The category defines two conditions, that when both exist, exclude the activities from consideration for exemption. The study can be exempt if the activities only meet one of the conditions below:
• the information gathered during these activities can be linked to the subject, either directly or by some coding system if the researchers can access the codes
• should a third party gain access to that information, the subject would be placed at risk. The risk can be for criminal or civil liability or can be the risk of damaging a subject’s financial standing, reputation, employability, or insurability.
1. First, if the taste test involves wholesome food without any additives it is then eligible for exemption. The IRB reviewer must make sure that the food product to be researched is “wholesome” (no additives).
An example of such a research project would be a taste-test conducted on different types of grapefruit to determine consumer preference. The grapefruits are those normally grown in different sections of the country, using normal agricultural practices, and do not involve the addition of food additives or chemicals. The subjects merely indicate which of the grapefruit tasted they prefer.
2. The second item (ii) involves food with ingredients (including additives) at or below a level found to be safe by the FDA or EPA and USDA. All foods purchased at a local grocery store would be exempt under this category.