Vasiliki Rahimzadeh

All Publications

• Benefits of sharing neurophysiology data from the BRAIN Initiative Research Opportunities in Humans Consortium NEURON Rahimzadeh, V., Jones, K., Majumder, M. A., Kahana, M. J., Rutishauser, U., Williams, Z. M., Cash, S. S., Paulk, A. C., Zheng, J., Beauchamp, M. S., Collinger, J. L., Pouratian, N., McGuire, A. L., Sheth, S. A., NIH Res Opportunities Humans ROH C 2023; 111 (23): 3710-3715

  Abstract

  Sharing human brain data can yield scientific benefits, but because of various disincentives, only a fraction of these data is currently shared. We profile three successful data-sharing experiences from the NIH BRAIN Initiative Research Opportunities in Humans (ROH) Consortium and demonstrate benefits to data producers and to users.

  View details for DOI 10.1016/j.neuron.2023.09.029

  View details for Web of Science ID 001135333000001

  View details for PubMedID 37944519

• Ethically cleared to launch? Science (New York, N.Y.) Rahimzadeh, V., Fogarty, J., Caulfield, T., Auñón-Chancellor, S., Borry, P., Candia, J., Cohen, I. G., Covington, M., Lynch, H. F., Greely, H. T., Hanlon, M., Hatt, J., Low, L., Menikoff, J., Meslin, E. M., Platts, S., Ravitsky, V., Ruttley, T., Seidler, R. D., Sugarman, J., Urquieta, E., Williams, M. A., Wolpe, P. R., Donoviel, D., McGuire, A. L. 2023; 381 (6665): 1408-1411

  Abstract

  Rules are needed for human research in commercial spaceflight.

  View details for DOI 10.1126/science.adh9028

  View details for PubMedID 37769066

• Integrating Social Determinants of Health into Ethical Digital Simulations AMERICAN JOURNAL OF BIOETHICS Kostick-Quenet, K., Rahimzadeh, V., Anandasabapathy, S., Hurley, M., Sonig, A., Mcguire, A. 2023; 23 (9): 57-60

  View details for DOI 10.1080/15265161.2023.2237443

  View details for Web of Science ID 001058425800017

  View details for PubMedID 37647482

  View details for PubMedCentralID PMC10502902

• Ethics Education for Healthcare Professionals in the Era of chatGPT and Other Large Language Models: Do We Still Need It? AMERICAN JOURNAL OF BIOETHICS Rahimzadeh, V., Kostick-Quenet, K., Barby, J., McGuire, A. L. 2023: 1-11

  Abstract

  In this paper, we contend with whether we still need traditional ethics education as part of healthcare professional training given the abilities of chatGPT (generative pre-trained transformer) and other large language models (LLM). We reflect on common programmatic goals to assess the current strengths and limitations of LLMs in helping to build ethics competencies among future clinicians. Through an actual case analysis, we highlight areas in which chatGPT and other LLMs are conducive to common bioethics education goals. We also comment on where such technologies remain an imperfect substitute for human-led ethics teaching and learning. Finally, we conclude that the relative strengths of chatGPT warrant its consideration as a teaching and learning tool in ethics education in ways that account for current limitations and build in flexibility as the technology evolves.

  View details for DOI 10.1080/15265161.2023.2233358

  View details for Web of Science ID 001035978100001

  View details for PubMedID 37487184

• Ethical hazards of health data governance in the metaverse NATURE MACHINE INTELLIGENCE Kostick-Quenet, K., Rahimzadeh, V. 2023

  View details for DOI 10.1038/s42256-023-00658-w

  View details for Web of Science ID 000988363100001

• Achieving Procedural Parity in Managing Access to Genomic and Related Health Data: A Global Survey of Data Access Committee Members. Biopreservation and biobanking Lawson, J., Rahimzadeh, V., Baek, J., Dove, E. S. 2023

  Abstract

  Data access committees (DACs) are critical players in the data sharing ecosystem. DACs review requests for access to data held in one or more repositories and where specific constraints determine how the data may be used and by whom. Our team surveyed DAC members affiliated with genomic data repositories worldwide to understand standard processes and procedures, operational metrics, bottlenecks, and efficiencies, as well as their perspectives on possible improvements to quality review. We found that DAC operations and systemic issues were common across repositories globally. In general, DAC members endeavored to achieve an appropriate balance of review efficiency, quality, and compliance. Our results suggest a similarly proportionate path forward that helps DACs pursue mutual improvements to efficiency and compliance without sacrificing review quality.

