NIH Fairy Grants Your Wish for Unlimited A0s

In a new Notice, the NIH went beyond reversing its decision to eliminate the A2 submission to allow, in theory, unlimited A0 submissions of the same proposal (hopefully improved with each submission).

Effective immediately, the NIH and AHRQ will accept a new (A0) application following an unsuccessful resubmission (A1) application. The subsequent new application need not demonstrate substantial changes in scientific direction compared to previously reviewed submissions, and must not contain an introduction to respond to the critiques from the previous review.

Although reviewers of this subsequent A0 might think it sounds familiar, they will not have the prior applications or summary statements and will be instructed to treat each A0 as new (and it will have a new grant number assigned).

The NIH and AHRQ will not assess the similarity of the science in the new (A0) application to any previously reviewed submission when accepting an application for review. Although a new (A0) application does not allow an introduction or responses to the previous reviews, the NIH and AHRQ encourage applicants to refine and strengthen all application submissions.

However, if it feels like Groundhog Day without hope of ever reaching Feb 3 or a competitive score, reviewers will also likely be encouraged to comment on unproductive repetitive submissions in the Additional Comments to Applicant.

Also, the new policy makes clear that PIs cannot resubmit the application as soon as they know their score and still cannot have overlapping proposals under review at the same time.

This means that the NIH will not review:

  • a new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping resubmission (A1) application.

  • a resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

  • an application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101). {writedit: yet another reason not to appeal}

PIs should communicate with their PO about resubmission strategy. An ND (not discussed) A0 might do better just going back as an A0 again (skipping a written introduction as an A1). If the PI would do better to write the introduction to clarify/highlight improvements based on the A0 discussion, then an A1 might be the more strategic submission (plus the extra month may be useful). A Type 2 (competing renewal) would need to go in as an A1 to remain under consideration as a Type 2 (if/when subsequently submitted as A0, becomes Type 1 again and loses the Progress Report and competing renewal submission date/status). Some FOAs will limit whether an application can be submitted as an A1, too. You should definitely talk with your PO for advice. There will also be FAQs issued [update: a new Notice provides some clarification].

This strategy should bypass the prior “getting in line” philosophy of the A0-A1-A2 progression while allowing PIs to continue refining, improving, and submitting proposals from their evolving research program. As the Notice notes, this should particularly help early career investigators who have not had the time or resources to begin developing parallel research programs attractive to different ICs and SRGs. Let the writing and rewriting begin.

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NIH FY15 Budget in Brief

The President made a friendly suggestion about how Congress might spend federal monies appropriated for FY15.

As shown in the Budget in Brief released by HHS, the additional $211M suggested for the NIH (bringing the appropriation to $30.4B) is not evenly distributed.

Winners include NIAID (+$31M), NCATS (+$25M), NIMH (+$23M), NINDS (+$23M), and NIDDK (+$12M).

The remaining increases are all single-digit millions, and while no IC lost funding, several received no increase in their appropriation above FY14: NIDCR, NIDCD, NINR, NIMHD, NCCAM, FIC.

Several more only get an additional $1M (i.e., an extra R01): NEI, NIA, NIAMS, NIAAA, NHGRI.

Over half (53.4%) the extra $211M goes toward RPGs - $120M – which the NIH estimates will translate into 9,326 new and competing awards (or 329 more grants than in FY14).

NIH estimates that it will spend $566M on Alzheimer’s disease research and more than $3B on HIV/AIDS research.

The NIH will devote $100M to the BRAIN initiative (up from $40M in FY14).

The Cures Acceleration Network appropriation jumps to $30M (up from $10M in FY14).

There will be a 2% increase in stipends for pre- and postdoctoral trainees supported by National Research Service Awards (Fs & Ts).

Intramural research increases by $39M from FY14 to $3.4B (11.3% of the NIH appropriation).

In the unlikely event that the proposed Opportunity, Growth, and Security Initiative comes to pass (i.e., President’s request for $56B above the Congressionally mandated cap on discretionary spending offset by higher tax revenues and other cuts), the NIH would receive an additional $970M.

