NIH Challenge Grant RFA & Review Process

It’s here!

Recovery Act Limited Competition: NIH Challenge Grants in Health and Science Research (RC1)

The NIH Challenge Grants have a 12-page application addressing a list of 15 broad challenges due April 27th and allow requests up to $500K/y for 2 years (total of $1M). At least 200 awards will be made. The NIH Challenge Grant Website is now live and loaded, as are the IC-specific Challenge Grant Websites .

The 15 broad challenges are:

(01) Behavior, Behavioral Change, and Prevention
(02) Bioethics
(03) Biomarker Discovery and Validation
(04) Clinical Research
(05) Comparative Effectiveness Research (CER)
(06) Enabling Technologies
(07) Enhancing Clinical Trials
(08) Genomics
(09) Health Disparities
(10) Information Technology for Processing Health Care Data
(11) Regenerative Medicine
(12) Science, Technology, Engineering and Mathematics Education (STEM)
(13) Smart Biomaterials – Theranostics
(14) Stem Cells
(15) Translational Science

Theranostics?

The 12-p research plan instructions follow on the tradition of EUREKA, Pioneer, and T-R01:

Research Area: State which broad Challenge Area (e.g., (01: Behavior, Behavioral Change, and Prevention) described within this FOA and specific Challenge Topic (e.g., Mechanisms of Behavior Change Research: 01-GM-104) will be addressed. Also include the project title on the first page.

The Challenge and Potential Impact: What is the research opportunity, scientific knowledge gap or technology that will be addressed? How broad is the potential impact in science and/or health? Which community (ies) will be affected? What is (are) the size(s) of the community(ies)? Will the potential impact be major?

The Approach: How will you attempt to explore or solve the stated research problem? How will your rationale and/or approach overcome existing challenges or barriers in the field? If you propose to improve existing technologies or to develop new technologies, which needs are being addressed and what is unconventional and exceptionally innovative about your approach? Provide enough information for reviewers to determine what you are proposing to do, but do not include a detailed experimental plan.

Timeline and Milestones: Provide a timeline for the proposed research indicating points where intermediate objectives will be assessed and decisions will be made regarding the course and direction of the continuing research effort. Possible alternative paths that may be followed at critical junctures in the project plan should be described and indicated on the timeline.

Preliminary data are not required but may be included, if necessary to demonstrate the feasibility of the proposed studies. The presentation must be clear and particularly compelling. No detailed scientific plan should be provided, but timelines must be presented.

No appendices and no post-submission supplemental material/updates are permitted.

These Challenge Grant applications will be reviewed using the new criteria and scoring procedures.

Also, per the RFA, “Because the awards made under this program are substantial competing NIH research grants, recipients will not be considered New PIs or ESIs when they apply for NIH research grants in the future.” Ready to sign away your new/early stage investigator status for a million bucks over two years? My guess is yes.

20 Comments »

  1. pinus said

    Wild, time to get writing!

  2. D said

    Interesting Notice from NIH. Especially this sentence.

    “In addition, the NIH will suspend the appeals procedures (NIH Guide: APPEALS OF INITIAL SCIENTIFIC PEER REVIEW) for investigators responding to Recovery Act FOAs, due to the time sensitivity of the Recovery Act granting process. ”

    Or to rephrase it…The usual whiners need not apply.

    http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-054.html

    I advise PIs to never use this appeal process in any case, but I’m worried that the attention drawn to its existence will encourage an up-tick in appeals in non-challenging grants. Well, just so long as they aren’t “my” PIs, appeal away … – writedit

  3. whimple said

    Does anyone ever actually appeal?

    “Theranostics”… I had to look that up too… turns out, theranostics is what I’m doing. Who knew? : )

    No wonder study sections haven’t been scoring your translational research well – you weren’t using the right fifty-cent word to describe it. – writedit

  4. D said

    OMG, they appeal all the time. Or at least threaten too. The bigger the name/ego the more likely they are to appeal. That said, the appeals almost never (at least in some institutes) upheld. Sometimes they are given another chance for review, sometimes they get to talk to someone very high up on the phone etc..

    Of course this all works better for the big wheels than the little wheels.

    This is why I counsel PIs not to appeal – don’t bite the hand that feeds you (study section) when no benefit (other than mental-ego balm, I guess) will be gained. – writedit

  5. BB said

    I know of one person who appealed a score on PI’s RO1. The RO1 was rescored and funded. The PI knew that was a final straw thing to do – would never pick that study section again.

