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Question: 1 / 400

What should be provided to subjects if new information may affect their willingness to continue participation?

No information, they can assume safety

New information that may affect their willingness

Participants in clinical trials have the right to be informed of any new information that may affect their willingness to continue in the study. This principle is grounded in ethical standards, such as those outlined in the Belmont Report and the Declaration of Helsinki, which emphasize the importance of informed consent.

When new data emerges that could impact the safety, efficacy, or any other significant aspect of the study, researchers are ethically obligated to share this information with participants. This enables subjects to make an informed decision about their continued participation, ensuring that they can weigh the potential risks and benefits in light of the new information.

Providing participants with relevant updates enhances transparency and trust between researchers and subjects, reinforcing the ethical practice of clinical research. This practice ultimately helps safeguard the welfare of participants and uphold the integrity of the research process.

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Only information that is positive

Information is not necessary

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