Protection of subject (human)


Publishing complications and patient safety


Journal A is dedicated to communication about practical treatments related directly to patient and personal experiences. These ongoing discussions have been part of this specific medical profession for the past 50 years and journal A is a platform for these discussions.


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.


Data anonymity


A paper was submitted to our journal. The managing editor was concerned about patient information in the paper and queried the authors. The authors responded that the data were collected from routine samples and so consent was never obtained. The patients were lost to follow-up, and there was no ethics committee approval as it involved the study of existing data, but they did discuss with the institutional review board who said it was exempt.


The ethics of self-experimentation


The author was the subject of his study. He depleted himself of a vital nutrient until he had overt clinical and biochemical signs of the deficiency. He monitored various biochemical parameters as he became more deficient and submitted two manuscripts presenting his results: one detailing the biochemical changes and one detailing the differences in results obtained from different commercially available assays for the nutrient.


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.


Inadequate assurance of human research ethics for a questionnaire


A questionnaire was distributed to knowledge workers in an organisation to investigate the following hypotheses:

— H1.There is a positive and significant relationship between ethics and organizational performance.
— H2. There is a positive and significant relationship between ethics and intellectual capital.
— H3. There is a positive and significant relationship between intellectual capital and organizational performance.


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.


No ethics committee approval of a study


Our journal received a manuscript describing a comparison of two different techniques for patients in the intensive care unit. There was no information on ethics committee approval and so we asked the authors if approval was obtained. They replied that they had not applied for ethics committee approval “as it was a clinical comparison of two existing methods, none of them experimental.