The November 18, 2011 edition of the National Institutes of Health’s Weekly Funding Opportunities and Announcements included notice of two new funding opportunities for research into myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS):
ME/CFS: Etiology, Diagnosis, Pathophysiology, and Treatment (for RO1 awards) (PAR-12-032)
ME/CFS: Etiology, Diagnosis, Pathophysiology, and Treatment (for R21 awards) (PAR-12-033)
Funding opportunities announcements (FOAs) are circulated by the NIH Office of Extramural Research to “support research in an understudied area of science, to take advantage of current scientific opportunities, to address a high scientific program priority, or to meet additional needs in research training and infrastructure.”
There are two kinds of FOAs: Program Announcements (PAs) and Requests for Applications (RFAs). The difference between the two is significant. Here are the definitions:
Program Announcement (PA): A PA is a formal statement about a new or ongoing extramural activity or program. It may serve as a reminder of continuing interest in a research area, describe modification in an activity or program, and/or invite applications for grant support. Most applications in response to PAs may be submitted to a standing submission date and are reviewed with all other applications received at that time using standard peer review processes. NIH may also make funds available through PARs (PAs with special receipt, referral, and/or review considerations) and PASs (PAs with set-aside funds).
PAs may be used for any support mechanism other than construction awards. Unless otherwise specified in the PA, new applications (and associated renewal and revision applications) submitted in response to PAs are treated as investigator-initiated. PAs also are used to annually solicit applications for the SBIR and STTR programs. Those applications must be received by the dates specified in the PA. (http://grants.nih.gov/grants/glossary.htm#P27) There are currently 802 active PAs.
Request for Applications (RFA): An RFA is a formal statement that solicits grant or cooperative agreement applications in a well-defined scientific area to accomplish specific program objectives. An RFA indicates the estimated amount of funds set aside for the competition, the estimated number of awards to be made, whether cost sharing is required, and the application submission date(s). For cooperative agreements, the RFA will describe the responsibilities and obligations of NIH and awardees as well as joint responsibilities and obligations. Applications submitted in response to an RFA are usually reviewed by a Scientific Review Group (SRG) specially convened by the awarding component that issued the RFA. (http://grants.nih.gov/grants/glossary.htm#R11) There are currently 97 active RFAs.
The new ME/CFS PAs replace two PAs titled, “Chronic Fatigue Syndrome: Pathophysiology and Treatment” that were set to expire Jan. 8, 2012. Neither the new nor the expiring PAs were attached to set-aside funds. The most recent CFS-specific RFA was issued in 2005, “Neuroimmune Mechanisms and CFS.” RFAs are generally issued after an NIH-sponsored conference or meeting that helps identify promising areas of research or gaps. Many hoped that the ME/CFS State of the Knowledge Workshop held by NIH in April 2011 would prompt the issue of a new RFA, as the DHHS CFS Advisory Committee had recommended at its May 2011 meeting.
These PAs announce opportunities for researchers to submit “investigator-initiated” proposals. Applications submitted in response to these announcements will be reviewed by the CFS Special Emphasis Panel. Applicants can choose to apply for either an R01, the most common type of NIH grant, or an R21. Here are the definitions for those two programs:
Ro1: The R01 mechanism allows an investigator to define the scientific focus or objective of the research based on a particular area of interest and competence. Although the Project Director/Principal Investigator writes the grant application and is responsible for conducting the research, the applicant is the research organization. (http://grants.nih.gov/grants/funding/r01.htm)
R21: The R21 grant mechanism is intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development. The NIH has standardized the Exploratory/Developmental Grant (R21) application characteristics, requirements, preparation, and review procedures in order to accommodate investigator-initiated (unsolicited) grant applications. (http://grants.nih.gov/grants/funding/r21.htm)
R01s are generally longer term grants with higher funding amounts (of up to $250,000 per year for 5 years), made on the basis of accumulated data. R21 awards are for earlier stage research and the investigator may or may not have pilot data to support the application. R21s are sometimes referred to as “high risk-high reward” proposals. R21s cannot be for more than 2 years and the total budget must not exceed $275,000.
