Archive for NIH Advice

Best Timing for NIH Applications

My standard advice is always to apply when the application is ready – strong, competitive, and not submitted just to get feedback (especially now with just one resubmission). I always give caveats on the various standard receipt dates and review cycles, such as Cycle 1 carrying the highest risk of delayed or deferred funding. Now, NIAID (who else) has a nice table summarizing all this for me.

New R01 Application Timing Characteristics and Considerations

Review Cycle 1
Apply February 5, 2010
(AIDS: May 7.)
Council in September 2010.

  • This cycle allows you to resubmit within the same fiscal year for review cycle 3.
  • You may experience a delay in your funding while we don’t have a budget or NIAID Paylines. We fund very few grants until we have a budget.
  • If your application is deferred — in the gray zone — for possible funding at the end of the fiscal year, you have the longest wait. Consider revising for cycle 3 instead of waiting.

Review Cycle 2
Apply June 7, 2010
(AIDS: September 7.)
Council in February 2011.

  • When you get your score in October or November 2010, we may have an interim NIAID Payline but not an actual payline.
  • You’re less likely to experience the long delay for funding we described above.
  • The earliest you could resubmit would be for review cycle 1 of the next fiscal year, which means your application would be funded under the next year’s payline. That could mean a long wait.

Review Cycle 3
Apply October 5, 2010
(AIDS: January 7, 2011.)
Council in May 2011.

  • We usually have a budget when you get your score in February or March 2011, so you can compare it with the NIAID Payline.
  • If your score falls in the gray zone, you won’t wait long before NIAID starts making end-of-year funding decisions in June or July.
  • The earliest you could resubmit would be for review cycle 2 of the next fiscal year, which means your application would be funded under the next year’s payline.

Other great articles in this week’s issue of the NIAID Funding News cover the roles and responsibilities of the Advisory Council , whether securing an R21 helps new investigators receive an R01 later (yes, by a 2:1 ratio), and conducting your own “peer review” prior to submitting an application to the NIH.

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R01 Success (or lack thereof) by K08/K23 Awardees

The Annals of Internal Medicine has a report entitled Sex Differences in Attainment of Independent Funding by Career Development Awardees … but I found the overall attainment statistics quite telling. The authors measured the rates at which recipients of K08 and K23 awards (2,784 awardees from 1997-2003 were studied) subsequently secured R01 awards. The bottom line:

Overall, 31.4% of the 1919 K08 awardees and 43.7% of the 865 K23 awardees were female (P < 0.001). Women were less likely than men to receive an R01 award (P < 0.001). The actuarial rate of R01 award attainment at 5 years was 22.7% overall, 18.8% among women, and 24.8% among men. At 10 years, the rate was 42.5% overall, 36.2% among women, and 45.6% among men. Sex persisted as an independent significant predictor of R01 award attainment (hazard ratio, 0.79 [95% CI, 0.68 to 0.92]; P = 0.002) in multivariate analysis controlling for K award type, year of award, funding institute, institution, and specialty.

This is through the 2007 cycle. Imagine the stats in a couple of years.

The authors were looking at a potential blockage in the pipeline to increase the number women faculty and chairs, noting that “in 2007, women constituted 49% of the medical student body but only 33% of medical faculty, 17% of full professors, and 12% of department chairs at U.S. medical schools.” A couple of their discussion point apply to any K awardee though:

K awards are designed to provide both protected time and mentoring to support the research career development of recipients. However, qualitative evidence collected by the NIH (18) suggests that the financial support offered by K awards may sometimes be insufficient to protect three quarters of the recipient’s working time, as these awards are generally intended to do. Some recipients may face pressure to allocate substantial time to clinical activities. To the extent that women receive smaller awards, protecting time for research may be particularly problematic for them.

The quality of the mentoring relationships of K award recipients also merits further investigation and targeted support. Mentoring is essential to the success of junior investigators in general and may be particularly important for female junior investigators (21–24). Mentoring has long been heralded as a mechanism by which to combat sex disparities in the professions. Some studies have suggested that the quality of mentoring received by women may be inferior to that received by men (15, 25), but others have found no differences (26, 27). K awards require recipients to receive designated mentorship. The low rate of R01 award attainment demonstrated in our study raises important concerns about the quality of mentoring within the K award program and whether mentors are prepared to deal with the special challenges female award recipients face.

