Chair's Column: Frontiers Of Medical Research
by Andrew J. Demetriou, Fulbright & Jaworski LLP, Los Angeles, CA

Not long ago, medical research concerned itself primarily with understanding the causes of death, based on examination of cadavers. What would now be called clinical trials were highly risky experimental administration of potential cures for disease, often administered to the researcher and his intimates or possibly criminals and mental defectives, the latter on the theory that they were expendable members of the population. We have come a very long way in the past century, to an era where medical research holds the promise for dramatically improving the quality of life for all mankind, through innovations not well understood even a decade ago. In addition to the development of new and increasingly effective drugs, researchers are exploring the use of gene-based therapies to enlist the body's own mechanisms for the recognition and correction of disease. Stem cell therapies may give new hope to people with diseased organs and eventually displace organ transplantation as a preferred therapy. Enhanced understanding of the operation of cancer cells offers the prospect of early detection of cancer risks and means to combat many forms of the disease without resort to toxic therapies such as chemotherapy and radiation.

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Certificates of Confidentiality Protect Individual Privacy and Promote Public Health
by Bruce F. Howell, Powell Goldstein, LLP, Dallas, TX and Alex M. Hendler, Powell Goldstein, LLP, Washington, DC

In the atmosphere of heightened confidentiality concerns, entities conducting clinical research must seriously consider the privacy requirements and protections for human subjects participating in clinical trials or research studies. Given the tremendous investigatory powers of both federal and State governments and the substantial public health value of research conducted with human subjects who feel free to discuss a history of unlawful or risky behavior such as illegal drug use, it is very important to protect the privacy of such individuals to the maximum extent permitted by law. Information about human subjects obtained in the course of clinical trials or research studies is not fully protected by the Health Insurance Portability and Accountability Act because of the exception found in HIPAA that can require certain information to be disclosed in court or to certain investigative or administrative bodies. Furthermore, while some State laws may be more stringent and thus preempt HIPAA, many of those laws do allow the release of information to certain entities for litigation or law enforcement purposes.

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Medical Research, Biotechnology & Clinical Ethical Issues Interest Group

The Medical Research, Biotechnology & Clinical Ethics Interest Group provides a forum in which members of the Health Law Section can consider and seek guidance about the legal and ethical implications of the difficult conundrums that arise in the clinical arena.

The IG is led by Chair Bruce F. Howell, Powell Goldstein LLP, Dallas, TX and Vice Chairs LaDale K. George, Chicago, IL; C. Elizabeth O'Keeffe, Fresenius Medical Care, Waltham, MA; Betty Pang, Latham & Watkins LLP, San Francisco, CA and Thomas Smith, St. Louis, MO.

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