25 Years: Celebrating a Legacy of Participant Protection Through Expanded Access Review

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2016 marks the 25th anniversary of Quorum Review IRB. When Quorum started in 1991 our founders considered customer service and consistent performance essential to the IRB role of ensuring the safety of people who joined human experiments. Those values have sustained us and have served to protect people in research while advancing scientific knowledge.

As part of our silver anniversary, we have developed a mission statement that is true to both our legacy and 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.

This is the first in our Silver Anniversary Series of blog articles that describe how we pursue our mission. This blog article examines how we support expanded access to experimental treatments to drive research forward.

Enhancing the Well-being of People Through Expanded Access

Medical care and medical research are taking welcome steps toward putting the patient (and research participant) at the center of care. Patient reported outcomes (PRO) are one example of this movement, as are the increasing efforts to include patient perspectives in the design of clinical studies. Along with this trend has come greater attention toward when and how experimental treatments can be available to people normally outside of a research project.

The FDA has a number of policies for these needs, often called Expanded Access and Compassionate Use. Along with the calls for a greater voice for participants come questions about and requests for these programs.

In two recent blog articles, Kinetiq Senior Regulatory Analyst Jessica Huening reviewed the FDA’s latest Expanded Use policy guidance. While the FDA rarely refuses requests for Expanded Use, many state governments are seeking to broaden these national policies. Numerous states (and a U.S. Senator) have introduced or passed “Right to Try” legislation, which aims to increase access to experimental treatments. The proposals have attracted close scrutiny as well as passionate appeals.

At Quorum, we have substantial experience reviewing these exceptional uses of experimental treatments, and we have expertise in evaluating both Expanded Access protocols and proposals for the emergency use of investigational devices and drugs. For 25 years the Quorum mission has compelled us to prioritize the people involved in research—our own employees, the busy staff at research centers and, most importantly, study participants —including the special circumstances when patients need to become participants.

Quorum takes its mission of improving the well-being of people seriously, and we are proud to work with investigators, sponsors, and patients within the complicated but potentially life-saving frameworks of providing special access to experimental treatments. In service of this mission, Quorum has policies in place not only to accommodate the unique needs of these protocols but also to waive a participant’s costs for IRB review.

Silver Anniversary Series

In the coming weeks, look for future blog articles as we celebrate 25 years of excellence in ethical research.

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