Activities must meet the definition of research and involve human subjects as defined in DHHS regulations, or be research and involve human subjects as defined in FDA regulations to be subject to the IRBs jurisdiction. How do I know if my project meets the definition of human research?
A form 129 (available at the IRB website) requesting a determination of whether the proposed activity is human research must be completed and submitted to the IRB office prior to beginning the project. The IRB Chair will review the form 129 and determine whether the proposed activity meets the definition of human research. A written response will be returned to the submitter. What are the 18 protected health information components mentioned? The identifiers are listed in the Code of Federal Regulations as: (1) Names; (2) All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census:(a) the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and (b) the initial three digits of a zip code for all such geographic u
