HLTH 3098 Chapter Notes - Chapter 2: Fetus, Institutional Review Board, Common Rule
Document Summary
Types of vulnerability defined in the federal regulations. Hhs at 45 cfr 46. 111(b) (protection of human subjects 2009) and the u. s. food and drug. Administration (fda) at 21 cfr 56. 111(b) (institutional review boards 2015) provide the following list of examples of vulnerable subjects: The hhs regulations have three subparts that discuss specific additional protections for identified vulnerable populations of individuals when they are going to participate in research. These subparts have been adopted, to varying extents, by some other federal agencies who have adopted the common rule (subpart a). Additional protections for pregnant women, human fetuses and neonates involved in research (45 cfr 46. 201-7) Embryos and fetuses are vulnerable because they have no capacity and are under the direct control of their mother. Though the regulations imply that the pregnant women herself is vulnerable (perhaps because of the unique dependent relationship with the fetus, not all commentators agree) (schonfeld 2013, 189-206).
