Research integrity and peer review最新文献

{"title":"Extent, transparency and impact of industry funding for pelvic mesh research: a review of the literature","authors":"Angela Coderre-Ball, Susan P. Phillips","doi":"10.1186/s41073-024-00145-9","DOIUrl":"https://doi.org/10.1186/s41073-024-00145-9","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background</h3><p>Conflicts of interest inherent in industry funding can bias medical research methods, outcomes, reporting and clinical applications. This study explored the extent of funding provided to American physician researchers studying surgical mesh used to treat uterine prolapse or stress urinary incontinence, and whether that funding was declared by researchers or influenced the ethical integrity of resulting publications in peer reviewed journals.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>Publications identified via a Pubmed search (2014–2021) of the terms mesh and pelvic organ prolapse or stress urinary incontinence and with at least one US physician author were reviewed. Using the CMS Open Payments database industry funding received by those MDs in the year before, of and after publication was recorded, as were each study’s declarations of funding and 14 quality measures.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Fifty-three of the 56 studies reviewed had at least one American MD author who received industry funding in the year of, or one year before or after publication. For 47 articles this funding was not declared. Of 247 physician authors, 60% received &gt; $100 while 13% received $100,000-$1,000,000 of which approximately 60% was undeclared. While 57% of the studies reviewed explicitly concluded that mesh was safe, only 39% of outcomes supported this. Neither the quality indicator of follow-up duration nor overall statements as to mesh safety varied with declaration status.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>Journal editors’ guidelines re declaring conflicts of interest are not being followed. Financial involvement of industry in mesh research is extensive, often undeclared, and may shape the quality of, and conclusions drawn, resulting in overstated benefit and overuse of pelvic mesh in clinical practice.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140834920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A structured, journal-led peer-review mentoring program enhances peer review training.","authors":"Ariel Maia Lyons-Warren, Whitley W Aamodt, Kathleen M Pieper, Roy E Strowd","doi":"10.1186/s41073-024-00143-x","DOIUrl":"10.1186/s41073-024-00143-x","url":null,"abstract":"<p><strong>Background: </strong>Peer review is essential to the advancement of knowledge. However, training on how to conduct peer review is limited, unorganized, and not well studied. Thus, we sought to determine if a structured mentored peer-review program improved peer review training as measured by multiple quantitative and qualitative assessments.</p><p><strong>Methods: </strong>This pre-post intervention study enrolled 55 mentees across 5 cohorts from 2020 to 2023. Each cohort completed pre-program evaluations, participated in 2 mentored reviews, and completed post-program evaluations over 6 months. Mentors and mentees completed pre-program demographic and review experience questionnaires. Outcome measures included (1) total and sub-scores on the modified Review Quality Index (mRQI) applied to the same pre-selected research manuscript reviewed by mentees both pre and post intervention, (2) mentee self-perceived comfort with and understanding of the review process using a custom questionnaire, and (3) mentor satisfaction surveys. Pre- and post-program measures were compared using the Wilcoxon signed-rank test.</p><p><strong>Results: </strong>Post-program total modified RQI score (median (IQR) = 31 (26.3-35.8)) was higher than pre-program total score (26.6 (19.7-29.7)) for the 42 mentees who completed both pre- and post-program reviews. Mentees reported improved perception of review (median (IQR) pre = 4 (3-4), post = 5 (4-5)) and editorial processes (pre = 3 (2-4), post = 4 (4-5)) as well as self-perceived confidence in completing an independent review of both scientific (median (IQR) pre = 2 (2-3), post = 4 (4-4)) and non-scientific (pre = 3 (2-4), post = 4 (4-5)) manuscripts following program participation. p < 0.0001 for all scores noted. Mentors reported high scores for enjoyment (median (range) 5/5 (3-5)) and interest in repeat participation (5/5 (2-5)).</p><p><strong>Conclusions: </strong>A 6-month structured mentored-review program including 2 mentored reviews improves peer review training as measured by the modified RQI as well as participant self-perceived understanding of publication science with high mentor satisfaction.