1) the problematic dualism between somatic and psychiatric disorders, (2) the impact of genetic testing on stigma, (3) fulfilling professional responsibilities, and (4) ethical issues in public health services. We provide basic recommendations to inform psychiatrists and other healthcare professionals involved in the clinical implementation of PsyGCT and conclude by pointing to avenues of future ethics research in PsyGCT. Conclusion This article draws attention to a set of unresolved ethical issues relevant for mental health professionals, professionals within clinical genetics, patients and their family members, and society as a whole and stresses the need for more interdisciplinary exchange to define standards in psychiatric counseling as well as in public communication. The use of PsyGCT may, in the future, expand and include genetic testing for additional psychiatric diagnoses. We advocate the development of pan-European ethical standards addressing the four identified areas of ethical–practical relevance in PsyGCT

• Bentzen, Heidi Beate (2024). Human organoids: things or data? I Dove, Edward S. (Red.), Confidentiality, Privacy, and Data Protection in Biomedicine International Concepts and Issues. Routledge. ISSN 9781032495866. s. 293–314. doi: 10.4324/9781003394518-15. Fulltekst i vitenarkiv Vis sammendrag

  Human organoids are stem cell–derived mini-organ models. These can model human biology and disease, including early human development, may replace animal experiments in clinical trials, and may in time make it possible to produce full-size organs for human transplantations. The field of organoid research requires global collaboration, but stem cell and biotechnology research are subject to highly diverse legislation across jurisdictions, and often very strict legislation, making international collaboration challenging. The challenges are exacerbated by technological advances. For embryonic stem cell lines, the parents may have made the donation years ago, often on the assumption of anonymity and sometimes in relation to an abortion. These days, DNA and RNA sequencing are routine practice in organoid research, with the potential for identification of relatives. Genetic sequencing may also identify the individuals who have contributed cells from which induced pluripotent stem cell lines have been generated. When organoids solely act as providers of information, it raises the question as to whether human organoids are things or data, and the consequences that answer has for potentially overlapping regulation of human biological samples and personal data, and in turn for the possibility for international collaboration and scientific progress in the organoid field. I address these questions with a particular focus on the European context.

• Isasi, Rosario; Bentzen, Heidi Beate; Fabbri, Morris; Fuhr, Antonie; Glover, Joel Clinton & Mah, Nancy [Vis alle 10 forfattere av denne artikkelen] (2024). Dynamic governance: A new era for consent for stem cell research. Stem Cell Reports. ISSN 2213-6711. 19(9), s. 1233–1241. doi: 10.1016/j.stemcr.2024.07.006. Fulltekst i vitenarkiv Vis sammendrag

  Governance infrastructures streamline scientific and ethical provenance verification of human pluripotent stem cell (SC) lines. Yet, scientific developments (e.g., SC-derived embryo models, organoids) challenge research governance approaches to stored biospecimens, questioning the validity of informed consent (IC) models. Likewise, e-health platforms are driving major transformations in data processing, prompting a reappraisal of IC. Given these developments, participatory research platforms are identified as effective tools to promote longitudinal engagement, interactive decision-making, and dynamic governance. Learning from European initiatives piloting dynamic IC for biobanking and SC research, this Perspective explores the benefits and challenges of implementing dynamic IC and governance for SC.

• Uberoi, Diya; Dalpé, Gratien; Cheung, Katherine; Kondrup, Emma; Palmour, Nicole & Arawi, Thalia [Vis alle 43 forfattere av denne artikkelen] (2024). The Key Features of a Genetic Nondiscrimination Policy: A Delphi Consensus Statement. JAMA Network Open. 7(9), s. e2435355–e2435355. doi: 10.1001/jamanetworkopen.2024.35355. Fulltekst i vitenarkiv Vis sammendrag

  Importance Governments worldwide have become increasingly cognizant of the spread of genetic discrimination (negative treatment or harm on the basis of actual or presumed genetic characteristics). Despite efforts by a number of governments to establish regulations addressing this phenomenon, public concern about genetic discrimination persists. Objective To identify key elements of an optimal genetic nondiscrimination policy and inform policymakers as they seek to allay genetic nondiscrimination and related public anxieties. Evidence Review Sixty multidisciplinary experts from 20 jurisdictions worldwide were consulted to understand their views on effective genetic nondiscrimination policies. Following standard requirements of the Delphi method, 3 rounds of surveys over the course of 1.5 years were conducted. Round 1 focused on assessing participants’ understanding of the intricacies of existing genetic nondiscrimination policies, while rounds 2 and 3 invited participants to reflect on specific means of implementing a more effective regime. A total of 60 respondents participated in the first round, 53 participated in round 2, and 43 participated in round 3. Findings While responses varied across disciplines, there was consensus that binding regulations that reach across various sectors are most useful in preventing genetic discrimination. Overall, experts agreed that human rights–based approaches are well suited to preventing genetic discrimination. Experts also agreed that explicit prohibition of genetic discrimination within nondiscrimination policies can highlight the importance of genetic nondiscrimination as a fundamental right and ensure robust protection at a national level. While most participants believed the international harmonization of genetic nondiscrimination laws would facilitate data sharing worldwide, they also recognized that regulations must reflect the sociocultural differences that exist among regions. Conclusions and Relevance As the reach of genetic discrimination continues to evolve alongside developments in genomics, strategic policy responses that are harmonious at the international and state levels will be critical to address this phenomenon. In seeking to establish comprehensive frameworks, policymakers will need to be mindful of regional and local circumstances that influence the need for and efficacy of unique genetic nondiscrimination approaches across diverse contexts.

