This is an observational study, not a clinical trial.

In the United States, the most authoritative bodies that determine what clinical trials are are the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). The FDA is responsible for regulating clinical trials to ensure the safety and effectiveness of new medical treatments, while the NIH is the largest public funder of medical research in the country, including clinical trials. Together, these two organizations play a key role in defining what constitutes a clinical trial and ensuring that clinical research is conducted ethically and responsibly.

Observational study vs. a clinical trial

An observational study is a type of research study in which researchers observe and collect data on subjects without interfering with their behavior or treatment. This is in contrast to a clinical trial, which is a research study in which subjects are assigned to different treatment groups, and the effects of the treatment are carefully monitored and measured. According to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), clinical trials are typically designed to test the safety and efficacy of new medical interventions, such as drugs, vaccines or other therapies. Observational studies, on the other hand, do not involve any active intervention by the researchers and are not designed to test the effectiveness of a specific treatment. Therefore, according to NIH and FDA policies, an observational study is not a clinical trial.

FOCI is an observational study

In this project, we aim to develop a method for detecting changes in cognitive functions, e.g., memory and attention. We collect data to measure your behaviors, but we do not interfere with them. For this reason, our study is observational. This study would be a clinical trial if we were testing a new drug or medication to improve your cognitive functions. However, we are not doing it, so FOCI is merely observational in nature.