What does informed consent mean in research?
Informed consent is the process of ensuring that participants understand the research and agree to participate voluntarily.
How is informed consent monitored during a study?
Monitoring involves ensuring that consent is obtained properly, participants are informed of their rights, and that they can withdraw at any time.
What are the consequences of not obtaining informed consent?
Not obtaining informed consent can lead to ethical violations, legal issues, and harm to participants, undermining the integrity of the research.
Are there specific guidelines for monitoring informed consent?
Yes, guidelines like the Belmont Report and regulations from bodies like the FDA and IRB outline the requirements for informed consent.
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