Research Integrity - where are we?

As introduced in Chapter 1, in this thesis, I developed guidelines to research institutions on how to foster research integrity. I did this by exploring how research institutions can develop policies to foster, and raise awareness about, research integrity. In Section 1 of the thesis, my goal was to set the research agenda by investigating current practices of research integrity promotion at research institutions (the descriptive step), and exploring which topics should be addressed in institutional research integrity policies (the normative step). I addressed the descriptive step of looking at current practices, through a scoping review (Chapter 2). In this chapter, I found that while there are already many institutional practices for research integrity promotion globally, most of them focus on researchers’, rather than institutions’ responsibilities for fostering research integrity. In Chapter 3, I tackled the normative question of which topics should be included in institutional research integrity policies. Using a Delphi study that included a number of research policy experts and research leaders, I developed a comprehensive list of 12 topics that research institutions should address to foster research integrity. Section 2 of the thesis focused on developing guidelines for research institutions on research integrity. I specifically zoomed in further into ‘Research integrity education and training’ as the topic of the guidelines here. The first step to developing the guidelines was to examine researchers’ and other research stakeholders’ views and preferences regarding how research institutions can develop and implement better research integrity education and training policies (Chapter 4). Using focus groups, I found that researchers and other research stakeholders support the provision of continuous research integrity education which targets all researchers (across ranks), and other institutional stakeholders (such as research integrity officers and institutional leaders). Next, I proceeded to co-creating institutional guidelines on research integrity education and training together with users. In Chapter 5, I discussed how research integrity guidelines can be jointly developed with users using co-creation methods – methods engaging participants in interactive exercises aimed at jointly developing user centered outputs. The resulting RI education and training guidelines are presented in detail Chapter 6. The guidelines address the research integrity education of a) bachelor, master and PhD students; b) post-doctorate and senior researchers; c) other research integrity stakeholders; as well as d) continuous research integrity education. In the guidelines, I recommend the implementation of mandatory research integrity training (for all academic ranks); follow-up refresher training; informal discussions about research integrity; appropriate rewards and incentives for active participation in research education; and evaluation of research integrity educational events across target groups. In Section 3 of this dissertation, I reflected on an implementation concern regarding the guidelines developed. I explored the question of how research institutions can combine the implementation of research integrity rules with fostering researchers’ commitment to engage in responsible research practices (Chapter 7). I argued that institutions can use and combine market (governance through incentives), bureaucracy (governance through rules) and network (cooperative governance) mechanisms to foster research integrity. Using Habermas’ Theory of Communicative Action, I discussed that institutions can use bureaucratic and market mechanisms to foster research integrity (such as rules and incentives, respectively), as long as these are rooted in network processes (e.g. involvement of stakeholders in the development and improvement of rules or incentives). In Chapter 8, I concluded that: 1) the framing of research integrity matters for institutional policies; 2) research integrity guidelines should be tailored to the local context at hand; 3) it is important to be aware of and countervail the danger of creating a box-checking mentality when implementing institutional research integrity policies; and 4) research integrity is a journey.

