PEOPLERoberta Biasiotto

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Roberta Biasiotto

Senior Researcher
Institute for Biomedicine

T +39 0471 055 488

roberta.biasiotto@eurac.edu

https://orcid.org/0000-0002-8845-9670

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About

I am a research fellow at the University of Modena and Reggio Emilia and visiting scientist at the Institute for Biomedicine, Eurac Research (Italy). My research focuses on participation in biomedical research, participant-centered approaches, and public views on health data use. In the frame of the Cooperative Health Research in South Tyrol (CHRIS) study, I work on communication and research participant engagement.

I hold an MSc in Medical Biotechnology and a PhD in Oncology from the University of Padua, Italy. I conducted research at the University of Padua, Karolinska Institutet, and Uppsala University in molecular and cellular biology of viral infections. I obtained a MA in Anthropology (University of Bologna, Italy) and a MA in African Studies (Dalarna University, Sweden) for my theses on the representation of HIV/AIDS and attitudes towards biomedicine in South African fictional literature.

Scientific Publications

Journal article2025

Beyond symbolic participation: Youth-led organisations’ voices and actions against antimicrobial resistance in Africa South of the Sahara

Samwel EV, Biasiotto R, Mosha M, Ancillotti M

Roberta Biasiotto

Background

Antimicrobial resistance (AMR) is a global health threat, disproportionately affecting Africa South of the Sahara, where young people have been identified as key stakeholders in AMR prevention and awareness; however, effective engagement beyond symbolic participation remains challenging, limiting the impact of youth-led initiatives in addressing AMR in the region.

Objectives

To examine how youth-led actors in Africa South of the Sahara engage in AMR awareness, education and advocacy; the challenges they encounter; and the institutional conditions needed to move beyond symbolic participation.

Methods

A qualitative study design was employed, involving semi-structured interviews with young professionals engaged in AMR efforts across Africa South of the Sahara. Participants were recruited through convenience and snowball sampling. Online interviews were conducted between March and September 2023. Data were analysed using reflexive thematic analysis.

Results

Seventeen participants (age range 22–34) from 15 countries shared insights on AMR awareness, community engagement, and barriers in their work. Major findings included the perception of AMR as an invisible threat, generational and structural challenges in community outreach, and the need for financial and institutional support. Despite these obstacles, participants demonstrated innovative approaches, including adapting AMR outreach methods to specific social groups and a strong commitment to AMR education and policy advocacy.

Conclusions

Findings underscore the essential role of youth in AMR efforts in Africa South of the Sahara and the need for greater institutional support and capacity-building. Enhancing youth involvement beyond symbolic roles is crucial to advancing AMR initiatives, particularly through tailored communication strategies and collaborative policymaking.

DOI Quelle

DOI: 10.1080/16549716.2025.2601409

Journal article2024

Artificial Intelligence Needs Data: Challenges Accessing Italian Databases to Train AI

Staunton C, Biasiotto R, Tschigg K, Mascalzoni D

Deborah Mascalzoni, Roberta Biasiotto

Population biobanks are an increasingly important infrastructure to support research and will be a much-needed resource in the delivery of personalised medicine. Artificial intelligence (AI) systems can process and cross-link very large amounts of data quickly and be used not only for improving research power but also for helping with complex diagnosis and prediction of diseases based on health profiles. AI, therefore, potentially has a critical role to play in personalised medicine, and biobanks can provide a lot of the necessary baseline data related to healthy populations that will enable the development of AI tools. To develop these tools, access to personal data, and in particular, sensitive data, is required. Such data could be accessed from biobanks. Biobanks are a valuable resource for research but accessing and using the data contained within such biobanks raise a host of legal, ethical, and social issues (ELSI). This includes the appropriate consent to manage the collection, storage, use, and sharing of samples and data, and appropriate governance models that provide oversight of secondary use of samples and data. Biobanks have developed new consent models and governance tools to enable access that address some of these ELSI-related issues. In this paper, we consider whether such governance frameworks can enable access to biobank data to develop AI. As Italy has one of the most restrictive regulatory frameworks on the use of genetic data in Europe, we examine the regulatory framework in Italy. We also look at the proposed changes under the European Health Data Space (EHDS). We conclude by arguing that currently, regulatory frameworks are misaligned and unless addressed, accessing data within Italian biobanks to train AI will be severely limited.