• Biasiotto, Roberta; Johansson, Jennifer Viberg; Alemu, Melaku Birhanu; Romano, Virginia; Bentzen, Heidi Beate & Kaye, Jane [Vis alle 20 forfattere av denne artikkelen] (2023). Public Preferences for Digital Health Data Sharing: Discrete Choice Experiment Study in 12 European Countries. Journal of Medical Internet Research (JMIR). ISSN 1439-4456. 25, s. e47066–e47066. doi: 10.2196/47066. Fulltekst i vitenarkiv Vis sammendrag

  Background With new technologies, health data can be collected in a variety of different clinical, research, and public health contexts, and then can be used for a range of new purposes. Establishing the public’s views about digital health data sharing is essential for policy makers to develop effective harmonization initiatives for digital health data governance at the European level. Objective This study investigated public preferences for digital health data sharing. Methods A discrete choice experiment survey was administered to a sample of European residents in 12 European countries (Austria, Denmark, France, Germany, Iceland, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the United Kingdom) from August 2020 to August 2021. Respondents answered whether hypothetical situations of data sharing were acceptable for them. Each hypothetical scenario was defined by 5 attributes (“data collector,” “data user,” “reason for data use,” “information on data sharing and consent,” and “availability of review process”), which had 3 to 4 attribute levels each. A latent class model was run across the whole data set and separately for different European regions (Northern, Central, and Southern Europe). Attribute relative importance was calculated for each latent class’s pooled and regional data sets. Results A total of 5015 completed surveys were analyzed. In general, the most important attribute for respondents was the availability of information and consent during health data sharing. In the latent class model, 4 classes of preference patterns were identified. While respondents in 2 classes strongly expressed their preferences for data sharing with opposing positions, respondents in the other 2 classes preferred not to share their data, but attribute levels of the situation could have had an impact on their preferences. Respondents generally found the following to be the most acceptable: a national authority or academic research project as the data user; being informed and asked to consent; and a review process for data transfer and use, or transfer only. On the other hand, collection of their data by a technological company and data use for commercial communication were the least acceptable. There was preference heterogeneity across Europe and within European regions. Conclusions This study showed the importance of transparency in data use and oversight of health-related data sharing for European respondents. Regional and intraregional preference heterogeneity for “data collector,” “data user,” “reason,” “type of consent,” and “review” calls for governance solutions that would grant data subjects the ability to control their digital health data being shared within different contexts. These results suggest that the use of data without consent will demand weighty and exceptional reasons. An interactive and dynamic informed consent model combined with oversight mechanisms may be a solution for policy initiatives aiming to harmonize health data use across Europe.

• Vears, Danya F.; Hallowell, Nina; Bentzen, Heidi Beate; Ellul, Bridget; Nøst, Therese Haugdahl & Kerasidou, Angeliki [Vis alle 13 forfattere av denne artikkelen] (2023). A practical checklist for return of results from genomic research in the European contex. European Journal of Human Genetics. ISSN 1018-4813. 31, s. 687–695. doi: 10.1038/s41431-023-01328-6. Fulltekst i vitenarkiv Vis sammendrag

  An increasing number of European research projects return, or plan to return, individual genomic research results (IRR) to participants. While data access is a data subject’s right under the General Data Protection Regulation (GDPR), and many legal and ethical guidelines allow or require participants to receive personal data generated in research, the practice of returning results is not straightforward and raises several practical and ethical issues. Existing guidelines focusing on return of IRR are mostly project-specific, only discuss which results to return, or were developed outside Europe. To address this gap, we analysed existing normative documents identified online using inductive content analysis. We used this analysis to develop a checklist of steps to assist European researchers considering whether to return IRR to participants. We then sought feedback on the checklist from an interdisciplinary panel of European experts (clinicians, clinical researchers, population-based researchers, biobank managers, ethicists, lawyers and policy makers) to refine the checklist. The checklist outlines seven major components researchers should consider when determining whether, and how, to return results to adult research participants: 1) Decide which results to return; 2) Develop a plan for return of results; 3) Obtain participant informed consent; 4) Collect and analyse data; 5) Confirm results; 6) Disclose research results; 7) Follow-up and monitor. Our checklist provides a clear outline of the steps European researchers can follow to develop ethical and sustainable result return pathways within their own research projects. Further legal analysis is required to ensure this checklist complies with relevant domestic laws.

