Integrating a Research Protocol into a Health Care Setting

Initiating a research protocol into any health care setting requires planning to ensure the research is conducted safely and efficiently, and will yield accurate data. An understanding of basic research principles is essential in this process. One agency that provides Good Clinical Practice guidelines for research is the International Council for Harmonization. This agency mandates Insti tutional Review Board (IRB) oversight for all studies that involve human subjects. The IRB ensures the research design and protocol protect the rights, welfare, and safety of human subjects, as well as appropriate data collection. Once IRB approval is obtained, protocol integration can begin, utilizing the planning described in this article.