The quality of a research study application sends a distinct signal to the institutional review board (IRB) about the skills, capacities, preparation, communication, experience, and resources of its authors. However, efforts to research and define IRB application quality have been insufficient. Inattention to the quality of an IRB application is…

Institutional review boards have a dual goal: first, to protect the rights and welfare of human research subjects, and second, to support and facilitate the conduct of valuable research. In striving to achieve these goals, IRBs must often consider conflicting interests. In the discussion below, we characterize research oversight as having three…

The significance of biorepositories has been known for many years but the latest advances in clinical and translational research and increased collaborations among investigators have made biorepositories even more prominent. Biorepositories collect and store human tissue and serum samples used in both the research and treatment of disease. In…

Within the sponsored research support offices in departments at research institutions, non-profits, and undergraduate institutions, research administrators are often perceived as servant leaders by their own membership organizations and those who work with them. This perception is influenced by survey results focusing on character. Parolini (2004)…

Ethical, Legal and Social Implications ("ELSI") research has played an increasingly important role in scientific research. Tens of millions of dollars, many of which are public, are spent funding scientific research projects. Taxpayers are demanding that scientific advancement move forward, hand-in-hand with careful examination of the many ethical…

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…

The following administrative aspects of scientific experimentation with human subjects are discussed: the definition of human experimentation; the distinction between experimentation and treatment; investigator responsibility; documentation; the elements and principles of informed consent; and the administrator's role in establishing and…