While the socio-ethical and legal issues surrounding clinical genetics have long been the subject of international interest, the thorny questions of genetic research and biobanking are more recent. Add to this the fact that national guidelines and laws usually precede international policymaking, and the delay in international approaches is understandable. In that regard, the United Nations Educational, Scientific and Cultural Organization’s 1997 Universal Declaration on the Human Genome and Human Rights is unique in its prospective guidance on genetic research. Also, it is in the very nature of international normative instruments to be general, except on specific issues considered to be in the interest of humanity, such as research into human reproductive cloning or access to AIDS drugs.

Biomedical research has always relied on access to human biological materials and clinical information, resources that when combined form biobanks. In the past, it appears that investigators sometimes used these resources with relatively little oversight, and without the consent of the individuals from whom these materials and information were obtained. Several developments in the last ten to fifteen years have converged to place greater emphasis on the role of individual consent in the creation and use of biobanks. The most important by far is the power of information technology, which has transformed our lives in almost every domain. In the research setting, it is now easy to abstract information from electronic medical records. Computers make it possible to analyze enormous datasets and have contributed in essential ways to the dramatic increases in our understanding of genomics and other areas of biomedical science.

We have a thriving biotechnology industry in the United States. There are over 1,450 biotechnology companies developing diagnostic and treatment technologies in medicine, creating more nutritional foods, and innovating new industrial processes. Yet this $28.5 billion sector of the economy is not without controversy. The “bio” in biotechnology comes from living, biological entities - people, plants, animals, and even bacteria. In the realm of biobanking, people are the source of the raw material for the discovery of genes for research, diagnosis, and therapy, raising a host of issues about rights and responsibilities, fiduciary duties and societal obligations.

Few things seem more a part of the material world than biological specimens. Yet the processes by which collections of specimens are assembled, translated into information, combined with more information, and distributed are taking research repositories into the virtual realm.

The term “virtual” has a number of meanings, and so a research repository can qualify as virtual in a variety of ways. The term would seem to apply, for example, to (1) constructing a repository by forming a network among institutions; (2) using the Internet or the World Wide Web to solicit specimens and information; (3) integrating web-based technology into the operation of the bank; (4) using the Internet or web-based technology to manage relationships with donors or collection sites and recipients; and (5) digitizing specimens. The all-digital repository would seem the most virtual of all possible repositories, a true cyberbank.

Biobanking activities for genetic research purposes have recently undergone nothing short of a small revolution. Many biobanks have left their traditional home of a small refrigerator in a laboratory to reach the unprecedented proportion of large, sophisticated storage centers containing DNA samples from whole populations. As we turn our attention to research on complex diseases and show great interest in human genetic variation and genetic epidemiology, we need to base our research not only on the DNA of small family cohorts, but on larger sample collections, coupled with geographic location, genealogical information, and environmental and medical data. Population genetic research projects are underway around the world. Setting up such large-scale population biobanks is a challenge for any researcher. Population genetic research projects raise legal, ethical, and social issues that need to be addressed properly in order to maintain the trust of the population, an absolute requirement for the success of such research endeavour.

Bioinformatics, the integration of information technology and biotechnology, is the primary means to make medical sense out of the map of the human genome, and bioinformatics capabilities continue to expand exponentially. Consequently, the demand for access to human biological samples and medical information has never been greater. This demand is giving rise to ambitious biobanking initiatives - meaning the organized collection of samples and medical information from human population.

Repositories of tissues, cell lines, blood samples, and other biological specimens are crucial to genomics, proteomics, and other emerging forms of biomedical research. Creation of these repositories by individual researchers and their affiliated organizations, commercial entities, and even governments has been labeled “biobanking” in the bioethics literature. Biobanking as a metaphor for the collection, transfer, and use of these specimens suggests a framework for the legal response to conflicts that may arise - one embedded in principles of contract law and property ownership with an overlay of legislatively authorized regulation of the “industry.”

Biobanks hold out the prospect of significant public and private benefit, as genetic information contained in tissue samples is mined for information. However, the storing of human tissue samples and genetic information for research and/or therapeutic purposes raises a number of serious privacy and autonomy concerns. These concerns are compounded when one considers the possibility that a biobank or its owner might go bankrupt. Insolvency impairs the ability of enforcement regimes, and liability-based regimes in particular, to enforce legal norms. The goal of this essay is to develop guideposts for thinking about private and public enforcement of privacy imposed by donors on tissue samples and/or genetic information when a biobank becomes insolvent.

