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.

 

 

Should You Ask An NIH Grantwriter For Their Success Rate?

The short answer is no. And if you find a grantwriter who maintains and advertises such a thing, you should probably run for the hills. Grantwriting is an iterative process. At NIH, few applications are funded on the first try, and it can take time to titrate a grantee’s submission strategy. Success in one agency, IC, or study section does not mean you will be successful at others. It takes time, patience, legwork, and usually multiple submissions to figure it out. Most of my clients understand this and are willing to invest time and energy in developing their relationship with a given agency over time.

While one should write an application as if it were your only shot at funding, the grantwriter and client must also understand that a first submission to a new agency, study section, or IC will likely wind up being a learning experience. I find it very rewarding to work with a client over time as they develop their understanding of a given IC and study section, and build a relationship with a PO. It is gratifying to help that client grow in terms of their NIH grantsmanship, and hopefully to land their grant on a subsequent submission and launch their relationship with NIH. The same holds true for experienced grantees looking to make the leap into center grants. It usually takes patience, hard work, and multiple submissions to succeed.

No matter how strong the science, NIH statistics show that few funded projects are successful on the A0. Therefore, a grantwriter who maintains their own funding statistics is not likely to accept inexperienced applicants as clients—yet these are the very clients who may benefit the most from your help. If grantwriters only accept projects they know have a strong chance of funding, then who will help inexperienced grantees learn the ropes?

If a grantwriter maintains success statistics, I would question their commitment to their clients. That said, you certainly don’t want to choose a grantwriter who never lands grants! But perhaps the better measure of “success” in this scenario is if their clients feel the grantwriter strengthened their application, educated them on the NIH grant process, and improved their overall approach to grantsmanship—skills they will carry with them throughout their career, whether they are successful on a given submission or not.

I assume I do not need to mention that you should steer clear of a grantwriter who guarantees success. Anyone fool enough to believe such a thing deserves what they get. Great writing and grantsmanship savvy are necessary, but not sufficient, to funding success. A grantwriter cannot change the science, and naturally many projects are not funded because of the science.

What would you look for in an NIH grantwriter? How would you interview one if you wanted help on a submission?

2013 Year In Review at NIH

Here is a link to a useful blog post written by NH Deputy Director Sally Rockey. It summarizes some of the main activities at NIH during the course of 2013. While it begins with a depressing recap of the far-reaching effects of the budget situation, it goes on to highlight some of the main goals and programs of the year. Major themes continue to include data science and efforts to diversify the scientific workforce. The blog is chock-full of hyperlinks to more information on numerous topics. If you plan to develop a long-term relationship with a federal funding agency, it is important to know its mission and funding priorities, and to familiarize yourself each year with the goals identified in the director’s appropriation report, and the suggestions made by the advisory council to the director. Read the full blog post here.