If significant new safety information arises after consent has been obtained, what should the sponsor do?

The appropriate action for a sponsor when significant new safety information arises after consent has been obtained is to notify participants of the new information. This approach is rooted in the ethical principles of transparency and participant safety, which are crucial in clinical research.

Informed consent is an ongoing process, and participants have the right to be informed about new information that may affect their willingness to continue participating in the study. By communicating this significant safety information, the sponsor acknowledges their responsibility to keep participants informed while ensuring their welfare is a top priority. This not only fosters trust between researchers and participants but also aligns with regulatory requirements to protect participant rights and safety throughout the research process.

The other choices reflect inadequate responses to the situation. Remaining silent or waiting until the study is completed would withhold critical information that could influence a participant's decision to continue, potentially compromising their safety. Settling the information as internal documentation could lead to serious ethical and legal repercussions if participants are later found to have been uninformed about pertinent safety issues. Thus, notifying participants is the ethical and transparent course of action.