Correcting the Scholarly Record for Research Integrity

society is an important but complex task for research. We know from other research on social identity that respondents are likely to report problems and coping strategies that are acceptable...

Research participants are crucial to the entire research enterprise, but they are still predominantly conceived as mostly passive, ‘silent’ partners in the field of research ethics. Participants generally have very limited opportunities to share their lived experiences of participation in research and their views about the ethics of research. This gap is particularly concerning for research participants whose agency is already undermined by unjust social structures, such as individuals living with mental illness. Our study investigates the perspectives on research of mental health research participants and mental health advocates in Canada. We found that many participants had positive experiences of participation in research and valued their experience. The positive impacts of research participation, however, depend the willingness of researchers to actively create an accessible and respectful research environment. Points of interest People with mental illness who participate in research projects do not often get to talk about their experiences. We think that this is a mistake and that researchers should learn from them. We interviewed 14 research participants and individuals who work to defend the rights of people with mental illness. The research participants said that participating in research had made them feel good. It made them feel respected, valued, and listened to. Participants do not want to feel like “things” or “objects” behind a glass wall. They want to be treated as equals. This research is important because it shows that participating in research can be a positive experience for people with mental illness.

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.

Medicine and ethics have increasingly more links caused by considerable progresses in biotechnology in different fields of medical diagnosis, treatment and prevention. The issue of research ethics is one of the most important subjects which have been emphasized by international and regional organizations, policy-makers, medical and religious professions, scientists and researchers in different countries in recent decade. Research ethics, as one of the main issues of modern bioethics, has attracted the interest of scientists and ethicists in various areas of science and technology around the world. Research Ethics Committees (RECs) have been established to improve putting ethics into practice in the field of research. A ‘Research Ethics Committee' (REC) is defined as a multidisciplinary, independent, body charged with reviewing research involving human participants to ensure that their dignity, rights and welfare are protected. Research ethics committees protect the welfare and rights of participants involved in research through reviewing research proposals, monitoring the conduct of research and dealing with complaints that arise from research. RECs, fortunately, have received a great deal of attention in different countries, and their mission, goals, and tasks have been described in many national and international guidelines. Ethical guidelines for biomedical research and RECs administrative regulations have been developed in Iran too. This manuscript will introduce you to the concepts underlying research ethics committees worldwide and in Iran. In this study, we present suggestions concerning course presentation and contents, which are provided by international assemblies. In view of the fact that many RECs in our country do not have specific plans for their members' primary training and continuing education, there seems to be a need for fundamental changes in the educational prerequisites for membership in this important organization. We hope the manuscript could enhance awareness of biomedical researchers about status and duties of research ethics committees and consequently strengthen the RECs in our country. Moreover, it is recommended that the Ministry of Health and Medical Education take more serious actions to establish and monitor ethics committees throughout the country. Therefore, a comparative study of ethical codes and guidelines is necessary to prevent the possible deviations in the course of research. This study is a literature review study and after reviewing the scientific literature in this field, review set of existing international codes such as Nuremberg, Helsinki, Belmont and... . The findings of this review article can help developing policymakers of codes of ethics.

