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Five Dimensions of Research Ethics: A Stakeholder Framework for Creating a Climate of Research Integrity
Abstract
The authors explore five dimensions of research ethics: (1) normative ethics, which includes meta-ethical questions; (2) compliance with regulations, statutes, and institutional policies; (3) the rigor and reproducibility of science; (4) social value; and (5) workplace relationships. Each of the five dimensions is important not only because it addresses an aspect of good research done in a good manner but also because it addresses the concerns of key stakeholders in the research enterprise. The five-dimension framework can guide institutions as they answer three questions central to any research ethics program: (1) Who should champion research ethics? (2) What should interventions look like? and (3) Who should participate in the interventions? The framework is valuable because the answers to these three questions are radically different depending on the dimension under consideration. An expanded vision of research ethics does not entail that institutions should require additional online training or approvals from institutional review boards. However, without acknowledging all five dimensions, programs risk missing an important aspect of research ethics or ignoring the interests of important stakeholders.
... They also recommended the development of a national RCR curriculum to reduce variability. More recently, Dubois and Antes (2018) identified five dimensions that are valuable for creating a climate of research integrity, via conceptual analysis of RCR curricula' statements across 25 years. The five dimensions are (1) normative ethics, which includes meta-ethical questions; (2) compliance with regulations, statutes, and institutional policies; (3) the rigor and reproducibility of science; (4) social value; and (5) workplace relationships. ...
... • Basic concepts in research integrity: Involve compliance, regulations, and core values, as well as RCR and research misconduct. This area was in line with the first two dimensions to foster a climate of research integrity suggested by Dubois and Antes (2018), including the normative ethics and compliance with regulations, statutes, an institutional policies. • RI considerations in the research procedure: Consist of the types of misconduct (i.e., falsification, fabrication, and plagiarism: FFP) and the suggested data management practices and writing skills to do good science. ...
... • RI considerations in the research procedure: Consist of the types of misconduct (i.e., falsification, fabrication, and plagiarism: FFP) and the suggested data management practices and writing skills to do good science. This area is consistent with the data management and research misconduct (FFP) in ORI's nine areas, and the rigor and reproducibility of science suggested by Dubois and Antes (2018). Additionally, we included instructional units about paraphrasing, summarizing, quoting, and referencing as positive intervention strategies to prevent FFP. ...
Graduate education is a critical period in shaping and fostering graduate students' awareness about the importance of responsible conduct of research and knowledge and skills in doing good science. However, there is a lack of a standard curriculum and assessment framework for graduate students in Taiwan. The aim of this study was to develop a literacy-based research integrity (RI) assessment framework, including five core RI areas: (1) basic concepts in RI, (2) RI considerations in the research procedure, (3) research ethics and research subject protection, (4) publication and authorship, and (5) conflict of interest. The five areas were derived through a comprehensive review of major topics and areas covered in existing research integrity education and training programs and were rated by RI experts with adequate content validity. Test items on the five core areas were developed across three literacy levels: remembering and understanding, applying and analyzing, and evaluating and creating. Seven thousand and eighty-seven graduate-level trainees took an 18-unit RI course covering the five RI areas. Upon finishing the course, trainees completed a computer-based RI assessment randomly selected from 26 RI testing booklets. The design of test items followed the mastery-oriented assessment principles to promote trainees’ learning of RI with adaptive assessment feedback. Results showed that the items in the RI assessment had adequate discrimination and low difficulty level. Thus, the RI assessment can be used to assess a range of trainees’ RI literacy and can provide the most information in identifying trainees in need of more instruction or alternative training. The low guessing parameters also indicated the online RI assessment had an appropriate control of test exposure and cheating prevention. Higher education authorities can use this framework to assess graduate students' RI literacy based on a standard curriculum and prepare them for conversations about the responsible conduct of research for RI culture-building.
... Ethical research requires maximizing the protection of human subjects, ensuring the quality, trustworthiness, and rigor of research, and following the rules and regulations established by professional fields, institutions, and funding agencies (DuBois & Antes, 2017). Research misconduct is often discussed in tandem with ethical research. ...
... Recent work has aimed to identify specific research lab leadership and management practices that foster rigorous research and regulatory compliance in research labs. Rigorous research is characterized by doing ethical, credible, and reproducible science (DuBois & Antes, 2017;Marcus, 2014). Regulatory compliance is characterized by following research ethics rules, policies, and standards (e.g., human subjects protocols) (DuBois & Antes, 2017). ...
... Rigorous research is characterized by doing ethical, credible, and reproducible science (DuBois & Antes, 2017;Marcus, 2014). Regulatory compliance is characterized by following research ethics rules, policies, and standards (e.g., human subjects protocols) (DuBois & Antes, 2017). Lab leadership and management practices encompass distinct behaviors that are practical for researchers to implement in a research setting. ...
Scientific work is demanding and complex, requiring those leading research to be simultaneously innovative and ethical in their work. Along with this, those leading scientific teams need to be able to influence both the work being done and lab members doing the work. Thus, both leadership and management skills are necessary to navigating the organizational, social, and ethical components of the research process in order to do rigorous, ethical, and high-quality scientific work. This paper recommends a number of practices that leaders of research teams should engage in, including management behaviors for "leading the work" and leadership behaviors for "leading the people" that foster excellence and integrity in research labs. Researchers can take an intentional approach to leadership and management to create a robust environment for ethical research. Overall, a researcher's routine behaviors as leaders of their labs should establish a healthy work environment and promote effective interpersonal interactions among lab members. Further, the lab requires routine procedures and structure to provide adequate oversight of the research. This paper also addresses challenges that may arise when implementing leadership and management practices, along with strategies for overcoming these strategies. Avenues for future research and policy development related to leadership and management in scientific contexts are discussed.
... The United States invests billions of dollars in research annually [1][2][3]. An array of stakeholders have an interest in how this research is carried out [4]. Funding agencies and the public are primarily interested in advancing scientific knowledge and solving real-world problems. ...
... Addressing these stakeholder interests in the research enterprise requires attending to several dimensions of research ethics-or "doing good research in a good manner"-at the institutional level and within research labs and teams [4,5]. In their labs, principal investigators (PIs) must foster research rigor and reproducibility, compliance with research rules and regulations, and effective workplace relationships. ...
... We adopted a causation coding framework to identify causal explanations for why the exemplars had reputations for exemplary research [38], which we defined as fostering rigorous research, regulatory compliance, and good relationships [4]. In the interviews, we asked for the exemplars to discuss their own theory of what explains their success and reputations by asking them to identify the routine practices and habits they employed. ...
Introduction
Conducting rigorous scientific inquiry within the bounds of research regulation and acceptable practice requires a principal investigator to lead and manage research processes and personnel. This study explores the practices used by investigators nominated as exemplars of research excellence and integrity to produce rigorous, reproducible research and comply with research regulations.
Methods
Using a qualitative research design, we interviewed 52 principal investigators working in the United States at top research universities and the National Institutes of Health Intramural Research Program. We solicited nominations of researchers meeting two criteria: (1) they are federally-funded researchers doing high-quality, high-impact research, and (2) have reputations for professionalism and integrity. Each investigator received an initial nomination addressing both criteria and at least one additional endorsement corroborating criteria 2. A panel of researchers and our research team reviewed the nominations to select finalists who were invited to participate. The cohort of “Research Exemplars” includes highly accomplished researchers in diverse scientific disciplines. The semi-structured interview questions asked them to describe the routine practices they employ to foster rigor and regulatory compliance. We used inductive thematic analysis to identify common practices.
Results
The exemplars identified a core set of 8 practices and provided strategies for employing them. The practices included holding regular team meetings, encouraging shared ownership, providing supervision, ensuring adequate training, fostering positive attitudes about compliance, scrutinizing data and findings, and following standard operating procedures. Above all, the use of these practices aim to create a psychologically safe work environment in which lab members openly collaborate to scrutinize their work and share in accountability for rigorous, compliant research.
Conclusions
Researchers typically receive limited systematic training in how to lead and manage their research teams. Training and education for principal investigators should include essential leadership and management practices and strategies that support doing high-quality research with integrity.
... Research ethics is determined by multifaceted factors that collectively shape ethical considerations and conduct within the realm of research. These determinants encompass a wide range of elements, including societal norms, legal regulations, institutional policies, cultural values, and individual moral principles (5). The need to ensure the well-being and rights of participants, maintain the integrity of scientific inquiry, and uphold the trust of the public are factors that have highlighted the importance of research ethics in recent years (6,7). ...
