25 Years: Collaborating with Institutions

 

Quorum: 25 Years2016 marks the 25th anniversary of Quorum Review IRB.  When Quorum started in 1991 our founders added the values of customer service and consistent performance to the essential IRB role of ensuring the safety of people who join human experiments. Those values have sustained us and protected people in research while advancing scientific knowledge.

As part of our silver anniversary, we have developed a mission statement that reflects our legacy and remains true to what we do today:

The Quorum Mission

Protect study participants through the highest quality reviews, build a community dedicated to the well-being of all people, and drive research forward together.

Driving Research Forward Together

Our previous articles have discussed our support for expanded access to experimental treatments and how the composition and roles of our review boards have evolved over the years. This article examines how Quorum works with research institutions.

Quorum has always understood that speedier processes are not an excuse to forego quality or integrity. When we work with institutions, we seek to apply our systems and review to support their contribution to research.

The central IRB review model for industry studies offers some gains in efficiency, but many institutions have been understandably reluctant to surrender much responsibility for ethical decisions and participant protection to an external authority. We point to accreditation, our institution-specific processes, and our emphasis on quality to reassure our research institution clients.

When Quorum convened its first IRB meeting in 1991, academic medical centers (AMCs) were involved with almost all industry-sponsored research. As the table below from CenterWatch shows, that has changed. In 1994, AMCs once participated in 74 percent of industry trials; now that share is 34 percent.

AMC Share of Trials

 

This shift happened during a time when public funding research grew much more slowly (or even decreased) in comparison to industry spending.

 

Building a Community

A key feature of any community is its shared bonds. In addition, we have board members with experience on institutional IRBs, as well as employees from academia. As we see each other at conferences throughout the year or communicate online, we share knowledge and strengthen our ties. One IRB member who served on a hospital’s IRB before coming to Quorum once said that the infrastructure around the board was different, but the issues and discussions at the meetings were the same.

One component of our founders’ vision for Quorum was that its regulatory and ethical review responsibilities should serve less of a policing role than one of training, communication, and guidance. That has shown up over the years as Quorum representatives have conducted IRB site visits, provided training at sites and research institutions, and presented at conferences.

For the past two years we have co-hosted conferences with the Northwest Association of Biomedical Research (NWABR), and we continue our tradition of support into the digital age with an ongoing series of webinars, online newsletters, and blogs. On a practical level, early engagement services such as our Chairperson Study Assessment provide timely guidance to researchers.

Over the years we have worked with over a thousand institutions in overseeing research, but we have always maintained that independent and local IRBs have distinct and necessary roles. While we have served as the IRB for all human subjects research at some institutions, often our best contribution to an existing human research protection programs is to serve as a central IRB in multisite studies and allow the local IRB office expand into other areas.

 

More about Our Relationships with Institutions

STAT News recently ran an essay by Executive IRB Chair Dr. Stephen Rosenfeld and content manager Jim Gearhart about assessing IRB quality.

To continue the conversation about our perspective on institutions, we have developed a whitepaper that examines how three research institutions work successfully with multiple independent IRBs.  If you are attending PRIM&R’s Advancing Ethical Research (AER) conference in November, visit Quorum at booth 404 to get a copy. Otherwise, watch for this publication in the coming weeks or contact your Quorum Representative.

 

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