    The problem being most PIs have few study section alternatives for their work. I should add, too, my concern is with the submission of the formal letter of appeal after first having an informal discussion with the SRO. The appeals process should be reserved for genuine procedural or factual errors – not differences of opinion or interpretation. Joyce Hunter has a couple of slides (58-59) on this in her NIH Grant Seminar presentation on scientific peer review. – writedit

  6. Sorry for the link to my blog, but have you heard of this happening with the Challenge Awards?

    No apology needed and in fact thanks for sharing your experience with the NIH Challenge Clusterf*ck. When my Division chief called the IC contact shortly after I sent out an alert e-mail mid-afternoon yesterday, the NIH guy didn’t know the RFA had been released and asked my guy to send the message & website. But unaware PO still blithely said sure, all those ideas sound great – get them in to us ASAP. Oh boy. I’m going to give them a week to get their acts together before attempting contact. Maybe by then they’ll also have a shareable clue about just-above-the-payline funding plans, R56 probabilities, and supplement SOPs. – writedit

  7. Yeah – it’s going to be interesting. The first PO I spoke to this morning (well, it was noon ET) sounded frazzled and confessed that she had freaked out when she arrived at work this morning to find her email and voicemail full and the phone ringing off the hook … all with people wanting information about topics she had never heard of even though she was listed as the contact person in the RFA … and that the POs weren’t aware the RFA had gone out! I had to email her the Omnibus pdf as she wasn’t aware of its existence. And the second PO I spoke to was arguing with me saying that I was looking at the wrong document and when I told him where it was on the RFA he freaked out, told me to call him tomorrow and hung up! He then emailed me the info I posted as well as the contact details of the PO who is (apparently) responsible for the specific topic I was looking at.

    Interesting times ahead indeed!

  8. writedit said

    I’ve posted an ARRA Resource Page with links to FOAs, IC sites, major ARRA sites, and a couple of nice University ARRA Websites (was going to list Penn, but it’s now password protected!).

  9. writedit said

    I just attended a presentation by Cheryl Kitt, PhD, Deputy Director of CSR, on the upcoming peer review changes (more on that later), but she also shared a few thoughts about the stimulus funding. Essentially, she said everyone should apply for a Challenge Grant, even those basic scientists who can’t find a naturally good fit in any of the gazillion priorities listed in the various compilations (Highest Priorities, Omnibus, IC-specific). All you need is a challenge topic number. She indicated more RFAs would be forthcoming, but to still respond to this Challenge Grant RFA. She also said everyone better be available to help review the thousands of applications they anticipate in June. Cheryl said they were working on “creative ways” to structure this review …. no other details than they don’t plan to come up with 2000 study sections. Stay tuned – and get writing!

  10. whimple said

    I have it on excellent authority that PO’s contacted individual research prior to the challenge grant RFA to have researchers “suggest potentially interesting topics”. So some of the RFA’s that look like they were designed with a specific lab in mind, may in fact have been written by those specific labs.

  11. D said

    I am not surprised or too upset by that. I think it is a good thing that NIH got some outside input. I wouldn’t even worry that the research topics might be tailored to a specific lab. You would be surprised how often someone else can write a grant that is better than the “World Expert’s” or “Field Founder’s'”grant.

  12. whimple said

    I’d be even more surprised to see this better grant get funded instead of the World Expert’s grant.😉

  13. writedit said

    A fair amount of interest in whether new investigators/ESIs should apply. The NIH is not encouraging new/early stage investigators to apply for Challenge Grants, which are just 2 years and not renewable, so this is good advice (similar to that urging these folks not to put their time into R21s). Except, given the level of competition, I suspect any new/ESI applicant who could secure $1M from the Challenge Grant program is already quite competitive and would probably do okay without the payline break/ESI award quota break. Applying doesn’t revoke the special status – just securing an award.

    Another consideration comes from NIAID’s characterization of what will happen in 2011. Although the NIH budget will likely get some relief in the coming years, NIAID is counseling applicants to brace themselves for very low – perhaps historically low – paylines:

    “The Institute does not expect the growth in our base funding level to be sufficient for establishing a payline to continue funding all those grants. Neither will NIAID have R56-Bridge award money to extend them. As a result, we expect the payline to drop precipitously. So FY 2011 will be a very difficult year for people to secure funding, whether they are funded from the stimulus funds or the regular appropriation.”

    NIAID recommends that you start writing your next grant now in time for FY2010 funding, complete your research on time to strongly justify your renewal (if it needs to be submitted in 2011), and keep your timing options open. I’d say the NIAID advice applies across all the ICs.

