RESPONSE TO GUIDANCE ON INFORMED CONSENT FOR IVD SPECIMENS

Although the American Association for Clinical Chemistry (AACC) supports a recent FDA guidance on informed consent for in vitro diagnostic device clinical trials, the group says several guidance details remain unclear.

The guidance, titled "Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable," seeks to ease restrictions on the use of leftover human specimens to speed clinical research. When leftover specimens are available, it is often difficult to locate the donor and obtain consent, which "may deter a manufacturer's research efforts [to] bring safe and effective IVDs to market more quickly," the April 25 guidance says.

In a May 23 letter, AACC President John Sherwin asked the FDA for clarification on several items in the guidance.

For one thing, it is unclear when the agency will enforce its informed consent requirements, Sherwin said.

The FDA also seems to assume those involved in clinical trials have more rigid roles than they often do, he noted. "Under 4(f), the FDA states: 'The specimens are provided to the investigator(s) without identifiers and the supplier of the specimens has established policies and procedures to prevent the release of personal information,'" Sherwin said. "This provision infers that the investigator and the supplier are different people," when the clinical investigator is often the director or supervisor of the clinical laboratory as well, "and therefore also the supplier of the specimens." (http://www.fdanews.com/ddl/33_28/)