Is it time for the human research protocol to be reviewed by the outside ethics committee?
Year: 2024
Type: article
Abstract: Dear Editor, There are many published articles in several journals that might be ethical dilemmas, and it is usually indicated in the published manuscript that the research protocol has been approved by a local ethical committee. A simple question is whether the approval from the local ethical committee is sufficient and acceptable. In real life, in some countries where corruption is common, the approval of any local committee might be questionable for the standards. As noted by Lunam, the possibility of corruption in ethics and international multi-center research are important issues that should be focused on but are rarely mentioned [1]. In several forms, engaging in politics and pushing for specific factions in research projects might be possible. The bias for intrainstitute researchers might be expected, and there might be a hidden agenda (such as bribery practices to get money for ethical committee approval). So, to maintain scientific accountability, we hereby raise a new possible means that might apply to any submitted article with a possible ethical problem. Ethical standards for human subject research in developing countries might be questionable [2]. For instance, many retracted articles have a clear notification of ethical approval in the retracted version of the article (for example, PMID: 26950950, PMID: 36882738, and PMID: 36459002). The case of PMID: 36459002 might be a good case study. In the retraction note, it is clearly stated that ‘the article’s author stated that without the Ministry’s approval, vitamin D was used in the study as a supplement rather than a medication. Even though vitamin D is frequently taken as a supplement when pregnant, the Local Ethics Committee recognized it as a medication and requested that the Ministry of Health authorize it.‘ In a suspicious case, even in well-established research systems, an additional third-party ethical committee might be asked to re-review the study protocols. This can supplement existing committees in situations where questions arise regarding the accountability and openness of the local ethical committee’s approval. This approach can further guarantee the moral principles of research involving human subjects and uphold scientific accountability. This will be useful for either pre-publication or post-publication management of suspicious studies. Acknowledgements Authors’ contribution RM 50% ideas, writing, analyzing, approval VW 50% ideas, supervision, approval. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
Source: Al-Azhar Assiut Medical Journal
Institution: Saveetha University
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $250
OpenAlex ID: W4407994295