Biobanks are repositories of human biological materials collected for biomedical research. There are over 300 million stored specimens in the United States, and the number grows by 20 million per year. In the post-genome world of high throughput gene sequencing and computational biology, biobanks hold the promise of facilitating large-scale research studies. New organizational and operational models of research repositories also raise complex issues of big science, big business, and big ethical concerns.

In the past twenty years, advances in forensic DNA technology have revolutionized the American criminal justice system. The use of forensic DNA testing in America began in 1987, and its demonstrated scientific accuracy quickly led jurisdictions to accept expert testimony regarding DNA matches between suspects and crime scene evidence. Wielding the power to exonerate the innocent and apprehend the guilty, the use of DNA identification technology has become an indispensable resource for prosecutors and law enforcement officials, as well as for defense lawyers representing persons falsely accused or wrongfully convicted of crimes they did not commit. As states began to compile DNA profiles from convicted offenders, the need for a repository for these profiles resulted in the DNA database.

Originally, DNA databases included only “those classes of offenders with a high recidivism rate, such as sex offenders and violent felons.” Recognizing the crime-solving potential of this technology, state legislatures soon began to expand the scope of DNA database statutes to include broader classes of offenders.

What are the Differences between Public Health Practice and Research? This perplexing question constantly arises in the planning and performance of public health activities involving the acquisition and use of identifiable health information. Public health agencies collect and analyze significant identifiable health data from health care providers, insurers, other agencies, or individuals to perform an array of public health activities. These activities include surveillance (e.g., reporting requirements, disease registries, sentinel networks), epidemiological investigations (e.g., to investigate disease outbreaks), and evaluation and monitoring (e.g., public health program development and analysis, oversight functions). Few debate that these essential public health activities, often specifically authorized by law, are classifiable as public health practice.

Other public health activities in which identifiable health data are acquired or used, however, can resemble, include, or constitute human subjects research. “Human subjects research” is legally defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” that involves living human subjects (or their identifiable, private data).

Over the past decade or so, no issue in medical ethics or bioethics law has raised more concerns about federal intervention in the practice of medicine, about judicial attempts to craft health policy, or about the wisdom of public mandates directing specific health care initiatives than the issue of physician-assisted suicide. State voter referenda, lower and federal court cases (including two U.S. Supreme Court decisions), proposed legislation in both houses of Congress, and orders and determinations from agencies within the executive branch of two administrations are representative of the kinds of actions taken in the last ten years implicating medical care at the end of life. Whether the intent was to codify into law physician-assisted suicide, to deny a constitutional right of assisted suicide, or to make “easier” physicians' efforts to alleviate intractable suffering at the risk of hastening death, or to prohibit physician aid in dying altogether, the impact on the patient-doctor relationship and on our understanding of what constitutes dignified and humane care at the end of life is undeniable.

For nearly twenty-five years, federal regulation of privacy issues in research involving human subjects was the primary province of the federal rule for Protection of Human Subjects (Common Rule). As of April 14, 2003, the compliance date for the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA), however, the Common Rule and the Privacy Rule jointly regulate research privacy. Although, in theory, the Privacy Rule is intended to complement the Common Rule, there are several areas in which the rules diverge. In some instances the inconsistencies result in gaps in privacy protection; in other instances the inconsistencies result in added burdens on researchers without additional privacy protections. In all instances, the lack of harmonization of these rules has created confusion, frustration, and misunderstanding by researchers, research subjects, and institutional review boards (IRBs). In this article, I review the major provisions of the Privacy Rule for research, explain the areas in which the Privacy Rule and Common Rule differ, and conclude that the two rules should be revised to promote consistency and maximize privacy protections while minimizing the burdens on research.

“There's a new whistleblower in Washington,” according to CNN News. He is Food and Drug Administration scientist David Graham, who claims that the FDA failed to warn the public about certain drugs' dangerous side effects and pressured him to change his research's conclusion that the arthritis drug Vioxx caused heart attacks. Another Washington whistleblower, Dr. Jonathan Fishbein of the National Institutes of Health, alleged that he was fired because “he had raised concerns about sloppy practices that might endanger patient safety” in a study of the AIDS drug nevirapine.

Graham and Fishbein thus joined the ranks of whistleblowers who have gained some prominence in recent years for their reporting of corporate or institutional misconduct. The best-known whistleblowers—the FBI's Coleen Rowley, Enron's Sherron Watkins, and WorldCom's Cynthia Cooper, who together received Time magazine's Whistleblower Person of the Year Award in 20024 - focused public attention on the reform of corporate accounting and legal practices.