Solidarity and reciprocity during the COVID-19 pandemic: a longitudinal qualitative interview study from Germany.

BACKGROUND: While solidarity practices were important in mitigating the Coronavirus Disease 2019 (COVID-19) pandemic, their limits became evident as the pandemic progressed. Taking a longitudinal approach, this study analyses German residents' changing perceptions of solidarity practices during the COVID-19 pandemic and examines potential reasons for these changes. METHODS: Adults living in Germany were interviewed in April 2020 (n = 46), October 2020 (n = 43) and October 2021 (n = 40) as part of the SolPan Research Commons, a large-scale, international, qualitative, longitudinal study uniquely situated in a major global public health crisis. Interviews were analysed using qualitative content analysis. RESULTS: While solidarity practices were prominently discussed and positively evaluated in April 2020, this initial enthusiasm waned in October 2020 and October 2021. Yet, participants still perceived solidarity as important for managing the pandemic and called for institutionalized forms of solidarity in October 2020 and October 2021. Reasons for these changing perceptions of solidarity included (i) increasing personal and societal costs to act in solidarity, (ii) COVID-19 policies hindering solidarity practices, and (iii) a perceived lack of reciprocity as participants felt that solidarity practices from the state were not matching their individual efforts. CONCLUSIONS: Maintaining solidarity contributes to maximizing public health during a pandemic. Institutionalized forms of solidarity to support those most in need contribute to perceived reciprocity among individuals, which might increase their motivation to act in solidarity. Thus, rather than calling for individual solidarity during times of crisis, authorities should consider implementing sustaining solidarity-based social support systems that go beyond immediate crisis management.

Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees.

BACKGROUND: In the course of the COVID-19 pandemic, the biomedical research community's attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees (RECs). METHODS: We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for the extraction and synthesis of challenges and potential solutions that we grouped under established principles for clinical research ethics. RESULTS: We received an overall response rate of 42%. The 22 responding RECs reported that they had assessed a total of 441 study proposals on COVID-19 until 21 April 2020. For the review of these proposals the RECs indicated a broad spectrum of challenges regarding (1) social value (e.g. lack of coordination), (2) scientific validity (e.g. provisional study planning), (3) favourable risk-benefit ratio (e.g. difficult benefit assessment), (4) informed consent (e.g. strict isolation measures), (5) independent review (e.g. lack of time), (6) fair selection of trial participants (e.g. inclusion of vulnerable groups), and (7) respect for study participants (e.g. data security). Mentioned solutions ranged from improved local/national coordination, over guidance on modified consent procedures, to priority setting across clinical studies. CONCLUSIONS: RECs are facing a broad spectrum of pressing challenges in reviewing COVID-19 studies. Some challenges for consent procedures are well known from research in intensive care settings but are further aggravated by infection measures. Other challenges such as reviewing several clinical studies at the same time that potentially compete for the recruitment of in-house COVID-19 patients are unique to the current situation. For some of the challenges the proposed solutions in our survey could relatively easy be translated into practice. Others need further conceptual and empirical research. Our findings together with the increasing body of literature on COVID-19 research ethics, and further stakeholder engagement should inform the development of hands-on guidance for researchers, funders, RECs, and further oversight bodies.

Prenatal diagnosis: do prospective parents have the right not to know?

Prenatal diagnosis (PND) challenges the issue of parental autonomy. Two ethical aspects of the parental decision making process with reference to PND have been taken into consideration: the duty to know and the right not to know. Whilst the first approach has been widely discussed in literature, the latter seems to be overlooked. In order to find good moral reasons supporting the right not to know, firstly the duty to know approach was critically analysed. Subsequently, the emphasis was put on the unconditional parental love and the issue of child's best interests as the features supporting parental right not to know. The clarification of what is good parenthood was presented as the best normative approach supporting the parental right not to know in case of PND. Apart from parental autonomy, raising the question of the right not to know is important in the debate about the place and role of people with disabilities in society.

Reporting of patient involvement: a mixed-methods analysis of current practice in health research publications using a targeted search strategy.