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"9 1","pages":"3"},"PeriodicalIF":7.2,"publicationDate":"2024-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10921741/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140061486","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A guide for social science journal editors on easing into open science.","authors":"Priya Silverstein, Colin Elman, Amanda Montoya, Barbara McGillivray, Charlotte R Pennington, Chase H Harrison, Crystal N Steltenpohl, Jan Philipp Röer, Katherine S Corker, Lisa M Charron, Mahmoud Elsherif, Mario Malicki, Rachel Hayes-Harb, Sandra Grinschgl, Tess Neal, Thomas Rhys Evans, Veli-Matti Karhulahti, William L D Krenzer, Anabel Belaus, David Moreau, Debora I Burin, Elizabeth Chin, Esther Plomp, Evan Mayo-Wilson, Jared Lyle, Jonathan M Adler, Julia G Bottesini, Katherine M Lawson, Kathleen Schmidt, Kyrani Reneau, Lars Vilhuber, Ludo Waltman, Morton Ann Gernsbacher, Paul E Plonski, Sakshi Ghai, Sean Grant, Thu-Mai Christian, William Ngiam, Moin Syed","doi":"10.1186/s41073-023-00141-5","DOIUrl":"10.1186/s41073-023-00141-5","url":null,"abstract":"<p><p>Journal editors have a large amount of power to advance open science in their respective fields by incentivising and mandating open policies and practices at their journals. The Data PASS Journal Editors Discussion Interface (JEDI, an online community for social science journal editors: www.dpjedi.org ) has collated several resources on embedding open science in journal editing ( www.dpjedi.org/resources ). However, it can be overwhelming as an editor new to open science practices to know where to start. For this reason, we created a guide for journal editors on how to get started with open science. The guide outlines steps that editors can take to implement open policies and practices within their journal, and goes through the what, why, how, and worries of each policy and practice. This manuscript introduces and summarizes the guide (full guide: https://doi.org/10.31219/osf.io/hstcx ).</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"9 1","pages":"2"},"PeriodicalIF":7.2,"publicationDate":"2024-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10870631/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139742810","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Librarians and information specialists as methodological peer-reviewers: a case-study of the International Journal of Health Governance.","authors":"Irina Ibragimova, Helen Fulbright","doi":"10.1186/s41073-023-00142-4","DOIUrl":"10.1186/s41073-023-00142-4","url":null,"abstract":"<p><strong>Background: </strong>Objectives of this study were to analyze the impact of including librarians and information specialist as methodological peer-reviewers. We sought to determine if and how librarians' comments differed from subject peer-reviewers'; whether there were differences in the implementation of their recommendations; how this impacted editorial decision-making; and the perceived utility of librarian peer-review by librarians and authors.</p><p><strong>Methods: </strong>We used a mixed method approach, conducting a qualitative analysis of reviewer reports, author replies and editors' decisions of submissions to the International Journal of Health Governance. Our content analysis categorized 16 thematic areas, so that methodological and subject peer-reviewers' comments, decisions and rejection rates could be compared. Categories were based on the standard areas covered in peer-review (e.g., title, originality, etc.) as well as additional in-depth categories relating to the methodology (e.g., search strategy, reporting guidelines, etc.). We developed and used criteria to judge reviewers' perspectives and code their comments. We conducted two online multiple-choice surveys which were qualitatively analyzed: one of methodological peer-reviewers' perceptions of peer-reviewing, the other of published authors' views on the suggested revisions.</p><p><strong>Results: </strong>Methodological peer-reviewers assessed 13 literature reviews submitted between September 2020 and March 2023. 55 reviewer reports were collected: 25 from methodological peer-reviewers, 30 from subject peer-reviewers (mean: 4.2 reviews per manuscript). Methodological peer-reviewers made more comments on methodologies, with authors more likely to implement their changes (52 of 65 changes, vs. 51 of 82 by subject peer-reviewers); they were also more likely to reject submissions (seven vs. four times, respectively). Where there were differences in recommendations to editors, journal editors were more likely to follow methodological peer-reviewers (nine vs. three times, respectively). The survey of published authors (87.5% response rate) revealed four of seven found comments on methodologies helpful. Librarians' survey responses (66.5% response rate) revealed those who conducted peer-reviews felt they improved quality of publications.</p><p><strong>Conclusions: </strong>Librarians can enhance evidence synthesis publications by ensuring methodologies have been conducted and reported appropriately. Their recommendations helped authors revise submissions and facilitated editorial decision-making. Further research could determine if sharing reviews with subject peer-reviewers and journal editors could benefit them in better understanding of evidence synthesis methodologies.