Category: Research Administration

Important Application Reminders for January Submissions

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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.

Changes in NIH Application Policies

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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.

Update: Status of hESC Applications and Grants

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NIH has rescinded the earlier notice regarding the status of applications and grants involving human embryonic stem cells. The new notice states that the receipt, processing, review and awarding of NIH applications and proposals involving human embryonic stem cells will continue. It goes on to list the following actions:

  • The suspension of further NIH activity to implement, apply or act pursuant to the NIH Guidelines is hereby lifted.
  • The suspension of the issuance of all pending competing, and noncompeting continuation hESC awards and contracts approved for funding is hereby lifted.
  • The suspension of the peer review of all pending competing hESC applications and proposals is hereby lifted.
  • The NIH Human Embryonic Stem Cell Registry will resume accepting submissions of information about hESC lines for the purpose of establishing eligibility for funding under the NIH Guidelines. The NIH review of hESC lines for inclusion on the Registry under the NIH Guidelines will also resume.

Status of hESC Applications and Grants

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NIH has issued a notice describing the status of applications and grants that propose research using human embryonic stem cells (hESC). Among its points are:

  • Any further NIH activity to implement, apply or act pursuant to the NIH Guidelines is hereby suspended until further notice.
  • Issuance of all pending competing, and noncompeting continuation hESC awards and contracts is suspended until further notice.
  • The peer review of all pending competing hESC applications and proposals is suspended until further notice.

Grants affected include all types of research and training. We expect more guidance soon and will let you know when it’s posted.

New Distributor for Knockout Mice

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MouseNIGMS (and other NIH) investigators previously have been able to obtain over 2,500 knockout mouse strains at a negotiated cost from Lexicon. These mouse strains are no longer available directly through Lexicon.

You may now request them, along with an additional 1,000 knockout strains, through Taconic. NIH investigators acquiring a Lexicon knockout mouse through Taconic are expected to place the mouse lines in a NIH-supported mouse repository.

The NIH Guide notice updates the policy and provides more details.

Elimination of Electronic Submission Error Correction Window

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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.

Impact Score Paragraph in Summary Statements, Plain Language in Public Sections of Grant Applications

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Extramural NexusThe August issue of NIH’s Extramural Nexus includes two announcements that might interest you.

Impact Score Paragraph in Summary Statements

Starting with September grant application reviews, reviewers will include a summary paragraph to explain what factors they considered in assigning the overall impact score. This should help investigators better understand the reasons for the score.

Plain Language in Public Sections of Grant Applications

The director’s column talks about the importance of communicating research value in your grant application.

Your grant title, abstract and statement of public health relevance are very important. Once a grant is funded, these items are available to the public through NIH’s RePORTER database. Many people are interested in learning about research supported with taxpayer dollars, so I encourage you to be clear and accurate in writing these parts of your application. Reviewers are being told to expect plain language in these sections.

The Nexus column includes links to these helpful resources:

Electronic Awards Administration

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As with the transition to electronic grant applications, NIH is now transitioning to electronic award administration. Here are some important upcoming changes.

Progress Reports

Beginning August 1, 2010, you must use the eRA Commons eSNAP (Electronic Streamlined Non-competing Award Process) feature to submit all eligible progress reports. Also, SNAP progress reports will be due 45 days prior to the next budget start date (instead of 60 days), and IRB and IACUC approval dates will not be required as part of the progress report.

You can refer to the Notice of Award to determine whether these new requirements apply to your grant. For detailed instructions, see the eSNAP User Guide.

Appointments and Terminations

Beginning January 1, 2011, you must use the xTrain feature in eRA Commons to electronically submit appointment forms and termination notices for research training, fellowship, education and career development awards. After this date, paper documents will not be accepted.

My NCBI Tool to Replace eRA Commons for Bibliography Management

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My NCBI screenshotNIH 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.

Opportunity to Comment on Proposed Changes to Financial Conflict of Interest Regulations

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One of my activities is representing NIGMS on the NIH Financial Conflict of Interest Panel. This group has put substantial time and effort into updating the financial conflict of interest regulations that apply to NIH grant applicants. The proposed changes to the regulations are reflected in a recently released notice of proposed rulemaking (link no longer available) that is now open for comment. You may submit comments electronically or by mail as long as they are received by July 20, 2010.

Although responsibility for reporting and managing financial conflicts of interest would remain with the grantee institution, several of the proposed changes would affect individual investigators. For example, investigator disclosure requirements would be expanded to include all significant financial interests related to the investigator’s institutional responsibilities. In addition, the dollar threshold for disclosure of significant financial interests would be $5,000 (it’s currently $10,000), and this amount would apply to both payments and equity interests. Equity interest of any amount in non-publicly traded entities is considered a significant financial interest and would have to be disclosed.

Investigators would also be required to complete financial conflict of interest training before engaging in NIH-funded research and every 2 years thereafter.

I encourage you to look over the proposed rulemaking document as well as to learn how your institution will be implementing the new financial conflict of interest policy.

UPDATE: The comment period on the proposed changes to financial conflict of interest regulations has been extended to August 19. For more details, see the NIH Guide.