Public Trust In Research Research Articles

The societal impact of Open Science:a scoping review.

Open Science (OS) aims, in part, to drive greater societal impact of academic research. Government, funder and institutional policies state that it should further democratize research and increase learning and awareness, evidence-based policy-making, the relevance of research to society's problems, and public trust in research. Yet, measuring the societal impact of OS has proven challenging and synthesized evidence of it is lacking. This study fills this gap by systematically scoping the existing evidence of societal impact driven by OS and its various aspects, including Citizen Science (CS), Open Access (OA), Open/FAIR Data (OFD), Open Code/Software and others. Using the PRISMA Extension for Scoping Reviews and searches conducted in Web of Science, Scopus and relevant grey literature, we identified 196 studies that contain evidence of societal impact. The majority concern CS, with some focused on OA, and only a few addressing other aspects. Key areas of impact found are education and awareness, climate and environment, and social engagement. We found no literature documenting evidence of the societal impact of OFD and limited evidence of societal impact in terms of policy, health, and trust in academic research. Our findings demonstrate a critical need for additional evidence and suggest practical and policy implications.

The Normative Power of Consent and Limits on Research Risks.

Research regulations around the world do not impose any limits on the risks to which consenting adults may be exposed. Nonetheless, most review committees regard some risks as too high, even for consenting adults. To justify this practice, commentators have appealed to a range of considerations which are external to informed consent and the risks themselves. Most prominently, some argue that exposing consenting adults to very high risks has the potential to undermine public trust in research. This justification assumes that it is not the magnitude of the risks themselves which raises concern, but the way in which the public might respond to them. This justification thus depends on the possibility that the public will find out about the risks and respond to them in the specified way. Like the other proposed external justifications, it thereby fails to offer a reason to think that exposing consenting adults to very high risks is problematic in itself. In the present paper, we describe and endorse a different justification. Rather than appealing to external factors, we argue that limits on risks for consenting adults trace to internal limits on informed consent, to limits on the things consent can and cannot make ethically permissible. In doing so, we aim to provide a firmer conceptual basis for the view that some research risks are unacceptably high, no matter how the research is conducted.

Ethical approval for controlled human infectious model clinical trial protocols – A workshop report

Controlled Human Infectious Model studies (CHIM) involve deliberately exposing volunteers to pathogens. To discuss ethical issues related to CHIM, the European Vaccine Initiative and the International Alliance for Biological Standardization organised the workshop “Ethical Approval for CHIM Clinical Trial Protocols”, which took place on May 30–31, 2023, in Brussels, Belgium. The event allowed CHIM researchers, regulators, ethics committee (EC) members, and ethicists to examine the ethical criteria for CHIM and the role(s) of CHIM in pharmaceutical development. The discussions led to several recommendations, including continued assurance that routine ethical requirements are met, assurance that participants are well-informed, and that preparation of study documents must be both ethically and scientifically sound from an early stage. Study applications must clearly state the rationale for the challenge compared to alternative study designs. ECs need to have clear guidance and procedures for evaluating social value and assessing third-party risks. Among other things, public trust in research requires minimisation of harm to healthy volunteers and third-party risk. Other important considerations include appropriate stakeholder engagement, public education, and access to health care for participants after the study.

People with HIV at the end-of-life and their next-of-kin/loved ones are willing to participate in interventional HIV cure-related research.

The Last Gift study at the University of California San Diego (UCSD), United States enrolls terminally ill people with HIV (PWH) in HIV cure research. From 2017 to 2022, we conducted surveys with Last Gift participants and their next-of-kin/loved ones to evaluate willingness to participate in different types of HIV cure research at the end of life (EOL). We analyzed willingness data descriptively. We surveyed 17 Last Gift participants and 17 next-of-kin/loved ones. More than half of Last Gift participants ( n = 10; 58.8%) expressed willingness to participate in studies involving totally new treatments or approaches ('first-in-human' studies), a combination of different approaches, the use of unique antibodies, proteins or molecules, or therapeutic vaccines. Under one-quarter of Last Gift participants ( n = 4; 23.5%) expressed willingness to participate in research involving interventions that may shorten their life expectancy to benefit medical research. Most Last Gift participants and their next-of-kin/loved ones also expressed high acceptance for various types of donations and biopsies at the EOL (e.g. hair donations and skin, lymph node or gut biopsies). Knowing whether people would be willing to participate in different types of EOL HIV cure research can help inform the design of future innovative studies. As a research community, we have a duty to design studies with adequate safeguards to preserve the public trust in research and honor PWH's important gift to humanity.

