13. Other Vulnerable Populations

Other Vulnerable Populations

Research with individuals who are prisoners [46.301-306] and pregnant women, human fetuses and neonates [46.201-207] require additional safeguards and precautions in research procedures to protect the rights and welfare of these subjects.

In addition, when some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, non-English speakers, etc. additional safeguards must be included in the protocol, recruitment and consent procedures to ensure the rights and welfare of these participants are adequately protected [46.111(a)(3)& 46.111(b)].