• Rocca, Luis A. La; Frank, Julia; Bentzen, Heidi Beate; Pantel, Jean Tori; Gerischer, Konrad & Bovier, Anton [Vis alle 7 forfattere av denne artikkelen] (2023). Understanding recessive disease risk in multi-ethnic populations with different degrees of consanguinity. American Journal of Medical Genetics. Part A. ISSN 1552-4825. doi: 10.1002/ajmg.a.63452. Fulltekst i vitenarkiv Vis sammendrag

  Abstract Population medical genetics aims at translating clinically relevant findings from recent studies of large cohorts into healthcare for individuals. Genetic counseling concerning reproductive risks and options is still mainly based on family history, and consanguinity is viewed to increase the risk for recessive diseases regardless of the demographics. However, in an increasingly multi‐ethnic society with diverse approaches to partner selection, healthcare professionals should also sharpen their intuition for the influence of different mating schemes in non‐equilibrium dynamics. We, therefore, revisited the so‐called out‐of‐Africa model and studied in forward simulations with discrete and not overlapping generations the effect of inbreeding on the average number of recessive lethals in the genome. We were able to reproduce in both frameworks the drop in the incidence of recessive disorders, which is a transient phenomenon during and after the growth phase of a population, and therefore showed their equivalence. With the simulation frameworks, we also provide the means to study and visualize the effect of different kin sizes and mating schemes on these parameters for educational purposes.

• Bentzen, Heidi Beate; Olav, Hilde Kvammen & Ursin, Giske (2023). Maximizing the GDPR potential for data transfers: first in Europe. The Lancet Regional Health - Europe. 27. doi: 10.1016/j.lanepe.2023.100600. Fulltekst i vitenarkiv Vis sammendrag

  During the pandemic, rapid international data sharing was key to finding medical solutions. Legal derogations made some pandemic data transfers possible.1 However, non-pandemic medical research, including cancer research, follows regular legal rules, and these rules currently create data transfer stalls, delaying medical advancements.1 Data transfers from the European Union (EU) to federal institutions in the United Stated (US) for medical research are currently impeded for legal reasons.2, 3, 4 Transfers to most of the US private sector can proceed provided appropriate safeguards are in place, but presently, US cloud providers such as Amazon Web Services, Google Cloud, and Microsoft Azure that provide large-scale, advanced data processing solutions can often not be used.5 Legal challenges therefore affect clinical trials when 1) the pharmaceutical company uses a US subcontractor providing a cloud-based analysis platform, and/or 2) legally mandated information including safety data must be reported to regulatory authorities such as the US Food and Drug Administration (FDA). In the following, we describe the use of a very narrow safety valve derogation in the EU General Data Protection Regulation (GDPR) 2016/679 to enable such transfers. The Norwegian Data Protection Authority (DPA) concurred with our use of this legal option. To our knowledge, this is the first time-use of this derogation in Europe.

• Hsieh, Tzung-Chien; Bar-Haim, Aviram; Moosa, Shahida; Ehmke, Nadja; Gripp, Karen W. & Pantel, Jean Tori [Vis alle 47 forfattere av denne artikkelen] (2022). GestaltMatcher facilitates rare disease matching using facial phenotype descriptors. Nature Genetics. ISSN 1061-4036. doi: 10.1038/s41588-021-01010-x. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2022). Exchange of Human Data Across International Boundaries. Annual Review of Biomedical Data Science. 5, s. 233–250. doi: 10.1146/annurev-biodatasci-122220-110811. Fulltekst i vitenarkiv
• Johansson, Jennifer Viberg; Bentzen, Heidi Beate & Mascalzoni, Deborah (2022). What ethical approaches are used by scientists when sharing health data? An interview study. BMC Medical Ethics. 23. doi: 10.1186/s12910-022-00779-8. Fulltekst i vitenarkiv Vis sammendrag

  Background Health data-driven activities have become central in diverse fields (research, AI development, wearables, etc.), and new ethical challenges have arisen with regards to privacy, integrity, and appropriateness of use. To ensure the protection of individuals’ fundamental rights and freedoms in a changing environment, including their right to the protection of personal data, we aim to identify the ethical approaches adopted by scientists during intensive data exploitation when collecting, using, or sharing peoples’ health data. Methods Twelve scientists who were collecting, using, or sharing health data in different contexts in Sweden, were interviewed. We used systematic expert interviews to access these scientists’ specialist knowledge, and analysed the interviews with thematic analysis. Phrases, sentences, or paragraphs through which ethical values and norms were expressed, were identified and coded. Codes that reflected similar concepts were grouped, subcategories were formulated, and categories were connected to traditional ethical approaches. Results Through several examples, the respondents expressed four different ethical approaches, which formed the main conceptual categories: consideration of consequences, respect for rights, procedural compliance, and being professional. Conclusions To a large extent, the scientists’ ethical approaches were consistent with ethical and legal principles. Data sharing was considered important and worth pursuing, even though it is difficult. An awareness of the complex issues involved in data sharing was reflected from different perspectives, and the respondents commonly perceived a general lack of practical procedures that would by default ensure ethical and legally compliant data collection and sharing. We suggest that it is an opportune time to move on from policy discussions to practical technological ethics-by-design solutions that integrate these principles into practice.

