Less than a month ago, Neuralink announced that its brain-computer interface had been approved for human testing. However, Reuters has now reported that the U.S. Food and Drug Administration (FDA) discovered that the company had failed to keep records of animal experiments. The FDA also said that there were some issues with quality control. Investigators found quality control lapses at Neuralink’s animal research facilities in California. However, similar inspections of facilities in Texas found no problems.
“These issues demonstrate a lack of attention to detail,” said Jerry L. Chapman, senior quality specialist at Redica Systems.
Among the lab problems found by FDA inspectors were missing instrument calibration records, such as a pH meter used in one of the studies. In another study, seven instruments, including a “vital signs monitor,” had no calibration records. Neuralink conducted experiments on hundreds of animals, including monkeys.
Other issues include the quality assurance officer not signing off on the final study report and not documenting any deviations from the approved protocol or standard operating procedures. Currently, Neuralink is undergoing real-person testing to help patients paralyzed by spinal cord injury or amyotrophic lateral sclerosis (also known as ALS) use brain-computer devices to re-communicate.
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In December 2022, investigators from the U.S. Department of Agriculture (USDA) checked for potential animal welfare violations at Neuralink after internal employees complained that its animal testing was rushed, causing unnecessary suffering and death. The Council for Responsible Medicine, an animal welfare advocacy group, filed formal complaints with the U.S. Department of Agriculture and the Food and Drug Administration, alleging violations by Neuralink.
Conclusion
In light of recent developments regarding Neuralink’s brain-computer interface, concerns have arisen regarding the company’s adherence to regulatory standards and animal welfare practices. The U.S. Food and Drug Administration’s findings of quality control lapses and record-keeping deficiencies at Neuralink’s animal research facilities raise important questions about the company’s commitment to safety and ethical conduct.
The discovery of issues such as missing instrument calibration records and deviations from approved protocols underscores the need for rigorous oversight and compliance in biomedical research, especially when conducting experiments on animals. While Neuralink’s endeavours to develop brain-computer interfaces hold promise for medical innovation and the treatment of neurological disorders, adherence to regulatory standards and ethical principles must remain paramount.
Furthermore, allegations of rushed animal testing and potential welfare violations underscore the importance of ensuring humane treatment and ethical conduct throughout the research and development process. The involvement of regulatory agencies and advocacy groups in investigating these concerns reflects the broader societal expectations regarding transparency, accountability, and ethical conduct in scientific research. As Neuralink progresses with its human testing, it is good for the company to address the identified deficiencies, implement robust quality control measures, and prioritize animal welfare in its research practices.
