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Science collected all publicly available data from the beginning of former President Barack Obama’s time in office through the first 3 years of President Donald Trump’s tenure on the following Food and Drug Administration (FDA) enforcement and compliance actions related to clinical trials and the institutional review boards (IRBs) that oversee them:
- inspection reports designated “official action indicated” (OAI),
- inspection reports designated “voluntary action indicated”,
- inspection reports designated “no action indicated”,
- warning letters, which sometimes follow OAI inspections,
- closeout letters, which sometimes follow warning letters and indicate that problems were corrected,
- disqualifications, which designate researchers barred from conducting trials, and
- untitled letters (rarely publicly posted), which sometimes follow OAI inspections and represent an intermediary step below a warning letter.
The federal Freedom of Information Act (FOIA) was used extensively to obtain additional nonpublic records. Some FOIA requests were made on behalf of Science by FDAzilla, a commercial service that tracks federal government actions.
The data sources also included, but were not limited to, the following:
- “bioresearch monitoring” inspection summaries (the FDA category that examines clinical research and IRBs): Inspection Classification Database Search; Clinical Investigator Inspection Search
- warning letters and closeout letters (January 2014–31 January 2020): Warning Letters; Compliance Actions
- warning letters and closeout letters (2009–13): Inspections, Compliance, Enforcement, and Criminal Investigations (Note: The practice of issuing closeout letters began on 1 September 2009, so earlier Obama-era cases would not qualify.)
- untitled letters: BIMO/Team Biologics/Internet Surveillance/Other; Vaccines, Blood & Biologics: BIMO/Team Biologics/Internet Surveillance/Other
- disqualification records for clinical investigators: Clinical Investigators - Disqualification Proceedings; FDA Debarment List (Drug Product Applications); Institutional Review Boards–Restrictions Imposed Letters and Disqualification Proceedings
- miscellaneous inspection reports: ORA FOIA Electronic Reading Room
Meagan Weiland assisted on the reporting for this investigation.