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. Researchers failed to protect their subjects; shining a light on these unethical cases could help to further the process of moral reckoning with past abuses, encourage political reforms improving health and welfare, and promote higher ethical standards in healthcare and research on those with diminished autonomy/self-determination.

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. We recommend that research communities, especially those involved in large scale collaborations, revisit the contributor model and embrace it as means for allocating credit more authentically and transparently.

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. The main method of detecting research misconduct depends primarily on whistleblowers. The current regulations are insufficient since dependence on whistleblowers manifests itself as an accidental hit or miss. No other endeavor in our society depends on such a poor system of discovery of misconduct to remedy it. Nearly a quarter of a century ago, I proposed data audit as a means to prevent/contain research misconduct. The audit has to protect the creative process and be non-obtrusive. Data audit evaluates the degree of correspondence of published data with the source data. The proposed data audit does not require any changes in the way researchers carry out their work.

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. Many former trainees developed research ethics curricula in their home institutions, established or enhanced their institutions' research ethics committees, provided leadership to national research ethics systems, and conducted research in research ethics. Based on our analysis, we make recommendations for how trainees can further address current regional research ethics needs in the Middle East and conduct future research. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program.

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 use of these technologies in intelligence and counterintelligence in the field without validation represents a major concern about its usefulness. Both research on this new technology and subsequent use on public raise ethical challenges. This article will address the overall ethical issues associated with these new technologies. The report identifies the ethical and cultural challenges in conducting research on these new tools, explores the possibility of using current U.S. regulatory requirements regarding drugs and devices as a model for regulating these new technologies, and suggests approaches for the future.

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. Federal regulations provide broad rules and guidance for the protection of human subjects in research. However, there are ethical issues that a physician may face when designing clinical trials of drugs in neonates that are routinely used off-label and widely believed to be beneficial. We attempt to describe these ethical challenges and provide recommendations, including alternative study designs, to resolve them in an ethical framework that takes into account the Belmont Report, the statement of the World Medical Association (WMA), and federal regulations.