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FDA Tightens Disclosure on Research Misconduct


8/29/2012 7:11:36 AM

In a bid to ensure that investigations into research misconduct by individuals who are performing work for the FDA are not compromised, the agency has proposed a new approach to recordkeeping that will tighten the dissemination of information related to any probes. The move would be modeled after a system already used by the US Department of Health & Human Services Office of Research Integrity, according to a notice published this week in the Federal Register. Specifically, the FDA seeks exemptions from provisions that require disclosing certain information that, under the Privacy Act, allow people who are under investigation to request information about proceedings. For instance, the FDA wants to avoid revealing the identity of any source who was expressly promised confidentiality and also proposes an exemption from disclosing a pending investigation over concerns that doing so might compromise its inquirty.

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