FDA Limits Research Misconduct Information Release
Posted 30 August 2012 | By
The U.S. Food and Drug Administration (FDA) wants exemptions
for releasing information tied to misconduct investigations, according to a
report by Pharmalot.
FDA wrote in a Federal
Register notice it is concerned premature release of names of sources could
affect evidence gathering, influence witnesses, or otherwise jeopardize the investigation. The new approach would be modeled after a system used by the
U.S. Department of Health and Human Services Office of Research Integrity,
according to Pharmalot.
The Privacy Act
allows people who are under investigation to request information about the
proceedings. FDA is concerned about revealing sources who were expressly
promised confidentiality, according to the report.
FDA is not expecting any challenges to the changes, but
comments are open until 13 November.