What should researchers do regarding informed consent when new risk information becomes available?

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When new risk information becomes available, researchers must inform participants and ensure their consent reflects that information. This upholds respect for autonomy and protects participants from ongoing harm by letting them make an informed choice about continuing. If new risks arise, the appropriate step is to re-consent participants or rely on an ongoing consent framework, where updated risk details are disclosed and participants can reaffirm their willingness to continue or withdraw. This often involves providing an updated consent document and, if needed, a formal re-consent process approved by an ethics review board.

Doing nothing ignores new information that could change a participant’s willingness to continue in the study. Limiting updates to new enrollees deprives existing participants of crucial information about risks they might face. Re-consent only at sponsor request shifts the responsibility away from the researcher’s duty to ensure participants’ informed decisions and undermines participant autonomy.