The protection of human subjects in gene transfer research explored at conference in July

June 22, 2004

The protection of human subjects as research volunteers in gene transfer clinical trials is the topic of a conference July 8-10, at the Hyatt Regency Hotel, Chicago, and sponsored by Rush University Medical Center, Chicago.

The conference is being held in collaboration with the federal Food and Drug Administration, the Office of Human Research Protection, the University of Chicago, the Department of Veterans Affairs, the University of Illinois, Chicago, and St. Jude Children's Research Hospital, Memphis.

Experts in the field of gene transfer and human subject protection will discuss the current and future state of gene transfer and the protection of human subjects, recombinant DNA, and the FDA perspective of good clinical practice.

The educational conference is open to the public with registration fees between $195-400. Topics to be covered include:
  • Introduction to Gene Transfer
  • Ethical Considerations in Research Involving Vulnerable Populations
  • Unique Issues Pertaining to Parental Permission and Minor Assent to Participate in Gene Transfer Research

    The July 8 workshop features experts from University of Nebraska Medical Center and Dartmouth College-Dartmouth Hitchcock Medical Center covering the history and regulations of the institutional review board (IRB) and the ethical principles underlying the conduct of research with human subjects.

    The July 9 morning program covers federal updates and gene transfer and hemophilia gene transfer trials. The afternoon sessions focus on parenting permission and minor assent for participation, ethical consideration in vulnerable populations, and a nuts and bolts program on human subject protection.

    Dr. Gary L. Shaer, director of the Cardiac Catherization Laboratories at Rush, will speak on "Gene Transfer to Stimulate Angiogenesis: Applications in Coronary and Peripheral Arterial Disease," in the afternoon session.

    The program is aimed at researchers and their staffs, research administrators, institutional review board members, legal counsel, public health officials, privacy and compliance officers and officials of universities, hospitals and other organization involved with medical research The Sunday program includes a panel discussion of serious adverse events and a session on ethical issues on applied research with individuals with disabilities.

    Public health officials; privacy and compliance officers; patient and participation advocates, legal counsel and staff, research staff and coordinators and institutional officials may register for continuing medical education (CME) credits.

    To register for the conference, call 1-866-761-7808.

    Rush University Medical Center

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