DOI Quelle

DOI: 10.1007/s41649-024-00282-9

Journal article2024

How to communicate and what to disclose to participants in a recall-by-genotype research approach: A multistep empirical study

Tschigg K, Consoli L, Brüggemann N, Hicks AA, Staunton C, Mascalzoni D, Biasiotto R

Andrew Hicks, Deborah Mascalzoni, Roberta Biasiotto

Recall-by-genotype (RbG) is a bottom-up approach using existing genetic data to design follow-up stratified studies. Genetic information may be partially disclosed at invitation, thus raising ethical issues which call for defined best practices for disclosure and communication in RbG approaches. Within the context of the ProtectMove sub-project of the Cooperative Health Research in South Tyrol (CHRIS) study, we investigated research participant perspectives on RbG communication strategies (Step 1 and 4, questionnaire with a subsample of CHRIS participants with and without previous experience of RbG, respectively). Additionally, we explored researchers’ and study personnel’s experience with RbG (Step 2 and 3, focus group discussion). In step 1 (N = 95), participants were generally satisfied with the study process. Most (71.6%) wanted to know their carrier status for personal and collective benefit. Tailored disclosure strategies and transparent, effective, and well-thought-out communication approaches were advocated by study personnel (Step 2, N = 6) and researchers (Step 3, N = 7). Challenges in dealing with uncertainty, concerns caused by RbG invitations, and the possibility of misunderstanding were also raised. In step 4 (N = 369), participants valued being informed of study details at the first invitation stage, and generally felt comfortable towards RbG study invitations (58.5%) and to receiving genetic information after the study (58.5–81.6%). Comfort and perceived impact of disclosure of genetic information varied according to the type of variant being potentially disclosed. This study suggested designing communication strategies, based on clear and understandable explanations, sensitive to participant expectations and preferences, developing case-by-case solutions for disclosure.

DOI Quelle

DOI: 10.1007/s12687-024-00733-8

Journal article2023

Participant perspective on the recall-by-genotype research approach: A mixed-method embedded study with participants of the CHRIS study

Biasiotto R, Kösters M, Tschigg K, Pramstaller PP, Brüggemann N, Borsche M, Klein C, Hicks AA,

Andrew Hicks, Deborah Mascalzoni, Peter P. Pramstaller, Roberta Biasiotto

Recall-by-genotype (RbG) research recruits participants previously involved in genetic research based on their genotype. RbG enables the further study of a particular variant of interest, but in recalling participants, it risks disclosing potentially unwanted or distressing genetic information. Any RbG strategy must therefore be done in a manner that addresses the potential ethical and social issues. As part of an RbG pilot on the penetrance of Parkinson’s disease variants, we conducted an empirical mixed-method study with 51 participants of the Cooperative Health Research in South Tyrol (CHRIS) study to understand participant views on RbG research approach. Participants were disclosed the disease under investigation but not the individual variant carrier status. Results showed that participants filtered the information received through personal experience and enacted mechanisms to address the concerns raised by invitation by resorting to personal resources and the support provided by experts. While the non-disclosure of the Parkin variant carrier status was deemed acceptable, disclosing the disease under study was important for participants. Participant preferences for disclosure of the disease under investigation and the carrier status varied according to how the knowledge of individual carrier status was perceived to impact the participant’s life. This study provided insights into participant response to the RbG research approach, which are relevant for RbG policy development. A suitable communication strategy and granular options addressing preferences for invitation in the original informed consent are critical for an ethically informed RbG policy.

DOI Quelle

DOI: 10.1038/s41431-022-01277-6

Journal article2023

Public Preferences for Digital Health Data Sharing: Discrete Choice Experiment Study in 12 European Countries

Biasiotto R, Viberg Johansson J, Alemu MB, Romano V, Bentzen HB, Kaye J, Ancillotti M, Blom JMC,

Deborah Mascalzoni, Roberta Biasiotto

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.