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"9 1","pages":"1"},"PeriodicalIF":0.0,"publicationDate":"2024-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10797710/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139491777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The quizzical failure of a nudge on academic integrity education: a randomized controlled trial.","authors":"Aurélien Allard, Anna Catharina Vieira Armond, Mads Paludan Goddiksen, Mikkel Willum Johansen, Hillar Loor, Céline Schöpfer, Orsolya Varga, Christine Clavien","doi":"10.1186/s41073-023-00139-z","DOIUrl":"https://doi.org/10.1186/s41073-023-00139-z","url":null,"abstract":"<p><strong>Background: </strong>Studies on academic integrity reveal high rates of plagiarism and cheating among students. We have developed an online teaching tool, Integrity Games ( https://integgame.eu/ ), that uses serious games to teach academic integrity. In this paper, we test the impact of a soft intervention - a short quiz - that was added to the Integrity Games website to increase users' interest in learning about integrity. Based on general principles of behavioral science, our quiz highlighted the intricacy of integrity issues, generated social comparisons, and produced personalized advice. We expected that these interventions would create a need for knowledge and encourage participants to spend more time on the website.</p><p><strong>Methods: </strong>In a randomized controlled trial involving N = 405 students from Switzerland and France, half of the users had to take a short quiz before playing the serious games, while the other half could directly play the games. We measured how much time they spent playing the games, and, in a post-experimental survey, we measured their desire to learn about integrity issues and their understanding of integrity issues.</p><p><strong>Results: </strong>Contrary to our expectations, the quiz had a negative impact on time spent playing the serious games. Moreover, the quiz did not increase participants' desire to learn about integrity issues or their overall understanding of the topic.</p><p><strong>Conclusions: </strong>Our quiz did not have any measurable impact on curiosity or understanding of integrity issues, and may have had a negative impact on time spent on the Integrity games website. Our results highlight the difficulty of implementing behavioral insights in a real-world setting.</p><p><strong>Trial registration: </strong>The study was preregistered at https://osf.io/73xty .</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"8 1","pages":"15"},"PeriodicalIF":0.0,"publicationDate":"2023-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10688455/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138464957","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Peer reviewers' willingness to review, their recommendations and quality of reviews after the Finnish Medical Journal switched from single-blind to double-blind peer review.","authors":"Piitu Parmanne, Joonas Laajava, Noora Järvinen, Terttu Harju, Mauri Marttunen, Pertti Saloheimo","doi":"10.1186/s41073-023-00140-6","DOIUrl":"10.1186/s41073-023-00140-6","url":null,"abstract":"<p><strong>Background: </strong>There is a power imbalance between authors and reviewers in single-blind peer review. We explored how switching from single-blind to double-blind peer review affected 1) the willingness of experts to review, 2) their publication recommendations, and 3) the quality of review reports.</p><p><strong>Methods: </strong>The Finnish Medical Journal switched from single-blind to double-blind peer review in September 2017. The proportion of review invitations that resulted in a received review report was counted. The reviewers' recommendations of \"accept as is\", \"minor revision\", \"major revision\" or \"reject\" were explored. The content of the reviews was assessed by two experienced reviewers using the Review Quality Instrument modified to apply to both original research and review manuscripts. The study material comprised reviews submitted from September 2017 to February 2018. The controls were the reviews submitted between September 2015 and February 2016 and between September 2016 and February 2017. The reviewers' recommendations and the scorings of quality assessments were tested with the Chi square test, and the means of quality assessments with the independent-samples t test.</p><p><strong>Results: </strong>A total of 118 double-blind first-round reviews of 59 manuscripts were compared with 232 single-blind first-round reviews of 116 manuscripts. The proportion of successful review invitations when reviewing single-blinded was 67%, and when reviewing double-blinded, 66%. When reviewing double-blinded, the reviewers recommended accept as is or minor revision less often than during the control period (59% vs. 73%), and major revision or rejection more often (41% vs 27%, P = 0.010). For the quality assessment, 116 reviews from the double-blind period were compared with 104 reviews conducted between September 2016 and February 2017. On a 1-5 scale (1 poor, 5 excellent), double-blind reviews received higher overall proportion of ratings of 4 and 5 than single-blind reviews (56% vs. 49%, P < 0.001). Means for the overall quality of double-blind reviews were 3.38 (IQR, 3.33-3.44) vs. 3.22 (3.17-3.28; P < 0.001) for single-blind reviews.</p><p><strong>Conclusions: </strong>The quality of the reviews conducted double-blind was better than of those conducted single-blind. Switching to double-blind review did not alter the reviewers' willingness to review. The reviewers became slightly more critical.