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By Melinda Young, Author
Research participants recently were asked to taste test chocolate chip cookies. One version was slightly darker and had a distinctive aroma. Researchers needed to know what they thought of their cookie’s appearance, taste, smell, and texture. The IRB reviewing the study wanted to know how exactly people were told that their cookie might be made from crickets.
“It presented a unique situation to our IRB, which we had to manage through,” says Alyssa Joy Bakke, PhD, a research technologist at Pennsylvania State University in University Park.
“What we were testing was looking at chocolate chip cookies, both ones with and without cricket flour in them,” Bakke says. “Can we make a food that has cricket powder in it and it’s still acceptable, and what are people’s perceptions of the product and what are some of the intrinsic personality characteristics that impact people’s liking of a novel food?”
During informed consent, researchers told participants that some products would contain crickets, but half of the subjects participated in blinded tests in which they didn’t know whether they were tasting the cricket cookies or regular cookies. The other half knew whether their cookies contained cricket flour.
“We had interesting results,” Bakke recalls. “People tended to be more accepting when they knew it had crickets in it, saying, ‘OK, this is pretty good for a cricket cookie.’”
It is still unusual for IRBs to receive protocols involving insect-derived food, but it can and does occur, so they should be prepared.
Bugs as food is a growing enterprise, with cricket farms, university “bug bowls,” and “insect delis” cropping up in recent years.
“For several years, when I was at Purdue, there was an annual bug bowl event,” says Kristine Hershberger, CIP, director of the human research protection program at the University of Tennessee in Knoxville.
A professor brought awareness of insects with edible insects and cricket spitting, she recalls.
Likewise, Penn State holds a fair in which the public is invited to try chili-encrusted crickets and other insect delicacies, Bakke says. “It’s for kids, and they get a bug sticker when they go through the line.”
Also, as people increasingly travel or meet people from international communities, they find that insect-derived food is commonplace in some other locales, says Harry McGee, MPH, IRB chair at Michigan State University in East Lansing.
“I worked in the Congo, Zaire, and Bangladesh, and in the Congo, eating insects was very common,” McGee says. “I ate these flying termites that tend to harvest during the rainy season and palm grubs, which are larvae of beetles that attack palm trees.”
Larvae are high in fat, so these can cook in their own fat, and termites are high in protein. In taste the palm larvae could be compared with shrimp, he says. “These are really good.”
Because of these types of edible bug exposures, Hershberger was not too surprised when an investigator recently submitted a protocol involving roasted crickets. “It was surprising that it’s taken this long.”
The IRB had some additional questions for investigators, and the review process is ongoing, Hershberger says.
“Our IRB chair brought the study to my attention, not really knowing if there were any requirements, so I said I’d do some digging to see what I came up with,” she explains.
Hershberger asked a question about insect food studies on the IRB Forum, and she researched it online.
“But all I could find were references to how many parts of insects were allowed in prepackaged foods, and the European Union had recently passed some legislation, and I found something about that with regards to edible insects,” Hershberger says. “And the U.S. FDA has been funding some projects in cricket farming.”
As IRBs receive inquiries about unusual studies and deal with new regulations about exemptions, institutions will need to update policies and processes to handle research that doesn’t fit the usual categories.
For example, insect food is food. But can IRBs really treat it like they would beef?
One U.S. code that might apply to insect-derived food studies is 42 U.S. Code 1791, the “Bill Emerson Good Samaritan Food Donation Act.” If the edible item is an “apparently fit grocery product,” meeting all quality and labeling standards by all applicable laws, then it’s food. It also could be “apparently wholesome food,” meaning the same thing.
If it’s food, then a taste test would be low risk and might qualify for exemption from IRB review.
Investigators of the cricket cookies found the most difficult part of the IRB process was finding a regulation that matched their investigational product, Bakke says.
“Under the Food, Drug and Cosmetic Act, bugs and insects are considered food, if that’s the intended use,” she explains. “Specifically, it has to be raised as human food and not for pet food.”
A study involving whole insects that were properly cooked might be of less concern to an IRB than would insect-derived foods, McGee says.
“For instance, if there’s a product with deriving material from insects, I’d want to know how they’re doing that in order to make the derivative material safe,” McGee says. “And how is it going to be prepared safely?”
Research of taste-testing that involves unusual foods like insects might be exempted under the wholesome food category, but sometimes researchers will seek IRB review if there’s a specific ingredient that might raise questions, Bakke says.
For example, research involving extracted, pure capsaicin, a compound that makes chili peppers spicy, might not be exempt research, she says.
“We might need to work with the IRB to make sure we’re not giving it at too high a level,” Bakke says.
Another risk could be food allergies. Less is known about insect food allergies, although some research suggests that people with shellfish allergies could be susceptible to problems with crickets and other insects, Hershberger says.
According to www.edibleinsects.com, people with shellfish allergies might be allergic to the chitin, the insect’s exoskeleton, which is similar to the chitin in crustaceans. Pesticides and herbicides also could be a problem with insects gathered in the wild and not on a farm for human consumption.
So the best strategy for handling insect-derived food studies might be to ask questions about the origin of the insect product and to make certain informed consent lists all potential risks.
“The potential for an allergic reaction would be my greatest concern, and it’s the biggest safety issue I can think of,” Hershberger says.
For Bakke’s cricket cookie study, investigators told participants in the informed consent that the cookies might contain crickets and that people with known shellfish allergies have reacted to insects in the past.
“We screened out allergies in the inclusion and exclusion, and we put it in the informed consent in case someone slipped through the cracks,” she says. “But that was the only risk. The way we worded it was that the risks are no greater than what you would encounter in daily living because there is a specific IRB exemption carve out for wholesome foods tests.”
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group Manager Terrey L. Hatcher, Physician Editor Lindsay McNair, MD, MPH, MSBioethics, and Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.