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.

To accommodate the transition to new application forms and instructions, NIH has temporarily extended the electronic application error correction window to five business days for applications due between January 25 and May 7, 2010. This allows additional time for applicants who may have inadvertently used the wrong forms to correct their applications. Please remember that applications using the wrong forms or that exceed the new page limits will not be reviewed.

For more on the application changes, see my October 13 post.

NIH Director Francis Collins announced today that the first 13 human embryonic stem cell (hESC) lines to be approved under the new NIH Guidelines for Human Stem Cell Research have been placed on the NIH Human Embryonic Stem Cell Registry, and NIH grantees may now use them. These lines were not previously eligible for NIH funding under the 2001 guidelines. Investigators whose grants were awarded with restrictions on using the funds for hESC research should check the registry to determine if any of the lines are suitable for their projects. Please see today's NIH Guide notice for more details, including procedures on how to request that the award restrictions be lifted. An additional 96 lines have been submitted for inclusion in the registry. We expect that more will become eligible for use in the coming months.

I recently had several peer-reviewed scientific manuscripts accepted. As an NIH-funded investigator (with an intramural laboratory in the National Institute of Diabetes and Digestive and Kidney Diseases), I complied with the NIH Public Access Policy and deposited the articles in NIH PubMed Central. I also included the PubMed Central ID numbers (PMCIDs) in my CV list of scientific publications.

I wanted to take this opportunity to remind other NIH-funded investigators of the public access policy, which also requires the inclusion of PMCIDs in all applications and progress reports, including those for training grants and fellowships. If a PubMed Central submission by a journal is in process and you do not have a PMCID yet, you can indicate "PMC Journal – In Process" at the end of the citation. If you have submitted the manuscript and so far only received an NIH Manuscript Submission System reference number (NIHMSID), NIH will accept it as a placeholder for the PMCID.

One area of confusion is that PMCIDs are not the same as PMIDs assigned by PubMed.

NIH’s frequently asked questions helped guide me through the PubMed Central submission process, and you may find the information there useful, as well.

Two major recommendations of the NIH Enhancing Peer Review Initiative were to shorten grant applications and restructure their content. These changes will affect applications due on or after January 25, 2010.

Here's a brief overview of the changes and their implementation. Be sure to follow the links for other details and important information.

New Application Structure and Length

These changes affect ALL applications (new, renewal, resubmission and revision). Exceptions will be considered only for AIDS applications from members of review committees. Specifics vary with the type of application (research, training, resource, etc.). For more, see:

• NIH Guide notice
• Details of application changes
• Table of page limits
• Links to more information for applicants and reviewers

Implementation

• When submitting an application due on or after January 25, you must download the new application forms. You may sign up to be notified when new application packages become available, which will be in December.
• Applications submitted early must follow the instructions for the actual due date (e.g., applications submitted on January 24 for the February 5 R01 due date must use the new forms).
• You can begin working on your applications now and paste the text into the appropriate form when it's available.
• NIH will not accept any applications using any part of the old forms, including biosketches.
• All existing Funding Opportunity Announcements (both electronic and paper) will be revised to incorporate these changes and will be reissued by December 2009.
• Parent announcements will be reissued and have new Funding Opportunity Announcement numbers.

If you have specific questions, please contact the NIH Grants Information Help Desk at grantsinfo@nih.gov.

At the recent meeting of the National Advisory General Medical Sciences Council, our Council members had their first opportunity to examine summary statements using the new peer review scoring system. Many aspects of the new scoring system are unfamiliar, including the use of overall impact scores as integers from 10 (best) to 90 (worst). A summary of the new scoring system is well described in a scoring system and procedure document, and an earlier version of this was shared widely with reviewers. As background, I compiled some data for approximately 300 NIGMS R01 applications reviewed under the new system.

This plot shows the distribution of overall impact scores along with the corresponding percentiles. Note the relative spread of percentile scores at a given impact score. This spread is due to the fact that percentiles are determined independently for each study section that considered 25 or more R01 applications. Otherwise, percentiles are determined across the overall pool of R01 applications reviewed by the Center for Scientific Review. For comparison, here is a plot of a similar number of NIGMS R01 applications reviewed using the old scoring system.

Note the similar spread of percentiles at a given score due to study section-specific percentiling. I would like to mention another major change as a result of the NIH Enhancing Peer Review effort. You must use restructured application forms and instructions, including a 12-page length limit for R01s, for applications due on or after January 25, 2010. For details, see the recent NIH Guide notice. We plan to post updates about these changes as key dates approach.

We’ve modified the receipt dates for our administrative supplement program Supplements for Collaborative Science (SCS), which helps grantees form new collaborations that enhance their NIGMS-funded research efforts. There will be only two submission deadlines in 2010: January 15 and May 15. All other details of the program remain the same. If you’re a grantee interested in applying for an SCS supplement, please read the entire NIH Guide notice and contact your program director to discuss your plans.

NIH recently announced policy changes for progress reports (aka PHS 2590 and noncompeting continuation). These will take effect on October 1, and corresponding changes to the eSNAP Commons Module will follow on October 9. The biggest change for most NIGMS grantees is the replacement of the Senior/Key Personnel Report with an All Personnel Report (Form page 7) that collects information on all personnel who participate in the project for at least one person month. The All Personnel Report also implements a new NIH requirement that all individuals with a postdoctoral role with one person month or more of measurable effort must have an eRA Commons user ID. Other progress report changes address the use of human embryonic stem cells, revisions related to the NIH Enhancing Peer Review initiative, and data required for institutional training awards that support graduate students. Revised instructions and forms are available at http://grants.nih.gov/grants/forms.htm. Inquires about preparing a specific progress report should be directed to your program official and/or grants management specialist.