Author: Paul Sheehy

In an earlier post, we outlined revised regulations on financial conflicts of interest. August 24, 2012, marks the deadline for institutions to implement the new policies. The changes are significant and will affect both investigators and administrators.

NIH recently held a Webinar on the new regulations, and you can view a recording or see the slide set. For more information, visit the NIH Financial Conflict of Interest Web site.

NIH has issued a notice requesting input by July 28 on potential revisions to reduce administrative burdens or costs related to compliance with OMB Circular A-21, Cost Principles for Educational Institutions. For more details, read this recent blog post from NIH’s Sally Rockey.

There is now a shortened review cycle for applications from new investigators. To give these applicants more time to prepare resubmissions (A1) between review cycles, NIH will accelerate the release of summary statements for the initial applications (A0). It has also pushed back the special submission date for new investigators to give them at least 30 days to prepare the revised application. Please refer to NOT-OD-11-057 for more details.

While we’re on this topic, I’d like to clear up confusion about when to submit a new application versus a resubmission. New applications and resubmissions typically differ in several important aspects (due date, introduction, etc.). For most funding opportunity announcements (FOAs), deciding whether to prepare a new submission (A0) or a resubmission (A1) is straightforward. But sometimes it’s not!

Here’s a little clarification. All applications in response to a request for applications (RFA) are considered new, unless the RFA says that applications to previous versions of the RFA may be submitted as resubmissions. For example, if NIGMS has issued an RFA and then decides to continue it via a non-RFA FOA, all applications to the FOA must be new the first time they are submitted. Similarly, if a PI continues an awarded U series application as an R series application (e.g., U01 to R01 after the original U01 FOA expired), then the R series application must be new.

Finally, applications to continue work started in a special Recovery Act activity code (RC1, RC2, RC3, RC4, etc.) should be submitted as new applications. Recovery Act competitive revision (S1) applications that were submitted to an existing FOA are an exception. They must be submitted as resubmissions (S1A1) and are subject to the NIH resubmission limit policy.

For those of you interested in a broader discussion of resubmissions, see the “Early Data on the A2 Sunset” blog post from OER director Sally Rockey.

NIH has issued a notice with important reminders affecting grant applications submitted on or after January 25.

The NIH policy on page limits means that reviewers need not consider text or materials that have been inappropriately placed in the Appendix or other sections without page limits, particularly when they circumvent page limitations for the Specific Aims and Research Strategy sections. In some instances, NIH may withdraw the application from review or funding consideration. For a reminder of what’s acceptable in the Appendix, see NOT-OD-10-077.

Also, post-submission application materials must adhere to new restrictions on timing and content; see NOT-OD-10-091.

As I previously posted on August 20 and October 8, other application policy changes also on the way for submissions on or after January 25 include:

1. Elimination of the error correction window from the application process for electronic and paper-based submissions; see NOT-OD-10-123.
2. Resubmission deadlines of no more than 37 months after the receipt date of the initial application; see NOT-OD-10-140.
3. New application forms for F, K, T and D series applications, which will apply to all other applications as of May 7, 2011; see NOT-OD-11-007 and NOT-OD-11-008.

Here are several new NIH Guide notices regarding applications:

New Time Limit for NIH Resubmission Applications
Revised applications must be submitted no later than 37 months after submission of the preceding version. In most cases, the clock will start at the original receipt date. For special cases, please refer to NOT-OD-10-140.

NIH to Require Use of Updated Electronic Application Forms in 2011
Submissions for deadlines after May 7, 2011, must use an updated forms package (ADOBE-FORMS-B1). For deadlines before then, applicants may use either the new forms package or the current one, ADOBE-FORMS-B. There are some exceptions: K, T, D or F series applications submitted for deadlines on or after January 25, 2011, must use the new forms package. For more information, see NOT-OD-11-008 and NOT-OD-11-007.

NIH announced this week that the 2-day “error correction window” to fix NIH system-identified errors or warnings after the submission deadline is being eliminated (see NOT-OD-10-123). This change will take effect for submission deadlines on or after January 25, 2011. You will still have up to 2 business days to view the application image and submit a corrected/changed application, as long as you do so before the deadline.

The error correction window was instituted by NIH as a temporary measure to facilitate the transition from paper to electronic applications.

In light of this change and another related to post-submission materials, it is really important to make sure that you submit an application early (before the submission deadline) so that you and your signing official have an opportunity to address any errors or warnings.

NIH’s Applying Electronically Web site includes many helpful resources, such as tips for avoiding common errors.

NIH has announced a significant upgrade to the citation management capability of investigators’ personal profiles in the eRA Commons.

With the integration of the National Center for Biotechnology Information (NCBI) “My Bibliography” portal, direct database queries will replace manual citation entry in the Commons. This will have many benefits, most immediately for your eSNAP progress reports due to more accurate data and automated evaluation of each citation’s Public Access Policy compliance status.

You must now enter citations via My Bibliography accounts. Users (investigators or delegates) will need to have a My NCBI account and link it to their Commons account. Instructions are available on the Commons Web site at https://era.nih.gov/.

Please note that beginning July 23, you will not be able to manually enter a citation directly into the Commons. You will still be able to manually enter citations of publications and other items not indexed in PubMed (book chapters, meeting abstracts, etc.), but this must be done using My Bibliography. Also note that beginning on October 22, all citations that had been manually entered into the Commons will no longer be displayed. Publications abstracted in PubMed will automatically appear in My Bibliography; other citations must be added to My Bibliography to appear.