Ethical conduct of research involving humans has gained relevance and importance over the years with the expansion of research beyond boundaries of traditional medical and clinical research into a multiplicity of disciplines with human participation. Human research is regarded as research conducted on or with or about people, or their tissues or cells or data obtained from them. Historically, it is stated that the Greek Philosopher Aristotle (384-322 BCE) was probably the first to discuss principles of ethics ‘by studying and offering criteria to assess human behaviour’. It is believed that he taught a course of ethics at the Lyceum during his mature years which was based on the many treatises he wrote on the subject. Increased attention to ethics in human research started after the Second World War following the judgment of the International Military Tribunal which also included 10 principles of permissible medical experiments which have since then been referred to as the Nuremburg Code (1949). Later discussions by the World Medical Assembly of the Code led to the adoption of the Helsinki Declaration (1964) which has been revised many times since then. The Council for International Organizations of Medical Sciences (CIOMS) which in association with the World Health Organizations (WHO) undertook its work on ethics in biomedical research in late 1970s. It has published an updated version with a wider scope of coverage titled ‘International Ethical Guidelines for Health-Related Research Involving Humans’ (2016). Close cooperation with World Medical Assembly has ensured that the guidelines are closely aligned to the Helsinki Declaration. Traditionally, ethics has received much attention both in clinical practice and in health research. Faculties of Medicine were the first to establish ethics review boards and ethics review committees in Sri Lanka to undertake review of research proposals with human participation for ethical aspects and issues and granting approval. The primary aim is to safeguard the interests and right of participants of research and prevent their exploitation. There is no doubt about the value of health research and the benefits it has brought and will continue to bring to ensure health, wellbeing, safety and quality of life of people. Most research on human participants is simple, observational, descriptive and non-invasive and the ethical issues though may be minimal, still needs explicit attention and review by an ethics review board before approval. The more complex research where human participants are subject to ‘experimentation’ or ‘interventions’ has many ethical issues that need to assessed by recognized ethics review committees with experience and capability to do so. If a new drug, a new vaccine, medicinal product, device, or equipment not already in use by people is to be tested on humans before being granted approval for use in day-to-day life by the appropriate authority, the researcher should adopt recommended procedures, regulations and registration mechanism prescribed. In Sri Lanka any interventional research requires applying and obtaining approval of ethics review committees that have been gazetted under the National Medicines Regulatory Authority (NMRA) as being approved by name to undertake ethics review. The interventional research should also be registered with the Sri Lanka Clinical Trials Registry. Both these need to be submitted to the Clinical Trials Evaluation Committee of the NMRA in order to be evaluated prior to being granted approval and registration. These approvals and registrations are also requested by peer reviewed high impact journals to consider such research manuscripts for publication. There are certain values which provides the framework for principles guiding formulation of research proposals and ethics of research. These include and are not limited to respect, integrity, justice, beneficence and research merit. It is implicit in research that badly designed, conduced, analysed and reported research is unethical. Clinical Centre researchers at National Institute of Health of USA have enunciated seven principles to guide the conduct of ethical research. These are social and clinical value, scientific validity, fair subject selection, favourable risk benefit ratio, independent review, informed consent, respect for potential and enrolled subjects. Given the importance of scientific merit and integrity of research, good research practice needs much attention both by researchers and research institutions. In order to meet these needs the National Health Research Council and the Education, Training and Research Unit of the Ministry of Health have taken steps to publish, ‘The Code of Conduct on Health Research in Sri Lanka’ (2018) (available at http://www.health.gov.lk/moh_final/english/public/elfinder/files/publications/2018/TheCodeofConduct.pdf). The Code covers aspects of: formulation of research proposals; management of research data and primary materials; collaborative research; conflict of interest; supervision of research; peer review, and dissemination of research findings, publication and responsible authorship. With the expansion of research on human participation into may other sciences such as branches of engineering, computing, bio technology, genetics, artificial intelligence, machine learning, nano technology and others, the ethical issues of human research have reached a new dimension. It has to be emphasized that whatever the branch of science or discipline, if the research requires human participants, then approval of an ethics review committee is a must. Thus, it behoves on research institutes, universities, and faculties to establish ethics review committees beyond the traditional practice of having ethics review committees in medical faculties. It is necessary that members of such a committee, functions within the set terms of references, standard operating procedures, ensure confidentiality and also have appropriate training in ethics of research, approval processes and documentation. In Sri Lanka too universities have gone one step ahead to establish ethics review committees at university level to facilitate research on humans in disciplines other than health and medical practice. Time has come when universities and research institutions take steps to develop codes of conduct on research, conduct courses on such practices and ethics of research for all researchers in order to safeguard the interests and safety of both researchers and participants of research.

