Bad apples or systematic problem? Is Italy struggling with maintaining high level of research integrity?

The recent scandal involving Prof. Schillaci has raised concerns about the integrity of the Italian academic landscape, highlighting potential deeper issues within the research ecosystem. Despite the existence of comprehensive guidelines for research integrity set by the National Council of Research (CNR) and some prominent universities, the emphasis on educating research personnel about the importance of research integrity remains lacking. Additionally, prevalent issues such as nepotism and the manipulation of metrics for career advancement pose further challenges to fostering a fair and accountable research environment. While certain legislative measures have been implemented to address these issues, their effectiveness remains limited, allowing unethical practices to persist. To address these challenges, a concerted effort at the national, institutional, and individual levels is necessary. By taking these steps, Italy has the opportunity to strengthen its research ethics landscape and move toward a more transparent and ethical academic environment.

Ethical reflections on organizing the first human trial of artificial womb technologies.

OBJECTIVE: To investigate how to protect participants in the artificial womb technology (AWT) human trials. METHOD: We compared randomized controlled trials and single arm trials to understand which trial design best balances the interests of science and participants. We also compared AWT trials with comparable settings to understand how to protect participants. RESULTS: Randomized trials might fail in reaching a sizeable sample, which could pointlessly expose participants to risks. Furthermore, parents who choose to participate in the trial might expect to receive AWT. Failed expectations might distress parents and hinder the therapeutic relationship. The trial is divided into two steps. First, delivery into AWT involves two participants: the mother and the fetus. As AWT requires a C-section, the procedure cannot be carried out without the mother's consent regardless of fetal benefit. Treatment in AWT, involves one participant: the infant. As for any other invasive intervention, the AWT trial should be suspended if harmful. CONCLUSIONS: A single arm trial could prevent some of the methodological and ethical challenges of the randomized trials. Moreover, better decisional tools should be developed to help parents decide whether to participate in the AWT trial. For example, using visual aids or showing the AWT.

Bridging the gap - how to walk the talk on supporting early career researchers.

Early career researchers (ECRs) play a crucial role in European and nationally funded research projects. They are at the forefront of planning, conducting, analysing, and reporting research. As part of the SOPs4RI project funded by the European Commission, we, as ECRs and members of this project's consortium, were given the opportunity to reflect on our role, obstacles, and possible opportunities that we experienced. Although several steps have been already taken to support early career researchers, more concrete actions have to be pursued. In our opinion, the EC should take the lead and serve as a global frontrunner (taken as exemplary also by national funding agencies) in implementing initiatives to support early career researchers during their research trajectory. We opine that the European Commission should explicitly (i) require the creation of a support system in which early career researchers will be able to build new skills and capacity, (ii) encourage and facilitate more involvement of early career researchers in decision-making roles of EC-funded projects, and (iii) provide resources to support career continuity between fixed-term contracts. The suggested actions can help early career researchers build competencies and expertise to establish stability and continuity within the research environment or to embrace and excel in careers outside academia.

Co-creating Research Integrity Education Guidelines for Research Institutions.

To foster research integrity (RI), research institutions should develop a continuous RI education approach, addressing various target groups. To support institutions to achieve this, we developed RI education guidelines together with RI experts and research administrators, exploring similarities and differences in recommendations across target groups, as well as recommendations about RI education using approaches other than formal RI training. We used an iterative co-creative process. We conducted four half-day online co-creation workshops with 16 participants in total, which were informed by the RI education evidence-base. In the first two workshops, participants generated ideas for guidelines' content, focusing on different target groups and various approaches to RI education. Based on this content we developed first drafts of the guidelines. Participants in the third and fourth workshop refined those drafts. We next organized a working group which further prioritized, reorganized, and optimized the content of the guidelines. We developed four guidelines on RI education focusing on (a) bachelor, master and PhD students; (b) post-doctorate and senior researchers; (c) other RI stakeholders; as well as (d) continuous RI education. Across guidelines, we recommend mandatory RI training; follow-up refresher training; informal discussions about RI; appropriate rewards and incentives for active participation in RI education; and evaluation of RI educational events. Our work provides experience-based co-created guidance to research institutions on what to consider when developing a successful RI education strategy. Each guideline is offered as a distinct, publicly available tool in our toolbox ( www.sops4ri.eu/toolbox ) which institutions can access, adapt and implement to meet their institution-specific RI education needs.Trial registration https://osf.io/zej5b .

Researchers on research integrity: a survey of European and American researchers.

