Ethical approval and informed consent reporting in ASEAN journals: a systematic review

Laothavorn, Junjira; Wongwai, Pantipa; Dumre, Shyam Prakash; Kongjam, Panida; Na‐Bangchang, Kesara; Karbwang, Juntra

doi:10.1080/03007995.2019.1647505

Cited by 6 publications

(12 citation statements)

References 20 publications

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“…Research integrity of RCTs requires attention to high ethical standards and professionalism with respect to methodology concerning design and statistics at the one end and obsession with adherence to protocol in conducting and reporting at the other end of the spectrum. Taking the adequacy of consent in RCT as an example captured through the included reviews, 48,65 we highlight the unethical Tuskegee experiments 88 about which Tobin wrote: “ Despite 15 journal articles detailing the results, no physician published a letter criticizing the Tuskegee study. Informed consent was never sought; instead, Public Health Service researchers deceived the men into believing they were receiving expert medical care .” These articles remain not retracted from the literature formally to this date.…”

Section: Discussionmentioning

confidence: 99%

“…48 The publication time range of the included studies was 1964 to 2021. Most of the reviews did not limit the included RCTs to a specific geographical area (49/55, 89%); some focused regionally on low-middle-income countries 25 and South East Asia, 48 and nationally on India, 62 China, 73 Brazil, 5 and the United States. 35 There was no patient involvement in the design, conduct, or interpretation of any of the included systematic reviews.…”

Section: Characteristics and Quality Of The Included Reviewsmentioning

confidence: 99%

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Research integrity in randomized clinical trials: A scoping umbrella review

Núñez-Núñez

Maes‐Carballo

Mignini

et al. 2023

Intl J Gynecology & Obste

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BackgroundRandomized clinical trials (RCTs) are experiencing a crisis of confidence in their trustworthiness. Although a comprehensive literature search yielded several reviews on RCT integrity, an overarching overview is lacking.ObjectivesThe authors undertook a scoping umbrella review of the research integrity literature concerning RCTs.Search strategy and selection criteriaFollowing prospective registration (https://osf.io/3ursn), two reviewers independently searched PubMed, Scopus, The Cochrane Library, and Google Scholar, without language or time restrictions, until November 2021. The authors included systematic reviews covering any aspect of research integrity throughout the RCT lifecycle.Data collection and analysisThe authors assessed methodological quality using a modified AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews) tool and collated the main findings.Main resultsA total of 55 relevant reviews, summarizing 6001 studies (median per review, 63; range, 8–1106) from 1964 to 2021, had an overall critically low quality of 96% (53 reviews). Topics covered included general aspects (15%), design and approval (22%), conduct and monitoring (11%), reporting (38%), postpublication concerns (2%), and future research (13%). The most common integrity issues covered were ethics (18%) and transparency (18%).ConclusionsLow‐quality reviews identified various integrity issues across the RCT lifecycle, emphasizing the importance of high ethical standards and professionalism while highlighting gaps in the integrity landscape. Multistakeholder consensus is needed to develop specific RCT integrity standards.

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Section: Discussionmentioning

confidence: 99%

Section: Characteristics and Quality Of The Included Reviewsmentioning

confidence: 99%

Research integrity in randomized clinical trials: A scoping umbrella review

Núñez-Núñez

Maes‐Carballo

Mignini

et al. 2023

Intl J Gynecology & Obste

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“…This situation requires urgent rectification. Laothavorn et al (2019) found that journals from Asian countries often reported ethical approval adequately, but many failed to report informed consent. Not surprisingly, they also found a significant relationship between ethical approval/ informed consent statement scores and journals' instructions:…”

Section: Discussionmentioning

confidence: 99%

“…The extracted ethical approval and informed consent statements were coded using a variant of a scoring scheme developed by Laothavorn et al . (2019). We expanded on their approach in that we split their highest score into two levels (scores 2 and 3, as described below) in order to differentiate between publications that reported some relevant details and publications that gave all relevant information.…”

Section: Methodsmentioning

confidence: 99%

How do journals publishing palliative and end‐of‐life care research report ethical approval and informed consent?

Godskesen,

Vie,

Bülow

et al. 2023

Learned Publishing

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This study explores how papers published in international journals in palliative and end‐of‐life care report ethical approval and informed consent. A literature search following PRISMA guidelines was conducted in PubMed, the Web of Science Core Collection, Scopus, the ProQuest Social Science Premium Collection, PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). A total of 169 empirical studies from 101 journals were deductively coded and analysed. The results showed that 5% of publications provided no information on ethical approval, 12% reported minimal information, 56% reported rudimentary information, and 27% reported comprehensive details. We also found that 13% did not report any information on informed consent, 17% reported minimal information, 50% reported rudimentary information, and 19% reported comprehensive details. The prevalence of missing and incomplete ethical statements and inadequate reporting of informed consent processes in recent publications raises concerns and highlights the need for improvement. We suggest that journals advocate high reporting standards and potentially reject papers that do not meet ethical requirements, as this is the quickest path to improvement.

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“…This inconsistency highlights the need for stricter enforcement of reporting requirements. Although poor reporting of ethics approval reflects a wider systemic issue, 27,28,29 the potential for ethical violations in research with conflict-affected populations requires greater ethical oversight of research practices. 13 Journals have a responsibility to ensure that all published articles contain details on ethical procedures, including, at a minimum, informed consent and institutional ethics approval.…”

Section: Reviewmentioning

confidence: 99%

Why We Need Stricter Oversight of Research Involving Human Subjects Affected by Conflict

Ataullahjan

Aziz

et al. 2022

AMA Journal of Ethics

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Background: Despite the potential for ethical violations when research is conducted with conflict-affected populations, there is limited information on how and the extent to which ethical considerations specific to doing research with these populations are integrated into national and international ethics guidelines and, in turn, how these guidelines translate into practice. This study aims to fill this gap by systematically analyzing the existing research ethics guidance of humanitarian donor countries, conflict-affected countries, United Nations (UN) agencies, and funding agencies, as well as ethics reporting in research articles on conflict-affected populations published in peer-reviewed journals.Methods: A review of 32 research ethics guidelines and granting regulations from UN agencies, donor agencies, and governments was conducted, and the reporting of ethics procedures and practices of 498 articles published in peer-reviewed journals was analyzed.Results: Of the reviewed guidelines and regulations, 87.5% did not mention conflict-affected populations, and only one guideline (3.1%) catalogued any of the complexities of conducting research with conflictaffected populations. Among the reviewed published research articles on conflict-affected populations, obtaining ethics approval or a waiver was reported in only 48.2% of articles, and obtaining informed consent was reported in only 46.6% of studies. In the subset of articles that did not report receiving ethics approval, 88.5% were published in journals that required reporting of ethics approval.Conclusions: This study highlighted a gap in current research guidelines and granting regulations on the ethical conduct of research with conflictaffected populations and illustrated the need for such guidance to be integrated into governing documents and research practices. Moreover, this study demonstrated that there is a need for stricter enforcement of

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Ethical approval and informed consent reporting in ASEAN journals: a systematic review

Cited by 6 publications

References 20 publications

Research integrity in randomized clinical trials: A scoping umbrella review

Research integrity in randomized clinical trials: A scoping umbrella review

How do journals publishing palliative and end‐of‐life care research report ethical approval and informed consent?

Why We Need Stricter Oversight of Research Involving Human Subjects Affected by Conflict

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