Acknowledgments: I would like to extend my gratitude to my colleagues, Eero Raittio and Sergio E. Uribe, for their valuable comments and input. Abstract Objective: To determine the magnitude and shape of the relationship between the proportion of retracted papers and the level of democracy at the country level. Methods: This was a cross-sectional study. The number of retracted articles for each country was collected from the Retraction Watch Database. The mean Democracy Index score 2006-2021 by the Economist Intelligence Unit was used as the independent variable. The number of citable documents 1996-2021 from SCImago was used to account for the population size of retractions. Poisson family regression and linear regression were used to explore the relationship between the proportion of retractions and the Democracy Index score. The adjusted model included: non-violent mass campaigns, gross domestic product per capita, Human Development Index, industry's share of the economy in percent, length of executive tenure, location, the Muslim share of the population, the number of top universities, and plurality/majority system. R was used for data handling, analysis and reporting. Results: Overall, data from 241 countries were analyzed. As of January 24, 2023, the Retraction Watch Database had retractions from 166 countries and territories. The highest number of retractions belonged to China (n=18,352), the United States (n=4,668), and India (n=2,554). Twenty-four countries had one retraction. The mean (and standard deviation) for the number of retractions and Democracy Index score were 180.4 (1246.42) and 5.5 (2.19), respectively. In the Poisson-inverse Gaussian regression models, the coefficient for the mean Democracy Index score was −0.120 (exp=0.877, P<0.001) in the unadjusted model and −0.040 (exp=0.961, P=0.630) after adjustment. In the linear regression models, the coefficients were −0.102 (P=0.007, R 2 =0.037) in the unadjusted model and −0.033 (P=0.623, R 2 =0.185) in the adjusted model. Sensitivity analyses using zero-truncated and outlier-eliminated datasets yielded similar results. Conclusion: There was an inverse association between the proportion of retractions and the Democracy Index scores. Democratic nations can provide an accountable research environment promoting ethical behaviour resulting in fewer number of publication retractions.
... Dichas interrogantes se relacionan con las brechas, desigualdades e inequidades que les afectan, su eventual vulnerabilidad, su representación en la investigación (especialmente biomédica), su capacidad de consentir, lo que ocurre con ellas cuando el estudio concluye, su acceso a los productos generados, entre otros. Como señalaron DuBois y Antes [3] "la ética de la investigación consiste en hacer buena ciencia, de buena manera", lo que se relaciona fundamentalmente con su valor social. El objetivo de este ensayo es reflexionar acerca de interrogantes éticas que plantea el envejecimiento poblacional, revisando algunos de los preceptos básicos de la ética de la investigación. ...
Aging population is a global reality that forces public policies based on transdisciplinary research focused on older adults. This raises a series of issues, such as feasability, inequalities, inequities, vulnerability, access to the products generated, and ability to consent, among others. This essay's objective is to reflect on some of the questions that arise from this reality, review basic precepts of research ethics in human beings, and expose the challenges for updating the current guidelines for ethical biomedical research. Aged adults participating in clinical research should be respected, assured of an adequate risk/benefit balance, and selected fairly. The available guidelines generally recognize these basic principles, but they are not entirely guaranteed, as evidenced during the COVID-19 pandemic. This issue poses various ethical challenges and deserves to be considered in the guidelines and regulations for biomedical research with the participation of older adults.
... The survey was developed by a team of PhD-level experts in the fields of research ethics and survey design [39][40][41][42]. We iteratively revised the survey with input from PIs, CRCs, and IRB members. ...
Introduction
Several evidence-informed consent practices (ECPs) have been shown to improve informed consent in clinical trials but are not routinely used. These include optimizing consent formatting, using plain language, using validated instruments to assess understanding, and involving legally authorized representatives when appropriate. We hypothesized that participants receiving an implementation science toolkit and a social media push would have increased adoption of ECPs and other outcomes.
Methods
We conducted a 1-year trial with clinical research professionals in the USA ( n = 1284) who have trials open to older adults or focus on Alzheimer’s disease. We randomized participants to receive information on ECPs via receiving a toolkit with a social media push (intervention) or receiving an online learning module (active control). Participants completed a baseline survey and a follow-up survey after 1 year. A subset of participants was interviewed ( n = 43).
Results
Participants who engaged more with the toolkit were more likely to have tried to implement an ECP during the trial than participants less engaged with the toolkit or the active control group. However, there were no significant differences in the adoption of ECPs, intention to adopt, or positive attitudes. Participants reported the toolkit and social media push were satisfactory, and participating increased their awareness of ECPs. However, they reported lacking the time needed to engage with the toolkit more fully.
Conclusions
Using an implementation science approach to increase the use of ECPs was only modestly successful. Data suggest that having institutional review boards recommend or require ECPs may be an effective way to increase their use.
... Several reasons support this view. First, good management and leadership of the laboratory helps to foster an ethical research climate. 2 Ethical management policies, attitudes, and decisions can encourage ethical conduct; unethical policies, attitudes, and decisions, by contrast, can encourage unethical conduct (Mumford et al. 2007;Martinson et al. 2010;Antes, Mart, and DuBois 2016;DuBois and Antes 2018;Antes, Kuykendall, and DuBois 2019;Hofman and Holm 2019;Haven et al. 2020;McIntosh, Sanders, and Antes 2020;Solomon et al. 2021). For example, if a principle investigator (PI) stresses the importance of ethics during lab meetings, members of the lab are more likely to understand the importance of ethics and comply with ethics policies than if the PI had not done so. ...
To obtain some exploratory, qualitative data on ethical issues and values in managing a research laboratory, we conducted three focus groups with experienced investigators and laboratory managers. After validating the focus group transcripts for accuracy, two coders used deductive and inductive coding to develop themes from the text. Participants regarded ethics as important in managing a laboratory (or research group) for various reasons, ranging from conducting research with integrity to exhibiting leadership and promoting an ethical research climate. Participants identified many different types of ethical issues that arise in managing a research laboratory, including issues involving the management people, financial and material resources, projects, and data. An overarching ethical dilemma identified by participants was balancing the desire for productivity against apparently competing values, such as treating people fairly and promoting the wellbeing of individuals. Participants also indicated that graduate and post-graduate education and training did not prepare them to deal with the ethical, financial, interpersonal, and other issues related to managing a research laboratory, and that communication and leadership are crucial to managing a research laboratory ethically.
... The existing research on why people fail to act ethically identifies a range of contributors, including: pressure (Belle and Cantarelli, 2017;Davis et al., 2007: 200;Kornfeld, 2012;Sovacool, 2008), gain (Belle and Cantarelli, 2017;Boes et al., 2017), mental/emotional state (Davis et al., 2007), character (Belle and Cantarelli, 2017;DuBois and Antes, 2018;Kornfeld, 2012;Ruiz-Palomino and Linuesa-Langreo, 2018;Sovacool, 2008), loss aversion (Belle and Cantarelli, 2017), health/ family trouble (Davis et al., 2007), relationships (Davis et al., 2007), competition (Boes et al., 2017), opportunity (Adams and Pimple, 2005), and cultural factors (Davis et al., 2007). These studies do not indicate which factors are most likely, only that they are factors in causing unethical behavior. ...
When scientists act unethically, their actions can cause harm to participants, undermine knowledge creation, and discredit the scientific community. Responsible Conduct of Research (RCR) training is one of the main ways institutions try to prevent scientists from acting unethically. However, this only addresses the problem if scientists value the training, and if the problem stems from ignorance. This study looks at what scientists think causes unethical behavior in science, with the hopes of improving RCR training by shaping it based on the views of the targeted audience ( n = 14 scientists). Previous studies have surveyed scientists about what they believe causes unethical behavior using pre-defined response items. This study uses a qualitative research methodology to elicit scientists’ beliefs without predefining the range of responses. The data for this phenomenographic study were collected from interviews which presented ethical case studies and asked subjects how they would respond to those situations. Categories and subcategories were created to organize their reasonings. This work will inform the development of future methods for preventing unethical behavior in research.
... data reported here was part of a larger survey focused on evidence-based informed consent practices, of which formatting and plain language were two of the practices included in the survey. Item writing was conducted by a team of PhD-level experts in the fields of research ethics, bioethics, and survey design (e.g., DuBois & Antes, 2018;DuBois, Chibnall, & Gibbs, 2015;DuBois, Chibnall, Tait, et al., 2015;English, Antes, Baldwin, & DuBois, 2017). The research team drafted and iteratively revised the first pool of survey items as a group, with expert input from Principal Investigators (PIs), Clinical Research Coordinators (CRCs), and IRB members. ...
Recent revisions to the Common Rule require that consent documents begin with a focused presentation of the study's key information that is organized to facilitate understanding. We surveyed 1,284 researchers working with older adults or individuals with Alzheimer's disease, supplemented with 60 qualitative interviews, to understand current use and barriers to using evidence-based formatting and plain language in key information. Researchers reported using formatting in 42% of their key information sections, and plain language in 63% of their key information sections. Perceived barriers included lack of knowledge, Institutional Review Board, other members of their team, and the burden associated with implementation. Education and training are required to increase adoption of the practices.
