• Neonates: Interventional research enrolling neonates cannot be conducted by VA investigators while on official duty, or at VA facilities, or at VA approved off-site facilities. VA investigators may conduct research involving noninvasive monitoring of neonates if the research is determined by the IRB to be minimal risk. Prospective observational and retrospective record review studies that involve neonates or neonatal outcomes are permitted. The VA medical facility Director must certify that the medical facility has sufficient expertise in neonatal health to conduct the proposed research.
  • Pregnant participants: The VA medical facility Director must certify that the medical facility has sufficient expertise in women’s health to conduct the proposed research if the research includes interventional studies or invasive monitoring of pregnant participants as subjects.
  • Research that involves provision of in vitro fertilization services can be conducted by VA investigators while on official VA duty, at VA facilities, or at VA-approved off-site facilities. This includes prospective and retrospective research involving provision of or the enhancement of FDA-approved methods of in vitro fertilization for studies involving consenting subjects, both male and female, undergoing or who have undergone in vitro fertilization for the treatment of certain forms of human infertility. In vitro fertilization is any fertilization of human ova that occurs outside the body of a female, either through a mixture of donor human sperm and ova or by any other means.
  • Prospective and retrospective studies that enroll or include pregnant subjects who conceived through in vitro fertilization or other artificial reproductive technologies are permitted.
  • Research that uses human fetal tissue or that focuses on either a fetus, or human fetal tissue, in-utero or ex-utero cannot be conducted by VA investigators while on official VA duty, at VA facilities, or at VA-approved off-site facilities. Use of stem cells shall be governed by the policy set by NIH for recipients of NIH research funding.