To foster research integrity (RI), it is necessary to address the institutional and system-of-science factors that influence researchers’ behavior. Consequently, research performing and research funding organizations (RPOs and RFOs) could develop comprehensive RI policies outlining the concrete steps they will take to foster RI. So far, there is no consensus on which topics are important to address in RI policies. Therefore, we conducted a three round Delphi survey study to explore which RI topics to address in institutional RI policies by seeking consensus from research policy experts and institutional leaders. A total of 68 RPO and 52 RFO experts, representing different disciplines, countries and genders, completed one, two or all rounds of the study. There was consensus among the experts on the importance of 12 RI topics for RPOs and 11 for RFOs. The topics that ranked highest for RPOs concerned education and training, supervision and mentoring, dealing with RI breaches, and supporting a responsible research process (e.g. through quality assurance). The highest ranked RFO topics concerned dealing with breaches of RI, conflicts of interest, and setting expectations on RPOs (e.g. about educating researchers about RI). Together with the research policy experts and institutional leaders, we developed a comprehensive overview of topics important for inclusion in the RI policies of RPOs and RFOs. The topics reflect preference for a preventative approach to RI, coupled with procedures for dealing with RI breaches. RPOs and RFOs should address each of these topics in order to support researchers in conducting responsible research.

Last year at the meeting of the National Conference in Ethics in Human Research (NCEHR), I discussed three aspects of research ethics and research integrity in relation to journal publishing. These were: conflict of interest; research ethics approval and research funding. This year, I want to reflect on the challenge of research integrity and journal publishing more broadly as well as discuss how these issues have changed over the past thirty years that I have been involved in journal editing. In revising this paper from the discussion at the NCEHR conference this year, I have included reference to the very helpful Singapore Statement on Research Integrity approved this past summer at the Second World Conference on Research Integrity. I begin with the first case of journal misconduct that I dealt with in the 1980s. An article that was co-authored was sent to one of the journals that I was editing. It was duly blindrefereed and accepted for publication. When it appeared in print, another academic contacted the journal saying that the first 5–6 pages of the article were identical to her article which had appeared in another scholarly journal two years previously. She then faxed her article which was as she had described it. Dealing with the co-authors was complex and unpleasant. One co-author immediately hired a lawyer who sent threatening letters, suggesting both suits to the publisher and personally to me and the editor-in-chief. The other author, among other things, suggested that he had not written any part of the article and that his co-author had forged his signature on the consent to publish form that all authors were required to sign prior to publication. Upon contacting the Vice-President Academic at his university, we discovered that he had included this article on his resume when he applied for promotion. One of the authors blamed his graduate student for being sloppy in entering material that he had only intended to quote and somehow this material had inadvertently been included in the article without due references. I could go on but the behaviour is clear. There was denial, threat, blaming others and deceit involved. There was never any adequate explanation of how a significant part of the article that we accepted was identical to the work of another author that had been published by another scholarly journal two years previously. J Acad Ethics (2010) 8:259–263 DOI 10.1007/s10805-010-9126-8

In recent years, research integrity and research ethics have received national and world attention, and people from all walks of life have carried out research on various aspects of research integrity and ethical approaches, but research on research integrity and ethics in companies is still very scarce.This paper provides an example of a PDCA-based approach to research integrity and ethics management for SouthNet, and briefly explains what is involved in carrying out the management to provide advice and assistance for the management of research integrity and ethics in companies.

