In the current era of limited funding, researchers need strategic alliances to launch or sustain programs of research to significantly impact the nation's health. This article presents a collaborative model, the Scholar Award Model, which is based on a strategic alliance between a College of Nursing in a research-intensive university and a…

This year the world commemorates the beginning of the tragic USPHS syphilis experiments that occurred in Tuskegee, Alabama from 1932 to 1972. In light of this sobering anniversary, this article will briefly examine four studies: the already mentioned USPHS syphilis studies in Tuskegee, the Nazi Holocaust Experiments and the resulting Doctors'…

To improve efficiency, consistency and transparency in clinical trial contract negotiations with industry sponsors, a Council of Academic Hospitals of Ontario (CAHO) committee facilitated the development of standard principles for member hospitals to follow during contract negotiation. Hospitals were encouraged to provide a link to the CAHO…

In recent years academic capitalism and a distancing from Mertonian scientific norms have shifted the traditional reward of academic science from peer recognition to the award of grants. With the shrinking of the NIH budget in real terms since 2003, there are increasing numbers of researchers whose careers are at risk from lack of funding. This…

Research is conducted in a variety of cultural settings. Ethical standards developed in Europe and the Americas are increasingly applied in these settings, many of which are culturally different from the countries in which these standards originated. To overcome these cultural differences, investigators may be tempted to deviate from ethical…

The reporting, analysis, and management of adverse events (AEs) provide an ongoing assessment of risk in the context of a clinical trial and enhance the protection of human research participants and the informed consent process. Effective and efficient review of AEs has been a long-standing challenge for Institutional Review Boards (IRBs) and…

PRINCE2, which stands for Projects in Controlled Environments, is a project management method covering the organisation, management, and control of projects and is widely used in both government and commercial IT and building projects in the UK. This paper describes the application of PRINCE2 to the management of large clinical trials…

Discusses the role of research administrators as executive administrators and executive managers of Institutional Review Board (IRB) ethical review programs within biomedical research institutions. Suggests that research administrators who serve as IRB executives can work to transform biomedical research organizations from being only associations…