Mapping literature reviews on coral health: A review map, critical appraisal and bibliometric analysis

Abstract The state of coral reefs has been of great concern, as documented in the growing amount of primary literature. These reports on coral health have accumulated, resulting in reviews of the primary studies (i.e. secondary literature). Recently, such reviews have also accumulated, creating an opportunity to review the secondary literature. Second‐order syntheses (reviews of secondary literature) provide an overview of the field, which can be used to guide future research. Based on our previously published protocol, we compiled peer‐reviewed secondary literature on coral health from Scopus and Web of Science databases. We synthesised 335 secondary literature papers on coral health, 35 of which underwent critical appraisal and 333 of which also underwent bibliometric analysis. The secondary literature consisted primarily of qualitative reviews (78%). Over 80% of papers stated informing coral conservation as the review's purpose. Climate change (50%) and coral resilience (42%) were the most studied topics, and bioerosion was the least (3.6%). Critically appraised papers scored poorly on Collaboration for Environmental Evidence Synthesis Assessment Tool criteria (studies did not meet standards 55% of the time). The authors of the secondary literature were highly interconnected (with 30% of the authors having more than 15 coauthors within our dataset) and included authors from countries with coral reefs (predominantly in Australia and USA; 79% of papers). The secondary literature on coral health had a median Altmetric score of 5.27. We have revealed key gaps in coral health topics for further review (e.g. coral range shifts and microbial biodiversity), particularly when considering conservation policy. Incorporating research in policy could be improved through greater research accessibility and continuing to gather public interest in coral reefs. We further recommend broadening research collaborations to include even more researchers from countries with coral reefs (e.g. Maldives). Finally, the secondary literature on coral health needs better reporting transparency (e.g. publishing code). Our second‐order synthesis is timely, pushing coral health research in a new direction—one which produces research of higher quality, collaboration, and efficiency. As coral reefs decline, we should also aim to rebuild public trust in research and strengthen the evidence base for conservation.

Community engagement in building public trust in research.

Community engagement in building public trust in research.

Can access and accessibility rebuild public trust in research?

Trust is built gradually, and it is easily threatened, particularly in relation to pharmaceutical research. The potential for open access publishing and plain language summaries to contribute to improved trust in pharmaceutical research was discussed by experts at the Open Pharma Satellite Symposium, held at the Association of Learned and Professional Society Publishers Annual Conference and Awards 2022 in Manchester, UK. No single endeavour will win public trust overnight, but removing paywall barriers between all readers and sources of trusted information, and publishing research summaries that are written in accessible, plain English are important steps towards fostering greater trust in research. Both endeavours also have the potential to help the public make informed decisions about their health.

How to Conduct and Publish Open Science in Management Research

Serious misconduct cases have shattered public trust in business research. Multiple scholars have already discussed how to overcome the credibility crisis and restore public trust in research. Hereby, they highlighted the importance of open science practices, especially in empirical and experimental research, to ensure rigor and ethical conduct through transparency and replicability. This symposium takes up this notion by showing participants how to conduct and publish open science in management research. First, Gernot Pruschak starts the symposium by introducing the theme and the presenters and providing a short motivation for the need of open science practices in empirical and experimental management research. Second, Andrew Timming highlights the needs for registered reports and presents advice on how to generate and submit registered reports to management journals. Third, Roman Briker introduces the participants to study pre- registration at the Open Science Framework and AsPredicted.org. Fourth, Christian Hopp highlights the necessity of conducting replication studies and exemplarily shows how to conduct a replication study combining experimental and empirical methods. Fifth, Nicolas Bastardoz gives insights into the editorial view on publishing registered reports and replication studies in top management journals. Hereby, he shares advice for authors on which types of replication studies editors seek and why they are important for journals and scientific stakeholders. Sixth, Jermain Kaminski discusses data sharing among management researchers and explains how research data can be openly shared. Registered Reports for Management Journals Presenter: Andrew Timming; Royal Melbourne Institute of Technology U. Study Preregistration at AsPredicted.org and OSF Presenter: Roman Briker; Maastricht U. Publishing Replication Studies in Top Management Journals Presenter: Christian Hopp; Bern U. of Applied Sciences Editor's Perspective on Publishing Rigor Replication Studies Presenter: Nicolas Bastardoz; KU Leuven Open Research Data Sharing in Management Research Presenter: Jermain Christopher Kaminski; Maastricht U., School of Business & Economics

Renegotiating the public good: Responding to the first wave of COVID-19 in England, Germany and Italy

We compare national education policy responses to the COVID-19 pandemic in England, Germany and Italy to explore negotiations about the public good and identify the role that research has played in framing, legitimating and rendering trustworthy the settlements reached. National data, comprising news media reports and publically available documents, are analysed and compared to identify debates about the public good and their consequences within and across national contexts. Our analysis contrasts policy contexts on three dimensions: (a) the range of interests included in debates; (b) the form and locus of decision-making; and (c) public acceptance of policy during implementation. These are related to processes of depoliticising debate and politicising research evidence in each context, as factions position themselves as trustworthy. We suggest that the way research is seen to inform decision-making during crises such as the current COVID-19 pandemic has enduring consequences for public trust in research, the politicians who employ it to justify their decisions and the schools tasked with putting these decisions into practice.

