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. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

‘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. (shrink)

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. (shrink)