Discuss the meaning of informed consent in vulnerable or und

Discuss the meaning of informed consent in vulnerable or underage populations. Can truly informed consent ever be obtained in these populations? How would you as a study investigator make sure that patients enrolled in the study were fully informed? What elements should go into an informed consent in this type of study?

Solution

Vulnerable population are those who cannot give the informed consent themselvesA. Example, children, mentally ill persons etc. In case of underage population, the informed consent is given by their parents or guardian. In these type of population truly informed consent cannot be obtained.

To ensure that the enrolled patients are fully informed, the information material should be prepared such that it can be easily and effectively understood by the participants. It should be prepared in familiar language.

The informed consent should include the information about the study, duration and its consequences. It should also inform about the side effects which may occur during the study. The participants should know that they can refuse or discontinue the study when they want.