The above bit string encodes personal information about one of the authors of this essay. Of course, without rules to decode the bit string, it is impossible to say whether it is genetic information, weight, age, fingerprint, religion, etc. Layered on top of that technical decoding process is a social decoding process – how sensitive is this information? How useful is it to the government for various purposes? The objective of this paper is to offer some key lessons for the regulation of genetic information collected by the state for law enforcement purposes. In the first part of the paper, we discuss two fundamental principles of informational privacy theory. Utilizing these, we then examine the statutory regimes that have emerged for the regulation of the information that the government collects in three different domains – fingerprints, department of motor vehicle (DMV) records, and tax records. In the third and final part we use the results of our analysis as analogies for similar regulatory challenges in the regulation of genetic information collected for law enforcement purposes, and make some tentative recommendations.

DNA profiling and databasing have become commonplace in criminal investigation and prosecution. There is a body of both state and federal legislation enabling the establishment and operation of profile databases for law enforcement purposes. Most legislation is specific as to who (or what evidence) may be profiled for inclusion in a database. The majority of state laws permit DNA profile databasing of offenders convicted of certain defined crimes, of missing persons and their relatives, and of DNA profiles from criminal-case evidence where the depositor is unknown. More recently, a few states have acted to permit databasing profiles of suspects of certain types of crimes, and there appears to be a trend toward wider adoption of this practice. The legislation adopted or proposed thus far defines whose DNA profiles can be databased, and under what circumstances. Less attention has been given to the matter of specimen retention following profiling and databasing.

The topic of offender DNA databases and the retention of offender's DNA samples are issues that continue to generate debate between privacy advocates and forensic DNA scientists. Considered previously by both the Federal DNA Advisory Board and the National Commission on the Future of DNA Evidence, recommendations were made that the existing statutory frameworks were sufficient to protect the confidentiality and use of the DNA samples solely for forensic identification purposes and that the issue be revisited. Now, approximately five years since these debates, privacy advocates and forensic scientists retain divergent views on this issue. This brief essay is not intended to fuel the debate, but rather, to describe the protections and safeguards currently in place for the protection of the offender DNA samples.

Surrounding the discussion of the sample retention issue are the underlying principles for the establishment of the Combined DNA Index System (CODIS) Program and the National DNA Index System (NDIS).

Wherever we go, we leave behind skin cells containing copies of our DNA molecule – unless we go forth hermetically sealed. This makes construction and maintenance of DNA identification databases enormously useful to crime investigators. DNA databases, linking numerical representations of a tiny portion of individuals' DNA with their names and other identifying information, are useful to identify suspects directly by matching DNA found at a crime scene with a DNA profile in a DNA identification database. They are useful indirectly too, because criminal investigations proceed by a process of elimination; and identifying the person whose DNA was found at a crime scene can make it unnecessary to continue investigating others. When the incriminating crime scene sample does not match the DNA of a “person of interest,” that person is freed from the hassles and risks of criminal investigation, including the risk of false conviction.

Over the past fifteen years, the United States has witnessed an extraordinary expansion in the banking and mining of DNA for law enforcement purposes. While the earliest state laws governing forensic DNA limited collection and retention of DNA samples to sexual offenders – on the theory that these persons were especially prone to recidivism and most likely to leave behind biological evidence – today forty-three states collect DNA from all felons, twenty-eight from juvenile offenders, and thirty-eight from those who commit certain categories of misdemeanors.

A few states have expanded their databases beyond convicted criminals. Virginia, Louisiana, Texas, and California have authorized DNA retention from persons merely arrested for various offenses, although to date only Virginia has implemented such a program. At the federal level, an ill-considered statute that allows for the seizure and storage of DNA from anyone arrested and from non-U.S. citizens detained under federal authorities was recently signed into law.

In 1890 a man sold the rights to his body after death to the Royal Caroline Institute in Sweden for research purposes. Later, he tried to return the money and cancel the contract. In the subsequent lawsuit, the court held that he must turn his body over to the Institute and also ordered him to pay damages for diminishing the worth of his body by having two teeth removed.

