In the past few years, there have been a number of high profile incidents that have emphasized the issues associated with financial conflicts of interest. As a result, commentators and policy-makers throughout the world have been directing their attention to how financial conflicts should be addressed. Despite such activity, however, there are few policies that provide specific guidance addressing one of the most common forms of financial conflict-the provision of generous remuneration packages to clinical investigators.

In this column, we explore the conflict of interest issues that flow from the pharmaceutical industry paying community physicians to be investigators in clinical drug trials. In particular, we are interested in the challenges associated with the management of this complex issue by local research ethics boards. We suggest the need for more research on this topic and specific guidelines to empower these boards to address this growing concern. We recognize that this is one of many current conflict issues faced by policy-makers today.

In 1996, Congress passed the Health Insurance Portability and Accountability Act (HIPAA), which required the enactment of new regulations to protect confidential patient health information. In December 2000, the U.S. Department of Health and Human Services (DHHS) published the agency's final rule on patient privacy and the proper use of privileged health information. The HIPAA privacy regulations cover all health-care providers that handle medical records or other identifiable patient health information. Most health-care organizations have until April 14,2003, to comply with HIPPA.

On January 22, 2002, California Governor Gray Davis released the state's long-anticipated, proposed regulations establishing hospital nurse-to-patient ratio requirements. The Safe Staffing Law (A.B. 394) mandating minimum ratios was enacted in October 1999 in response to legislators concerns that [q]uality of patient care is jeopardized because of staffing changes implemented in response to managed care. While the law was scheduled to take effect by January 1, 2002, conflict within the medical community regarding appropriate ratios slowed down the rulemaking process. Lawmakers now anticipate that the rule will be implemented by January 2003. Approximately 5,000 new nurses will need to be hired for California's hospitals to come into compliance with the proposed regulation.

In NX v. Cabrini Medical Center, New York's highest court overruled a divided Appellate Division and held that, as a matter of law, a jury could find a hospital negligent for its failure to protect a patient from sexual assault. The court refused, however, to adopt a higher standard of tort liability for health-care providers who treat incapacitated patients.

In Stovall v. Confimed.com, the Kansas Supreme Court held that an out-of-state medical doctor who sold a prescription drug to a Kansas minor over the Internet did not commit an unconscionable act under the Kansas Consumer Protection Act (KCPA). The Shawnee Country District Court had enjoined the doctor from prescribing or dispensing prescription medicine within the state of Kansas, and the doctor appealed the injunction to the Kansas Supreme Court. The Supreme Court affirmed the district court's decision to grant injunctive relief, but found no unconscionable conduct under the KCPA.

The appellee, Washington physician Dr. Howard J. Levine, sold the sexual enhancement drug Viagra over the Internet through his online pharmacy. Neither the physician nor the online pharmacy was licensed to practice in Kansas. The purchasers were two Kansas residents, one of whom was a minor. Both purchased the drugs in a sting operation conducted by the Kansas Attorney General and received the drugs after completing an online application.

In J.E.M. AG Supply, Inc. v. Pioneer Hi-Bred International, Inc., the U.S. Supreme Court held that utility patents may be issued for newly developed, sexually reproduced plants and plant seeds. Specifically, the Court denied the petitioner's contention that the exclusive means of protecting sexually reproduced plants and plant seeds are found in the Plant Patent Act of 1930 (PPA) and the Plant Variety Protection Act (PVPA). The Court instead affirmed the decisions of the District Courts and the Federal Circuit and held that 35 U.S.C. § 101 (§ 101 or the Utility Patent Act) also allows for the patenting of living organisms.

The respondent, Pioneer Hi-Bred, a large seed producer, filed suit for patent infringement on the part of the petitioner, J.E.M. AG Supply, doing business as Farm Advantage, Inc., for reselling bags of respondent's patented hybrid seeds. Pioneer is a major producer and manufacturer of hybrid seeds.

In United States ex rel. Quirk v. Madonna Towers, Inc., the U.S. Court of Appeals for the Eighth Circuit held that the failure of a skilled nursing facility's executives to seek a legal opinion regarding a billing practice they considered valid did not meet the definition of knowingly presenting a false claim for payment to the federal government under the False Claims Act (FCA). Alleging that the facility that provided care to his aunt fraudulently submitted claims to Medicare for services provided free of charge, the appellant brought this case qui tam on behalf of the federal government under the FCA.

The FCA was passed by the legislature in an effort to punish and deter fraud against the federal government. It provides financial incentives for private individuals to come forward with information about fraudulent activity.

In M.A.K. v. Rush-Presbyterian-St. Luke's Medical Center, the Illinois Supreme Court reversed the appellate court and held that the phrase any physician, medical practitioner, hospital, clinic, health care facility or other medical or medically related facility, in a patient's signed consent form met the general designation requirement of the Code of Federal Regulations for the release of alcohol and drug abuse treatment records. Thus, the Illinois Supreme Court held that the medical center's release of a patient's records did not violate the federal Confidentiality of Alcohol and Drug Abuse Patient Records regulations.