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This article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze – as an example – the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, either in the US or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non-uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries. [ABSTRACT FROM AUTHOR]

The article focuses on a course developed for first year medical students entitled "Race and Gender in Medicines" that was introduced in Washington University School of Medicine in 1989. The course, presented in a seminar format, enables the participants to discuss openly their concern about diversity and its impact on their institution and the medical enterprise. In the course, physician speakers described their experiences with gender bias, racism, and other discriminatory practices and then presented strategies, they used to overcome these obstacles in their career path. The course was designed to provide an understanding of, and facts about the pervasive discrimination, that minorities and women have suffered as patients, research subjects, physicians, and faculty members, as well as the benefits that fostering diversity brings to the entire medical enterprise. The course presents historical and current information concerning racial, cultural, and gender bias in medical care, research, and professional organizations.

The article focuses on the challenges for infusing diversity in medical schools in the United States. It describes the historical evolution and present status of affirmative action for introducing diversity in medical school admission polices. It also notes the increasing diversity of the general population and discusses the benefits of diversity to medical practice, research and education. The rationale for an innovative course on the history of bias in medicine and the benefits that diversity brings to the medical enterprise has also been presented. Race-sensitive admissions policies, known as affirmative action, developed in the wake of the Civil Rights movement during the late 1960s, when selective colleges and professional schools assumed a more prominent role in educating minority students. These institutions accepted qualified black students who had lower grades and test scores than many white students, and their efforts had a dramatic impact in the 1970s. The new affirmative action programs reflected both a sincere conversion of medical schools to the cause of integration. These results have been considered nothing less than a demographic revolution.

The author comments on the issue of whether physicians in the U.S. should consent to a patient's request that the left ventricular assist device (LVAD) implanted on his chest be disabled. She cites three factors that physicians should consider when faced with the same situation, including the patient's self-determination, the limits of medical technology and the physician's compassion. She maintains the belief that it is ethically justifiable that the LVAD be disabled by the compassionate physician.

Human embryonic stem cells offer the promise of a new regenerative medicine in which damaged adult cells can be replaced with new cells. Research is needed to determine the most viable stem cell lines and reliable ways to promote the differentiation of pluripotent stem cells into specific cell types (neurons, muscle cells, etc). To create new cell lines, it is necessary to destroy preimplantation blastocysts. This has led to an intense debate that threatens to limit embryonic stem cell research. The profound ethical issues raised call for informed, dispassionate debate.