OBJECTIVES: To evaluate the extent and quality of patient involvement reporting in examples of current practice in health research. DESIGN: Mixed-methods study. We used a targeted search strategy across three cohorts to identify health research publications that reported patient involvement: original research articles published in 2019 in the British Medical Journal (BMJ), articles listed in the Patient-Centered Outcomes Research Institute (PCORI) database (2019), and articles citing the GRIPP2 (Guidance for Reporting Involvement of Patients and Public) reporting checklist for patient involvement or a critical appraisal guideline for user involvement. Publications were coded according to three coding schemes: 'phase of involvement', the GRIPP2-Short Form (GRIPP2-SF) reporting checklist and the critical appraisal guideline. OUTCOME MEASURES: The phase of the study in which patients were actively involved. For the BMJ sample, the proportion of publications that reported patient involvement. The quality of reporting based on the GRIPP2-SF reporting guideline. The quality of patient involvement based on the critical appraisal guideline. Quantitative and qualitative results are reported. RESULTS: We included 86 publications that reported patient involvement. Patients were most frequently involved in study design (90% of publications, n=77), followed by study conduct (71%, n=61) and dissemination (42%, n=36). Reporting of patient involvement was often incomplete, for example, only 40% of publications (n=34) reported the aim of patient involvement. While the methods (57%, n=49) and results (59%, n=51) of involvement were reported more frequently, reporting was often unspecific and the influence of patients' input remained vague. Therefore, a systematic assessment of the quality and impact of patient involvement according to the critical appraisal guideline was not feasible across samples. CONCLUSIONS: As patient involvement is increasingly seen as an integral part of the research process and requested by funding bodies, it is essential that researchers receive specific guidance on how to report patient involvement activities. Complete reporting builds the foundation for assessing the quality of patient involvement and its impact on research.

The COVID-19 Vaccine: Trust, doubt, and hope for a future beyond the pandemic in Germany.

Public perceptions of COVID-19 vaccines are critical in reaching protective levels of herd immunity. Vaccine skepticism has always been relatively high in Germany, and surveys suggest that over the course of the pandemic, enthusiasm for the COVID-19 vaccine has dropped. Looking at the period just prior to the approval of the Pfizer/BioNTech and Moderna vaccines in Germany in the latter half of 2020, this paper aims to assess the reasons for and against COVID-19 vaccine uptake among residents of Germany, and to provide in-depth qualitative data to better understand and address concerns surrounding the safety and efficacy of a COVID-19 vaccine. Our findings indicate that there is widespread trust in German institutions and health experts to provide a safe vaccine for those who need it most. However, interviewees also point to the need for more information and the centrality of support from trusted medical authorities in making individual vaccination decisions. We also present the complexity of individual positions on vaccination, and suggest that vaccine hesitancy in relation to COVID-19 needs to be understood as a nuanced, and socially malleable, territory. This indicates that the goal of a vaccination campaign is not only achieving 'herd immunity,' but also a social endorsement of the collaborative effort that is required for a vaccine to be successful.

Motivations and Limits for COVID-19 Policy Compliance in Germany and Switzerland.

BACKGROUND: In contrast to neighboring countries, German and Swiss authorities refrained from general curfews during the first pandemic wave in spring 2020, calling for solidarity and personal responsibility instead. Using a qualitative methodology, this study aims to explore why people in Germany and Switzerland were motivated to comply with policy measures during the first wave of the coronavirus disease 2019 (COVID-19) pandemic, and what factors hindered or limited their motivation. While quantitative surveys can measure the level of compliance, or broadly ask what motives people had for compliance, we here strive to explain why and how these motives lead to compliance. METHODS: This publication has been made possible by the joint work of the members of the "Solidarity in times of pandemics" (SolPan) research commons. Seventy-seven semi-structured qualitative interviews were conducted with members of the general public in Germany (n = 46) and the German-speaking part of Switzerland (n = 31) in April 2020. Interviews were transcribed and analyzed following a grounded theory approach. RESULTS: Three themes were identified that summarize factors contributing to compliant or noncompliant behavior. (1) Social cohesion was, on the one hand, an important motivator for compliance, but at the same time related to conflicting needs, illustrating the limits of compliance. (2) Consequences were considered on both the individual level (eg, consequences of individual infection) and societal level (eg, the societal and economic consequences of restrictions). (3) While for some participants following the rules was perceived as a matter of principle, others stressed the importance of making their own risk assessment, which was often associated with with a need for evidence on the effectiveness and reasons behind measures. CONCLUSION: A variety of motives contribute to COVID-19 related compliance. Authorities should seek to address these multi-faceted aspects to support motivation for compliance in a large proportion of the population.

Democratic research: Setting up a research commons for a qualitative, comparative, longitudinal interview study during the COVID-19 pandemic.

