Whistleblowing in Clinical Trials: Is It Worth the Risk?

In this episode, Darshan Kulkarni and Edye Edens explore whether sites should consider whistleblowing on non-compliant sponsors. They acknowledge that non-compliance is a non-negotiable issue, but emphasize the difficulty of deciding when to report, especially given the financial and relational ties between sites and sponsors.

They discuss examples, like overpayments or data integrity violations, which might compel a whistleblower to act. However, they highlight the gray areas where judgment calls blur the lines between compliance and ethical obligations. Both caution that despite legal protections, whistleblowers often find themselves unemployable in the industry afterward.

Darshan and Edye stress the importance of thoughtful, informed decision-making, advising that while some situations clearly demand reporting, others might warrant cautious documentation and internal discussion first. They underscore that reporting mechanisms vary—from internal sponsor compliance officers to IRBs, FDA, or even the Attorney General’s office—depending on the severity of the issue.

Ultimately, they urge potential whistleblowers to weigh the risks carefully, seek legal advice, and remember that every situation is unique.

Support the show