Regulacje i polityka gospodarcza · 10/10/2000

NIH Modifies Guidelines for Human Gene Transfer Studies, Clinical Trial Proposals

The National Institutes of Health (NIH) has made changes to its guidelines for human gene transfer studies and clinical trial proposals, aiming to ensure that research participants are not enrolled in such studies until necessary approvals are obtained. The NIH Office of Biotechnology Activities will now review clinical trial proposals before local Institutional Review Board (IRB) approval, and before Institutional Biosafety Committee (IBC) approval in some cases.