United States · Amendment · HAMDT

HAMDT 552 (98th)

An amendment to the Shelby substitute amendment to prohibit waiver of requirements on fetal research unless application is made to the Secretary with the approval of the Institutional Review Board with jurisdiction over the applicant. The Secretary may not approve a waiver or modification of regulations without convening an ethics advisory board and determining that the risks to the fetus involved are so outweighed by the sum of the benefit to the fetus and the importance of the knowledge to be gained is so great as to granting the application. It must also be shown that without the waiver such benefits cannot be obtained. Waivers and modifications are to be published in the Federal Register.