• Bentzen, Heidi Beate (2022). Context as key: The protection of personal integrity by means of the purpose limitation principle. I Kosta, Eleni; Leenes, Ronald & Kamara, Irene (Red.), Research Handbook on EU Data Protection Law. Edward Elgar Publishing. ISSN 9781800371675. s. 380–403. doi: 10.4337/9781800371682.00024. Fulltekst i vitenarkiv Vis sammendrag

  One of the core principles of European Union data protection law, the purpose limitation principle, holds that personal data must be processed for specified, explicit, legitimate purposes, and not used in manners incompatible with those purposes. How the principle emerged around the world, how the two dimensions of the principle – purpose specification and compatibility – is to be understood in European Union data protection law, taking into account both Court of Justice of the European Union and European Court of Human Rights jurisprudence, and how the principle relates to people’s expectations of respect for context, is explored in this chapter. Respect for individuals’ reasonable expectations, respect for context, and the purpose limitation principle’s compatible use dimension are often touted as separate notions, yet, as argued in this chapter, their natures intertwine and these facets may aid in assessing compatibility in a manner that preserves social expectations.

• Shah, Nisha; Johansson, Jennifer Viberg; Haraldsdóttir, Eik; Bentzen, Heidi Beate; Coy, Sarah & Mascalzoni, Deborah [Vis alle 8 forfattere av denne artikkelen] (2021). Governing health data across changing contexts: A focus group study of citizen’s views in England, Iceland, and Sweden. International Journal of Medical Informatics. ISSN 1386-5056. doi: 10.1016/j.ijmedinf.2021.104623. Fulltekst i vitenarkiv Vis sammendrag

  Background The governance structures associated with health data are evolving in response to advances in digital technologies that enable new ways of capturing, using, and sharing different types of data. Increasingly, health data moves between different contexts such as from healthcare to research, or to commerce and marketing. Crossing these contextual boundaries has the potential to violate societal expectations about the appropriate use of health data and diminish public trust. Understanding citizens’ views on the acceptability of and preferences for data use in different contexts is essential for developing information governance policies in these new contexts. Methods Focus group design presenting data sharing scenarios in England, Iceland, and Sweden. Results Seventy-one participants were recruited. Participants supported the need for data to help understand the observable world, improve medical research, the quality of public services, and to benefit society. However, participants consistently identified the lack of information, transparency and control as barriers to trusting organisations to use data in a way that they considered appropriate. There was considerable support for fair and transparent data sharing practices where all parties benefitted. Conclusion Data governance policy should involve all stakeholders’ perspectives on an ongoing basis, to inform and implement changes to health data sharing practices that accord with stakeholder views. The Findings showed that (1) data should be used for ethical purposes even when there was commercial interest; (2) data subjects and/or public institutions that provide and share data should also receive benefits from the sharing of data; (3) third parties use of data requires greater transparency and accountability than currently exists, (4) there should be greater information provided to empower data subjects.

• Johansson, Jennifer Viberg; Bentzen, Heidi Beate; Shah, Nisha; Haraldsdóttir, Eik; Jonsdottir, Gudbjörg Andrea & Kaye, Jane [Vis alle 8 forfattere av denne artikkelen] (2021). Preferences of the Public for Sharing Health Data: Discrete Choice Experiment. JMIR Medical Informatics. 9(7). doi: 10.2196/29614. Fulltekst i vitenarkiv Vis sammendrag

  Background: Digital technological development in the last 20 years has led to significant growth in digital collection, use, and sharing of health data. To maintain public trust in the digital society and to enable acceptable policy-making in the future, it is important to investigate people’s preferences for sharing digital health data. Objective: The aim of this study is to elicit the preferences of the public in different Northern European countries (the United Kingdom, Norway, Iceland, and Sweden) for sharing health information in different contexts. Methods: Respondents in this discrete choice experiment completed several choice tasks, in which they were asked if data sharing in the described hypothetical situation was acceptable to them. Latent class logistic regression models were used to determine attribute-level estimates and heterogeneity in preferences. We calculated the relative importance of the attributes and the predicted acceptability for different contexts in which the data were shared from the estimates. Results: In the final analysis, we used 37.83% (1967/5199) questionnaires. All attributes influenced the respondents’ willingness to share health information (P<.001). The most important attribute was whether the respondents were informed about their data being shared. The possibility of opting out from sharing data was preferred over the opportunity to consent (opt-in). Four classes were identified in the latent class model, and the average probabilities of belonging were 27% for class 1, 32% for class 2, 23% for class 3, and 18% for class 4. The uptake probability varied between 14% and 85%, depending on the least to most preferred combination of levels. Conclusions: Respondents from different countries have different preferences for sharing their health data regarding the value of a review process and the reason for their new use. Offering respondents information about the use of their data and the possibility to opt out is the most preferred governance mechanism.