Today, it would be an anathema for a person's body to be used against his wishes and for a research subject not to be allowed to withdraw from a study. In fact, the Uniform Anatomical Gift Act allows people to change their minds and withdraw a previous agreement to donate organs and tissue after their death and the federal research regulations allow people to withdraw from studies without penalty or loss of benefits.

The currently evolving debate over ethical and legal approaches to DNA data banks reflects, in part, shifting societal perceptions of dividing lines between humanity and commodity, definitions of genetic inheritance between individuals and families, and the rights of the individual versus the rights of the community. Tensions arise whether the data bank has been created for medical or for forensic purposes. The authors, through their work as community activists described more fully below, have come to realize that the key to resolving these tensions and developing ethically acceptable DNA data bank practices is meaningful community engagement. Not unlike medical DNA data banks, personally identifiable DNA samples are routinely retained by states long after a convict's or arrestee's DNA profile has been derived from it and entered into the state database. The question arises, then, as to what, if any, non-forensic uses can these samples – ethically – be put.

Organ transplantation remains one of modern medicine's remarkable achievements. It saves lives, improves quality of life, diminishes healthcare expenditures in end-stage renal patients, and enjoys high success rates. Yet the promise of transplantation is substantially compromised by the scarcity of organs. The gap between the number of patients on waiting lists and the number of available organs continues to grow. As of January 2006, the combined waiting list for all organs in the United States was 90,284 (64,933, 17,269, and 3,006 for kidney, liver, and heart respectively). Unfortunately, thousands of potential organs are lost each year, primarily due to lack of consent to donation from the deceased before death, or from the family thereafter. Only fifty percent of potential donors – the “conversion” rate – become actual donors. The costs attributed to organ shortage are substantial – Medicare paid over $15.5 billion in 2002 for treating patients with end-stage renal-disease, who predominate on organ waiting lists.

Bioethics is currently witnessing unprecedented debate over the moral and legal norms governing the conduct of clinical research. At the center of this debate is the duty of care in clinical research, and its most widely accepted specification, clinical equipoise. In recent work, we have argued that equipoise and cognate concepts central to the ethics of clinical research have been left unnecessarily vulnerable to criticism. We have suggested that the vulnerability lies in the conspicuous absence of an articulated foundation in moral and legal theory of the physician-researcher's duty of care to the patient-subject. We have repeatedly suggested that the requisite foundation is in the ethics of trust and the law of fiduciaries.

Curiously, despite the absence of a published thorough exposition of our position, some have preemptively criticized our suggestion that the relationship between physician-researcher and patient-subject is fiduciary. Others have offered their own accounts of the implications of fiduciary law for the relationship.

In her recent article, “Evidence, Belief, and Action: The Failure of Equipoise to Resolve the Ethical Tension in the Randomized Clinical Trial,” Deborah Hellman gives a new twist to an old objection against clinical equipoise. Roughly, clinical equipoise is the requirement that there exist credible uncertainty in the expert medical community regarding the preferred treatment for a particular condition. This uncertainty is widely regarded as a necessary condition for enrolling participants in a clinical trial. The old objection is that clinical equipoise represents an overly permissive, and therefore morally unacceptable, mechanism for resolving the fundamental tension in clinical research between fidelity to the interests of the individual research participant, and fidelity to the statistical and scientific methods that are necessary to produce generalizable data in a reliable manner. Hellman's new twist on this objection utilizes some of the rudimentary architecture of Bayesian statistical theory to argue that clinical equipoise focuses our moral attention on the wrong issue.

Randomized Clinical Trials (RCTs) in the medical community are generally lasting longer due to a number of factors, including an increase in the total volume of biomedical research, expanded federal regulatory requirements, and a rise in patient interest in participating as research subjects. Leading national and international initiatives promote clinical research in children. The primary impetus for these initiatives is the need for adequate data for clinical application of new products and treatment approaches in the pediatric population. Clinical investigations must maintain ethical conduct as an essential component of pediatric research.