The article by Morris Brown on the impact of clinical trials legislation on clinical pharmacology [1]makes very sorry reading, as does the editorial appearing in the same issue, although less so than the Brown article. There is so much that is inaccurate in this article that it compromises the legitimate validity of his argument that bureaucracy in this country hampers clinical research. It so happens that, in my so-called retirement, I am closely involved with the research ethics review process throughout Europe, being co-chairman of the European Forum for Good Clinical Practice (EFGCP) Ethics Working Party and the EFGCP Ethics Officer, as well as having served on UK research ethics committees (RECs) for over 12 years, now being the alternate vice-chairman of Cambridgeshire 4 REC, which used to be the former East of England MREC. I was responsible for initiating the report on the structure and function of RECs published in the International Journal of Pharmaceutical Medicine in February 2007 and kept up to date on an annual basis on our EFGCP website (http://www.efgcp.be). I am therefore in a very strong position to maintain that the UK can be proud that it has as good a grasp of research ethics as any other European state, and I would be willing to debate that vigorously in public. Sadly, Brown has not acknowledged the efficiency that now demonstrably pervades the research ethics review system in this country, allowing himself to be overwhelmed by the deficiencies of the R&D Governance process in this country, with which the National Health Service has lumbered itself. This, I freely acknowledge, is a nightmare that only recently might have shown a first sign of waking itself up. Coupled with academic regulations, with which clinical pharmacologists might well be encumbered, too, I can therefore understand the frustration that Brown demonstrates, though it is partially misdirected. Without wishing to be personal in a letter to the Journal, I would remind Brown and his clinical pharmacology colleagues that one of the most irritating aspects of an application to a REC is the inadequacy of many patient information sheets, whether they come from pharmaceutical companies or academic departments. By and large, clinical pharmacologists ought to be as good as any group in the production of comprehensive yet comprehensible patient information sheets that, above all, are able to be understood by the patients who are the intended subjects of research projects. Time taken to produce a really good patient information sheet must be time well spent, as the time needed to take on board the concerns of a REC may well be much greater than for the drafting of a decent document in the first place. Referral back by a REC must be frustrating to an investigator, but the time taken to deal with the REC concerns can be minimized, and it is not right to accuse RECs of delaying tactics when the time taken for a response by an investigator may well be very protracted. Of more fundamental concern is Brown's clear lack of understanding of what research ethics are all about. No doubt Brown is a very sound medical ethicist and he tells us that medical ethics was his first academic interest. But research ethics is quite different from mainstream medical ethics. It is because RECs are established to look after the interests of patients who are the subjects of clinical research projects that they include in their membership lay persons as well as experts. The National Research Ethics Service (NRES) has ensured that all the members of RECs are properly trained in the principles of research ethics, and Brown's comments on the membership of RECs in his article are insulting in the extreme. It is the intelligent lay persons as well as the doctors, nurses, lawyers, statisticians, pharmacists, teachers and so on who are found on RECs that safeguard the interests of patients—and at Cambridgeshire 4 we operate to strict deadlines. I hope that readers of your Journal will recognize the efficiency with which research projects are dealt with by the NRES, through its research ethics committees, and will all contribute to putting pressure on other aspects of the research approval process that are still deficient. None declared.

Strengthening clinical and research ethics in Nigeria—an agenda for change

Leadership style adopted by nursing managers is a key element in progress and development of nursing and quality of healthcare services received by the patients. In this regard, the role of ethical leadership is of utmost importance. The objective of the study was to elaborate on the ethical leadership and its role in professional progress and growth of nurses in the light of work condition in health providing institutes. The study was carried out as a qualitative study following conventional content analysis method. In total, 14 nursing faculty members and nursing managers at different levels were selected through purposive sampling method. Semi-structured interviews were used for data gathering. The data were analyzed using latent content analysis and constant comparison analysis. This study was conducted in accordance with ethical issues in research with human participants and national rules and regulations related to informed consent and confidentiality. The study was approved by the Committee of Ethics in Research at the Shahid Beheshti University of Medical Sciences in Tehran, Iran, under the code: sbmu.rec.1393.695 on 15 February 2015. Five subcategories were obtained based on the analysis, which constituted two main categories including "all-inclusive satisfaction" and "productivity." Nursing leaders highlighted the point that their ethical behavior creates "inner satisfaction of the leader," "employees' job satisfaction," and "patients' satisfaction." Improvement of productivity was another outcome of ethical behavior of the leaders. This kind of behavior resulted in "providing better services" and "inspiring ethical behavior in the employees." It has great influence on progress and growth of the nursing profession. By creating an ethical climate, ethical leadership leads to positive and effective outcomes-for the patients as well as for the nurses and the leaders-and professional progress and development of the nursing profession. Therefore, an ethical work environment that supports nurses' progress and development can be developed by paying more attention to moralities in recruitment, teaching ethical values to the leaders, and using a systematic and objective approach to assess morality in the environment.

Ethical tensions are part of the everyday practice of doing research—all kinds of research. How do researchers deal with ethical problems that arise in the practice of their research, and are there conceptual frameworks that they can draw on to assist them? This article examines the relationship between reflexivity and research ethics. It focuses on what constitutes ethical research practice in qualitative research and how researchers achieve ethical research practice. As a framework for thinking through these issues, the authors distinguish two different dimensions of ethics in research, which they term procedural ethics and “ethics in practice.” The relationship between them and the impact that each has on the actual doing of research are examined. The article then draws on the notion of reflexivity as a helpful way of understanding both the nature of ethics in qualitative research and how ethical practice in research can be achieved.

