Forum to focus on rules on human subjects in research



Representatives of five federal agencies and researchers from across the country will gather to discuss human research protections at a community forum hosted by the University of Notre Dames Office of Research on May 16 (Tuesday) in McKenna Hall.

The event is one of only two community forums being held nationally this yearby the Department of Health and Human Services(DHHS) Office for Human Research Protection (OHRP). The forum will address topics regarding human subjects protections in biomedical and social/behavioral research.

Having five federal agencies on campus is a great opportunity for our research community,said Jeffrey Kantor, Notre Dames vice president for Graduate Studies and Research.

DHHS regulations guarantee basic protections to human subject research participants. Each institution engaged in DHHS-supported human subject research is required to negotiate an approved federal assurance that its research meets federal regulatory requirements.

According Jennifer Morehead, assistant director of sponsored programs at Notre Dame, organizers anticipate that the Notre Dame forum will draw 300 participants regionally and nationally from institutions such as Northwestern University, the University of Michigan, the University of Illinois and Tufts University.The forum will examine special protections for vulnerable population groups, address the responsibilities of researchers and investigators involved with human subjects, discuss the application of ethical principles and guidelines for human subject research and provide insight into the National Institutes of Health (NIH) and the peer review process.

The forums keynote address,How Far Have We Come and How Far Still to Go? Can the Federal Regulations Accommodate All Types of Research,will be delivered by Eric M. Meslin, director of the Indiana University Center for Bioethics.

A panel discussion titledHighlights and Updateswill feature Bernard A. Schwetz, director, OHRP; David A. Lepay, senior adviser for Clinical Services and director of the Food and Drug Administrations Good Clinical Practice Program; Chris B. Pascal, director, Office of Research Integrity, DHHS; Lorraine G. Fitzsimmons, senior health policy analyst (contractor), Clinical Research Policy Analyst and Coordination (CRpac) Program, Office of Science Policy, NIH; and Jeffrey W. Rodamar, protection of human subjects coordinator for the U.S. Department of Education.

The OHRP community forum is cosponsored by the Notre Dame-based National Consortium for Graduate Degrees for Minorities in Engineering and Science Inc., Indiana University-Purdue University at Indianapolis and the University of Michigan.

_ Contact: Jennifer Morehead, assistant director, Office of Research, 574-631-5537,_

TopicID: 17283