Human Subjects in Research to be Topic of UB Workshop

BUFFALO, N.Y. -- A workshop on the rules and regulations governing the use of human subjects in research will be held from 8:30 a.m. to 4:15 p.m. April 13 in the Center for Tomorrow on the University at Buffalo North (Amherst) Campus.

The workshop is being sponsored by the UB Office of the Vice President for Research, headed by Dale M. Landi, Ph.D., and the Research Foundation of the State University of New York. There is no charge for the workshop.

Research universities have been on particular alert recently concerning their handling of human-research subjects following the federal government's temporary suspension of research at five universities in the past 10 months because of violations of the regulations by institutional review boards.

The workshop will be led by Jeffrey M. Cohen, Ph.D., associate director for education in the Office of Protection from Research Risks (OPRR) in the Department of Health and Human Services, and Paul W. Goebel, Jr., a senior member of that department and, until recently, associate director for human subject protection at the Food and Drug Administration (FDA).

The morning session will be geared to members and administrators of institutional review boards, while the afternoon session will be directed toward principal investigators on research grants. Morning topics to be discussed are "Recent OPRR Regulatory Measures: Lessons Learned" and "Overlapping Federal Regulations: The Common Rule and the FDA."

Afternoon topics will be "Understanding the Basis for the Regulations: The History and Ethics of Human Subjects Protection" and "A Heightened Awareness: Current Developments in Human Subjects Protection."