The sudden and dramatic advent of the COVID-19 pandemic led to urgent demands for timely, relevant, yet rigorous research. This paper discusses the origin, design, and execution of the SolPan research commons, a large-scale, international, comparative, qualitative research project that sought to respond to the need for knowledge among researchers and policymakers in times of crisis. The form of organization as a research commons is characterized by an underlying solidaristic attitude of its members and its intrinsic organizational features in which research data and knowledge in the study is shared and jointly owned. As such, the project is peer-governed, rooted in (idealist) social values of academia, and aims at providing tools and benefits for its members. In this paper, we discuss challenges and solutions for qualitative studies that seek to operate as research commons.

Transcranial direct-current stimulation and pediatric attention deficit hyperactivity disorder (ADHD)-Findings from an interview ethics study with children, adolescents, and their parents.

INTRODUCTION: Transcranial direct current stimulation (tDCS) is a brain stimulation technique for an alternative or complementary treatment for various neurological disorders, including pediatric ADHD. However, little is known about the experiences of participants undergoing tDCS treatments in clinical trials. Exploration of their views on the matter is an important contribution to the societal debate on ethical issues of tDCS, allowing for a responsible translation into clinical practice and timely identification of potential challenges. METHODS: in-depth interviews study with children with ADHD undertaking tDCS and their parents (n=32). RESULTS: Children reported overall good experiences with the stimulation, although they found participation in the clinical study very tiring and time consuming. Their responses to the actual effects of the stimulation were mixed. Parents were very keen for their children to participate in the study as they saw it as a promising and safe alternative to medication. Even though many of them understood the techniques, they often did not see the link between the (current) lack of side effects and an absence of longitudinal studies. Unlike children, interviewed parents were cautious about using tDCS for non-medical/enhancement purposes. DISCUSSION: There is a need for more transparent information about the state of the art of tDCS, its function and what it actually might be able to offer. It is especially important in order to prevent unrealistic hopes and to make sure that future pediatric patients and their carers are more aware of the potential side-effects and long-term effects of tDCS.

A Network-Based Mixed Methods Approach to Analyze Current Perspectives on Personalized Oncological Medicine in Austria.

Personalized medicine (PM) to tailor healthcare (HC) to the individual, is a promising but challenging concept. So far, no study exists investigating stakeholders' perspectives on PM in oncology in Austria potentially hindering implementation, which was the aim of this study. We performed semi-structured interviews among experts (n = 14) and cancer patients (n = 2) of the Vienna General Hospital and the Medical University of Vienna and analyzed them by a mixed methods network theoretical approach. Study results show a great variety of topics addressed by the interviewees. Clear differences in the topic selection between patients and experts could be observed. Patient-doctor relationship was the most prominent theme among experts, whereas HC systems and public health in PM was more relevant for the patients. Although promising new molecular pathology methods were explicitly mentioned, the experts believed that their practical implementation and the implementation of PM in standard care will take a long time in Austria. A variety of concerns regarding PM were mentioned by the experts, including communication issues and knowledge gaps. Besides important insights into the current situation of PM in Austria, the study has shown that network theory is a powerful tool for analyzing qualitative interview data.

Unmet Needs in Children With Attention Deficit Hyperactivity Disorder-Can Transcranial Direct Current Stimulation Fill the Gap? Promises and Ethical Challenges.

Attention deficit hyperactivity disorder (ADHD) is a disorder most frequently diagnosed in children and adolescents. Although ADHD can be effectively treated with psychostimulants, a significant proportion of patients discontinue treatment because of adverse events or insufficient improvement of symptoms. In addition, cognitive abilities that are frequently impaired in ADHD are not directly targeted by medication. Therefore, additional treatment options, especially to improve cognitive abilities, are needed. Because of its relatively easy application, well-established safety, and low cost, transcranial direct current stimulation (tDCS) is a promising additional treatment option. Further research is needed to establish efficacy and to integrate this treatment into the clinical routine. In particular, limited evidence regarding the use of tDCS in children, lack of clear translational guidelines, and general challenges in conducting research with vulnerable populations pose a number of practical and ethical challenges to tDCS intervention studies. In this paper, we identify and discuss ethical issues related to research on tDCS and its potential therapeutic use for ADHD in children and adolescents. Relevant ethical issues in the tDCS research for pediatric ADHD center on safety, risk/benefit ratio, information and consent, labeling problems, and nonmedical use. Following an analysis of these issues, we developed a list of recommendations that can guide clinicians and researchers in conducting ethically sound research on tDCS in pediatric ADHD.