Human embryo research, stem cell-derived embryo models and invitro gametogenesis: Considerations leading to the revised ISSCR guidelines.

SummaryThe ISSCR Guidelines for Stem Cell Research and Clinical Translation were last revised in 2016. Since then, rapid progress has been made in research areas related to in vitro culture of human embryos, creation of stem cell-based embryo models, and in vitro gametogenesis. Therefore, a working group of international experts was convened to review the oversight process and provide an update to the guidelines. This report captures the discussion and summarizes the major recommendations made by this working group, with a specific emphasis on updating the categories of review and engagement with the specialized scientific and ethical oversight process.

Can citizen science increase trust in research? A case study of delineating Polish metropolitan areas

We assess the relationship between citizens’ participation in scientific research and public trust in research results within social sciences. We conduct an online citizen science quasi-experiment concerning the delineation of metropolitan areas of Poland’s two major cities. It consists of two stages. In stage one, participants in one region are exposed to citizen science and directly involved in delineating the boundaries of their local metropolitan area. In stage two, we add another region in which participants are not involved in the research process. In both regions we ask the participants to evaluate the level of their trust in the presented maps of respective metropolitan areas: based on citizen science in one region and historical data regression analysis in the other region. Our contribution to the literature lies in two areas. First, we demonstrate how citizen science can be used in urban studies to delineate boundaries of urban and metropolitan areas exhibiting strong functional connections. Second, we show that the participation of local residents in the research process increases public trust in the study results compared to non-participatory ‘traditional academic’ research. These results confirm that citizen science programs deserve to be strongly supported by European institutions as a possible means to resolving the credibility crisis of science, research and evidence-based policies.

Perspectives of Singaporean biomedical researchers and research support staff on actual and ideal IRB review functions and characteristics: A quantitative analysis.

BackgroundBiomedical research is overseen by numerous Institutional Review Boards (IRBs) in Singapore but there has been no research that examines how the research review process is perceived by the local research community nor is there any systematic data on perceptions regarding the review process or other research ethics processes and IRB characteristics. The aim of this study was to ascertain general views regarding the overall perceived value of ethics review processes; to measure perceptions about local IRB functions and characteristics; to identify IRB functions and characteristics viewed as important; and to compare these views with those of other international studies.MethodsAn online survey was used with the main component being the IRB-Researcher Assessment Tool (IRB-RAT), a validated tool, to evaluate perceptions of ideal and actual IRB functions and characteristics held by Singaporean researchers and research support staff. Data were analysed descriptively first, with mean and SD of each item of IRB-RAT questionnaire reported, excluding the respondents whose answers were unknown or not applicable. The Wilcoxon Sign Rank test was used to compare the ideal and actual ratings of each IRB-RAT item, while the Mann-Whitney U test was used to compare the ratings of each IRB-RAT item between respondents with different characteristics. The Z-test was used to compare the mean ratings of our cohort with the mean ratings reported in the literature. The correlation between our mean ideal scores and those of two international studies also employing the IRB-RAT was examined.ResultsSeventy-one respondents completed the survey. This cohort generally held positive views of the impact of the ethics review process on: the quality of research; establishing and maintaining public trust in research; the protection of research participants; and on the scientific validity of research. The most important ideal IRB characteristics were timeliness, upholding participants’ rights while also facilitating research, working with investigators to find solutions when there are disagreements, and not allowing biases to affect reviews. For almost all 45 IRB-RAT statements, the rating of the importance of the characteristic was higher than the rating of how much that characteristic was descriptive of IRBs the respondents were familiar with. There was a significant strong correlation between our study’s scores on the ideal IRB characteristics and those of the first and largest published study that employed the IRB-RAT, the US National Validation (USNV) sample in Keith-Spiegel et al. [19].ConclusionsAn understanding of the perceptions held by Singaporean researchers and research support staff on the value that the ethics review process adds, their perceptions of actual IRB functions and characteristics as well as what they view as central to high functioning IRBs is the first step to considering the aspects of the review process that might benefit from improvements. This study provides insight into how our cohort compares to others internationally and highlights strengths and areas for improvement of Singapore IRBs as perceived by a small sample of the local research community. Such insights provide a springboard for additional research and may assist in further enhancing good relations so that both are working towards the same end.

