Federal regulations stipulate that certain research activities may be considered exempt from regulatory requirements under the Common Rule (45 CFR 46) if approved by the Institutional Review Board (IRB) and confirmed in writing to the Principal Investigator (PI). These activities must fall into one of the eight predefined Exempt categories set forth by the Office of Human Research Protections (OHRP).
Researchers may believe that “exempt” review means they do not need to submit a protocol to the IRB. However, studies that are categorized as “exempt” are only exempt from federal regulations stipulated in the Common Rule (45 CFR 46). In other words, this type of research is still subject to state, city, and institutional policies. At Teachers College (TC), all human subjects research must be submitted to the IRB for review, including dissertation research.
Researchers new to the Institutional Review Board (IRB) may be unfamiliar with the different activities within each Exempt category. This post will provide examples of research that typically falls under Exempt Review - Category 6.
Category 6 indicates that protocols may be categorized as exempt if the research poses no more than minimal risk to participants and involves “taste and food quality evaluation and consumer acceptance studies:
- If wholesome foods without additives are consumed; OR
- If 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.”
Below are a few scenarios that we will review to see if they meet the requirements for Exempt Category 6.
Example A: A researcher plans to ask participants to taste-test six different types of raw berries in order to determine consumers’ preferences. The participants will be given three berries from each variety, totaling 18 berries. Participants will be asked to rate the different berry varieties on a 5-point Likert scale. The berries do not have any additives and are administered to the participants thoroughly cleaned and raw. Participants will be screened beforehand for allergies.
- Is it Exempt Category 6? Yes, this research meets the criteria for Exempt Category 6 as the data collection only involves participants eating “wholesome” berries without additives and rating them. The total amount of food consumed during the course of the study, 18 berries, would be considered within “reasonable” eating behaviors, and the consumption of berries does not present a risk to the participants. Researchers would have safety protocols in place to monitor any participant discomfort or any unanticipated allergies.
Example B: A researcher wants to examine consumers’ preferences among three different types of chewable vitamins. All three vitamins will be presented to the participants in random order. Participants will rate the vitamins on their taste, texture, look, and smell. The researcher will also ask the participants which vitamin they would be most willing to consume on a regular basis.
- Is it Exempt Category 6? No, this study does not qualify as Exempt Category 6. Typically, alcohol, vitamins, and other supplements are not considered food and thus, do not qualify for exempt status.
Example C: In 1972, researchers at Stanford measured preschoolers’ ability to delay their gratification when a high-reward item (a marshmallow) was present. The researchers offered the child two choices: 1) they could have the marshmallow right away, or 2) they could wait for the researcher to return and receive a second marshmallow. The children who waited in the same room as the marshmallow had much shorter delay times than the children who could not see the desired marshmallow.
- Is it Exempt Category 6? While the research study activities are minimal risk (including the risk of tantrums!), this study does not meet the criteria for Exempt Category 6 as it is not a “taste and food quality evaluation [or] consumer acceptance” study, but rather a measure of gratification. The study’s inclusion of youth might subject it to additional protections as defined by the OHRP.
Research activities may fall into one or more Exempt categories depending on a variety of factors, including the study population, researcher expertise, coinciding events, etc. TC IRB administrators will always review research on a case-by-case basis.