  View details for DOI 10.1089/bio.2022.0205

  View details for PubMedID 37192473

• Institutional review boards need new skills to review data sharing and management plans. Nature medicine Rahimzadeh, V., Serpico, K., Gelinas, L. 2023

  View details for DOI 10.1038/s41591-023-02292-w

  View details for PubMedID 37055570

• Passive monitoring by smart toilets for precision health. Science translational medicine Ge, T. J., Rahimzadeh, V. N., Mintz, K., Park, W. G., Martinez-Martin, N., Liao, J. C., Park, S. M. 2023; 15 (681): eabk3489

  Abstract

  Smart toilets are a key tool for enabling precision health monitoring in the home, but such passive monitoring has ethical considerations.

  View details for DOI 10.1126/scitranslmed.abk3489

  View details for PubMedID 36724240

• The Ethical Data Practices Framework and Its Implications for Data Privacy Relations between the United States and the European Union. The American journal of bioethics : AJOB Rahimzadeh, V. 2023; 23 (11): 29-33

  View details for DOI 10.1080/15265161.2023.2256618

  View details for PubMedID 37879019

• Enhancing Reciprocity, Equity and Quality of Ethics Review for Multisite Research During Public Health Crises: The Experience of the COVID-19 Clinical Research Coalition Ethics Working Group JOURNAL OF LAW MEDICINE & ETHICS Rahimzadeh, V., Ambe, J., de Vries, J. 2023; 51 (2): 258-270

  Abstract

  In this paper we report findings from a commissioned report to the COVID-19 Clinical Research Coalition on approaches to streamline multinational REC review/approval during public health emergencies. As currently envisioned in the literature, a system of REC mutual recognition is theoretically possible based on shared procedural REC standards, but raises numerous concerns about perceived inequities and mistrust.

  View details for DOI 10.1017/jme.2023.75

  View details for Web of Science ID 001168735700014

  View details for PubMedID 37655583

  View details for PubMedCentralID PMC10881265

• Automating Justice: An Ethical Responsibility of Computational Bioethics. The American journal of bioethics : AJOB Rahimzadeh, V., Lawson, J., Baek, J., Dove, E. S. 2022; 22 (7): 30-33

  View details for DOI 10.1080/15265161.2022.2075051

  View details for PubMedID 35737496

• Regulatory Angels and Technology Demons? Making Sense of Evolving Realities in Health Data Privacy for the Digital Age. The American journal of bioethics : AJOB Rahimzadeh, V. 2022; 22 (7): 68-70

  View details for DOI 10.1080/15265161.2022.2075981

  View details for PubMedID 35737504

• Leveraging Algorithms to Improve Decision-Making Workflows for Genomic Data Access and Management. Biopreservation and biobanking Rahimzadeh, V., Lawson, J., Rushton, G., Dove, E. S. 2022

  Abstract

  Studies on the ethics of automating clinical or research decision making using artificial intelligence and other algorithmic tools abound. Less attention has been paid, however, to the scope for, and ethics of, automating decision making within regulatory apparatuses governing the access, use, and exchange of data involving humans for research. In this article, we map how the binary logic flows and real-time capabilities of automated decision support (ADS) systems may be leveraged to accelerate one rate-limiting step in scientific discovery: data access management. We contend that improved auditability, consistency, and efficiency of the data access request process using ADS systems have the potential to yield fairer outcomes in requests for data largely sourced from biospecimens and biobanked samples. This procedural justice rationale reinforces a broader set of participant and data subject rights that data access committees (DACs) indirectly protect. DACs protect the rights of citizens to benefit from science by bringing researchers closer to the data they need to advance that science. DACs also protect the informational dignities of individuals and communities by ensuring the data being accessed are used in ways consistent with participant values. We discuss the development of the Global Alliance for Genomics and Health Data Use Ontology standard as a test case of ADS for genomic data access management specifically, and we synthesize relevant ethical, legal, and social challenges to its implementation in practice. We conclude with an agenda of future research needed to thoughtfully advance strategies for computational governance that endeavor to instill public trust in, and maximize the scientific value of, health-related human data across data types, environments, and user communities.

