Risky Research Research Articles

Risky first-in-human clinical trials on medically fragile persons: owning the moral cost.

The purpose of a first-in-human (FIH) clinical trial is to gather information about how the drug or device affects and interacts with the human body: its safety, side effects, and (potential) dosage. As such, the primary goal of a FIH trial is not participant benefit but to gain knowledge of drug or device efficacy, i.e., baseline human safety knowledge. Some FIH clinical trials carry significant foreseeable risk to participants with little to no foreseeable participant benefit. Participation in such trials would be a bad deal for participants, and the research is considered justifiable because of the promise of significant potential social benefit. I argue that there is an ethical tension inherent in risky FIH research and that researchers should fairly compensate risky FIH trial participants. This does not make the risk-benefit outcome more favorable for participants; rather, it amounts to a collective reckoning with the ethical tension inherent in the research.

Rationalizing risk aversion in science: Why incentives to work hard clash with incentives to take risks.

Scientific research requires taking risks, as the most cautious approaches are unlikely to lead to the most rapid progress. Yet, much funded scientific research plays it safe and funding agencies bemoan the difficulty of attracting high-risk, high-return research projects. Why don't the incentives for scientific discovery adequately impel researchers toward such projects? Here, we adapt an economic contracting model to explore how the unobservability of risk and effort discourages risky research. The model considers a hidden-action problem, in which the scientific community must reward discoveries in a way that encourages effort and risk-taking while simultaneously protecting researchers' livelihoods against the vicissitudes of scientific chance. Its challenge when doing so is that incentives to motivate effort clash with incentives to motivate risk-taking, because a failed project may be evidence of a risky undertaking but could also be the result of simple sloth. As a result, the incentives needed to encourage effort actively discourage risk-taking. Scientists respond by working on safe projects that generate evidence of effort but that don't move science forward as rapidly as riskier projects would. A social planner who prizes scientific productivity above researchers' well-being could remedy the problem by rewarding major discoveries richly enough to induce high-risk research, but in doing so would expose scientists to a degree of livelihood risk that ultimately leaves them worse off. Because the scientific community is approximately self-governing and constructs its own reward schedule, the incentives that researchers are willing to impose on themselves are inadequate to motivate the scientific risks that would best expedite scientific progress.

The Gain-of-Function Research in Virology: Concerns, Risks, and Benefits

Gain-of-function (GOF) research is biotechnological research that genetically modifies microbial gene products to enhance their biological function. The basic aim of this research is to elucidate the pathogenesis of infectious diseases, develop new vaccines and therapeutics, improve cancer treatments, and achieve specific goals by adding beneficial trait expression to the genome. Despite these significant potential benefits, GOF research can pose some important and serious biosafety risks. The main group of pathogens of concern in GOF research are respiratory viruses with pandemic potential. While laboratory accidents and ongoing discussions in recent years have raised important awareness that these studies should be carried out in high-safety laboratories, concerns about the results of these studies remain unclear due to the inadequacy or absence of mechanisms to prevent misuse for informal research, despite the strict controls in research funded by international organizations. The most important issue to be discussed is the need to establish regulations that ensure the sustainability of scientific studies and developments that can benefit humanity, as well as strict control or, if necessary, a moratorium on potentially risky research. Debates on the value, safety, ethics, and validity of GOF studies are still ongoing. In this article, it is aimed to examine the status of GOF research in virology, with examples from the current literature, together with benefit and risk perspectives.

"It Is Scary, but Then I Just Do It Anyway": Children's Experiences and Concerns about Risk and Challenge during Loose Parts Play.

Children's risky play opportunities depend on supervising adults' attitudes and the play environment. The possibilities to engage in risk-taking outdoor play for children have seriously decreased over the last few decades, due to safety concerns and adults' preoccupation with protection. In response to this shift, research has increasingly focused on influencing factors on professional attitudes toward risk-taking in children's play. However, children's perspective on risky play is underrepresented in the recent literature. This study generates awareness of children's risky play preferences and interests to help professional caretakers hone their facilitating role. We explored children's notions of risk and challenge in play during a loose parts intervention stimulating risky play and facilitated by after-school childcare practitioners. A thematic analysis examined observations, informal conversations, and roundtable talks with children about their risky play experiences. Children describe their risk-taking in play as experimental and daring. The findings report on children's general views on risky play, their play experiences with loose parts, their real-life risky play experiences, and their opinions on the role of practitioners. By relating the results to risky play research and self-determination theory, this study offers insight into children's innate needs. Taking risks on their own terms gives children a sense of self-confidence and mastery, and forces them into new relationships with other children and guiding adults. Consequently, children fulfill the three universal needs of self-determination theory: autonomy, competence, and relatedness.

Green industrial policy, information asymmetry, and repayable advance

AbstractThe energy transition requires the deployment of risky research and development programs, most of which are partially financed by public funding. Recent recovery plans, associated with the COVID‐19 pandemic and the energy transition, increased the funding available to finance innovative low‐carbon projects and called for an economic evaluation of their allocation. This paper analyzes the potential benefit of using repayable advance: a lump‐sum payment to finance the project that is paid back in case of success. The relationship between the state and innovative firms is formalized in the principal‐agent framework. Investing in an innovative project requires an initial observable capital outlay. We introduce asymmetric information on the probability of success, which is known to the firm but not to the state agency. The outcome of the project, if successful, delivers a private benefit to the firm and an external social benefit to the state. In this context a repayable advance consists in rewarding failure. We prove that it is a superior strategy in the presence of pure adverse selection. We investigate under what conditions this result could be extended in the presence of moral hazard. Implications for green industrial policy are discussed.

Risky research? Exploring the potentially detrimental effects of employing stigma scales

Research on stigma is confronted with major ethical challenges. One potential risk of investigating stigma utilizing self-reports includes the unintentional reinforcement of stigma. Commonly used self-report scales to assess stigma usually include items that directly confront people with the negative stereotypes underlying the stigma. Even though findings in the domain of priming research suggest that such a way of assessing stigma might potentially activate and reinforce existing stigma-relevant beliefs, research to date has neglected the issue of potential detrimental effects. A preregistered online experiment was conducted with a sample of 762 participants (51.1% female, Mage = 49.7 years, SDage = 16.4, 69.9% with some form of tertiary education). The objective of the study was to explore the potential impact of exposure to stigma scales which incorporate negative stereotypes on the development of stigmatizing attitudes toward two specific groups: individuals who use pre-exposure prophylaxis for HIV prevention and patients who undergo weight loss surgery. The findings underline the relevance of the issue by showing that responding to negative stereotypical items on a stigma scale bears the risk of facilitating scale-related stereotype accessibility, negative judgment, and promoting social demarcation from the groups under investigation.

U.S. scientists brace for greater scrutiny of risky research

Expert panel recommends broader reviews of research involving pathogens or toxins that could have "dual use".

Klinische Forschung im Dienst der Heilkunde: Kontexte, Praxis, Methodik und Theorie des „klinischen Beweises“ von Paul Martini – Beitrag 1

This is the first contribution to a quadripartite series on Paul Martini, internist and early clinical epidemiologist (1889–1964), and his clinical proof (“klinischer Beweis”). Following a historical introduction and the presentation of our programme, the text deals with Martini as a person and his socio-cultural background between the end of the Great War and the 1960s. It throws light on his original, innovative and risky research programme, and outlines various factors which led Martini to his central life issue: the therapeutic-clinical proof based on controlled investigations.

Uncertainty and risk-taking in science: Meaning, measurement and management in peer review of research proposals

Concern that the selection of research projects by peer review disfavors risky science has called attention to ways to incorporate risk into the evaluation of research proposals. This discussion often occurs in the absence of well-defined and developed concepts of what risk and uncertainty mean in science. This paper sets out to address this void with the goal of providing building blocks to further the discussion of the meaning of risk and uncertainty in science. The core contributions of the paper are fourfold. First, we outline the meaning of risk in science, drawing on insights from literatures on risk and uncertainty. Second, based on this outline, we discuss possible ways in which programs can embrace a more comprehensive concept of risk and embed it in peer review of proposals, with the goal of not penalizing risky research proposals with the potential of high return when funding decisions are made. Third, we make an important distinction between research projects involving high-risk and research projects whose evaluation is subjected to ambiguity/radical uncertainty. Fourth, we discuss possible ways of addressing ambiguity/radical uncertainty by funding agencies.

Strengthen oversight of risky research on pathogens.

Policy reset and convergence on governance are needed.

Global Catastrophic Risk and the Drivers of Scientist Attitudes Towards Policy

An anthropogenic global catastrophic risk is a human-induced risk that threatens sustained and wide-scale loss of life and damage to civilisation across the globe. In order to understand how new research on governance mechanisms for emerging technologies might assuage such risks, it is important to ask how perceptions, beliefs, and attitudes towards the governance of global catastrophic risk within the research community shape the conduct of potentially risky research. The aim of this study is to deepen our understanding of emerging technology research culture as it relates to global catastrophic risks, and to shed new light on how new research governance mechanisms might be developed. We analyse in-depth interviews with leading AI and biotech researchers both from universities and the private sector. We develop new insights in terms of four salient themes. First, ‘engineering mindset’, which highlights the premium placed by many interviewees on pursuing interesting research about the physical world for its own sake. Second, ‘self-government’, which looks at how self-regulation of technological development currently occurs. Third, ‘pure incentives’, focussing on how career and other incentives shapes research. Fourth, ‘norms and persuasion’, which examines the role of moral considerations in guiding the research choices of scientists. We end by considering the implications of these findings for future research on governance of anthropogenic global catastrophic risk.

