Why do journals publish research protocols?

A protocol is defined as “the detailed plan of the study.” Every research study should have a protocol, and the protocol should be written explicitly [1]. The increasing emphasis on transparency in research has been accompanied by a growing recognition of the importance of research protocols. Furthermore, it is well known that various biases, including publication bias and selective outcome reporting bias, can be reduced through protocol registration. In recent years, there has been a shift from registering research protocols to publishing them. This article describes the reasons for publishing research protocols and the foreseeable impacts of this trend.

According to the Declaration of Helsinki, “Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject” [2]. The most important reason for pre-registration of study protocols is that human subjects research carries risks to patients. However, a significant number of human studies have not been published. For instance, it was reported that 31% of studies conducted for Food and Drug Administration approval were unpublished, and the results of unpublished studies were mostly negative [3]. Selective outcome reporting is another problem with the non-publication of research. According to the same study, 62% (51/82) of 102 protocols for clinical trials approved for antidepressants showed that the actually reported outcome variables were different from those of the original protocols [4]. Furthermore, the International Committee of Medical Journal Editors mandated the registration of all clinical trial protocols [5].

For some time, protocols were subject to registration, not publication. However, this trend has recently been changing. A search for “protocol [ti]” in PubMed (https://pubmed.ncbi.nlm.nih.gov/) shows a sharp increase from 469 results in 2000 to 9,815 in 2021. The purpose of protocol publication may differ slightly according to the researcher’s point of view, the point of view of academia, and the point of view of society as a whole (Table 1).

Several issues are related to protocol publication. The first is the emergence of protocol-only journals. Several international journals are launching journals that only publish protocols, like spin-offs. For example, Nature publishes a journal called Nature Protocols, and JMIR Research publishes a protocol-only journal called JMIR Research Protocols.

The second issue is whether protocol registration or publication will predominate. Although this is not easy to predict, from the author’s point of view, there is a possibility that there will be a push toward publication, since authors receive credit for publications. Furthermore, since protocol publication is easy to manage and promote in the academic world, publication may be advantageous.

The third issue is the possibility of publishing protocols in domestic journals in various countries. At the moment, no Korean academic journals publish protocols. However, publication of a protocol guarantees at least one citation, so it can be a breakthrough strategy for journals that want to increase their citations or suffer from a shortage of manuscripts.

Registration of research protocols has been essential for clinical studies to reduce or minimize the risk of publication bias and selective outcome reporting bias. The advantages of protocol registration include preventing duplicate research, enabling more explicit research conduct and analysis, informing ongoing clinical trials, and protecting authors’ rights in a clinical study. There has also been a recent trend for protocol publication, and journals that only publish protocols have appeared. It is time for local clinical journal editors to consider whether they should publish research protocols more actively. Academic society publishers in the medical field should also consider publishing protocol-only journals.