Choosing an IRB

by Cami Gearhart

CEO Remembers 2017: Starting 2018 With Exceptional Commitment

At Quorum we are committed to a three-pronged mission: to protect study participants through high quality ethical reviews, to build a community dedicated to the well-being of all people, and to drive research forward together.

This mission also permeates our consulting and technology division, Kinetiq, which focuses on accelerating the success of life sciences organizations through innovative thinking, expert advice, and collaboration.

As CEO, I am proud that we don’t just declare these missions—we live them. And as we look back on 2017, accomplishments across the organization reveal our missions in action, from individual contributions to the launch of innovative new services.

 

High Quality Reviews

As the world’s leading IRB, we believe the first step to providing high quality ethics reviews is to rely on IRB members who understand both research and ethics. We’re proud that in 2017 the Executive Chair of our IRB, Dr. Stephen Rosenfeld, stepped into the role of Chair of the federal Secretary’s Advisory Committee on Human Research Protections (SACHRP), the committee charged with advising the Secretary of the Department of Health and Human Services on issues pertaining to the responsible conduct of research involving human subjects. Dr. Rosenfeld brings his nationally renowned expertise to every panel at Quorum Review IRB.

We also are committed to bringing superior IBC administration to the research community. In March, Kinetiq launched its IBC consulting service to assist research sites in establishing their own IBCs, and in June, Quorum engaged Bruce Busby, CHP, RSM, as its Biosafety and Radiation Officer. These steps set the stage for Quorum to launch an IBC administration and review service in early 2018 that will integrate with our award-winning IRB review services. Our clients will be able to leverage the Quorum One Touch Collaboration service commitment to manage both IRB and IBC review of protocols involving immunotherapy and other genetic technologies.

And our mission stretches beyond Quorum to support high quality reviews by and for other IRBs and institutions. In May, Quorum became the first independent IRB to join SMART IRB, a network of IRBs committed to a single reliance agreement in support of single IRB (sIRB) review. Quorum also has launched new tools and procedures to support fast and efficient delegation to Quorum as an sIRB.

 

Building a Community

Building a community dedicated to the well-being of all people is central to the work of both Quorum and Kinetiq. It was especially important this past year, as we all worked to determine how best to implement revisions to the Common Rule, the NIH requirement for single IRB (sIRB) review, and the 21st Century Cures Act.

The thought leaders of Quorum and Kinetiq tackled these issues with other leaders across the country. We are active in national organizations such as MRCT, CTTI, and ACRES, and in July we spearheaded a conference with NWABR on Disruption in Ethics. Quorum and Kinetiq leadership have made 20 presentations at major conferences across the country, on topics ranging from diversity in research to the use of big data and eConsent. We’ve offered five webinars free of charge that have reached over 11,000 people. We’ve published three whitepapers and 36 blog posts. And our materials aren’t just infomercials; as one researcher said to me, “You’re the IRB with a smart blogger!”

And Quorum’s commitment to community reaches even further. The devastating hurricanes that struck the American southeast and Puerto Rico this summer damaged research sites and upended the lives of research participants. In addition to swiftly setting up special communications channels for managing trials in the affected areas, Quorum supported the affected communities by donating to each of the three major hurricane relief funds.

 

Driving Research Forward Together

The launch of Q Consent™ reflects the third prong of our mission: to drive research forward together with our researchers and the clinical research industry. Q Consent is the first product launched by our Kinetiq technology team, and it is an eConsent tool designed to move the consent process into the paperless world of the 21st century.

How does Q Consent drive research forward? It is carefully crafted to satisfy the needs of the front lines of the research community as well as research participants. Q Consent:

  • Integrates with Quorum consent form review processes, so electronic consent forms can be pushed out to sites within days of IRB approval at a reasonable cost,
  • Accommodates multiple signatures by legally authorized representatives, parents, guardians, witnesses and investigators, and
  • Provides each participant with an individual portal by which the participant can receive revised consent forms, educational videos, retention materials, diaries, questionnaires, and other materials pushed out by the study team.

Furthermore, Q Consent is managed through the Quorum OnQ portal, minimizing the burden of study sites struggling with a variety of software applications.

To support the work of research monitors and sponsors, Q Consent allows the electronic oversight and management of consent forms within the confines of HIPAA requirements, and it can be used in the U.S. and Canada in compliance with PIPEDA, HIPAA, HITECH, Part 11, and the Children’s Online Privacy Protection Act (COPPA).

We’re thrilled at the warm reception that Q Consent has received and the success of our initial projects. We look forward to driving Q Consent forward into 2018 with more industry-leading eIC features and functionality.

 

Looking Forward to 2018

As we enter the New Year, Quorum and Kinetiq are poised to deliver even more solutions for accelerating research. New technologies, especially back-office integration, help us drive efficiency for our clients. Quorum already has two eTMF integrations activated with Veeva Vault, and we look forward to establishing many more in 2018. We’re also eager to see more initiatives come to life:

  • Our new, integrated IBC review service will launch in early 2018 and offer unparalleled speed and accuracy
  • Q Consent will be available for all sites, even if Quorum is not the IRB of record
  • Kinetiq has engagements with organizations across the country—and the world—to deliver success in clinical research, including compliance with the new Common Rule and with Part 11; with biospecimen collection and maintenance requirements; and with launching research overseas and in the U.S.

Quorum’s success now and in the future is rooted in the values and mission that have inspired our employees for more than 25 years. We are proud to be active members of the community that brings life-saving medications to the world.

As we celebrate the New Year with our clients and colleagues, we look forward to moving research forward together and strengthening our community ties to help you further accelerate the frontiers of science.

 

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