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”).