• O'Doherty, Kieran C.; Shabani, Mahsa; Dove, Edward S.; Bentzen, Heidi Beate; Borry, Pascal & Burgess, Michael M. [Vis alle 24 forfattere av denne artikkelen] (2021). Toward better governance of human genomic data. Nature Genetics. ISSN 1061-4036. 53, s. 2–8. doi: 10.1038/s41588-020-00742-6. Fulltekst i vitenarkiv Vis sammendrag

  Here, we argue that, in line with the dramatic increase in the collection, storage and curation of human genomic data for biomedical research, genomic data repositories and consortia have adopted governance frameworks to both enable wide access and protect against possible harms. However, the merits and limitations of different governance frameworks in achieving these twin aims are a matter of ongoing debate in the scientific community; indeed, best practices and points for consideration are notably absent in devising governance frameworks for genomic databases. According to our collective experience in devising and assessing governance frameworks, we identify five key functions of ‘good governance’ (or ‘better governance’) and three areas in which trade-offs should be considered when specifying policies within those functions. We apply these functions as a benchmark to describe, as an example, the governance frameworks of six large-scale international genomic projects.

• Johansson, Jennifer Viberg; Shah, Nisha; Haraldsdóttir, Eik; Bentzen, Heidi Beate; Coy, Sarah & Kaye, Jane [Vis alle 8 forfattere av denne artikkelen] (2021). Governance mechanisms for sharing of health data: An approach towards selecting attributes for complex discrete choice experiment studies. Technology in society. ISSN 0160-791X. 66(101625). doi: 10.1016/j.techsoc.2021.101625. Fulltekst i vitenarkiv Vis sammendrag

  Background Discrete Choice Experiment (DCE) is a well-established technique to elicit individual preferences, but it has rarely been used to elicit governance preferences for health data sharing. Objectives The aim of this article was to describe the process of identifying attributes for a DCE study aiming to elicit preferences of citizens in Sweden, Iceland and the UK for governance mechanisms for digitally sharing different kinds of health data in different contexts. Methods A three-step approach was utilised to inform the attribute and level selection: 1) Attribute identification, 2) Attribute development and 3) Attribute refinement. First, we developed an initial set of potential attributes from a literature review and a workshop with experts. To further develop attributes, focus group discussions with citizens (n = 13), ranking exercises among focus group participants (n = 48) and expert interviews (n = 18) were performed. Thereafter, attributes were refined using group discussion (n = 3) with experts as well as cognitive interviews with citizens (n = 11). Results The results led to the selection of seven attributes for further development: 1) level of identification, 2) the purpose of data use, 3) type of information, 4) consent, 5) new data user, 6) collector and 7) the oversight of data sharing. Differences were found between countries regarding the order of top three attributes. The process outlined participants’ conceptualisation of the chosen attributes, and what we learned for our attribute development phase. Conclusions This study demonstrates a process for selection of attributes for a (multi-country) DCE involving three stages: Attribute identification, Attribute development and Attribute refinement. This study can contribute to improve the ethical aspects and good practice of this phase in DCE studies. Specifically, it can contribute to the development of governance mechanisms in the digital world, where people's health data are shared for multiple purposes.

• Bentzen, Heidi Beate (2020). In the Name of Scientific Advancement: How to Assess what Constitutes 'Scientific Research' in the GDPR to Protect Data Subjects and Democracy. I Terzis, Georgios; Kloza, Dariusz; Kużelewska, Elżbieta & Trottier, Daniel (Red.), Disinformation and Digital Media as a Challenge for Democracy. Intersentia. ISSN 9781780689753. s. 341–366. Fulltekst i vitenarkiv
• Høstmælingen, Njål & Bentzen, Heidi Beate (2020). How to operationalise human rights for COVID-19 measures. BMJ Global Health. doi: 10.1136/bmjgh-2020-003048. Fulltekst i vitenarkiv
• Solbakk, Jan Helge; Bentzen, Heidi Beate; Holm, Søren; Heggestad, Anne Kari Tolo; Hofmann, Bjørn Morten & Robertsen, Annette [Vis alle 10 forfattere av denne artikkelen] (2020). Back to WHAT? The role of research ethics in pandemic times. Medicine, Health care and Philosophy. ISSN 1386-7423. s. 1–16. doi: 10.1007/s11019-020-09984-x. Fulltekst i vitenarkiv Vis sammendrag

  The Covid-19 pandemic creates an unprecedented threatening situation worldwide with an urgent need for critical reflection and new knowledge production, but also a need for imminent action despite prevailing knowledge gaps and multilevel uncertainty. With regard to the role of research ethics in these pandemic times some argue in favor of exceptionalism, others, including the authors of this paper, emphasize the urgent need to remain committed to core ethical principles and fundamental human rights obligations all reflected in research regulations and guidelines carefully crafted over time. In this paper we disentangle some of the arguments put forward in the ongoing debate about Covid-19 human challenge studies (CHIs) and the concomitant role of health-related research ethics in pandemic times. We suggest it might be helpful to think through a lens differentiating between risk, strict uncertainty and ignorance. We provide some examples of lessons learned by harm done in the name of research in the past and discuss the relevance of this legacy in the current situation.