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FY13 Funding Trends

In working on the book, I was disappointed that we could not get funding trend data for more ICs (10 of 24). Publishing the range of percentiles over which applications are scored versus funded allows applicants to see patterns of skipping awards at lower percentiles and how high an IC will go for select pay decisions. Even though seeing these charts does not affect the outcome of an individual application, some data are better than no data for overall mental health as well as application and career planning.

Here at MWEG, I have a page with links to available funding trend data, which I will update as new data show up at IC Websites.

Those with FY12 data online include NHLBI (success rate only), NIAAA (success rates only), NIAMS, NIGMS, and NINDS (NIAID has FY11 data). The book adds charts for NIA, NIDA, NIMH, and NIEHS (FY11 only). Success rate data (by IC, activity code, FY, etc.) can always be found at NIH RePORT.

FY13 funding trend data are now available from NCI and NIDDK.

NIDDK went down a couple points on its R01 payline (13/18 in FY12 down to 11/16 in FY13 for established/new-ESI), and they seem to be accommodating more new R01s at the expense of renewals and the amount spent per award. NIDDK covers all the award mechanisms and even breaks out Ks by activity code.

NCI focuses on R01s and R21s but does include some R03 and RFA data. Perhaps most interesting is the comparison of FY12 and FY13 success rate data:

—FY12:

  • —R01 unsolicited: 620 awards, 15% success rate
  • —R21 unsolicited: 200 awards, 11% success rate
  • —R03: 101 awards, 20% success rate
  • —RFAs: 88 awards, 9% success rate
  • —Total RPGs: 1085 awards, 14% success rate
—FY13:
  • —R01 unsolicited: 582 awards, 15% success rate
  • —R21 unsolicited: 241 awards, 10% success rate
  • —R03: 100 awards, 15% success rate
  • —RFAs: 82 awards, 16% success rate
  • —Total RPGs: 1095 awards, 14% success rate

Not sure whether the drop in RFA applications in FY13 is due to fewer RFAs issued or fewer applicants to the RFAs issued; it’s a little tricky to figure out by searching the Guide, since some RFAs have multiple receipt dates spanning FYs, and the Provocative Questions RFAs were broken out into 4 groups per activity code (so 8 FOAs covering same ground as 2 FOAs previously).

NCI also includes success rate data for new-ESI applicants for both the R01 and R21 activity codes. Only applicants to the R01 are given special consideration at review and award time, and the data confirm this: the success rate for new/ESI applicants to the R01 activity code was 12% (18% for ESI – compared with 13% for new applications from experienced PIs) versus 8% for R21s (experienced PIs stayed at 13%).

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NIH FY14 Appropriation in the Omnibus Appropriation Bill

From the summary for the Labor, HHS, and Education Appropriations:

National Institutes of Health (NIH) – The bill includes $29.9 billion for the NIH, $1 billion above the fiscal year 2013 level. This funding will continue support for basic biomedical research and translational research through the programs like the Clinical and Translational Science Awards (CTSA) and Institutional Development Award (IDeA) to support scientists as they conduct research to discover cures. Further, it provides full support for the NIH Office of Science Education and programs like the Science Education and Partnership Awards (SEPA) to support biomedical research for the future.

While a billion more is good news, relatively speaking, it is not great news. The last time the NIH appropriation was below $30B was in FY08 ($29.6B).

Could be worse … could be raining.

Update: Here is the NIH text (with individual IC appropriations) from the House Bill – NIH_FY14_Appropriation

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Findings of Research Misconduct

A hat trick, including cases demonstrating  a role for alert readers and the reason ORI must operate outside the NIH …

Notice is hereby given that ORI has taken final action in the following case:

Dong-Pyou Han, Ph.D., Iowa State University of Science and Technology: Based on the report of an inquiry conducted by the Iowa State University of Science and Technology (ISU), a detailed admission by the Respondent, and additional analysis conducted by ORI, ORI and ISU found that Dong-Pyou Han, PhD, former Research Assistant Professor, Department of Biomedical Services, ISU, engaged in research misconduct in research supported by grants P01AI074286, R33AI076083, and U19AI091031.