... PhD-level experts in the fields of research ethics, bioethics, and survey design wrote all items with expert input from PIs, CRCs, and IRB members. [39][40][41][42] We modified some items to create a PI version and CRC version where relevant. The survey focused on multiple evidence-based consent practices, and we present here only the data on using validated assessments of consent. ...
Introduction
Participants and research professionals often overestimate how well participants understand and appreciate consent information for clinical trials, and experts often vary in their determinations of participant’s capacity to consent to research. Past research has developed and validated instruments designed to assess participant understanding and appreciation, but the frequency with which they are utilized is unknown.
Methods
We administered a survey to clinical researchers working with older adults or those at risk of cognitive impairment ( N = 1284), supplemented by qualitative interviews ( N = 60).
Results
We found that using a validated assessment of consent is relatively uncommon, being used by only 44% of researchers who had an opportunity. Factors that predicted adoption of validated assessments included not seeing the study sponsor as a barrier, positive attitudes toward assessments, and being confident that they had the resources needed to implement an assessment. The perceived barriers to adopting validated assessments of consent included lack of awareness, lack of knowledge, being unsure of how to administer such an assessment, and the burden associated with implementing this practice.
Conclusions
Increasing the use of validated assessments of consent will require educating researchers on the practice and emphasizing very practical assessments, and may require Institutional Review Boards (IRBs) or study sponsors to champion the use of assessments.
... The concept of research ethics is generally used in a broad and inclusive way, similar to [11], who consider research ethics as "doing good science in a good manner" (p. 550). ...
The purpose of this paper is to analyze how current research information systems (CRIS) take into account ethical issues, especially in the environment of open science. The analysis is based on a review of the literature on research information management, CRIS, open science and research ethics. The paper provides a framework for the assessment of CRIS on two levels: are CRIS (= their data model, format, functionalities, etc.) compliant with ethical requirements from the research community, funding bodies, government, etc., i.e., can they appropriately process data on research ethics (protocols, misconduct, etc.), and which are the ethical issues of the development, implementation and usage of CRIS? What is the impact of new ethical requirements from the open science movement, such as integrity or transparency? Can CRIS be considered as ethical infrastructures or “infraethics”? Concluding this analysis, the paper proposes an empirical approach for further investigation of this topic. The originality of the paper is that there are very few studies so far that assess the implications of research ethics and open science on the CRIS.
... An individualized remediation program such as The University of Washington in St. Louis' 3-day Professionalism and Integrity in Research Program that has been attended by 39 researchers from 24 institutions has yielded promising results for those who have had their research privileges suspended [26,27]. DuBois and Antes thus define five dimensions of research ethics, including "compliance with regulations, statutes, and institutional policies" as ethical imperatives in the context of the responsible conduct of research [28]. The range of ways the research community might address misconduct beyond implementing programs targeting researchers who have had their research privileges suspended remains the topic of intense interest [1,10,29]. ...
The P rincipal IN vestigator D evelopment and R esources (PINDAR) program was developed at the NYU-H+H Clinical and Translational Science Award (CTSA) hub in response to a perceived need for focused good clinical practice (GCP) training designed specifically for principal investigators (PIs) performing human subject research. PINDAR is a novel 6-hour, instructor lead, participatory, in-person course for PIs developed de novo , piloted, and implemented. One hundred and seventeen faculty PIs participated in PINDAR from November 2016 through September 2018. All obtained mutual recognition for ICH E6 GCP training from TransCelerate Biopharma . PINDAR was well received by participant PIs, and feedback surveys have revealed a high degree of satisfaction with the program. Other CTSA hubs and research-intensive health systems should consider adopting a similar course focused on GCP for PIs.
... Furthermore, cultivating such an environment is important for fostering ethical research (DuBois and Antes 2017). Investigators are responsible for ensuring that their groups' procedures and interactions support doing rigorous science and following research rules and regulations, such as standards for protecting research subjects or reporting on findings transparently and accurately. ...
We conducted semi-structured, telephone interviews with 52 federally-funded researchers nominated as exemplars for their integrity and professional conduct, and their scientific achievements. The aim was to identify the practices they report utilizing to build respectful relationships in their teams. We found four practices, holding meetings, providing supervision and guidance, encouraging shared ownership, and expressing values, which were also important to performing high-quality, compliant research, were essential to fostering relationships. The most common practice described for building relationships was actively and deliberately cultivating a positive team environment. Additionally, exemplars described the need to lead by example, tailor their approach to the needs of individuals, address interpersonal conflict, and hire team members cautiously. We also identified practices the exemplars reported as important to managing the demands of their work and found that encouraging shared ownership and tailoring to individuals supported this goal. Additional strategies related to prioritization and planning, seeking advice, engaging in self-care, and managing emotional reactions. Finally, we identified priorities guiding the exemplars’ practices. Key priorities included providing outstanding mentoring, building collaborations and relationships, and engaging in discovery and innovation. Investigators require exceptional leadership skills but receive limited systematic leadership training. Addressing this gap would advance research excellence and integrity.
... In such situations, responsible research relies on the decisions made by researchers. These decisions serve to bolster, or undermine, workplace interactions, compliance with research regulations, adherence to accepted research practice, and ultimately the quality of research, its impact, and the trust of the public in the scientific enterprise (De Vries et al. 2006;DuBois et al. 2016a;DuBois and Antes 2018). ...
Researchers encounter challenges that require making complex professional decisions. Strategies such as seeking help and anticipating consequences support decision-making in these situations. Existing evidence on a measure of professional decision-making in research (the PDR) that assesses the use of decision-making strategies revealed that NIH-funded researchers born outside of the U.S. tended to score below their U.S. counterparts. To examine potential explanations for this association, this study recruited 101 researchers born in the United States and 102 born internationally to complete the PDR and measures of basic personal values, values in scientific work, discrimination between the seriousness of rules in research, exposure to unprofessional research practices, and acculturation to American culture. Several variables were associated with PDR scores—discrimination between types of rules in research, exposure to unprofessional research practices, acculturation, and the basic personal values of power, security, and benevolence. However, only security, benevolence, acculturation, and rule discrimination were also associated with nation of origin. In multivariate models, the variance explained by these variables in accounting for the association of nation of origin and PDR scores was somewhat overlapping, thus, only security and benevolence remained as unique, statistically significant predictors. Thus, this study identified some important variables in the association of nation of origin and PDR, but more research is needed. In a secondary analysis to examine the “clinical significance” (the practical importance) of scores on the PDR, this study examined aggregated PDR score data from the present sample and past samples of investigators. This analysis identified scores that may suggest a concern versus those scores that may be interpreted as excellent, proficient, or marginal. Implications for training and mentoring, along with considerations for future research are discussed.
Scientists who manage research laboratories often face ethical dilemmas related to conflicts between their different roles, such as researcher, mentor, entrepreneur, and manager. It is not known how often uncertainty about conflicting role obligations leads scientists to engage in unethical conduct, but this probably occurs more often than many people would like to think. In this paper, we reflect on ethical decision-making in scientific laboratory management with special attention to how different roles create conflicting obligations and expectations that may produce moral uncertainty and lead to violations of research norms, especially when combined with self-interest and other factors that increase the risk of misbehavior. We will also offer some suggestions and guidance for investigators and research institutions.
The study analyses the mapping of the research publications on research ethics, the Scientometrics profile was applied in the field of research during 2000-2022. The data out of 78308 publications, the largest 8751 (10.71%) of publications was distributed by the researchers in 2021. The EGR ranges between 0.068 and 2.044 in the years 2002 and 2019 respectively. The study found ranked authors, out of which twenty-five authors in the research field were concerned. The most prolific author found in the series, Shine, was the top ranked and had published 164 (0.201%) of the publications. The study explored the productivity of the publications contributed among twenty-five researchers. The ranking of the counties in order was England in second with 13353 (16.34%), then Australia 11777 (14.41%), Canada 8424 (10.31%), Peoples Republic of China 5293 (6.48%), Germany 4512 (5.52%), Netherlands 3920 (4.79%), France 2733 (3.34%), Spain 2391 (2.92%) and Sweden 2294 (2.80%).
This work examines the process of developing responsible research and innovation (RRI) at Universitat Jaume I, a public university in Castelló Spain. In this context, the chapter presents some basic characteristics of RRI implementation by exploring thestepsin the process, and some barriers and drivers. In particular, the authors examine the development of a code of good research practice and the university’s ethics committees. Both tools are developed in line with the European ETHNA System project, which provides practical guides for RRI institutionalisation processes.
