Question

Under what conditions may an investigator enter a human subject into a research study employing the exception from general informed consent requirements? Prior to enrolling a subject, both investigator and an independent MD must clarify in writing:

Answer 1

Under certain conditions, an investigator may enter a human subject into a research study employing the exception from general informed consent requirements.

Step-by-step explanation:

Under certain conditions, an investigator may enter a human subject into a research study employing the exception from general informed consent requirements. One condition is when the study involves emergency research, such as in life-threatening situations or when time-sensitive interventions are necessary.

Another condition is when the research involves minimal risk and it is impractical to obtain informed consent from each individual participant due to the large number of participants. In these cases, the investigator and an independent MD must clarify in writing the justification for the exception from general informed consent requirements.