The authors acknowledged their time frame may have been too short … but, aside from career breaks for family reasons, I don’t know of too many tenure clocks that extend beyond 10 years, even for clinicians, and the idea is for K awardees to secure their R01 during the K support period. It only gets harder once the K runs out.

Success of career development award recipients, who have a demonstrated aptitude and commitment to research and in whom considerable societal resources have been invested, is critical evidence of whether the physician-scientist pipeline is functioning adequately.

Indeed.

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New NIH Instructions & Forms Available

The NIH issued a notice summarizing the changes to the application packages for submissions on or after January 25, 2010. Most important is this reminder for those planning electronic submissions (i.e., most of you):

Applicants MUST return to the FUNDING OPPORTUNITY ANNOUNCEMENT (FOA), or the reissued Parent Announcement, to download the new application forms for due dates on or after January 25, 2010.

The sample biosketch in the PHS 398 form list is always convenient to have on hand though. The PHS 398 (paper submission) page includes instructions and forms, while you’ll of course find the instructions only for SF 424 electronic submissions (Adobe Forms B).

Have fun.

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NIH OppNet Launched

Yes, OptNet is indeed short for Opportunity Network, which, according to the NIH news release, will be supported in its first year with $10M in ARRA funds. Hmm. Don’t spend it all in one place.

To further explain, this is the Basic Behavioral and Social Science Opportunity Network, which will fund studies of

mechanisms and processes that influence behavior at the individual, group, community and population level. Research results lead to new approaches for reducing risky behaviors and improving the adoption of healthy practices.

… Twenty-four ICs and five programs within the Office of the Director will integrate existing NIH efforts, target research challenges best met collectively and collaborate on new research initiatives in complementary scientific areas. OppNet will also develop a plan for focused multi-year programs across ICs to advance priority topics within b-BSSR [basic behavioral and social sciences research].

… OppNet expects to release these first funding opportunity announcements by December 2009. Starting in Fiscal Year 2011, OppNet will be supported through NIH’s pool of common funds shared among the ICs.

Jeremy Berg (NIGMS) and Richard Hodes (NIA) are driving the bus, with plenty of help from their friends (“a steering committee of IC Directors and with facilitation from the Office of Behavioral and Social Sciences Research”). Watch the OBSSR Website for updates on OppNet as it unfolds.

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Science Works For Us

Literally, considering ARRA research awards are tax-payer funded.

ScienceWorksForUS, which highlights all aspects of stimulus funding for university-based research activities, is brought to you by the Association of American Universities, the Association of Public and Land-grant Universities, and The Science Coalition. You’ll find the expected news feeds about the economic stimulus program generally, ARRA-funded research anecdotes, and research findings stemming from ARRA-funded efforts.

The level of detail at the state level is nicely organized: total dollars and number of awards plus links to individual universities (the Web pages on which they report their ARRA awards and whatnot), a breakdown by funding agency (NIH, NSF, DoE), and more state- and university-specific news releases related to ARRA-funded research. You can run your cursor over the US map to quickly compare who’s getting what out of this initiative and click on individual states for the aforementioned details.

As a reminder, NIAID invites you to contribute your own story of how ARRA funds have helped you, as does the US DHHS, which invites you to submit stories or comments about ARRA funding.

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ResearchMatch.org

No, not an online dating service … ResearchMatch is an NCRR-funded secure registry that allows individuals to sign up to receive alerts about clinical research in which they might be interested and for which they might be eligible — and researchers to sign up to find potentially eligible participants for their studies.

Currently, 40 of the 46 current CTSA sites are participating, and the registry will eventually expand to include non-CTSA institutions. As described in the NIH’s news release:

After an individual has self-registered to become a volunteer, ResearchMatch’s security features ensure that personal information is protected until volunteers authorize the release of their contact information to a specific study that may be of interest to them. Volunteers are notified electronically when they are a possible match and then make the decision regarding the release of their contact information. It also will promote choice as there are no obligations on the volunteer to participate in studies.

