OHRP: ALL 'UNANTICIPATED PROBLEMS' IN HHS CLINICAL TRIALS MUST BE REPORTED

All "unanticipated problems" affecting participants in clinical trials sponsored or supported by HHS must be reported, a new guidance from the Office for Human Research Protections (OHRP) says.

These are not the same as adverse events, although there is some overlap, the guidance says. Adverse events must be reported only if they are also unanticipated problems, the guidance explains. "Only a small subset of adverse events occurring in human subjects participating in research are unanticipated problems that must be reported," but there are also unanticipated problems that are not adverse events and yet must be reported.

Federal regulations currently contain the phrase "unanticipated problems involving risks to subjects or others," but do not explain what it means. The new guidance says that OHRP considers any incident, experience or outcome an unanticipated problem if it:

Is of an unexpected nature, severity or frequency given the research procedures described in the IRB-approved research protocol, informed consent form or related documents and taking into account the characteristics of the subject population;

Is or may be related (with "reasonable possibility") to participation in the clinical trial; and

May place trial participants or others at greater risk of physical, psychological, economic or social harm than was previously known or recognized.

Despite the difficulty in determining what is unexpected and what may be related to the clinical trial, the guidance states that in the event of any unanticipated problem that meets all three of the above criteria, those responsible for the clinical trial should consider taking corrective action.

The guidance can be accessed at www.hhs.gov/ohrp/policy/AdvEvntGuid.htm (http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm).