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NIH Clinical Trials Definition and Regulations

Find information and links on the changes and clarifications by NIH regarding clinical trials definition and regulations.

The National Institutes of Health (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 reporting of results. These initiatives include:  

  • Clarification of the definition of clinical trials (effective January 1, 2018)
  • Good Clinical Practices training for clinical trials (effective January 2017)
  • Clinical trial specific funding opportunities (proposals due on or after January 25, 2018)
  • New PHS Human Subjects and Clinical Trials Information form (proposals due 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, see:

NIH Definition of Clinical Trials

It is important for UC San Diego investigators to understand NIH’s definition of a Clinical Trial.

The 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.

All NIH-funded clinical trials will be subject to the additional application requirements, registration, oversight and reporting.  While some aspects of the NIH requirements have been in place for some time, 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.   

Two articles from Dr. Michael Lauer, NIH’s Deputy Director of Extramural Research titled “4 Questions for Researchers and Institutions involved in Human Subjects Research” and the more recently published article “’Continuing to Clarify the NIH Definition of Clinical Trials” The first article explains the changes in the definition and provides an opportunity for researchers to post comments through the “Open Mike Blog.” The second one responds to some of the feedback and provides further clarification. 

Colleagues at University of California Office of the President, in coordination with the UC campus’ 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.