DOI Quelle

DOI: 10.2196/47066

Journal article2022

Ethical, legal and social/societal implications (ELSI) of recall-by-genotype (RbG) and genotype-driven-research (GDR) approaches: a scoping review

Tschigg K, Consoli L, Biasiotto, Mascalzoni D

Deborah Mascalzoni, Roberta Biasiotto

Recall by Genotype (RbG), Genotype-driven-recall (GDR), and Genotype-based-recall (GBR) strategies are increasingly used to conduct genomic or biobanking sub-studies that single out participants as eligible because of their specific individual genotypic information. However, existing regulatory and governance frameworks do not apply to all aspects of genotype-driven research approaches. The recall strategies disclose or withhold personal genotypic information with uncertain clinical utility. Accordingly, this scoping review aims to identify peculiar, explicit and implicit ethical, legal, and societal/social implications (ELSI) of RbG study designs. We conducted a systematic literature search of three electronic databases from November 2020 to February 2021. We investigated qualitative and quantitative research methods used to report ELSI aspects in RbG research. Congruent with other research findings, we identified a lack of qualitative research investigating the particular ELSI challenges with RbG. We included and analysed the content of twenty-five publications. We found a consensus on RbG posing significant ethical issues, dilemmas, barriers, concerns and societal challenges. However, we found that the approaches to disclosure and study-specific recall and communication strategies employed consent models and Return of Research Results (RoRR) policies varied considerably. Furthermore, we identified a high heterogeneity in perspectives of participants and experts about ELSI of study-specific RbG policies. Therefore, further fine-mapping through qualitative and empirical research is needed to draw conclusions and re-fine ELSI frameworks.

DOI Quelle

DOI: 10.1038/s41431-022-01120-y

Journal article2022

Italians locked down: people’s responses to early COVID-19 pandemic public health measures

Romano V, Ancillotti M, Mascalzoni D, Biasiotto R

Deborah Mascalzoni, Roberta Biasiotto

DOI

DOI: 10.1057/s41599-022-01358-3

Journal article2022

Prospective epidemiological, molecular, and genetic characterization of a novel coronavirus disease in the Val Venosta/Vinschgau: the CHRIS COVID-19 study protocol

Pattaro C, Barbieri G, Foco L, Weichenberger CX, Biasiotto R, De Grandi A, Fuchsberger C, Egger C,

Andrew Hicks, Cristian Pattaro, Christian Weichenberger, Roberta Biasiotto, Martin Gögele, Roberto Melotti, Deborah Mascalzoni, Luisa Foco, Peter P. Pramstaller, Alessandro De Grandi, Clemens Egger, Christian Fuchsberger, Vera Amon

Projekt: PACE: Partnership to Accelerate Covid-19 rEsearch in South Tyrol

The COVID-19 pandemic has been threatening the healthcare and socioeconomic systems of entire nations. While population-based surveys to assess the distribution of SARS-CoV-2 infection have become a priority, pre-existing longitudinal studies are ideally suited to assess the determinants of COVID-19 onset and severity.The Cooperative Health Research In South Tyrol (CHRIS) study completed the baseline recruitment of 13,393 adults from the Venosta/Vinschgau rural district in 2018, collecting extensive phenotypic and biomarker data, metabolomic data, densely imputed genotype and whole-exome sequencing data.Based on CHRIS, we designed a prospective study, called CHRIS COVID-19, aimed at: 1) estimating the incidence of SARS-CoV-2 infections; 2) screening for and investigating the determinants of incident infection among CHRIS participants and their household members; 3) monitoring the immune response of infected participants prospectively.An online screening questionnaire was sent to all CHRIS participants and their household members. A random sample of 1450 participants representative of the district population was invited to assess active (nasopharyngeal swab) or past (serum antibody test) infections. We prospectively invited for complete SARS-CoV-2 testing all questionnaire completers gauged as possible cases of past infection and their household members. In positive tested individuals, antibody response is monitored quarterly for one year. Untested and negative participants receive the screening questionnaire every four weeks until gauged as possible incident cases or till the study end.Originated from a collaboration between researchers and community stakeholders, the CHRIS COVID-19 study aims at generating knowledge about the epidemiological, molecular, and genetic characterization of COVID-19 and its long-term sequelae.

