It requires that all research be reviewed by an entity certified by the Secretary. This standard is more restrictive than that used by IRBs. Rather than creating additional layers of oversight, legislation should protect patients by establishing clear rules governing the use of information and penalties for violations of these rules. Federal legislation should create national, uniform protections. Federal legislation should create national, uniform confidentiality protections.
Clinical trials are multi-state ventures.
National standards allow researchers to create informed consent and other procedures that will be legal in all states. If federal legislation allows individual states to impose restrictions on top of these standards, research will be slowed. Strong national standards will also give the public peace of mind because they will know that their medical information is subject to appropriate protections. This, in turn, will make them more willing to share information with medical researchers. Unfortunately, neither HR 1057 nor HR 1941 provide such standards.