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Integrity of randomized clinical trials: Performance of integrity tests and checklists requires assessment

Khan KS, Fawzy M, Chien PFW

Int J Gynaecol Obstet, 2023 Dec;163(3):733-743.
PMID: 37184087 DOI: 10.1002/ijgo.14837

The integrity of randomized clinical trials (RCT) has become a concern owing to a recent rise in the number of retractions and the repercussions this has for evidence-based patient care. However, there is little research on the subject of RCT integrity assessment. Recent literature reviews have revealed that journals' authors' instructions concerning integrity and their investigation policies concerning allegations of misconduct are heterogeneous. The judicious use of integrity tests applied to RCT manuscripts is hampered by an absence of data concerning misconduct prevalence (pre-test probability), a failure to evaluate test performance (validity) and a lack of consensus over a gold standard (against which test accuracy can be evaluated). These deficiencies hinder the post-publication correction of RCT records, the integrity evaluations in systematic reviews of RCTs and the prospective application of preventive solutions in RCT peer-review and preprint assessment. Dealing with the current controversy about trustworthiness of RCT evidence requires a strong investment in research, reform and education concerning research integrity. The purpose of this review article is to highlight the current limitations in dealing with trial integrity-related concerns and to propose solutions to some of these issues.

Matched MeSH terms: Scientific Misconduct*
Fulltext Retraction Note: Acute Toxicity and Gastroprotection Studies of a New Schiff Base Derived Manganese (II) Complex against HCl/Ethanol-Induced Gastric Ulcerations in Rats

Ibrahim MY, Hashim NM, Dhiyaaldeen SM, Al-Obaidi MMJ, El-Ferjani RM, Adam H, et al.

Sci Rep, 2020 04 17;10(1):6792.
PMID: 32303687 DOI: 10.1038/s41598-020-63217-y

This paper has been retracted.

Matched MeSH terms: Scientific Misconduct
Research misconduct

Khalid BA

Med J Malaysia, 2000 Aug;55 Suppl B:14-6.
PMID: 11125514
Matched MeSH terms: Scientific Misconduct*
The jurisprudential nature of fraud in biomedical publishing

Candlish J

Med Law, 2008 Jun;27(2):285-305.
PMID: 18693482

When instances of fraud in biomedical publishing come to light there is widespread indignation, not least because the consequences seem usually only to be internal enquiries and professional displeasure. A number of bodies have been constituted to improve publishing ethics and but these are largely advisory. Potentially though, actions in the tort of deceit and negligence, possibly misfeasance in a public office, and loss of chance could be brought against those responsible. These aspects are examined in the context of English law. In addition the new Fraud Act (2006) appears to be wide enough in scope to cover publishing fraud as a criminal offence. Any organisation such as a drug company financing clinical trials which produce spurious results could face serious losses and might well look to remedies in contract as well as in tort. A theoretical scenario centered on a drug trial is presented in order to explore these issues.

Matched MeSH terms: Scientific Misconduct/legislation & jurisprudence*
Fulltext Response: Scientific misconduct encountered by APAME journals: insight?

Looi LM, Wong LX, Koh CC

Malays J Pathol, 2016 Apr;38(1):73.
PMID: 27126670
Matched MeSH terms: Scientific Misconduct/statistics & numerical data*
Fulltext Scientific misconduct encountered by APAME journals: an online survey

Looi LM, Wong LX, Koh CC

Malays J Pathol, 2015 Dec;37(3):213-8.
PMID: 26712665 MyJurnal

In June 2015, invitations were sent by email to 151 APAME journals to participate in an online survey with an objective of gaining insight into the common publication misconduct encountered by APAME editors. The survey, conducted through SurveyMonkey over a 20-day-period, comprised 10 questions with expansions to allow anecdotes limited to 400 characters, estimated to take less than 10 minutes to complete. Only one invitation was issued per journal, targeting (in order of priority) editors, editorial board members and editorial staff, and limited by email availability. 54 (36%) journals responded. 98% of respondents held Editor or Editorial Board positions. All respondent journals have editorial policies on publication ethics and 96% provide instructions related to ethics. 45% use anti-plagiarism software to screen manuscripts, the most popular being iThenticate, CrossCheck and Turnitin. Up to 50% of journals had encountered studies without IRB approval. Author misconduct encountered were (in rank order): plagiarism (75%), duplicate publication (58%), unjustified authorship (39%), authorship disputes (33%), data falsification (29%), data/image manipulation (27%), conflict of interest (25%), copyright violation (17%) and breach of confidentiality (10%). Reviewer misconduct encountered were: conflict of interest (19%), plagiarism (17%), obstructive behavior (17%), abusive language (13%) and breach of confidentiality (13%). Notwithstanding the limitations of the survey and the response rate, a few insights have been gained: (1) the need for strengthening the ethical culture of researchers/authors and reviewers, (2) anti-plagiarism software can improve plagiarism detection by about 15%, and (3) the need for technical support to detect plagiarism, duplicate publication and image manipulation.