  View details for DOI 10.1089/bio.2022.0042

  View details for PubMedID 35772014

• Institutional Review Board Use of Outside Experts: A National Survey. AJOB empirical bioethics Serpico, K., Rahimzadeh, V., Gelinas, L., Hartsmith, L., Lynch, H. F., Anderson, E. E. 2022: 1-12

  Abstract

  BACKGROUND: Institutional review board (IRB) expertise is necessarily limited by maintaining a manageable board size. IRBs are therefore permitted by regulation to rely on outside experts for review. However, little is known about whether, when, why, and how IRBs use outside experts.METHODS: We conducted a national survey of U.S. IRBs to characterize utilization of outside experts. Our study uses a descriptive, cross-sectional design to understand how IRBs engage with such experts and to identify areas where outside expertise is most frequently requested.RESULTS: The survey response rate was 18.4%, with 55.4% of respondents reporting their institution's IRB uses outside experts. Nearly all respondents who reported using outside experts indicated they do so less than once a month, but occasionally each year (95%). The most common method of identifying an outside expert was securing a previously known subject matter expert (83.3%). Most frequently, respondents sought consultation for scientific expertise not held by current members (69.6%). Almost all respondents whose IRBs had used outside experts reported an overall positive impact on the IRB review process (91.5%).CONCLUSIONS: Just over half of the IRBs in our sample report use of outside experts; among them, outside experts were described as helpful, but their use was infrequent overall. Many IRBs report not relying on outside experts at all. This raises important questions about what type of engagement with outside experts should be viewed as optimal to promote the highest quality review. For example, few respondents sought assistance from a Community Advisory Board, which could address expertise gaps in community perspectives. Further exploration is needed to understand how to optimize IRB use of outside experts, including how to recognize when expertise is lacking, what barriers IRBs face in using outside experts, and perspectives on how outside expert review impacts IRB decision-making and review quality.

  View details for DOI 10.1080/23294515.2022.2090459

  View details for PubMedID 35748820

• A systematic literature review to identify ethical, legal, and social responsibilities of nonprofit organizations when funding clinical trials in pediatric cancer. Pediatric blood & cancer Rahimzadeh, V., Wolfert, S., Buenger, V., Campbell, C., French, R., Ludwinski, D., Weinstein, A., Barrett, C. 2022: e29854

  Abstract

  Nonprofit organizations (NPOs) play critical roles as funding sources, research partners, and disseminators of drug developments in pediatric cancer. Yet the literature provides limited guidance about ethical best practices when NPOs make trial funding decisions in this space. We conducted a systematic review of the literature indexed in PubMed and Web of Science to identify the ethical, legal, and social responsibilities of NPOs to four key stakeholder groups in funding pediatric cancer trials: i) patients/families, ii) researchers, iii) industry sponsors, and iv) donors. We applied the lifecycle framework for patient engagement in drug research and development proposed by Geissler and colleagues to analyze themes related to NPOs' responsibilities across 54 articles that met our inclusion criteria. Emergent themes included transparency surrounding conflicts of interest, the rigor of scientific review, and communication with patients/communities about trial progress. Our research identified critical gaps in best practices for negotiating research partnerships, managing competing research priorities, and pursuing alternative financing models including venture philanthropy. Results from our review informed a set of best practices to guide NPOs in making trial funding decisions which align with stakeholder values and interests. This article is protected by copyright. All rights reserved.

