In addition to protections for pregnant women, fetuses, and neonates, the HHS regulations also extend specific safeguards to other vulnerable populations, including children and individuals with cognitive impairments. These protections are designed to ensure that research involving these groups is conducted ethically and with informed consent, prioritizing their safety and well-being. Additional oversight, such as Institutional Review Board (IRB) review, is often required to mitigate risks and ensure appropriate considerations are made for their unique needs.
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