Unlike the ordinary expanded access situation, it is unethical to withdraw an effective investigational product from a research subject who has a serious disorder or faces a significant risk of death and who has responded favorably to the investigational product.

Question

Quizplus · Accepted Answer

Withdrawing an effective investigational product from a research subject who has a serious disorder or faces a significant risk of death and has responded favorably to the product can be considered unethical because it may harm the patient by depriving them of a potentially life-saving treatment. Ethical guidelines suggest that researchers should consider the well-being of participants, and abruptly stopping an effective treatment contradicts this principle.

Unlike the Ordinary Expanded Access Situation, It Is Unethical to Withdraw