  View details for DOI 10.1002/pbc.29854

  View details for PubMedID 35713116

• Insights for Teaching During a Pandemic: Lessons From a Pre-COVID-19 International Synchronous Hybrid Learning Experience. Family medicine Rodríguez, C., Rahimzadeh, V., Bartlett-Esquilant, G., Carver, T. 2022; 54 (6): 471-476

  Abstract

  Medical educators and researchers have increasingly sought to embed online educational modalities into graduate medical education, albeit with limited empirical evidence of how trainees perceive the value and experience of online learning in this context. The purpose of this study was to explore the experiences of hybrid learning in a graduate research methods course in a family medicine and primary care research graduate program.This qualitative description study recruited 28 graduate students during the fall 2016 academic term. Data sources included qualitative group discussions and a 76-item online survey collected between March and September 2017. We used thematic analysis and descriptive statistics to analyze each data set.Nine students took part in three group discussions, and completed an online survey. While students reported positive learning experiences overall, those attending virtually struggled with the synchronous elements of the hybrid model. Virtual students reported developing research skills not offered through courses at their home institution, and students attending the course in person benefited from the diverse perspectives of distance learners. All stressed the need to foster a sense of community.Quality delivery of online graduate education in family medicine research requires optimizing social exchanges among virtual and in-person learners, ensuring equitable engagement among all students, and leveraging the unique tools afforded by online platforms to create a shared sense of a learning community.

  View details for DOI 10.22454/FamMed.2022.319716

  View details for PubMedID 35675463

• Promoting Ethical Deployment of Artificial Intelligence and Machine Learning in Healthcare. The American journal of bioethics : AJOB Spector-Bagdady, K., Rahimzadeh, V., Jaffe, K., Moreno, J. 2022; 22 (5): 4-7

  View details for DOI 10.1080/15265161.2022.2059206

  View details for PubMedID 35499568

• Institutional Review Board Use of Outside Experts: What Do We Know? Ethics & human research Serpico, K., Rahimzadeh, V., Anderson, E. E., Gelinas, L., Lynch, H. F. 2022; 44 (2): 26-32

  Abstract

  Institutional review boards (IRBs) are permitted by regulation to seek assistance from outside experts when reviewing research applications that are beyond the scope of expertise represented in their membership. There is insufficient understanding, however, of when, why, and how IRBs consult with outside experts, as this practice has not been the primary focus of any published literature or empirical study to date. These issues have important implications for IRB quality. The capacity IRBs have to fulfill their mission of protecting research participants without unduly hindering research is influenced by IRBs' access to and use of the right type of expertise to review challenging research ethics, regulatory, and scientific issues. Through a review of the regulations and standards permitting IRBs to draw on the competencies of outside experts and through examination of the needs, strategies, challenges, and concerns related to doing so, we identify critical gaps in the existing literature and set forth an agenda for future empirical research.

  View details for DOI 10.1002/eahr.500121

  View details for PubMedID 35218600

• Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials. Contemporary clinical trials Federico, C. A., Heagerty, P. J., Lantos, J., O'Rourke, P., Rahimzadeh, V., Sugarman, J., Weinfurt, K., Wendler, D., Wilfond, B. S., Magnus, D. 2022: 106703

  Abstract

  Stepped-wedge cluster randomized trial (SW-CRT) designs are increasingly employed in pragmatic research; they differ from traditional parallel cluster randomized trials in which an intervention is delivered to a subset of clusters, but not to all. In a SW-CRT, all clusters receive the intervention under investigation by the end of the study. This approach is thought to avoid ethical concerns about the denial of a desired intervention to participants in control groups. Such concerns have been cited in the literature as a primary motivation for choosing SW-CRT design, however SW-CRTs raise additional ethical concerns related to the delayed implementation of an intervention and consent. Yet, PCT investigators may choose SW-CRT designs simply because they are concerned that other study designs are infeasible. In this paper, we examine justifications for the use of SW-CRT study design, over other designs, by drawing on the experience of the National Institutes of Health's Health Care Systems Research Collaboratory (NIH Collaboratory) with five pragmatic SW-CRTs. We found that decisions to use SW-CRT design were justified by practical and epistemic reasons rather than ethical ones. These include concerns about feasibility, the heterogeneity of cluster characteristics, and the desire for simultaneous clinical evaluation and implementation. In this paper we compare the potential benefits of SW-CRTs against the ethical and epistemic challenges brought forth by the design and suggest that the choice of SW-CRT design must balance epistemic, feasibility and ethical justifications. Moreover, given their complexity, such studies need rigorous and informed ethical oversight.

