Response to NIH Guideline: “Encouraging Early Transition to Research Independence"

November 24, 2010

Response to the new NIH Guidelines, “Encouraging Early Transition to Research Independence: Modifying the NIH New Investigator Policy to Identify Early Stage Investigators” Notice Number: NOT-OD-08-121

Presented by the AGA Institute Research Policy Committee
Prepared by James M. Anderson, MD, PhD, Chair, Research Policy Committee

Overall Comment:

On September 26th 2008 the National Institutes of Health (NIH) announced the following new guideline, “NIH New Investigator policies designed to encourage early transition to independence”.  Under this policy, New Investigators (Defined as being at any career stage but never having received an RO1), are within ten years of completing their terminal research degree or are within ten years of completing their medical residency; they will be designated as Early Stage Investigators (ESIs). Traditional NIH research grant (R01s) applications from ESIs will be identified and the career stage of the applicant will be considered at the time of review and award.

This policy will specifically identify the most junior applicants (ESI) from all those who have never been awarded an RO1. This group will receive special consideration, which has not been fully defined, during the review process. Data previously presented by the  American Gastroenterological Association (AGA), (1) supports the notion that junior investigators are especially likely to leave research if they fail to make the transition from a K award to RO1 or fail to receive their first RO1. Anecdotally many of those who opt out of research at this early stage are equally talented and have equal potential compared to those who succeed.  ESIs are particularly vulnerable because of financial, family and conditional institutional support peculiar to this early stage of their careers.

Thus, if these new policies lead to the retention of a higher fraction of ESIs in the investigator career pathway, the RPC supports their implementation and awaits the details of their implications for the review process. Our concerns focus on 1) composition of the IRGs which will review ESIs, 2) making review guidelines clear and enforced and 3) the unintended consequences of preferential treatment of ESIs, such as reducing success of established investigators.

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