ORI and ISU found that the Respondent falsified results in research to develop a vaccine against HIV-1 by intentionally spiking samples of rabbit sera with antibodies to provide the desired results. The falsification made it appear that rabbits immunized with the gp41-54 moiety of the HIV gp41 glycoprotein induced antibodies capable of neutralizing a broad range of HIV-1 strains, when the original sera were weakly or non-reactive in neutralization assays. Falsified neutralization assay results were widely reported in laboratory meetings, 7 national and international symposia between 2010 and 2012, and in grant applications and progress reports. Specifically:

a. Respondent falsified research materials when he provided collaborators with sera for neutralization assays from (i) rabbits immunized with peptides from HIV gp41-54Q (and related antigens HR1-54Q, gp41-54Q-OG, gp41-54Q-GHC, gp41-54Q-Cys and Cys-gp41-54Q) to assay HIV neutralizing activity, when Respondent had spiked the samples with human IgG known to contain broadly neutralizing antibodies to HIV-1; and (ii) rabbits immunized with HIV gp41-54Q to assay HIV neutralizing activity, when Respondent had spiked the samples with sera from rabbits immunized with HIV-1 gp120 that neutralized HIV.

b. Respondent falsified data files for neutralization assays, and provided false data to his laboratory colleagues, to make it appear that rabbits immunized with gp41-54Q and recombinant Lactobacillus expressing gp41-64 produced broadly reactive neutralizing antibodies, by changing the numbers to show that samples with little or no neutralizing activity had high activity.

Dr. Han has entered into a Voluntary Exclusion Agreement and has voluntarily agreed for a period of 3 years, beginning on November 25, 2013:

(1) To exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as “covered transactions’ pursuant to HHS’ Implementation (2 CFR Part 376 et seq) of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR Part 180 (collectively the “Debarment Regulations’); and

(2) To exclude himself voluntarily from serving in any advisory capacity to the U.S. PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

More at Retraction Watch.

Notice is hereby given that ORI has taken final action in the following case:

Based on the report of an investigation conducted by SAIC-Frederick, Inc., and additional analysis conducted by ORI in its oversight review, ORI found that Timothy Sheehy, BA, BSc, former Manager, DNA Extraction and Staging Laboratory, SAIC-Frederick, Inc., the Operations and Technical Services Contractor for the Frederick National Laboratory for Cancer Research, Frederick, MD, engaged in research misconduct in research supported by NCI contract HHSN2612008000001E to SAIC-Frederick, Inc., and the intramural program at the Occupational and Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics, NCI.

ORI found that the Respondent engaged in research misconduct by fabricating and/or falsifying U.S. PHS-supported data in Table 1 included in Cancer Epidemiol Biomarkers Prev 19(4):973-977, 2010 (hereafter referred to as the “CEBP paper’). Specifically, ORI found that Respondent fabricated the quantitative and qualitative data for RNA and DNA purportedly extracted from 900 formalin-fixed, paraffin-embedded (FFPE) colorectal tissue samples presented in Table 1 of the CEBP paper and falsely reported successful methodology to simultaneously recover nucleic acids from FFPE tissue specimens, when neither the extractions nor analyses of the FFPE samples were done. Thus, the main conclusions of the CEBP paper are based on fabricated data and are false.

Mr. Sheehy has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of 3 years, beginning on November 8, 2013:

(1) To have his research supervised; Respondent agreed that prior to the submission of an application for U.S. PHS support for a research project on which the Respondent’s participation is proposed and prior to Respondent’s participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of his duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent’s research contribution; Respondent agreed that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed-upon supervision plan;

(2) That any institution employing him shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract;

(3) To exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant; and

(4) That a letter will be submitted to the editors of CEBP requesting that the journal retract the publication.

More at Retraction Watch.

Notice is hereby given that ORI has taken final action in the following case:

Based on allegations made by readers of a published paper, additional review by the (NIH and ORI, and a limited admission by the Respondent that “some better looking strips were repeatedly used as representatives for several times [sic],’ ORI found that Baoyan Xu, MD, PhD, formerly a Postdoctoral Fellow, Hematology Branch, Systems Biology Center, NHLBI, and currently at the Institute of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chonqing, China, engaged in research misconduct in research supported by intramural research at NHLBI.

