See below for some helpful summaries of recent NIH Notices from Jeff Warner at UCOP. Please read and redistribute as you feel appropriate.
Office of Research
NOT-OD-15-015 – Notice of Revised NIH Definition of “Clinical Trial”
The purpose of this Notice is to inform the research community that NIH has revised its definition of “clinical trial.” The revision is designed to make the distinction between clinical trials and clinical research studies clearer and to enhance the precision of the information NIH collects, tracks, and reports on clinical trials. It is not intended to expand the scope of the category of clinical trials. No changes have been made to the NIH definition of a “Phase III clinical trial.” In addition, because clinical trials are subject to additional oversight, a clearer definition will help investigators ensure that they are meeting all of their obligations, and it will help NIH ensure that the additional oversight is occurring when it is needed.
The following revised definition will replace the current clinical trial definition in relevant extramural and intramural NIH policies, guidance, and instructional materials. It will apply to competing grant applications that are submitted to NIH for the January 25, 2015 due date and subsequent due dates and contracts proposals that are submitted to NIH on or after January 25, 2015.
NOT-OD-15-013 – Notice of Clarification of 4-Year Limit of Postdoctoral Research Eligibility for K99 Applicants for PA-14-042 “NIH Pathway to Independence Award (Parent K99/R00)”
The purpose of this Notice is to clarify the eligibility requirement that K99 applicants must have no more than 4 years of postdoctoral research experience at the time of the initial application or resubmission or revision. Specifically, this Notice describes situations in which time is not counted against the 4-year limit.
Eligible Individuals (Program Director/Principal Investigator):
K99 applicants must have no more than 4 years of postdoctoral research experience at the time of the initial or the subsequent resubmission or revision application, and must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If an applicant achieves independence (i.e., any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be issued.
Parental leave or other well-justified leave for pressing personal or family situations of generally less than 12 months duration (e.g., family care responsibilities, disability or illness, active military duty) is not included in the 4-year eligibility limit. In addition, time spent conducting postgraduate clinical training that does not involve research is not considered as part of the 4-year research training eligibility limit. Only time dedicated to research activities would count toward the 4-year limit.
Additional clarifications are provided under Frequently Asked Questions. Potential candidates are encouraged to discuss their individual situation with an NIH Institute or Center Scientific Program Contact before applying.
Research Policy Analyst
Research Policy Analysis and Coordination
University of California, Office of the President