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Answer :
Final answer:
When a study involves more than minimal risk, safeguards must be implemented to minimize risk and ensure potential benefits outweigh risks. This includes a process called informed consent where participants are thoroughly briefed about potential risks and give consent in writing. Regulatory bodies like the IRB oversee such safeguards to ensure participant safety.
Explanation:
If a study is deemed to involve more than minimal risk, the appropriate additional safeguards that needs to used are that the risks to participants must be minimized and reasonable with respect to projected benefits. This is done in a process called informed consent, which means that the risks of participation must be clearly explained to the subjects of the study. Subjects must consent in writing, and researchers are required to keep documentation of their consent.
Safeguards such as these are overseen by regulations and bodies like the Institutional Review Boards (IRB), which are purposed to protect study participants. It should also be noted that for a few cases, deception can be used to maintain the integrity of the study, but it needs to be non-harmful. These are some of the safeguards that are put into place when conducting a study with more than minimal risk.
Learn more about Ethics in Medical Studies here:
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