Robust Ethics Program Key to Successful Trials

Jack Corman, Principal Consultant to JHC Consultations

Jack Corman, Principal Consultant to JHC Consultations

“While the majority of people are well-intentioned, honest people, there are [those] who will bend the rules, break the rules, potentially hurt subjects, [and] hurt science,” says Jack Corman, principal consultant to JHC Consultations and the 2018 chair of ACRP’s Professional Ethics Committee.

“ACRP’s primary function is to improve the professionalization of clinical research,” he adds. Developing and maintaining a robust ethics regime is critical to that effort.

“I’m concerned by what I’ve seen over the years in clinical research in general,” Corman adds. While he’s not suggesting negative ethical issues are necessarily on the rise, he’s also not convince they’re in decline, either. “Has society progressed to the point where it’s anything goes, and cheating is what you need to do?” Corman asks.

As a member of ACRP’s ethics committee, he’s hoping to be part of the effort to “identify and root out” the most serious violations. There’s work to be done, Corman adds.

“We’ve been actively working with members to help promote the highest possible standards for everyone in our industry,’ says ACRP Executive Director Jim Kremidas. It’s a group effort that must incorporate the latest information and new understandings, he adds (Read More).

Ensuring Patient Safety and Ethics in the Trenches – Join us at ACRP 2018 this April for an active discussion of ethical and patient safety considerations related to informed consent, inclusion and exclusion criteria rationale, the difference between clinical care and clinical research, and much more. This interactive session will address the importance of ethics and patient safety with passion, props, and audience participation. View Session Details

ACRP 2018

While ethics matter everywhere, ACRP professionals literally work in life-and-death environments, Kremidas stresses. “I can think of no other situation where strong, clearly defined, ethical best practices are so important.”

“Some of the things that we have seen are shocking,” Corman says. For example, security footage at a site showing an unauthorized person gaining access to a computer holding sensitive data in order to manipulate it, or evidence of staff cutting corners in informed consent practices. The relatively few bad actors in the field such as these can give the entire industry a black eye, especially when the bad faith performance is splashed across the front pages of newspapers and leading the nightly news.

Corman’s advice to would-be whistleblowers? “If they observe troubling, unprofessional behavior by anybody who is conducting, or seeks to conduct, clinical research or seeking certification by ACRP, the ethics committee is the place to come.”

Before reaching out to the committee, whether anonymously or on the record, Corman advises pulling together as much documentation as possible. The whistleblower should do his or her homework in order to understand the code of ethical conduct in question and understand the alleged violation.

“Every single complaint is taken seriously,” Corman says. Enforcing ethics is a serious charge, and the committee’s way of operating reflects this. “We don’t jump to conclusions—we look at things from all sides, and that’s how we conduct our deliberations for any disciplinary actions, if warranted.”

Author: Michael Causey