There are numerous definitions of "Research Integrity", but we chose a definition that indicates the role of institutional environment and policies in ensuring fairness and honesty in research activities. This article is an overview of the historical context and current needs to build workable policies on research integrity. Core values, common actions of compliance and violations in practicing research integrity will also be presented. Besides synthesizing basic knowledge of these matters, we propose to use responsive regulatory theory to develop sanctions policies. The application of this theoretical framework is shown in a specific example, the University of Leicester's regulations on plagiarism. Principles of the responsive regulatory theory are expected to be applicable for other research misconducts.
 Keywords
 Research integrity, research misconduct, sanctions policy, responsive regulatory theory

Researchers, organizations, and governments are trying to foster research integrity. In France, the law recently permitted the appointment of research integrity officers (RIOs) in each university, to promote research integrity and handle misconducts. Since we assumed that having adequate bodies to deal with research integrity could foster research integrity, we wanted to understand how this might work more concretely. We interviewed 11 newly appointed RIOs in medical schools about how they perceive their role and cope with their responsibilities. We analyzed data following the Paillé and Muchielli’s thematic analysis approach. The RIOs report a strong and interesting appropriation of concepts of research integrity, which allows them to warrant their role. Although they report that they did not seek their appointment, they show a real desire to cope with their responsibilities. They are willing to build a role which is currently poorly defined. They assert their legitimacy through their position and experience. They identify themselves with a preventive and corrective role, in an altruistic way. They emphasize their independent and collective role, congruent with other actors. The RIOs intend to be enablers of a responsible conduct of research. These results are encouraging about the potential impact of RIOs to foster research integrity.

In the context of academic research, a diversity of ethical issues, conditioned by the different roles of members within these institutions, arise. Previous studies on this topic addressed mainly the perceptions of researchers. However, to our knowledge, no studies have explored the transversal ethical issues from a wider spectrum, including other members of academic institutions as the research ethics board (REB) members, and the research ethics experts. The present study used a descriptive phenomenological approach to document the ethical issues experienced by a heterogeneous group of Canadian researchers, REB members, and research ethics experts. Data collection involved socio-demographic questionnaires and individual semi-structured interviews. Following the triangulation of different perspectives (researchers, REB members and ethics experts), emerging ethical issues were synthesized in ten units of meaning: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. This study highlighted several problematic elements that can support the identification of future solutions to resolve transversal ethical issues in research that affect the heterogeneous members of the academic community.

Click to increase image sizeClick to decrease image sizeKeywords: Singapore Statementresearch integrityethicsinternational research Acknowledgments This research was supported by the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). It does not represent the views of the NIEHS, NIH, or U.S. government.

Reliable scientific knowledge allows us to better understand the natural world, grounds interventions to improve health and wellbeing of humans and other entities, contributes to economic development, and informs policymaking. Ensuring the integrity of scientific research is necessary to advance these various benefits and to safeguard the public’s warranted trust in science. Although a variety of complex factors are likely to play a role in advancing or hindering research integrity, some evidence shows that institutional and national policies can be more or less conducive to promoting research integrity and preventing misconduct. I focus here on Spain. I critically assess Spanish legislation and institutional policies and argue that while they proclaim ethical values consistent with fostering research integrity and preventing misconduct, these values fail to be put into practice. I explain some factors that contribute to these failings, and I also offer some suggestions that could contribute to ensuring the respect of ethical values already enshrined in Spanish policies.

A the concept of integrity in human actions is universal and inherent to any relationship in a civilized society, some guidance should be given to specific situations to set standards of good practice. In times of great academic pressure to publish, double care is necessary to preserve the integrity of research and to prevent publication misconduct. The Revista Odonto Ciencia (Journal of Dental Science) strongly recommends that our authors, reviewers and editors follow the “Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publications” by the International Committee of Medical Journal Editors (ICMJE) and the guidelines by the Committee on Publication Ethics (COPE). Furthermore, our journal is affiliated with the Brazilian Association of Scientific Editors (ABEC) and the BVS Virtual Community of Scientific Editors, which provide additional discussion on editorial policies. Our journal also supports the Singapore Statement on Research Integrity, an international initiative that discloses fundamental principles and professional responsibilities related to research and publication integrity. During the 2nd World Conference on Research Integrity, July 2010, in Singapore, scholars, researchers, funders, representatives of research institutions and publishers from all over the world developed this global guide to the responsible conduct of research. In synergy with this scenario, the Revista Odonto Ciencia (Journal of Dental Science) attended the First Brazilian Meeting on Research Integrity, Science and Publication Ethics (I BRISPE), in December 2010. One of the goals of the meeting was “to stimulate the involvement of the country’s academic community in the development of policies and in decision making concerning ethics and research integrity at the international level”. The Revista Odonto Ciencia (Journal of Dental Science) is committed to help to disseminate this important information and the good practices in research and publication. Further information can be found at:

