Archive for the 'NIH funding' category

Ask DrugMonkey: JIT and Progress Reports

Nov 10 2015 Published by under Ask DrugMonkey, NIH, NIH Careerism, NIH funding

Two quick things:

Your NIH grant Progress Report goes to Program. Your PO. It does not go to any SRO or study section members, not even for your competing renewal application. It is for the consumption of the IC that funded your grant. It forms the non-competing application for your next interval of support that has already passed competitive review muster.

Second. The eRA commons automailbot sends out requests for your JIT (Just In Time; Other Support page, IRB/IACUC approvals) information within weeks of your grant receiving a score. The precise cutoff for this autobot request is unclear to me and it may vary by IC or by mechanism for all I know. The point is, that it is incredibly generous. Meaning that when you look at your score and think "that is a no-way-it-will-ever-fund score" and still get the JIT autobot request, this doesn't mean you are wrong. It means the autobot was set to email you at a very generous threshold.

JIT information is also requested by the Grants Management Specialist when he/she is working on preparing your award, post-Council. DEFINITELY respond to this request.

The only advantage I see to the autobot request is that if you need to finalize anything with your IRB or IACUC this gives you time. By the time the GMS requests it, you are probably going to be delaying your award if you do not have IRB/IACUC approval in hand. If you submit your Other Support page with the autobot request, you are just going to have to update it anyway after Council.

15 responses so far

NIH grant application changes are in the offing

Oct 16 2015 Published by under NIH, NIH Careerism, NIH funding

The Weekly NIH Guide (for 16 October 2015, that link will update) has a whole slew of changes summarized in NOT-OD-16-004.

NOT-OD-16-006 seeks to simplify the Vertebrate Animals section by deleting requirement for describing vet care, euthanasia if consistent with AVMA guidelines and justification for the number of animals used.

NOT-OD-16-011 seeks to implement rigor and transparency in grant applications. Focus is on "the scientific premise forming the basis of the proposed research, rigorous experimental design for robust and unbiased results,consideration of relevant biological variables , and authentication of key biological and/or chemical resources."

oh, and for certain people around here NOT-OD-16-009 plans a change in allowable fonts that can be used in NIH grant applications. Key features are black text, 6 lines per vertical inch, 15 characters per linear inch and 11 pt type. The usual fonts are "recommended" although "other fonts (both serif and non-serif) are acceptable if they meet the above requirements"

15 responses so far

Publisher wants to take journal Open Access

Someone forwarded me what appears to be credible evidence that Wiley is considering taking Addiction Biology Open Access.

To the tune of $2,500 per article.

At present this title has no page charges within their standard article size.

This is interesting because Wiley purchased this title quite a while ago at a JIF that was at or below my perception of my field's dump-journal level.

They managed to march the JIF up the ranks and get it into the top position in the ISI Substance Abuse category. This, IMO, then stoked a virtuous cycle in which people submit better and better work there.

At some point in the past few years the journal went from publishing four issues per year to six. And the JIF remains atop the category.

As a business, what would you do? You build up a service until it is in high demand and then you try to cash in, that's what.

Personally I think this will kill the golden goose. It will be a slow process, however, and Wiley will make some money in the mean time.

The question is, do most competitors choose to follow suit? If so, Wiley wins big because authors will eventually have no other option. If the timing is good, Addiction Biology makes money early and then keeps on going as the leader of the pack.

All y'all Open Access wackaloons believe this is inevitable and are solidly behind Wiley's move, no doubt.

I will be fascinated to see how this one plays out.

50 responses so far

End of year pickups

Sep 29 2015 Published by under NIH, NIH funding

It's one of those times of years to go a-RePORTERing, my friends. Select 9/1 or 9/15 in the Project Start Date field and put your favorite IC in the field for that.

As the NIH reaches the end of the federal fiscal year, they have to balance their budget. Meaning that in many cases they will pick up out-of-order grants to satisfy some goal or other. No doubt sometimes it is just making the dollars and cents add up by slotting in a few more R03 or R21 grants.

Maybe it is a chance for them to trigger on priorities that they have been letting simmer on the back burner or maybe it is a class of grants that has to wait until the end of the year for some reason. BigMechs seem to be funded during September in several of my favorite ICs.