Foucault's work has given rise to increased methodological sensitivity of the political dangers associated with traditional qualitative approaches in the social sciences. There is a growing awareness that the widespread use of the research interview is not indicative of a deepening insight into the workings of culture, but is part of a broader social technology for its reproduction. In an effort to re-imagine interview methodology, scholars have read Foucault to suggest the need for greater attention to the active co-construction of research conclusions arising from interview based research. This has led in turn to the view that post modern approaches produce localized, temporally specific knowledge that fails to shed light on deeper, more enduring social structures. This paper questions these interpretations of Foucault's work, arguing that they fail to accurately represent his genealogical method or to consider its implications for research ethics. Foucault rejects a view of knowledge as emerging from the active social constructions of agents or of institutionalised ‘interests’. Rather, Foucault sees knowledge as an outcome, often accidental, of interrelated historical practices and discourses that produce the subjects and objects of social science discourse itself. The implications of Foucault's work for thinking about research ethics is not a return to authenticity or to analyses of social structure, but a rejection of the centralised, regulatory claims of an organised scientific discourse. The paper comprises a review of social science responses to post structural insights, coverage of the critical epistemological differences between Foucault's method and other key social theory paradigms, and a discussion of the critical ethical issues these differences raise for the social sciences.

Objective: Biomedical research and the health sciences are a key element to improve the quality and life expectancy of the citizens and to improve their well-being, which has substantially changed, both methodologically as well as conceptually in the last years. Methodology: The appearance of new analytic tools has led to great discoveries which allow us to foster reasonable hopes on the treatment and even the cure in a not very distant future of pathologies which are not capable of being dealt with at present. The incidence of serious misconduct in research, which will be referred, is the clear evidence of attention the widespread to the issue of ethics in research. In fact, ((protection of human subjects in biomedical research)) is prime mover in initiating and maintaining attention to the issue of ethics in research. Results: The purpose of this research is to try to examined the criminal aspects of this phase of the research (research on humans), Ie criminal liability arising from injury or damage to in the investigation of third parties, patients and participants will be entered explored, and on the one hand look at the criminalization and dos and don'ts that pursuant to the rules of international conventions in this field and in order to dealt with protect the rights of the subjects. Conclusion: The respective results of the experiments and research, can be very beneficial for mankind the growth and development of the science of genetics and biotechnological provide route to prevention and treatment of diseases.

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.

Conducting research during disease outbreaks can be ethically challenging as evidenced in the 2014-2016 Ebola outbreak in West Africa and COVID-19 pandemic. Yet, there has been little empirical research conducted for understanding the views and perspectives of different stakeholders regarding ethical issues in conducting research during disease outbreaks. This preliminary study was conducted to empirically explore African public health research stakeholders' views about research ethics issues during infectious disease outbreaks in Africa. We conducted an online survey of 330 participants attending the International Conference on Re-emerging and Emerging Infectious Disease (ICREID) meeting that took place from 13-15 March 2019 in Addis Ababa, Ethiopia to elicit their views on various research ethics complexities experienced in the 2014 Ebola outbreak. Study results revealed some divergent views on several ethical themes including: ethics of using unregistered interventions in outbreaks; acceptable study design; ethics review processes; risks-benefit assessment; exclusion of pregnant women and children; and biological sample and data sharing. Majority (76.3%) of respondents felt that in the absence of available standard treatments or prevention modalities, the use of investigational interventions can be ethically justifiable if there is a strong scientific rationale and favorable risk-benefit ratio. Regarding conventional placebo-controlled trials during outbreaks with high case fatality rates, respondents that considered this unethical were more than three times those that felt such design were ethically justifiable. We were somewhat surprised that a majority (almost 60%) of respondents were satisfied with the exclusion of pregnant women and children in clinical trials during outbreaks. All respondents concurred with the prioritization of informed consent for research during an outbreak. Based on our findings, research ethics guidance is needed to equip research stakeholders in dealing with ethical complexities arising in the conduct of research during emerging disease outbreaks-especially regarding using experimental interventions; placebo trial design; inclusion or justified exclusion of pregnant women and children; and biological sample/data sharing. The findings will be used in ongoing efforts of developing a consultative and coherent African-centric framework to support ethical conduct of research for future emerging infectious disease outbreaks in Africa.

BackgroundBrazil is among the sixteen countries that conducts the most clinical trials in the world. It has a system to review research ethics with human beings made up by the National Commission on Research Ethics (CONEP) and 779 Research Ethics Committees (RECs), in 2017. The RECs are supposed to follow the same rules regarding their membership, although the RECs that review Social Science and Humanities (SSH) researches must respect Resolution 510/16. There are Brazilian RECs that review SSH and clinical trials. This study aimed to analyze the academic professional profile of the members of the CONEP and Brazilian RECs, their adequacy to the norms, and the challenges faced by the REC’s Chairs to compose their membership.MethodsAll 779 Brazilian RECs’ chairs are invited to fill in a questionnaire informing academic and professional background of the RECs members, and 92 answered. However, eight were excluded for having sent an incomplete questionnaire, leaving a total of 84 participants. The variables were described by absolute and relative frequency. The Chi-square test and ANOVA was used to analyze regional differences related difficulties to compose the committee. The significance level was 95%.ResultsThe results showed a predominance of members from the biomedical area (57%), while 33% were members of the Social Sciences and Humanities and 5.5% were community representatives. As for the academic degree, there were (45.2%) PhD and (27.9%) masters. The divergences in relation to the guidelines result from the difficulties of having participants in some areas and the little interest in the work carried out by the committees.ConclusionThe RECs are partially adequate to the norms and their performance may be compromised by the low participation of community representatives. The organization of REC’s specifics to review biomedical research could improve the ethical review process, ensuring a membership more qualified for these protocols.

BackgroundGood governance and regulatory supervision are required to conduct research in an international public health emergency context and to ensure compliance with ethical standards. The “Strengthening research ethics governance and regulatory oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic” study is a regional effort in which research ethics stakeholders participated in addressing research ethics governance and preparedness response challenges to the COVID-19 pandemic in Central America and the Dominican Republic.MethodsA qualitative action research study was conducted following a participatory approach. Research ethics stakeholders in Central America and the Dominican Republic were mapped; a regional webinar and three virtual workshops were conducted discussing research ethics governance, ethics review and collaborative research practice during the pandemic. A roundtable session presented results and obtained feedback on a draft of a policy to strengthen regional research ethics governance.ResultsCountries across Central America and the Dominican Republic are at different stages in their development of research ethics systems. Countries with more established systems before COVID-19 were better organized and prepared to respond. This finding argues against improvisation and supports further work on strengthening governance of research ethics systems. Community engagement in research ethics public policy-making is practically absent in the region. Research and research ethics collaboration schemes are lacking amongst the countries; however, there are incipient initiatives in the region, such as the Central America and Caribbean Network of Research Ethics Committees. A policy brief with recommendations on how to advance towards strengthening the governance of research ethics systems was prepared and submitted to the Central American Integration System for analysis and possible approval.ConclusionNational research ethics systems in Central America and the Dominican Republic were unprepared to respond to the COVID-19 pandemic with respect to research oversight and effective collaboration. In most cases, national research ethics systems were found to be weak, and regional research collaboration was practically absent. To promote collaboration, a joint strategy needs to be developed with a regional vision towards sharing knowledge and best practices.

Cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines for several reasons. For one, the units of allocation, intervention, and observation often may differ within a single trial. In the absence of tailored and internationally accepted ethics guidelines for CRTs, researchers and research ethics committees have no common standard by which to judge ethically appropriate practices in CRTs. Moreover, lack of familiarity with and consideration of the unique features of the CRT design by research ethics committees may cause difficulties in the research ethics review process, and amplify problems such as variability in the requirements and decisions reached by different research ethics committees. We aimed to characterize research ethics review of CRTs, examine investigator experiences with the ethics review process, and assess the need for ethics guidelines for CRTs. An electronic search strategy implemented in MEDLINE was used to identify and randomly sample 300 CRTs published in English language journals from 2000 to 2008. A web-based survey with closed- and open-ended questions was administered to corresponding authors in a series of six contacts. The survey response rate was 64%. Among 182 of 285 eligible respondents, 91% indicated that they had sought research ethics approval for the identified CRT, although only 70% respondents reported research ethics approval in the published article. Nearly one-third (31%) indicated that they have had to meet with ethics committees to explain aspects of their trials, nearly half (46%) experienced variability in the ethics review process in multijurisdictional trials, and 38% experienced negative impacts of the ethics review process on their trials, including delays in trial initiation (28%), increased costs (10%), compromised ability to recruit participants (16%), and compromised methodological quality (9%). Most respondents (74%; 95% confidence interval (CI): 67%-80%) agreed or strongly agreed that there is a need to develop ethics guidelines for CRTs, and (70%; 95% CI: 63%-77%) that ethics committees could be better informed about distinct ethical issues surrounding CRTs. Thirty-six percent of authors did not respond to the survey. Due to the absence of comparable results from a representative sample of authors of individually randomized trials, it is unclear to what extent the reported challenges result from the CRT design. CRT investigators are experiencing challenges in the research ethics review of their trials, including excessive delays, variability in process and outcome, and imposed requirements that can have negative consequences for study conduct. Investigators identified a clear need for ethics guidelines for CRTs and education of research ethics committees about distinct ethical issues in CRTs.