“We have a big challenge when we talk about oversight of research…[and] we need to recognize that investigators are human” and may regrettably behave in ways leading to noncompliance or research misconduct, says Ernest D. Prentice, PhD, associate vice chair for academic affairs with the University of Nebraska Medical Center.
Presenting a session on “Breaches in Research Integrity: Maintaining the Public’s Trust and Confidence” today at the Association of Clinical Research Professionals (ACRP) 2017 Meeting & Expo in Seattle, Prentice, who also serves on ACRP’s Association Board of Trustees and Editorial Advisory Board, spelled out to a capacity crowd the nuances between nonserious and serious noncompliance, and between noncompliance and research misconduct. He says all such behaviors in the conduct of clinical research can be recognized and dealt with according to institutional and/or governmental definitions of regulations, institutional review board (IRB) expectations, and study protocols, and in terms of whether the rights and/or welfare of a study’s volunteer participants are adversely affected.
“It’s a privilege, not a right” for investigators to work in research with volunteers, Prentice reminds his audiences wherever he speaks. A typical investigator is concerned with human subject protections, he adds, whereas an atypical investigator lets his or her feelings that IRBs are too bureaucratic and regulations are too burdensome pave the way to occasional (and sometimes intentional) violations of rules and regulations.
Pressures that may lead to noncompliance or research misconduct include:
- Peer competition
- Power differentials between new investigators and those to whom they report
- The “publish or perish” expectation in academia
- The race for fame
However, probably the most important characteristic of a dedicated and professional investigator is a commitment to keeping the public’s trust where clinical research is concerned, Prentice notes. This remains of ongoing importance to the clinical research enterprise, he says, because when questions are raised about “is there a lot of noncompliance out there, we don’t really know for sure.”
Author: Gary Cramer