  View details for DOI 10.1016/j.cct.2022.106703

  View details for PubMedID 35176501

• The Serious Factor in Expanded Prenatal Genetic Testing. The American journal of bioethics : AJOB Kleiderman, E., Rahimzadeh, V., Knoppers, B., Roy, M. C., Laberge, A. M., Ravitsky, V. 2022; 22 (2): 23-25

  View details for DOI 10.1080/15265161.2021.2013991

  View details for PubMedID 35089840

• Exome/Genome-Wide Testing in Newborn Screening: A Proportionate Path Forward. Frontiers in genetics Rahimzadeh, V., Friedman, J. M., de Wert, G., Knoppers, B. M. 2022; 13: 865400

  Abstract

  Population-based newborn screening (NBS) is among the most effective public health programs ever launched, improving health outcomes for newborns who screen positive worldwide through early detection and clinical intervention for genetic disorders discovered in the earliest hours of life. Key to the success of newborn screening programs has been near universal accessibility and participation. Interest has been building to expand newborn screening programs to also include many rare genetic diseases that can now be identified by exome or genome sequencing (ES/GS). Significant declines in sequencing costs as well as improvements to sequencing technologies have enabled researchers to elucidate novel gene-disease associations that motivate possible expansion of newborn screening programs. In this paper we consider recommendations from professional genetic societies in Europe and North America in light of scientific advances in ES/GS and our current understanding of the limitations of ES/GS approaches in the NBS context. We invoke the principle of proportionality-that benefits clearly outweigh associated risks-and the human right to benefit from science to argue that rigorous evidence is still needed for ES/GS that demonstrates clinical utility, accurate genomic variant interpretation, cost effectiveness and universal accessibility of testing and necessary follow-up care and treatment. Confirmatory or second-tier testing using ES/GS may be appropriate as an adjunct to conventional newborn screening in some circumstances. Such cases could serve as important testbeds from which to gather data on relevant programmatic barriers and facilitators to wider ES/GS implementation.

  View details for DOI 10.3389/fgene.2022.865400

  View details for PubMedID 35860465

• A mixed-methods protocol to develop and validate a stewardship maturity matrix for human genomic data in the cloud. Frontiers in genetics Rahimzadeh, V., Peng, G., Cho, M. 2022; 13: 876869

  Abstract

  This article describes a mixed-methods protocol to develop and test the implementation of a stewardship maturity matrix (SMM) for repositories which govern access to human genomic data in the cloud. It is anticipated that the cloud will host most human genomic and related health datasets generated as part of publicly funded research in the coming years. However, repository managers lack practical tools for identifying what stewardship outcomes matter most to key stakeholders as well as how to track progress on their stewardship goals over time. In this article we describe a protocol that combines Delphi survey methods with SMM modeling first introduced in the earth and planetary sciences to develop a stewardship impact assessment tool for repositories that manage access to human genomic data. We discuss the strengths and limitations of this mixed-methods design and offer points to consider for wrangling both quantitative and qualitative data to enhance rigor and representativeness. We conclude with how the empirical methods bridged in this protocol have potential to improve evaluation of data stewardship systems and better align them with diverse stakeholder values in genomic data science.

  View details for DOI 10.3389/fgene.2022.876869

  View details for PubMedID 36313457

• Assessing the quality of deliberative stakeholder consultations involving allied health professionals in pediatric palliative care and hematology/oncology in Canada. BMC palliative care Rahimzadeh, V., Longo, C., Gagnon, J., Fernandez, C., Bartlett, G. 1800; 20 (1): 189