Coronavirus Human Infection Challenge Studies: Assessing Potential Benefits and Risks.

Human infection challenge studies (HCS) have been proposed as a means to accelerate SARS-CoV2 vaccine development and thereby help to mitigate a prolonged global public health crisis. A key criterion for the ethical acceptability of SARS-CoV2 HCS is that potential benefits outweigh risks. Although the assessment of risks and benefits is meant to be a standard part of research ethics review, systematic comparisons are particularly important in the context of SARS-CoV2 HCS in light of the significant potential benefits and harms at stake as well as the need to preserve public trust in research and vaccines. In this paper we explore several considerations that should inform systematic assessment of SARS-CoV-2 HCS. First, we detail key potential benefits of SARS-CoV-2 HCS including, but not limited to, those related to the acceleration of vaccine development. Second, we identify where modelling is needed to inform risk-benefit (and thus ethical) assessments. Modelling will be particularly useful in (i) comparing potential benefits and risks of HCS with those of vaccine field trials under different epidemiological conditions and (ii) estimating marginal risks to HCS participants in light of the background probabilities of infection in their local community. We highlight interactions between public health policy and research priorities, including situations in which research ethics assessments may need to strike a balance between competing considerations.

Restoring public trust in science with the help of the humanities.

A thorough analysis of the underlying worldviews and anthropologies of science and the language it uses could help to maintain the rigour of science and public trust in research.

Building a birth cohort of births and their outcome in England and Wales using linkage of administrative data

Background/rationaleWhen a baby is born in England and Wales, the event is recorded in several separate systems, each of which contains different data items. Data recorded at birth registration are mainly socio-demographic, while some different data items are recorded when the birth is notified to the NHS. The data recorded in hospital systems in England and in Wales about the majority of babies who are born in NHS maternity units are largely clinical.
 Over a ten year period, a series of three collaborative projects have linked data about 7,013,804 births registered in 2005-14 to establish a birth cohort for use in research and national statistics and to quality assure the linkage. Data about outcomes of birth in terms of death and subsequent readmissions to hospital have also been linked in. The linked data are held in the Secure Research Service at the Office for National Statistics.
 The data have been used for analyses of pattern of births by time of day, day of the week and season and in relation to obstetric intervention in labour and birth. They are now being used by other researchers.
 strong>Challenges encounteredThere were major problems in accessing NHS data for England, compounded by intermittent availability of funding.
 Lessons learnedDespite the many challenges, it proved feasible to construct a linked birth cohort which has increased the scope and range of national maternity data for England and Wales. NHS Digital’s opt-outs are causing gaps in national data and could invalidate linkage.
 RecommendationsThe cohort should be updated with data for more recent years. Linkage should be undertaken within ONS by teams who are not subject to NHS Digital’s opt-out policy. Data access policies should reflect the higher public trust in research uses of NHS data compared to commercial uses.

Safeguarding Participants in Psychiatric Genetic Research: Perspectives of Key Stakeholder Groups.

Public trust in research depends on implementation of research protections. Genetic and psychiatric research may elicit "exceptionalism," the belief that these types of research deserve special protections. Genetic information has been viewed as different from other health information. Psychiatric research has been scrutinized based on concerns about the impact of psychiatric illness on individuals' abilities to make decisions. This study compared four stakeholder groups' attitudes toward research safeguards. Psychiatric genetic researchers and institutional review board chairs received structured surveys. Individuals with mental illness and family members participated in semistructured interviews. Paired sample t-tests were used to compare mean ratings of importance of safeguard procedures for genetic versus nongenetic research on physical versus mental illnesses. All groups provided higher ratings for the importance of safeguards for genetic research and for mental illness. Individuals with mental illness and family members rated the importance of safeguards more highly than researchers and chairs did. Results of generalized linear models showed significant effects of gender and ethnicity.

