Patchwork of Protections
As of this writing, reporting ethical misconduct involving federally sponsored clinical research is not expressly protected by any single statute, regulation, or common-law rule. Rather, research-ethics whistle-blowers are forced to rely on a diverse patchwork of protections.
Frequently, these provisions are too narrow in scope, inadequate in remedy, or poorly enforced. Some protect reporting only if a law was actually violated. Others allow a reasonable belief. Some cover enumerated laws, while others limit by jurisdiction, and still others do not discriminate at all—any infraction will do. Many focus only on specific policy priorities (e.g., threats to public health and safety). Moreover, safeguards can depend on the recipient of the whistle-blower’s report, be restricted to public employees, or apply widely.
They have many sources, falling into four general categories: (1) federal statutes, (2) regulations and agency guidance, (3) state statutes, and (4) state common law causes of action. Consider each in turn:
Federal statutes. Most federal statutes are topic-specific and of no benefit to research-ethics whistle-blowers. There are two exceptions: the Whistleblower Protection Act of 1989 (WPA) and the federal False Claims Act (FCA). Technically, the WPA applies to violations of “any law, rule, or regulation . . . abuse of authority, or a substantial and specific danger to public health or safety.” In practice, however, the WPA has no teeth. Only government servants are protected, and, after the Supreme Court’s opinion in Garcetti v. Ceballos, disclosures made in the course of official duties, or made to supervisors or co-workers, are excluded.
The WPA established the Merit System Protection Board to decide retaliation claims independently; yet, since 2000, only three whistle-blowers have prevailed before it. The U.S. Court of Appeals for the Federal Circuit has jurisdiction on appeal. But the circuit has steadily narrowed the scope of WPA protection by increasing whistle-blowers’ burdens of proof and production. The result: less than 1.5% of whistle-blowers now win their appeal. These are astonishingly low rates of success for so broad a law.
But the FCA is no more potent. Because institutions with FWAs promise to comply with 45 C.F.R. 46 as a condition of DHHS funding, allegations of research misconduct fall under the aegis of the FCA’s anti-retaliation provisions. Failure to obtain fully informed consent from participants, IRB approval that deviates from IND conditions, nondisclosure of investigator conflicts of interest—all have been reported in this way. But FCA cases seeking remedies for ethics lapses are rare. Most have failed. Courts recognize that the FCA was never intended as a vehicle for compliance oversight.
Regulations and agency guidance. Neither OHRP nor the regulations it administers speak to whistle-blowers in human-subjects research. The DHHS Office of Research Integrity (ORI) does protect whistle-blowers who make good faith allegations of scientific misconduct. Under 42 C.F.R. Part 50.103(d)(13), institutions applying for research-related grants are required to “undertak[e] diligent efforts to protect the[ir] positions and reputations.”
Part 493(e) of the Public Health Service Act—a whistle-blower protection statute enacted by Part 163 of the NIH Revitalization Act of 1993—provides overlapping coverage. But, because “scientific misconduct” is narrowly defined as “fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community,” none of these provisions may apply.
State statutes. While virtually every state has enacted whistle-blower legislation in some form, and at least 18 expressly protect employees who report health and safety violations, statutory language varies considerably from jurisdiction to jurisdiction, and judicial interpretation has magnified the differences.
Dr. Stratton has the benefit of Illinois’ relatively broad Whistleblower Protection Act, which covers violations of any “federal law, rule, or regulation.” But the very same misconduct in another jurisdiction might be far more dangerous to report. Especially in the context of DHHS-funded research, similarly situated whistle-blowers currently receive disparate legal treatment based merely on the accident of their geography.
State common law. The common law tort of retaliatory discharge in violation of public policy may be available to research-ethics whistle-blowers not covered by state statutes. Over 40 states and the District of Columbia have recognized the tort in some form. But here again, the elements of the cause of action vary substantially from state to state. Courts have achieved no consensus on the elements of the public-policy claim. In some cases it is pre-empted by weaker state statutory provisions. And plaintiffs have achieved mixed results.