Toasting the Past, Present, and Future of Ethics in Research

 

Quorum: 25 YearsAt a recent reception for our 25th anniversary, Quorum Review IRB CEO Cami Gearhart and Executive IRB Chair Dr. Stephen Rosenfeld each reflected on the state of ethical review and medical research today. Here are some highlights of their speeches.

 

 

Cami: Bringing Perspectives Together for 25 Years

Cami noted how much has changed in the world of ethics review and for Quorum since 1991. When the first CEO was hired, Quorum had 12 employees; we now have more than 200. Quorum has expanded from one institutional review board (IRB) panel in Seattle to multiple panels located on each coast of the U.S. and in Canada, with members and consultants located across North America. “Quorum works with over 1,100 institutions, is consistently ranked as the most preferred IRB to work with, and its new division Kinetiq provides regulatory consulting and IT services and products,” Cami said. And for 2017, she added that Quorum and Kinetiq “are excited to be bringing an eConsent tool to the market.”

The four Quorum founders had distinct perspectives on an IRB’s mission, as Cami recalled. “Our founders included a university professor, a hospital administrator, a private research site coordinator, and a former IRB Chair,” She said. “Despite their differences, these four were aligned by the belief that ethics review could be done better.”

Cami said that the Quorum mission statement focuses on three components of the founders’ original goals: to provide high quality ethics review; to build a community dedicated to the well-being of all people; and to drive research forward together.

“I am proud to continue the legacy of bringing together experiences from academia, hospital systems, private research sites, and ethics review professionals. And I am proud to continue striving to do ethics review better.”

Dr. Stephen Rosenfeld: It is an Exciting Time

Dr. Rosenfeld opened by admitting the five years he has spent as the Quorum IRB Chair “is the longest period in my career during which I’ve had the same role or the same title.” He added, “As a Board chair, working on one side of the necessary board/business division, I have the privilege of engaging in the fundamental jobs of the IRB, which are the immediate protection of research participants and the evolution of research ethics.”

Medical research is changing rapidly, a fact that Dr. Rosenfeld pointed out. For one, while the distinctions between research, health care, and the activities of living used to be clear and useful, they “are now blurring.” These fading boundaries “challenge the whole idea of the therapeutic misconception. They also force us to confront the cost society is willing to pay for knowledge, and who speaks for ‘society.’”

Dr. Rosenfeld discussed the role of IRBs in looking at these ideas. “In the absence of law, regulation or even clear ethical norms, IRBs are the ones struggling with these issues. We owe it to society and to our children to address them responsibly, consistently, and transparently. Our decisions will serve either as the building blocks or as points of failure in developing a modern research ethic.”

He also challenged the idea of a deeply divided America. Instead, he argued that we are at a time of historic distrust in “elites and those in authority.” The medical and research communities have a new responsibility: “to find every opportunity to demonstrate our trustworthiness based on 21st century concerns.”

“It really is an exciting time,” Dr. Rosenfeld said. “And I can’t imagine a place I’d rather be than at Quorum, as we begin our second 25 years.”

 

Tags: , , ,