According to the ResearchMatch.org participant FAQ, “[approved] researchers will not be given access to begin looking for potential study Volunteers through ResearchMatch until approximately January 2010.” As further explained by the researcher FAQ:

ResearchMatch is a not-for-profit activity and is free for any participating site & their researchers. … Researchers at participating sites will be given access to register through the ResearchMatch system. Upon registration, researchers may request either feasibility or recruitment access … your access to recruit via ResearchMatch will last only as long as your IRB-study approval.

After you have been granted recruitment access, you will be able to search for appropriate matches amongst the non-identifiable ResearchMatch Volunteer profiles in the system. You will enter your study’s criteria in the ResearchMatch Search Builder which will yield a list of these potential matches. You will send out IRB-approved content in your initial recruitment message to these potential matches through ResearchMatch. The secure ResearchMatch clearinghouse will route your message to each of these potential matches and they will have the option of replying yes, no, or no response. Your study’s home page will feature all those Volunteers who say yes and show aggregate figures/charts demonstrating the response rate to your initial recruitment message. Once the Volunteer has authorized ResearchMatch to release their contact information to you, you will be responsible for managing this contact information as called for by your IRB-study protocol.

Vanderbilt, which maintains and whose IRB oversees ResearchMatch.org, also has its own DNA bank called BioVu, which includes leftover blood from all patients seeking treatment unless they opt out when signing the the Vanderbilt Consent for Treatment and Agreement to Pay form.

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NIBIB Quantum Projects

NIBIB has released the RFA for Phase II (Implementation) of its Quantum Grant Program - aka Medical Moonshots.

Letter of intent due December 22, application receipt date on January 22, 2010 (just misses the Jan 25 transition to enhanced shorter applications, so these use a 25-p research narrative … “typewritten” paper submission no less).

The goal is to achieve a profound (quantum) impact on the prevention, diagnosis, or treatment of a major disease or national public health problem through the development and implementation of biomedical technologies.

Total costs (i.e., direct plus indirect/F&A costs) for any single year (5-y project period) may not exceed $3M. NIBIB expects most applicants to request $1-3M in total annual costs.

Before you get too excited, only 1-3 awards will be made.

NIBIB made 5 awards in the Phase I competition “on stem cell therapies for diabetes and stroke, nanoparticles to help eliminate brain tumors, development of an implantable device to replace kidney dialysis, and a microchip to capture circulating tumor cells for clinical and research purposes” — but anyone can apply for Phase II funding so long as their research plan “demonstrates the potential for a quantum advance by the end of Phase II via substantial pre-clinical data or a first clinical implementation.”

How much of an advance? NIBIB envisions that the “technology being developed would overcome a major, present-day disease or national public health problem (i.e., leading categories of disease burden, high-mortality/morbidity diseases affecting more than 100,000 individuals annually, technologies that revolutionize over 200,000 procedures annually), or change the paradigm of prevention, diagnosis, treatment in the practice of medicine.” In 5 years. I guess $3M a year will do that for you. I can’t wait to read the way cool announcements in NIH Research Matters.

What I want to know is where NIBIB finds reviewers with the vision needed to foresee a paradigm shift and quantum advance in the practice of medicine within the next 5 years … and whether these reviewers are available to take a look at my 401K portfolio.

Lots more detail in the RFA. Happy reading.

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ARRA Funding Opp: Administrative Supplements to Support Core Consolidation

Of interest to a select audience … one application per parent grant but no limit on the number of applications from a given institution. The big “have” institutions will have lots of these big core center awards and will no doubt get in line for an extra $1.2M+ for each of these facilities, complements of ARRA.

Today’s notice of Administrative Supplements to Support Core Consolidation provides up to $500,000 in equipment, up to $500,000 for alteration and renovation, and/or up to $200,000 (DC) for other costs such as personnel and supplies. The NIH plans to spend ~$15 million of ARRA funds by September 30, 2010 to support requests submitted in response to this notice. Participating ICs include NCRR (G12 plus all P and U awards), NCI (only Cancer Center Support P30s are eligible), NIAID (only CFAR P30s are eligible), NIAMS (only P30s are eligible), NIDDK (only P30s & P60s are eligible), NIEHS (only P30s are eligible), and NIDA (“particularly interested in consolidation that results in synergistic enhancement of existing research capabilities, while continuing current services”).

