A rich academic literature exists about issues of informed consent in medical care, and, to a lesser extent, about a variety of issues posed by human experimentation. Most commentators regard patient autonomy as a desirable— though in practice often unattainable—goal, and near unanimity exists about the necessity for even fuller disclosure before experimenting on subjects. Although this Article intentionally side-steps the broader debate about informed consent, it challenges the conventional wisdom that special disclosure rules should apply in the experimental context.

Clinical trials have become big business. Estimates suggest that as many as twenty million Americans have enrolled in formal biomedical studies, though, as a measure of the full scope of medical experimentation on humans, that figure may represent only the proverbial tip of the iceberg. Historically, sponsors of clinical trials recruited subjects informally, counting on word of mouth among physicians and also perhaps posting flyers around college campuses.

While science does advance steadily over time, occasionally a scientific breakthrough occurs that does not merely augment current scientific explanations and understandings, but instead radically redirects the focus of the scientific inquiry, fundamentally reconfigures our conception of our world and community, and threatens our existing social and moral conventions. We are currently experiencing such a scientific revolution, precipitated by advances in decoding our genetic makeup. While the revolution began at least by 1952 with the discovery by James Watson and Francis Crick of the structure of the DNA molecule–the molecule that contains our genetic information–the pace of the revolution has accelerated most rapidly in the last ten years. The engine for this change is the Human Genome Project.

A substantial segment of the American population consists of adolescents. Adolescents, defined as persons between the ages of fourteen and eighteen, have traditionally been regarded as “minors” by law. Minors, as a group, are legally disabled, meaning they are presumed to lack the skills necessary for capable decision-making. Capable decision-making is requisite to the exercise of legal rights. Although the U.S. Supreme Court has extended federal constitutional guarantees to minors, including the liberty right for decision-making in intimate, personal matters, the Supreme Court has observed that vulnerability impairs their decision-making capability. Accordingly, the law regulates decision-making liberties of minors far more extensively than those of adults.

The underlying tenet of law governing adolescents—that they lack the skills required for capable decision-making—seems well-settled. It is an artifact from an industrial society that spawned legislation authorizing governmental regulation of adolescents for education and labor in order to protect and promote their health and well-being.

Parts and products of the human body are increasingly important to biomedical research. Tumors removed in surgery help researchers map the molecular progression of cancer. Blood samples matched to clinical profiles suggest the role of genes and other factors in disease. Both hospital patients and visitors to the World Wide Web may be approached to provide tissues for study.

Sometimes this research results in commercial developments that produce substantial financial rewards for researchers, biotechnology companies and pharmaceutical or medical device makers. Frequently, the use of human tissue is crucial to the scientific discoveries on which those products rely. Yet, the individual sources of tissue seldom share in the ensuing profits.

We humans tend to worry first about our own happiness, then about our families, then about our communities. In times of great stress, such as war or natural disaster, we may focus temporarily on our country but we rarely think about Earth as a whole or the human species as a whole. This narrow perspective, perhaps best exemplified by the American consumer, has led to the environmental degradation of our planet, a grossly widening gap in living standards between rich and poor people and nations and a scientific research agenda that focuses almost exclusively on the needs and desires of the wealthy few. Reversing the worldwide trends toward market-based atomization and increasing indifference to the suffering of others will require a human rights focus, forged by the development of what Vaclav Havel has termed a “species consciousness.”

Imagine a world in which parents can genetically enhance their child's height so that he becomes a professional basketball player. Or imagine a law school student preparing for the bar who takes out an extra loan to genetically enhance his intelligence. What if going to your physician for a routine physical included the option of genetically enhancing any trait you desired? And what if such a practice was expensive and, therefore, only available to the privileged members of society? Is this desirable or should the U.S. government ban genetic enhancement? What if the government bans it and citizens travel abroad to receive genetic enhancement treatments? Can the U.S. government do anything to prevent access to illegal genetic enhancement abroad?

On the October 18, 2001 episode of The Late, Late Show with Craig Kilborn, the show's host announced that a woman in Georgia had sued her employer, WalMart, for not covering her contraceptives under its health insurance plan. He then cracked, “Hey, isn't working at WalMart all the birth control you need?” Kilborn's crude joke met with howls of laughter from the audience, but it likely struck a raw nerve with the millions of American women who do not have access to health insurance plans that cover birth control, and the many men and women who are battling to ensure that all women ultimately obtain such coverage.