    For new/ESI applicants who by-pass or are not funded by a Challenge Grant, your golden year of opportunity could well be FY2010.

  14. writedit said

    Oops …. in reference to Whimple’s question over in Paylines & Resources

    I wasn’t talking about the challenge grants. I mean the 2-year R56esque pickups of previously scored, but unfunded R01s. Do you want to take the guaranteed 2-year R01 pickup, or take your close but no cigar grant back for resubmission to try to get 5 years on it? (not that I’m in this position, but others might be interested and I haven’t formally heard an answer to this yet)

    Doh! You even said that above. Too few firing neurons here. No, per the official NIH definition, receiving an R56, which is bestowed like manna from heaven, does not revoke new investigator status. However, I am gleaning that the NIH would prefer to fund new/ESI applicants for the full 4-5 requested years rather than just 2 years in these stimulus pick-ups. For example, NIAID will be “Awarding new and early-stage investigators a four- or five-year grant according to our FY 2009 funding policy.” I’ve seen similar comments elsewhere. I assume the ICs hope to use stimuls funding to make more FY09 appropriation funding available for these new-ESI applications … but that’s my best guess. In any case, no, the R56 does not kill new-ESI status, but it seems the NIH does not plan to use R56 or other stimulus-truncated 2-y R01 funding for new-ESI folks either. – writedit

  15. whimple said

    Are these 2-year R01 pickups going to be called “R56″s? Do they come with the same ARRA reporting rules? I haven’t heard a lot of direct NIH guidance on these guys, even though these will probably suck back way more ARRA cash than the RC1’s will.

  16. D said

    I think the 2 year R01s will be called R01s. And, will have the same reporting rules. The R56s are paid without peer review. They are also called Bridge Awards, to bridge gaps in funding. http://grants.nih.gov/grants/funding/r56.htm. They will also have the same ARRA reporting rules. Whether you fill a pot whole, hire a tech or paint a bridge Barack wants to know how the stim money was used.

  17. whimple said

    So, what they call these matters because if they call the 2-year R01’s “R01”, then getting one should remove your status as a New/Early Stage Investigator (bad), whereas that wouldn’t happen if they were called R56 (good). NIAID seems to have policy worked on this (per writedit above) but I haven’t heard much on the topic out of other institutes yet.

  18. D said

    But, the only way to get an R56, I think, is if you already have an R01. That is you extend it. These are both different from the challenge grants which are called RC1s. Again, I think, that you do not lose your ESI status if you get one of these. The details are still a little murky about all of this. I will see what I can find out.

    D

  19. D said

    I saw this on the NIH ARRA FAQ site about the RC1 grants and ESIs.(http://grants.nih.gov/recovery/faqs_challenge.html#a5)

    If a New Investigator or Early Stage Investigator is awarded an NIH Challenge Grant, will he or she retain status as New or Early Stage Investigator?

    No. New Investigators and Early Stage Investigators (ESIs) are invited to apply, however, because the awards made under this program are competing NIH research grants of substantial size, recipients will not be considered New Investigators or ESIs when they apply for NIH research grants in the future. More information can be found at http://grants.nih.gov/grants/new_investigators/index.htm.

    So, this will be a tough choice for ESIs.

    D

  20. D said

    These reporting requirements are interesting too. Note that these are quarterly reports. In addition, how scientists spend the ARRA money is going to be available for all to see at Recovery.gov.

    Not later than 10 days after the end of each calendar quarter, starting with the quarter ending June 30, 2009 and reporting by July 10, 2009, the recipient must submit quarterly reports to HHS that will posted to Recovery.gov, containing the following information:
    a.
    The total amount of ARRA funds under this award;
    b.
    The amount of ARRA funds received under this award that were obligated and expended to projects or activities;
    c.
    The amount of unobligated award balances;
    d.
    A detailed list of all projects or activities for which ARRA funds under this award were obligated and expended, including

    The name of the project or activity;

    A description of the project or activity;

    An evaluation of the completion status of the project or activity;

    An estimate of the number of jobs created and the number of jobs retained by the project or activity; and

    For infrastructure investments made by State and local governments, the purpose, total cost, and rationale of the agency for funding the infrastructure investment with funds made available under this Act, and the name of the person to contact at the agency if there are concerns with the infrastructure investment.
    e.
    Detailed information on any sub-awards (sub-contracts or sub-grants) made by the grant recipient to include the data elements required to comply with the Federal Funding Accountability and Transparency Act of 2006 (Public Law 109-282).

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