In the Matter of Carrot Neurotechnology, Inc., File No. 1423132
The standard of only accepting placebo-blinded research for low-risk educational software products goes against the common research standard for these programs. Educational games have been considered low-risk by regulatory agencies such as the FDA. The FDA doesn't consider these games to qualify as medical devices any more than they consider other learning materials, such as educational school textbooks to be medical devices. If any school textbook retailer had to meet the bar of "double-blind, placebo-controlled" studies for proving that their textbooks are effective, we would have greatly stifled access to textbooks across the country. In general, the field of educational computer games is still searching for appropriate controls that could serve as 'placebos', since behavioral interventions in general can't 100% control for participant expectations. While this research (still in its infancy) searches for appropriate control conditions, we can't hold back all these research innovations from the public. For example, behavioral techniques such as Applied Behavior Analysis do not typically have placebo-controlled research but are still considered to be highly effective at intervening on behavioral skills such as language and are required to be covered by many insurance companies. Several software products that don't have placebo-controlled research are being already paid for by medical insurance companies. It is easy to control for expectations for real medical drugs that come with high risks, but not for learning from behavioral training techniques where a person is actively engaged with learning materials that they are aware of while they interact with the materials. Thus, raising the bar higher than any behavioral and education researchers can realistically meet stifles development of applied research for ALL behavioral intervention products (whether delivered in-person or by computer). While this current website may have made some poor decisions with regards to advertising, stifling ALL future dissemination of American research via heavy-handed fines on technology transfer companies sets a poor precedent for the future. Stifling technology transfer directly coming from Universities has a risk of depriving Americans from any potentially useful low-risk educational product. Rather than adopting risk, applied researchers may stop making their applications available to the public. The FCC should be working to help researchers come up with strategies for using marketing strategies that are appropriate for the current stage of research, not shutting down all technology transfer from Universities out of fear of fines for failing to meet unrealistic and inappropriate FCC expectations. Leveraging huge fines at tiny University technology transfer companies is overbearing and stifles the ability for any future University to make low-risk computer software products available to the public. Rather than risking hundreds of thousands of dollars in fines, most educational computer technology will sit in the shelves of research offices and never make it to the public after enough researchers are shut down via heavy-handed and inappropriate FCC fines. The public wants the educational games that University Research Labs are creating. The public doesn't want the FCC to block researchers from making their games available to the public. This company is backed by some fairly reasonable scientific research that backs the claims they make about their products, even if it doesn't meet the FCC's somewhat unreasonable bar for researchers to jump over to meet their standards. In addition, the FCC is holding the researchers accountable for misrepresentations of their work by outside media companies they can't control. Press stories often over-exaggerate findings from research and the researchers have little or no control over what the media says. Holding researchers financially liable for what the media says about their research is inappropriate.