Serious and continuing research noncompliance and integrity violations undermine the quality of research and trust in science. When researchers engage in these behaviors, institutional officials (IOs) often develop corrective action plans. Ideally, such plans address the root causes so noncompliance or research integrity violations discontinue. The aim of this study was to identify what IOs perceive as causes and action plan activities typically prescribed. We conducted semi-structured in-depth interviews with 47 IOs at research institutions across the U.S. including: institutional review board and institutional animal care and use committee chairs and directors, chief research officers, research compliance and integrity officers, and institutional conflicts of interest chairs and directors. The most common root causes identified were: 1) lack of knowledge or training, 2) failure to provide research team supervision, and 3) researcher attitudes toward compliance. The most common action plan activities include: 1) retraining in compliance or research integrity, 2) follow-up and hands-on involvement with the researcher, and 3) mandated oversight or mentoring. Because the most commonly identified action plan activities fail to adequately address the majority of root causes, our findings suggest a need for IOs to rethink existing approaches to action plan development to more effectively target root causes.
Doctoral students in clinical, counseling, and school psychology programs
often collaborate with faculty on research projects in their training as scientist-
practitioners. Yet, the determination of publications' credit and order of
authorship on resulting manuscripts continues to be a major concern and
challenging process for professional psychologists and student collaborators.
This article describes the use of case-based learning and semi-structured
interview approaches to instruct first-year clinical psychology doctoral students
in publication ethics during a research seminar. The instructor models
ethical decision-making with 1) a discussion of four cases from his own
professional experiences and 2) a description of the Authorship Eligibility
Assessment form, which he developed for use with junior researchers. The
authors advocate for more educational strategies to supplement the APA
standards in teaching the ethics of the publication process. Implications in
terms of graduate student development and research collaborations in the
field of professional psychology were discussed.
Research collaboration is a common practice in higher education, and so is the discourse of research ethics. However, the colonial orientation of some research as well as the managerial models of higher education practices undermine the connectedness and relationality of collaborative research. In this article, I argue this point with a focus on disengagement or withdrawal of collaborators from research projects before they are completed. I argue that this practice has ethical implications at various levels, especially the level of the researched or colonised communities. Drawing from multi-disciplinary literature, I follow a conceptual analysis method, focusing on research collaboration, research ethics and disengagement. The article identifies the types and benefits of collaborative research, as well as common reasons and ethical implications of disengagement from such projects. It concludes by recommending an extension of research ethics regulations to incorporate disengagement, in consideration of the relationality of collaborative research projects. Keywords: collaborative research, disengagement, relational ethics, managerialism, higher education
Current research information systems (CRIS) evaluate research performance and are intended to contribute to the continuous improvement of research. Based on former research on the ethical dimensions of CRIS, our paper presents the results of a survey with a small sample of representatives of ethics committees from different European countries on ethical aspects of CRIS. Ethics committees and experts are rarely associated with CRIS-related projects. However, their opinion on ethical indicators and the implementation and use of a CRIS is undoubtedly essential for the future development and management of these systems. Against this background, our purpose is to provide a deeper understanding of the ethical aspects in the field of research information management, to show how CRIS represent ethical dimensions of scientific research and to suggest some adjustment of their development, implementation and use.
The open science policy questions the criteria and procedures of research assessment, while at the same time emphasizing the fundamental principles of scientific ethics, such as transparency, openness and integrity. In this context, since 2020 we have been conducting an analysis of the ethical dimension of information systems dedicated to research evaluation (research information management systems or CRIS). This article presents the results of an international survey conducted in 2021 with a small sample of professionals and researchers on two aspects: ethics as an object of the systems’ data model (metrics), and the ethical aspect of the implementation and use of these systems. The discussion links to the quality of these systems, highlights the distinction between the evaluation of institutions and individuals and proposes the analysis of these systems from the concept of a distributed moral responsibility of ethical infrastructures (infraethics).
Concern over social scientists’ inability to reproduce empirical research has spawned a vast and rapidly growing literature. The size and growth of this literature make it difficult for newly interested academics to come up to speed. Here, we provide a formal text modeling approach to characterize the entirety of the field, which allows us to summarize the breadth of this literature and identify core themes. We construct and analyze text networks built from 1,947 articles to reveal differences across social science disciplines within the body of reproducibility publications and to discuss the diversity of subtopics addressed in the literature. This field-wide view suggests that reproducibility is a heterogeneous problem with multiple sources for errors and strategies for solutions, a finding that is somewhat at odds with calls for largely passive remedies reliant on open science. We propose an alternative rigor and reproducibility model that takes an active approach to rigor prior to publication, which may overcome some of the shortfalls of the postpublication model.
In this article, we present the results of 30 ethnographic interviews in which we asked STEM graduate and undergraduate students at a university in the Midwest of the United States about topics related to the culture of their research group, how group members communicate and interact, and their experience with ethical issues that arise within the laboratory. Here we focus on the culture of research laboratories and describe the key categories that emerged through analysis, including communication, community structure, governance, and collaboration that influence and shape lab culture. We also consider the critical role of the principal investigator (PI) to influence conditions in the lab that facilitate or inhibit lab culture and the subsequent effects on student feelings and behaviors, interpersonal communication, collaboration, work output, and ethics. Our findings suggest that the quality of research and the wellbeing of the lab members depend not only on purely scientific factors and routine research and work practices but are also dependent on the culture of the lab as it manifests in interpersonal relationships. The interviews reveal the critical role students ascribe to the PI in shaping the lab culture. Based on this study, we suggest how ethical lab cultures might be encouraged.
Promoting and implementing research integrity is considered the joint responsibility and effort of multiple stakeholders in the research community. We conducted a scoping review and analyzed 236 research articles and grey literature publications from biomedical sciences, social sciences, natural sciences (including engineering), and humanities that dealt with the factors that may positively or negatively impact the promotion and implementation of research integrity. Critical appraisal of evidence was performed for studies describing interventions aimed at research integrity promotion in order to provide insight into the effectiveness of these interventions. The results of this scoping review provide a comprehensive taxonomy of factors with positive or negative impact and their relatedness to individual researchers, research performing and funding organizations, and the system of science. Moreover, the results show that efforts for fostering and promoting research integrity should be implemented at all three levels (researcher, institution, system) simultaneously to deliver greater adherence and implementation of research integrity practices. Although various educational interventions aiming at research integrity promotion exist, we were not able to conclude on the effectiveness of explored interventions due to the methodological quality issues in the studies.
Bringing our collective experiences of past collaborations through a virtual connection, we created an international research team of 16 multidiscipline, multicultural, and multilingual academic women called “COVID GAP” (Gendered Academic Productivity) to explore the ongoing challenges and effects of COVID-19. Identifying as insider researchers, we engaged in a two-phase, primarily qualitative research project to better understand the lived experiences of academics during the pandemic. Our past individual experiences with cooperative research informed our roles and responsibilities and how we organized and communicated. This article is a reflection of how COVID GAP has refined our collaborative process in response to an evolving comprehension of our own lessons learned including understanding the nature of cooperative research and that it takes time and effort. From our experience, we provide specific recommendations for group collaborations emphasizing the need to identify a team coordinator to organize efforts, the establishment of a safe and equitable working environment for all involved, and the explicit attention to building a network for research partnerships.
Worldwide, undergraduate science and pre-medical students are encouraged to participate in authentic active learning lab work and undergraduate research experiences. Unfortunately, these experiences rarely include training in science or research ethics. Although several governmental and scientific organizations have called for increased training in responsible research conduct, relatively few studies report on the effectiveness of different pedagogical approaches. Too often science ethics socialization and training is limited to conversations with individual mentors. This paper describes how viewing an interactive theatrical presentation of several research misconduct scenarios was associated with an increase in first-year students’ self-assessed understanding of the topics addressed: proper treatment of data images, respect for animal protocols, authorship considerations, and plagiarism issues. There was no decrease in self-reported responsible conduct of research (RCR) knowledge for students surveyed 10 weeks, as compared to 2 weeks, after the science ethics presentations. RCR test question scores showed only a slight decrease in correct answers from 2 to 10 weeks. Theatrical presentation is an inexpensive yet engaging approach that provides students with a chance to actively consider the importance of RCR and the complexities of contexts surrounding ethics decisions before starting a research career.
The author was invited to write a commentary on the ethics of health professions education research. Based on the author’s own experiences, published guidelines, and discussions with international colleagues, the author found that research ethics can be roughly grouped into 3 distinct areas, each with its own distinct aims: protecting the integrity of science, protecting the integrity of research subjects, and protecting the integrity of authorship. The focus of this commentary is to provide some guiding thoughts on each of the 3 areas for mentors of emerging health professions education scholars.
While any framing logic is arbitrary, the 3 areas of research ethics can be illustrated by 9 distinct breaches of ethical principles, ranging from outright fraud to strategic authorship practices, and 27 practical lessons for learners to counter these and shape ethical research conduct. In general, the international variations in habits, rules, and regulations do not strike the author as being substantially different, but there are cultural variations in terms of what is emphasized and regulated.
The ethics of research in health professions education has developed quite extensively in the past few decades, following advances in biomedical and other research domains, and are now grounded in several useful and authoritative guidelines. At the end of the day, however, ethical research conduct is a matter of internalized rules and regulations that researchers must develop over time. Emerging scholars need both instruction and role models to develop their own moral compass to navigate the rules, regulations, and purposes of research ethics.
