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.

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.

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.

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.