Neonates conducted

s/have, in the judgment of the Department or Agency head,to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to Federal regulation). §46.124 Conditions. With respect to any research project or any class of research projects the Department or Agency head mayprior to or at the time of approval when in the judgment of the Department or Agency head additional conditions are necessary for the protection of human subjects. Subpart B Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research Source: Federal Register: November 13, 2001 (Volume 66, Number 219), Rules and Regulations, Page 56775-56780, from the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr13no01-9]. §46.201 To what do these regulations apply? (a) Except as provided in paragraph (b) of this section, this subpart applies to allpregnant women, human fetuses, neonates of uncertain viability, or non