This work aims to elaborate a governance composite index for research laboratories in public university. This index is composed by an indicator of responsible liberalism associating effectiveness and ethics, to which are added an organizational management indicator and a strategic management indicator. To achieve the above aim, several methods are used, such as adjusted data envelopment analysis and geometric mean to aggregate indicators to calculate the composite index, Vigier index to compute responsible liberalism indicator, and tools to measure the validity and the reliability of indicators. The findings show that the developed index can be applied in any context.
The outburst of the COVID-19 pandemic has boosted the need for seamless, unrestricted, fast, and free access to the latest research results on the virus, on its treatment, prevention, protocols, and so on. Open access to publications and research data, suddenly, became self-evident, not only for researchers in life and medical sciences but also for politicians, journalists, and society as a whole. At the same time, this sudden awareness triggered another debate on the quality and, moreover, the trustworthiness of this mass of information made available most often without any form of quality control (peer review). Thousands of datasets from research on COVID-19 and related topics have already been deposited on data repositories. Our chapter discusses the issue of the quality and trustworthiness of research data in data repositories using examples from the ongoing pandemic. It offers insights into some fundamental concepts and summarizes recommendations for quality assurance and evaluation of research data.
The objective of this research is to assess the impact of ethics on research productivity within laboratories of public universities. To achieve this objective, neural networks’ method is used to highlight impacting and impacted variable modalities. Findings show ethical variables having the greatest impact on research productivity are ethics supporting document and transparency, while the variables most impacted by ethics are publications and scientific projects. Finally, the originality of this work lies in the reconciliation of two dimensions that appear to be irreconcilable a priori, namely, ethics which has a social connotation and productivity which has an economic connotation. It also resides in employing neural networks’ method, with is rarely used in social sciences.
Health research ethics (HRE) training programmes are being developed and implemented globally, often with a goal of increasing local capacity to assure ethical conduct in health-related research. Yet what it means for there to be sufficient HRE capacity is not well-defined, and there is currently no consensus on outcomes that HRE training programmes should collectively intend to achieve. Without defining the expected outcomes, meaningful evaluation of individual participants and programmes is challenging. In this article, we briefly describe the evolution of formal education in HRE, articulate the need for a framework to define outcomes for HRE training programmes, and provide guidance for developing HRE competency frameworks that define outcomes suited to their contexts. We detail critical questions for developing HRE competency frameworks using a six-step process: (1) define the purposes, intended uses and scope of the framework; (2) describe the context in which practice occurs; (3) gather data using a variety of methods to inform the competency framework; (4) translate the data into competencies that can be used in educational programmes; (5) report on the competency development process and results and (6) evaluate and update the competency framework. We suggest that competency frameworks should be feasible to develop using this process, and such efforts promise to contribute to programmatic advancement.
In this article, we summarize the key findings of an exploratory study in which students and faculty completed a survey that sought to identify the most important ethical issues in STEM fields, how often these issues are discussed in research groups, and how often these ethical issues come up in the daily practice of research. Participants answered a series of open-ended and Likert-scale questions to provide a detailed look at the current ethical landscape at a private research university in the Midwest. The survey also looked at potential differences between faculty and undergraduate and graduate students’ perceptions in answering these questions. The results indicate that while all community members tended to view issues that can be classified as research misconduct as the most important activities to avoid in STEM-related research, the level of discussion and actual witnessing of these practices was relatively low. The study points to a consensus among students and faculty about the important ethical issues in STEM and the need for more discussion and attention to be paid to communication, collaboration, and interpersonal relationships in the research environment.
Researchers must conduct research responsibly for it to have an impact and to safeguard trust in science. Essential responsibilities of researchers include using rigorous, reproducible research methods, reporting findings in a trustworthy manner, and giving the researchers who contributed appropriate authorship credit. This “how‐to” guide covers strategies and practices for doing reproducible research and being a responsible author. The article also covers how to utilize decision‐making strategies when uncertain about the best way to proceed in a challenging situation. The advice focuses especially on graduate students, but is appropriate for undergraduates and experienced researchers. It begins with an overview of responsible conduct of research, research misconduct, and ethical behavior in the scientific workplace. The takeaway message is that responsible conduct of research requires a thoughtful approach to doing research in order to ensure trustworthy results and conclusions, and that researchers receive fair credit. © 2021 Wiley Periodicals LLC.
This article was corrected on 25 July 2022. See the end of the full text for details.
The environment researchers work in influences their ethical decisions and behavior. A “climate” for research ethics in a research lab exists when members of the lab perceive that the group values and is committed to principles of research ethics. In this study, we aimed to develop a short, reliable and valid measure assessing perceptions of climate for research ethics at the lab level. The resulting measure, Lab Climate for Research Ethics, was developed using standard scale development guidelines. In a large sample of postdoctoral researchers (N = 570), we found preliminary evidence that the new measure has adequate internal consistency reliability. It was also correlated with an existing measure of climate for research ethics and was not correlated with social desirability, demonstrating evidence of construct validity. The new measure can be used in a variety of contexts, including research administrators seeking information about climate within labs across an institution and researchers who study lab environments.
Definition of the problem
Concepts of stakeholder engagement are well established in business ethics and medical ethics. However, current approaches tend to see it as an end in itself. Thereby, two important aspects are often neglected: first, the general normative presuppositions of stakeholder engagement; second, moral implications concerning different modes of communication.
Arguments
The present article argues that normative presuppositions of stakeholder engagement can be understood by reconstructing existing approaches. Here, three ethical theories are relevant: deontology, contractualism, and discourse ethics. Furthermore, stakeholder involvement is related to modes of communication that range from information to empowerment. Drawing upon the example of clinical research, we argue that these modes have different normative weight in relation to the respective stakeholder’s form of affectedness.
Conclusion
We show why it is important for bioethics to reflect on the particular relation of affectedness and modes of participation, and how this can be realized in practice.
Implementation research (IR) is growing in recognition as an important generator of practical knowledge that can be translated into health policy. With its aim to answer questions about how to improve access to interventions that have been shown to work but have not reached many of the people who could benefit from them, IR involves a range of particular ethical considerations that have not yet been comprehensively covered in international guidelines on health research ethics. The fundamental ethical principles governing clinical research apply equally in IR, but the application of these principles may differ depending on the IR question, context, and the nature of the proposed intervention. IR questions cover a broad range of topics that focus on improving health system functioning and improving equitable and just access to effective health care interventions. As such, IR designs are flexible and often innovative, and ethical principles cannot simply be extrapolated from their applications in clinical research. Meaningful engagement with all stakeholders including communities and research participants is a fundamental ethical requirement that cuts across all study phases of IR and links most ethical concerns. Careful modification of the informed consent process may be required in IR to permit study of a needed intervention. The risks associated with IR may be difficult to anticipate and may be very context-specific. The benefits of IR may not accrue to the same groups who participate in the research, therefore justifying the risks versus benefits of IR may be ethically challenging. The expectation that knowledge generated through IR should be rapidly translated into health policy and practice necessitates up-front commitments from decision-makers to sustainability and scalability of effective interventions. Greater awareness of the particular ethical implications of the features of IR is urgently needed to facilitate optimal ethical conduct of IR and uniform ethical review.
Empirically analyzing empirical evidence
One of the central goals in any scientific endeavor is to understand causality. Experiments that seek to demonstrate a cause/effect relation most often manipulate the postulated causal factor. Aarts et al. describe the replication of 100 experiments reported in papers published in 2008 in three high-ranking psychology journals. Assessing whether the replication and the original experiment yielded the same result according to several criteria, they find that about one-third to one-half of the original findings were also observed in the replication study.
Science , this issue 10.1126/science.aac4716
In the world of research, compliance with research regulations is not the same as ethics, but it is closely related. One could say that compliance is how most societies with advanced research programs operationalize many ethical obligations. This paper reports on the development of the How I Think about Research (HIT-Res) questionnaire, which is an adaptation of the How I Think (HIT) questionnaire that examines the use of cognitive distortions to justify antisocial behaviors. Such an adaptation was justified based on a review of the literature on mechanisms of moral disengagement and self-serving biases, which are used by individuals with normal personalities in a variety of contexts, including research. The HIT-Res adapts all items to refer to matters of research compliance and integrity rather than antisocial behaviors. The HIT-Res was administered as part of a battery of tests to 300 researchers and trainees funded by the US National Institutes of Health. The HIT-Res demonstrated excellent reliability (Cronbach's alpha = .92). Construct validity was established by the correlation of the HIT-Res with measures of moral disengagement (r = .75), cynicism (r = .51), and professional decision-making in research (r = -.36). The HIT-Res will enrich the set of assessment tools available to instructors in the responsible conduct of research and to researchers who seek to understand the factors that influence research integrity.
