(Newswire.net — July 25, 2019) — The risks of brain damage, and the awareness of the issue thanks to professional sports, has led to an increase in clinical studies on the brain. Scientists who are conducting studies have been fighting back against government regulations that make basic studies more expensive and delay scientists unnecessarily.
Requirements, which were established in 2017, require any NIH-funded clinical study to be registered and reported.
Scientists in any clinical research organization conduct basic tests that often do not include drugs or other treatments. Under the law, scientists would have to make all of their findings public, which scientists claim would be a burden to the public. These internal studies are often burdensome and demanding when reporting.
Since scientists are not conducting trials on medication or treatments, the studies would be difficult to make meet the basic format required by ClinicalTrials.gov. Scientists often conduct preliminary experiments, prior to conducting major experiments that they report. The law would require scientists to also publish information on these preliminary studies which are more of a brainstorming session for some of the larger studies.
NIH staff members looked into the issue and found that scientists do deserve a reprieve when conducting basic studies on the brain. Staff members found that these studies often do not have an expected outcome, and when they were reported, they often included only one person’s results rather than an entire group.
The staff found that these studies led to designing experiments that would be properly filed within the public database.
The most recent reprieve will last until a complete review of the matter is conducted. The NIH granted a year reprieve last July which is set to end on September 24, 2019. Congress stepped in last year to request that the NIH delay the requirement for a year.
Studies that do fall within the definition of a clinical trial will have to take training courses that teach the researcher basic clinical practices. The course may be a brief seminar which is fully conducted online.
Delays will allow for lawmakers to ensure that the proper studies are required to be submitted while not hindering research into brain development and damage. Scientists that are conducting studies on the brain will benefit from not getting in trouble for conducting a study without documenting it properly.
Last year, academics and scientific groups urged the NIH to drop basic science from the definition of clinical trials because the basic research is not a clinical trial.