  Abstract

  BACKGROUND: In this paper we assess the quality of six deliberative stakeholder consultations regarding the implementation of a precision diagnostic for life-threatening pediatric brain tumors. Decision makers who base policy recommendations on the outputs of consultative exercises can presuppose that all deliberants are well informed of the policy issue, that participation in the deliberative process was fair, and that overcoming implementation barriers will necessarily result in practice change. Additional evidence is therefore needed to substantiate the informational quality of the deliberation, measure the equality of participation andstudy the effects on stakeholder reasoning to appropriately guide uptake of proposedrecommendation(s).METHODS: Using the DeVries framework for assessing the deliberative quality, we analyzed data from 44 post-consultation evaluation surveys completed by pediatric oncology and palliative care teams at two tertiary pediatric healthcare centers in Canada. We also conducted turn-taking and word-contribution analyses from the text transcriptions of each deliberation to assess equality of participation using descriptive statistics.RESULTS: Deliberants agreed the quality of the deliberative process was fair (median ratings ranging from 9-10 out of 10) and the opportunities to receive expert information and discuss with others about the implementation of a new LDT were helpful (9.5 out of 10). While the session improved understanding of the implementation barriers and opportunities, it had marginal effects on deliberants' reasoning about whether LDTs would change their own clinical practice (3-10 out of 10). Participation was proportionate in at least four of the six deliberations, where no deliberant took more than 20% of total turns and contributed equal to, or less than 20% of total words.CONCLUSION: The quality assessment weperformed demonstrates high informational value and perceivedfairness of two deliberative stakeholder consultations involving pediatric palliative care and oncology teams in Canada. Quality assessments canreveal how the process of deliberation unfolds, whether deliberative outputs are the result of equitable participationamong deliberants and what, if any, stakeholder voices may bemissing. Such assessments should be routinely reported as a condition of methodological rigor and trustworthiness of deliberative stakeholder engagement research.

  View details for DOI 10.1186/s12904-021-00884-2

  View details for PubMedID 34906102

• A policy Delphi study to validate the key implications of data sharing (KIDS) framework for pediatric genomics in Canada. BMC medical ethics Rahimzadeh, V., Bartlett, G., Knoppers, B. M. 2021; 22 (1): 71

  Abstract

  BACKGROUND: The highly sensitive nature of genomic and associated clinical data, coupled with the consent-related vulnerabilities of children together accentuate ethical, legal and social issues (ELSI) concerning data sharing. The Key Implications of Data Sharing (KIDS) framework was therefore developed to address a need for institutional guidance on genomic data governance but has yet to be validated among data sharing practitioners in practice settings. This study qualitatively explored areas of consensus and dissensus of the KIDS Framework from the perspectives of Canadian clinician-scientists, genomic researchers, IRB members, and pediatric ethicists.METHODS: Twelve panelists participated in a three-round online policy Delphi to determine the desirability, feasibility, relative importance and confidence of twelve individual statements of the KIDS Framework. Mean and IQR were calculated from panelists' ratings to determine the strength of consensus and polarity. Qualitative content analysis of panelists' written responses was used to assess degree of support. Statements were validated when their combined ratings and qualitative rationales indicated high-moderate consensus (at least 70% agreement across two contiguous categories), low to no polarity (IQRat least1.0) and strong support.RESULTS: Nine original, and one new statement reached consensus. These statements outlined essential elements of the informed consent process, including a realistic evaluation of benefits and risks and assurance of future ethics oversight for secondary data use. Discrepant views on appropriate protections for anonymized and coded i.e. de-identified genomic data were primary sources of dissensus.CONCLUSIONS: The validated statements provide institutions with empirically supported best practices for sharing genomic and associated clinical data involving children from the perspectives of key stakeholders. Concerted efforts to quantify informational risks that can be conveyed to patients and families are further needed to align data sharing policy with stakeholder priorities.

