Solid Definitions of ‘Noncompliance’ Can Minimize Clinical Trial Risks

Ernest Prentice, PhD, Associate Vice Chancellor for Academic Affairs, University of Nebraska Medical Center

Ernest Prentice, PhD, Associate Vice Chancellor for Academic Affairs, University of Nebraska Medical Center

Breaches in research integrity can happen anywhere, anytime, and at any point in the clinical trial process, warns Ernest Prentice, PhD, associate vice chancellor for academic affairs at the University of Nebraska Medical Center.

The public must see that clinical research is ethical and in full compliance with regulations, Prentice says. “Conducting clinical trials is a privilege, not a right,” he adds. It’s incumbent upon everyone in the clinical trial chain to recognize that.

Research misconduct, the more serious charge, is relatively clear cut (e.g., plagiarism, falsification of data). However, noncompliance—while also problematic—is not as easy to define, and that’s one of the challenges.

In many cases, noncompliance is more the result of honest oversight or lack of clarity, Prentice says. Clinical research coordinators and others are “under a lot of pressure” to do more and do it more quickly, he adds. That can be a prescription for “fuzzy data” produced without any bad motive.

Learn to proactively identify and eliminate the factors and environment that can compromise your organization’s reputation and research at Prentice’s ACRP 2017 Meeting & Expo session, Breaches in Research Integrity: Maintaining the Public’s Trust and Confidence. Through an examination of various case studies that resulted in lawsuits and criminal prosecution, you will learn about research integrity, how financial incentives can lead to “sloppy science,” and more. View Program and Schedule

ACRP 2017 Meeting & Expo

While it’s unclear whether the problem is on the rise, Prentice believes it remains an issue. Any major academic institution is likely to have had cases of research misconduct it had to investigate, he says. “Usually it’s a case of noncompliance” you hope is not serious, he explains.

Definitions are key to successfully grappling with potential noncompliance issues. “We have definitions that I think are clear and strong,” Prentice says of his medical center. Many other facilities have them, too. However, the institutional review boards weighing in on research proposals and active projects don’t always have accreditation, which can lead to inconsistency.

Prentice stresses that an effective noncompliance program must have consistent, easy-to-understand definitions. Here’s a test: Would you feel comfortable explaining your program to the U.S. Food and Drug Administration inspector waiting in your reception lounge?

Author: Michael Causey