Enhancing ethical standards in clinical pharmacology research: The need for additional review procedures

Editor, We want to bring your attention to a serious ethical problem that needs more debate in the context of clinical pharmacology research. Although published studies frequently stress the need for regional ethical organizations to approve study protocols, it is important to consider if local support is adequate on its own, especially in countries where corruption is rife. Although rarely discussed, Luna has successfully drawn attention to the problem of corruption in relation to ethics and global multicenter research.1 The scientific community has long harbored ethical concerns about biomedical research.1 It is necessary to address any biases and hidden intentions within organizations, such as the ethics committee approving a project in exchange for bribery. We thus propose a novel approach that can be applied to every submitted manuscript that may raise ethical concerns in order to assuage concerns and sustain ethical standards. We look into the ethical obligations associated with using human subjects in research, particularly in low-resource settings where subject reliability may be questioned. In this sense, retracted articles are useful case studies. Remarkably, in numerous retracted versions, prior ethical permission is frequently indicated directly. It may be prudent to have a second, independent ethics committee assess the study protocols in circumstances where there are reasons for concern. This additional examination could be implemented in conjunction with current committees, particularly in cases where questions arise regarding the accountability and openness of decisions made by the local ethics committee. This approach would increase scientific responsibility and give research involving human participants a stronger moral foundation. In the biomedical industry, which is infamous for corruption, bribery is frequently found in local committees that oversee medical purchasing and product approval.2 As mentioned by Luna, there should be more discussion and attention given to corruption in international multi-center research and ethics.1 Vested interests in research initiatives and political alliances can take many different shapes. It is reasonable to anticipate a bias in favor of intra-institute researchers, and there may be covert objectives at work, such as funding-seeking tactics meant to secure ethics committee approval. Therefore, we suggest a novel strategy that is applicable to any submitted work raising ethical questions in order to guarantee scientific responsibility. In poorer nations, the ethical guidelines governing research involving human subjects are frequently questioned.3 It is an interesting topic to address how to support the upholding of research ethics in all nations. Notably, many retracted articles clearly indicate the ethical approval in the retraction note. A strong case study is provided by PMID: 36459002, which makes it abundantly evident that “the author of the paper indicated that Vitamin D was utilized in the study as a supplement rather than a drug without the Ministry’s consent. The Ministry of Health was asked to approve Vitamin D authorization by the local ethics committee, even though it is commonly taken as a supplement during pregnancy.” We support the implementation of this extra review process to handle potentially dubious research, both before and following publication. By putting such safeguards in place, we can respect the highest ethical standards and guarantee the integrity of clinical pharmacology research involving human subjects. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.