Signe Mezinska

The COVID-19 pandemic demonstrated the benefits of international data sharing. Data sharing enabled the health care policy makers to make decisions based on real-time data, it enabled the tracking of the virus, and importantly it enabled the development of vaccines that were crucial to mitigating the impact of the virus. This data sharing is not the norm as data sharing needs to navigate complex ethical and legal rules, and in particular, the fragmented application of the General Data Protection Regulation (GDPR). The introduction of the draft regulation for a European Health Data Space (EHDS) in May 2022 seeks to address some of these legal issues. If passed, it will create an obligation to share electronic health data for certain secondary purposes. While there is a clear need to address the legal complexities involved with data sharing, it is critical that any proposed reforms are in line with ethical principles and the expectations of the data subjects. In this paper we offer a critique of the EHDS and offer some recommendations for this evolving regulatory space.

Biobanks’ activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first–hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four‐step checklist aiming to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU.

Two decades have passed since the first attempts were made to establish systematic ethical review of human research in the Baltic States. Legally and institutionally much has changed. In this paper we provide an historical and structural overview of ethical review of human research and identify some problems related to the role of ethical review in establishing quality research environment in these countries. Problems connected to (a) public availability of information, (b) management of conflicts of interest, (c) REC composition and motivation of REC members, and (d) differing levels of stringency of ethical review for different types of studies, are identified. Recommendations are made to strengthen cooperation among the Baltic RECs.

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.

At the core of medicine is the idea to help fellow human beings by improving or even restoring their health. Let us call this the auxiliary stance of medicine—the motivation of medical intervention by reference to a moral obligation to guide our peers in their attempt to live a healthy and productive life. In parallel, the auxiliary stance is also central to public health, with a focus on prevention and health promotion. Taken together, we can view medicine and public health as the two main human auxiliary endeavors to protect individuals and populations from health risks and help them to heal when sick.

Biobanks act as the custodians for the access to and responsible use of human biological samples and related data that have been generously donated by individuals to serve the public interest and scientific advances in the health research realm. Risk assessment has become a daily practice for biobanks and has been discussed from different perspectives. This paper aims to provide a literature review on risk assessment in order to put together a comprehensive typology of diverse risks biobanks could potentially face. Methodologically set as a typology, the conceptual approach used in this paper is based on the interdisciplinary analysis of scientific literature, the relevant ethical and legal instruments and practices in biobanking to identify how risks are assessed, considered and mitigated. Through an interdisciplinary mapping exercise, we have produced a typology of potential risks in biobanking, taking into consideration the perspectives of different stakeholders, such as institutional actors and publics, including participants and representative organizations. With this approach, we have identified the following risk types: economic, infrastructural, institutional, research community risks and participant’s risks. The paper concludes by highlighting the necessity of an adaptive risk governance as an integral part of good governance in biobanking. In this regard, it contributes to sustainability in biobanking by assisting in the design of relevant risk management practices, where they are not already in place or require an update. The typology is intended to be useful from the early stages of establishing such a complex and multileveled biomedical infrastructure as well as to provide a catalogue of risks for improving the risk management practices already in place.

Background Genomic research on neurodevelopmental disorders (NDDs), particularly involving minors, combines and amplifies existing research ethics issues for biomedical research. We performed a review of the literature on the ethical issues associated with genomic research involving children affected by NDDs as an aid to researchers to better anticipate and address ethical concerns. Results Qualitative thematic analysis of the included articles revealed themes in three main areas: research design and ethics review, inclusion of research participants, and communication of research results. Ethical issues known to be associated with genomic research in general, such as privacy risks and informed consent/assent, seem especially pressing for NDD participants because of their potentially decreased cognitive abilities, increased vulnerability, and stigma associated with mental health problems. Additionally, there are informational risks: learning genetic information about NDD may have psychological and social impact, not only for the research participant but also for family members. However, there are potential benefits associated with research participation, too: by enrolling in research, the participants may access genetic testing and thus increase their chances of receiving a (genetic) diagnosis for their neurodevelopmental symptoms, prognostic or predictive information about disease progression or the risk of concurrent future disorders. Based on the results of our review, we developed an ethics checklist for genomic research involving children affected by NDDs. Conclusions In setting up and designing genomic research efforts in NDD, researchers should partner with communities of persons with NDDs. Particular attention should be paid to preventing disproportional burdens of research participation of children with NDDs and their siblings, parents and other family members. Researchers should carefully tailor the information and informed consent procedures to avoid therapeutic and diagnostic misconception in NDD research. To better anticipate and address ethical issues in specific NDD studies, we suggest researchers to use the ethics checklist for genomic research involving children affected by NDDs presented in this paper.

