Medical Writing, Editing & Grantsmanship

The NIH is piloting new Adobe application forms in 3 RFAs with receipt dates in October: RFA-AI-08-020, RFA-DE-09-001 (R01), and RFA-DE-09-002 (R21) (the latter two were originally posted with PureEdge application forms and were reposted on July 1 with the new Adobe forms, which must be used). The SF424 Application Guide for Adobe forms will be available on or before August 1, 2008. Full conversion from PureEdge to Adobe forms is planned for December 2008. A quick summary of the NIH notice on these matters is available from our very helpful friends at NIAID.

In other news (from NIAID), NIH has scheduled the transition to electronic application of the following grant types:

Career development awards (K) — February 12, 2009.
Fellowships (F) — April 8, 2009.
Institutional Training Grants (T) — September 25, 2009.

Still undetermined is the date for moving multiproject grants into the electronic sphere.

From H.R. 2642 (Supplemental Appropriations Act, 2008 - signed into law by our very own Dear Leader on June 30):

For an additional amount for `Office of the Director’, $150,000,000, which shall be transferred to the Institutes and Centers of the National Institutes of Health and to the Common Fund established under section 402A(c)(1) of the Public Health Service Act in proportion to the appropriations otherwise made to such Institutes, Centers, and Common Fund for fiscal year 2008: Provided, That these funds shall be used to support additional scientific research and shall be merged with and be available for the same purposes and for the same time period as the appropriation or fund to which transferred: Provided further, That this transfer authority is in addition to any other transfer authority available to the National Institutes of Health: Provided further, That none of these funds may be transferred to `National Institutes of Health-Buildings and Facilities’, the Center for Scientific Review, the Center for Information Technology, the Clinical Center, the Global Fund for HIV/AIDS, Tuberculosis and Malaria, or the Office of the Director (except for the transfer to the Common Fund).

No word as yet from the Great Zerhouni as to how these funds might be distributed. I’m sure it will be transformative, though.

Now, the NIH is not the only agency celebrating Christmas (or your favorite giving holiday) in July. NASA receives “an additional amount for `Science, Aeronautics and Exploration’, $62,500,000″, while the Department of Energy gets “an additional amount for `Science’, $62,500,000, to remain available until expended.”

The NSF receives a split dividend: “For an additional amount for `Research and Related Activities’, $22,500,000, of which $5,000,000 shall be available solely for activities authorized by section 7002(b)(2)(A)(iv) of Public Law 110-69″ and “For an additional amount for `Education and Human Resources’, $40,000,000: Provided, That of the amount provided, $20,000,000 shall be available for activities authorized by section 10 of the National Science Foundation Authorization Act of 2002 (42 U.S.C. 1862n-1) and $20,000,000 shall be available for activities authorized by section 10A of the National Science Foundation Authorization Act of 2002 (42 U.S.C. 1862n-1a).”

Science provides a nice overview of these goodies as well as current House and Senate versions of the FY09 budget … which won’t see the light of day until well into 2009. For now, a 4% increase for the NIH, and a healthy 13% increase for the NSF. In addition to the big 4 noted above, Science also briefly reviews budget requests for NOAA, NIST, USDA, EPA, and the US Geological Survey.

As noted here previously, the NIH is developing a new electronic reporting tool called Research, Condition, and Disease Categorization (RCDC). NIAID has a nice summary, as usual. The basic idea is to consistently categorize NIH-funded work according to “nearly” 360 predetermined research areas, conditions, and diseases. Except, that is, projects in such minor areas as women’s health, minority health, AIDS, biodefense, climate change, nanotechnology, and “Networking IT Research and Development.” Hmmm.

To prepare for the February 2009 launch, NIH is hosting a webinar on Wednesday, June 11 at 2 p.m. to introduce the RCDC system. Get the popcorn ready …

Update: Nature provides its brief take on the reforms, as does Science.