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"8 1","pages":"14"},"PeriodicalIF":0.0,"publicationDate":"2023-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10598992/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50159492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bridges of perspectives: representation of people with lived experience of spinal cord injury in editorial boards and peer review.","authors":"Anna Nuechterlein, Tanya Barretto, Alaa Yehia, Judy Illes","doi":"10.1186/s41073-023-00138-0","DOIUrl":"10.1186/s41073-023-00138-0","url":null,"abstract":"<p><strong>Background: </strong>Diversity among editorial boards and in the peer review process maximizes the likelihood that the dissemination of reported results is both relevant and respectful to readers and end users. Past studies have examined diversity among editorial board members and reviewers for factors such as gender, geographic location, and race, but limited research has explored the representation of people with disabilities. Here, we sought to understand the landscape of inclusivity of people with lived experience of spinal cord injury specifically in journals publishing papers (2012-2022) on their quality of life.</p><p><strong>Methods: </strong>An open and closed 12-question adaptive survey was disseminated to 31 journal editors over a one-month period beginning December 2022.</p><p><strong>Results: </strong>We received 10 fully completed and 5 partially completed survey responses (response rate 48%). Notwithstanding the small sample, over 50% (8/15) of respondents indicated that their journal review practices involve people with lived experience of spinal cord injury, signaling positive even if incomplete inclusivity practices. The most notable reported barriers to achieving this goal related to identifying and recruiting people with lived experience to serve in the review and editorial process.</p><p><strong>Conclusions: </strong>In this study we found positive but incomplete trends toward inclusivity in journal practices involving people with lived experience of spinal cord injury. We recommend, therefore, that explicit and genuine efforts are directed toward recruitment through community-based channels. To improve representation even further, we suggest that editors and reviewers be offered the opportunity to self-identify as living with a disability without discrimination or bias.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"8 1","pages":"12"},"PeriodicalIF":0.0,"publicationDate":"2023-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10512589/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41159668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Authorship and citation patterns of highly cited biomedical researchers: a cross-sectional study.","authors":"Thomas Perneger","doi":"10.1186/s41073-023-00137-1","DOIUrl":"10.1186/s41073-023-00137-1","url":null,"abstract":"<p><strong>Background: </strong>Scientific productivity is often evaluated by means of cumulative citation metrics. Different metrics produce different incentives. The H-index assigns full credit from a citation to each coauthor, and thus may encourage multiple collaborations in mid-list author roles. In contrast, the Hm-index assigns only a fraction 1/k of citation credit to each of k coauthors of an article, and thus may encourage research done by smaller teams, and in first or last author roles. Whether H and Hm indices are influenced by different authorship patterns has not been examined.</p><p><strong>Methods: </strong>Using a publicly available Scopus database, I examined associations between the numbers of research articles published as single, first, mid-list, or last author between 1990 and 2019, and the H-index and the Hm-index, among 18,231 leading researchers in the health sciences.</p><p><strong>Results: </strong>Adjusting for career duration and other article types, the H-index was negatively associated with the number of single author articles (partial Pearson r -0.06) and first author articles (-0.08), but positively associated with the number of mid-list (0.64) and last author articles (0.21). In contrast, all associations were positive for the Hm-index (0.04 for single author articles, 0.18 for first author articles, 0.24 for mid-list articles, and 0.46 for last author articles).</p><p><strong>Conclusion: </strong>The H-index and the Hm-index do not reflect the same authorship patterns: the full-credit H-index is predominantly associated with mid-list authorship, whereas the partial-credit Hm-index is driven by more balanced publication patterns, and is most strongly associated with last-author articles. Since performance metrics may act as incentives, the selection of a citation metric should receive careful consideration.