Ethics committees are a necessary resource to guarantee ethical integrity in human research; they must apply international standards in their ethical evaluation of research projects involving human subjects. The ethics committees for human research of Colombia were characterized, and recommendations for strengthening them were formulated. In 2003, 280 groups with research projects involving human subjects were selected from a list of research groups which form part of the science and technology network of Colciencias. (Colciencias is the Colombian national agency that promotes and funds science and technology.) Eighty percent (224) of the projects were associated with 40 institutions, consisting of universities, hospitals, and public or private research centers. Thirty of these institutions had at least one ethics committee for evaluating use of human subjects. A questionnaire was mailed to each of these Committees, requesting information concerning its their compostition, regulations, multidisciplinarity, plurality, representativity and independence. The World Health Organization's Operational Guidelines for Ethic Committees that Evaluate Biomedical Research (TDR/PRD/ETHICS/2000) was used as reference for the analysis. In 5 of the cities, supplemental information was obtained by direct discussions with members of the ethics committees. Twenty-six committees responded to the questionnaire. The results indicated that 47% of the committee members were physicians, but only 23% of the committees had representatives from the community. In 60% of the Committees, members were not independent from the organization in which it was based. Seventy percent had established operating procedures. Lack of national regulations and limited education in research ethics were mentioned as the main drawbacks in providing effective guidance. These observations led to the conclusion that national guidelines must be established for ethics committees that correspond to international standards. Committee members must be trained before accepting committee responsibilities. Finally, new committees must be created along with the improvement of the currently existing committees for reinforcing and promoting the importance of ethical integrity in research.

Amid an increasingly demanding research environment, there has been a growing interest in studies concerning Research Integrity and Research Ethics (RIRE). Between 1990 and 2020, over 9700 publications were published to address problematic research conduct such as falsification, plagiarism, and related protocols and standards. In this work, country-level trends and collaborative structures are examined with respect to economic group. Our results showed that RIRE publications are predominantly led by the West, with North America and Western Europe contributing the most. While there is interest within growing economies such as China, the pace is not comparable to its overall publications. However, international collaborations on RIRE grew to account for nearly 30% of all publications on the subject in 2020. Although there is a stronger preference for high income countries to collaborate with other high income countries, we observe a rise in partnerships between high-/middle-income and middle-/lower-income co-authorship pairs in the last decade. These trends point to a maturing global community with distributed knowledge transfer, towards more unified international standards for research ethics and integrity.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11192-022-04400-y.

Researchers often refer to "research integrity", "scientific integrity", "research misconduct", "scientific misconduct" and "research ethics". However, they may use some of these terms interchangeably despite conceptual distinctions. The aim of this paper is to clarify what is signified by several key terms related to research integrity, and to suggest clearer conceptual delineation between them. To accomplish this task, it provides a conceptual analysis based upon definitions and general usage of these phrases and categorization of integrity-breaching behaviours in literature and guidelines, including clarification of the different domains and agents involved. In the first part of the analysis, following some initial clarifications, I explore the distinction between internal and external rules of integrity. In the second part, I explore the distinction between integrity and lack of misconduct, before suggesting a recategorisation of different types of integrity breach. I conclude that greater clarity is needed in the debate on research integrity. Distinguishing between scientific and research integrity, reassessing the relative gravity of different misbehaviours in light of this distinction, and recognising all intentional breaches of integrity as misconduct may help to improve guidelines and education.