Update: In addition, NIAID reports that “This month, NIH will launch some pilots and try some changes, such as shortening the length of R01 and some other applications, developing a new scoring system, and giving applicants more useful feedback.” This month? June???

Today the Great Zerhouni announced “Enhancements to Peer Review” of the sort that would not wind up in your spam folder. The Advisory Council to the Director met today, and Larry Tabak’s presentation to the same about Enhancing Peer Review actually has some meat to it.
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So, last October I had a little fun working out the logic for my office pool picks for the next CTSA sites. Today we learn that 14 new sites have joined the consortium:

Albert Einstein College of Medicine of Yeshiva University (New York City)
Boston University (Boston)
Harvard University (Cambridge, Mass.)
Indiana University School of Medicine (Indianapolis)
Northwestern University (Chicago and Evanston, Ill.)
The Ohio State University (Columbus, Ohio)
The Scripps Research Institute (La Jolla, Calif.)
Stanford University (Palo Alto, Calif.)
Tufts University (Boston)
The University of Alabama at Birmingham (Birmingham, Ala.)
University of Colorado Denver (Aurora, Colo.)
The University of North Carolina at Chapel Hill (Chapel Hill, N.C.)
The University of Texas Health Science Center at San Antonio (San Antonio)
The University of Utah (Salt Lake City)

I only missed Scripps, but they have a heck of a lot of collaborating sites (including, interestingly, the Center for Applied Genomics at CHOP - Children’s Hospital of Philadelphia …)

Only 22 spots remaining in the Consortium. Who’s left?

UCLA, UMd, UMinn, Georgetown, Medical College of Wisconsin, NYU, SUNY Stony Brook, U Cinncinati, U Florida, U South Florida, U Tennessee, Baylor, Penn State, UCSD, U Vermont , U Illinois-Chicago , MUSC , U Missouri, UNM, Dartmouth, LSU, U Arkansas, U Hawaii, U Kansas, U Kentucky, U Louisville, U ND, U Oklahoma, UVa

Plus, I’m sure, at least a dozen or so not named here, such as an Arizona contingent, U Nebraska, a Mountain State rep, (never mind - the KY & TN sites would cover Appalachia), et al. (and then there is VCU with their corporate partner Philip Morris USA)

Yawn. The May edition of Peer Review Notes includes exciting job opportunities (folks looking to leave the lab: SROs wanted, not to mention a director for the new Translational & Clinical Sciences Division … perhaps a glimmer of hope, Whimple), an asynchronous electronic discussion review anecdote, updates on IRG realignments, and the story of a $10 grant awarded to a 10-year-old in 1957 (project had NO public health significance no less!).

I’m still wondering how the following peer review recommendations (a la Great Zerhouni) - apparently to be phased in via a pilot program in JUNE - represent a significant enhancement of the process:

Restructured Applications: The recommendations also [in addition to shorter R01 application length] call for R01 applications that are structured according to the review criteria with an emphasis on an application’s impact and significance in advancing scientific knowledge. Each application would be rated against individual criteria and also given an overall score. Applications would then be ranked, and any necessary adjustments in scoring made. [okay, the ranking is new - so you would get priority score, percentile, and rank?]

More Focused Reviews: Reviews themselves would be shorter and more specifically address how applications fared in terms of the criteria—impact, investigator, innovation/originality, research plan and environment. This set of changes will emphasize the impact of the application, versus the methodology, allow reviewers to read more applications and give applicants, councils and staff clearer feedback. [hmmm]

Enhanced Training: The recommendations also call for enhanced training for Scientific Review Officers, chairs and members and incentives for reviewers. [don't hold back folks - let them know what might incentivize you!]

The Scientist discusses a case study of a budget-crunch-induced lab closure, the personal and professional fall-out, and the concept of intramural bridge funding. In this case study, the PI (at Man’s Greatest Hospital) received a couple of Type 1 R01s during the NIH budget doubling that were not scored (article refers to them being returned without review - I assume she means without discussion/score) as Type 2s, resulting in funding loss … personnel loss … job changes … the works. Very interesting & engaging series of comments in response as well.

