Documents

The following link will take you to the Office for Human Research Protections (OHRP) graphic aids for use as a guide for (as noted at the linked site) "institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46."

http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html