Institutional Review Boards (IRBs) or research ethics board of an institute is meant to provide safety and protection to all the concerns being raised in human and animal research.1 These boards are meant to cover wide range of ethical concerns which includes respect­ing autonomy, consent, confidentiality, beneficence, non-maleficence, justice and other such concepts ini­tially raised in the verdict of Nuremberg (United States) and then covered in declaration of Helsinki and Coun­cil of International Organizations of Medical Scientists (CIOMS).2-5 Since then, such research committees are continuously being evolved from national to institution­al levels with certain Terms of References (ToRs) to reg­ulate the ethical aspects in research conduction. One must understand here, the responsibility of the institutions, colleges, and universities to curb the men­ace of unethical research and promote research integ­rity. It is the institutions which provide clean chit to the authors/investigators for conducting ethical research, while its practise during the research and maintaining integrity is something that remains unaddressed. Im­portantly, concerns about knowledge regarding ethics in research among the members of such boards, the number of functional ethics/review boards in an insti­tute, and number of meetings conducted & recorded by the board annually is something which always raises doubts. It is presumed that a common practise is be­ing adopted by many boards, wherein the Chairperson or Secretary of such board issues approvals without scheduling any meeting or analysing the proposals. Approval of such unethical research might have le­thal outcomes for the research participants as has happened in the past, wherein conduction of studies without following ethical concerns had fatal outcomes.3 Accountability, and regularisation of ethical boards is a dire need in order to uplift research from an ethi­cal perspective. In the United States of America, Office for Human Research Protections (OHRP) is one such department to overview the ethical conduction of re­search for a better outcome.6 In a study conducted on 313 protocols submitted to OHRP, only 47.1% of proto­cols were reviewed by full boards.6 In Pakistan, National Bioethics Committee (NBC) is the designated authority to look after ethical research, but institutions must also prioritise their role towards ethical research and ensuring research integrity. Proper training of members by different recognised certificate courses can be one solution. Courses like Certificate of Medical Editing or Journalism or biomedical ethics can play a pivotal role in teaching basic concepts of ethical research. In addition, proper ToRs, scheduling of meetings, records of approvals along with follow up monitoring and a functional regulating body are some other things which would help and promote ethics in research. The role of investigators, writers, and authors is another important pillar in the whole process of main­taining the ethics for research in humans. Mostly, the investigators are unaware of the Ethics/Review Board approval part of the study.7,8 Here, the knowledge of ethics among investigators is yet to be assessed, as it is believed that many are not fully aware of issues re­lated to research integrity in this region.8 The investiga­tors’ only concern is getting an ethical board approval for publication, which is a step made mandatory by the journals. The board on the other hand, merely check the words “ethical considerations will be met” written in the methodology and grants the approval. This situation obviously calls for remedial steps, wherein it is the re­sponsibility of Medical Colleges, Institutions, & Univer­sities to incorporate these basic principles of research ethics in the curriculum of the undergraduate and post­graduates. Regular workshops, Continuing Medical Ed­ucation (CME), and refresher courses addressing these concerns are the need of the day for the investigators. This is one means through which investigators can be guided and equipped with important principles of ethi­cal research and research integrity. Lastly, on part of journals, majority of whom, just ask for the Ethics/Review Board approval certificate as a pre-requisite.7 The concerns regarding the knowledge of ethical research among editors and its representa­tion on the website of many journals is yet to be explored properly. It is pertinent to add and appreciate that in the past, it was due to persistent pressure by different journals and the input by Pakistan Association of Medical Editors, in this context that made institutions formulate Ethical/Review Boards.9 Policies published by Higher Education Commission (HEC) are also a source of guidance towards better research outcomes.10 Moreover, con­tinuous training and refresher courses for the editorial board can also be a means to spread knowledge regarding ethical re­search and uplift research integrity. Nonetheless, research without ethics is not only meaningless but also more impor­tantly, an unprincipled thing to attempt. The role of institutional bodies, investigators and journals along with their editorial board is irrefutable in promoting ethics in research, and should be appreciated at all levels.