Eroding norms over release of self-spreading viruses

Risky research on lab-modified self-spreading viruses has yet to present credible paths to upsides

Do Funding Agencies Select and Enable Risky Research: Evidence from Erc Using Novelty as a Proxy of Risk Taking

Do Funding Agencies Select and Enable Risky Research: Evidence from Erc Using Novelty as a Proxy of Risk Taking

Mapping and identifying technological coopetition: a multi-level approach

Firms competing over technologies are often forced to collaborate while pursuing their risky research and development (RD this is called “technological coopetition.” Such coopetition creates complex interfirm technological relationships, which vary according to the technology field wherein the competition and cooperation are occurring. This study proposes a framework by which to map and identify technological coopetition at both the interfirm and industry levels in order to clarify the complex relational state of technological coopetition. The framework distinguishes between coopetition types by considering the relatedness between the technology areas in which competition and cooperation occur, while showing how interfirm relationships change over time. At the industry level, the framework shows the technology fields in which competition, cooperation, and coopetition occur frequently. We illustrate the framework by applying it to the semiconductor industry. This study is expected to contribute to the coopetition literature as well as R&D management practice.

The Beautiful Risk of Collaborative and Interdisciplinary Research. A Challenging Collaborative and Critical Approach toward Sustainable Learning Processes in Academic Profession

In this article, we aim to identify and explore possibilities and challenges of academic interdisciplinary capacities and ethos. The objective is that this knowledge could be used both in future interdisciplinary research projects and in educational settings. We achieve this through self-reflective learning processes among a group of interdisciplinary scholars from four distinctly different subjects. The method used is an autoethnographic and empirical self-reflective approach to data collection, analysis and deconstruction of professional learning processes. This also serves to establish research methodological trustworthiness and authenticity. The results show that interdisciplinarity is undervalued by grant-giving institutions and the academic system, in general. It also entails time-consuming and risky research practices. However, interdisciplinary and collaborative research creates a more innovative and stimulating learning environment and enforces new ways of thinking and doing, in ascertaining each individual’s knowledge and competences. We argue that a long-term interdisciplinary and collaborative research process could enhance and raise a critical thinking and creative consciousness among scholars, contributing to a more holistic, sustainable and socially robust learning in research and higher education. Finally, we conclude that this academic interdisciplinary capacity and ethos could be framed and enhanced by the notion of Challenge-Based Learning.

CEO pay sensitivities in innovative firms

PurposeThis study aims to investigate whether compensation committees provide the chief executive officers (CEOs) with incentives to undertake “income-decreasing” but potentially “value-enhancing” innovation expenditures. The authors specifically analyze pay–performance relationships for innovative firms relative to all other firms. This study is critical because innovation is expensive and has uncertain outcomes.Design/methodology/approachUsing alternative accounting performance measures and market performance measures, the authors estimate an econometric model of CEO compensation in innovative firms that incorporates the interaction of endogenous innovation and firm performance.FindingsThe authors document an incremental positive association between changes in accounting performance measures and CEO compensation changes in innovative firms relative to other firms. This sensitivity of executive pay to firm performance is higher for firms that innovate. These results support the hypothesis that compensation committees provide incentives to carry out risky innovation by tying executive compensation more closely to firm performance. This finding survives a battery of sensitivity tests.Practical implicationsThe implications of this study are significant. Capital needs to support risky research and development investments (Tidd and Besant, 2018; Baldwin and Johnson, 1995) form the basis of innovative firms' operations. Considering these expenses, if CEOs, who play a critical role in the scanning, adapting and implementing innovative needs in a firm, are not protected and compensated for making risky choices, the entire investment itself will be threatened. Hence, the findings reiterate and support earlier findings that speak to the importance of compensating CEOs to make high-risk investments that will lead to long-term economic and financial gains for the firm when the innovative behaviors result in competitive market shares and profits.Originality/valueThe original work is related to the investigation of pay–performance sensitivity in the presence of innovation, which has not been fully investigated in prior literature.

