PRESS RELEASES and NEWS

April 9, 2009

As part of an intensive review of Coast IRB’s SOPs and internal processes, we have implemented a 30-day suspension of the processing of new study submissions. We sincerely apologize for this inconvenience. We appreciate your understanding and patience as we work through this important process. Please contact your Coast representative for additional information or check back here at CoastIRB.com for continuous updates on our progress. As always, we value and cherish your continued patronage.

March 31, 2009

Effective immediately, Coast IRB is undergoing a 30-day internal audit of procedures until May 1, 2009. The purpose of this is to allow us to review our operations, SOPs and forms to validate the services we provide. To assist us in our evaluation, Coast IRB has hired a nationally-recognized consulting firm. We have chosen to review every aspect of Coast IRB, to reinvent the company and make it stronger and most importantly, to further protect the rights and welfare of subjects in clinical trials. As we receive and implement their recommendations and performed the necessary analysis, we will be accepting new study submissions on a case-by-case basis. We appreciate your patience and support. This will not affect any current or on-going studies currently under Coast IRB review. Please contact us with any questions. Thank you

Letter from Dan Dueber, President / CEO Coast IRB, LLC

March 30, 2009

To Our Valued Customers,

Coast IRB was invited to testify before the United States House Energy Subcommittee on Oversight and Investigations hearing titled, "Institutional Review Boards that Oversee Experimental Human Testing for Profit" on Thursday, March 26, 2009. The hearing examined whether Institutional Review Boards (IRBs) and the federal government are adequately protecting human subjects of biomedical research. It is important that Coast IRB communicate to you, our valued customers of what we have learned and of our intentions moving forward; detail how we intend to incorporate sustainable development of improvement into our policy and our operations, how we will support our staff in doing so and the mechanisms for reporting our progress.

Since first joining Coast IRB in October of 2008, I have seen that the protection of human subjects is a solemn trust and is the paramount concern of every Coast IRB employee. However, from the Committee's proceedings I have learned that across the board changes to procedures governing intake and evaluation of clinical trials are needed, both at Coast IRB and throughout the clinical trials system. As a result, I pledge to you that Coast IRB will not await new law to bring about those changes. We will lead in that reform, not follow.

Our action plan for improving the process of clinical review is education and skills. After listening to members of the Subcommittee and evaluating their discoveries from their investigation, it is apparent there is much need for process improvement. While the media has not provided an accurate description of the facts, I have taken the criticisms of the Subcommittee to heart. I see vulnerabilities in a system I thought well protected by virtue of the professional credentials of the distinguished men and women who serve on our review board. I have listened carefully to the criticisms of the members and will implement changes to address each one. There are three broad ways that we aim to become more sustainable: in our policies; in the way we operate as an organization; and through our staff development and behaviors.

Effective immediately, Coast IRB is taking the following steps:

Coast IRB is investigating all clinical trials now under its review to verify that the qualifications of all principal investigators are accurate and up-to-date, to determine that identified sites for the conduct of clinical trials are real, and to determine that all government approval numbers and references are valid.

As a part of its standard operating procedures, Coast IRB will perform the same checks mentioned in 1 above on every new clinical trial protocol and all supporting information supplied to Coast IRB.

Coast IRB is revising its questionnaire for evaluation of new clinical trials to exceed industry standards and has hired a professional consultant expert in IRB administration and protocol reviews to develop that questionnaire and define the standard operating procedures needed to validate questionnaire responses.

Coast IRB is creating express criteria for professional board review of clinical trial protocols that will compel written analyses and determinations covering everything from a second verification of qualifications to a detailed analysis of the biochemistry and administration of drugs and devices for testing. Coast IRB has hired a professional consultant expert in IRB administration and protocol reviews to develop these criteria.

Coast IRB is terminating its practice of guaranteeing a 24 to 48 hour delivery of protocol submissions to its Board.

Coast IRB is requiring full board risk assessments of all new studies regardless of the regulatory status of the product.

Coast IRB is removing its present Board chair from that role and is replacing her with a new chair having not only a scientific background approved by its professional consultant but also experience in the critical review of IRB administration.

Coast IRB is hiring a professional clinical trial auditor and is increasing the number and frequency of random audits and is expanding the nature and scope of those audits.

In aid of expert training, Coast IRB is having its professional consultant expert in IRB administration and protocol reviews participate as a witness in all Board meetings over the next three months, to provide post-meeting critiques of the meetings, and to have authority to require additional board meetings to address issues deemed not adequately addressed by the board.

In aid of administrative training, Coast IRB is having its professional consultant expert in IRB administration and protocol reviews provide Coast IRB's intake staff with detailed intake assessment training and to observe and critique that training over a three month period.

At the end of the three month period specified in 8 and 9 above, the professional consultant expert in IRB administration and protocol reviews will recommend to Coast IRB the adoption of additional standard operating procedures to ensure permanent implementation of reforms designed to institutionalize her critiques of board and administration functions. Those SOPs will be implemented promptly.

All changes are being made in a transparent fashion with FDA being supplied documentation corroborating the reforms.

These twelve steps are just a start. They are among the comprehensive reforms Coast

IRB will implement immediately. Do we anticipate additional reforms? Yes, we contemplate continuous reexamination and improvement. Each designed to enhance our commitment to excellence. Our goal is to continue to serve you our customers and community with stability, strength and integrity while protecting the rights and welfare of subjects in clinical trials by providing an ethical and thorough review in a timely and efficient manner.

Thank you for your continued confidence in Coast IRB.

Respectfully,

Daniel S. Dueber
President / CEO Coast IRB, LLC

PRESS RELEASE FOR IMMEDIATE RELEASE: 3/30/2009
CONTACT: Diane Morrow (800-927 1517) or cell (817 319 9805)

COAST IRB HEEDS CALL OF CONGRESS;
PLEDGES COMPREHENSIVE REFORMS

Washington, D.C.:  Following yesterday’s hearing of the House Subcommittee on Oversight and Investigations, Coast IRB CEO Dan Dueber announced that his company would institute immediate and sweeping reforms.  “We share Congress’s objective of ensuring maximum protection for human subjects in clinical trials,” said Dueber.  “We are instituting comprehensive reforms to prevent recurrence of the vulnerabilities the Subcommittee brought to light,” he said.  “Our number one priority is the protection of human subjects.” 

Today, Coast is sending a written post-hearing statement to the Subcommittee for inclusion in the record.  That statement lists twelve specific reforms from background checks on every sponsor of a clinical trial to the hiring of an expert consultant to revamp Coast’s IRB reviews.  In addition, Coast is replacing the current chair of its IRB with a new chair and explains that the reform process will be continuing in nature even after the twelve specific reforms are instituted.

The reforms Coast now institutes may one day be required by law for all IRBs if Congress enacts legislation based on the Subcommittee’s deliberations.  “For Coast, this process of reform is not going to end,” said Dueber.  “We mean for it to be continuous, making reexamination and improvement a dynamic, not a static condition,” he said.  “Coast intends to exceed the requirements of the law, not just meet them.”

Copies of the Post-Hearing Statement of Daniel S. Dueber are available upon request.

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