In emergency situations, if prior consent is not possible, what should happen according to ICH guidelines?

In emergency situations, if prior consent is not possible, what should happen according to ICH guidelines?

• A. Only verbal consent should be necessary.
• B. Consent from the legally acceptable representative should be sought if available.
• C. Subjects should not be enrolled without prior consent.
• D. Subjects must be informed after enrollment only.

Answer: (B)

According to ICH guidelines, in emergency situations where obtaining prior consent is not feasible, it is crucial to seek consent from a legally acceptable representative if one is available. This approach acknowledges the ethical principle of respect for persons and the right to make decisions regarding participation in clinical research. In cases where immediate intervention is necessary to protect the health or life of a potential subject, and obtaining consent from the individual is impractical, relying on a legally acceptable representative ensures that the individual's interests and rights are still protected. This representative can provide the necessary consent on behalf of the participant, maintaining compliance with ethical standards. Furthermore, it's also important to inform the subject, or their representative, of their involvement in the study as soon as possible after the intervention, which underscores the commitment to ethical research conduct.

According to ICH guidelines, in emergency situations where obtaining prior consent is not feasible, it is crucial to seek consent from a legally acceptable representative if one is available. This approach acknowledges the ethical principle of respect for persons and the right to make decisions regarding participation in clinical research.

In cases where immediate intervention is necessary to protect the health or life of a potential subject, and obtaining consent from the individual is impractical, relying on a legally acceptable representative ensures that the individual's interests and rights are still protected. This representative can provide the necessary consent on behalf of the participant, maintaining compliance with ethical standards.

Furthermore, it's also important to inform the subject, or their representative, of their involvement in the study as soon as possible after the intervention, which underscores the commitment to ethical research conduct.