• Nicol, Dianne; Eckstein, Lisa; Bentzen, Heidi Beate; Borry, Pascal; Burgess, Mike & Burke, Wylie [Vis alle 23 forfattere av denne artikkelen] (2019). Consent insufficient for data release. Science. ISSN 0036-8075. 364(6439), s. 445–446. doi: 10.1126/science.aax0892. Fulltekst i vitenarkiv
• Goisauf, Melanie; Martin, Gillian; Bentzen, Heidi Beate; Ljøsne, Isabelle Sylvie Budin; Ursin, Lars Øystein & Durnová, Anna [Vis alle 13 forfattere av denne artikkelen] (2019). Data in question: A survey of European biobank professionals on ethical, legal and societal challenges of biobank research. PLOS ONE. 14(9). doi: 10.1371/journal.pone.0221496. Fulltekst i vitenarkiv Vis sammendrag

  Biobanks have evolved, and their governance procedures have undergone important transformations. Our paper examines this issue by focusing on the perspective of the professionals working in management or scientific roles in research-based biobanks, who have an important impact on shaping these transformations. In particular, it highlights that recent advances in molecular medicine and genomic research have raised a range of ethical, legal and societal implications (ELSI) related to biobank-based research, impacting directly on regulations and local practices of informed consent (IC), private-public partnerships (PPPs), and engagement of participants. In our study, we investigate the ways that these concerns influence biobanking practices and assess the level of satisfaction of the cross-national biobanking research communities with the ELSI related procedures that are currently in place. We conducted an online survey among biobankers and researchers to investigate secondary use of data, informing and/or re-contacting participants, sharing of data with third parties from industry, participant engagement, and collaboration with industrial partners. Findings highlight the need for a more inclusive and transparent biobanking practice where biobanks are seen in a more active role in providing information and communicating with participants; the need to improve the current IC procedures and the role of biobanks in sharing of samples and data with industry partners and different countries, and the need for practical, tangible and hands-on ethical and legal guidance.

• Hsieh, Tzung-Chien; Mensah, Martin A.; Pantel, Jean T.; Aguilar, Dione; Bar, Omri & Bayat, Allan [Vis alle 94 forfattere av denne artikkelen] (2019). PEDIA: prioritization of exome data by image analysis. Genetics in Medicine. ISSN 1098-3600. 21(12), s. 2807–2814. doi: 10.1038/s41436-019-0566-2. Fulltekst i vitenarkiv Vis sammendrag

  Purpose Phenotype information is crucial for the interpretation of genomic variants. So far it has only been accessible for bioinformatics workflows after encoding into clinical terms by expert dysmorphologists. Methods Here, we introduce an approach driven by artificial intelligence that uses portrait photographs for the interpretation of clinical exome data. We measured the value added by computer-assisted image analysis to the diagnostic yield on a cohort consisting of 679 individuals with 105 different monogenic disorders. For each case in the cohort we compiled frontal photos, clinical features, and the disease-causing variants, and simulated multiple exomes of different ethnic backgrounds. Results The additional use of similarity scores from computer-assisted analysis of frontal photos improved the top 1 accuracy rate by more than 20–89% and the top 10 accuracy rate by more than 5–99% for the disease-causing gene. Conclusion Image analysis by deep-learning algorithms can be used to quantify the phenotypic similarity (PP4 criterion of the American College of Medical Genetics and Genomics guidelines) and to advance the performance of bioinformatics pipelines for exome analysis.

• Bentzen, Heidi Beate & Høstmælingen, Njål (2019). Balancing Protection and Free Movement of Personal Data: The New European Union General Data Protection Regulation. Annals of Internal Medicine. ISSN 0003-4819. 170(5), s. 335–337. doi: 10.7326/M18-2782. Fulltekst i vitenarkiv
• Mascalzoni, Deborah; Bentzen, Heidi Beate; Ljøsne, Isabelle Sylvie Budin; Bygrave, Lee Andrew; Bell, Jessica & Dove, Edward S. [Vis alle 21 forfattere av denne artikkelen] (2019). Are Requirements to Deposit Data in Research Repositories Compatible With the European Union's General Data Protection Regulation? Annals of Internal Medicine. ISSN 0003-4819. 170(5), s. 332–334. doi: 10.7326/M18-2854. Fulltekst i vitenarkiv

Se alle arbeider i NVA

• Cairns, Patrick; Knapstad, Ida Katrine; Ishaq, Bushra; Bache-Mathiesen, Lena Kristin; Wangensteen, Urd Teresia & Pedersen, Reidar [Vis alle 10 forfattere av denne artikkelen] (2026). Norway Update – Nordic ChiCaP symposium. Fulltekst i vitenarkiv Vis sammendrag

  Conference talk at symposium for members of the Nordic Childhood Cancer Predisposition collaboration group – 13th-14th April 2026.

