Protection of subject (human)


A case of child abuse


Child abuse is a common but underdiagnosed problem in our country. The abuse ranges from minor injury to severe head trauma. The true incidence of intentional head injury in children remains uncertain.


Pedigree descriptions: genotyping results for family members


We received a paper which describes genotyping results from a large number of individuals (>50) from five unrelated families, in which family members had various blood and liver conditions. On submission we noted that the paper included specific details regarding the clinical histories of individuals in each family. Some individuals were described in substantial detail, others only briefly.


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.


HIV homeopathy


The authors carried out a study. A homeopathic treatment was given to people with HIV/AIDs. The outcome was quality of life, as measured by a questionnaire after 1 month and 18 months of treatment. Participants were selected for inclusion if they had a HIV seropositive status at the time of study and were not taking any other kind of HIV/AIDs treatment.


Has formal ethical approval been granted that satisfies publication criteria?


The issue here is whether formal ethics approval has been granted in order to satisfy publication criteria. By way of some background information, a lot of screening data are collected on many athletes in many sports, both nationally and internationally. Historically, clubs and associations have disclaimers whereby athletes sign consent for their data to be used for audit purposes on the proviso they will not be identified individually.


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.


Is ethics approval required?


The journal received a paper on an imaging technique which reported changes in a normal healthy volunteer. No adverse events were experienced. This study demonstrated the feasibility and safety of the imaging studies in a particular condition.


A survey of doctors’ opinions, with no IRB approval or written consent


A doctor who trained in country A took the licensing examinations in country B because he wished to work in country B.


Unusual consent process in a vulnerable population


A clinical trial was conducted in a low income country. The trial involved two schools. At the first school (the control school), children would receive a one-off drug treatment for a common infection (such “mass drug administration” is the norm for treating and breaking the transmission cycle of this infection). At the second school, children would receive the same one-off drug treatment plus a long term oral nutritional supplement.


HIV testing without offering treatment to affected individuals


A team of Western researchers carried out a longitudinal study of pregnant nomadic tribeswomen in Africa between 2002 and 2003. They took blood samples during and after pregnancy to test for a specific disease. Those who tested positive were treated. An attempt was also made to trace contacts, and the women’s status was rechecked after pregnancy to ensure effective treatment.