Matched MeSH terms: Scientific Misconduct/statistics & numerical data*
Whistle blowing and research integrity: Potential remedy for research misconduct in Malaysian institutions of higher education

Olesen AP, Amin L, Mahadi Z, Ibrahim M

Account Res, 2019 01;26(1):17-32.
PMID: 30489163 DOI: 10.1080/08989621.2018.1554444

This study found that less than half of the respondents are willing to blow the whistle. The results reveal that a lack of protection with regard to the whistleblower's identity, the tedious investigative process, and the notion of avoiding confrontation, which is more apparent in Asian cultures as compared to the West, are among the reasons why individuals who witnessed misconduct chose to remain silent. Adhering to the Asian cultural upbringing where the young must respect the old, those of lower rank must obey those with higher authority, and subordinates do not question the actions of their superior, has become a norm even in the working environment. Therefore, emphasize the need for better protection for whistleblowers including using experienced individuals with a research ethics background to handle allegations from whistleblowers. In addition, established guidelines and procedures for whistleblowers with regard to voicing their allegations against colleagues engaged in research misconduct is still lacking or, to a certain extent, is still unknown to researchers. Thus, the concern indicates a need for institutions to create awareness among researchers regarding the existing platform for whistleblowers, or to develop a systematic and clear procedure which is reliable and independent to promote professionalism in academia.

Matched MeSH terms: Scientific Misconduct/ethics*
Malaysian researchers talk about the influence of culture on research misconduct in higher learning institutions

Olesen AP, Amin L, Mahadi Z

Account Res, 2017;24(8):469-482.
PMID: 29087734 DOI: 10.1080/08989621.2017.1399358

Based on a previous survey by the Office of Research Integrity (ORI) in the USA, a considerable number of foreign research scientists have been found guilty of research misconduct. However, it remains unclear as to whether or not cultural factors really contribute to research misconduct. This study is based on a series of interviews with Malaysian researchers from the local universities regarding their own professional experiences involving working with researchers or research students from different countries or of different nationalities. Most of the researchers interviewed agreed that cultures do shape individual character, which influences the way that such individuals conduct research, their decision-making, and their style of academic writing. Our findings also showed that working culture within the institution also influences research practices, as well as faculty mentorship of the younger generation of researchers. Given the fact such misconduct might be due to a lack of understanding of research or working cultures or practices within the institution, the impact on the scientific community and on society could be destructive. Therefore, it is suggested that the institution has an important role to play in orienting foreign researchers through training, mentoring, and discussion with regard to the "does" and "don'ts" related to research, and to provide them with an awareness of the importance of ethics when it comes to conducting research.

Matched MeSH terms: Scientific Misconduct/ethics*
Researchers experience of misconduct in research in Malaysian higher education institutions

Olesen AP, Amin L, Mahadi Z

Account Res, 2018;25(3):125-141.
PMID: 29394103 DOI: 10.1080/08989621.2018.1429925

This article offers a qualitative analysis of research misconduct witnessed by researchers during their careers, either by research students or fellow researchers, when conducting or supervising research in their respective departments. Interviews were conducted with 21 participants from various research backgrounds and with a range of research experience, from selected universities in Malaysia. Our study found that misbehavior such as manipulating research data, misrepresentation of research outcomes, plagiarism, authorship disputes, breaching of research protocols, and unethical research management was witnessed by participants among junior and senior researchers, albeit for different reasons. This indicates that despite the steps taken by the institutions to monitor research misconduct, it still occurs in the research community in Malaysian institution of higher education. Therefore, it is important to admit that misconduct still occurs and to create awareness and knowledge of it, particularly among the younger generation of researchers. The study concludes that it is better for researchers to be aware of the behaviors that are considered misconduct as well as the factors that contribute to misconduct to solve this problem.

