Doubtful Life-Saving

[The following text is an example or "case", which can serve as a starting point for reflection and discussion. Some examples may be based on real events, while others are fictional representations.] 

In emergency medicine, a life-saving procedure has been followed for 15 years without any of the medications used being scientifically tested. The mortality rate for this treatment is approximately 90%. Research from other countries suggests that this medication does not increase survival rates, and may even have side effects that lower survival chances. However, the studies are not robust enough to be conclusive. Still, some countries have stopped administering this medication.

It has now been decided that the benefits and risks of the medication for critically ill patients will be tested in a large controlled study, where a random sample will receive standard treatment, and the rest will receive treatment without the medication. Since all patients are unconscious and the treatment is urgent, consent cannot be obtained.

• Is it ethically acceptable to conduct research on this group of patients?
• Does this research fall under Article 32 of the Helsinki Declaration?
• Should the patients who survive be informed that they were part of an experiment?
• Should the relatives of the patients who die be informed that the patients were part of an experiment?

Read more about the Helsinki Declaration.

Note: This is a translation of the Norwegian original text by Johanne Svanes Oskarsen.