Transparency, openness, and reproducibility are readily recognized as vital features of science (1, 2). When asked, most scientists embrace these features as disciplinary norms and values (3). Therefore, one might expect that these valued features would be routine in daily practice. Yet, a growing body of evidence suggests that this is not the case (4–6).
In this paper, we report on the development and validity of the Professional Decision-Making in Research (PDR) measure, a vignette-based test that examines decision-making strategies used by investigators when confronted with challenging situations in the context of empirical research. The PDR was administered online with a battery of validity measures to a group of NIH-funded researchers and research trainees who were diverse in terms of age, years of experience, types of research, and race. The PDR demonstrated adequate reliability (alpha = .84) and parallel form correlation (r = .70). As hypothesized, the PDR was significantly negatively correlated with narcissism, cynicism, moral disengagement, and compliance disengagement; it was not correlated with socially desirable responding. In regression analysis, the strongest predictors of higher PDR scores were low compliance disengagement, speaking English as a native language, conducting clinical research with human subjects, and low levels of narcissism. Given that the PDR was written at an eighth grade reading level to be suitable for use with English as a second language participants and that only one-fourth of items focused on clinical research, further research into the possible roles of culture and research ethics training across specialties is warranted. This initial validity study demonstrates the potential usefulness of the PDR as an educational outcome assessment measure and a research instrument for studies on professionalism and integrity in research.
Low reproducibility rates within life science research undermine cumulative knowledge production and contribute to both delays and costs of therapeutic drug development. An analysis of past studies indicates that the cumulative (total) prevalence of irreproducible preclinical research exceeds 50%, resulting in approximately US$28,000,000,000 (US$28B)/year spent on preclinical research that is not reproducible-in the United States alone. We outline a framework for solutions and a plan for long-term improvements in reproducibility rates that will help to accelerate the discovery of life-saving therapies and cures.
Efforts to advance research integrity in light of concerns about misbehavior in research rely heavily on education in the responsible conduct of research (RCR). However, there is limited evidence for the effectiveness of RCR instruction as a remedy. Assessment is essential in RCR education if the research community wishes to expend the effort of instructors, students, and trainees wisely. This article presents key considerations that instructors and course directors must consider in aligning learning objectives with instructional methods and assessment measures, and it provides illustrative examples. Above all, in order for RCR educators to assess outcomes more effectively, they must align assessment to their learning objectives and attend to the validity of the measures used.
One of the most enjoyable parts of a science career is collaborative team experiences and developing life-long social networks. When the hypothesis being tested requires innovative efforts greater than any single laboratory, collaboration becomes an essential component for success - everyone is a stakeholder and trust is the driving force.
We analyzed 40 cases of falsification, fabrication, or plagiarism (FFP), comparing them to other types of wrongdoing in research (n = 40) and medicine (n = 40). Fifty-one variables were coded from an average of 29 news or investigative reports per case. Financial incentives, oversight failures, and seniority correlate significantly with more serious instances of FFP. However, most environmental variables were nearly absent from cases of FFP and none were more strongly present in cases of FFP than in other types of wrongdoing. Qualitative data suggest FFP involves thinking errors, poor coping with research pressures, and inadequate oversight. We offer recommendations for education, institutional investigations, policy, and further research.
This study examined the role of reflection on personal cases for making ethical decisions with regard to new ethical problems. Participants assumed the position of a business manager in a hypothetical organization and solved ethical problems that might be encountered. Prior to making a decision for the business problems, participants reflected on a relevant ethical experience. The findings revealed that application of material garnered from reflection on a personal experience was associated with decisions of higher ethicality. However, whether the case was viewed as positive or negative, and whether the outcomes, process, or outcomes and processes embedded in the experience were examined, influenced the application of case material to the new problem. As expected, examining positive experiences and the processes involved in those positive experiences resulted in greater application of case material to new problems. Future directions and implications for understanding ethical decision-making are discussed.
With supplement funding to the Washington University CTSA, the Restoring Professionalism and Integrity in Research (RePAIR) program was developed at Saint Louis University to meet the remediation needs of institutions nationwide regarding investigators who violate research regulations. With the aim of determining the frequency and kinds of wrongdoing at leading research institutions in the United States, as well as institutional responses and levels of interest in a formal remediation program, an online questionnaire was distributed by email to a research integrity officer (RIO) and institutional review board (IRB) chair at all medical schools and comprehensive doctoral institutions in the United States (N = 194). One hundred sixty-one individuals responded (44%) representing 66% of institutions. For those institutions that had both RIOs and IRB chairs responding, 96% had investigated at least one case over the past 2 years; the modal individual response was 3-5 cases, with a range from 0 to more than 16 cases. The most common forms of wrongdoing were violations of procedure, informed consent, research integrity (fabrication, falsification, plagiarism), privacy, and conflict of interest policies. Most RIOs and IRB chairs expressed interest in the RePAIR program, despite concerns about costs and faculty resistance.
Recent scandals and controversies-such as the falsification, fabrication, and plagiarism of data in federally funded science; the manipulation and distortion of research sponsored by private companies; human embryonic stem cell research; cloning; and the patenting of DNA and cell lines-illustrate the importance of ethics in scientific research. This book provides an introduction and overview of many of the social, ethical, and legal issues facing scientists today. The book includes chapters on research misconduct, conflicts of interest, data management, mentoring, authorship, peer review, publication, intellectual property, research with human subjects, research with animal subjects, genetic and stem cell research, international research, and ethical decision making. The book also features dozens of real and hypothetical cases for discussion and analysis and introduces the reader to important research regulations and guidelines. Now in its second edition, this book synthesizes the diverse talents and experiences. This second edition of this book includes new chapters and cases and has been brought up to date on the latest issues and problems in research ethics.
The Survey of Organizational Research Climate (SORC) is a validated tool to facilitate promotion of research integrity and research best practices. This work uses the SORC to assess shared and individual perceptions of the research climate in universities and academic departments and relate these perceptions to desirable and undesirable research practices. An anonymous web- and mail-based survey was administered to randomly selected biomedical and social science faculty and postdoctoral fellows in the United States. Respondents reported their perceptions of the research climates at their universities and primary departments, and the frequency with which they engaged in desirable and undesirable research practices. More positive individual perceptions of the research climate in one's university or department were associated with higher likelihoods of desirable, and lower likelihoods of undesirable, research practices. Shared perceptions of the research climate tended to be similarly predictive of both desirable and undesirable research practices as individuals' deviations from these shared perceptions. Study results supported the central prediction that more positive SORC-measured perceptions of the research climate were associated with more positive reports of research practices. There were differences with respect to whether shared or individual climate perceptions were related to desirable or undesirable practices but the general pattern of results provide empirical evidence that the SORC is predictive of self-reported research behavior.
This report is based on the Federation of American Societies for Experimental Biology's symposium, "Engaging basic Scientists in Translational Research: Identifying Opportunities, Overcoming Obstacles," held in Chevy Chase, MD, March 24-25, 2011. Meeting participants examined the benefits of engaging basic scientists in translational research, the challenges to their participation in translational research, and the roles that research institutions, funding organizations, professional societies, and scientific publishers can play to address these challenges.
In recent years, we have seen a new concern with ethics training for research and development professionals. Although ethics training has become more common, the effectiveness of the training being provided is open to question. In the present effort, a new ethics training course was developed that stresses the importance of the strategies people apply to make sense of ethical problems. The effectiveness of this training was assessed in a sample of 59 doctoral students working in the biological and social sciences using a pre-post design with follow-up, and a series of ethical decision-making measures serving as the outcome variable. Results showed that this training not only led to sizable gains in ethical decision-making, but that these gains were maintained over time. The implications of these findings for ethics training in the sciences are discussed.
Improved quality of care is a policy objective of health care systems around the world. Implementation research is the scientific study of methods to promote the systematic uptake of clinical research findings into routine clinical practice, and hence to reduce inappropriate care. It includes the study of influences on healthcare professionals' behaviour and methods to enable them to use research findings more effectively. Cluster randomized trials represent the optimal design for evaluating the effectiveness of implementation strategies. Various codes of medical ethics, such as the Nuremberg Code and the Declaration of Helsinki inform medical research, but their relevance to cluster randomised trials in implementation research is unclear. This paper discusses the applicability of various ethical codes to obtaining consent in cluster trials in implementation research.
The appropriate application of biomedical codes to implementation research is not obvious. Discussion of the nature and practice of informed consent in implementation research cluster trials must consider the levels at which consent can be sought, and for what purpose it can be sought. The level at which an intervention is delivered can render the idea of patient level consent meaningless. Careful consideration of the ownership of information, and rights of access to and exploitation of data is required. For health care professionals and organizations, there is a balance between clinical freedom and responsibility to participate in research.