Ethical issues associated with clinical research in general have received prominent public and scientific attention. Of particular interest is informed consent, or assent, as applied to pediatrics. There is little practical guidance concerning pediatric assent from legal and ethical disciplines; the law has played only a small role in few cases.

Academic medical centers and drug manufacturers have traditionally occupied very distinct positions with regard to public trust. As collaborations among medical researchers and pharmaceutical companies expand, however, worries about the aggressive pursuit of profit that has tarnished the reputation of the pharmaceutical industry may be transferred to medical institutions and clinical investigators, suggesting to some that biomedical research is more about increasing profit than promoting public health. Consequently, when medical institutions forge research collaborations with industry they should be mindful of the potential for these relationships to erode public confidence in the integrity of clinical research.

Recent events have heightened concerns about the financing of clinical research. These include the widely publicized deaths of several research volunteers, scandals at the nation's largest funder of biomedical research, and evidence of fabricated research findings in prominent medical journals. These unfortunate events have prompted many to re-examine strategies for managing industry relationships and the financial conflicts of interest they may create.

The Ethics and Regulation of Research with Human Subjects, edited by Professors Carl Coleman of Seton Hall, Jerry Menikoff of the University of Kansas, Jesse Goldner of Saint Louis University, and Nancy Dubler of the Albert Einstein College of Medicine, is an up-to-date and authoritative collection of readings on ethical, legal, and policy issues in research with human subjects. The authors have modeled their text on the casebook style commonly used in law schools. At 746 pages, plus front matter and an appendix, this book contains just about everything one needs to know for a thorough grasp on human subjects research, including federal and state regulations governing this research, interpretive guidance from federal agencies, international guidelines and codes, court decisions, historical documents and case studies, and selected readings from scholarly articles and books. The book includes written comments and questions to help students understand and interpret the readings.

The United States Court of Appeals for the First Circuit recently upheld a United States District Court for the District of Maine Judge's decision to dismiss a Maine plaintiff's medical malpractice claim against a Massachusetts hospital defendant for want of personal jurisdiction over the hospital. The Court of Appeals found it unreasonable to hale hospitals into an out-of-state court merely because they accept out-of-state patients.

Plaintiff Danielle Harlow is a Maine resident who suffered a stroke at the age of six while undergoing a medical procedure at Children's Hospital of Boston, Massachusetts (“Children's Hospital”). The stroke, allegedly caused by the Hospital's negligence, led to brain damage resulting in partial paralysis and cognitive and behavioral impairments. The procedure was supposed to treat Harlow's rapid heartbeat, a condition related to her Wolff-Parkinson-White Syndrome. Harlow's pediatrician in Maine recommended that she visit Children's Hospital in Boston to treat her arrhythmia.

On January 18, 2006, the United States Supreme Court unanimously held that the constitutional challenge to New Hampshire's Parental Notification Prior to Abortion Act would be remanded to the United States Court of Appeals for the First Circuit, to determine whether the Court of Appeals could, consistent with New Hampshire's legislative intent, formulate a narrower remedy than a permanent injunction against enforcement of the parental notification law in its entirety.

In 2003, New Hampshire enacted the Parental Notification Prior to Abortion Act (“The Act”). The Act specifies, in pertinent part, that “No abortion shall be performed upon an unemancipated minor or upon a female for whom a guardian or conservator has been appointed… until at least 48 hours after written notice of the pending abortion has been delivered....” The Act allows for three exceptions where a physician may perform an abortion on a minor child without parental or guardian notification.

The United States Court of Appeals for the District of Columbia Circuit (“Appeals Court”) held that the district court did not have jurisdiction over the American Chiropractor's Association's (“ACA”) federal question claims brought under the Medicare Act, despite affirming the ACA's prudential standing to pursue its claims. The Appeals Court reversed the lower court's decision allowing a doctor of medicine or osteopathy to perform manual manipulations of the spine on Medicare beneficiaries to correct a subluxation.

The Medicare program “subsidizes medical insurance for elderly and disabled persons.” An enrollee selects a physician or obtains medical services through a managed-care provider, such as a health maintenance organization (“HMO”).