I seem to notice SBIR/STTR grants (R41, R42, R43, R44 mechs) rolling out, which makes sense. The overall NIH has a certain percentage it has to meet in terms of SBIR awards and I assume this rolls downhill to the IC level. So this is part of the balancing of books for the final accounting.

The thing I was noticing this year is that the list of grant awards from my favorite ICs seems...interesting. To me anyway. And given when I tend to find interesting (i.e., the unusual) it would be no surprise if this was as feature not a bug. I.e, real.

Look at it this way. The unusual has the potential to be treated somewhat poorly by study sections or it wouldn't be an unusual application. If you subscribe to a view that study sections suffer from a certain conservatism (and I do subscribe) than it makes sense that the end of year pickups might be interesting due to them being unusual. Perhaps there are POs who likewise look at the list of near-misses and are attracted to the grant application that offers a little breath of fresh air. Perhaps it is because there are the odd RFA extras that can be squeezed under the budget line.

...or maybe I am extrapolating too far from very limited data.

13 responses so far

A medium sized laboratory

How many staff members (mix of techs, undergrads, graduate students, postdocs, staff sci, PI) constitute a "medium sized laboratory" in your opinion? 

36 responses so far

Grantsmack: Overambitious

Aug 25 2015 Published by under Grant Review, NIH, NIH Careerism, NIH funding

If we are entering a period of enthusiasm for "person, not project" style review of NIH grants, then it is time to retire the criticism of "the research plan is overambitious".

There was a comment on the Twitters to the effect that this Stock Critique of "overambitious" is a lazy dismissal of an application. This can use some breakdown because to simply dismiss stock criticisms as "lazy" review will fail to address the real problem at hand.

First, it is always better to think of Stock Critique statements as shorthand rather than lazy.

Using the term "lazy" seems to imply that the applicant thinks that his or her grant application deserves a full and meticulous point-by-point review no matter if the reviewer is inclined to award it a clearly-triagable or a clearly-borderline or clearly-fundable score. Not so.

The primary job of the NIH Grant panel reviewer is most emphatically not to help the PI to funding nor to improve the science. The reviewer's job is to assist the Program staff of the I or C which has been assigned for potential funding decide whether or not to fund this particular application. Consequently if the reviewer is able to succinctly communicate the strengths and weaknesses of the application to the other reviewers, and eventually Program staff, this is efficiency, not laziness.

The applicant is not owed a meticulous review.

With this understood, we move on to my second point. The use of a Stock Criticism is an efficient communicative tool when the majority of the review panel agrees that the substance underlying this review consideration is valid. That is, that the notion of a grant application being overambitious is relevant and, most typically, a deficiency in the application. This is, to my understanding, a point of substantial agreement on NIH review panels.

Note: This is entirely orthogonal to whether or not "overambitious" is being applied fairly to a given application. So you need to be clear about what you see as the real problem at hand that needs to be addressed.

Is it the notion of over-ambition being any sort of demerit? Or is your complaint about the idea that your specific plan is in fact over-ambitious?

Or are you concerned that it is unfair if the exact same plan is considered "over-ambitious" for you and "amazingly comprehensive vertically ascending and exciting" when someone else's name is in the PI slot?

Relatedly, are you concerned that this Stock Critique is being applied unjustifiably to certain suspect classes of PI?

Personally, I think "over-ambitious" is a valid critique, given my pronounced affection for the NIH system as project-based, not person-based. In this I am less concerned about whether everything the applicant has been poured into this application will actually get done. I trust PIs (and more importantly, I trust the contingencies at work upon a PI) of any stage/age to do interesting science and publish some results. If you like all of it, and would give a favorable score to a subset that does not trigger the Stock Critique, who cares that only a subset will be accomplished*?

The concerning issue is that a reviewer cannot easily tell what is going to get done. And, circling back to the project-based idea, if you cannot determine what will be done as a subset of the overambitious plan, you can't really determine what the project is about. And in my experience, for any given application, there are going to usually be parts that really enthuse you as a reviewer and parts that leave you cold.

