Proposals to reform whistle-blower laws are nothing new. Historically, the human-subjects research community has paid little attention. That is beginning to change. Dr. Stratton’s case illustrates why. Robust whistle-blower protection may well be essential to effective oversight of clinical trials—especially at the many hundreds of community hospitals across the nation.
Federally funded cancer research is dependent on these sites. Collectively, they enroll over one-third of all participants in the nation’s cancer trials. Ethical misconduct at community centers is thus a grave threat to public trust. With the absolute level of NIH and industry funding for research declining for the first time in decades, according to a recent study published in the Journal of the American Medical Society, it is a threat we can ill afford.
Whistle-blowers can help. But, in order to come forward, they require better safeguards. Empirical research strongly indicates that prospective whistle-blowers engage in a cost-benefit analysis in which personal risks are weighted heavily. Thus, disincentives must be removed, and whistle-blowing regarded—even rewarded—as virtuous.
How best to accomplish this goal requires further study, although an effective reform proposal will likely involve at least three components: First, the regulatory gaps must be addressed. The federal regulations should be amended to include express, dedicated protection for those who report violations of ethics rules applicable to human-subject research.
OHRP and the FDA should promulgate guidance for institutions on responding to allegations. And the definition of “scientific misconduct” should be amended to reach human-subjects protections, thereby bringing research-ethics violations under the joint jurisdiction of ORI’s whistle-blower provisions.
Second, uniformity and certainty as to applicable law must be promoted. To that end, the WPA should be amended to encompass most public and private employment relationships. This includes employees of CROs, pharmaceutical and medical device firms, private IRBs, and FDA contractors. Likewise, a wider range of external report recipients, as well as up-the-chain disclosures made internally, should be covered.
The scope of covered wrongdoing should be broad enough to cover any duty—whether emanating from statute, regulation, guidance, or policy, whether judicially created or professional, whether international, federal, state, or municipal—owed to or potentially relevant to the protection of human subjects. Potential recovery should be expanded beyond the usual equitable remedies of reinstatement and back pay to include full compensatory damages. A case might also be made for punitive damages and reasonable attorneys’ fees, although both impose trade offs that must be carefully weighed.
For misconduct under OHRP jurisdiction, the federal WPA should also preempt competing state or common-law protections—even if more protective. Overprotection may foster over-reporting, dramatically slowing the pace and raising the costs of research without justification. To avoid this inefficiency and as a prophylactic to employee abuse, a good faith element is essential. An objectively reasonable belief in the occurrence of the reported violation should be a prerequisite to protection.
Finally, antiretaliation provisions are necessary only because whistle-blowing is regarded as disloyal, disobedient, and a breach of trust. This perception is deeply misguided. Human-subjects research is unique. The primary duty of anyone involved in a clinical trial is to the patient/subjects without whom no research would be possible and whose sacrifices benefit us all. Protecting their welfare, their autonomy, their dignity, and their rights supersedes other obligations in all but the most rare circumstances.
Clinical research is a social good. To promote and perpetuate it, all stakeholders in the research endeavor—in our labs and in the classroom, from our research centers to our corporate offices, on cancer wards before research subjects and on camera before the public—must strive to foster an ethical culture aligned with these values.