Relational aspects, such as involvement of donor’s relatives or friends in the decision-making on participation in a research biobank, providing relatives’ health data to researchers, or sharing research findings with relatives should be considered when reflecting on ethical aspects of research biobanks. The aim of this paper is to explore what the role of donor’s relatives and friends is in the process of becoming and being a biobank donor and which ethical issues arise in this context. We performed qualitative analysis of 40 qualitative semi-structured interviews with biobank donors and researchers. The results show that relatedness to relatives or other types of close relationships played a significant role in the donors’ motivation to be involved in a biobank, risk-benefit assessment, and decisions on sharing information on research and its results. Interviewees mentioned ethical issues in the context of sharing relatives’ health-related data for research purposes and returning research findings that may affect their relatives. We conclude that the question of what information on family members may be shared with a biobank by research participants without informed consent of those relatives, and when family members become research subjects, lacks a clear answer and detailed guidelines, especially in the context of the introduction of the European Union’s (EU) General Data Protection Regulation. Researchers in Latvia and EU face ethical questions and dilemmas about returning research results and incidental findings to donors’ relatives, and donors need more information on sharing research results with relatives in the informed consent process.

‘Women-protective’ language is broadly used as a frame in political discussions on women’s reproductive healthcare and labour rights. This article addresses the use of ‘women-protective’ language in online news articles in the Latvian media about the proposed prohibition of oocyte donation for nulliparous women. The main focus of the recent Latvian debate has not been on the technology itself, but rather on the female body and women’s rationality and decision-making capacity. The results of the analysis show that use of the ‘women-protective’ frame positions women as victims, increases control over the female body and restricts women’s rights to make autonomous decisions. The application of this frame is especially dangerous when used by politicians as it may lead to the legal restriction of women’s rights.

BackgroundPublic awareness and engagement are among the main prerequisites for protecting the rights of research participants and for successful and sustainable functioning of research biobanks. The aim of our study was to analyse public awareness and attitudes towards research biobanks in Latvia, and to compare these data with the results of the 2010 Eurobarometer study. We also analysed the influence of awareness and attitudes towards biobanks on willingness to participate in biobank studies and on preferred type of informed consent.MethodsWe developed a 12-question survey repeating seven questions about biobanks from the 2010 Eurobarometer questionnaire and adding five others. After describing the study variables, we performed a two-stage analysis of the results. In the first stage we analysed differences between the answers from 2010 and 2019 and conducted univariate analyses of relationships among particular variables, and between those variables and the socio-demographic characteristics of participants. In the second stage we investigated multivariable associations of willingness to participate and type of consent with awareness, trust and the socio-economic characteristics of participants.ResultsAccording to our study, the general public in Latvia is still not well informed about research biobanks. Fewer respondents have heard about research biobanks than in 2010. At the same time, the number of respondents who are willing to donate biological samples and personal data to a biobank has increased, e.g. the number of respondents who would definitely or probably be willing to provide information about themselves has increased from 25.8.% to 40.7 since 2010. Overall, concerns about the donation of different types of biological samples and data to a biobank have slightly decreased.ConclusionsPublic awareness about biobanks is important for their sustainability. It needs to be increased not only by traditional methods of informing the public, but also by more innovative and participatory approaches, e.g. by citizen science projects. There is a need to strengthen the public visibility and trustworthiness of ethics committees in Latvia in the field of biobanking.

Based on a critical interpretative review of existing qualitative research investigating accounts of ‘lived experience’ of surrogates and intended parents from a relational perspective, this article proposes a typology of surrogacy arrangements. The review is based on the analysis of 39 articles, which belong to a range of different disciplines (mostly sociology, social psychology, anthropology, ethnology, and gender studies). The number of interviews in each study range from as few as seven to over one hundred. Countries covered include Australia, Canada, Greece, India, Iran, Israel, Italy, Mexico, Norway, Russia, Sweden, UK, Ukraine, and the USA. Most studies focus only on surrogacy practices in one country (although often with intended parents from other countries), and some include several countries (e.g. interviewees from several countries or fieldwork in different field-sites). The proposed typology goes beyond the division between altruistic versus commercial, and traditional versus gestational surrogacy, in order to inform further research and to contribute to bioethical and policy debates on surrogacy in a transnational context. Four types of relations are identifiable: open, restricted, structured, and enmeshed. The criteria which influence these relationships are: the frequency and character of contact pre- and post-birth; expectations of both parties; the type of exchange involved in surrogacy arrangements; and cultural, legal, and economic contexts. The theoretical contribution of the article is to further the development of a relational justice approach to surrogacy.