So what does that mean in terms of my review being influenced by these considerations? Well, I suppose the more a plan creates an impression of priority and choice points, the less concern I will have. If I am excited by the vast majority of the experiments, the less concern I will have-if only 50% of this is actually going to happen, odds are good if I am fired up about 90% of what has been described.

*Now, what about those grants where the whole thing needs to be accomplished or the entire point is lost? Yes, I recognize those exist. Human patient studies where you need to get enough subjects in all the groups to have any shot at any result would be one example. If you just can't collect and run that many subjects within the scope of time/$$ requested, well.....sorry. But these are only a small subset of the applications that trigger the "overambitious" criticism.

42 responses so far

Grumble of the Day

Jul 06 2015 Published by under NIH, NIH Careerism, NIH funding

I still get irritated every time a PO gives me some grant advice or guidance that is discordant with my best understanding of the process. It's not so much that I take it seriously for my own strategy...I've been around this block once or twice. 

What kills me is thinking that there are poor newcomer applicants who get this advice and may think it is Gospel. This would then lead them into making suboptimal strategic or tactical decisions.

Related Reading:
POs do not understand...

28 responses so far

Ronald Germain Explains How To Fix The NIH

Continue Reading »

99 responses so far

Re-Repost: The funding is the science II, "Why do they always drop the females?"

The NIH has recently issued the first round of guidance on inclusion of Sex as a Biological Variable in future NIH research grants. I am completely behind the spirit of the initiative but I have concerns about how well this is going to work in practice. I wrote a post in 2008 that detailed some of the reasons that have brought us to the situation where the Director of the NIH felt he had to coauthor an OpEd on this topic. I believe these issues are still present, will not be magically removed with new instructions to reviewers and need to be faced head-on if the NIH is to make any actual progress on ensuring SABV is considered appropriately going forward.

The post originally appeared December 2, 2008.

The title quote came from one of my early, and highly formative, experiences on study section. In the course of discussing a revised application it emerged that the prior version of the application had included a sex comparison. The PI had chosen to delete that part of the design in the revised application, prompting one of the experienced members of the panel to ask, quite rhetorically, "Why do they always drop the females?"

I was reminded of this when reading over Dr. Isis' excellent post [Update: Original Sb post lost, I think the repost can be found here] on the, shall we say less pernicious, ways that the course of science is slanted toward doing male-based research. Really, go read that post before you continue here, it is a fantastic description.

What really motivated me, however, was a comment from the always insightful Stephanie Z:

Thank you. That's the first time I've seen someone address the reasons behind ongoing gender disparities in health research. I still can't say as it thrills me (or you, obviously), but I understand a bit better now.

Did somebody ring?

As I pointed out explicitly at least once ([Update: Original 2007 post]), research funding has a huge role in what science actually gets conducted. Huge. In my book this means that if one feels that an area of science is being systematically overlooked or minimized, one might want to take a close look at the manner by which science is funded and the way by which science careers are sustained as potential avenues for systematic remedy.


There are a couple of ways in which the generalized problems with NIH grant review lead to the rhetorical comment with which I opened the post. One very common StockCritique of NIH grant review is that of an "over ambitious" research plan. As nicely detailed in Isis' post, the inclusion of a sex comparison doubles the groups right off the bat but even more to the point, it requires the inclusion of various hormonal cycling considerations. This can be as simple as requiring female subjects to be assessed at multiple points of an estrous cycle. It can be considerably more complicated, often requiring gonadectomy (at various developmental timepoints) and hormonal replacement (with dose-response designs, please) including all of the appropriate control groups / observations. Novel hormonal antagonists? Whoops, the model is not "well established" and needs to be "compared to the standard gonadectomy models", LOL >sigh<.

Grant reviewers prefer simplicity
Keep in mind, if you will, that there is always a more fundamental comparison or question at the root of the project, such as "does this drug compound ameliorate cocaine addiction?" So all the gender comparisons, designs and groups need to be multiplied against the cocaine addiction/treatment conditions. Suppose it is one of those cocaine models that requires a month or more of training per group? Who is going to run all those animals ? How many operant boxes / hours are available? and at what cost? Trust me, the grant proposal is going to take fire for "scope of the project".

