Medical Writing, Editing & Grantsmanship

Per a Notice released today, new and ESI applicants will now have an extra couple of weeks to prepare their A1 submission in time to make the next review cycle. Previously, they needed to resubmit by the 20th of the month in which they typically received their summary statement, and now they have until the 10th of the next month, which should offer a little more breathing room for both the SROs and the applicants. For each cycle, the timing would look like this:

As a reminder, this only applies to R01 applications (no other mechanisms) and only to applications submitted for one of the standard deadlines (applications submitted in response to RFAs and PARs with special deadlines do not fall under this policy).

And as the Notice helpfully concludes,

New Investigators are encouraged to consult with officials at their institution and the NIH Program Director assigned to their application (identified on the summary statement) [aka PO or program officer] in making the decision on whether to utilize this option.

A recent editorial in Nature presents a rather different slant on the NCRR-NCATS situation at the NIH than has been portrayed previously in their various news, commentary, and blog pieces. For example:

The process to set up the centre, with an initial budget of more than US$600 million, has certainly been hasty, and has by its nature alienated a significant element of the NIH-funded community. But Collins is right to seek to accomplish quickly what otherwise threatens to become a drawn-out and even more disruptive period of necessary change. Band-Aids are best torn off quickly.

Band-Aids? What Band-Aids? The NCRR was functioning at the peak of health, and the other ICs are funding billions of dollars in translational research. What has alienated the NIH and the NIH-funded community is the unscientific, non-transparent, and one-sided approach to making decisions. Which, the editorialist in fact noted:

In what can only be termed an executive decision, taken quickly in December and presented to the NIH community effectively as a fait accompli, Collins wants to dismantle the remaining 60% of the NCRR and move its programmes elsewhere …

The move to dismantle NCRR was indeed a calculated executive decision to bypass the SMRB and the rest of the NIH intra- and extra-mural communities.

The editorial moves on to mention a few of the concerns associated with these maneuvers:

It is certainly risky to dismember a $1.3-billion centre and scatter its programmes without the months of analysis that, for instance, went into the decision to create a new addictions institute at the NIH in 2013. And grant recipients of NCRR-supported programmes have been forced to settle for verbal promises from Collins that the money, staff and commitment will remain unchanged in their new institutional homes. In dire budget times for the agency, such assurances are understandably cold comfort. The new NCATS will also take tremendous institutional investment to make it work, far more than is reducible to dollars and cents. The learning curve for all involved will be steep.

The rationale given for this haste is worrisome:

What’s more, he has reason to hurry. It is entirely possible that he will be out of a job 18 months from now if Republicans capture the White House in next year’s presidential election.

Surely if this is so obviously the right thing to do and the right time to do it, the next NIH Director could be trusted to continue the process at a reasonable pace. Is by-passing the SMRB and its intended role as well as any careful analysis and thoughtful planning worth the trade-off of having Collins preside over the ribbon-cutting ceremony?

Oddly, the editorial names someone never previously mentioned in conjunction with these organizational changes, someone not involved with the SMRB:

It’s worth noting, too, that the new ‘infrastructure entity’ in his office will be overseen by James Anderson, a thoughtful manager with a reputation for being smart, effective and organized — and with a keen eye for checking that programmes are well run.

I am somewhat surprised that the editors of a British science journal are so attuned to program administrators buried in NIH bureaucracy. Or that the new a newly appointed division director already has such a strong track record of success. Anderson arrived last fall to direct the Division of Program Coordination, Planning, and Strategic Initiatives (formerly known as OPASI). How the editors at Nature knew about his key role in overseeing the remnants of NCRR is a bit of a mystery. Perhaps ghostly.

Those on the NCRR Task Force might have worked out on paper where the “programs” go, but how much thought has been given to the logistics of the actual transition, especially if the personnel with years of experience managing these complicated programs do not move along with them? Then there is the issue of managing funding announcements and applications during the transition, which could be especially tricky for construction mechanisms.

The National Advisory Research Resources Council expressed their frustrations with regard to lack of consideration of these and other issues in their public comment to the SMRB:

The process undertaken over these past months leading to the decision to eliminate NCRR was rushed and excluded members of the affected scientific community, the NCRR leadership, and the NCRR advisory council from any input into the process. Congress and the public expect and deserve, among other things, transparency, stakeholder input, meaningful deliberation and consideration, and importantly, analysis of impact and consequences before the fact, not after decisions have been made. This is essential to ensure continued public trust.

The mission of the NCRR is unique at the NIH, providing flexibility and independence not easily available in categorical ICs. Its programs contribute substantially to ICs that provide extramural funding. The outcry from the research community following announcement of the intention to eliminate NCRR and to reassign its programs to other ICs should be considered in a meaningful way. …

We strongly urge the SMRB and Office of the Director to delay any further decisions based on the recommendation to eliminate NCRR and to delay any reassignment of NCRR programs. Proposed changes to existing NCRR programs must involve further open discussion with the scientific community, as well as the other NIH ICs. We see no scientific justification for rushing these decisions in order to complete the reorganization prior to October 1, 2011.

Clearly the SMRB has never had any role in this, and the Office of the Director is, in light of the editorial observation above, concerned more with short-term legacy than long-term planning. Congress, however, could still have something to say since NCATS will need to be specifically written into the first CR for FY12 (in light of the current debate ongoing for FY11, we clearly will not have any appropriation bills passed before Oct 1), and NCRR will need to be specifically written out of it.

When H.R. 1 imposed a $1.6B-cut in the NIH budget, FASEB quickly sent out a press release and analysis of NIH funding trends. Among the findings highlighted in their statement:

• Over the past 6 years, the number of research project grants funded by NIH has declined in almost every year, and we now fund 2,000 fewer grants than in FY2004
• NIH made 9,455 competing (new and renewed) awards in FY2010, 1,000 fewer than in FY2003
• Success rates have fallen more than 10 percentage points in the past decade
• Success rates for new (type 1) applications have fallen for 3 straight years and are now at 17%

Some specific slides that may be of interest …

You can also monitor these sorts of data at the NIH Funding Facts Website.

with “patient advocacy groups, medical research foundations and other stakeholders of the medical research system.”

An hour-long Webinar sponsored by FasterCures is scheduled for Wednesday, March 16th, starting at 4 p.m. EDT; registration is required and limited.

As Collins says on the Feedback site:

Next week I will speak to the community about my vision for NCATS on a webinar hosted by the nonprofit organization FasterCures. I will be joining Margaret Anderson, the Executive Director of FasterCures, who will moderate a question and answer period following my talk. Please join me and have your questions ready.

Please do.

… the NIH Early Independence Award, which, at least in its initial FOA, provides $250K DC per year for 5 years to grad students so they can skip the postdoc period and immediately become independent faculty researchers. An interesting report on how to structure this program presents some alternative models and considers existing successful programs (e.g., Carnegie, Whitehead, Janelia Farm, RWJF, etc.). According to the RFI Notice, you have until March 18 to chime in. I wonder if we can comment on the rather unusual image the NIH Director has selected to represent this program.

… and the planned transfer of NCRR programs to NIGMS by Jeremy Berg at the Feedback Loop. Congress still has time to recognize this might not be the best use of taxpayer dollars, but in the absence of a sudden burst of clear thinking, the reorganization will move forward, and Director Berg would genuinely appreciate feedback from the key constituency (namely, the extramural research community the NCRR serves … served). Reflections on the whole process and what this might portend for the NIH more broadly would likely be welcome as well.