The Role of the Federal Government in Overseeing Medical Research

I. INTRODUCTION II. FEDERAL FUNDING OF MEDICAL RESEARCH A. Selecting the Medical Research To Fund B. Funding Acceptable Medical Research III. EMERGING AVENUES OF RESEARCH RAISE DIFFICULT QUESTIONS A. Determining What Is Acceptable B. Determining Who Decides What Is Acceptable 1. The Federal Government: Establishing the Laws of the Land 2. The Federal Government: Establishing Legal Parameters 3. The Federal Government: Establishing the Federal Budget C. Determining What To Do When an Ambiguity Exists IV. CONCLUSION I. INTRODUCTION The United States enjoys a unique position among the world community in a number of respects. Although it is not the largest or most populated country in the world, the United States is considered one of the wealthiest. (1) Our significant national wealth affords us with some interesting opportunities. In particular, it allows us to devote a portion of those resources toward causes that we as a nation feel are worthy and significant. For example, such causes include charitable aid programs, in the name of promoting global economic development and world peace. The United States leads in this category as well, donating an annual $27.5 billion in unrestricted charitable foreign aid to promote international economic development through the Office of Development Assistance of the United Nations. (2) Private philanthropy from the United States is even greater, with an estimated $71 billion being given in 2004 from private individuals, foundations, churches, and other organizations. (3) In total, nearly one percent of our national income is given away to individuals, groups, and countries in need around the world. (4) Another one of the ways in which we have chosen to spend (or invest--depending on one's perspective) a portion of our national wealth is in the area of research. Such research covers a broad range of areas, including medical research, technology development, space-related research, material sciences, and a host of other activities. The funding provided to conduct this research comes from both public and private sources. We invest heavily as a nation in government sponsored research across a range of areas. One area in particular rises above the rest in terms of committed resources--medical research. Note that this funding is provided almost entirely to not-for-profit entities, such as colleges, universities, and research institutions, and is distinct from the funding provided by the private sector. II. FEDERAL FUNDING OF MEDICAL RESEARCH The National Institutes of Health (NIH) is the primary governmental agency charged with conducting and supporting medical research. According to the official NIH website, the explicit objective of the agency is to "lead the way toward medical discoveries that improve people's health and save lives." (5) Although the NIH can trace its roots back to 1887, our national effort and commitment to invest tax dollars in medically related research took a dramatic turn in the early 1970's when then-President Richard Nixon declared "war on cancer" in his State of the Union address in January 1971. (6) With the approval and oversight of Congress, the National Cancer Act was passed in December 1971, and federal funding toward diagnosing and treating cancer and other diseases began to dramatically increase. (7) As recent statistics demonstrate, this long-term investment in conjunction with other events (such as a decline in the rate of smoking) is apparently starting to yield dividends in the form of a reduced rate of deaths due to cancer, cardiovascular disease, and other significant causes of morbidity and mortality. (8) The explicit objective of the dramatic increase in NIH funding is to improve the health and well being of the citizens of the United States--clearly a laudable objective (at least for those of us that value our health and well being). …