Defending against research misconduct is the responsibility of everyone involved in a trial, from the principal investigator down to the lowest lab technician.
Red flags can appear in any aspect of a trial, ranging from missing or altered data, significant omissions in published reports, investigators’ failure to disclose intellectual property interests or industry relationships, and generally results that seem too good to be true or apparently “perfect” protocol compliance, Donna Kessler, Duke University research misconduct review officer, reminded attendees at the Society of Clinical Research Associates annual conference last week.
Another warning sign, she said, is an investigator’s refusal to share raw data or detailed methods. And serious or recurring episodes of non-compliance also bear a closer look.
Kessler also noted that there are practices that aren’t misconduct themselves but can create the environment for misconduct to flourish. For instance, unprofessional behavior — bullying, harassment and discrimination in the lab — can create a barrier to staff reports of misconduct.
Trial staff actually identify more cases of misconduct than trial monitors do, said attorney Debra Parrish.
For example, a financial audit of a Stanford University trial turned up evidence of falsified data and led to a three-year disqualification for the principal investigator. In another instance at the University of Vermont, a lab technician suspected the investigator had falsified data. The tech’s report eventually led to the investigator’s admission that he had committed research misconduct in multiple cases.
It’s important to create an environment in which reporters feel protected, Kessler said. Research institutions should normalize the process with such policies as anonymous reporting options, ombudsman services and prohibition of retaliation. They also can provide their investigators with role models, peer counseling and mentoring of professional behavior.
“Cultivate good citizens, managers and mentors, not just good researchers,” she said.
Although research integrity is a universal obligation, the ultimate responsibility is on the principal investigator’s shoulders. “Some places take the position that the PI is the captain of the ship,” said Parrish. “If the ship goes down, the captain goes down.”
Research scientists need to practice more transparency, Kessler said, explaining their methods, outlining results obtained and sharing source data. Investigators also need to provide better oversight, supervision and mentoring of the trial staff. Frequent discussions about ethics and integrity in research can help keep the ideas fresh in their minds, she said.
PIs should set expectations for data management and conduct routine reviews, Kessler said, recommending giving staff tools to improve record-keeping and reporting, such as auditable systems and electronic notebooks.
Research is not flawless, she said, and researchers need to acknowledge that errors and experimental failure are a normal part of science. Deal with problems transparently and ethically.
“Make the error occur the right way,” she said, and learn from it.