The paper problematises the reliability and ethics of using social media data, such as sourced from Twitter or Instagram, to carry out health-related research. As in many other domains, the opportunity to mine social media for information has been hailed as transformative for research on well-being and disease. Considerations around the fairness, responsibilities and accountabilities relating to using such data have often been set aside, on the understanding that as long as data were anonymised, no real ethical or scientific issue (...) would arise. We first counter this perception by emphasising that the use of social media data in health research can yield problematic and unethical results. We then provide a conceptualisation of methodological data fairness that can complement data management principles such as FAIR by enhancing the actionability of social media data for future research. We highlight the forms that methodological data fairness can take at different stages of the research process and identify practical steps through which researchers can ensure that their practices and outcomes are scientifically sound as well as fair to society at large. We conclude that making research data fair as well as FAIR is inextricably linked to concerns around the adequacy of data practices. The failure to act on those concerns raises serious ethical, methodological and epistemic issues with the knowledge and evidence that are being produced. (shrink)

Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, (...) Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. (shrink)

Volume 19, Issue 6, June 2019, Page 66-68.

This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how growing complexity and (...) commodification in research have shed light on the importance of transparency. The repercussions of Belmont's emphasis on the protection of vulnerable populations is also explored, as is the relationship between the report's ethical principles and their applications. It is concluded that while the Belmont Report was an impressive response to the ethical issues of its day, the field of research ethics involving human subjects may have outgrown it. (shrink)

ABSTRACT Online research has become a critical recruitment modality for understanding and reducing health disparities among hidden populations most at risk for HIV infection. There is a lack of consensus and guidelines for the responsible conduct of online recruitment for HIV risk populations. Using semi-structured phone interviews, this study drew on the experiences of principal investigators engaged in online HIV research to illuminate scientific and ethical benefits and challenges of social media recruitment. Using Thematic Analysis five major themes emerged: sampling (...) advantages and disadvantages; challenges of data integrity; control of privacy protections; researcher competence and responsibility; and resources. (shrink)

Volume 19, Issue 6, June 2019, Page 62-64.

As social media becomes increasingly popular, human subjects researchers are able to use these platforms to locate, track, and communicate with study participants, thereby increasing participant retention and the generalizability and validity of research. The use of social media; however, raises novel ethical and regulatory issues that have received limited attention in the literature and federal regulations. We review research ethics and regulations and outline the implications for maintaining participant privacy, respecting participant autonomy, and promoting researcher transparency when using social (...) media to locate and track participants. We offer a rubric that can be used in future studies to determine ethical and regulation-consistent use of social media platforms and illustrate the rubric using our study team’s experience with Facebook. We also offer recommendations for both researchers and institutional review boards that emphasize the importance of well-described procedures for social media use as... (shrink)

Count Me In (CMI) was launched in 2015 as a patient-driven research initiative aimed at accelerating the study of cancer genomics through direct participant engagement, electronic consent and open-access data sharing. It is an example of a large-scale direct-to-patient (DTP) research project which has since enrolled thousands of individuals. Within the broad scope of ‘citizen science’, DTP genomics research is defined here as a specific form of ‘top-down’ research endeavour developed and overseen by institutions within the traditional human subjects research (...) context; in novel ways, it engages and recruits patients with defined diseases, consents them for medical information and biospecimens sharing, and stores and disseminates genomic information. Importantly, these projects simultaneously aim to empower participants in the research process while increasing sample size, particularly in rare disease states. Using CMI as a case study, this paper discusses how DTP genomics research raises new questions in the context of traditional human subjects research ethics, including issues surrounding participant selection, remote consent, privacy and return of results. It aims to demonstrate how current research ethics frameworks may be insufficient in this context, and that institutions, institutional review boards and investigators should be aware of these gaps and their role in ensuring the conduct of ethical, novel forms of research together with participants. Ultimately, a broader question is raised of whether the rhetoric of participatory genomics research advocates for an ethic of personal and social duty for contributing to the advancement of generalisable knowledge about health and disease. (shrink)

Research Ethics, Volume 18, Issue 1, Page 24-38, January 2022. Are social science, cross-border research projects, where recruitment and data collection are carried out remotely, required to follow similar ethical and data-sharing procedures as ‘on-the-ground’ studies that use traditional means of recruitment and participant engagement? This article reflects on our experience of dealing with this question when we had to switch to online data collection due to the restrictions posed by the COVID-19 pandemic, such as the inability to travel or (...) work in person with local communities and collaborators. Using social media platforms and online data collection when conducting research brings many advantages, such as being able to communicate remotely but directly with gatekeepers and collaborators, and in reaching potential participants on a global scale. However, neither the guidelines and advice for conducting ethically sound internet-based research, nor the academic literature focussed on building equitable research partnerships between the Global North and the Global South, offer much information regarding the ethical concerns, or address the grey areas, posed by this type of digital and distanced transnational research. In our experience, conducting research remotely made negotiations of access very challenging due to the politics of positionality between Global North and South researchers, lack of clarity on ethical processes and perceptions of gatekeepers who we could not meet in person. We hope the reflections on, and discussion of, our experience encourage deliberation on the present ethical challenges posed by online and social-media-disseminated data collection, particularly in cross-border circumstances. (shrink)

Are social science, cross-border research projects, where recruitment and data collection are carried out remotely (e.g. through social media and online platforms), required to follow similar ethical and data-sharing procedures as ‘on-the-ground’ studies that use traditional means of recruitment and participant engagement? This article reflects on our experience of dealing with this question when we (multi-national but UK based researchers) had to switch to online data collection due to the restrictions posed by the COVID-19 pandemic, such as the inability to (...) travel or work in person with local communities and collaborators. Using social media platforms and online data collection when conducting research brings many advantages, such as being able to communicate remotely but directly with gatekeepers and collaborators, and in reaching potential participants on a global scale. However, neither the guidelines and advice for conducting ethically sound internet-based research, nor the academic literature focussed on building equitable research partnerships between the Global North and the Global South, offer much information regarding the ethical concerns, or address the grey areas, posed by this type of digital and distanced transnational research. In our experience, conducting research remotely made negotiations of access very challenging due to the politics of positionality between Global North and South researchers, lack of clarity on ethical processes and (mis)perceptions of gatekeepers who we could not meet in person. We hope the reflections on, and discussion of, our experience encourage deliberation on the present ethical challenges posed by online and social-media-disseminated data collection, particularly in cross-border circumstances. (shrink)

Volume 19, Issue 6, June 2019, Page 64-66.

Bhatia-Lin and associates (2019) consider ethical and regulatory issues when social media platforms are used to track and locate research subjects who were recruited during hospitalization. They me...