NIH Extramural Nexus

The Office of Management and Budget just published a notice in the Federal Register asking for public comment on potential reforms to federal grant policies contained in OMB circulars such as A-21, A-133, and A-122. These include ideas that would standardize information collection across agencies, adopt a risk-based model for single audits, and provide new administrative approaches for determining and monitoring the allocation of federal funds. These ideas reflect the input of a number of groups that have been considering these issues over the past few months, including the A-21 Task Force, which I have mentioned here before.

I encourage you to read the notice in full. To give you an idea of the scope of the proposed reform, here are some of the ideas discussed:

• Exploring alternatives to time-and-effort reporting requirements for salaries and wages
• Charging directly allocable administrative support as a direct cost
• Including the cost of certain computing devices as allowable direct cost supplies
• Consolidating the cost principles into a single document, with limited variations by type of entity
• For indirect (“facilities and administrative”) costs, using flat rates instead of negotiated rates

As you can see, some of these changes, if implemented, will have a broad, long-lasting effect on how federal grants are administered. Therefore, it is important to take advantage of this opportunity to provide input to OMB as they consider the proposed reforms.

You can submit comments at http://www.regulations.gov. The comment period closes on March 29, 2012 April 30, 2012.

We get questions all the time about how much we spend on a variety of diseases and conditions—breast cancer research, Alzheimer’s disease, or childhood leukemia to name a few. Luckily, there is an easy way to find out. Go to RePORT’s Categorical Spending page. Listed there are 233 diseases, conditions, and areas of research. Each year in February, we update the numbers, and the latest set (actual fiscal year 2011 spending) has just been posted.

With the doubling of the NIH budget between 1998 and 2003 and the coinciding internet technology boom, there was demand for a consistent categorization process for all extramural grants, intramural projects, R&D contracts, and inter/intra agency agreements. Congress requested we provide an automated, electronic solution for NIH-wide categorization of research projects, and so, our Research, Condition, and Disease Categorization (RCDC) Project was born. We started by developing and defining the scientific categories. Then, by mining scientific words and multi-word phrases from NIH projects, we assign projects to one or more categories.

We released the first categorical funding data in January 2009, which categorized fiscal year 2008 awards. If you visit the website, you will see for each category actual funding levels by year, as well as funding estimates for the next two fiscal years. Clicking on a number will provide a detailed project listing for your category of interest, and you can find out further information about each project by clicking on the project number.

One question I always get is, “Why do the amounts add up to more than the annual budget level?” Here is the answer. The categories are not mutually exclusive. A particular project can, and often does, fall into more than one category. In these cases, the amount of funding for the project is counted in each assigned category.

I am happy to report that we’ve found other ways of using this categorization process to help us here at NIH, as well as provide useful information to the extramural community. The “similar projects” tab in a project listing in RePORTER uses the RCDC technology and data, as does the “LikeThis” tool we recently developed for investigators to use within the eRA Commons.  

RCDC provides more insight into what research NIH is supporting, and I hope you will take a look.

As you may know, the President’s budget request for fiscal year 2013 was released on Monday. The request for the NIH is $30.86B, the same overall level as fiscal year 2012. The full details of the NIH budget request are posted on the NIH Office of Budget website, but I want to highlight some topics I often discuss here, namely the number and management of research grants.   

As described in the budget document, we estimate that these funds will support 9,415 new and competing research project grants (RPGs) in fiscal year 2013, an increase of 672 above fiscal year 2012. In order to maximize resources in fiscal year 2013 for investigator-initiated grants, and to continue to focus on resources for young, first-time researchers, we propose to reduce non-competing RPGs by one percent from the fiscal year 2012 level, and to negotiate the budgets of competing RPGs to avoid growth in the average award size (estimate of -1 percent) from fiscal year 2012. Also, we will no longer build in the inflationary increases that were included for planning purposes in the out-years of competing and non-competing awards.

We will continue to follow current policies that allow new investigators to receive grants at rates equal to those of established investigators.

Finally, we will establish a process for additional scrutiny and review of awards to any principal investigator with existing grants of $1.5 million or more in total costs. The review will be conducted by an institute’s or center’s advisory council. This is similar to a policy NIGMS has had for many years, which will likely serve as good model for how we may implement this policy. 

If some of the measures described above sound familiar, you may be thinking of the information we posted last October on ways of managing NIH resources. We asked for your comments on this information, either as responses on the blog (here and here) or directly to us by email. We received comments from 348 entities (individuals and institutions), with many people commenting multiple times on the blog. The vast majority of commenters were individuals, but we also heard from some institutions.

