FDA plows forward with researcher misconduct privacy rule

July 8, 2013 by Arezu Sarvestani

Despite prior objections, the FDA's newly finalized privacy rule prevents researchers under misconduct investigations from accessing sensitive information on their own proceedings.

FDA investigation

The FDA this month issued a rule that would keep confidential certain records pertaining to investigations into potential researcher misconduct at the National Institutes of Health, exempting such documents from federal Privacy Act requirements.

The rule aims to protect the identities of confidential sources in NIH investigations by preventing researchers under investigation from accessing records pertaining to their proceedings, according to an FDA notice in the Federal Register.

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Under Public Health Service Policies on Research Misconduct, NIH and the Health & Human Services Dept. must maintain records related to all alleged or actual research misconduct, defined by as "fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results." That includes records on activities conducted in NIH facilities by any researcher, funded by NIH in any location or undertaken by any NIH employee as part of a training program.