While ethical justification for clinical trials relies heavily on individual consent, for implementation research aspects of distributive justice, economics, and political philosophy underlie the debate. Societies may need to trade off decisions on the choice between individualized consent and valid implementation research. We suggest that social sciences codes could usefully inform the consideration of implementation research by members of Research Ethics Committees.
Public health ethics, like the field of public health it addresses, traditionally has focused more on practice and particular cases than on theory, with the result that some concepts, methods, and boundaries remain largely undefined. This paper attempts to provide a rough conceptual map of the terrain of public health ethics. We begin by briefly defining public health and identifying general features of the field that are particularly relevant for a discussion of public health ethics.
Public health is primarily concerned with the health of the entire population, rather than the health of individuals. Its features include an emphasis on the promotion of health and the prevention of disease and disability; the collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment; a recognition of the multidimensional nature of the determinants of health; and a focus on the complex interactions of many factors—biological, behavioral, social, and environmental—in developing effective interventions.
Traditional boundaries among basic research, clinical research and patient-oriented research are yielding to a single, continuous, bidirectional spectrum commonly termed 'translational research' or 'translational medicine.' These encompass (i) the definition of guidelines for drug development or for the identification and validation of clinically relevant biomarkers; (ii) experimental nonhuman and nonclinical studies conducted with the intent of developing principles for the discovery of new therapeutic strategies; (iii) clinical investigations that provide a biological foundation for the development of improved therapies; (iv) any clinical trial initiated in accordance with the above goals; and (v) basic science studies that define the biological effects of therapeutics in humans. Although these goals are essentially no different from those of traditional academic clinical research, translational research emphasizes strategies to expedite their successful implementation. Unfortunately, several barriers that delay this process need to be surmounted to make translational research more than just an interesting concept.
This is the third and completely revised edition of a now classic handbook that focuses specifically on management challenges faced by research scientists and technical professionals. In Lab Dynamics, Carl and Suzanne Cohen draw on their unparalleled professional experience (Carl as a scientist and Suzanne as a psychologist) and as workshop directors to provide invaluable, practical advice on how to succeed in science for working scientists and those in or preparing for management or leadership roles. The book is also required reading for anyone with an administrative role in the research enterprise who must understand that world and its complexities.
At its core, the book is about human interactions in science and how they can be made most effective and productive. The authors explain, without jargon or preaching, how to apply self-awareness and interpersonal skills to problems that science professionals encounter every day.
For this third edition, two new chapters have been added. The new Chapter 4, on hiring scientists, provides a data-driven approach along with step-by-step guidance and editable and downloadable forms for use in evaluating and ranking applicants. The new Chapter 6 gives a guide to keeping scientists focused and motivated through appropriate feedback. Scientists at all levels want and need to hear how they’re doing from mentors, managers, or leaders.
All other chapters have additional sections, many based on case studies and examples shared with the authors by working scientists. They include “Ten essential characteristics of scientific team leaders” with specific examples of each behavior and its impact.
Government organizations, academic institutions, and funders are increasingly focused on the management of science and the improvement of the scientific enterprise. With this update, Lab Dynamics is a resource like no other for those who lead and strive to succeed in a scientific setting.
Common compliance situations can get good researchers into trouble, warn James M. DuBois and colleagues.
The professional decision-making in research (PDR) measure was administered to 400 NIH-funded and industry-funded investigators, along with measures of cynicism, moral disengagement, compliance disengagement, impulsivity, work stressors, knowledge of responsible conduct of research (RCR), and socially desirable response tendencies. Negative associations were found for the PDR and measures of cynicism, moral disengagement, and compliance disengagement, while positive associations were found for the PDR and RCR knowledge and positive urgency, an impulsivity subscale. PDR scores were not related to socially desirable responding, or to measures of work stressors and the remaining impulsivity subscales. In a multivariate logistic regression analysis, lower moral disengagement scores, higher RCR knowledge, and identifying the United States as one's nation of origin emerged as key predictors of stronger performance on the PDR. The implications of these findings for understanding the measurement of decision-making in research and future directions for research and RCR education are discussed.
Reproducibility is a defining feature of science, but the extent to which it characterizes current research is unknown. We conducted replications of 100 experimental and correlational studies published in three psychology journals using high-powered designs and original materials when available. Replication effects were half the magnitude of original effects, representing a substantial decline. Ninety-seven percent of original studies had statistically significant results. Thirty-six percent of replications had statistically significant results; 47% of original effect sizes were in the 95% confidence interval of the replication effect size; 39% of effects were subjectively rated to have replicated the original result; and if no bias in original results is assumed, combining original and replication results left 68% with statistically significant effects. Correlational tests suggest that replication success was better predicted by the strength of original evidence than by characteristics of the original and replication teams.
Education in the responsible conduct of research typically takes the form of online instructions about rules, regulations, and policies. Research Ethics takes a novel approach and emphasizes the art of philosophical decision-making. Part A introduces egoism and explains that it is in the individual's own interest to avoid misconduct, fabrication of data, plagiarism and bias. Part B explains contractualism and covers issues of authorship, peer review and responsible use of statistics. Part C introduces moral rights as the basis of informed consent, the use of humans in research, mentoring, intellectual property and conflicts of interests. Part D uses two-level utilitarianism to explore the possibilities and limits of the experimental use of animals, duties to the environment and future generations, and the social responsibilities of researchers. This book brings a fresh perspective to research ethics and will engage the moral imaginations of graduate students in all disciplines.
Reproducibility, rigor, transparency, and independent verification are cornerstones of the scientific method. Of course, just because a result is reproducible does not necessarily make it right, and just because it is not reproducible does not necessarily make it wrong. A transparent and rigorous approach, however, can almost always shine a light on issues of reproducibility. This light ensures that science moves forward, through independent verifications as well as the course corrections that come from refutations and the objective examination of the resulting data.
Much of what Ruth Faden and colleagues say squarely meshes with the ideas of the U.S. Department of Health and Human Services about reforming the system for protecting research subjects. Having said that, I want to turn to a very different part of the research universe, the elephant in the room, as it were: the world of interventional randomized clinical trials. Under the current regulatory system, these research subjects receive substantial protections. Most importantly, they are generally enrolled only after they give their informed consent. The rationale for this approach is that research subjects are denied the core ethical protection provided to patients: there is no requirement that everything done to them be in their best interests. Faden and colleagues appear to be proposing to eliminate this informed consent requirement for a significant range of such trials.
Francis S. Collins and Lawrence A. Tabak discuss initiatives that the US National Institutes of Health is exploring to restore the self-correcting nature of preclinical research. A growing chorus of concern, from scientists and laypeople, contends that the complex system for ensuring the reproducibility of biomedical research is failing and is in need of restructuring 1,2 . As leaders of the US National Institutes of Health (NIH), we share this concern and here explore some of the significant interventions that we are planning. Science has long been regarded as ‘self-correcting’, given that it is founded on the replication of earlier work. Over the long term, that principle remains true. In the shorter term, however, the checks and balances that once ensured scientific fidelity have been hobbled. This has compromised the ability of today’s researchers to reproduce others’ findings.
This article describes a systematic approach for developing instructional programs that emphasizes defining learning needs, planning the learning environment, and evaluating learning to ensure continuous course improvement. This review outlines the nature of these interrelated components of instructional development and draws attention to issues specific to instruction in research ethics. Guiding questions summarize key, practical considerations, and the discussion suggests future steps in the pursuit of effective instruction in research ethics. Overall, the variety of approaches to instruction and mixed findings regarding its effectiveness underscore the need to apply a systematic framework to instruction in research ethics.
A disconnect exists between research resources and the health and health care needs of people those resources are designed to serve. While a great deal of research is being produced at academic institutions across the country, the topics investigated are often driven by researchers' interests or by funding announcements focused on specific research areas of interest to the funder. PURPOSE OF THE ARTICLE: The purpose of this article is to describe a process that connects community identified health priorities with research funds as well as capacity building efforts.
The North Carolina Translational and Clinical Sciences Institute (NC TraCS) developed a process to identify the health priorities of North Carolina communities through a partnership with the network of county Healthy Carolinians partnerships. The priorities identified were obesity, youth issues, healthcare delivery/access, mental health/ substance abuse, specific chronic diseases, cancer/tobacco, and injury/ violence. NC TraCS then used these research priorities to guide pilot funding and facilitate research capacity building.
Tapping into an established community-based network and linking researchers to community-identified priorities ensures that NC TraCS addresses the most pressing health needs of North Carolina's residents.
In an effort to foster research integrity, the National Institutes of Health and the National Science Foundation mandate education of all trainees in the responsible conduct of research (RCR). Nevertheless, recent studies suggest that rates of questionable research practices and scientific misconduct are both high and considerably underreported. In part, this may be due to the fact that some ethical norms (e.g., authorship assignment) are far from clear and researchers are unsure how to respond to perceived misconduct. With funding from the U.S. Office of Research Integrity (ORI), we convened four panels of experts to develop a consensus on the overarching goals and teaching content of RCR instruction. Our panelists recommended nine overarching objectives for RCR instruction that require us to rethink common modes of instruction, and they identified issues and standards that should be covered within controversial areas such as authorship assignment and whistle-blowing. Additionally, our experts recommended two new core areas for RCR instruction: The social responsibilities of scientists and current topics in RCR.