• Cairns, Patrick; Ishaq, Bushra; Knapstad, Ida Katrine; Pedersen, Reidar; Hofmann, Bjørn Morten & Wangensteen, Urd Teresia [Vis alle 10 forfattere av denne artikkelen] (2026). Hopes and Concerns of Adolescent Patients and their Caregivers Related to Genetic Predisposition Testing in Childhood Cancer Care: A Three-Year Longitudinal Follow-Up. Fulltekst i vitenarkiv
• Ishaq, Bushra; Cairns, Patrick; Knapstad, Ida Katrine; Bache-Mathiesen, Lena Kristin; Bentzen, Heidi Beate & Pedersen, Reidar [Vis alle 10 forfattere av denne artikkelen] (2025). The PROTECT-CARE study: Psychosocial, communication, ethical and legal aspects of childhood cancer predisposition testing in clinical care. Fulltekst i vitenarkiv
• Cairns, Patrick; Ishaq, Bushra; Knapstad, Ida Katrine; Hofmann, Bjørn Morten; Bentzen, Heidi Beate & Wangensteen, Urd Teresia [Vis alle 9 forfattere av denne artikkelen] (2025). Exploring psycho-social-ethico-legal issues related to genetic predisposition testing in pediatric cancer – the PROTECT-CARE study. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2022). Overføring av pseudonyme helseopplysninger for medisinsk forskning til land utenfor EØS – Rettslige utfordringer. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2022). Sky i offentlig sektor. Fulltekst i vitenarkiv
• Goodwin, Morten; Bentzen, Heidi Beate & Spears, Brian (2022). Law and Ethics. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2022). U.S.-Norway AI collaboration – Best practices for Transatlantic collaboration. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2022). U.S.-Norway AI collaboration – Law & Ethics. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2022). Kvalitetsregister: Juridiske betraktninger. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2022). Data sharing between countries. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2022). Governance of Health Data: Lessons from a contextual integrity perspective. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2022). Main findings from the ALLEA-EASAC-FEAM report on international data sharing – Legal challenges. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2021). Main findings from the project – Legal challenges. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2021). Panelist: Digital sovereignty in a world of interdependencies. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2021). How to transfer genomic data internationally in compliance with the GDPR. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2021). GDPR for dummies: A survival guide for genetics research. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate; Castro, Rosa; Fears, Robin; Griffin, George; Meulen, Volker ter & Ursin, Giske (2021). Remove obstacles to sharing health data with researchers outside of the European Union. 27, s. 1329–1333. doi: 10.1038/s41591-021-01460-0. Fulltekst i vitenarkiv Vis sammendrag

  COVID-19 has shown that international collaborations and global data sharing are essential for health research, but legal obstacles are preventing data sharing for non–pandemic-related research among public researchers across the world, with potentially damaging effects for citizens and patients.

