It isn’t in our nature to seek the limelight or to sing our own praises.
But when you turn 50, well, that’s something pretty special. Being the first independent ethical review board and a global leader in research ethics, we wanted to take a moment to celebrate the pioneering spirit that brought us to life, the can-do attitude that’s kept us going, and the vision that guides us into the future. And, we want to celebrate it with all of those who have been a part of our journey, because we realize that the real power comes from working together.
Being first is never easy, but it’s always important. Ours is not a job, it’s a calling. We are passionate about protecting people, and are inspired by science and medical discovery.
This is the story of how a single idea changed the world. And how together with our partners we are protecting lives and helping to fuel scientific and medical progress, all around the world, every single day.
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. Now—fifty years later—WIRB remains the first and largest independent review board in the world, and is widely regarded as the “gold-standard” of research ethics.
The NIH requires ethical review of human research. The first academic IRBs are established to carry out this mandate.
News of the U.S. Public Health Service Syphilis Study at Tuskegee causes public outcry. It is uncovered that the U.S. government-sponsored trial, studying Untreated Syphilis in the Negro Male, was performed without the informed consent of its participants, and continued long after penicillin was adopted as the standard of care. The study raises public awareness regarding the importance of ethical oversight in clinical research. Law suits are filed on behalf of the participants, and they are granted medical benefits and damages, as well as a Presidential Apology.
Following four years of intense deliberation, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research publishes its historic Belmont Report, which identifies basic ethical principles and guidelines to address ethical issues arising from the conduct of research with human subjects. The Belmont Report was—and still is—the foundation upon which modern human subject protection is based.
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, WIRB is the trusted IRB partner to over 3,000 institutions, including 150 academic medical centers. Proudly, the University of Rochester continues to be one of them.
WIRB solidifies its partnership with institutions by expanding its services to include the administration of Institutional Biosafety Committees (IBCs). Today, WIRB is the unrivaled leader in this domain: its IBC services team (now recognized as WCG Biosafety) has administered IBCs for more than 580 institutions, reviewed more than 310 human gene transfer clinical protocols and 27 bench research projects, and reached an important milestone of having conducting 4,000 convened IBC meetings in the U.S and abroad.
In partnership with the World Health Organization (WHO), the NIH, and the University of Washington, WIRB establishes the International Fellows Program, 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 (AAHRPP), for meeting rigorous standards of ethics, quality, and protections for human research. WIRB has maintained its AAHRPP accreditation since 2003, and currently administers 7 individually accredited review panels. As such, WIRB is one of the world’s most respected and trustworthy research oversight bodies.
Together with Copernicus Group IRB, the leading provider of independent IRB services to research sponsors and contract research organizations, WIRB becomes a founding member and namesake 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.
WCG announces, on behalf of its IRB Division, the creation of an oncology-focused IRB supported by a world-class advisory committee, to ensure that the company stays ahead of the many advances in cancer research. WCG Oncology is constituted of three dedicated IRB panels, which focus wholly on the ethical oversight of oncology research, a cadre of expert oncological specialists to assist in the review of complex and scientifically-challenging research, and an expert advisory board to provide the company with strategic counsel regarding this rapidly evolving field. Each year, WCG’s IRB Division reviews over 1,000 oncology protocols and oversees significant advances in gene therapy, targeted treatments, and companion diagnostics.
WCG establishes WCG Foundation, the first 501(c)(3) public charity founded by an independent IRB to strengthen protections for research participants and improve health and well-being worldwide. As part of its mission, the WCG Foundation makes IRB reviews more affordable for patients who are desperate to gain access to experimental treatments. Since its earliest days, WIRB has performed these reviews at no cost to the treating physician or patient. Today, WIRB continues this proud tradition, collaborating with WCG Foundation to improve the quality and accessibility of IRB review and decrease the IRB approval time for expanded access patients, thereby maximizing their chances for a positive outcome.
2015- 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 will spend learning about clinical research oversight at the WIRB campus in Washington State, the program now includes a two weeks during which they will study research ethics at the NYU Center for Bioethics in New York City.
WCG establishes a Gene Therapy Advisory Board 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.
WCG continues its legacy of innovation by supporting its clients in bringing historic and revolutionary treatments to market. In 2017, Novartis introduced Kymriah™, the first cell-based gene therapy approved for use in the U.S., and Otsuka Pharmaceuticals won FDA approval for Abilify MyCite® (aripiprazole tablets with sensor), the first pill to include a digital sensor that tracks if and when it has been ingested. WCG is extremely proud to have supported Novartis and Otsuka in these extraordinary achievements.
WIRB celebrates 50 years as a trusted advisor, esteemed partner, and ethical counselor to the biomedical research industry.