NIH Funding Opportunity Announcements

Andy

Andy

Senior Member (Voting rights)
Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (R01 Clinical Trials Not Allowed)

Funding Opportunity Announcement (FOA) Number PAR-20-165

This Funding Opportunity Announcement (FOA) encourages investigator(s)-initiated applications that propose to examine the etiology, diagnosis, pathophysiology and manifestations of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) 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 individuals with ME/CFS, and the common mechanisms influencing the multiple affected body systems in ME/CFS are encouraged.

The NIH is particularly interested in funding interdisciplinary research that will enhance our knowledge of disease processes 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 and/or characterize the pathophysiological response of organ systems in individuals with ME/CFS. Applicants are encouraged to propose novel and innovative research that will break new ground or extend previous discoveries toward new directions.

https://grants.nih.gov/grants/guide/pa-files/PAR-20-165.html


Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (R21 Clinical Trials Not Allowed)

Funding Opportunity Announcement (FOA) Number PAR-20-168

This Funding Opportunity Announcement (FOA) encourages investigator(s)-initiated applications that propose to examine the etiology, diagnosis, pathophysiology and manifestations of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) 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 individuals with ME/CFS, and the common mechanisms influencing the multiple affected body systems in ME/CFS are encouraged.

The NIH is particularly interested in funding interdisciplinary research that will enhance our knowledge of disease processes 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 and/or characterize the pathophysiological response of organ systems in individuals with ME/CFS.

The R21 Grant mechanism is intended to support innovative, high impact research projects. Such projects would either 1) generate pilot data to assess the feasibility of a novel avenue of investigation; 2) involve high risk experiments that could lead to a breakthrough in ME/CFS; 3) demonstrate the feasibility of new technologies that could have a major impact on ME/CFS research. Applications submitted under this mechanism should be limited to those with the potential for truly ground-breaking impact.

https://grants.nih.gov/grants/guide/pa-files/PAR-20-168.html
 
This seems... good?
Especially this language. It suggests exploratory research, which is what we need to happen.
Applicants are encouraged to propose novel and innovative research that will break new ground or extend previous discoveries toward new directions.
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Breaking new ground? I like that language. Let's break all the damn grounds!
 
From https://en.wikipedia.org/wiki/NIH_grant

"The most common research grant mechanism is the R01. It is the oldest funding mechanism of the NIH. R01s are generally awarded for 3–5 years, and are used to support a "discrete, specified, circumscribed research project"."
and
"R21, NIH Exploratory/Developmental Research Grant Award, limited to 2 years of funding for a total less than $275k, and does not require preliminary data."

So it would seem to me that the R21 is the type of grant that we have needed more of - an opportunity for researchers to be funded to try to obtain the initial data that so far we have been lacking.
 
When Joseph J. Breen from NIH visited Oslo last year, he said that researchers from all over the world are welcome to submit applications for grants for research projects into ME. If the quality of the application is high enough, and they consider the project important enough, they'll support it.
 
This was a good point that the Columbia CRC team made that I hadn't considered
We don’t have any further information on the specifics at this time. However, considering that the NIH has shifted all non-mission-critical lab operations to a maintenance phase during the #COVID19 pandemic, the fact that this was released during this time is highly encouraging.
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Could just be coincidence, but I wonder if it might have anything to do with a concern that they might see an increase in ME/CFS cases in the wake of the COVID-19 pandemic.

There have been a lot of stories of people who have recovered describing the intensity of COVID-19 symptoms as being much more severe than the typical flu. If there is anything to the idea that the severity of symptoms is a factor in the infectious onset of ME/CFS, this seems like a time when you might expect to see a spike in ME/CFS case.

It seems like someone or some agency should be trying to monitor this. I honestly don't even know if ME/CFS or PVFS is reportable. It should be.
 
Some info on Cort johnsons blog regarding Ron Davis/Stanford applications
All, unfortunately, were rejected in the latest round, with one reviewer rejecting a grant for a diagnostic test, reasoning that because there’s no cure for ME/CFS – why would we want to diagnose it better?
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Note that the Davis grant applications, most of which involved technology, may not have gone to the special emphasis ME/CFS grant panel (CFS SEP) – which has had good grant acceptance rates over the past couple of years.
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According to the NIH site March 2019 is the last ME/CFS panel listed, so maybe these latest applications all went through standard channels.......
https://public.csr.nih.gov/StudySections/DNDA/IFCN/CFSSEP
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Next ME/CFS special Emphasis Panel meeting is in May 2020 - ZRG1 CFS-N 80
https://public.csr.nih.gov/StudySections/SpecialEmphasis