BACKGROUND: Reports of questionable or detrimental research practices (QRPs) call into question the reliability of scientific evidence and the trustworthiness of research. A critical component of the research ecosystem is the organization within which research takes place. We conducted a survey to explore the attitudes and beliefs of European and American researchers about the organisations in which they work, their own research practices and their attitudes towards research integrity and research integrity policies. METHODS: We administered an online survey (International Research Integrity Survey (IRIS)) to 2,300 active researchers based in the US and 45,000 in Europe (including UK, Norway, Iceland and Switzerland).  We employed a stratified probability sample of the authors of research articles published between 2016 and 2020 included in Clarivate's Web of Science citation database. Coverage includes researchers in the humanities, social sciences, natural sciences and medical sciences, who hold at least a master's level degree. RESULTS: In comparison to researchers in the US, European researchers admit to more QRPs and are less confident in maintaining high research integrity (RI) standards. In the US and Europe, many researchers judge their organization to fall short of best RI practice. All researchers recognize the benefits of RI, reliable knowledge and the trust of colleagues and the public, and there is support for RI training particularly among Europeans. CONCLUSION: To create and maintain a culture of integrity in scientific research, a collective commitment from researchers, their institutions and funders is needed. Researchers rely on many channels of communication about research integrity and thus the involvement of many different participants in the research system is required to make improvements. Policies must be developed to reinforce best practice rather than being seen as an irrelevance to the real business of research.

The Mentor's Role in Fostering Research Integrity Standards Among New Generations of Researchers: A Review of Empirical Studies.

Promoting research integrity practices among doctoral candidates and early career researchers is important for creating a stable and healthy research environment. In addition to teaching specific technical skills and knowledge, research supervisors and mentors inevitably convey research practices, both directly and indirectly. We conducted a scoping review to summarise the role of mentors in fostering research integrity practices, mentors' responsibilities and the role that institutions have in supporting good mentorship. We searched five different databases and included studies that used an empirical methodology. After searching, a total of 1199 articles were retrieved, of which 24 were eligible for analysis. After snowballing, a total of 35 empirical articles were selected. The review discusses various themes such as the importance of good mentorship, poor mentorship practices, virtues and qualities of mentors, responsibilities and activities of mentors, group mentoring and responsibilities of the institution in supporting good mentorship. This review demonstrates the importance of mentors instilling responsible research practices and attitudes, and promoting research integrity among their mentees. Mentors are responsible for providing explicit guidance and for acting as good role models. The review highlights how poor mentorship can have a bad impact on the research climate. In addition, the review highlights the important influence that institutions can have in supporting mentorship.

Using co-creation methods for research integrity guideline development - how, what, why and when?

Existing research integrity (RI) guideline development methods are limited in including various perspectives. While co-creation methods could help to address this, there is little information available to researchers and practitioners on how, why and when to use co-creation for developing RI guidelines, nor what the outcomes of co-creation methods are. In this paper, we aim to address this gap. First, we discuss how co-creation methods can be used for RI guideline development, based on our experience of developing RI guidelines. We elaborate on steps including preparation of the aims and design; participant sensitization; organizing and facilitating workshops; and analyzing data and translating them into guidelines. Secondly, we present the resulting RI guidelines, to show what the outcome of co-creation methods are. Thirdly, we reflect on why and when researchers might want to use co-creation methods for developing RI guidelines. We discuss that stakeholder engagement and inclusion of diverse perspectives are key strengths of co-creation methods. We also reflect that co-creation methods have the potential to make guidelines implementable if followed by additional steps such as revision working groups. We conclude that co-creation methods are a valuable approach to creating new RI guidelines when used together with additional methods.

Research Integrity Supervision Practices and Institutional Support: A Qualitative Study.

Scientific malpractice is not just due to researchers having bad intentions, but also due to a lack of education concerning research integrity practices. Besides the importance of institutionalised trainings on research integrity, research supervisors play an important role in translating what doctoral students learn during research integrity formal sessions. Supervision practices and role modelling influence directly and indirectly supervisees' attitudes and behaviour toward responsible research. Research supervisors can not be left alone in this effort. Research institutions are responsible for supporting supervisors in being more aware of their RI function, and in supporting responsible supervision practices to have a positive cascading effect on supervisees' research practices. We interviewed 22 European research supervisors to investigate how they perceive their role as research integrity trainers and their real-life supervision practices. Moreover, we investigated their points of view concerning the role of research institutions in supporting supervision practices. Although there are different commonalities in supervisors' perception of their research integrity-related role, differences are emphasised depending on the supervisors' characteristics such as academic domain, seniority, working country and gender. In addition, supervisors' way of mentoring depend also on supervisees' learning curve. Overall, all supervisors agreed on institutions playing an important role in support their supervision effort and practices. This study aims to be a starting point for better understanding research integrity supervision practices and the role of institutions in supporting them. Moreover, it puts the basis to further investigate differences in supervision practices depending on supervisors' characteristics. Supplementary Information: The online version contains supplementary material available at 10.1007/s10805-022-09468-y.

