Reconsidering Local Ethical Committees: An Open Discussion on the Need for Third-Party Approval in Human Research

Dear Editor, We would like to raise an interesting issue that has been little mentioned. For human research, it generally requires good practices according to the research code of conduct. In reviewing the submitted manuscript by the standard journal, a general requirement is the ethical approval evidence, which is usually issued by the local ethical committee of the submitting author. However, this is an issue that should be discussed. Some kinds of human research, such as the use of new surgical techniques without prior study for efficacy and safety in animal models, study on using new chemicals or drugs as well as stem cells to treat the disease without scientifically supported evidence, or the use of heterologous vaccine administration that is out of the instructions given by the drug company. These kinds of human research might be a dilemma, and they might violate the basic rule of “first do no harm.” In fact, it should indicate that we should do nothing that might lead to a possible risk to the subjects participating in the research. It is also necessary to approve that there is clear information given to the participant in the research without any disguising.[1] Then, the concern is the local ethical committee’s approval. Bribery of local committees in the medical purchasing and product approval processes without solid supporting backup data is not unusual in the biomedical industry, an area with a high rate of corruption. This is a significant management concern.[2] One potential way to preserve the openness and responsibility of the local ethical committee’s approval of the author’s institute would be to urge the newly appointed third-party ethical committee to reevaluate the study protocols. We raise an open question for further discussion: “Is a third-party ethics committee for evaluation and approval necessary?” There might be challenges emerging when putting in place a third-party ethics committee to review and approve human research methods in various nations and research backgrounds. The authors believe that it is worthwhile to consider the establishment of an impartial ethical commission for assessment and approval. Nevertheless, it is imperative to discuss and look into the scope of this suggestion in further details. An open discourse on this specific matter to determine whether this idea is important not only for developing countries but also in elsewhere human research might give rise to possible moral dilemmas. It is critical to recognize that questionable standards and possible corruption can lead to questionable ethical practices and possible bias among local ethics approval bodies. This raises questions regarding the trustworthiness and validity and reliability of ethical approval gained through the local bodies. While this idea addresses specific concerns in some settings with corruption issues, in fact, it also encourages a broader reflection on ethical review methods globally. Whether the present methods are sufficient to guarantee ethical approval is rigorous and free of bias is an interesting query. It might be a new topic for discussion whether third-party ethics committees should be considered more extensively, even in settings with well-established research systems. These topics demand additional thought and strategic plan to improve the standards of ethics and integrity of research. Lastly, we would want to reiterate this fascinating topic about ethical oversight in health-related research involving human subjects that has not received much attention. An international organization created a benchmarking ethics oversight tool with the following goals: to evaluate the effectiveness of ethical oversight; to pinpoint organizational structure and legal deficiencies; to offer suggestions for enhancements; to encourage best practices; and to guarantee the safety and preservation of human rights in research.[3] The significance of maintaining ethical standards and averting potential hazards in research procedures is underscored by the potential critical role that national regulatory authorities could play in guaranteeing ethical oversight and protecting human subjects in research. Author contribution HP involved in 50% of ideas, writing, analyzing, and approval of the manuscript. VW involved in 50% of ideas, supervision, and approval of the manuscript. Data availability statement There is no new data generated. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.