Clinical Investigator Cited for Failing to Inform IRB of Subject Deaths

A clinical investigator studying an asthma drug failed to report the deaths of two patients and the hospitalization of a third to the institutional review board (IRB) and failed to get informed consent or assent for most of the patients he enrolled, the FDA said in a warning letter.

The FDA found that Nagarjuna Ponugoti of Allergy, Asthma & Immunology Associates in Terre Haute, Ind., did not obtain informed consent for 30 of 34 subjects he enrolled until six months after the start of the study. He also did not get assent from two pediatric subjects, according to the warning letter, which was sent June 6 and posted to the FDA website earlier this month. It was based on an inspection conducted Sept. 10–19, 2007.

Ponugoti said the sponsor did not send an informed consent form in the starter packages for the study, so he had subjects sign an “authorization form” when they enrolled, according to the letter. The FDA said this form “does not contain any of the elements required to be provided to subjects to constitute informed consent.”

Ponugoti also told the FDA investigator that he was unaware he needed to report serious adverse events to the IRB, according to the letter. In his written response to the letter, he said he was “under the impression that the sponsor would communicate with the IRB,” an explanation the FDA rejected.

Ponugoti also was cited for continuing the study by doing follow-up visits and obtaining informed or parental consent from subjects after the IRB had notified him it was withdrawing its approval. He told the FDA that he did not know he was not permitted to conduct follow-up visits after approval had been withdrawn, a response the agency rejected.

The warning letter can be viewed at www.fda.gov/foi/warning_letters/s6839c.htm.