Matched MeSH terms: Scientific Misconduct/ethics*
Fulltext Recent research trends in dentistry

Tandon S, Venkiteswaran A, Baliga SM, Nayak UA

J Indian Soc Pedod Prev Dent, 2017 5 12;35(2):102-105.
PMID: 28492186 DOI: 10.4103/0970-4388.206038

Research being an investigative process is employed to increase or revise the current knowledge. Scientific research involves the conduct of a methodical study to prove a hypothesis or give an answer to a specific question with the main aim of finding definitive answer. This paper aims to advance knowledge of research and develop interest in the postgraduate students. It also throws light on the existing and emerging research strengths within a "high-performance culture." The trends in dental research worldwide are looked at, in particular, a comparison between the publication status in two countries, namely India and Australia. The current themes in dental research are also discussed to facilitate future projects for the aspiring pediatric dentists. Stress is given to the importance of evidence-based dentistry as the current times call for high-quality and ethical papers which are devoid of plagiarism. The common reasons for failure of a research are explored and the strengthening factors are highlighted. Proper planning of a pertinent research project is beneficial to the researcher as well as the dental community.

Matched MeSH terms: Scientific Misconduct
Research Ethics: Researchers Consider How Best to Prevent Misconduct in Research in Malaysian Higher Learning Institutions Through Ethics Education

Olesen AP, Amin L, Mahadi Z

Sci Eng Ethics, 2019 08;25(4):1111-1124.
PMID: 29717467 DOI: 10.1007/s11948-018-0054-0

The purpose of this study is to encourage and highlight discussion on how to improve the teaching of research ethics in institutions of higher education in Malaysia. Drawing on semi-structured interviews with 21 academics in a research-intensive university in Malaysia, interviewees agreed on the importance of emphasizing the subject of research ethics among students, as well as academics or researchers. This study reveals that participants felt that there is an urgent need to improve the current awareness and knowledge of issues related to misconduct in research among students and academics. The results of this study indicate a need for better teaching on the subject of research ethics in order to prevent misconduct in research. Finally, it concludes with suggestions that there should be a clear definition of research misconduct, to include consequences when engaging in misconduct; a separate research ethics syllabus for pure and social sciences should be conducted; research ethics should be implemented as a core subject, and there should be an early intervention and continuous learning of research ethics, with an emphasis on ethics training.

Matched MeSH terms: Scientific Misconduct/classification*; Scientific Misconduct/ethics*
Fulltext Academic dishonesty among academics in Malaysia: a comparison between healthcare and non-healthcare academics

Tiong JJL, Kho HL, Mai CW, Lau HL, Hasan SS

BMC Med Educ, 2018 Jul 17;18(1):168.
PMID: 30016945 DOI: 10.1186/s12909-018-1274-3

BACKGROUND: This study was carried out to gauge the prevalence of academic dishonesty among academics in Malaysian universities. A direct comparison was made between academics of healthcare and non-healthcare courses to note the difference in the level of academic integrity between the two groups. In addition, the predisposing factors and implications of academic dishonesty, as well as the different measures perceived to be effective at curbing this problem were also investigated.
METHODS: A cross-sectional study design with mixed qualitative and quantitative approaches was employed and data collection was carried out primarily using self-administered questionnaire.
RESULTS: Approximately half (52.5%, n = 74) of all respondents (n = 141) reported having personally encountered at least one case of academic dishonesty involving their peers. The results also revealed the significantly higher prevalence of various forms of academic misconduct among healthcare academics compared to their non-healthcare counterparts. Although respondents were generally conscious of the negative implications associated with academic dishonesty, more than half of all cases of misconduct were not reported due to the indifferent attitude among academics. Low levels of self-discipline and integrity were found to be the major factors leading to academic misdeeds and respondents opined that university managements should be more proactive in addressing this issue.
CONCLUSIONS: The outcome of this study should serve as a clarion call for all relevant stakeholders to start making immediate amends in order to improve the current state of affairs in academia.