Purpose This paper presents an ethnographic study of gamete donation in Latvia. The aim of the study is to describe and analyse the practice of applying responsibility in gamete donation cases from the perspective of anthropology and ethics. Methods We performed thirty semi-structured interviews with laypeople and five focus group discussions among adolescents. The third source of data was media analysis: 57 articles discussing assisted reproduction in Latvian electronic popular media as well as internet discussions among ART participants. The data were processed using Atlas.ti. Results The data showed that the situation of ART responsibility is formulated through defining one’s relationship to the gametes, to the nation and the relationship between parent and child. Conclusions The practice of gamete donation does not create new responsibilities but uses already existing relations in a situation marked by new knowledge. Relationships among ART users, donors and physicians often result in an imbalance of responsibility sharing. The framework of relational ethics is one possible way to change the practice of balancing and sharing responsibility in ART applications.

Background European legislation prohibits direct-to-consumer advertising of prescription medicines, but allows drug manufacturers to provide information to the public on health and diseases. Our aim was to measure the frequency of disease awareness campaigns in Latvian media and assess their compliance with international and European standards. Methods Materials on health/disease and treatments were collected between April and September 2015 from 12 newspapers and magazines and six online portals. Disease awareness campaigns were assessed using a previously developed instrument based on the WHO Ethical Criteria for Medicinal Drug promotion and European standards (EU law and pharmaceutical industry self-regulatory guidelines). Collected materials were used to examine the information provided on medical conditions and their diagnosis and treatment. The inter-rater reliability was calculated. Results We collected 263 materials from print (n = 149) and online media (n = 114); 94 were news items and 169 were disease-awareness advertisements. Cancer, cardiovascular problems, allergies and respiratory diseases were common topics. Of the 157 campaigns assessed, non-compliance was identified in 149 cases (inter-rater reliability 90%), mainly due to misleading or incomplete information, lack of balance and the absence of a listed author/sponsor. Six disease awareness campaigns directly mentioned a pharmaceutical product by brand name and other four included the logo or name of a manufacturer, referred to a condition and indirectly mentioned a treatment, all in contravention with European law. Conclusions The compliance of disease awareness campaigns in Latvian media with international and European standards is low. This raises concerns about the nature of information being conveyed. Through lack of balance, missing sponsorship information, and misleading or incomplete information, these campaigns could contribute to inaccurate self-diagnosis and generate demand among those who might not need medical treatment.

‘Women-protective’ language is broadly used as a frame in political discussions on women’s reproductive healthcare and labour rights. This article addresses the use of ‘women-protective’ language in online news articles in the Latvian media about the proposed prohibition of oocyte donation for nulliparous women. The main focus of the recent Latvian debate has not been on the technology itself, but rather on the female body and women’s rationality and decision-making capacity. The results of the analysis show that use of the ‘women-protective’ frame positions women as victims, increases control over the female body and restricts women’s rights to make autonomous decisions. The application of this frame is especially dangerous when used by politicians as it may lead to the legal restriction of women’s rights.

Two decades have passed since the first attempts were made to establish systematic ethical review of human research in the Baltic States. Legally and institutionally much has changed. In this paper we provide an historical and structural overview of ethical review of human research and identify some problems related to the role of ethical review in establishing quality research environment in these countries. Problems connected to (a) public availability of information, (b) management of conflicts of interest, (c) REC composition and motivation of REC members, and (d) differing levels of stringency of ethical review for different types of studies, are identified. Recommendations are made to strengthen cooperation among the Baltic RECs

We analyse the system of ethical review of human research in the Baltic States by introducing the principle of equivalent stringency of ethical review, that is, research projects imposing equal risks and inconveniences on research participants should be subjected to equally stringent review procedures. We examine several examples of non-equivalence or asymmetry in the system of ethical review of human research: (1) the asymmetry between rather strict regulations of clinical drug trials and relatively weaker regulations of other types of clinical biomedical research and (2) gaps in ethical review in the area of non-biomedical human research where some sensitive research projects are not reviewed by research ethics committees at all. We conclude that non-equivalent stringency of ethical review is at least partly linked to the differences in scope and binding character of various international legal instruments that have been shaping the system of ethical review in the Baltic States. Therefore, the Baltic example could also serve as an object lesson to other European countries which might be experiencing similar problems.

