PRINCETON, N.J.—WIRB-Copernicus Group (WCG), which touts itself as the world’s largest provider of regulatory and ethical review services and software to support clinical research, has launched the WCG Foundation. It is reportedly the first 501(c)(3) public charity founded by an independent institutional review board (IRB) to strengthen protections for research participants and improve health and well-being worldwide.
WCG Chairman and CEO Dr. Donald A. Deieso points out that federal law requires that an IRB review any clinical trial involving a human being to be sure the trial is protective, noting, “The IRB reviews the protocol, investigators’ backgrounds and reviews and approves informed consent forms.”
“As the industry leader, it is our responsibility to introduce new and transformative ideas, ones that will result in an improvement in the quality of clinical research and the enhancement of human health,” says Deieso. “We established WCG Foundation because we believe in the power of the independent public charity and in its extraordinary potential to make differences in the lives of desperately ill patients, research professionals and research participants.”
WCG Foundation will initially focus on three programs: advancing education and training in research ethics at U.S. academic institutions, providing scholarships for the Western Institutional Review Board (WIRB) International Fellows Program and making IRB review more affordable for patients who are desperate to gain access to experimental treatments.
“Desperately ill patients and their families learn about experimental treatments in different ways,” notes Dr. Marjorie Speers, who was tapped to serve as WCG Foundation executive director. “They may hear about them from others patients or their families, from their physicians or social media. There is no formal system to which desperately ill patients can turn to learn about experimental treatments. One of the foundation goals is to work with others to develop a transparent and equitable process for patients and their families to navigate the expanded access process so that patients gain access, when it is appropriate, in a timely manner and without barriers. This is the reason that the foundation has created a program to reimburse at cost for institutional review board review of expanded access applications. Currently, the foundation is accepting gifts that may be used to support this program.”
“We see an enormous opportunity—and obligation—to build an educational infrastructure that can strengthen research protections, elevate the quality of research and, ultimately, increase its benefit to humankind,” adds Speers. “We also empathize with patients seeking one last source of hope and, therefore, will work to reduce financial barriers and help make experimental treatments more accessible.”
To improve training in research ethics, IRB review and management and IRB regulatory compliance, WCG Foundation will provide grants for academic institutions to develop courses and certificate and degree programs that professionalize IRB training. The foundation will also expand the existing WIRB International Fellows Program, providing scholarships to help enable global healthcare professionals to receive research ethics education in the United States.
WCG Foundation will award scholarships to cover traveling and living expenses for healthcare professionals who wish to attend the WIRB International Fellows Program but cannot afford the costs of traveling to and living in the United States for an extended period of time. Scholarships will be granted based on financial need.
The former president and CEO of the Association for the Accreditation of Human Research Protection Programs, Speers served as acting executive director of the National Bioethics Advisory Commission and oversaw research protections for domestic and international research at the U.S. Centers for Disease Control and Prevention.
In addition to the educational and training aspects, as an act of compassion, WCG Foundation will help desperately ill patients who have exhausted all other options and are seeking access to experimental drugs and medical devices. To help reduce these patients’ financial burden, the Foundation will cover the cost of IRB review for applications for single-patient expanded use.
WCG is a family of companies that includes five IRBs: WIRB, Copernicus Group Independent Review Board, Aspire Independent Review Board, Midlands Independent Review Board and New England Independent Review Board. In addition, it includes IRBNet, which provides research compliance software for institutions, and ePharmaSolutions, a leading developer of technology-enabled solutions to optimize study startup.
For more than 40 years, WCG has demonstrated its commitment and leadership in the field of research ethics, driving the industry to adopt new and innovative processes to improve the protection of research subjects.