Invasive intervention without consent

Case number:
99-24

Case text (Anonymised)

A study was submitted on the safety and feasibility of treating patients with acute stroke with an invasive procedure that would cause them considerable discomfort. The editor did not want to publish the study because it had negative results, did not include a power calculation, and was almost certainly too small to detect a clinically useful difference. The study had obtained local ethics committee approval, but the editor was worried about the level of consent.The authors were therefore contacted and they responded: “Besides the approval from the local ethics committee, all patients or their relatives had to give spoken as well as written informed consent before inclusion in the treatment group. The majority of the patients were awake, and therefore able to understand the information both orally as well as in writing. All the signed informed consents “in the local language” are kept for further documentation if needed. None of the patients included withdrew their consent during or after the study period. As you may know already, a national body controls the ethical aspects of clinical trials in this country very rigidly. This study could never have been performed without informed consent from the patients or their relatives.” Should the editors accept this statement or is further action required?

Advice: 

_ Whatever the ethics committee said is almost irrelevant because the study design was poor and the sample too small to give meaningful results. _ The editor should write to the institution and report that the ethics committee was not functioning correctly, stipulate that the study design was poor, and request the consent forms.

Follow up: 

No further action taken.

Year: