Background: Communicating clinical trial results to research participants is seldom accomplished in a timely or an effective manner.
Objective: To evaluate the effectiveness of a plan to communicate results in an industry-sponsored randomized controlled trial for Huntington disease.
Design, Setting, And Participants: Postal survey to research participants at 28 of 41 research sites (including 217 of 316 participants) in Canada and the United States.
The current ethical structure for collaborative international health research stems largely from developed countries' standards of proper ethical practices. The result is that ethical committees in developing countries are required to adhere to standards that might impose practices that conflict with local culture and unintended interpretations of ethics, treatments, and research. This paper presents a case example of a joint international research project that successfully established inclusive ethical review processes as well as other groundwork and components necessary for the conduct of human behavior research and research capacity building in the host country.
View Article and Find Full Text PDFBackground: Research with human subjects is essential for most clinical and social science research. As such, the ethical treatment of subjects, including the role of Institutional Review Boards (IRBs), is of paramount concern. The prevailing system of IRBs in the United States reflects an integrated approach in which research organizations have their own local IRB.
View Article and Find Full Text PDFPurpose: Recent reports have claimed that institutional review boards (IRBs) are underfunded, yet little is known about the costs of operating IRBs. This study estimated the costs for operating high-volume and low-volume IRBs.
Method: IRB costs were calculated from published summary data.