The Notice provides full application details. Applications are due January 13, 2010.

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OER Strikes Back

I took a pass in September on noting Les Costello’s piece in The Scientist entitled NIH R01s: No Longer the Best Science, in which he expresses concern over policies designed to increase funding to new/early stage investigators. This month, Walter Schaffer and Sally Rockey from OER (NIH’s Office of Extramural Research, which brings you the NIH Guide, Extramural Nexus, NIH Regional Grant Seminars, and all you need to know about grant application and management policies) respond with NIH Continues to Support the Best Science through R01s. {see Alison McCook’s comment below for the corrected subtitle to the Schaffer-Rockey piece.}

Essentially, Schaffer and Rockey lay out the history of NIH’s efforts to promote funding to new and early stage investigators (ESI) and the rationale for doing so:

When Dr. Costello [who "vehemently" objects to the new/ESI policy] received his first traditional NIH research grant (R01) in 1963, success rates were near 58%, and 35% of the competing R01s went to first-time recipients. … In 1977, the average age of new investigators was nearly 37, success rates had decreased to 28%, and the proportion of R01s going to new investigators had decreased to 33% … by 2006, less than 24% of the recipients of competing R01s were new investigators, success rates were below 21%, and the average age at first award of an R01 had increased to more than 42.

The first comment, however, keeps on with The Scientist theme about whether the NIH is funding the best science … not necessarily due to any potential discrimination favoring new investigators so much as penalizing amended applications by percentiling them separately (intended to reduce review burden by funding more A0s than A1s based on historical data showing that ~70% of A0s are eventually funded as A1s or A2s). The opening line probably sums up the scientific community’s mood though:

The angst over new and early stage scientists indicates a broader anxiety among established NIH investigators over what is seen as administrative meddling adding to an already capricious peer review process.

And then, of course, we have the forum over at Genome Technology asking Is Peer Review Broken? (review of grant applications and journal manuscripts). Clearly, CSR and OER need to keep the communication channels open for continued feedback on their enhancements to the application and review processes.

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Is Peer Review Broken?

So asks the cover story by Meredith Salisbury for Genome Technology.

She starts the ball rolling in her accompanying editorial:

Get three scientists together, and it’s almost a guarantee that the conversation will eventually turn toward the vagaries of the peer review process. Be it for winning grant funding or getting a paper published, this system of relying on a handful of fellow scientists to select the most promising and influential research shapes — at least to some degree — every single researcher’s career path.

And then she gets 3+ scientists together, with the tone set right off the bat by Ferric Fang:

“For something that is of and for scientists, the peer review process is very unscientific,” says Ferric Fang, a professor of laboratory medicine and microbiology at the University of Washington. Whether it’s for papers or grants, having just a handful of people review someone’s work is statistically unsound, he adds. “If these [reviews] were data that you generated in your lab, you would say, ‘I don’t know what the conclusion of this is.’”

And per the suggestions made on grant review processes, apparently efforts to enhance peer review at the NIH haven’t gone far enough. A sampling to get you over to Genome Technology for the full report:

One hope is that having a larger pool of reviewers could help reduce the impact of any individual review, says Fang. Under the current system, “one bad review can sink an application.”

Another take on the grant review system in general is that focus needs to shift away from today’s model of specific proposals for short-term periods. …

Lawrence [Peter Lawrence at the zoology department of the University of Cambridge] would prefer a system where reviewers considered the track record of the investigator more than the details of the new research proposal (with special dispensation for new investigators). …

According to Fang, this concept of awarding funds on a track record basis would also serve the purpose of weeding out people who are very skilled at writing proposals but are less competent at actually performing the science.

Oh no! What’s a writedit to do?! Well, I am the first to acknowledge that no amount of skilled grantsmanship can make up for poor science, so I think, to a certain extent, this last concern can be dispensed with.

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