  View details for DOI 10.1186/s12910-021-00635-1

  View details for PubMedID 34107925

• Communication of Pharmacogenomic test results and treatment plans in pediatric oncology: deliberative stakeholder consultations with parents. BMC palliative care Longo, C., Rahimzadeh, V., Bartlett, G. 2021; 20 (1): 15

  Abstract

  BACKGROUND: Effective communication in support of clinical decision-making is central to the pediatric cancer care experience for families. A new laboratory derived pharmacogenetic test (LDT) that can diagnose difficult-to-treat brain cancers has been developed to stratify children based on their ability to respond to available treatment; however, the potential implementation of the LDT may make effective communication challenging since it can potentially remove the option for curative treatment in those children identified as non-responders, i.e. those with a catastrophic diagnosis.OBJECTIVE: We solicited the perspectives of parents of children with difficult-to-treat brain cancer on communication preferences surrounding the potential implementation of the LDT in standard care using deliberative stakeholder consultations.METHODS: Eight bereaved parents of children who succumbed to difficult-to-treat brain cancer, and four parents of children currently undergoing treatment for similar cancers attended separate small-group deliberative consultations - a stakeholder engagement method that enables the co-creation of recommendations following the consideration of competing arguments and diverse opinions of parents with different experiences. In the small-group consultations (Phase I), parents discussed four questions about potential communication issues that may arise with the LDT in practice. In Phase II, a total of five parents from both stakeholder groups (4 bereaved and 1 in current treatment) attended a consultation, known as the 'mixed' consultation, with the purpose of co-developing concrete recommendations for implementation of the LDT.RESULTS: Explaining the risks, benefits, and accuracy of the LDT were considered essential to parents. Once an LDT-based diagnosis/prognosis can be made, parents valued honesty, empathy, and clarity in communication. Parents also requested that all results and treatment options be presented to them in measured doses, and in an unbiased manner over the course of several meetings. This communication strategy allowed sufficient time to understand and accept the diagnosis/prognosis, particularly if it was catastrophic. Continuous access to the appropriate psychological and social support or counselling at and post-diagnosis was also strongly recommended.CONCLUSIONS: Deliberants co-created family-centered recommendations surrounding communication issues of the LDT, providing guidance to pediatric oncologists that could implement the test in practice.

  View details for DOI 10.1186/s12904-021-00709-2

  View details for PubMedID 33435936

• Ethics and Informatics in the Age of COVID-19: Challenges and Recommendations for Public Health Organization and Public Policy. Journal of the American Medical Informatics Association : JAMIA Subbian, V., Solomonides, A., Clarkson, M., Rahimzadeh, V. N., Petersen, C., Schreiber, R., DeMuro, P. R., Dua, P., Goodman, K. W., Kaplan, B., Koppel, R., Lehmann, C. U., Pan, E., Senathirajah, Y. 2020

  Abstract

  The COVID-19 pandemic response in the United States has exposed significant gaps in information systems and processes to enable timely clinical and public health decision-making. Specifically, the use of informatics to mitigate the spread of SARS-CoV-2, support COVID-19 care delivery, and accelerate knowledge discovery bring to the forefront issues of privacy, surveillance, limits of state powers, and interoperability between public health and clinical information systems. Using a consensus building process, we critically analyze informatics-related ethical issues in light of the pandemic across three themes: (1) public health reporting and data sharing, (2) contact tracing and tracking, and (3) clinical scoring tools for critical care. We provide context and rationale for ethical considerations and recommendations that are actionable during the pandemic, and conclude with recommendations calling for long-term, broader change (beyond the pandemic) for public health organization and policy reform.

  View details for DOI 10.1093/jamia/ocaa188

  View details for PubMedID 32722749

• Pros and cons of prosent as an alternative to traditional consent in medical research. Journal of medical ethics Rahimzadeh, V. N. 2020

  Abstract

  In their recent article, Porsdam Mann et al propose to share biomedical research data more widely, securely and efficiently using blockchain technologies.1 They present compelling arguments for how the blockchain presents both a technological innovation, and a deontologically grounded policy innovation to traditional research consent. Their proposal can be read in conversation with a rich body of evidence to suggest current consent processes are problematic on at least one of tripartite bases in biomedical research: that it be fully informed. This response attempts to further the author's discussion of social justice discourse in, and of their proposed prosent model to enhance engagement among under-represented and vulnerable populations in research, specifically. Motivating this response is the view that advancing technological capabilities is no doubt necessary, but on its own insufficient to reinvigorate distributive, procedural and social justice as guiding principles for con/prosent processes. I offer three pros and cons to consider in effort to deepen the model's commitments to social justice to historically marginalised groups in the biomedical research enterprise.