In an effort to increase the number of researchers with skills "in identifying and addressing the ethical, legal, and social implications of their research," the National Institutes of Health (NIH) solicited training grant proposals from 1999 to 2004 and subsequently funded approved programs. The authors describe the content, format, and outcomes of one such training program that ran from 2002 to 2006 and share key lessons learned about program formats and assessment methods. Jointly developed by the Saint Louis University Center for Health Care Ethics and the Missouri Institute of Mental Health Continuing Education department, the training program focused on mental health research and adopted a train-the-trainer model. It was offered in on-site and distance-learning formats. Key outcomes of the program included educational products (such as 70 case studies posted on the course Web site, a textbook, and an instructional DVD) and program completion by 40 trainees. Assessment involved pre- and posttesting focused on knowledge of research ethics, ethical problem-solving skills, and levels of confidence in addressing ethical issues in mental health research. The program succeeded in increasing participants' knowledge of ethical issues and their beliefs that they could identify issues, identify problem-solving resources, and solve ethical problems. However, scores on the case-based problem-solving assessment dropped in posttesting, apparently because of diminished confidence about the right course of action in the specific dilemma presented; the implications of this finding for ethics assessment are discussed. Overall satisfaction was high, and dropout rates were low but three times higher for distance-learners than for on-site participants.
Community-based participatory research (CBPR) has been promoted as an approach to understanding complex health problems not amenable to research conducted solely by outside investigators. Although broad dissemination of research results is a key element of the CBPR approach, existing dissemination efforts have not been assessed.
In this systematic review, researchers evaluated studies utilizing the CBPR approach to characterize dissemination of research results beyond scientific publication. Specifically, the focus was on dissemination to community participants and the general public. The literature search encompassed articles published between January 1, 2005, and December 31, 2009. Corresponding authors were also invited to complete a web-based survey. Data were collected and analyzed between July 1, 2008, and March 8, 2010.
In all, 101 articles met inclusion criteria. All articles were assessed for the quality of community involvement in research. Scores ranged from 1.4 to 3.0 (on a 3-point scale), with a mean of 2.3. The 21 articles in which an intervention was evaluated were scored for the rigor of research methods. Scores ranged from 2.0 to 2.9 (on a 3-point scale), with a mean of 2.4. Dissemination beyond scientific publication was reported in 48% of publications with varying levels of detail. However, among survey respondents, 98% reported dissemination of results to community participants and 84% reported dissemination to the general public.
Among research meeting strict criteria for inclusion as CBPR, dissemination beyond scientific publication is largely occurring. However, myriad challenges to timely and widespread dissemination remain, and current dissemination to community participants and the general public is variable.
The National Institutes of Health (NIH) require instruction in the responsible conduct of research (RCR) as a component of any Clinical and Translational Science Award (CTSA). The Educational Materials Group of the NIH CTSA Consortium's Clinical Research Ethics Key Function Committee (CRE-KFC) conducted a survey of the 38 institutions that held CTSA funding as of January 2009 to determine how they satisfy RCR training requirements. An 8-item questionnaire was sent by email to directors of the Clinical Research Ethics, the Educational and Career Development, and the Regulatory Knowledge cores. We received 78 completed surveys from 38 CTSAs (100%). We found that there is no unified approach to RCR training across CTSAs, many programs lack a coherent plan for RCR instruction, and most CTSAs have not developed unique instructional materials tailored to the needs of clinical and translational scientists. We recommend collaboration among CTSAs and across CTSA key function committees to address these weaknesses. We also requested that institutions send electronic copies of original RCR training materials to share among CTSAs via the CTSpedia website. Twenty institutions submitted at least one educational product. The CTSpedia now contains more than 90 RCR resources.
To examine the effects that existing courses on the responsible conduct of research (RCR) have on ethical decision making by assessing the ethicality of decisions made in response to ethical problems and the underlying processes involved in ethical decision making. These processes included how an individual thinks through ethical problems (i.e., meta-cognitive reasoning strategies) and the emphasis placed on social dimensions of ethical problems (i.e., social-behavioral responses).
In 2005-2007, recruitment announcements were made, stating that a nationwide, online study was being conducted to examine the impact of RCR instruction on the ethical decision making of scientists. Recruitment yielded contacts with over 200 RCR faculty at 21 research universities and medical schools; 40 (20%) RCR instructors enrolled their courses in the current study. From those courses, 173 participants completed an ethical decision-making measure.
A mixed pattern of effects emerged. The ethicality of decisions did not improve as a result of RCR instruction and even decreased for decisions pertaining to business aspects of research, such as contract bidding. Course participants improved on some meta-cognitive reasoning strategies, such as awareness of the situation and consideration of personal motivations, but declined for seeking help and considering others' perspectives. Participants also increased their endorsement of detrimental social-behavioral responses, such as deception, retaliation, and avoidance of personal responsibility.
These findings indicated that RCR instruction may not be as effective as intended and, in fact, may even be harmful. Harmful effects might result if instruction leads students to overstress avoidance of ethical problems, be overconfident in their ability to handle ethical problems, or overemphasize their ethical nature. Future research must examine these and other possible obstacles to effective RCR instruction.
THIS STUDY EXAMINED BASIC PERSONALITY characteristics, narcissism, and cynicism as predictors of ethical decision-making among graduate students training for careers in the sciences. Participants completed individual difference measures along with a scenario-based ethical decision-making measure that captures the complex, multifaceted nature of ethical decision-making in scientific research. The results revealed that narcissism and cynicism (individual differences influencing self-perceptions and perceptions of others) showed consistently negative relationships with aspects of ethical decision-making, whereas more basic personality characteristics (e.g., conscientiousness, agreeableness) were less consistent and weaker. Further analyses examined the relationship of personality to metacognitive reasoning strategies and socialbehavioral response patterns thought to underlie ethical decision-making. The findings indicated that personality was associated with many of these social-cognitive mechanisms which might, in part, explain the association between personality and ethical decisions.
This article has no abstract; the first 100 words appear below.
HUMAN experimentation since World War II has created some difficult problems with the increasing employment of patients as experimental subjects when it must be apparent that they would not have been available if they had been truly aware of the uses that would be made of them. Evidence is at hand that many of the patients in the examples to follow never had the risk satisfactorily explained to them, and it seems obvious that further hundreds have not known that they were the subjects of an experiment although grave consequences have been suffered as a direct result of experiments described . . .
*From the Anaesthesia Laboratory of the Harvard Medical School at the Massachusetts General Hospital.
‡At the Brook Lodge Conference on "Problems and Complexities of Clinical Research" I commented that "what seem to be breaches of ethical conduct in experimentation are by no means rare, bul are almost, one fears, universal." I thought it was obvious that I was by "universal" referring to the fact that examples could easily be found in all categories where research in man takes place to any significant extent. Judging by press comments, that was not obvious; hence, this note.
Source Information
BOSTON
†Dorr Professor of Research in Anaesthesia, Harvard Medical School.
Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value-enhancements of health or knowledge must be derived from the research; (2) scientific validity-the research must be methodologically rigorous; (3) fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review-unaffiliated individuals must review the research and approve, amend, or terminate it; (6) informed consent-individuals should be informed about the research and provide their voluntary consent; and (7) respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted. JAMA. 2000;283:2701-2711.
Unlabelled:
INVESTIGATED: This study presents findings from a series of focus groups, composed of stakeholders both on Capitol Hill and among national stakeholder organizations, used to identify strategies health services researchers can use for the effective dissemination and expanded use of health services research in health policy.
Methods:
Focus groups were created to assess the usefulness of rural health research products and approaches for disseminating information, and in each focus group, respondents were asked for their evaluation of several types of dissemination products and approaches, as well as participants' utilization of research findings.
Conclusions:
The focus groups identify strategies that include tailoring products to policymakers' needs, making Research products accessible, expanding working relationships with end users, and investing in greater capacity for dissemination. Implications are drawn for researchers who need to be proactive in thinking about the applications of their research to health policy, and who need to identify and seek resources to help them fund dissemination efforts.
The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research
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Implementing a Comprehensive Research Compliance Program: A Handbook for Research Officers
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Measuring value: Societal benefits of research
- E Hazelkorn
Hazelkorn E. Measuring value: Societal
benefits of research. Chron High Educ.
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com/blogs/worldwise/measuring-valuesocietal-benefits-of-research/30179. Accessed
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Dynamic Issues in Scientific Integrity: Collaborative Research
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Discovering Right and Wrong
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The unbelievable rightness of being in clinical trials. Commentary.
- Menikoff