Thank you, Mr. Chairman, for holding this hearing. The National Institutes of Health (NIH) is one of the world's foremost medical research centers, and the federal focal point for medical research in the United States. The NIH has the mission of uncovering new knowledge that will lead to better health for all people, and conducts research in its own laboratories as well as supports research of non-federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad. NIH also supports the training of research investigators and other components of the clinical research enterprise.

It is imperative that the NIH keep pace with the growing demands on research and technology, and that efforts in clinical research today develop into practices and technologies that will make for a better, healthier tomorrow. I commend Dr. Zerhouni for his efforts towards this end; the recently developed NIH Roadmap appears to be a step in the right direction. I would caution, however, that this is but one step in a long and possibly arduous journey. There are several issues that I hope today's witnesses will address in their testimony.

I am aware of the fact that clinical researchers are often concerned about how the HIPAA Privacy Rule will affect both their research activities and the privacy of the medical and research related information of their patients and subjects. Researchers must be aware of the privacy rule because it establishes the conditions under which protected health information can be used or disclosed. Although not all researchers are required to comply with the privacy rule, the manner in which the rule safeguards protected health information could affect certain aspects of research. This is necessary to ensure the protection and utmost respect for human participants in clinical trials.

Along these same lines, I would like for our panel to address issues of informed consent. While many Americans are all too familiar with the litany of forms that must be completed prior to most medical procedures, it is important to note that informed consent to participate in clinical trials involve much more than just reading and signing a piece of paper; it involves a document and a process. This process is designed to provide human participants with ongoing explanations that help them make educated decisions about whether to begin or continue participating in a trial. The trial's purpose, procedures, risks, and potential benefits, and participant rights all must be fully disclosed in a complete, understandable, and consistent manner.

Another major concern is a very sensitive but vital topic -- genetic nondiscrimination. I would like to hear from our witnesses on this subject and specifically whether they believe the time has come for Congress to enact strong legislation on this subject.

I am also interested in learning more about NIH's response to health disparities. Although some causes of disparate health outcomes are beyond the scope of bio-medical and bio-behavioral research, the NIH can indeed play a vital role in addressing and easing health disparities involving cancer, diabetes, cardiovascular illnesses, HIV/AIDS, and many other illnesses.