  View details for DOI 10.1136/medethics-2020-106443

  View details for PubMedID 32571849

• A Policy and Practice Review of Consumer Protections and Their Application to Hospital-Sourced Data Aggregation and Analytics by Third-Party Companies. Frontiers in big data Rahimzadeh, V. n. 2020; 3: 603044

  Abstract

  The Office of the National Coordinator for Health Information Technology estimates that 96% of all U.S. hospitals use a basic electronic health record, but only 62% are able to exchange health information with outside providers. Barriers to information exchange across EHR systems challenge data aggregation and analysis that hospitals need to evaluate healthcare quality and safety. A growing number of hospital systems are partnering with third-party companies to provide these services. In exchange, companies reserve the rights to sell the aggregated data and analyses produced therefrom, often without the knowledge of patients from whom the data were sourced. Such partnerships fall in a regulatory grey area and raise new ethical questions about whether health, consumer, or health and consumer privacy protections apply. The current opinion probes this question in the context of consumer privacy reform in California. It analyzes protections for health information recently expanded under the California Consumer Privacy Act ("CA Privacy Act") in 2020 and compares them to protections outlined in the Health Information Portability and Accountability Act ("Federal Privacy Rule"). Four perspectives are considered in this ethical analysis: 1) standards of data deidentification; 2) rights of patients and consumers in relation to their health information; 3) entities covered by the CA Privacy Act; 4) scope and complementarity of federal and state regulations. The opinion concludes that the CCPA is limited in its application when health information is processed by a third-party data aggregation company that is contractually designated as a business associate; when health information is deidentified; and when hospital data are sourced from publicly owned and operated hospitals. Lastly, the opinion offers practical recommendations for facilitating parity between state and federal health data privacy laws and for how a more equitable distribution of informational risks and benefits from the sale of aggregated hospital data could be fostered and presents ways both for-profit and nonprofit hospitals can sustain patient trust when negotiating partnerships with third-party data aggregation companies.

  View details for DOI 10.3389/fdata.2020.603044

  View details for PubMedID 33693425

  View details for PubMedCentralID PMC7931961

• Ethical, Legal, and Social Issues (ELSI) of Responsible Data Sharing Involving Children in Genomics: A Systematic Literature Review of Reasons. AJOB empirical bioethics Rahimzadeh, V. n., Knoppers, B. M., Bartlett, G. n. 2020: 1–13

  Abstract

  Progress in precision medicine relies on the access to, use of, and exchange of genomic and associated clinical data, including from children. The ethical, legal, and social issues (ELSI) of such data access, use, and exchange may be accentuated in the pediatric context due in part to the highly sensitive nature of genomic data, children's consent-related vulnerabilities, and uncertain risks of reidentification. Systematic analyses of the ELSI and scientific reasons for why and how genomic data may be shared responsibly are, however, limited. Methods: We conducted a modified systematic review of reasons according to Sofaer and Strech to examine the ELSI and scientific reasons for "responsible" sharing of children's genomic and associated clinical data. Empirical articles, commentaries, and data-sharing policies indexed in Medline, Scopus, Web of Science, and BIOSIS were included in the analysis if they discussed ELSI and were published between 2003 and 2017 in English. Results: One hundred and fifty-one records met our inclusion criteria. We identified 11 unique reasons and 8 subreasons for why children's genomic data should or should not be shared. Enhancing the prospect of direct and indirect benefits and maximizing the utility of children's data were top reasons why data should be shared. Inadequate data privacy protection was the leading reason why it should not. We furthermore identified 8 reasons and 30 subreasons that support conditional data sharing, in which recontact for the continued use of children's data once they reach the age of majority was the most frequently endorsed condition. Conclusions: The complete list of ELSI reasons and responsible conditions provides an evidentiary basis upon which institutions can develop data-sharing policies. Institutions should encourage the sharing of children's data to advance genomic research, while heeding special reconsent and data protection mechanisms that may help mitigate uncertain longitudinal risks for children and families.

  View details for DOI 10.1080/23294515.2020.1818875

  View details for PubMedID 32975491