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Organ transplantations and ethical publishing

 

Research involving human participants needs to follow the highest standards. The respect for human life requires that this research is conducted not only rigorously and with utmost care, but that it also follows the strongest ethics standards.

 

At PLOS ONE we have seen with concern reports that suggest that prior to 2010 and to some degree afterwards organ transplants from mainland China have relied on organs procured from prisoners.

 

International ethics guidelines from the World Health Organization, the World Medical Association and the Transplantation Society are clear. Those donating organs need to do so at their free will. If any vulnerable population is involved special considerations must be given during the informed consent process to ensure the donors are not improperly influenced or coerced. As some of these guidelines state, prisoners are not in a position to truly provide free consent, even if a signed agreement has been obtained in accordance with local laws and regulations.

 

In accordance with these international ethics standards, we initiated a review of around 20 published articles from our journal where concerns were identified about the source of the organs for transplantation studies. We are looking into the specific circumstances and relevant documents such as study protocols and background of the organ donors on a case-by-case basis. Where we do not receive satisfactory assurance and documentary evidence that the transplant procedures met international standards for ethics and reporting, we will retract the articles. We are in the process of completing our follow-up, and the first decisions on these cases should be published soon.

 

In discussion with our Human Research Advisory Group we had already taken prior steps to strengthen our requirements for submissions of organ and tissue transplantation studies to PLOS ONE, in addition to our general requirements on human subjects research. We will build on that and going forward we will further ensure that any studies involving organ transplantations report sufficient details regarding the donors and their consent in the manuscript. This will be a requirement for studies from any country, as the current cases have demonstrated a deficit of reporting standards in some instances. We will reject submissions where authors are unable to provide sufficient information on, for example, the source of the organs, or the steps taken to ensure that informed and voluntary consent was obtained from the donors.

 

We are grateful to all those who have identified the concerns around organ procurement from prisoners and brought these to our attention, and we are grateful to those who are addressing this concern locally and are working towards upholding ethics standards in clinical practice and in clinical research. We applaud these activities and are fully committed to supporting and upholding the highest ethics standards in human subjects research as well as in academic publishing.

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