Another StockCritique to blame is "feasibility". Two points here really. First is the question of Preliminary Data- of course if you have to run more experimental conditions to establish that you might have a meritorious hypothesis, you are less likely to do it with a fixed amount of pilot/startup/leftover money. Better to work on preliminary data for two or three distinct applications over just one if you have the funds. Second aspect has to do with a given PIs experience with the models in question. More opportunity to say "The PI has no idea what s/he is doing methodologically" if s/he has no prior background with the experimental conditions, which are almost always the female-related ones. As we all know, it matters little that the hormonal assays or gonadectomy or whatever procedures have been published endlessly if you don't have direct evidence that you can do it. Of course, more latitude is extended to the more-experienced investigator....but then s/he is less likely to jump into gender-comparisons in a sustained way in contrast to a newly minted PI.

Then there are the various things under grantspersonship. You have limited space in a given type of grant application. The more groups and comparisons, the more you have to squeeze in with respect to basic designs, methods and the interpretation/alternative approaches part. So of course you leave big windows for critiques of "hasn't fully considered...." and "it is not entirely clear how the PI will do..." and "how the hypothesis will be evaluated has not been sufficiently detailed...".


Although research funding plays a huge role in career success, it is only part of the puzzle. Another critical factor is what we consider to be "great" or "exciting" science in our respective fields.

The little people can fill in the details. This is basically the approach of GlamourMagz science. (This is a paraphrase of something the most successful GlamourMagz PI I know actually says.) Cool, fast and hot is not compatible with the metastasizing of experimental conditions that is an inevitable feature of gender-comparison science. Trouble is, this approach tends to trickle down in various guises. Lower (than GlamourMag) impact factor journals sometimes try to upgrade by becoming more NS-like (Hi, J Neuro!). Meticulous science and exacting experimental designs are only respected (if at all) after the fact. Late(r) in someone's career they start getting props on their grant reviews for this. Early? Well the person hasn't yet shown the necessity and profit for the exhaustive designs and instead they just look...unproductive. Like they haven't really shown anything yet.

As we all know splashy CNS pubs on the CV trump a sustained area of contribution in lower journals six ways to Sunday. This is not to say that nobody will appreciate the meticulous approach, they will. Just to say that high IF journal pubs will trump. Always.

So the smart young PI is going to stay away from those messy sex-differences studies. Everything tells her she should. If he does dip a toe, he's more likely to pay a nasty career price.
This is why NIH efforts to promote sex-comparison studies are necessary. Promoting special funding opportunities are the only way to tip the equation even slightly more favorable to the sex-differences side. The lure of the RFA is enough to persuade the experienced PI to write in the female groups. To convince the new PI that she might just risk it this one time.

My suspicion is that it is not enough. Beyond the simple need to take a stepwise approach to the science as detailed by Isis, the career and funding pressures are irresistible forces.

9 responses so far

NIH Mandate to Consider Sex as a Biological Variable in Grant Apps

Jun 09 2015 Published by under NIH, NIH funding, Sex Differences

The NIH has published NOT-OD-15-102 Consideration of Sex as a Biological Variable in NIH-funded Research which informs us:

This notice focuses on NIH's expectation that scientists will account for the possible role of sex as a biological variable in vertebrate animal and human studies. Clarification of these expectations is reflected in plans by NIH's Office of Extramural Research (OER) to update application instructions and review questions; once approved by the Office of Management and Budget (OMB), these updates will take effect for applications submitted for the January 25, 2016, due date and thereafter.


Accounting for sex as a biological variable begins with the development of research questions and study design. It also includes data collection and analysis of results, as well as reporting of findings. Consideration of sex may be critical to the interpretation, validation, and generalizability of research findings. Adequate consideration of both sexes in experiments and disaggregation of data by sex allows for sex-based comparisons and may inform clinical interventions. Appropriate analysis and transparent reporting of data by sex may therefore enhance the rigor and applicability of preclinical biomedical research.4

NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies. Strong justification from the scientific literature, preliminary data, or other relevant considerations must be provided for applications proposing to study only one sex. Investigators are strongly encouraged to discuss these issues with NIH program staff prior to submission of applications.

