Institutional Review Board (IRB) approval of research is imperative to the ethical conduct of research, to the protection of human subjects and to ensure compliance with federal regulations governing research. In the early stages of project planning, the investigators should incorporate IRB processes into the research timeline.
There are a number of available resources that may assist you in this task:Protection of human subjects is addressed under Title 45, Part 46, of the Code of Federal Regulations. One of the questions that investigators raise frequently is what type of review – expedited or full – will occur or if a study will be exempted from review. See the Code of Federal Regulations §46.101(b) for information on those types of studies that are exempted from review.
Read information about federal regulations that address expedited review.
The Secretary of the Department of Health and Human Services has determined a list of research categories that may be reviewed through an expedited review procedure.The National Institutes of Health also provide guidance on developing the human subjects section of a research plan.See a review of the history of IRBs and their role in overseeing research, by Wesley G. Byerly, Pharm.D.