How can research institutions support responsible supervision and leadership?

Supervisors, PhD candidates and research leaders are expected to be the primary persons responsible for maintaining a high research integrity standards. However, research institutions should support them in this effort, by promoting responsible supervision and leadership practices. Although it is clear that institutions play a crucial role in this, there is a lack of institutional guidelines focusing on these topics. The development of the experience-based guidelines presented in this article consisted of a multi-step, iterative approach. We engaged 16 experts in supervision and research integrity in four workshops to co-create institutional guidelines for responsible supervision and leadership. To revise the guidelines and make them operational, we formed a dedicated working group and consulted experts in the field of supervision. This resulted in three guidelines focusing on what institutions can do to support: responsible supervision, PhD candidates during their PhD trajectory, and responsible leadership. The recommendations focus on the rights and responsibilities of the three targeted stakeholder groups, and institutions' responsibilities for the personal development and well-being of supervisors, PhD candidates and research leaders. The three guidelines can be used by institutions to foster responsible supervision and leadership by supporting researchers to conduct research with integrity.

Designing and implementing a research integrity promotion plan: Recommendations for research funders.

Various stakeholders in science have put research integrity high on their agenda. Among them, research funders are prominently placed to foster research integrity by requiring that the organizations and individual researchers they support make an explicit commitment to research integrity. Moreover, funders need to adopt appropriate research integrity practices themselves. To facilitate this, we recommend that funders develop and implement a Research Integrity Promotion Plan (RIPP). This Consensus View offers a range of examples of how funders are already promoting research integrity, distills 6 core topics that funders should cover in a RIPP, and provides guidelines on how to develop and implement a RIPP. We believe that the 6 core topics we put forward will guide funders towards strengthening research integrity policy in their organization and guide the researchers and research organizations they fund.

Reverse mentoring to enhance research integrity climate.

Mentors have the responsibility to guide their mentees through academic and scientific challenges that they might encounter during their educational and professional development. In embodying the role of mentors, senior academics are also expected to transmit knowledge and competencies on the topic of research integrity to their junior colleagues. However, senior academics do not always succeed in transmitting responsible research practices and enhancing the research integrity climate. The implementation of the concept of reverse mentoring can be an option to overcome this issue. Different from traditional mentoring, the flow of information is reversed, going from juniors to seniors. Reverse mentoring, as a developmental partnership between mentees and mentors, has been already used successfully within the private sector and in medical education. In times in which most universities invest resources in organizing dedicated research integrity trainings for PhD candidates and junior researchers, it would be valuable to consider reverse mentoring for fostering responsible research practices and enhancing the research integrity climate. PhD candidates and junior researchers can join and fully contribute to the endeavor of enhancing the research integrity climate by co-creating, together with their senior colleagues a new-shared learning environment.

Stakeholders' perspectives on research integrity training practices: a qualitative study.

BACKGROUND: Even though research integrity (RI) training programs have been developed in the last decades, it is argued that current training practices are not always able to increase RI-related awareness within the scientific community. Defining and understanding the capacities and lacunas of existing RI training are becoming extremely important for developing up-to-date educational practices to tackle present-day challenges. Recommendations on how to implement RI education have been primarily made by selected people with specific RI-related expertise. Those recommendations were developed mainly without consulting a broader audience with no specific RI expertise. Moreover, the academic literature lacks qualitative studies on RI training practices. For these reasons, performing in-depth focus groups with non-RI expert stakeholders are of a primary necessity to understand and outline how RI education should be implemented. METHODS: In this qualitative analysis, different focus groups were conducted to examine stakeholders' perspectives on RI training practices. Five stakeholders' groups, namely publishers and peer reviewers, researchers on RI, RI trainers, PhDs and postdoctoral researchers, and research administrators working within academia, have been identified to have a broader overview of state of the art. RESULTS: A total of 39 participants participated in five focus group sessions. Eight training-related themes were highlighted during the focus group discussions. The training goals, timing and frequency, customisation, format and teaching approach, mentoring, compulsoriness, certification and evaluation, and RI-related responsibilities were discussed. Although confirming what was already proposed by research integrity experts in terms of timing, frequency, duration, and target audience in organising RI education, participants proposed other possible implementations strategies concerning the teaching approach, researchers' obligations, and development an evaluation-certification system. CONCLUSIONS: This research aims to be a starting point for a better understanding of necessary, definitive, and consistent ways of structuring RI education. The research gives an overview of what has to be considered needed in planning RI training sessions regarding objectives, organisation, and teaching approach.