EDIT : May 2020 SEP headed by
BENNETT, M CATHERINE, PHD
SCIENTIFIC REVIEW OFFICER
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
BETHESDA, MD 20892
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Who's Bibliography shows
Division:
Division of Neuroscience, Development and Aging – DNDA
IRG:
Integrative, Functional and Cognitive Neuroscience – IFCN
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So I just learnt something new. The ME/CFS Special Emphasis Panel falls under "Integrative, Functional, and Cognitive Neuroscience IRG – IFCN" group
https://public.csr.nih.gov/StudySections/DNDA/IFCN
The ten study sections comprising the Integrative, Functional, and Cognitive Neuroscience [IFCN] IRG review applications within a very wide range of neuroscience research aimed at furthering our understanding of how the nervous system is organized and functions at an integrative, systems level.

Specific areas reviewed by the IFCN IRG include:
* studies of the neural basis of emotional and motivational behavior;
* regulation of function, at the systems level, by neuroendocrine and neuroimmune influences;
* the analysis of system function under varying behavioral states, such as sleep and hibernation;
* the basis of biological rhythms; the maintenance of homeostasis; chemosensation, hearing, balance, touch, somatosensation, and visual perception;
* motor systems and sensorimotor integration;
* the integration of multisensory information;
* the neurobiological basis of learning, memory and other cognitive processes;
* computational and theoretical models of cognitive processes;
* mechanisms underlying neural coding of complex stimuli (e.g., pattern recognition, spatial transformations, speech perception);
* and attention and its effects on information processing in the nervous system.

Research proposed in applications reviewed by study sections in the IFCN IRG may have relevance to disorders or disease processes, but the emphasis would be on the effect of the process on the structure or function of the system under investigation, rather than on the disease process itself.
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***Formatted for easier reading
 
wigglethemouse said:
Some info on Cort johnsons blog regarding Ron Davis/Stanford applications

All, unfortunately, were rejected in the latest round, with one reviewer rejecting a grant for a diagnostic test, reasoning that because there’s no cure for ME/CFS – why would we want to diagnose it better?
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Assuming Cort Johnson's source is reliable, this is worrying. This means the basis for rejecting the grant application wasn't the science behind the diagnostic test -- which must have been solid enough to reach the last round of reviews -- so any change of methods post-review won't help it be accepted if it's submitted again.

If the NIH want ME/CFS researchers to develop treatments rather than finding a biomarker, how can they even set up clinical trials without confirming that participants have ME via a diagnostic test?

ETA: Janet Dafoe confirms the reviewer's comment mentioned by Cort Johnson.

 
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cassava7 said:
Assuming Cort Johnson's source is reliable, this is worrying. This means the basis for rejecting the grant application wasn't the science behind the diagnostic test -- which must have been solid enough to reach the last round of reviews -- so any change of methods post-review won't help it be accepted if it's submitted again.

If the NIH want ME/CFS researchers to develop treatments, how can they even set up clinical trials without confirming that participants have ME via a diagnostic test?
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Cort said these applications didnt go to the more M.E aware panels which is probably why the unacceptable response, I think that lipkin Was falling victim to these unhelpful attitudes in the past. I think that from The helpful explanation #meaction gave, the latest nih calls for research, although it doesn’t guarantee increased funding success, it will mean papers will be reviewed by more helpful or informed panels.

this reason given by the reviewer echos one of my early drs who hadn’t bothered sending me for a diagnosis because he believed there was nothing that could be done anyway.
 
cassava7 said:
Unfortunately, these rejected applications did go to the CFS SEP, and they were recent (from the last cycle -- 2019?).



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Ah cort said “may” not, I checked. Wow, that’s pretty terrible, i hope that the Nih are being made aware of discriminatory attitudes

Note that the Davis grant applications, most of which involved technology, may not have gone to the special emphasis ME/CFS grant panel (CFS SEP) – which has had good grant acceptance rates over the past couple of years.
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Cinders66 said:
Ah cort said “may” not, I checked. Wow, that’s pretty terrible, i hope that the Nih are being made aware of discriminatory attitudes
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This is disheartening. The best thing we can hope for is that the reviewer who made that comment won't be on this year's ME/CFS SEP committee, but I don't know if the committee is renewed every year.
 
cassava7 said:
Assuming Cort Johnson's source is reliable, this is worrying. This means the basis for rejecting the grant application wasn't the science behind the diagnostic test -- which must have been solid enough to reach the last round of reviews -- so any change of methods post-review won't help it be accepted if it's submitted again.
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I read “latest round” as referring to the most recent round/cycle rather than the last round in a series of reviews. But worrying it was mentioned in any review.
 
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