OR WAIT null SECS
© 2023 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
Applied Clinical Trials
PRINCETON, N.J., June 19, 2015 – WIRB-Copernicus Group® (WCG), the world’s largest provider of regulatory and ethical review services and software to support clinical research, announced today that its 13th annual WCG International Fellows Program in Research Ethics now includes ethics training at New York University (NYU) Langone Medical Center.
The program was originally founded in 2002 by Western Institutional Review Board (WIRB), a subsidiary of WCG, in partnership with the World Health Organization (WHO) Research and Training in Tropical Diseases, the National Institutes of Health (NIH), and the University of Washington. The training program is for global healthcare professionals who intend to establish or improve institutional review boards (IRBs) in their countries. It is an intensive six-month program designed to help participants develop the knowledge necessary to create, manage, and/or administer international review boards that will operate in compliance with all relevant regulations and ethics standards intended to protect the rights and welfare of human research subjects. WHO chose WIRB to host this program because of WIRB's undisputed leadership in the field of bioethics.
“At WCG, we are committed to promoting the highest ethical and regulatory standards in clinical research worldwide,” commented WCG Chairman and CEO Donald A. Deieso, Ph.D. “As drug development trials are being conducted in an expanding list of countries, there is an acute shortage of well-organized local IRBs and trained professionals to provide the necessary oversight for research involving human subjects. Through our fellows program, we provide our international fellows with a deep knowledge of regulations and guidelines and a comprehensive understanding of the best practices in human subject protection. Once they are so empowered, we expect that they will return to their countries and establish high-quality, compliant local IRBs.”
To date, 138 international fellows have graduated from the program, and many have made significant contributions to the field of clinical research in their home countries. A WCG fellow from Liberia played a key role during the 2014 Ebola outbreak in West Africa: he was appointed to the country’s new National Research Ethics Board, which is now registered with the Office for Human Research Protections at the U.S. Department of Health & Human Services, and was selected to serve on the regulatory and ethics team for the U.S.-Liberia Partnership for Research on Ebola Vaccines in Liberia, which is evaluating two candidate vaccines to prevent against Ebola.
Participants in the 2015 WCG International Fellows Program have come from Peru, Liberia, China and Thailand – all countries in which clinical research is on the rise. During their time in the U.S., the fellows will study on both coasts: in New York at NYU Langone Medical Center, and in Washington at WIRB.
At NYU Langone Medical Center, the fellows will attend classes led by noted bioethicist Arthur Caplan, Ph.D., founding director of the Center’s Division of Medical Ethics. Dr. Caplan is one of the most highly sought-after opinions in medical ethics. He has served on a number of national and international committees including the Advisory Committee to the United Nations on Human Cloning, Advisory Committee to the Department of Health and Human Services on Blood Safety and Availability, and the Special Advisory Panel to the National Institutes of Mental Health on human experimentation on vulnerable subjects. Most recently, Dr. Caplan was appointed to the WHO Expanded Working Group on Ethics, which was established to respond to the ethical issues raised by the recent Ebola outbreak, and by Johnson & Johnson, which appointed Dr. Caplan to create aCompassionate-Use Advisory Committee to help the company make decisions regarding compassionate use of its investigational medicines.
“We are proud to partner with WCG on the expansion of its International Fellows Program, and we are delighted to welcome the fellows to NYU Langone Medical Center,” said Dr. Caplan. “The global medical research community will benefit tremendously from the knowledge and experience gained by these students during their time in the U.S.”
The fellows will supplement their coursework in human research ethics, informed consent, and subject protections with practical training, mentorship and observation of actual IRB meetings at WIRB. Founded in 1968, WIRB is the world’s first and oldest independent IRB. Recognized for its industry-leading quality practices, including ISO 9001:2008 certification, accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and its commitment to Lean Six Sigma principles, WIRB is known globally as the “gold-standard” of human research protections.