Questionable/unethical treatments


Reproducibility of methodology


A whistle blower contacted journal A regarding two published articles. The articles focus on the effect of energy healing on an in-vitro model of disease. The whistle blower raised concerns about the appropriateness and reproducibility of the energy healing methodology used.


Ethics of non-active management of a control group


An article was submitted involving over 200 pregnant patients with a systemic illness (from 2010 to 2015) who were recruited and assigned to a control group or an active intervention group (of their systemic illness). The control group received routine antenatal care while the intervention group had active surveillance and management of their systemic illness during the pregnancy.


Ethical concerns about a study involving human subjects


A manuscript was submitted to our journal describing a study of a new drug. The manuscript had only one author who gave their affiliation as a company that we can find no record of online. It describes a study in which they appear to have developed a new drug, carried out a toxicology study in mice and then, because no adverse effects were seen, tested it on one patient and five healthy volunteers. There appear to have be no stages in between.


Possible violation of the Helsinki Declaration on Scientific Research with Humans


A manuscript underwent peer review and the resulting reviewer comments raised grave concerns about the ethical legitimacy of the study.
The reviewer:


Was this study unethical?


We reviewed and published a randomised controlled trial in which children’s exposure to parental secondhand smoke (SHS) was either sustained (usual practice control) or parents were asked to avoid smoking around their children (intervention group). The study included more than 400 children averaging 9 years old. Parents provided written informed consent. The study was approved by the ethics committee of the researchers’ institution.


Ethics and consent in research


A letter was sent to the chief editor of our journal in response to a recently published article in our journal. The author had serious concerns about the ethics and consent obtained as a result of this study and the follow-up by the researchers.


Should we always follow the decisions of ethics committees?


A paper was submitted to our journal describing a study in which children received general anaesthesia for a minor operation. The authors chose to induce anaesthesia with a mask and 8% sevoflurane inhalation for 8 minutes. The aim was to study the EEG over various brain areas to see where the epileptogenic activity is located. The reason for doing the study was that it has been shown that sevoflurane can cause epileptogenic activity on the EEG.


Retraction of article from 1994


Professor A and professor B has been in a dispute over a certain type of treatment for over 15 years. Professor A has accused professor B of killing a patient while he was (in professor A’s view) doing research on the patient without consent.


Legal advice


We have just had a paper submitted as an ethical debate in which the author details ethical concerns about a study previously published in another journal. The study involved complementary/alternative therapy for an infectious disease in children. The author alleges that the study gave insufficient protection to vulnerable subjects, who were exposed to unwarranted risks and discomfort; and that the study had violated the accepted tenets of human studies ethics and national regulations.


Consent and ethics approval questioned after acceptance


In a paper detailing a physiological study of healthy human volunteers the authors stated that ethics committee approval had been granted and that the participants had given informed consent. After peer review the paper was revised and accepted.