SUBJECT:

Recent Changes by NIH Regarding Clinical Trials Definitions and Regulations

To all current and future funded NIH researchers,

It is important for UC San Diego investigators to understand NIH’s new definition of a Clinical Trial. The new definition includes as clinical trials any studies that involve human participants assigned to an intervention in which the study is designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome. This change will be effective January 1, 2018.

All NIH funded clinical trials will be subject to the additional application requirements, registration, oversight and reporting required by the NIH. While some aspects of the NIH requirements have been in place for some time, the change in the clinical trial definition and the expanded pre-conditions requiring reporting and registration for all studies defined as clinical trials are more recent and are beginning to be communicated through many venues by NIH.

I invite our research community to read the article from Dr. Michael Lauer, NIH’s Deputy Director of Extramural Research titled “4 Questions for Researchers and Institutions involved in Human Subjects Research.” This article explains the changes in the definition and provides an opportunity for researchers to post comments through the “Open Mike Blog.” Additionally, there is an online petition circulating that dozens of AAU universities' faculty have signed. You may view and/or sign it here: https://ipetitions.com/petition/open-letter-nih-collins

Colleagues at University of California Office of the President, in coordination with the ten UC Clinical Trials offices and IRB Directors, are also evaluating the new definitions and will engage in dialogue with their counterparts and the NIH. In the very near future, we will post more information and guidance about how UC San Diego will be managing these new requirements.

NIH is launching a series of initiatives that are rolling out in 2017 - 2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the whole clinical trial lifecycle from concept to results reporting. These initiatives include:

• Change in definition of clinical trials (as discussed above, effective January 1, 2018)
• Good Clinical Practices training for clinical trials (effective January 2017)
• Clinical trial specific funding opportunities (due dates on or after January 25, 2018)
• New PHS Human Subjects and Clinical Trials Information form (due dates on or after January 25, 2018)
• Single IRB for multi-site research (effective January 2018)
• ClinicalTrials.gov registration and reporting requirements (effective January 2017)

For additional information, please see
https://grants.nih.gov/policy/clinical-trials.htm.

Sandra A. Brown Vice Chancellor for Research