(6) Taste and food quality evaluation and consumer studies, (i) if wholesome food without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
This category addresses two different types of research activity.
- 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.
- The second item (ii) is more difficult to understand. Research conducted on human subjects who consume plants or animals raised for food products may qualify for exempt review.
The Food and Drug Administration has determined levels of safety for various agricultural chemicals, referred to as GRAS (FDA generally recognized as safe) and GRAE (generally recognized as effective) additives which are fed to animals raised for food production. If these agricultural additives are given to animals at or below the levels found to be safe by FDA, the research can receive exempt review.
An example of such research would be taste-testing pork products where the swine have been fed corn and a chemical additive at a level designated below FDA guidelines that make the animal gain weight more quickly. The objective of the study is to determine whether the addition of the chemical changes the flavor of the pork.
There are also approved levels for environmental contaminants set forth by the Food and Drug Administration, the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA) that may affect the grass or grain consumed by grazing food animals such as chemicals sprayed on a field to combat chickweed. If the research involves taste-testing of food products that come from animals exposed to environmental contaminants and the investigator can show that the use of these contaminants was at or below those approved levels, the research can receive exempt review.
In all of these situations, the investigator should provide some documentation that the alterations, either chemical, environmental or agricultural, have been found to be safe by FDA, USDA, and/or EPA.
However, if there have been food and color additives incorporated into the food product and these additives are used in research with the intent to apply to FDA for marketing that additive, the research would not qualify for exemption. Even if the procedures are preliminary in nature, if the research would eventually lead to FDA approval for marketing the food or color additive, it would not qualify for exempt review. The additives are viewed as investigational by FDA and, therefore, do meet the exemption criteria.
2008 Guidance from OHRP regarding exemptions and the HIPAA Privacy Rule
The Privacy Rule and the IRB regulations differ with respect on what is considered individually identifiable.
The Privacy Rule is a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (see 45 CFR part 160 and subparts A and E of part 164). The Privacy Rule permits covered entities under the Rule to determine that health information is de-identified even if the health information has been assigned, and retains, a code or other means of record identification, provided that:
- the code is not derived from or related to the information about the individual;
- the code could not be translated to identify the individual; and
- the covered entity under the Privacy Rule does not use or disclose the code for other purposes or disclose the mechanism for re-identification (see HHS guidance entitled, Institutional Review Boards and the HIPAA Privacy Rule, page 6, Q and A #3, at http://privacyruleandresearch.nih.gov/pdf/IRB_Factsheet.pdf).
Regarding condition (1) above, in contrast to the Privacy Rule, information that is linked with a code derived from identifying information or related to information about the individual is not considered to be individually identifiable under the HHS regulations for the protection of human subjects at 45 CFR 46.102(f), if the investigators cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimen pertains. Therefore, some coded information, in which the code has been derived from identifying information linked to or related to the individual, would be individually identifiable under the Privacy Rule, but might not be individually identifiable under 45 CFR part 46.