Computational Nuclear Oncology Toward Precision Radiopharmaceutical Therapies: Ethical, Regulatory, and Socioeconomic Dimensions of Theranostic Digital Twins.

Computational nuclear oncology for precision radiopharmaceutical therapy (RPT) is a new frontier for theranostic treatment personalization. A key strategy relies on the possibility to incorporate clinical, biomarker, image-based, and dosimetric information in theranostic digital twins (TDTs) of patients to move beyond a one-size-fits-all approach. The TDT framework enables treatment optimization by real-time monitoring of the real-world system, simulation of different treatment scenarios, and prediction of resulting treatment outcomes, as well as facilitating collaboration and knowledge sharing among health care professionals adopting a harmonized TDT.

Running in the FAMILY: understanding and predicting the intergenerational transmission of mental illness.

Over 50% of children with a parent with severe mental illness will develop mental illness by early adulthood. However, intergenerational transmission of risk for mental illness in one's children is insufficiently considered in clinical practice, nor is it sufficiently utilised into diagnostics and care for children of ill parents. This leads to delays in diagnosing young offspring and missed opportunities for protective actions and resilience strengthening.

Ethical and social reflections on the proposed European Health Data Space.

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).

Ethical, legal, and social implications in research biobanking: A checklist for navigating complexity.

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.

Post-identifiability in changing sociotechnological genomic data environments.

Data practices in biomedical research often rely on standards that build on normative assumptions regarding privacy and involve 'ethics work.' In an increasingly datafied research environment, identifiability gains a new temporal and spatial dimension, especially in regard to genomic data. In this paper, we analyze how genomic identifiability is considered as a specific data issue in a recent controversial case: publication of the genome sequence of the HeLa cell line.

A practical checklist for return of results from genomic research in the European context.

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.

Health Humanities in Medicina: The Auxiliary Stance.

At the core of medicine is the idea to help fellow human beings by improving or even restoring their health [...

Biobanking and risk assessment: a comprehensive typology of risks for an adaptive risk governance.

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.

Ethical issues in genomics research on neurodevelopmental disorders: a critical interpretive review.

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.

Becoming and being a biobank donor: The role of relationships and ethics.

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.

Public awareness of and attitudes towards research biobanks in Latvia.

Background: Public 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.

Legal and Ethical Issues in Secondary Use of Administrative Health Data: The Case of Latvian Healthcare Monitoring Datalink.

The paper presents analysis of the legal and ethical issues surrounding establishment of the Latvian Healthcare Monitoring Datalink. The paper covers three interconnected issues in the context of the use of administrative health data for research purposes - anonymization of data, concept of 'public interest' and involvement of research ethics committees. The analysis has been put into broader context of interaction between General Data Protection Regulation (GDPR), national legislative measures and practical needs of researchers.

Correction to: Medical, pharmacy and nursing students in the Baltic countries: interactions with the pharmaceutical and medical device industries.

Following publication of the original article [1], we have been notified that the publication is missing a link to the data repository.

Medical, pharmacy and nursing students in the Baltic countries: interactions with the pharmaceutical and medical device industries.

Background: Interactions between pharmaceutical and medical device industries and students can lead to commercial influences on educational messages, with a potential to bias future treatment choice. This is the first study in the Baltic countries describing exposure and attitudes of medical, pharmacy and nursing students towards cooperation with industry.

Methods: A cross-sectional on-line survey of current medical, pharmacy and nursing students (n = 918) in three Baltic countries was carried out.

Surrogacy relationships: a critical interpretative review.

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.

Use of generic medicines in Latvia: awareness, opinions and experiences of the population.

Background: To stimulate use of generic medicines a combination of supply and demand side mechanisms are employed in the Latvian reimbursement system. It is reported that patients have high out-of-pocket pharmaceutical spending and that they overpay by not choosing generic medicines. Patient preferences may be an important obstacle in implementing generic policy.

Disease awareness campaigns in printed and online media in Latvia: cross-sectional study on consistency with WHO ethical criteria for medicinal drug promotion and European standards.

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.

Sunshine Policies and Murky Shadows in Europe: Disclosure of Pharmaceutical Industry Payments to Health Professionals in Nine European Countries.

Relationships between health professionals and pharmaceutical manufacturers can unduly influence clinical practice. These relationships are the focus of global transparency efforts, including in Europe. We conducted a descriptive content analysis of the transparency provisions implemented by February 2017 in nine European Union (EU) countries concerning payments to health professionals, with duplicate independent coding of all data.

Research in disaster settings: a systematic qualitative review of ethical guidelines.

Background: 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.

'I had to help my child!': The role of emotions, risk, and trust in use of nasal decongestants in children.

Recent studies suggest that a number of common cold medicines, including nasal decongestants are not suitable for small children. In Latvia nasal decongestants are primarily over-the-counter (OTC) medicines, and patient information leaflets generally permit use of these medicines for small children. The previous studies in Latvia investigating the use of medicines in cases of common cold demonstrated extensive use of decongestants in children less than six years of age, marking a necessity for more profound research.

Twenty years of human research ethics committees in the Baltic States.

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.

Non-equivalent stringency of ethical review in the Baltic States: a sign of a systematic problem in Europe?

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.