Some commenters thought we should keep the current system, but many others supported implementation of one or more of the options. Specifically, a number of commenters were in favor of the following options (in order of the support they received):

• Limit the number of awards per PI
• Limit the amount of funds per PI
• Limit salaries of PIs
• Reduce or limit size of awards

In addition, many commenters suggested options that were not described in the Ways of Managing Resources presentation. Some options that were mentioned include limiting indirect costs, limiting certain programs (for example, large project grants), and providing more resources to small labs and individuals by limiting grants to large labs.

So thank you for your thoughtful comments. As you can see, having a dialog with the community in as many venues as possible is essential as we continue to consider how to manage our resources to fund as much of the best science as possible in these challenging fiscal times.

Recently we explored the increase in average age of new investigators. While that average age has remained relatively constant over the past ten years, we are seeing something different in our entire pool of principal investigators (PIs). Today, I want to discuss this by comparing the average age of NIH PIs to the age of faculty in medical schools using data generously provided by the Association of American Medical Colleges (AAMC). We recognize that slightly more than 45% of all awards are made to PIs that work outside of medical schools, but the AAMC has been very successful in collecting information on faculty that work in that setting, and it’s interesting to see the comparison.

(This video does not have an audio track. If you are unable to view it, you can also download it. View the presentation slides here.)

The NIH started recording the age of most PIs around 1980, which is why the presentation above starts at that year. As you move through the years from 1980 to 2010, you can see that both populations of faculty and PIs become less compressed in the age period between 28 and 65. In more recent years, you see fewer people entering the faculty at ages 28 and below, and very few people receiving an R01 award before age 33. But, the biggest difference is seen at the later ages. The elimination of mandatory retirement during the 80s and increasing life expectancy allowed people to remain employed much longer[1]. We also suspect that the current economic situation is forcing many people to reconsider their retirement.

In 1980, less than 1% of PIs were over age 65, and now PIs over age 65 constitute nearly 7% of the total. In parallel, in 1980, close to 18% of all PIs were age 36 and under. That number has fallen to about 3% in recent years. These are big changes.

Another factor that jumps out is the increasing gap between entry into faculty and receipt of the first R01. Although not all AAMC faculty members apply for NIH research grants, the gap is interesting and suggests that institutions and other non-NIH funding sources are increasingly responsible for research start-up costs.

When we produced this same presentation five years ago, I had predicted we were at the cusp, and that the average age of a supported NIH PI would remain relatively constant going forward. However, obviously, I was wrong. As we continue to look at the age distribution of NIH PIs, we will keep you updated.

I’ve talked to you over the past year on many aspects of the biomedical research pipeline. But one issue, the plight of the early career researcher, has been front and center almost from the first day I joined NIH. Over a long period of time, NIH has made a concerted effort to make sure that faculty members in their early careers have a fair chance when they compete against more established investigators. If you enjoy history, a complete description of our programs starting in 1977 is available on our website.        

Over the past three decades, we’ve seen profound shifts in the average age at which a principal investigator receives their first R01. During the period from 1980 to 2001, the average age increased nearly 0.3 years per year. Since that time, the average age at first R01 award has leveled off near 42 for PhDs. It is higher for researchers with an MD or an MD/PhD.

In more recent years, our new investigator (new to NIH funding) policies shifted to numerical targets, and you can see a substantial increase of new R01 investigators beginning in 2007. By 2010, the proportion of new investigators increased to approximately 30 percent of all competing R01s, replicating entry rates not seen since 1987. The imposition of numerical targets appears to have had little effect on the average age at which a new investigator receives their first award, however. In order to encourage earlier transition to independence, the NIH initiated the Early Stage Investigator policy for applications submitted for funding in fiscal year 2009. Early stage investigators are defined as being within ten years of completing their terminal degree or their medical residency. 

Our current policy requires that approximately half of all new investigators are early stage investigators, but, so far we’ve seen no decrease in the age at entry. Maybe it is too early to expect an impact. We’ve also made one additional change in the new investigator policy. Rather than using numerical targets, we’ve set targets based on success rates. The success rate for investigators submitting a new R01 application should be the same whether they are new or experienced investigators. Current policies related to new investigators are described on the Financial Operations webpage (note that some of the IC-specific policies are currently being updated for fiscal year 2012).   

We believe it is important to continually refresh the pool of talented scientists and to give them an opportunity to manage their own project while they are still relatively young. We also believe in evaluating the results of our efforts, so we are analyzing the outcomes of these the new investigator policies. For example, how successful are these new investigators after they get their first award and has that changed as we fund more of these researchers? So, as always, stay tuned.