Educating PhD Students in Research Integrity in Europe.

No university or research institution is immune to research misconduct or the more widespread problem of questionable research practices. To strengthen integrity in research, universities worldwide have developed education in research integrity. However, little is known about education in research integrity for PhD students in European research-intensive universities. We conducted a content analysis of didactic materials of 11 of the 23 members of the League of European Research Universities (LERU) to map out the content, format, frequency, duration, timing, and compulsory status of their training programmes and the characteristics of instructors of the onsite courses. Quantitative results revealed substantial variation in educational materials among the studied institutions. This variation might be because European research universities are free to design curricula without any requirements from the European, national, or institutional public funding channels. Given the challenges inherent to modern science and preventing misconduct, research institutions should empower future generations of researchers to engage in responsible research practices. To promote integrity in research among PhD students, we provide a set of recommendations for university-wide education in research integrity for doctoral trainees based on our investigation of educational resources.

The TOTAL trial dilemma: A survey among professionals on equipoise regarding fetal therapy for severe congenital diaphragmatic hernia.

OBJECTIVE: Running randomized clinical trials (RCT) in fetal therapy is challenging. This is no different for fetoscopic endoluminal tracheal occlusion (FETO) for severe left-sided Congenital Diaphragmatic Hernia (CDH). We assessed the knowledge, attitude and practice (KAP) of maternal-fetal medicine specialists toward the antenatal management of CDH, and the randomized controlled clinical (RCT) "Tracheal Occlusion To Accelerate Lung growth-trial." METHODS: A cross-sectional KAP-survey was conducted among 311 registrants of the 18th World Congress in Fetal Medicine. RESULTS: The overall knowledge of CDH and FETO was high. Remarkably only 45% considers prenatal prediction of neonatal outcome reliable. Despite, in their clinical practice they perform severity assessment (80%) and refer families for FETO either within the context of an RCT (43%) or on patient request (32%). Seventy percent perceives not offering FETO on patient demand seems as if no treatment is provided to a fetus with predicted poor outcome. Only 20% of respondents considers denying access to FETO on patient demand not as a psychological burden. CONCLUSION: Often the views of individual respondents contradicted with their clinical practice. It seems that, for severe CDH, clinicians face personal and practical dilemmas that undermine equipoise. To us, this indicates the tension between the clinical and scientific obligations physicians experience.

Collecting and characterizing existing and freely accessible research integrity educational resources.

In addition to effective training practices, well-structured educational resources are important for developing successful research integrity training programs. A considerable amount of educational material has been developed in the last years, but there is a necessity to find better ways to assess and categorize the already existing resources. We collected 237 freely available online RI educational resources with the aim to describe them in as much detail as possible using a set of well-defined criteria. We developed a grid that gives a full description, based on our 21 criteria, for each collected resource. Mainly videos and online RI training are present in our collection. Worldwide, resources are mainly from the US, whereas in Europe mainly from the UK. In the majority of the cases, the educational resources are not customized, presenting the big three (falsification, fabrication, and plagiarism) as the most addressed topics. Making RI educational resources easily accessible might help to increase awareness about the topic. Moreover, the characterization we provide might help researchers and students to deal with daily RI-related issues, to look for the right tool at the right time, and might help institutions and trainers to develop new trainings without the need to develop new tools.Abbreviations: CITI: Collaborative Institutional Training Initiative; COPE: Committee on Publication Ethics; ENERI: European Network of Research Ethics and Research Integrity; ENRIO: the European Network of Research Integrity Offices; EU: European Union; NIH: National Institutes of Health; NSF: National Science Foundation; NRIN: the Netherlands Research Integrity Network; ORI: the Office of Research Integrity; PPT: powerpoint; QRP: questionable research practice; RI: research integrity; RCR: responsible conduct of research.