Historically, Type 2 R01s (competing renewals) enjoy roughly twice the success rate of Type 1s: 49.1% vs 24.5% in 2002 … 42.1% vs 20.0% in 2004 … 33.5% vs 16.3% in 2006. Hence the encouragement to pursue R01 vs R21 or R03 funding if possible (since the latter non-renewable mechanisms cannot take advantage of this higher success rate for Type 2s). In 2007, the gap narrowed a tad, with 36.1% success rate for Type 2 vs 19.2% for Type 1. As The Scientist points out, this meant 4,108 Type 2 applicants ended FY07 with out an award in hand.

I was pleased to see The Scientist feature institutional bridge funds. I strongly feel no research institution with a shred of integrity can get by operating without such a mechanism in place and transparent criteria for evaluating requests and distributing funds (distributive & procedural justice). These institutions gladly take the indirect costs their investigators bring in (70% at Dana Farber! and when I left another HMS teaching hospital in the late 80s, it was at … 92.3%!!! compared with a paltry 49% here at Baby It’s Cold Outside). In a cut-throat climate, they also dangle the damnedest recruitment packages to lure/buy funded researchers from other institutions. They better be ready to step up to the plate when the loyal productive PIs need help weathering the storm.

Apparently the Dana Farber will help those with scores within the 15th percentile that still weren’t funded. Baby It’s Cold Outside gives some weight to the percentile but just as much to the summary statement (some scores are outliers due to easily fixable application weaknesses rather than lack of productivity or scientific significance), the PI’s response to the critiques, and other funding sources. Budget requests must be prioritized, with students who need support in that particular lab for that particular project to finish up experiments for their thesis or dissertation receiving the highest priority. Maintaining a specialized animal model/pedigree or ensuring data collection continuity for a clinical cohort rank up there as well. Explicit reviewer requests for specific data to include in the amended application can qualify as bridge worthy. So, some strategies to consider for those of you trying to make a case for internal bridging monies at your home institution.

As discussed here last spring, NIH R56 bridge awards are also available, not via direct application by the affected PI but by recommendation of program directors and ICs. Last January, the Great Zerhouni reissued official notice of the NIH Director’s Bridge Awards. Usually program officers nominate their best & most worthy PIs without saying anything to said PI (so as not to get hopes up, especially when people’s careers are at stake in many cases) … but they shouldn’t mind if you send a quick e-mail reminding them that your A0 was really close and you could sure use a funding safety net until the A1 or A2 is awarded. Now, if your application was more than 10 percentile points above the current payline, probably not much they can do (don’t even think about asking about R56 support for an unscored application).

As I type this, it occurs to me that the case study in The Scientist was unscored but still received $50K a year for 2 years from the MGH as bridge fund grants, so clearly they have more liberal standards than the Dana Farber … or the NIGMS … as well.

Next week, I check out Life on Mars. Maybe it will look better on the red planet.

Update: Thus Spake Zerhouni … the projection of Age Distribution of PIs out to 2020 is amusing.

Update: The Chronicle of Higher Education has an article about NIH efforts to lure back senior reviewers, including an update on pilot peer review reform projects underway and a table at the end showing the percentage of assistant professors serving on CSR panels for 2002, 2005, and 2007. The numbers? 8%, 10%, 7%, respectively.

The Peer Review Advisory Committee (not to be confused with the Working Group of the Advisory Committee to the NIH Director on NIH Peer Review) met today, and the presentations seem to all be uploaded … except for the Great Zerhouni’s update on NIH Peer Review Enhancements. So, we have:

- Toni Scarpa on CSR Initiatives to Improve Peer Review (most bang for the buck re: content)

- Megan Columbus on Electronic Submission Update (transition to Adobe not until Dec 2008 - tentatively)

- Don Scheider on CSR Realignments (neuroscience case studies) & Clustering of Applications (orphan applications explained)

- Marion Mueller on Peer Review in Germany (leads with quote “Peer review is 50% garbage, 50% malice, and 10% good advice.”)