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"8 1","pages":"13"},"PeriodicalIF":0.0,"publicationDate":"2023-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10478343/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10159698","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reporting quality of abstracts and inconsistencies with full text articles in pediatric orthopedic publications.","authors":"Sherif Ahmed Kamel, Tamer A El-Sobky","doi":"10.1186/s41073-023-00135-3","DOIUrl":"10.1186/s41073-023-00135-3","url":null,"abstract":"<p><strong>Background: </strong>Abstracts should provide a brief yet comprehensive reporting of all components of a manuscript. Inaccurate reporting may mislead readers and impact citation practices. It was our goal to investigate the reporting quality of abstracts of interventional observational studies in three major pediatric orthopedic journals and to analyze any reporting inconsistencies between those abstracts and their corresponding full-text articles.</p><p><strong>Methods: </strong>We selected a sample of 55 abstracts and their full-text articles published between 2018 and 2022. Included articles were primary therapeutic research investigating the results of treatments or interventions. Abstracts were scrutinized for reporting quality and inconsistencies with their full-text versions with a 22-itemized checklist. The reporting quality of titles was assessed by a 3-items categorical scale.</p><p><strong>Results: </strong>In 48 (87%) of articles there were abstract reporting inaccuracies related to patient demographics. The study's follow-up and complications were not reported in 21 (38%) of abstracts each. Most common inconsistencies between the abstracts and full-text articles were related to reporting of inclusion or exclusion criteria in 39 (71%) and study correlations in 27 (49%) of articles. Reporting quality of the titles was insufficient in 33 (60%) of articles.</p><p><strong>Conclusions: </strong>In our study we found low reporting quality of abstracts and noticeable inconsistencies with full-text articles, especially regarding inclusion or exclusion criteria and study correlations. While the current sample is likely not representative of overall pediatric orthopedic literature, we recommend that authors, reviewers, and editors ensure abstracts are reported accurately, ideally following the appropriate reporting guidelines, and that they double check that there are no inconsistencies between abstracts and full text articles. To capture essential study information, journals should also consider increasing abstract word limits.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"8 1","pages":"11"},"PeriodicalIF":0.0,"publicationDate":"2023-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10463470/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10121003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Raising concerns on questionable ethics approvals - a case study of 456 trials from the Institut Hospitalo-Universitaire Méditerranée Infection.","authors":"Fabrice Frank, Nans Florens, Gideon Meyerowitz-Katz, Jérôme Barriere, Éric Billy, Véronique Saada, Alexander Samuel, Jacques Robert, Lonni Besançon","doi":"10.1186/s41073-023-00134-4","DOIUrl":"10.1186/s41073-023-00134-4","url":null,"abstract":"<p><strong>Background: </strong>The practice of clinical research is strictly regulated by law. During submission and review processes, compliance of such research with the laws enforced in the country where it was conducted is not always correctly filled in by the authors or verified by the editors. Here, we report a case of a single institution for which one may find hundreds of publications with seemingly relevant ethical concerns, along with 10 months of follow-up through contacts with the editors of these articles. We thus argue for a stricter control of ethical authorization by scientific editors and we call on publishers to cooperate to this end.</p><p><strong>Methods: </strong>We present an investigation of the ethics and legal aspects of 456 studies published by the IHU-MI (Institut Hospitalo-Universitaire Méditerranée Infection) in Marseille, France.</p><p><strong>Results: </strong>We identified a wide range of issues with the stated research authorization and ethics of the published studies with respect to the Institutional Review Board and the approval presented. Among the studies investigated, 248 were conducted with the same ethics approval number, even though the subjects, samples, and countries of investigation were different. Thirty-nine (39) did not even contain a reference to the ethics approval number while they present research on human beings. We thus contacted the journals that published these articles and provide their responses to our concerns. It should be noted that, since our investigation and reporting to journals, PLOS has issued expressions of concerns for several publications we analyze here.</p><p><strong>Conclusion: </strong>This case presents an investigation of the veracity of ethical approval, and more than 10 months of follow-up by independent researchers. We call for stricter control and cooperation in handling of these cases, including editorial requirement to upload ethical approval documents, guidelines from COPE to address such ethical concerns, and transparent editorial policies and timelines to answer such concerns. All supplementary materials are available.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"8 1","pages":"9"},"PeriodicalIF":7.2,"publicationDate":"2023-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10398994/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9938883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}