• Ursin, Giske & Bentzen, Heidi Beate (2021). Rettslige utfordringer struper medisinsk forskning. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2021). Panel debate on Balancing Fundamental Rights in Data Regulation. Fulltekst i vitenarkiv
• Ursin, Giske & Bentzen, Heidi Beate (2021). Open science and sharing personal data widely–legally impossible for Europeans? Acta Oncologica. ISSN 0284-186X. doi: 10.1080/0284186X.2021.1995894. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2021). Forskere slår alarm: – Tusenvis av prosjekter er satt på vent og nye stanses. [Journal]. Dagens Medisin. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2021). Europeiske forskere krever GDPR-løsninger. [Internet]. Kreftregisteret. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2021). Legal Aspects of Health Data Processing in the Cloud after Schrems II. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2021). Europe's Genomics Community Wrestling with Uncertainty Presented by Privacy Legislation. [Internet]. GenomeWeb. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2021). Governance of Health Data in Cyberspace: Nordic Research Results. Fulltekst i vitenarkiv
• Casati, Sara; Metzler, Ingrid; Mayrhofer, Michaela Th.; Moons, Pieter; Halouzka, Radek & Jahns, Roland [Vis alle 18 forfattere av denne artikkelen] (2021). A workable regulatory framework for multicentre and multinational biobank-based research: Where are we in 2021? Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2021). The Legal Framework for Return of Results. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2021). Overføring av pseudonyme helseopplysninger for medisinsk forskning til land utenfor EØS – Rettslige utfordringer. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2021). Europe's data protection rules are hampering international health research. [Internet]. Politico. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2020). FHI lager app for å spore folk i kampen mot koronaviruset. [Internet]. NRK . Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2020). Mapping a moral grey zone: Interview with Heidi Beate Bentzen. [Journal]. EHDN News. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2020). Overvåker og deler informasjon om koronasmittede. [Internet]. NRK . Fulltekst i vitenarkiv
• Casati, Sara; Ellul, Bridget; Mezinska, Signe; Ljøsne, Isabelle Sylvie Budin; Martin, Gillian & Tzotzartou, Olga [Vis alle 10 forfattere av denne artikkelen] (2020). Mapping European RECs & ethics review processes for biobank-based research. Fulltekst i vitenarkiv
• Johansson, Jennifer Viberg; Shah, Nisha; Kaye, Jane; Haraldsdóttir, Eik; Jónsdóttir, Guðbjörg Andrea & Mascalzoni, Deborah [Vis alle 8 forfattere av denne artikkelen] (2020). Identifying the Public's Preferences for Sharing Health Data Digitally. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2020). FHI-app skal lagre info om dine bevegelser i 30 dager. [Internet]. NRK . Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2020). Transport, indkøbsvaner og mobiltelefoner: Sådan skal data hjælpe med at træffe beslutninger om coronakrisen. [Internet]. DR. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2020). Moderator: Open Science with Health and Genetic Data: A Contradiction? Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2020). Current activities at the Nordic and European level to enable personal data transfers for scientific research to non-EEA countries. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2020). Chat with Kristine Beitland: How governance mechanisms for health data can be designed to share, access, and prevent the risks associated with data collaboration and use. Fulltekst i vitenarkiv
• Solbakk, Jan Helge; Bentzen, Heidi Beate; Holm, Søren; Heggestad, Anne Kari Tolo; Hofmann, Bjørn Morten & Robertsen, Annette [Vis alle 10 forfattere av denne artikkelen] (2020). Høyrisikostudier på alle mennesker i Covid-19-sammenheng er etisk uforsvarlig. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2020). GDPR for dummies: A survival guide for genetics research. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2020). Bias and discrimination, misuse, and ethics vs law as a way to regulate AI. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2020). Legal aspects of data sharing. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2020). Genetisk selvtesting av barn. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2020). A World View. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). Deling av data i forskning. Fulltekst i vitenarkiv
• Høstmælingen, Njål & Bentzen, Heidi Beate (2019). – GDPR har blitt et symbol på konflikt. [Journal]. Dagens Medisin. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). GDPR-forsker: – Det trengs nye tekniske løsninger. [Journal]. Dagens Medisin. Fulltekst i vitenarkiv
• Høstmælingen, Njål & Bentzen, Heidi Beate (2019). EUs personvernforordning har to ansikter. doi: 10.4045/tidsskr.19.0166. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). Europeisk GDPR atferdsnorm for helseforskning. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). Paneldebattant: Dialogue on the value of health data. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). Trenger vi etiske retningslinjer for kunstig intelligens? Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). Oversikt over pågående initiativer for behandling av helseopplysninger. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). Ethical and social issues surrounding the balancing of individual vs. community interests in psychiatric genetics. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). “I ain’t lookin’ to block you up”: International Collaboration and Data Flow Under the EU GDPR. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). Recommendation on the protection and use of health-related data. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). Introduksjon til GDPR for helseforskning. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). AI – Giving medicine an edge and pushing privacy to its edge. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). The Legal Regulation of Precision Medicine. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). Kunstig intelligens og helse. En oversikt over juridiske hovedutfordringer. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). Balancing protection and free movement of personal data. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). Introduksjon til GDPR for helseforskning i praksis. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2019). Utfordringer med økt tilgjenge­lighet av genomiske data. Bestpractice Onkologi/Hematologi. ISSN 2245-0440. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2018). Amid GDPR Implementation, European Effort Drafts Code of Conduct for Sharing Health Research Data. [Internet]. GenomeWeb. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2018). Panelsamtale: Fra forskning og kunnskap til handling! Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2018). Formålsbestemthet. Om prinsippet og implikasjonene av prinsippet. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2018). Session chair: Brave New World: Learning Health Systems. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2018). Doing Right: Law and Precision Medicine. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2018). Shedding Light on Legal Aspects of Genetic Data Processing in the Cloud. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2018). Doing Right: Law and Precision Medicine. Fulltekst i vitenarkiv
• Bentzen, Heidi Beate (2018). Personvern og datadeling i medisinsk og helsefaglig forskning. Fulltekst i vitenarkiv
• Rochambeau, Mathieu; Konach, Teodora; Bernabe, Rosemarie de La Cruz; Bentzen, Heidi Beate; Mocheche, Lilian Kwamboka & Dash, Keziah Chanyisa Khayadi [Vis alle 20 forfattere av denne artikkelen] (2025). ROSiE Field-specific Guidelines on Responsible Open Science. Zenodo. doi: https:/zenodo.org/records/14969023. Fulltekst i vitenarkiv
• Griffin, George; Meulen, Volker ter; Albert, Adelin; Bentzen, Heidi Beate; Boiten, Jan-Willem & Danesh, John [Vis alle 22 forfattere av denne artikkelen] (2021). International Sharing of Personal Health Data for Research. The ALLEA, EASAC and FEAM joint initiative on resolving the barriers of transferring public sector data outside the EU/EEA. ALLEA, EASAC and FEAM. ISSN 9783804742499. Fulltekst i vitenarkiv

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