Holding the Guardrails on Involuntary Commitment.

In response to the increasing number of mentally ill people experiencing homelessness, some policy-makers have called for the expanded use of involuntary commitment, even for individuals who are not engaging in behaviors that are immediately life-threatening. Yet there is no evidence that involuntary commitment offers long-term benefits, and significant reasons to believe that expanding the practice will cause harm. In addition, these proposals ignore research showing that most people with mental illness have the capacity to make medical decisions for themselves.

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.

Rethinking the Regulatory Triggers for Prospective Ethics Review.

Under the Common Rule, federally-supported activities involving human participants are presumptively required to undergo prospective ethics review if they are "designed to develop or contribute to generalizable knowledge." However, the "generalizable knowledge" standard is inherently ambiguous; moreover, it is both over- and under-inclusive of the type of activities that warrant prospective ethical oversight. Rather than conditioning prospective ethics review on an ethically irrelevant criterion like the generalizable knowledge standard, this article proposes that prior ethics review should be required when some individuals are exposed to greater-than-minimal risks for the potential benefit of others, at least when the activity in question is conducted or supported by federal agencies.

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.

Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative 'Pre-Review' Mechanism for a Study of Fexinidazole for Human African Trypanosomiasis.

Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs.

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.

Vulnerability as a regulatory category in human subject research.

This article examines and critiques the use of the term "vulnerability" in U.S. and international regulations and guidelines on research ethics.

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.

Recovery of function following grafting of human bone marrow-derived stromal cells into the injured spinal cord.

This study evaluates functional recovery after transplanting human bone marrow-derived stromal cells (BMSCs) into contusion models of spinal cord injury (SCI). The authors used a high-throughput process to expand BMSCs and characterized them by flow cytometry, ELISA, and gene expression. They found that BMSCs secrete neurotrophic factors and cytokines with therapeutic potential for cell survival and axon growth.

MCT-4, A511/Basigin and EF5 expression patterns during early chick cardiomyogenesis indicate cardiac cell differentiation occurs in a hypoxic environment.

We have identified the presence of the hypoxia marker EF5 in the stage 4/5 chick heart fields. This suggests that cardiac cell differentiation occurs in a relatively anaerobic environment. Monocarboxylate transporter (MCT) studies in adult cardiac myocytes have demonstrated that MCTs catalyze proton-linked pyruvate and lactate transport activity.

Conceiving harm: disability discrimination in assisted reproductive technologies.

Applying the Americans with Disabilities Act (ADA) to denials of treatment by assisted reproductive technology (ART) practitioners raises particularly challenging legal and ethical issues. On the one hand, the danger that physicians will inappropriately deny treatment to patients with disabilities is especially worrisome in the context of ARTs, given the widespread stigma associated with reproduction by individuals with disabilities. On the other hand, patients' disabilities may sometimes have potentially devastating implications for any child resulting from treatment, including the possibility that the child will be born with life-threatening or seriously debilitating impairments.