Genetic Data, Tissue Samples and Research Subjects with Cognitive Impairment are Among the Sensitive Issues to be Explored at Two-Day Conference Orga

June 01, 2000

A review of current and evolving concerns about medical research with human subjects will be presented at a two-day educational conference for researchers and institutional review boards on Thursday and Friday, June 8th and 9th, at the Hyatt Regency Chicago.

Representatives from the two federal agencies that regulate medical research, the Office for Protection from Research Risks (OPRR), and the Food and Drug Administration (FDA), will lead off the conference that will also feature ethicists, researchers, physicians and administrators from across the country.

Some of the topics that will be covered include protecting the privacy of subjects who donate genetic materials and/or tissue samples for research; ensuring every volunteer's understanding of the full nature of the research study as well as related risks and benefits; and limits on accepting the informed consent of volunteers who have cognitive impairments. Officials from Rush's Office of Research Affairs solicited funding from the National Institutes of Health (NIH) for the conference, as well as well as the agency's cooperation and support.

Physicians who attend can receive continuing medical education credit through the University of Illinois at Chicago, an institution participating in the conference with Rush. More than 300 individuals had registered for the conference.

Issues related to the safety and ethics of medical research have been making headlines for the past two years.

Working with OPRR, Rush reorganized its research structure in 1998 to improve its administration, policy and procedures governing human research. Since that time, several other prestigious academic medical centers have updated their research efforts as well.

Rush has benefited from its experience by becoming a model institution in terms of human subject protection, according to several federal officials. Rush research officials have been asked to advise many other academic medical centers about how to manage a research program in complete compliance with federal regulations. Another example of Rush's leadership role in this area is the forthcoming national conference.

The federal government continues to raise its expectations for the conduct of research involving human subjects since June 1998 when the Health and Human Services inspector general called on the FDA and the NIH to reform human subjects protection.

On May 23, the Clinton administration announced that it is about to implement a number of new initiatives to improve the ways scientists involve human subjects in medical research. Clinton indicated he will seek authority from Congress to fine scientists up to $250,000 for violating federal rules for human research, and $1 million on the universities that employ them.
*NOTE TO EDITORS, REPORTERS: You are invited to attend the workshop. To register or for additional information, contact Rush Media Relations at 312-942-5579.

Rush-Presbyterian-St. Luke's Medical Center includes the 809-bed Presbyterian-St. Luke's Hospital; 154-bed Johnston R. Bowman Health Center for the Elderly; Rush University (Rush Medical College, College of Nursing, College of Health Sciences and Graduate College); and seven Rush Institutes providing diagnosis, treatment and research into leading health problems. The medical center is the tertiary hub of the Rush System for Health, a comprehensive healthcare system capable of serving about three million people through its outpatient facilities and seven member hospitals.

Rush University Medical Center

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