Citing the need to provide advanced training and education in research ethics, extend scholarships for an international fellows program and make institutional review board (IRB) reviews more affordable for patients who are desperate to gain access to experimental treatments, WIRB-Copernicus Group has launched the WCG Foundation, a nonprofit public charity, to pursue those three programs.

As the nation’s largest IRB, the nonprofit is reportedly the first of its kind to build an infrastructure designed to strengthen research protection, elevate the quality of research and strive to make a difference in the lives of desperately ill patients, according to foundation CEO Marjorie Speers, Ph.D.

“The timing was right to establish the foundation with these three program areas that could benefit patients, the public and research participants,” said Speers, who previously served as president and CEO of the Association for the Accreditation of Human Research Protection Programs. “We see ourselves as a catalyst through the foundation to transform clinical research to a different level.”

The advanced education training and ethics program at the university level will go beyond theoretical and ethics concepts. The foundation plans to work with universities to develop courses and curriculum that could lead to a certificate or a degree in applied research ethics.

“What we don’t have in our institutions of higher learning are applied ethics research programs, where students can learn the theoretical basis of ethics but also the practical, where this combination is part of IRB reviews and regulatory compliance,” said Speers. “On the other side, we have IRB administrators and professionals who are dealing with ethical issues but don’t necessarily have a very broad or deep background on the conceptual side of research ethics. What we would like to do is award grants to the innovators who can develop courses that bring together conceptual and application ethics.”

Nowadays, she noted, an IRB professional may not have any formal academic training in IRB review and management or regulatory compliance.

The foundation also will expand the existing WIRB International Fellows Program, providing scholarships to help enable global healthcare professionals to receive travel and living expenses in the U.S. The scholarships are for two-month and six-month training programs designed to help participants develop the knowledge necessary to create, manage or administer international review boards that will operate in compliance with all relevant regulations and ethics standards to protect the rights and welfare of human research subjects.

Since its inception in 2002, 138 international fellows have graduated from the program. This year’s participants are from Peru, Liberia, China and Thailand—countries in which clinical research is on the rise. Classes will continue to be held at WIRB and New York University’s Langone Medical Center. The foreign fellows supplement their coursework in human research ethics, informed consent and subject protections with practical training, mentorship and observation of actual IRB meetings.

The WCG Foundation also will provide financial assistance to desperately ill patients who have exhausted all other options and are seeking access to experimental drugs and medical devices. The foundation will cover the cost of IRB review of applications for single-patient expanded use.

“Improving access for very ill patients hoping that a promising medication which doesn’t have final FDA approval is one very important and welcome area that the foundation is getting involved in, along with putting more research ethics into higher education and medical school curriculums, which is surely needed,” said Elizabeth A. Bankert, former assistant provost at Dartmouth College and now director of the Dartmouth IRB.

Speers said the FDA estimates that through 2013, fewer than 1,000 seriously ill patients had been approved for single-use applications annually—but that number doubled in 2014, as more patients sought access. The foundation, she explained, will be able to help others participate in the IRB review process for experimental treatments under “compassionate use.”

“We don’t want the IRB review to be a financial barrier to these patients, as we want them to get a good IRB review, so the foundation plans to work with IRBs willing to review applications at cost, with the foundation reimbursing them,” said Speers.

She added that some severely ill patients seeking unapproved medications undergoing clinical trials will need an IRB decision on their application in a matter of hours. The foundation also will work with patient advocacy groups, the FDA and biopharmaceutical companies to make the process fair, transparent and equitable without jeopardizing ongoing trials and the regulatory process.

Speers said most of the programs being pushed by the foundation could begin next year as her organization is looking to raise money to fund them.

WCG Chairman and CEO Donald Deieso, Ph.D., who convinced Speers to lead the foundation, said WCG’s responsibility is to introduce new and transformative ideas that will result in an improvement in the quality of clinical research and enhance human health.

“We established the WCG Foundation because we believe in the power of the independent public charity,” Deieso said in a prepared statement, “and in its extraordinary potential to make a difference in the lives of desperately ill patients, research professionals and research participants.”

Ronald Rosenberg is a former business and science reporter for The Boston Globe. He has written features for New Scientist and Inc. magazine. His lengthy journalism career includes editing an award-winning weekly newspaper in Cornwall, N.Y. Ron also was a media relations specialist for the science faculty at Boston University, and a Knight Science Journalism Fellow at the Massachusetts Institute of Technology. 

This article was reprinted from Volume 19, Issue 46, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »