FDA Limits Action Against HIV Investigator

A story linked via FierceBioTech today from an article published last week in the Chicago Tribune describes the apparently light touch the FDA is using to discipline an investigator whose clinic allegedly submitted fictitious data in a clinical drug trial.  Standard procedure in such cases is usually either disqualification from running clinical trials altogether or restriction of the number of trials an investigator may conduct or the number of patients they may enroll.  This investigator, whose writings about HIV are easily searchable on the Web, apparently escaped all such restrictions and instead is allowed to continue clincal trial operations under the supervision of an outside medical monitor for the next three years and is required to submit annual reports to the FDA in that same three year period.  This seemingly light slap runs counter to the message being sent to drug manufacturers themselves for whom the agency is stepping up its oversight with warning letters, product recalls and threats of prosecution, according to the Fierce story. 

Switching gears entirely, here is a link to the OHRP's 2010 International Compilation of Human Research Protections.  This is an absolutely invaluable resource covering the key organizations, legislation, regulation and guidelines pertaining to human subjects protection of 96 countries, updated every year with clickable links.  Every clinical research professional planning studies anywhere in the world including the emerging regions should make this document their first stop.