For Immediate Release: July 14, 2010

Contact: Sarah Bilofsky (518.588.7562; sbilofsky@uniongraduatecollege.edu)

Union Graduate College’s New Research Ethics Concentration is First of its Kind in the U.S.

Responding to a Fast-Growing Field and More International Human Testing, New

On-Line Master’s Program Prepares Students to Design Ethical Studies that Meet Tighter FDA Oversight

SCHENECTADY, NY – Union Graduate College is now offering the country’s first-ever specialization in Research Ethics, as part of its Masters of Science in Bioethics degree. Launched to meet growing demand in this emerging field, the new program focuses on the protection of human participants and animal subjects in drug trials and other biomedical research. It is offered online, with three intensive “on-site” courses of one to two weeks during the summer. Designed as a part-time program, it takes about three years to complete, allowing students anywhere in the country to maintain a full time job while completing the degree.

“With the rapid advancement in technology, plus a few high-profile scandals the Avandia case, the research ethics field has exploded in the last decade,” explains Robert Baker, Ph.D. director of Union Graduate College’s Center for Bioethics and Clinical Leadership. “It is like a child who went from crawling to a full run overnight. As a result, many organizations lack the depth of expertise that is suddenly required—especially when conducting studies in other countries. This research ethics specialization fills that gap, and our online, part-time format allows organizations to keep a valuable employee on the job while they are pursuing their degree.”

While many may be unfamiliar with research ethics, the most have heard of the scandal that thrust it into the spotlight: the 2004 global recall of popular painkillers Vioxx and Celebrex. In both cases, the FDA approved the drugs based on submitted data and testing, but later studies proved the drugs had far higher risks for heart attacks and death than originally reported. Since then, the Federal Drug Administration (FDA) has tightened the reins on the drug approval process – as evidenced by a panel vote this week to restrict the use of the diabetes drug Avandia.

Union Graduate College already offers a Master’s in Science in Bioethics with a specialization in Clinical Ethics. Currently offered in partnership with the Mt. Sinai School of Medicine in New York City, Mt. Sinai will also partner in the new research ethics specialization. Clinical ethics deals with decisions made at the hospital bedside, while research ethics focuses on the design and testing of new drugs or medical interventions before they reach the patient.

The new degree specialization is the first of its kind in the U.S., however Union Graduate College has been teaching a similar research ethics program in Eastern and Central Europe for

the last six years through a grant from the National Institutes of Health. Young countries in that region have been a hotbed of human testing in recent years, as companies take advantage of lax laws and poor populations. The purpose of the NIH grant is to improve protections by educating lawyers, lawmakers, scientists, doctors, professors and other professionals in those countries about research ethics. Building on its success in Eastern and Central Europe, Union Graduate College has tailored courses in the new research ethics program to meet the needs of North American students.

Sean Philpott, Ph.D. directs the new research ethics specialization. A public health expert, Philpott has conducted extensive HIV prevention and transmission research in Africa and Asia, working with organizations like UNAIDS and the Centers for Disease Control and Prevention (CDC). Philpott currently chairs the U.S. Environmental Protection Agency's Human Studies Review Board.  Founded in 2006, the board reviews scientific and ethical aspects of research that is submitted to the EPA for regulatory purposes.

Philpott says he expects Union Graduate College’s new research ethics program to draw students from drug companies, biomedical firms, major university and government labs, as well as think tanks, not-for-profits and health policy groups.

“Today, more than 90% of all drug research is being done outside of the United States,” says Philpott. “Most of it is being done in developing countries with little legal regulation or oversight. The students we train in research ethics will be shaping global research ethics policy and standards for years to come. This isn’t just about meeting tighter FDA regulations – it is also about making sure companies are doing the right thing to protect human test subjects around the world.”

To learn more about the Union Graduate College Bioethics Program, visit: www.uniongraduatecollege.edu.