- Olivia Bartlett & Shamala Srinivas on Instantaneous Electronic Scoring of Multicomponent Applications (P01, P50, U19, U54)

Norka Ruiz Bravo has two slides comparing outcomes in women and men and new and established investigators. For 2006, it seems 11% of women and 9% of men scored within the top 10% in CSR study sections. According to the May 2008 council meetings (nice trick to provide these data on April 30th), 13% of new investigators and 18% of established investigators had Type 1 applications scoring within the 20th percentile. Interestingly, the May councils in 2001 and 2002 showed the distribution to be 15% and 17%, respectively, with the gap creeping up in May 2006 (14% vs 18%) and again in May 2007 (14% vs 19%).

Case study from the writedit files with excerpts from a triaged R21 summary statement, which means the PI would have only one page in which to respond to all 3 reviewers. For those of you out there who have not yet had the pleasure of discerning the true meaning of an unscored summary statement, enjoy this taste of what you might have to look forward to.

Reviewer #1: “The application is not competitive, suffers from a lack of precision, and describes a series of weakly related studies aimed at investigating the …”

Reviewer #2: “This excellent application seeks to delineate the interactions of … and their roles in … . The investigator and environment are outstanding, and the work is highly innovative.” [note: "Excellent" refers to score range of 150-200]

Reviewer #3: “As a proof of concept, this application has great appeal. However, it was not clear to this reviewer that … is a worthy target for all of this effort.”

These would be from the “Overall Evaluation” sections at the end of the first two individual critiques (no summary of study section discussion in this case due to traiged status) and extracted from the last of 3 paragraphs provided by the third reviewer. I’m guessing a lot of NIH applicants out there are smiling (grimacing) & nodding knowingly.

Many clues can be found in the summary statement. The second laudatory reviewer (<1 p review) regurgitates the applicant’s main points but provides no real additional commentary. So, not a lot of weight to this “critique” no matter how attractive it might be to consider this to be the only one worth listening to.

The first (2.75 p review) and third (0.75 p review) reviewers cite specific concerns and their rationale for being concerned, which is what adds weight to their input. If the PI were responding, these would be the points to address in the Intro and to correct in the scientific approach & the application.

In its favor, consider that the significance and innovation of the application were uniformly recognized, the PI thought to be well qualified, and the environment cited as strong … so not total discouragement. And, for those curious about this point in relation to the R21 mechanism, yes, assume preliminary data were presented (& discussed in the first & third critiques).

From an SRO’s explanation of how COI on a study section is appropriately handled:

“It sounds like you are concerned with conflict of interest rules for member conflicts. … At CSR, member conflicts generally occur if someone has a “significant” role on a project. If a member is participating as a consultant, this is considered to be an individual conflict rather than one for the entire study section. So, the member would be in CF and would leave the room during the review, but the study section could then review it.

However, once involvement reaches a certain point, the study section itself is in conflict. If involvement exceeds 5% of effort (more than 0.6 calendar months), or if the member is described in the budget justification as participating in the preparation of manuscripts for publication or receiving other tangible benefit, then a line has been crossed and the study section itself is in conflict. At this point, the “member conflict application” is assigned to a member conflict review group or to another appropriate study section if there is one. These situations are evaluated on an individual basis. It is a question of both (1) tangible benefit, and (2) extent of involvement (e.g., would this be considered “this person’s research”, as our Chief says). There is also the important matter of “perception” of conflict; this is always a matter of judgment by the SRO for the group doing the review. We are to avoid actual conflict of interest, as well as the perception of conflict.”