PAs issued for CFS have typically paired two announcements, one for R01s and one for R21s, as is the case with the new PAs. Both new announcements provide the following description of the type of research proposals they seek to stimulate:
This Funding Opportunity Announcement (FOA) issued by the Office of Research on Women’s Health (ORWH) and co-sponsoring Institutes and Centers (ICs) of the National Institutes of Health (NIH) encourages investigator(s)-initiated applications that propose to examine the etiology, diagnosis, pathophysiology, and treatment of chronic fatigue syndrome (CFS), sometimes referred to as myalgic encephalomyelitis (ME), in diverse groups and across the lifespan. Applications that address gaps in the understanding of the environmental and biological risk factors, the determinants of heterogeneity among patient populations, the common mechanisms influencing the multiple body systems that are affected in ME/CFS are encouraged. The NIH is particularly interested in funding interdisciplinary research that will enhance our knowledge of the disease process and provide evidence based solutions to improve the diagnosis, treatment, and quality of life of all persons with ME/CFS. This interdisciplinary research may include the building of scientific teams to study and develop biomarkers, innovative treatment modalities, and/or the modifiable risk and protective processes specifically targeted by preventive and/or treatment interventions.
Twelve NIH institutes and offices support the PAs, indicating their interest to fund proposals that are successful in the review process and fall within their respective portfolios:
Office of Research on Women’s Health (ORWH)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Center for Complementary and Alternative Medicine (NCCAM)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Dietary Supplements (ODS)
The next deadline for submitting proposals in response to these PAs is Feb. 24, 2012, with letters of intent due on Jan. 24, 2012.
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“Neither the new nor the expiring PAs were attached to set-aside funds.”
Why not?
Several people gave empassioned remarks at the CFSAC session, including a 30-year government health staff member and recent retiree who has CFIDS.
What will it take for the NIH to recognize and fund what it lists?
Cheryl Kitt, head of the NIH’s Center for Scientific Review, spoke at the CFS Advisory Committee on Nov. 9. She indicated that one of the barriers to issuing an RFA (with set-aside funds) is the low volume of grant applications submitted to NIH for ME/CFS research, demonstrating insufficient interest from the scientific community. She reported that for each of the 3 rounds of review per year, the CFS SEP receives 6-18 grant applications; the usual volume for a study section is 60-200 per round. According to Dr. Kitt, this rate of CFS applications has been static for 10 years. There was discussion from the committee about the 2005 CFS RFA and the fact that it generated about 35 applications for the $4 million set aside, and how researchers don’t apply because the “word” is that the review panel is populated by people who are not qualified to review the proposals and change each time the application is submitted with revisions.
I JUST MIGHT BE TOO TIRED TO UNDERSTAND THIS..BUT WHAT DOES ALL THIS MEAN?
WAS THE RESEARCH THAT CFIDS FUNDED ABLE TO RECEIVE ANY N.I.H. GRANTS TO CONTINUE ON WITH THE RESEARCH ?
Yes, Patricia — The researchers that we funded have been able to secure nearly $5 million in additional funding from NIH and Dept. of Defense to continue and expand their research studies. We hope you’ll support our latest campaign to fund another round of grants and support them with the kind of networking and other support that made our last group of grantees successul. Learn more about it the Catalyst Fund: http://www.cfids.org/about/catalyst-fund.pdf
@Patricia White — LOL! I was thinking the exact same thing as I skimmed the text through the dense fog in my head! (P.S. I’m not sure if you’re aware of this, but when you use all capital letters in text online, it’s interpreted as shouting. You might want to adjust you keyboard/cap lock setting in the future).
@Kim – Discussions surrounding NIH funding seem to always exist in this Catch-22. No researchers apply for funding so the NIH says there’s no interest. Researchers won’t spend the enormous time and expense it takes just to write and submit a grant proposal because they believe the reviewers will automatically turn down their proposal (and all the months of effort that went into it).
It seems to me that the NIH needs to put a lot more effort into encouraging researchers and assuaging their concerns. Yet I can’t shake the feeling that NIH is quite happy with things the way they are, wherein ME/CFS remains a $4-6 million year issue for them.
What I think would be helpful to have in this informative piece about NIH proposal process is a clear message about why it’s important for patients to know this and — most importantly — what they should DO with that information. As most of us are a bit short of money, there must be something more we can do than hope patients who actually still have some money give to a fund for CAA to encourage and assuage researchers applying for NIH grants?
Hi Michelle,
Our last group of grantees has secured nearly $5 million in follow-on funding from NIH and other institutions, representing a 7-fold return on investment! We’re in the process of reviewing the 26 grants proposals we received for scientific and strategic merit. The number of proposals we can fund will be determined, in part, by how much money we have available. Thanks to the McGrath Family Foundation, for the next two weeks, donations made online will be tripled! Here are the details about how your impact can have three times the impact: http://www.research1st.com/2011/11/23/triple-your-impact/
Michelle — very good points and questions.
