May 5, 2006

The FDA has issued its guidance on informed consent for in vitro diagnostic device studies using unidentifiable biologic material. The guidance is intended to inform sponsors, institutional review boards (IRBs), clinical investigators and agency staff that the FDA will exercise discretion in enforcing its policies on informed consent when human specimens are used for agency-regulated in vitro diagnostic (IVD) device investigations.

The agency "does not intend to object to the use, without informed consent, of leftover human specimens" in investigations that meet investigational device exemption (IDE) criteria, as long as subject privacy is protected by "using only specimens that are not individually identifiable," the guidance states. This includes specimens obtained from repositories and those left over from other, unrelated research.

A specimen is considered to be not individually identifiable when the identity of the subject is not known by the investigator or any other individual associated with the investigation, including the sponsor, the guidance says.

When leftover specimens are available, it is often difficult to locate the donor and obtain consent, the guidance acknowledges. "This difficulty may deter a manufacturer's research efforts [to] bring safe and effective IVDs to market more quickly." Some researchers have indicated that it is unclear how current informed consent policies protect human subjects, and they have suggested that consent issues be addressed through "less burdensome measures," the guidance notes.

The guidance can be viewed at http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0150-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0150-gdl0001.pdf).