Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use.

Institutional review boards (IRBs) have been criticized for inconsistency and lack of transparency in decision-making, problems that undermine both trust in their ability to protect human research participants and respect for their decisions among researchers. The absence of robust documentation of their decisions and the inability or unwillingness to share those decisions together represent a missed opportunity for IRBs to learn from one another and advance debates about challenging ethical issues. The concept of IRB precedent, modeled upon the system of legal precedent, has been proposed as a potential solution to these problems.

Payment Theory and the Last Mile Problem.

Health reform debate understandably focuses on large system design. We should not omit attention to the "last mile" problem of physician payment theory. Achieving fundamental goals of integrative, patient-centered primary care depends on thoughtful financial support.

Reining in IRB Review in the Revised Common Rule.

The revised Common Rule contains several changes designed to reduce the time institutional review boards (IRBs) spend on overseeing low-risk studies, including an expansion of the categories of research that are exempt from the regulations and a list of specific activities that do not satisfy the regulatory definition of "research." While these changes go a long way toward the goal of reducing unnecessarily regulatory burden, they leave several important questions about IRB jurisdiction unresolved.  The most significant omission is the failure to address when IRB review is necessary for quality assurance activities.

Toward evidence-based conflicts of interest training for physician-investigators.

The increased focus in recent years on the risks posed by conflicts of interest arising from financial relationships between physician-investigators and the pharmaceutical and medical device industries has led to a variety of measures that can broadly be described as "regulatory" interventions, including new federal and state laws, criminal prosecutions and private lawsuits, requirements attached to government funding, and institutional policies. Studies suggest, however, that physician-investigators have not internalized the message that financial conflicts of interest have the potential to influence their decision making. Simply informing physician-investigators of the content of relevant rules and the consequences of noncompliance - as appears to be the practice in many existing compliance training activities - is unlikely to lead to lasting changes in norms or behavior.

Commercial speech and off-label drug uses: what role for wide acceptance, general recognition and research incentives?

This article provides an overview of how the constitutional protections for commercial speech affect the Food and Drug Administration's (FDA) regulation of drugs, and the emerging issues about the scope of these protections. A federal district court has already found that commercial speech allows manufacturers to distribute reprints of medical articles about a new off-label use of a drug as long as it contains disclosures to prevent deception and to inform readers about the lack of FDA review. This paper summarizes the current agency guidance that accepts the manufacturer's distribution of reprints with disclosures.

Access to medicine in an era of fractal inequality.

This article evaluates the legitimacy and degree of inevitability of unequal access to medicine. The author introduces 'fractal inequality' to the access issue by using the term to describe skewed patterns in distributions of income and wealth that lead to reallocative effects of higher spending on health care by the wealthiest that can cascade down the distributive ladder. 'Fractal inequality' is transposed to the U.

Changing expectations for board oversight of healthcare quality: the emerging paradigm.

Within healthcare institutions, leadership is an essential driver of expectations, performance, and culture. Yet boards of directors traditionally played a limited role in overseeing healthcare quality, providing final approval of credentialing decisions but deferring to the medical staff to set standards for the institution. Case law and standards provide little guidance for board performance in overseeing quality of care.

How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review.

Background: Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.

Discussion: Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest.

Legal regulation of the use of race in medical research.

In this article, we discuss current legal restrictions governing the use of race in medical research. In particular, we focus on whether the use of race in various types of research is presently permitted under federal law and the federal constitution. We also discuss whether federal restrictions on the use of race in research ought to be expanded, and whether federal policies that encourage the use of race ought to be abandoned.

Exposing the myths surrounding preventive outpatient commitment for individuals with chronic mental illness.

Using New York's "Kendra's Law" as an illustrative vehicle, this article addresses the principal criticisms lodged by opponents of preventive outpatient commitment. The authors argue that preventive outpatient commitment is a useful adjunct to conditional release or placement in the least restrictive alternative that has neither produced revolutionary change in psychiatric commitment standards nor will be used inappropriately to assert governmental control over mentally ill citizens. The authors contend additionally that preventive outpatient commitment does not violate federal constitutional norms or represent bad policy making.

Heal the damage: prescription drug consumer advertisements and relative choices.

The process of choosing and prescribing prescription drugs is complex. While the choice about which drug to prescribe is made by the physician, the physician may be influenced by patient demand, which, in turn, may be influenced by consumer advertisements. As a result, consumer advertisements for prescription drugs need to provide information that gives consumers an understanding, not only of drug risks and efficacy but also of the notable limits on benefits claimed.