Zdrowie i gospodarka · 6.07.2004

Institutional Review Boards; Registration Requirements

The Food and Drug Administration (FDA) is proposing to require institutional review boards (IRBs) to register at a site maintained by the Department of Health and Human Services (HHS). The registration information would include contact information, the number of active protocols involving FDA-regulated products reviewed in the previous calendar year, and a description of the types of FDA-regulated products involved in the protocols reviewed. The proposed IRB registration requirements would make it easier for FDA to inspect IRBs and to convey information to IRBs.