Conducting Risky Research with Teens

The methods in which we study the online experiences of adolescents should be evidence-based and informed by youth. This is especially true when studying sensitive topics, such as the online risk behaviors of minors. We directly engaged 20 adolescents (ages 12-18) in the co-design of two different research methodologies (i.e., diary studies and analyzing social media trace data) for conducting adolescent online safety research. We also interviewed 13 of their parents to understand their perspectives. Overall, teens wanted to share their personal experiences and benefit society, while parents wanted researchers to tackle a topic that they felt was a prevalent problem for teens. Yet, they both had significant concerns regarding data privacy of the sensitive disclosures made by teens during such studies. Teens' feared getting in trouble. Participants emphasized the importance of developing a trusting relationship with the researcher to overcome these concerns. Participants also saw the potential for using the research study as a tool for risk-reporting and mitigation, where researchers could act as liaisons between the teens and other parties (e.g., counselors, law enforcement, parents) to share pertinent risk details and facilitate resources or even help teens directly by giving them strategies for mitigating online risks they encountered during the study. Our research delves into important ethical considerations for conducting risk-focused research with adolescents and uncovers the critical need for designing risk-based research for youth protection. We provide researchers with heuristic guidelines for conducting ethical research with vulnerable populations (i.e., adolescents) and keeping participants safe while doing so.

A Global Pandemic Remedy to Vaccine Nationalism

The COVID-19 pandemic has had devastating effects on our social, economic and political lives. While the race to develop vaccines has yielded results in record time, ensuring widespread, affordable access to these vaccines remains a major challenge. Vaccines are now in a race against new, more virulent variants of COVID-19, and unless everyone can be vaccinated soon, these new variants may lead to many more deaths. Current vaccine supplies fall far short of what is needed, however, and in what has become known as “vaccine nationalism,” wealthier countries have poured billions of dollars into advance purchasing agreements that guarantee themselves preferential access. The distribution inequities resulting from this nationalistic response undermines the interest all countries have in speedy and universal inoculation. At the heart of the problem is the fact that the pharmaceutical industry has taken a market-driven rather than public-health driven approach to vaccine development and distribution. A market-driven approach makes sense to some extent, as the pharmaceutical companies must have some means of recovering their investments in the risky research and development required to create new vaccines. Patent protections and other exclusive rights are widely regarded as necessary incentivizes for investment in pharmaceutical innovation, as they allow supracompetitive pricing. In times of global public health crises, however, the ordinary principles of exclusivity must give way to the pressing need for immediate, affordable, and widely available access. We desperately need other manufacturers to be able to help boost vaccine supplies and lower vaccine prices.Recognizing the need for flexibility in times of emergency and building upon knowledge gained from existing international and domestic compulsory licensing laws, we propose a global, centralized scheme to provide access to vaccines during pandemics. In many ways our proposal mirrors some of the WHO’s COVID-19 vaccine initiatives but consolidates and expands them into a much more efficacious form. Under the proposed model, the World Health Organization’s declaration of a pandemic would trigger a global procurement and distribution scheme for vaccines. The proposed scheme would be mandatory and would require that all countries operate as one buyer vis-à-vis vaccine developers. A single buyer scheme provides a buyer with significant economic leverage, allowing not only to negotiate vaccine pricing and distribution from a better bargaining position, but also to discourage defection. This procurement scheme would be supported by the power to issue global compulsory licenses of patent, trade secret, regulatory data, and other assets necessary for vaccine production, to become effective if and when consensual negotiations with vaccine developers fail. The success of such a global procurement initiative, especially at times of emergency where each country is tempted to defect and take a nationalistic approach, depends on mandatory global participation and a firm commitment to the scheme.

Uncertainty and Risk-Taking in Science: Meaning, Measurement and Management

An underlying rationale for public support of science is that private companies underinvest in research of a risky nature. Yet, risk in science is a poorly understood concept. This paper sets out the foundations for understanding, measuring and managing risk in science. We review insights offered from existing fields that study risk. These contributions, combined with knowledge gained from studies of science, are used to build a conceptual model of risk in science. The model is illustrated with examples drawn from the development of the IceCube Neutrino Observatory. It disentangles different components that determine risk and is used to operationalize an expert-based risk metric, potentially useful in peer review. Moreover, we review emerging empirical work on risk-taking in science, most of which suggests that the current reward structure of science discourages risky research. We develop and outline strategies for hedging and encouraging risk taking. We conclude by proposing a rich agenda for future studies, which is both intellectually challenging and critical for the future of science.

The impact of tenure on faculty course evaluations

ABSTRACT The conferment of tenure at a United States university provides substantial job security to its recipients. Tenure is designed to allow a professor the ability to explore new and risky research questions without fear of losing their position due to lack of publications. At the same time, this policy creates an incentive system with an ambiguous effect on how the professor performs in the classroom. Professors may no longer care about teaching evaluations since future evaluations are unlikely to affect their job security. Alternatively, tenured professors, no longer having strenuous research priorities, may devote more resources to the teaching component of their job. This paper investigates the impact of the conferment of tenure on student evaluations of teaching. Data comes from a large, flagship state university and spans 22 semesters (2006–2017). We use an instructor-level fixed effects structure to compare end-of-semester course survey scores before and after an instructor receives tenure. We find that conditional on being granted tenure, professors experience a small, but persistent, decrease in student course evaluations. This effect is driven by professors in the top half of the course evaluation distribution.