Kristine Bærøe, Associate Professor at the Department of Global Public Health and Primary Care, University of Bergen
A couple of months ago a new Research Ethics Act was implemented in Norway. The rationale for replacing the preceding regulation was to strengthen legal responsibilities of researchers and institutions for promoting acceptable research . According to the new regulation, researchers are held legally responsible for ensuring that they ‘act with caution to ensure that all research is conducted according to recognised research ethical norms’ . At the same time ‘institutions are responsible for: a) necessary training of candidates and employees in recognised research ethical norms and b) that everyone who conducts or participates in the research is familiar with recognised research ethical norms’ . The lawmakers have explicitly left it to the researcher community to define what is covered by ‘recognised norms’ , but implicitly the community will also have to define what should go into ‘necessary training’.
Continue reading “What is ‘necessary training’ in health-related research ethics?”
Kate Sahan, The Ethox Centre, Nuffield Department of Population Health, University of Oxford
A current emergency medicine trial, Paramedic2, which randomizes patients to adrenaline versus saline in cardiac arrest has put emergency medicine research (EMR) back under the spotlight. There are concerns that a ‘totally useless placebo’ will be more harmful than the standard adrenaline shot given during the resuscitation protocol. However, the history of EMR has taught us that some emergency interventions rest on an insufficiently-explored and updated evidence base. For example, up until the early 2000s, corticosteroids were given to tens of thousands of severe head trauma patients in the belief they were medically beneficial. But it took a systematic, placebo-controlled research study of their use called CRASH to make an unwholesome discovery: steroids had no benefit, and caused actual harm by killing or severely brain-damaging more patients than placebo.
Continue reading “It’s an emergency: should we ‘rescue’ vulnerable emergency care patients from research?”