WCG IRB History

Western Institutional Review Board (WIRB) is founded by medical research pioneer, celebrated physician and noted philanthropist Dr. Angela J. Bowen. WIRB becomes the first organization of its kind, dedicated to protecting the rights and welfare of patients involved in clinical trials. WIRB is established three years before the National Institutes of Health (NIH) required ethics review of human research, four years before the news media brought the Tuskegee study to public awareness, and eight years before federal regulations demanded IRB review of human research.

Midlands IRB is founded in 1981, soon to become the leading specialist in Early Phase review.

New England IRB is founded in 1989 to provide regional ethical review support in Massachusetts, now the largest R&D hub in the United States.

Copernicus Group Independent Review Board (CGIRB) was founded in 1996, soon growing to become a leading provider of independent IRB services to research sponsors and contract research organizations.

Following the death of a research subject, WIRB assumes responsibility for the oversight of research at the University of Rochester, allowing research at the institution to continue. This is the first time that an institution has relied on an independent review board, but it will not be the last: as of 2018, WCG IRB is the trusted IRB partner to more than 3,000 institutions, including 150 academic medical centers. Proudly, the University of Rochester continues to be one of them.

IRBNet introduces technology to institutional research management through an NIH Grant in 2001.

WCG IRB solidifies its partnership with institutions in 2001 by expanding its services to include the administration of Institutional Biosafety Committees (IBCs).

In partnership with the World Health Organization, the NIH, and the University of Washington, WIRB establishes the International Fellows Program in 2002.

The International Fellows Program was designed to address the acute shortage of high-quality, compliant research oversight in developing nations. Through this intensive training program, WIRB provides its International Fellows with a deep knowledge of regulations and guidelines, as well as a comprehensive understanding of the best practices in human subject protection.

Since its inception, the WIRB International Fellows Program has educated 150 research professionals from over 20 countries.

WIRB is the first independent IRB to earn accreditation by the Association for Accreditation of Human Research Protection Programs.

WIRB earned AAHRPP accreditation for meeting rigorous standards of ethics, quality, and protections for human research, and has maintained accreditation since 2003. WIRB currently administers seven individually accredited review panels. As such, WIRB is one of the world’s most respected and trustworthy research oversight bodies.

Aspire is founded in 2004, becoming the first female- and minority-led independent IRB.

In 2010 Copernicus Group becomes the first IRB to achieve ISO Certification, in recognition of rigorous quality management.

WIRB and Copernicus Group IRB become the founding members and namesakes of the WIRB-Copernicus Group (WCG).

Consisting of 20 of the clinical research industry’s most well-respected and innovative service companies, WCG endeavors to increase the speed and quality with which new therapies are brought to market. WIRB and Copernicus Group IRB, with New England IRB, Midlands IRB, Aspire IRB and IRBNet, make up the IRB Division of the WCG Clinical Services Organization.

WIRB follows its sister organization, Copernicus Group IRB, to become the second independent IRB to achieve ISO 9001:2008 certification in recognition of its rigorous quality management standards. WIRB, like all members of WCG’s IRB Division, is recognized for its extraordinary commitment to efficiency, the hallmark of its many continuous process improvement, quality management and lean six sigma initiatives.

WIRB expands its International Fellows Program to include the study of research ethics at New York University (NYU) Langone Medical Center.

In addition to the six months the Fellows spend learning about clinical research oversight at the WIRB campus in Washington state, the program now includes two weeks during which participants study research ethics at the NYU Center for Bioethics in New York City.

The WCG Gene Therapy Advisory Board is assembled in 2016 to advise the company on the latest advances in the complex and fast-growing field of human gene therapy research. Comprised of experts from diverse backgrounds with specialized knowledge of the commercial development, regulatory oversight, and clinical application of products involving recombinant DNA, the Advisory Board provides guidance and strategic counsel to inform the company’s oversight of human gene transfer research, which, among other considerations, involves the careful coordination of IRB and IBC reviews.

In 2017 WCG celebrates milestone of 4,000 convened IBC meetings within the United States and abroad.

WIRB celebrates 50 years as a trusted advisor, esteemed partner, and ethical counselor to the biomedical research industry.

On September 8, 2020, WCG announced the formal unification of their five industry-leading IRBs – Western IRB (WIRB), Copernicus Group IRB (CGIRB), Midlands IRB (MLIRB), New England IRB (NEIRB), and Aspire IRB – into the single WCG IRB brand.

Since 2012, the organization has successfully assembled and integrated a powerful array of premiere IRBs, now synthesized into a single, industry leading world-class IRB. WCG clients will experience a singular, unified process, fee schedule, and revolutionary submission platform that will not only elevate their user experience but also continue to deliver gold standard service always with the highest regard to ethics and integrity.

“WCG IRB now represents the most powerful single IRB in the world – with hundreds of thousands of users among sponsors, CROs, and institutions who rely on the global industry leader to set the standard for quality, efficiency, and timeliness in this critical step of the clinical trial process,” said Don Deieso, PhD, WCG CEO. “It’s just one more example of our commitment to leading the way for this industry and continuing to enable clinical research in a positive way..”

“We’ve been acting operating internally as a single IRB for years,” says Dawn Flitcraft, head of WCG’s Ethical Review Division. “This final step in the unification of our IRBs is the natural move toward what our clients have told us they need and want. WCG clients love the teams they work with – and they love the simplicity of the single IRB. Under the WCG IRB banner, they get the best of all worlds – they continue to work with the teams they know and trust, who have set the standard for our industry for decades – and those teams are now connected seamlessly for a more powerful, unified experience for our clients and partners.”