Matched MeSH terms: Scientific Misconduct/statistics & numerical data*
In Their Own Words: Research Misconduct from the Perspective of Researchers in Malaysian Universities

Olesen AP, Amin L, Mahadi Z

Sci Eng Ethics, 2018 12;24(6):1755-1776.
PMID: 29249021 DOI: 10.1007/s11948-017-9997-9

Published data and studies on research misconduct, which focuses on researchers in Malaysia, is still lacking, therefore, we decided that this was an area for investigation. This study provides qualitative results for the examined issues through series of in-depth interviews with 21 researchers and lecturers in various universities in Malaysia. The aims of this study were to investigate the researchers' opinions and perceptions regarding what they considered to be research misconduct, their experience with such misconduct, and the factors that contribute to research misconduct. Our findings suggest that the most common research misconducts that are currently being witnessed in Malaysian universities are plagiarism and authorship disputes, however, researchers seldom report incidents of research misconduct because it takes too much time, effort and work to report them, and some are just afraid of repercussions when they do report it. This suggests possible loopholes in the monitoring system, which may allow some researchers to bypass it and engage in misconduct. This study also highlights the structural and individual factors as the most influential factors when it comes to research misconduct besides organizational, situational and cultural factors. Finally, this study highlights the concerns of all participants regarding the 'publish or perish' pressure that they believe would lead to a hostile working environment, thus enhancing research misconduct, as researchers tend to think about their own performance rather than that of whole team or faculty. Consequently this weakens the interpersonal relationships among researchers, which may compromise the teaching and supervision of junior researchers and research students.

Matched MeSH terms: Scientific Misconduct*
Promoting Ethics and Integrity in Management Academic Research: Retraction Initiative

Ayodele FO, Yao L, Haron H

Sci Eng Ethics, 2019 04;25(2):357-382.
PMID: 29441445 DOI: 10.1007/s11948-017-9941-z

In the management academic research, academic advancement, job security, and the securing of research funds at one's university are judged mainly by one's output of publications in high impact journals. With bogus resumes filled with published journal articles, universities and other allied institutions are keen to recruit or sustain the appointment of such academics. This often places undue pressure on aspiring academics and on those already recruited to engage in research misconduct which often leads to research integrity. This structured review focuses on the ethics and integrity of management research through an analysis of retracted articles published from 2005 to 2016. The study employs a structured literature review methodology whereby retracted articles published between 2005 and 2016 in the field of management science were found using Crossref and Google Scholar. The searched articles were then streamlined by selecting articles based on their relevance and content in accordance with the inclusion criteria. Based on the analysed retracted articles, the study shows evidence of ethical misconduct among researchers of management science. Such misconduct includes data falsification, the duplication of submitted articles, plagiarism, data irregularity and incomplete citation practices. Interestingly, the analysed results indicate that the field of knowledge management includes the highest number of retracted articles, with plagiarism constituting the most significant ethical issue. Furthermore, the findings of this study show that ethical misconduct is not restricted to a particular geographic location; it occurs in numerous countries. In turn, avenues of further study on research misconduct in management research are proposed.

Matched MeSH terms: Scientific Misconduct*
Fulltext Ethical issues in qualitative research among postgraduate students in Malaysia

Nurshaidah Mohamad Sari, Nur Sofurah Mohd Faiz

Malaysian Journal of Qualitative Research, 2019;5(2):31-40.
MyJurnal

The issue in research ethics has been a long-standing problem in the academic world. In qualitative research, most of the studies carried out involve human subjects and require awareness of ethical issues that may arise, such as misconduct in research, plagiarism and authorship disputes. However, the emphasis on this issue has been given little exposure mostly among postgraduate students in Malaysia. This paper will highlight the most common ethical issues that arise in qualitative research studies, why this has happened, and how to overcome these important issues across institutions. In order to discover these issues, the databases Scopus, Google Scholar and Google Search were queried in the searching. The databases were assessed through the criteria of research ethics, research misconduct, and ethical issue in qualitative research from the year 1995 to 2019. The results revealed that there are studies on ethics in qualitative research especially in health and business area but insufficiently addressed in education. Besides, there are also several types of ethical problems in qualitative researches being identified which are commonly engaged by students despite research classes or courses that have been provided. Finally, it is concluded that not only does the research ethics component needs to be clearly addressed in the teaching among postgraduate students when conducting qualitative research, but there is also an urgent need to improve the institution curriculum in the research subject.

Matched MeSH terms: Scientific Misconduct
Young scientists in Malaysia have made integrity training fun and relevant

Chau DM

Nature, 2020 11;587(7832):9.
PMID: 33144704 DOI: 10.1038/d41586-020-03082-x
Matched MeSH terms: Scientific Misconduct

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