Taking patient involvement seriously: a critical ethical analysis of participatory approaches in data-intensive medical research

BackgroundData-intensive research in medicine and healthcare such as health-related big data research (HBDR) implies that data from clinical routine, research and patient-reported data, but also non-medical social or demographic data, are aggregated and linked in order to optimize biomedical research. In this context, notions of patient participation and involvement are frequently invoked to legitimize this kind of research and improve its governance. The aim of this debate paper is to critically examine the specific use and ethical role of participatory concepts in the context of HBDR and data-intensive research in medicine and healthcare.DiscussionWe introduce basic conceptual distinctions for the understanding of participation by looking at relevant fields of application in politics, bioethics and medical research. Against this backdrop, we identify three paradigmatic participatory roles that patients/subjects are assigned within the field of HBDR: participants as providers of biomaterials and data, participants as administrators of their own research participation and participants as (co-)principal investigators. We further illustrate these roles by exemplary data-intensive research-initiatives. Our analysis of these initiatives and their respective participatory promises reveals specific ethical and practical shortcomings and challenges. Central problems affecting, amongst others, ethical and methodological research standards, as well as public trust in research, result from the negligence of essential political-ethical dimensions of genuine participation.ConclusionsBased on the conceptual distinctions introduced, we formulate basic criteria for justified appeals to participatory approaches in HBDR and data-intensive research in medicine and healthcare in order to overcome these shortcomings. As we suggest, this is not only a matter of conceptual clarity, but a crucial requirement for maintaining ethical standards and trust in HBDR and related medical research.

Reproducibility and replicability of systematic reviews

Irreproducibility of research causes a major concern in academia. This concern affects all study designs regardless of scientific fields. Without testing the reproducibility and replicability it is almost impossible to repeat the research and to gain the same or similar results. In addition, irreproducibility limits the translation of research findings into practice where the same results are expected. To find the solutions, the Interacademy Partnership for Health gathered academics from established networks of science, medicine and engineering around a table to introduce seven strategies that can enhance the reproducibility: pre-registration, open methods, open data, collaboration, automation, reporting guidelines, and post-publication reviews. The current editorial discusses the generalisability and practicality of these strategies to systematic reviews and claims that systematic reviews have even a greater potential than other research designs to lead the movement toward the reproducibility of research. Moreover, I discuss the potential of reproducibility, on the other hand, to upgrade the systematic review from review to research. Furthermore, there are references to the successful and ongoing practices from collaborative efforts around the world to encourage the systematic reviewers, the journal editors and publishers, the organizations linked to evidence synthesis, and the funders and policy makers to facilitate this movement and to gain the public trust in research.

COVID-19 Pandemic

As Editor-in-Chief, International Surgery, I dedicate this editorial letter to those many thousands of persons around the world impacted by the COVID-19 pandemic. International Surgery staff conveys condolences to the 350,000 plus persons globally who have died from the virus. We stand in solidarity with those families of the victims of the coronavirus. We stand in solidarity with all of the courageous front-line health professionals battling the pandemic day in and day out. The global fear and uncertainties that are now prevalent must be addressed with an urgent timeline.International Surgery pledges to work together with other organizations fostering collaborative teamwork in developing and sharing data, and in sponsoring open, clear, and transparent communications. Building public trust in research on a sustainable, ongoing basis is absolutely critical to overcome the global fear and uncertainty that pervades the thinking of everyone, particularly those most vulnerable.International Surgery staff encourages authors conducting scientific, medical research related to COVID-19 to submit your manuscripts to International Surgery for consideration and peer review. We pledge to expedite the review of these manuscripts with the goal of communicating your research findings to the world at large as soon as possible.As the Editor in Chief of International Surgery, I pledge to work collaboratively with authors who submit manuscripts and to do everything reasonably possible to expedite publishing your research findings following successful peer review. Together, we can and will defeat COVID-19.Sincerely,Christopher ChenEditor-in-ChiefInternational Surgery

Trust in Community-Engaged Research Partnerships: A Methodological Overview of Designing a Multisite Clinical and Translational Science Awards (CTSA) Initiative.

Community-engaged research (CEnR) builds on the strengths of the Clinical and Translational Science Awards (CTSA) framework to address health in underserved and minority communities. There is a paucity of studies that identify the process from which trust develops in CEnR partnerships. This study responds to the need for empirical investigation of building and maintaining trust from a multistakeholder perspective. We conducted a multi-institutional pilot study using concept mapping with to better understand how trust, a critical outcome of CEnR partnerships, can act as "social capital." Concept mapping was used to collect data from the three stakeholder groups: community, health-care, and academic research partners across three CTSAs. Concept mapping is a mixed-methods approach that allows participants to brainstorm and identify factors that contribute to a concept and describe ways in which those factors relate to each other. This study offers important insights on developing an initial set of trust measures that can be used across CTSAs to understand differences and similarities in conceptualization of trust among key stakeholder groups, track changes in public trust in research, identify both positive and negative aspects of trust, identify characteristics that maintain trust, and inform the direction for future research.