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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Clinical Investigators - Disqualification Proceedings

FDA regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical devices. Physicians and other qualified experts ("clinical investigators") who conduct these studies are required to comply with applicable statutes and regulations intended to ensure the integrity of clinical data on which product approvals are based and, for research involving human subjects, to help protect the rights, safety, and welfare of those subjects.

In certain situations in which FDA alleges a clinical investigator has violated applicable regulations, FDA may initiate a clinical investigator disqualification proceeding. The Clinical Investigator - Disqualification Proceedings database, linked at the bottom of this webpage, provides a list of clinical investigators who are or have been subject to an administrative clinical investigator disqualification action and indicates the current status of that action.  For each clinical investigator who is listed, links to related FDA regulatory documents (e.g., NIDPOEs, NOOHs, Presiding Officer Reports, Commissioner's Decisions) are provided, when available. 

Definitions for certain terms (e.g., NIDPOE) that are used in the context of clinical investigator disqualification proceedings are listed below.

NIDPOE - A Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) letter informs the recipient clinical investigator that FDA is initiating an administrative proceeding to determine whether the clinical investigator should be disqualified from receiving investigational products pursuant to the Food and Drug Administration's regulations.

NOOH - The Notice of Opportunity for Hearing (NOOH) provides an individual with the opportunity for a hearing on a regulatory action, including a proposed action (such as disqualification), before a presiding officer designated by the Commissioner.

Not Disqualified Clinical Investigator - FDA may discontinue a disqualification proceeding when an investigator offers an explanation in response to the NIDPOE that is accepted by the applicable Center. If an explanation is offered by an investigator but not accepted by the applicable Center, the investigator is given an opportunity for an informal regulatory hearing to determine whether the investigator should remain eligible to receive FDA-regulated test articles. After review of the administrative record of a regulatory disqualification proceeding, the Commissioner of Food and Drugs may determine that the investigator should continue to be eligible to receive FDA-regulated test articles and to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA.

Disqualified Clinical Investigator - FDA may disqualify a clinical investigator if the clinical investigator has repeatedly or deliberately failed to comply with applicable regulatory requirements or the clinical investigator has repeatedly or deliberately submitted false information to the sponsor or, if applicable, to FDA, in any required report. A disqualified clinical investigator is not eligible to receive investigational drugs, biologics, or devices, and is not eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA (including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products). In the past, the phrase "totally restricted" was also used to refer to clinical investigators who had been disqualified. Where an investigator has been reinstated, it is so noted.

Totally Restricted Clinical Investigator - In the past, the phrase "totally restricted" was also used to refer to clinical investigators who had been disqualified. It is important to underscore the difference between "totally restricted" clinical investigators and "restricted" clinical investigators. "Totally restricted" investigators are ineligible to receive investigational products (absent reinstatement).

Restricted Clinical Investigator - FDA may, in some instances, allow a clinical investigator to enter into a restricted agreement when the agency believes that lesser sanctions than disqualification would be adequate to protect the public health. The decision to offer a restricted agreement is within the discretion of FDA. A restricted clinical investigator is still eligible to receive investigational products, provided the investigator conducts regulated studies in accordance with the restrictions specified in their agreement with FDA and all applicable regulatory requirements.

Restrictions Removed - Under the terms of the restricted agreement with the clinical investigator, the restrictions in their agreement no longer apply and are removed. The investigator is again eligible to receive investigational products in accordance with all applicable regulatory requirements.

 

Resources

Other Reference:

  •  The Department of Health and Human Services (HHS), Public Health Service, Office of Research Integrity (ORI), maintains an Administrative Action Bulletin Board located at http://ori.hhs.gov/misconduct/AdminBulletinBoard.shtml. This Bulletin Board includes the names of individuals who currently have administrative actions imposed against them by ORI, the Assistant Secretary of Health, and/or HHS.