Protection of subject (human)


Effect of the British Human Tissue Acts on biological monitoring


Biological monitoring is a common procedure in assessing the dose of contaminants from a workplace atmosphere.  It may include measuring a contaminant, such as lead in blood, or a resulting metabolic product, such as mandelic acid in urine following styrene exposure.


No ethics approval or informed consent?


A thesis published by a student was submitted by his guide for publication. One of the journal editors found the research unethical and asked for confirmation of ethics committee approval. The editor received a verbal commitment that the approval had been given prior to the research being started and the approval letter would be submitted in due course.


Ethical approval for a study


We had a presubmission enquiry from a group regarding a paper reporting what seemed to be an uncontrolled trial in infertile women who were given soft tissue physical therapy.


A case of scientific misconduct?


We had a paper submitted reporting results of a randomized trial. The trial seemed to look at immune responses in lung fluid in participants receiving either a particular vaccine or placebo. We got a copy of the trial protocol before going to peer review as per our normal editorial policy, and made sure the trial was registered.


Ethics approval for audit 3


In this case, an international organisation wished to study the use of various regimens for medical termination of pregnancy in a developing world setting where termination of pregnancy is not supported by the state. They have performed an audit and have obtained data which will be of considerable value in other similar settings around the world.


Ethics approval for audit 1


A group in a developing country decided to do a survey of maternal mortality in relation to the available local facilities in the various regions of their country. They set up a small committee to look at the incidence and causes. They obtained the permission of the local authorities, including the local elders, community leaders, and local health care providers, to scrutinise records and assess aetiology and quality of care. In the paper, aggregated results are described.


Ethical approval and parental consent


A journal received a paper from a single author, attributed to a UK institution, in which 10 children were operated on using two techniques, each child having one technique to one side and one to the other side, at the same operation.

The paper went to review, and neither reviewer spotted that this was a prospective surgical study on children, with no mention of consent or ethical approval.


Ethical approval for retrospective study


A paper reported the clinical outcomes of patients suffering from a neglected disease before and after a change in the national treatment policy which raised the threshold of one laboratory parameter before a more toxic, but more effective drug could be used. The authors did a retrospective cohort study of patients treated under both policies, to see how this change affected outcomes.


Patient consent


The journal received a case report for a patient presenting with a particular syndrome in which patients give approximate answers to simple questions. This syndrome has been considered as a dissociative condition but others have argued that it reflects simulation of psychiatric symptoms. The case report was an individual who had crashed his car and, following that, developed complaints of memory impairment and at psychiatric review this syndrome was diagnosed.


A case report of an experimental therapy, submitted by the patient


We received a pre-submission enquiry about whether we were interested in publishing a case report of a novel therapy that provided “a complete cure for heart disease.” The therapy involved a “membranotrophic drug” combined with diet and exercise.

 The therapy had been given to a patient who had experienced a myocardial infarction.  Eighteen months later, the patient was apparently free of heart disease.