Research on the acute treatment of unconscious patients

In emergency medicine, a life-saving procedure has been followed for 15 years without one of the medications used (Medication X) ever having been scientifically tested. The mortality rate with this treatment is about 90%. Research from other countries suggests that Medication X does not contribute to increased survival, and may even have side effects that reduce survival. However, the studies are not of sufficient quality to be conclusive. Nevertheless, some countries have stopped using Medication X.

It has now been decided that the benefit and harm of Medication X for severely ill patients will be tested in a large controlled study in which a random selection receives standard treatment, while the rest are treated without Medication X. Because all the patients are unconscious and the treatment is acute, it is not possible to obtain consent.

Questions:

• Is it ethically acceptable to conduct research on this group of patients?
• Does this research fall under point 30 of the Declaration of Helsinki?
• Is the trial a good method for improving medical knowledge about what constitutes the best treatment?
• Should patients who survive be informed that they were included in a study? Should they give consent afterward?
• Should the relatives of patients who die be informed that the patients were included in a study? Should they give consent afterward?

Read more:

• Declaration of Helsinki