New NIH Clinical Trial definition is delayed

March 22, 2018

According to the just published DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 2018, "The agreement appreciates efforts NIH has taken to increase transparency and improve oversight of its clinical trials and recognizes that the results of NIH-funded clinical trials have not always been reported in a timely manner, reducing the potential benefit from the findings. The agreement urges NIH to continue to address this problem through enhanced registration and reporting through There is concern, however, that in addressing this issue, many fundamental research studies involving human participants are being redefined as clinical trials without sufficient notification and consultation with this segment of the research community. Fundamental research is critical to the NIH mission and of value to the public, and there is concern that policy changes could have long-term, unintended consequences for this research, add unnecessary regulatory burdens, and substantially increase the number of studies in the database that are not clinical trials. For fiscal year 2018, the agreement directs NIH to delay enforcement of the new policy published in the Federal Register on September 21, 2017 - including NIH's more expansive interpretation of "interventions" - in relation to fundamental research projects involving humans. The new policy should go forward for research projects that would have been considered clinical trials under the prior policy. This delay is intended to provide NIH sufficient time to consult with the basic research community to determine the reporting standards best suited to this kind of research."