Over the last three quarters of a century, international guidelines and regulations have undergone significant changes in how children are problematised as participants in biomedical research. While early guidelines enacted children as vulnerable subjects with diminished autonomy and in need of special protection, beginning in the early 2000s,…

In the biomedical and behavioral sciences, it is widely recognized that researchers conducting studies involving human participants must respect the autonomy of research subjects. There is significant debate in the clinical research ethics and bioethics literatures about what it means for an individual to be autonomous. According to proponents of…

The National Institutes of Health (NIH) is the largest source of funding for biomedical research in the world. Funding decisions are made largely based on the outcome of a peer review process that is intended to provide a fair, equitable, timely, and unbiased review of the quality, scientific merit, and potential impact of the research. There have…

In many institutions, the institutional review board/research ethics board (IRB/REB) uses the traditional audit approach that emerged from the biomedical community (e.g., Nuremburg Code, Belmont Report) to review the ethical acceptability of research using humans as participants. This approach is guided by participant protection and risk…

The House Interstate and Foreign Commerce Committee's regulatory legislation on recombinant DNA technology is discussed along with university reactions to it. Violations of federal guidelines and legal efforts are described. (LBH)

The advantages and justifications for using small animals in human-oriented research are reviewed. Some of the pitfalls of extrapolating animal-derived data to humans are discussed. Several specific problems with animal experimentation are highlighted. (CW)

A Pittsburgh program to encourage physicians to choose clinical investigation careers consists of nine months of formal lectures and laboratory training and 15 months of a supervised laboratory research project. The curriculum ranges from basic laboratory techniques and biomedical content to advanced instrumentation, statistical analysis, computer…

Developing an effective vaccine remains a critical long-term approach to HIV prevention. Every efficacy trial should be responsive to the concerns of participating communities because the successful development of an HIV preventive vaccine will require long-term involvement of people who have been marginalized and who distrust the government and…

A policy statement drafted by the Association of American Medical Colleges is presented that reviews the goals, environment, and mechanisms of support of biomedical and behavioral research.