The questioned research involves a Western blot analysis of IgM and IgG antibodies from Chinese subjects in patients with non-A-E hepatitis and control subjects to test reactivity towards a newly discovered virus. Analysis of Figure 6 of the published paper and Figure S4 of the online supplemental information identified 13 pairs of Western blot bands which had a common origin yet were labeled as from different subjects and usually as detecting a different class of immunoglobulin. [notice includes full table]

The Respondent agreed to correction of Figures 6 and S4 of the PNAS paper [Xu, B., Zhi, N., Hu, G., Wan, Z., Zheng, X., Liu, X., Wong, S., Kajigaya, S., Zhao, K., Mao, Q., & Young, N.S. ``Hybrid DNA virus in Chinese patients with seronegative hepatitis discovered by deep sequencing.' Proc. Natl. Acad. Sci. (US) 110(25):10264-10269].

Dr. Xu has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of 3 years, beginning on December 6, 2013:

(1) That prior to the submission of an application for U.S. PHS support (including NIH support) for a research project on which the Respondent’s participation is proposed, and prior to Respondent’s participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of her duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent’s research contribution; Respondent agrees that she shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed-upon supervision plan;

(2) That any institution employing her shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived, that the data procedures, and methodology are accurately reported in the application, report, manuscript, or abstract, and that the text in such submission is her own or properly cites the source of copied language and ideas; and

(3) To exclude herself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

More at Retraction Watch.

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K99 Clarification

In announcing the re-issued career development parent announcements, the NIH highlighted significant changes to the K99/R00 program that bring much needed and appreciated guidance to applicants, particularly with regard to uniform expectations across ICs:

  • Candidates for the K99/R00 award must have no more than 4 years of postdoctoral research training experience at the time of the initial application or the subsequent resubmission.
  • Although the duration of postdoctoral training may vary across scientific disciplines, candidates must propose a plan for a substantive period of mentored training not to exceed 2 years.
  • It is expected that K99 awardees will benefit from no less than 12 months of mentored research training and career development before transitioning to the independent, R00 phase of the program.
  • Individuals who are close to achieving an independent faculty position, and cannot make a strong case for needing a minimum of 12 months of additional mentored training, are not ideal candidates for this award.
  • If an applicant achieves independence prior to initiating the K99 phase, neither the K99 nor the R00 phase will be awarded.

This has been a tricky award, since K99 applicants stressed with career planning decisions and deadlines late in their postdoc often applied for faculty positions as funding decisions dragged on for months and months after the initial submission and review (and resubmission and review), and the ICs handled these situations differently, particularly during the initial years of the program. Nice to have everyone on the same page.

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How the NIH Can Help You Get Funded

Although this cat is partly out of the bag thanks to DrugMonkey, I am pleased to announce that I finally committed to page some of what I have learned in working with academic researchers and the NIH for more than 28 years. First and foremost, I want to thank all of you supporting this blog over the past 7 years, because without you, the book never would have been written. Literally.

When Oxford University Press was looking for someone to author a book about NIH grantwriting, they went to the NIH, where a PO said if they could find whoever was responsible for this blog, they would find the right person. And so the editor sent an email to “writedit”, which I fortunately did not dismiss as spam but instead wrote back that what would be more useful than another book on how to “write a grant” would be one focused on how to understand and work with the NIH as part of an overall grant-seeking strategy. Fortunately, they liked my ideas, and a year or so later, and the addition of a killer co-author who I was thrilled to have move to BICO, Jeremy Berg, How the NIH Can Help You Get Funded made it to press.

My motivation for maintaining this blog comes from my genuine enjoyment of helping researchers succeed (and learning a lot of cool science along the way), and it was a no brainer to dedicate the book to you and the extramural staff at the NIH. I am happy to freely give any advice that I can here, but in case you want the fundamentals in one convenient volume, the book (paperback and Kindle) is available from OUP (20% discount code: 32398) as well as through Amazon, Barnes & Noble, and other booksellers. I kept the book small to keep the price down for students and postdocs, so there are topics I would have liked to have covered in more detail and will try to expand upon here in the blog, especially as folks continue to ask questions.

Currently, I am looking for a WordPress guru to help make the blog itself more user-friendly, so hopefully soon you will find this site easier to search and find shared intel in the comments on grant mechanisms, ICs, study sections, etc. of particular interest to you. And yes, I’ll finally change the color scheme to be more readable …

So, thank you all again for contributing to this collective effort and making MWEG a valuable resource - and thanks for all the memories.

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