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Answer :
Final answer:
Informed consent is a key safeguard that protects research subjects in first-in-human research by ensuring they are fully aware of all details of the study, including risks and benefits, and allows them to make an informed decision about their participation without coercion.
Explanation:
One safeguard that can be used to protect healthy research subjects involved in first-in-human research is informed consent. Informed consent ensures that participants are fully aware of the study's purpose, procedures, risks, and benefits before agreeing to take part. Other methods such as placebo administration, randomization, and blinding are used to control for bias and ensure the reliability of the research data but do not inherently protect participants.
Under informed consent, potential participants are given all the relevant information about the study. This includes all risks and benefits, which must be clearly outlined to allow individuals to make a well-informed decision about their participation. For example, if a study involves comparing a new medication to a placebo, individuals must be told that they may receive the placebo instead of the active drug. Moreover, researchers must respect participants' autonomy to accept or decline participation without coercion.
Violations of informed consent can occur if participants are not fully informed or are misled regarding the study's details and their participation. For example, not informing them that they might receive a placebo, or influencing their consent through promises or incentives that could affect their decision-making.
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