About FDA

Ombuds Principles and Code of Ethics

The CDER Ombuds Office draws its ethical principles and standards from those established by the Coalition of Federal Ombudsmen (COFO), the United States Ombudsman Association (USOA), and the International Ombudsman Association (IOA).  These include standards for ensuring confidentiality, neutrality, and informality. 

Confidentiality: If requested, the CDER Ombuds will hold all information confidential to the extent the law allows. Keep in mind that it can be difficult to conduct an investigation or effectively facilitate resolution of a dispute or complaint without some disclosure of privileged information, so the Ombuds might request allowance for disclosure. “The Ombudsman should have the privilege and discretion to keep confidential or release any information related to a complaint or investigation. This standard balances the need to protect sensitive information so that a complainant can come forward, and witnesses and subjects can speak openly, with the need to disclose information as a part of an investigation or public report.” - Governmental Ombudsman Standards by USOA

Confidentiality is also discussed in the Administrative Dispute Resolution Act of 1996 (PDF - 38KB) and this Federal Register notice (PDF - 157KB).

The most commonly stated reason for seeking confidentiality is the fear of retaliation. Retaliation or the threat of retaliation is regarded as a very serious violation of the rules of employee conduct, and it will not be tolerated. 

Neutrality & Impartiality: "The Ombudsman should receive and review each complaint in an objective and fair manner, free from bias, and treat all parties without favor or prejudice.This standard instills confidence in the public and agencies that complaints will receive a fair review, and encourages all parties to accept the Ombudsman's findings and recommendations." - Governmental Ombudsman Standards by USOA 

Informality: The CDER Ombuds informally receives and listens to complainants, provides advice and feedback, and informally investigates complaints. The Ombuds does not make binding decisions or mandate change. Use of the Ombudsman's Office is purely voluntary.

Page Last Updated: 06/24/2015
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