Basic human neuroscience studies should not be treated as clinical trials…

In the last year of my service at NSF, the NIH issued a new policy with regards to a particular kind of neuroscience that has become the bread and butter of psychology departments, especially those that focus on cognitive science. These experiments are the modern versions of 20thcentury social psychology experiments where the experimental subjects would be healthy college students (and definitely not patients). In the modern versions, students receive brain scans using functional magnetic resonance imaging machines (fMRI; completely non-invasive) so that the investigator can actually visualize the functioning of the subject’s brains as they perform some task (or even play a game).

The new NIH policy will consider these studies to be “clinical trials”.

Clinical trials are a special animal from the standpoint of NIH’s regulations. In particular, the entire constellation of medical ethics: from informed consent all the way to how results are analyzed and revealed fall under the jurisdiction of a complex set of compliance requirements. That makes sense for patients because they are sick and on the vulnerable side of a power relationship with their caregivers (clinicians). The question is should this thicket of compliance rules apply to the above type of psychology experiments? I don’t think so. Yes, there should be rules but to my mind they should not rise to the levels seen in the medical trials context. These types of studies are qualitatively different. Let’s not force apples to be oranges. This piece in Science has the latest development in this story: NIH has agreed to postpone for one year putting this new policy in place.