The CFS community is a pretty financially deprived one unless spouses and family members can help out. Many of us can’t work due to our limitations.
It’s good that the McGrath Family and the Hutchins Family have stepped up to the plate. Also, a generous individual is funding Dr. Enlander’s center at Mount Sinai.
It’s rather frustrating to hear about the NIH. Is there any other mechanism to get their funding or other govrnment funding. (Glad to read about the nearly $5 million the CAA obtained.)
Can there be national e-mail blitz campaigns to raise funds? Are there mailing lists of possible donors? Can there be e-mail petitions or appeals made to the NIH or other agencies about this health emergency? (It is for those of us with the disease.)
There must be a way. I’m sure CAA has discussed this ad infinitum, but rather than ask those of us with limited funds, aren’t there other ways to do this?
Kim –
The question for me is not whether the CAA can select promising research to fund. CAA has been doing an extraordinary job at finding and — despite profoundly limited resources — funding exceptional research for a number of years now. It is without a doubt the CAA’s strong suit.
The issue, rather, is the seeming lack of support and interest from the NIH. For a disease with the impact ME/CFS has, and considering the funding NIH provides for research of similar diseases, five million dollars is not something to be celebrated (even as the CAA’s hard work is). It’s not even merely something at which to feel insulted. It is negligence of staggering proportion. And considering the woeful lack of funding for other diseases primarily affecting women (fibromyalgia, endometriosis, vulvodynia, etc.), it is yet another example of naked sexism in medicine.
It’s true that the NIH is dealing with less money in this era of budget cuts. Yet they still manage to find over a billion dollars to fund heart disease research, another three billion for HIV/AIDS research, and hundreds of millions more for the research of many other diseases — including autism, the research of which was not that long ago as woefully underfunded as ME/CFS is.
Perhaps holiday preparations had you skimming my comment too quickly and responding in almost Pavlovian fashion with the one suggestion your job has you accustomed you to giving. However my question, again, is what can we do about this Catch 22 in which NIH has placed ME/CFS? Patients will never be able to match the level of funding the NIH ought to be providing for ME/CFS research, a level that should be a minimum of $100 million given, again, the funding of research for diseases of similar morbidity and financial impact.
I need not explain to you that the whole point of CAA funding is to act as seed money for research that has the potential to get NIH funding. If NIH is only interested in maintaining ME/CFS research funding at an annual rate of around $5 million or so (which it certainly appears to be when one looks at past and projected funding levels), then that seven-fold investment would seem to be the ceiling for CAA-seeded research hoping to attract NIH investment. Which will guarantee that ME/CFS research remains the domain of a small (if passionate) group of researchers who are able to get NIH funding for their other areas of research — or are willing to forgo feeding their families.
But then, perhaps I am expecting to much from CAA. Perhaps it is best for the CAA to simply focus on that finding and seeding task it does so well. It’s just that…well, I’ve seen you use that inside voice of yours to, rather deftly, take another government health agency to task. And it would appear the NIH could use some serious taking to task.
Hi Michelle,
I note from your postings elsewhere that you are an academic, so you may be in a better position than me to answer the question about how to escape the Catch-22 of there not being enough good grants submitted to dramatically expand the funding level for CFS, while researchers don’t believe it’s worth their time to submit proposals that aren’t going to get a fair review.
I don’t think it’s a problem that advocacy alone can solve, no matter which organization/group/individual leads the advocacy.
Consider the math: Depending on the particular institute at NIH, the “success rate” for applications varies from a low of 7.5% (National Institute on Minority Health and Health Disparities) to a high of 66.7% (Office of the Director) (see http://report.nih.gov/award/success/Success_ByIC.cfm). The high award rate for the Office of the Director is due largely to the types of awards made, under the Common Fund (http://commonfund.nih.gov/index.aspx) and for special programs like the Director’s Transformative Research Awards (http://commonfund.nih.gov/TRA/index.aspx). (I wonder if anyone has ever applied for CFS funding under OD-sponsored programs?) Most of the major institutes, with large budgets, fund in the range of 19.9% (National Heart Lung and Blood Institute) to 23.9% (National Institute of Allergy and Infectious Diseases).
For the sake of argument, let’s say we’d expect the success rate for CFS grant applications to be 25%, under some “preferred status” program secured through some kind of political influence. To get to the $100 million annual funding level you feel is adequate, there would need to be $400,000,000 in grant applications submitted each year. An RO1 grant has a maximum of $250,000 per year and an R21 award has a maximum of $137,500 per year (half of the $175,000 total for 2 years), making the average award $193,750 per year.
