Sites Should Have a Plan to Deal With Incidental Trial Findings

Incidental findings that are not relevant to the trial, but which may be important to the subject, can present an ethical quandary for sites. Investigators should discuss the possibility of incidental findings with subjects during the informed consent process, offering to disclose findings that could benefit the subject, Bernard Lo, a medical ethicist with the University of California-San Francisco, says. FDA guidance also calls for sites to have a plan for “dealing with medical issues that arise as a consequence of study participation or during study participation,” agency spokeswoman Karen Mahoney said. HHS’ Office of Human Research Protection has a separate guidance.
Clinical Trials Advisor