Additional information is provided in a three page PDF overview:

Literature review. Consider and describe how sex and gender may influence the research question(s) at hand. Conduct a review of the human clinical literature and any relevant preclinical literature. If there are differences between males and females in previous preclinical or clinical studies, this would provide a strong rationale for building consideration of sex into the research design and analyses of data. The absence of previous study data in an area of research does not, by itself, constitute strong justification to study only one sex.

Very nice. So helpful. Look NIH, clearly this is going to be a place where applicants who do not wish to incorporate SABV into the design are going to seek a loophole. What would be helpful here would be a more assertive statement about what does and, most importantly does not, constitute a "strong justification to study only one sex". Uncontrolled, this will devolve back to the reviewers who are already failing (going by your highly effortful and high profile new initiative) to appropriately favor* SABV in research grant proposals. They are the ones that will decide that the tiniest fig leaf of excuse making is acceptable "justification" if you give them half a chance to do so. This part needs strengthening.

and later on in the document:

Single-sex studies. Applicants must provide strong justification for applications proposing to study only one sex. Such justification may include the study of sex-specific conditions or phenomena (e.g., ovarian or prostate cancer), acutely scarce resources (e.g., non-human primates), or investigations in which the study of one sex is scientifically appropriate. The absence of evidence regarding sex differences in an area of research does not constitute strong justification to study only one sex.

Sex-specific conditions or phenomena, check. Good. Will hard-to-breed mice constitute "acutely scarce resources"? Human drug abusers of various characteristics that make it hard to recruit female or male participants? The devil will be in the detail. But "scientifically appropriate"? Again, this holds open a big old loophole of escape. And a repeat of the absence-of-evidence statement. What does this mean? What are the limits on this strong justification? How are you going to get reviewers on board with this, instead of leaving them to accept any old excuse?

Research design, data analysis, and reporting.
....Where little or no sex-specific data is available, sex-specific hypotheses may not be possible, whereas previously observed sex differences may prompt sex-specific hypotheses.

Dude what? Are you kidding with this? We all know there must be a supported hypothesis in the research plan. And if there has not been any sex-differences research in the past, well, there are no hypotheses we can advance. And therefore, so sorry, we must avoid proposing anything that investigates SABV because the study section will kill us for lack of a clear hypothesis**. Another whoppingly huge escape clause for the SABV resistant PI.

Acknowledge limitations in the applicability of findings that may arise from the samples, methods, and analyses used, in the research plan as well as in progress reports and publications.

Emphasis added. HAHAHAHHAHHAA!!!! Yeah RIGHT! Every NIH Grant awardee who does not explicitly include SABV in a paper must make sure to add the caveat in the Discussion that their results cannot be extended to the other sex. Sure that's going to happen. Sure.

Finally, one for my peers who already conduct SABV research with regularity.

Researchers working with animal models should consider if and how the female estrous cycle is relevant for experimental design and analysis; it may be relevant for some research questions and not others

This one is pointed straight at the buzz saw of the sex-differences aficionado Stock Criticism of grant applications. One of the ways that sex-differences gets stamped out of research proposals is that the "real" experts start in on "YOU MUST DO THE SEX-COMPARISONS RIGHT AND AS WE HAVE DONE". This may include cycle synchronization, gonadectomy, pharmacologico-hormonal manipulations, endless groups, etc, etc, etc.

There is little tolerance from these people for "First, let's give it a go in female (or male) animals/cells/tissues and see what we turn up" exploratory fishing expeditions.

I would argue that tolerance for fishing expeditions is precisely what the NIH needs if they want to jumpstart real change. You have to make the barrier low and, especially in this day and age, of low cost. Demanding that it has to be SABV design 101eleventy at all times or it is not worth doing is going to motivate resistance. Resistance on the part of PIs doing their grant proposing and on the part of peers doing the grant reviewing.

I propose that a NIH policy of "Any old Third Aim that will engage in sex-differences comparisons is good enough and a total freebie for the first five years***" is what is necessary.

*oh yes, believe you me there are puh-lenty of investigators who propose SABV aspects in proposals and get it beat out of them at review.


***that may have to be slightly more formal

34 responses so far

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