The National Heart, Lung, and Blood Institute (NHLBI) has an important legacy of conducting and funding clinical trials. As stewards of the nation’s investment in heart, lung, blood, and sleep research, the NHLBI continues to work with its partners on optimizing NHLBI’s clinical trials enterprise through robust management, oversight, and monitoring of clinical trials.
Over the last few years, the National Institutes of Health has begun implementing a series of clinical trials reforms designed to enhance the accountability and transparency of clinical research. These reforms affect grants and contracts involving clinical trials, and several changes took effect on January 25, 2018.
Below are several key NIH reforms of importance to the NHLBI research community:
- Clinical trial-specific funding opportunities: Applications and proposals involving clinical trials with due dates on or after January 25, 2018, must be submitted to a funding opportunity announcement (FOA) or request for proposal (RFP) that explicitly states it will accept clinical trials. After January 25, 2018, the NIH will only accept clinical trial applications when submitted to parent announcements or other FOAs that specify clinical trials.
- New Human Subjects and Clinical Trial Information form: The NIH will require the use of a new application form that consolidates all information related to human subjects and clinical trials into one place, and also expands the information required for studies that meet the NIH definition of a clinical trial. This form will be included in the new FORMS-E Application Packages to be used for all due dates after January 25, 2018.
- Single IRB policy for multi-site research: For applications with due dates after January 25, 2018, and contract solicitations published after January 25, 2018, the NIH expects that all sites participating in multi-site studies that involve non-exempt human subjects research funded by the NIH will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects. This requirement applies to all applicable human subjects studies, not just trials.
- Registering and reporting for NIH-funded clinical trials: All NIH-funded clinical trials are expected to register and submit results information to ClinicalTrials.gov to help ensure that information about clinical trials and their results are made publicly available, in a timely manner.
- Clinical Trials Protocol Template for Phase II and III Clinical Trials Conducted Under an IND or IDE: Investigators are encouraged to use a template and electronic protocol-writing tool, developed by the NIH and the Food and Drug Administration, to help evaluate the scientific basis of their assumptions, minimize uncertainty in the interpretation of outcomes, and prevent loss of data.
- Good Clinical Practice Training: The NIH expects all NIH-funded clinical investigators and trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice to help ensure the safety, integrity, and quality of clinical trials.
Resources for more information:
- Clinical Trial Requirements for Grants and Contracts
- Why Changes to Clinical Trial Policies?
- Overview of New NIH Policies on Human Subjects Research (tutorial)
- NHLBI Funding Opportunities and Related Resources
Any questions? Please email: NHLBIClinicalTrials@mail.nih.