To yield $100,000,000 in awards, you’d need:
$400,000,000 divided by $193,750 = 2,065 grant applications
(That’s sort of simplified given that awards are multi-year and renewals can compete as well and generally have higher success rates, but perhaps you’ll grant the premise.)
For the past 10 years, according to information provided by Cheryl Kitt, deputy director of the NIH’s Center for Scientific Review, for each of the three rounds of review per year, the CFS review group receives 6-18 grant applications, so a low of 18 and a maximum of 54 per year.
How do we get from 18-54 applications per year to 2,065?
In 2007, we carefully evaluated the gaps and opportunities (see http://www.research1st.com/2011/11/28/accelerate/). Three important themes emerged from this review:
- The literature was essentially a collection of “one and done” studies with few attempts to validate early observations or extend findings. These had limited benefit for improving patient care.
- Studies were hampered by the use of multiple case definitions and the lack of standardized ways of collecting data about patients or samples from them.
- Research priorities were driven by “in vogue” hypotheses, with few organized efforts to connect the dots or link findings from one study to another.
The same things came up in the summary session of the NIH State of the Knowledge Workshop held earlier this year (see http://orwh.od.nih.gov/CSF%202011/ORWH_SKW_Report.pdf).
Before anyone can expect 2,065 principal investigators (with willing/capable teams of at least three to five researchers, or some 6,000-10,000 researchers) to submit applications for funding, the issues of case definition, standard ways of collecting data and recruiting well-characterized subjects will need to be addressed more capably than they have up to now. There is also the problem that the current environment has left some researchers feeling that CFS is a “toxic” area because of the backlash that has played out over the past two years. Although it’s been mostly a small group of activists campaigning against certain researchers and types of research, the impact of those actions has spread more broadly. It’s not an added incentive to recruit new investigators – especially some 6,000-10,000 of them – to the field.
Would an RFA or some other sort of set-aside funding for CFS help? Undoubtedly. Is there more NIH could be doing to promote CFS as an area worthy of investigators’ time and talent? Unquestionably. In my opinion, it’s going to take some kind of “breakthrough” finding to make researchers believe that they can reasonably succeed with a study of CFS. HIV/AIDS funding didn’t climb until after HIV was discovered and determined to be the cause. MS funding didn’t climb until demyelination was visible on MRI scans. (I learned a lot from FasterCures’ recent report on HIV/AID advocacy: “Back to Basics.” See http://www.fastercures.org/documents/file/Back2BasicsFinal(1).pdf)
XMRV gave researchers a focus. The initial report linking XMRV to CFS was published on Oct. 8, 2009 and within two years there were more than 20 studies attempting to repeat that observation, from groups around the world, funded by…? There was no set-aside for XMRV/CFS. I don’t know of any special program issued by any government agency in any country to answer the question of whether CFS was associated with XMRV, yet the studies got done, mostly by people who had not previously published on CFS. Whether they were done to everyone’s satisfaction is another issue, but my point here is that when there is a “toe-hold,” the research community will be attracted. The 4,000 or so studies in the literature now paint an impressionist’s picture of lots of different abnormalities, some subtle, some non-specific, some replicated, most not. To an outside scientist, that’s a confusing picture, one that might lead down a dark alley instead of toward the light. To them, that’s a risk.
So, aside from the CFIDS Association funding pilot projects that help investigators accumulate data to be successful in competition for larger sums from bigger funding institutions, how do you think we get from the 35 or so groups interested in CFS research (based on the number of letters of intent we received response to our 2011 RFA) to 2,054?
We’ve got to de-risk the proposition. That will take more than letters to the current NIH director or campaigning with signs, voices, whatever. Funding pilot studies and linking investigators through a network are two ways we’ve identified to help investigators and build the field. We’ve also established the SolveCFS BioBank and are working on common tools and data-sharing platforms as additional ways to de-risk the proposition for applicant and funder when it comes to spending the big money we all agree is warranted. I encourage you to share other ideas you might have.
Kim
I need help here.Brain Fog is bad and i`m very ill,I want to get into a study but do not know how to go about it properly.Can someone please lead me in the right direction.Kentucky is no help with these diseases and my Doctors will not agree to nothing!Thanks so much!
Hi PamME,
Here is a list of active research studies for CFS: http://www.cfids.org/about-cfids/clinical-trials.asp. Hope this is helpful.