Unethical medical treatment and research in US territories.

In 1898, the Treaty of Paris agreement concluding the Spanish-American War gave the US rights to claim and colonize Puerto Rico, the Philippines, and Guam. Along with the many consequences of such colonization came reports of significant harm to the native populations in healthcare and medical research by the occupying forces. Reports about unethical medical treatment and research on Puerto Ricans and Filipinos have existed but are often ignored, yet they include experiments and treatment with Total Body Irradiation (TBI), research on oral contraception leading (for some) to sterilization, and careless use of contaminated vaccines on humans.

Rethinking authorship in the era of collaborative research.

The size and complexity of research teams continues to grow, especially within the realms of science and engineering. This has intensified already existing concerns about relying on traditional authorship schemes as the way to allocate credit for a contribution to a research project. In this paper, we examine current authorship problems plaguing research communities and provide suggestions for how those problems could potentially be mitigated.

Enhancing research ethics capacity in the Middle East: experience and challenges of a Fogarty-sponsored training program.

We describe the research ethics capacity needs of the countries from the Middle East region. Against this background, we relate the experience of an international training program focused on providing long-term training in research ethics to individuals from low and middle-income countries in the Middle East area. We describe our pedagogical approach to training, program changes to address challenges faced, and accomplishments of trainees.

Data audit as a way to prevent/contain misconduct.

Research misconduct is frequently in the media headlines. There is consensus among leading experts on research integrity that the prevalence of misconduct in research is at least 1%, and shoddy work may even go over 5%. Unfortunately, misconduct in research impacts all walks of life from drugs to human subject protections, innovations, economy, policy, and even our national security.

Ethical and regulatory challenges in psychophysiology and neuroscience-based technology for determining behavior.

In the past three decades, there has been an explosion in research to understand the mechanisms of brain function. Recent advances in psychophysiology and neuroscience, while still limited, have sparked great interest in developing technologies that could peer into the brain and be used to identify or indicate certain behaviors. The polygraph (lie detector) represents an old technology used for discerning clues to the human brain; functional magnetic resonance imaging (fMRI) represents one of the newest efforts.

The myth of equipoise in phase 1 clinical trials.

Phase 1 clinical research trials using healthy volunteers are conducted for the sole purpose of serving the public good (a utilitarian concept). The literature on equipoise analysis does not exclude phase 1 trials with controls or healthy volunteers from the claim of being in "equipoise." The continued perpetuation of this ethically and scientifically invalid concept undermines the ethics of research with human subjects.

Clinical trials of drugs used off-label in neonates: ethical issues and alternative study designs.

The use of drugs for indications unapproved by the Food and Drug Administration (FDA), often called "off label use, "is widespread in children, including neonates. The widespread off-label use of drugs in neonates presents ethical and safety challenges. Since the passage of the Best Pharmaceuticals for Children Act (BPCA) in 2002, both the FDA and National Institutes of Health (NIH) have taken initiatives to facilitate and encourage research to achieve the necessary labeling for drugs routinely used in infants and children.

Strategies to minimize risks and exploitation in phase one trials on healthy subjects.

Most of the literature on phase one trials has focused on ethical and safety issues in research on patients with advanced cancer, but this article focuses on healthy, adult subjects. The article makes six specific recommendations for protecting the rights and welfare of healthy subjects in phase one trials: 1) because phase one trials are short in duration (usually 1 to 3 months), researchers should gather more data on the short-term and long-term risks of participation in phase one studies by healthy subjects; 2) researchers should develop strict inclusion/exclusion criteria that exclude unhealthy or vulnerable subjects, such as decisionally impaired people, in phase one studies; 3) subjects should not participate in more than one phase one study at the same time and should wait at least 30 days between participating in different studies; 4) researchers should develop a database to keep track of phase one participants; 5) subjects should be guaranteed a minimum wage equivalent to the equivalent type of unskilled labor, but there should be no upper limits on wages; and 6) subjects should be allowed to engage in collective bargaining with research sponsors.