*New* Clinical Trial Requirements for Grants and Contracts
In 2016, NIH launched a multi-faceted effort to enhance its stewardship over clinical trials. The goal of this effort is to encourage advances in the design, conduct, and oversight of clinical trials while elevating the entire biomedical research enterprise to a new level of transparency and accountability. The NIH definition of a clinical trial was revised in 2014 in anticipation of these stewardship reforms to ensure a clear and responsive definition of a clinical trial.
Federal Policy for the Protection of Human Subjects (Published January 19, 2017)
The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight.
Inclusion Across the Lifespan - Policy Implementation (Published December 19, 2017)
The purpose of the Inclusion Across the Lifespan Policy is to ensure individuals are included in clinical research in a manner appropriate to the scientific question under study so that the knowledge gained from NIH-funded research is applicable to all those affected by the researched diseases/conditions. The policy expands the Inclusion of Children as Participants in Clinical Research Policy to include individuals of all ages. The policy also:
Clarifies potential justifications for age-based exclusion criteria
Requires participant age at enrollment to be provided in progress reports
The Inclusion Across the Lifespan policy applies to all grant applications submitted on or after January 25, 2019. Until then, ongoing research and grant applications/proposals are subject to the Inclusion of Children in Clinical Research Policy.
Next Generation Researchers Initiative
NIH has launched the Next Generation Researchers Initiative to address longstanding challenges faced by researchers trying to embark upon and sustain independent research careers, and to take steps to promote the growth, stability and diversity of the biomedical research workforce.