DOI Quelle

DOI: 10.1080/20477724.2021.1978225

Journal article2022

Ten years of dynamic consent in the CHRIS study: Informed consent as a dynamic process

Mascalzoni D, Melotti R, Pattaro C, Pramstaller PP, Gögele M, De Grandi A, Biasiotto R

Cristian Pattaro, Martin Gögele, Roberto Melotti, Deborah Mascalzoni, Peter P. Pramstaller, Alessandro De Grandi, Roberta Biasiotto

The Cooperative Health Research in South Tyrol (CHRIS) is a longitudinal study in Northern Italy, using dynamic consent since its inception in 2011. The CHRIS study collects health data and biosamples for research, and foresees regular follow-ups over time. We describe the experience with the CHRIS study dynamic consent, providing an overview of its conceptualization and implementation, and of the participant-centered strategies used to assess and improve the process, directly linked to participation and communication. In order to comply with high ethical standards and to allow broadness in the areas of research, CHRIS dynamic consent was conceived as an interactive process: based on a strong governance and an ongoing tailored communication with participants, it aims to promote autonomy and to develop a trust-based engaged relationship with participants, also relevant for retention. Built within an online platform, the consent allows granular choices, which can be changed over time. In a process of co-production, participants views have been investigated and kept into account in policy development. Participants showed a high degree of participation, thus enabling the consolidation of the CHRIS resources. Even though a low change rate was reported in the baseline, participants valued the possibility of changing their informed consent choices. Communication (language-tailored, ongoing, multimedia) was important for participants, and for participation and retention. In our experience, dynamic consent was proven to be a flexible consent model, which allowed to meet ethical and legal standards for participation in research, and to accommodate participants’ and researchers’ needs.

DOI Quelle

DOI: 10.1038/s41431-022-01160-4

Journal article2021

Balancing scientific interests and the rights of participants in designing a recall by genotype study

Mascalzoni D, Biasiotto R, Borsche M, Brüggemann N, De Grandi A, Goegele M, Frygner-Holm S, Klein C,

Andrew Hicks, Roberta Biasiotto, Deborah Mascalzoni, Peter P. Pramstaller, Alessandro De Grandi

Recall by genotype (RbG) studies aim to better understand the phenotypes that correspond to genetic variants of interest, by recruiting carriers of such variants for further phenotyping. RbG approaches pose major ethical and legal challenges related to the disclosure of possibly unwanted genetic information. The Cooperative Health Research in South Tyrol (CHRIS) study is a longitudinal cohort study based in South Tyrol, Italy. Demand has grown for CHRIS study participants to be enrolled in RbG studies, thus making the design of a suitable ethical framework a pressing need. We here report upon the design of a pilot RbG study conducted with CHRIS study participants. By reviewing the literature and by consulting relevant stakeholders (CHRIS participants, clinical geneticists, ethics board, GPs), we identified key ethical issues in RbG approaches (e.g. complexity of the context, communication of genetic results, measures to further protect participants). The design of the pilot was based on a feasibility assessment, the selection of a suitable test case within the ProtectMove Research Unit on reduced penetrance of hereditary movement disorders, and the development of appropriate recruitment and communication strategies. An empirical study was embedded in the pilot study with the aim of understanding participants’ views on RbG. Our experience with the pilot study in CHRIS allowed us to contribute to the development of best practices and policies for RbG studies by drawing recommendations: addressing the possibility of RbG in the original consent, implementing tailored communication strategies, engaging stakeholders, designing embedded empirical studies, and sharing research experiences and methodology.

DOI

DOI: 10.1038/s41431-021-00860-7

Journal article2021

The dynamic consent of the Cooperative Health Research in South Tyrol (CHRIS) study: broad aim within specific oversight and communication

Biasiotto R, Pramstaller PP, Mascalzoni D

Roberta Biasiotto, Deborah Mascalzoni, Peter P. Pramstaller

In biobanking and genomics research, data and samples are stored for longtime and used in further studies, which may not be sufficiently specified or foreseen at the time of the initial consent. The dynamic consent of the CHRIS study integrates broad research aims, specific oversight and governance mechanisms, and continuous
communication with participants, and allows nuanced choices to be changed over time. With this paper, we describe the CHRIS dynamic consent, and illustrate, by discussing data sharing and ongoing consent in the CHRIS study, how dynamic consent can actualize an informed consent model that is suitable for biobanking and genomic research.

DOI Quelle

DOI: 10.15168/2284-4503-786

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Journal article2023

Public Preferences for Digital Health Data Sharing: Discrete Choice Experiment Study in 12 European Countries

Biasiotto R, Viberg Johansson J, Alemu MB, Romano V, Bentzen HB, Kaye J, Ancillotti M, Blom JMC,

Deborah Mascalzoni, Roberta Biasiotto

Objective: This study investigated public preferences for digital health data sharing.

DOI Quelle

DOI: 10.2196/47066