WalMart is one of hundreds of employers in the United States that do not cover any of the five most common forms of birth control that were created exclusively for women. In fact, half of the large health insurance plans in America do not cover any form of contraception. Some of these plans do, however, cover Viagra, a drug used to treat male impotence.

Dave and Susan brought five-year-old Liliana home from Romania in January. The couple was ecstatic about their new beautiful blonde-haired daughter. They had waited months for Liliana after beginning the international adoption process with a reputable agency based in the United States. Many aspects of the process—carrying large amounts of cash to Romania, bribing officials to release their new daughter from the orphanage and the total lack of information about Liliana's health or background—had disturbed them. Dave and Susan were relieved when Liliana received a visa to travel to the United States because they thought that the physical examination for her visa had revealed nothing of import. Their concerns disappeared when they boarded the plane to head home to the United States. Liliana seemed healthy and happy, and she would adjust in no time.

Many of the societal challenges associated with the genetic revolution rest on predictions about the effects of the future development and diffusion of technologies for manipulating the human genome. Identity testing is different. Relatively sophisticated techniques for identity testing using DNA currently exist, and these techniques are already creating conflicts and challenges for families and policymakers. More precisely, scientific advances and social trends are raising difficult questions about the source and nature of parental obligation, the steps required to protect the privacy of individuals when suspicion begins to corrode family relationships and the role of attorneys and other professionals in these volatile situations.

While the new Health Insurance Privacy and Accountability Act (HIPAA) research rules governing privacy, confidentiality and personal health information will challenge the research and medical communities, history teaches us that the difficulty of this challenge pales in comparison to the potential harms that such regulations are designed to avoid. Although revised following broad commentary from researchers and healthcare providers around the country, the HIPAA privacy requirements will dramatically change the way healthcare researchers do their jobs in the United States. Given our reluctance to change, we risk overlooking potentially valid reasons why access to personal health information is restricted and regulated. In an environment of electronic information, public concern, genetic information and decline of public trust, regulations are ever-changing. Six categories of HIPAA requirements stand out as transformative: disclosure accounting/tracking, business associations, institutional review board (IRB) changes, minimum necessary requirements, data de-identification, and criminal and civil penalties.

By now everyone is familiar with the recent accomplishments of the Human Genome Project. Accomplished in ten, rather than the initially expected fifteen, years, the human genome has been fully sequenced. Genetics is in its golden age. A product of the technology era, genetics has, in a short time, offered vast amounts of information. This increased knowledge promises potential benefits for our understanding of the disease process and, ultimately, treatment and prevention. The rapid flow of information, however, presents complications and challenges. It can complicate the decision making process for those involved in genetic testing, not only because our knowledge of genetics is more complex, but because there is so much more potential information to obtain. The sheer quantity of information for both researcher, clinician and especially patient, can be overwhelming. In addition, our ability to glean predictive or susceptibility information has vastly exceeded our ability to develop cures for diseases; patients can increasingly identify risks for conditions that they can do little to avoid.

In justifying the cost of the Human Genome Project, supporters predicted fantastic benefits would result from decoding the human genome: cures for fatal diseases, effective treatments for common illnesses burdening individuals and society and a greater understanding of ourselves as human beings. Fear that genetic information will be misused to harm individuals, however, casts a shadow over this glowing portrait of the future of genomic medicine. Over the last decade, these concerns have led approximately twenty-six states to enact genetic nondiscrimination laws. Although no similar law has been passed by Congress, many, including Francis Collins, Director of the National Center for Human Genome Research, have repeatedly endorsed proposed federal legislation aimed at prohibiting health insurers and employers from using predictive genetic information. The result has been growing bipartisan support for The Genetic Nondiscrimination in Health Insurance and Employment Act introduced in February of 2001 by Representative Louise Slaughter in the House and by Senators Kennedy and Daschle in the Senate.

The science of genetics holds great promise. Ideally, the more scientists learn about the human genome and the functions of specific genes, the better they will understand what causes disease, what can prevent disease and what can cure it. But the hoped for advances in medicine that genetics may bring about will never happen if people are afraid to provide their DNA and work with scientists and doctors on the necessary research. From a privacy perspective, two things are clear: 1) people are afraid of genetic testing and 2) genetic information has been used to hurt people, rather than to help them.