NIH Funding to Study Sex as a Fundamental Variable in Clinical Research

Credit: Photokanok at FreeDigitalPhotos.net

I am popping up from my mountain of R01 drafts to bring attention to an important NIH news release. Yesterday, NIH announced it has devoted over $10 million in supplemental funding for 82 grantees to explore sex differences in their clinical and pre-clinical research.

The news release states, “These awards are the latest round of funding in a program described in a May 2014 Nature commentary by [Janine Austin Clayton, M.D., NIH associate director for women’s health research] and NIH Director Francis S. Collins, M.D., Ph.D. This commentary informed NIH grantees and other stakeholders of the agency’s intent to develop policies that will require applicants to address the influence of sex in the design and analysis of biomedical research with animals and cells.”

The news release states that the goal of the supplements is to serve as “…a catalyst for considering sex as a fundamental variable in research.”

NIH began this program in FY13, initially funding 50 supplements ($4.6 million total.) The initiative has been led by the Office of Research on Women’s Health. Most of the NIH ICs have funded supplements since the inception of the program.

Historically, medical research has been conducted predominantly on white male subjects. NIH has made efforts to expand the scope of clinical research to include both sexes and to represent multiple races and ethnicities. Grantees who want to succeed in the NIH arena would be wise to incorporate such variables into current and future studies.

 

 

Sequester Cuts to the NIH Budget Look Increasingly Likely

Guest Blog by Luke Bouvier, PhD

The day of reckoning is fast approaching as concerns the sweeping federal budget cuts known as “sequestration,” scheduled to go into effect on March 1.  Originally slated for January 1, 2013, the cuts were mandated by the Budget Control Act of 2011, which was enacted as part of that year’s fight over the increase in the federal debt ceiling.  In the hope that a long-term budget deal would make the automatic cuts unnecessary, their implementation was postponed by the New Year’s Day deal that averted the so-called “fiscal cliff,” but most observers now agree that there is little appetite for a political compromise that could avoid them once again.  On January 24, incoming chair of the Senate Budget Committee Senator Patty Murray (D-WA) released a memo outlining the history of the budget deals reached over the past two years as well as the current state of affairs.  The details are messy, but the consequences for the NIH are clear:  a cut of approximately 5.1% to the current year’s budget, or $1.57 billion, which would be all the more severe in that it would have to be squeezed into the remaining seven months of the fiscal year.

In an interview with Politico last month, NIH Director Francis Collins called the impending cuts “a profound and devastating blow” to medical research, adding that “there’s no sort of lever you can pull and all of a sudden everything will be fine” in the face of a cut of that magnitude.  Collins noted that over the past ten years, the NIH budget has been essentially flat, which means that inflation has whittled away about 20% of its value.  The looming cuts would greatly exacerbate that trend, at a time when cancer research is “just exploding with potential,” Collins said.  “We could go faster and faster; … it’s an incredibly exciting science, but it will go slower.”

Nature reported last week that scientists are already cutting back expenditures in anticipation of the cuts.  Senior officials at the science agencies are under White House orders not to discuss specific plans for implementing the cuts, but the Office of Management and Budget has directed them to minimize the impact of the cuts on their core missions and to give priority to concerns over life, safety, or health.  Nature reports that the cuts to the NIH budget would be spread over all of its 27 institutes and centers, with only its Clinical Center spared in order to avoid putting patients’ lives in danger.  Directors would have some discretion in apportioning the cuts, as long as the total adds up to 5.1%.  Given the uncertainty, the NIH has been paying only 90% of the promised amounts for previously awarded grants; if the sequester goes into effect, the final 10% of these grants would almost certainly suffer a significant cut, leaving principal investigators with difficult spending decisions to make.

As if sequestration weren’t enough, looming right behind it is another impending budget crisis, as the current fiscal year’s Continuing Resolution expires on March 27.  If no budget deal is reached by then, a government shut-down is a real possibility.  And following along close behind that deadline is the expiration of the debt ceiling suspension on May 19, which could lead to a US government default on its payment obligations in the absence of congressional action.

How to Shop Your Research Idea(s) Around at NIH Before You Write a Proposal

As you may have surmised I like to discuss strategies for grantsmanship in this blog. A number of people have questioned the wisdom of this approach given that I run a medical writing business, a large portion of which is devoted to proposal writing. Why should the client buy the cow if they are getting the milk for free? I have plenty of proposal writing work and, wise or not, I like to provide some measure of relief to the hordes of desperate grantees out there (see previous post re: despair.) So here is a tip I give out frequently:

If you are like most researchers, you have several ideas for projects percolating in your brain at any given time. The question is, which should you write up as a proposal? Writing a quality proposal takes dozens of hours of work, usually squeezed into an already over-full work schedule. Then it takes many months to get the funding decision back. Then there is the time spent reworking the proposal for resubmission, then the months awaiting that funding decision. All in all, when you embark on this process, you are agreeing to several hundred hours of work and potentially several precious years of your career, as start-up funds and Early Stage Investigator status may be dwindling. And that’s before we consider the additional gray hairs, sleepless nights, and years shaved off your life due to the stress of a (potentially) unscored application.

Given the pound of flesh the proposal writing process will exact, why not put some time in before you write in order to maximize your chances of success? You are already putting in a few hundred hours on the proposal and resubmission, what’s a few more? I suggest that you take each one of your ideas and mock up a one-page Specific Aims. Think of different ways you could frame the research question to make it relevant to more than one Institute. For example, if you are examining a behavioral effect, could you look at it in the aging population and shop it to NIA? Could you look at it in children and shop it to NICHD? If you are doing SNP work, do you want to examine SNPs in cancer (NCI), diabetes (NIDDK), cardiovascular disease (NHLBI)? Once you have drafted the Specific Aims for each of your ideas and/or each version of an idea, email it to the appropriate Program Officer at the relevant IC. Ask if they would be willing to discuss the Aims with you briefly on the phone to determine its relevance to the IC’s funding priorities. This fishing expedition may well lead to an enthusiastic PO (or two.) Once you find someone who is encouraging and helpful, work with them to polish the Aims so that the project is tailored to the Institute and program, and makes sense in terms of the timeline and budget in the funding opportunity announcement. Remember that POs sit in on study sections, so they likely have their finger on the pulse of what will be well received there. Send your Aims to your trusted mentors and colleagues for their input, then discuss further with the PO. Revise the Aims repeatedly, beat them up until everyone is satisfied with them.

THEN you can start writing the proposal.

As for getting the milk for free: I think when it comes to writing proposals, grantees can be rather superstitious. I had a client post on my business Facebook page the other day likening what I do to correctly reading tea leaves (no, he was not being facetious. Yes, he has paid for my advice, more than once.) I have known superstitious scientists not to shave while they are writing grants, or to wear their lucky socks (that latter ripe-smelling group is probably best dealt with via Skype). I think this cohort will do whatever it takes to maximize their chances of funding, including hiring an experienced and successful proposal writer. And as for those grantees who feel they can brave the perilous grant process on their own simply by reading my tips in this blog, I remind them of Paul Newman’s line to his protégé as they are about to face off in a high-stakes pool game in The Color Of Money: “I taught you everything you know, but I didn’t teach you everything I know.”

And now that I have managed to equate my work to reading tea leaves and hustling pool all in one post, I will sign off for the evening.