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What action does a sponsor take to comply with informed consent regulations?

  1. Provides participants with financial incentives

  2. Ensures FDA and all investigators are informed of new AEs or risks

  3. Provides investigators with the information they need

  4. Maintains the Investigational New Drug application (IND)

The correct answer is: Ensures FDA and all investigators are informed of new AEs or risks

A sponsor takes several actions to comply with informed consent regulations, including providing participants with all necessary information and obtaining their voluntary consent. Option A is incorrect because providing financial incentives can be seen as coercive and may interfere with the participant's ability to make an informed decision. Option C is incorrect because it is the responsibility of the investigator, not the sponsor, to provide information to other investigators. Option D is incorrect because maintaining the Investigational New Drug application (IND) is a requirement for conducting clinical trials but has no direct relation to informed consent regulations. Option B is the correct answer because by ensuring that the FDA and investigators are informed of any new adverse events or risks, the sponsor is ensuring that participants are fully informed and protected.