Obtaining consent from the human subject is a requirement unless the assigned investigator and a physician who is not connected in any way with the clinical trial make specific discoveries before the person is used in the trial.
We will now take a look at the specifications where consent is not needed.
1. Life-Threatening Situation
Firstly, this can happen when the human subject is faced with a life-threatening situation which makes it needful for the test article to be used in the attempt to save a life.
2. Inability to Communicate
Secondly, it is impossible to gain informed consent from the human subject because there is an inability to communicate with the person or to obtain legally effective consent.
3. Inadequate Time for Legal Consent
Thirdly, there is not adequate time to get legal consent from the legal representative of the human subject.
4. No Other Course of Treatment
Fourthly, there is no other recognized or approved course of treatment available that can provide an equal or greater possibility of saving the person’s life.