Financial support disclosure (research)

Case

Sponsorship, ethical approval and consent for study done as part of an expanded access program

07-32

We received a paper describing the results of an analysis of pathogen gene sequences from patients who had been given an investigational drug as treatment for their infection. The study had been done in Europe. One reviewer said that the paper did not explain whether the patients had been treated in the context of a trial or not and that no information about study sponsorship, ethical approval or patient consent had been included.

Case

Research on volunteers without informed consent or ethics committee approval

04-12

An experiment on a volunteer in hospital was written up. The volunteer was an asthmatic who was stable at the time and given a combination of intravenous magnesium sulphate and salbutamol to observe the pharmacological effects. The drugs were given under supervision in intensive care as they carry some risk of cardiovascular side effects.