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An Update to the Human Subjects Research Policy on PLOS ONE

PLOS ONE has always had high ethics standards for the research that we publish. Our publication criteria require that “research meets all applicable standards for the ethics of experimentation and research integrity”, which are described in more detail in our publication policies. Moreover, compliance with PLOS policies is checked at multiple points by journal staff. This important work helps ensure that articles published by PLOS ONE meet all applicable national and international regulations, and adhere to high standards for research and publication ethics.

The competitive nature of academic publishing, tenure, and hiring decisions can incentivize researchers to take shortcuts, compromising on ethics to boost or accelerate their publication records. In some cases, this might mean conducting research before all requisite approvals have been obtained. In others, it might mean purchasing authorship or article content, or compromising the integrity of the peer review process. These unethical practices can pollute the literature with problematic articles that are harmful to the broader community, including people endeavoring to replicate fraudulent research and those directly impacted by the published findings.

PLOS and other publishers have recently seen a rise in large-scale cases involving manipulation of the publication process, and we are working to increase the stringency of our processes to keep problematic articles out of the literature. As part of this work, we are introducing a change to the PLOS ONE Human Subjects Research Policy to require that authors of manuscripts reporting research involving human participants provide original ethics approval documentation at the time of submission. This also applies to studies that use human participants’ data or primary tissue samples, except for studies that are exempt from ethics approval requirements per institutional and/or national requirements.

Up to this point, PLOS ONE policy has required that submissions of studies involving human participants include an Ethics Statement reporting information about the study’s ethics approval and informed consent procedures. On occasion, journal staff have requested ethics approval documents for studies where there were concerns about adherence to the policy.

Several observations support further strengthening our Human Subjects Research Policy. Recently, the PLOS Publication Ethics team has handled higher volumes of cases where ethics documents received during their investigations raised concerns about whether ethics standards were upheld during the research process, whether measures were in place to protect participants in the research, or whether the reported findings were reliable. 

In light of these concerns, PLOS ONE ran a trial in 2022 wherein cohorts of authors were asked to supply ethics approval documents before peer review. Compliance was high, but what journal staff found was deeply troubling: in one cohort, nearly two-thirds of submissions did not meet PLOS ONE’s human subjects research requirements and were therefore rejected. Importantly, journal staff would not have detected the issues had they not requested the ethics documentation.

Given these observations, we are updating the Human Subjects Research Policy for PLOS ONE, PLOS Climate, PLOS Global Public Health and PLOS Water (effective 1 March 2023) and we are considering similar updates for other PLOS journals. Under the new policy, original ethics approval documentation will be required at the time of submission. These documents will be evaluated by journal staff before peer review, but will not be published. If there are any concerns about the ethics approval documents, if they are not provided, or if they indicate the study did not comply with our policies, the manuscript will be rejected without external review. Per our longstanding policy, we will continue to request ethics documents for manuscripts submitted before this date if deemed necessary by journal staff or editorial board members.

We recognize that this policy alone will not identify all potentially fraudulent or unethical research. Nevertheless, it is an important advance in our efforts to safeguard the integrity of human subjects research publications, uphold our ethics policies, and ensure that the community can continue to trust, reuse, and build upon the work that we publish.

Renee Hoch, Managing Editor, PLOS Publication Ethics Team

Emily Chenette, Editor in Chief, PLOS ONE

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