Accepting Preliminary Data as Post-Submission Material and Other COVID-19-Related Application Flexibilities
Dr. Michael Lauer is NIH's Deputy Director for Extramural Research, serving as the principal scientific leader and advisor to the NIH Director on the NIH extramural research program.
Column Dr. Michael Lauer, NIH Deputy Director for Extramural Research:
As our nation looks to begin reopening, NIH continues to track how well our policies are meeting the evolving needs of the research community. In this post, we would like to highlight allowance of preliminary data as a new special exception to our post-submission materials policy and our guidance for reviewers.
Many of you are well aware that COVID-19 mitigation measures have adversely affected the ability of many researchers to generate preliminary data. Now that all 50 states have begun to reopen, and investigators may be better positioned to develop preliminary data, we want to give them the opportunity to have that data considered for this application submission round. The Guide Notice we issued today announces that for applications submitted for due dates beginning May 25, 2020 for the Fall 2020 review meetings/January 2021 Council round, NIH will accept a one-page update with preliminary data as post-submission materials for single component applications, or one page for each component of a multi-component application. A few items to note:
- The FOA must allow preliminary data.
- The deadline for submitting all post-submission materials, including preliminary data, will be 30 days before the study section meeting.
- Emergency competitive revisions and urgent competitive revisions, since they are undergoing expedited reviews, do not allow any type of post-submission materials.
As you are developing your application, you should keep in mind that NIH has issued guidance for reviewers. This guidance makes it clear that reviewers should assume that temporary, emergency situations resulting from the coronavirus pandemic will be rectified and/or dealt with by NIH staff, and therefore should not affect scores. It is the responsibility of NIH staff to request the information needed to resolve issues related to temporary, emergency conditions prior to award, as many of these temporary issues may be resolved before or during the early stages of the award.
We hope that the special exception for post-submission materials, and the guidance for reviewers, will provide our applicant community with some additional support as we all navigate this evolving landscape.