Conducting research during or in the aftermath of disasters poses many specific practical and ethical challenges. This is particularly the case with research involving human subjects. The extraordinary circumstances of research conducted in disaster settings require appropriate regulations to ensure the protection of human participants. The goal of this study is to systematically and qualitatively review the existing ethical guidelines for disaster research by using the constant comparative method. We performed a systematic qualitative review of disaster research ethics guidelines to collect and compare existing regulations. Guidelines were identified by a three-tiered search strategy: 1) searching databases, 2) an Internet search, and 3) a search of the references in the included documents from the first two searches. We used the constant comparative method for analysis of included guidelines. Fourteen full text guidelines were included for analysis. The included guidelines covered the period 2000-2014. Qualitative analysis of the included guidelines revealed two core themes: vulnerability and research ethics committee review. Within each of the two core themes, various categories and subcategories were identified. Some concepts and terms identified in analyzed guidelines are used in an inconsistent manner and applied in different contexts. Conceptual clarity is needed in this area as well as empirical evidence to support the statements and requirements included in analyzed guidelines.

This article discusses the impact of social representations of ageing, such as breakdown, inevitability of illnesses and unfitness, on chronic illness experience of elderly people in Latvia. The qualitative study is based on theoretical framework of symbolic interactionism and uses grounded theory methodology. The results of the study lead to the conclusion that in Latvia certain social representations of ageing have a negative impact on chronic illness experience of elderly people, decreasing health-related quality of life and hampering reception of required medical assistance, adaptation of environment to the needs of elderly people with chronic illnesses and successful incorporation of the chronic illness in the context of biography.

PurposeThis paper presents an ethnographic study of gamete donation in Latvia. The aim of the study is to describe and analyse the practice of applying responsibility in gamete donation cases from the perspective of anthropology and ethics.MethodsWe performed thirty semi-structured interviews with laypeople and five focus group discussions among adolescents. The third source of data was media analysis: 57 articles discussing assisted reproduction in Latvian electronic popular media as well as internet discussions among ART participants. The data were processed using Atlas.ti.ResultsThe data showed that the situation of ART responsibility is formulated through defining one’s relationship to the gametes, to the nation and the relationship between parent and child.ConclusionsThe practice of gamete donation does not create new responsibilities but uses already existing relations in a situation marked by new knowledge. Relationships among ART users, donors and physicians often result in an imbalance of responsibility sharing. The framework of relational ethics is one possible way to change the practice of balancing and sharing responsibility in ART applications

The aim of this article is to analyse the role of metaphors for the infertile body in the context of assisted reproduction, using conceptual metaphor theory as a framework, and to evaluate the moral significance of these metaphors. This sub-study is part of a larger study examining the biosafety practices of new biotechnologies in Latvia. In the sub-study, special attention was paid to metaphors used by assisted reproductive technology users, egg donors and experts. It can be concluded that not only does the infertility experience influence the choice of metaphors, but the use of certain metaphors can also change the infertility experience. In this process the practice of infertility treatment and the meaning of the body are socially and culturally shaped. The main groups of metaphors for the infertile body discovered through interview analysis are: order/disorder, the body as a resource, the body as a container, the body as a project, and anthropomorphization of gametes.

Changes regarding patient empowerment are taking place nowadays. Users of medicines are becoming more educated, confident and want to be involved in their healthcare issues. Cases when users of medicines do not consult medical specialists but take decisions based on their own knowledge or other sources show the global tendency of self-medication. Self-medication is easy to be implemented in cases when illness symptoms are not heavy, e. g., conventional common cold. A quantitative study in Latvia, examining information sources during the previous common cold episode and the opinion about the availability of non-commercial information for medicine users, showed that “friends and relatives” were consulted most often. Medical specialists took the fourth and the sixth place, respectively. The research data have shown that people feel they lack independent information about medicines for treating or relieving symptoms of common cold as only less than one fifth of the population consider such information fully available in Latvia. The global tendency of self-medication needs to be supported by healthcare professionals offering consumers good quality information about medicines. Medical nuries involved into patient consultations about common cold related issues can considerably facilitate the work of physicians. A non-commercial source about healthcare-related issues, including medicines, has to be established

The aim of this paper is to analyze the process of risk communication in the context of assisted reproduction in Latvia. The paper is based on a qualitative methodology and two types of data: media analysis and 30 semi-structured interviews (11 patients, 4 egg donors, 15 experts). The study explores a broad definition of risk communication and explores three types of risks: health, psychosocial, and moral. We ask (1), who is involved in risk communication, (2), how risks are discussed using different channels of communication, and (3), what ethical problems arise during this process. In the process of analysis, we identified four types of information channels and two strategies of risk communication used by patients, as well as several ethical problems. In our view, the analysis of risk communication practices is significant to improve patient/physician relationship, as well as better meet patients' needs for comprehensive risk information.