Background: The peer review of clinical research projects is an essential step in project preparation. While some projects undergo rigorous review by grant-giving organizations, this does not apply to all clinical research. In many cases, peer review, if undertaken at all, is not rigorous, fully independent, or timely. Depending on their…

This paper presents findings from interviews with US Research Integrity Officers (RIOs) on their overall responsibilities as well as perspectives on Data Management Plans (DMPs). DMPs are formal documents describing the roles and activities for managing data during and after research. DMPs are now a required research criterion by many funding…

Research activities often involve enrolling human subjects as volunteers to participate in research studies. Federal regulations mandate that research institutions are responsible for protecting the ethical rights and welfare of human subjects from research risks. This is usually accomplished by requiring approval of research protocols by an…

Introduction: The increased availability of mobile sensing technologies is creating a paradigm shift for health research by creating new opportunities for measuring and monitoring behavior. For example, researchers can now collect objective information about a participant's daily activity using wearable devices that have: 1- Global Positioning…

Research institutions are charged with developing and managing conflict of interest (COI) policies regarding the design, conduct, and reporting of research. Prior research indicates that university researchers may not understand the purpose of these policies and may resent the time taken to demonstrate compliance. Policy communication is not a…

The principal ethics committee in Australia's Capital, Canberra, underwent a major revision in the last three years based on changes debated in the literature. Committee or Board structure varies widely; regulations determining minimum size and membership differ between countries. Issues such as the effectiveness of committee management,…

Despite the presence of several funded research projects at academic and research institutions in sub-Saharan Africa, the quality of the pre/post grant award process in these institutions is inadequate. There is a need to strengthen research administration through infrastructural, organizational, and human resource development to match the dynamic…

In an effort to foster research integrity, the National Institutes of Health and the National Science Foundation mandate education of all trainees in the responsible conduct of research (RCR). Nevertheless, recent studies suggest that rates of questionable research practices and scientific misconduct are both high and considerably underreported.…

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…

Describes the research administration curriculum developed by the Office of Research Administration (ORA) at the Naval Medical Research Center. The curriculum educates students in the philosophical, legal, and sociological values and principles that undergird the responsible conduct of research, and serves as an important new pathway for promoting…