The COVID-19 pandemic and associated shutdown negatively affected research as it did many other industries. With a near-total work stoppage, researchers had to pause research and clinical studies, in particular any studies that involved contact with human subjects. Recognizing that many applicants would be delayed in their ability to generate preliminary data in time for their grant applications, NIH, AHRQ, and NIOSH effected a policy that allowed applicants to submit preliminary data up to 30 days before the study section meeting, as part of allowable post-submission materials.
The policy has been extended several times throughout the pandemic, including most recently on February 1st. Given that the White House announced recently that the COVID-19 emergencies will be ended effective May 11, 2023, it is possible that this is the final time that the NIH grants this exception.
NIH will accept preliminary data as post-submission materials to applications submitted for the August/October 2023 council (beginning with submissions for the Jan 25, 2023 due date). The policy comes with a few conditions to note: (1) The funding opportunity announcement (FOA) to which the applicant is responding must allow preliminary data; (2) The preliminary data update is limited to 1 page for a single component application or 1 page for each component of a multi-component application; and (3) The deadline for submitting all post-submission materials, including preliminary data, will be 30 days before the study section meeting unless specified otherwise in the FOA. The full notice is available here: https://bit.ly/3JYXIz1