Regulatory issues - informed consent for a device investigation.
For any patient about to undergo surgery, consent must be given; otherwise, the surgeon would be committing an assault. When a subject is to participate in a medical device investigation which is basically an experiment, a great deal more information is needed to assure that consent is really inform...
| Опубликовано в:: | IEEE Engineering in medicine and biology magazine 23, 3 (2004). |
|---|---|
| Главный автор: | |
| Формат: | Статья |
| Язык: | English |
| Предметы: |