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Multiple Choice

What information will participants have access to regarding trial results?

The main idea is that participants should be informed about trial results and about the treatment they actually received as soon as that information is available from the sponsor. This supports transparency and respect for participants, helping them understand the outcomes that may affect their health and care. Results aren’t meant to wait for a journal publication; the sponsor (through the investigator) should share results that are relevant to the participant and clarify what their own treatment was and how it performed. If the trial design involved blinding, information for the participant would be shared in a way that respects the consent and privacy rules, and as appropriate to their care. Providing only overall results or delaying access until publication, or giving no access at all, would withhold information participants need to make informed decisions about their health and would conflict with ethical expectations in clinical research.

The main idea is that participants should be informed about trial results and about the treatment they actually received as soon as that information is available from the sponsor. This supports transparency and respect for participants, helping them understand the outcomes that may affect their health and care. Results aren’t meant to wait for a journal publication; the sponsor (through the investigator) should share results that are relevant to the participant and clarify what their own treatment was and how it performed. If the trial design involved blinding, information for the participant would be shared in a way that respects the consent and privacy rules, and as appropriate to their care. Providing only overall results or delaying access until publication, or giving no access at all, would withhold information participants need to make informed decisions about their health and would conflict with ethical expectations in clinical research.