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NIH Presses Forward on 'Rushed' NCATS Plan

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The National Institutes of Health's plans to break up the National Center for Research Resources to make way for a new translational research center continue to take shape, even as the effort is being criticized as too hasty and poorly thought through.

In a teleconference held Wednesday, NIH leadership outlined its latest models for where NCRR's constituent programs will land when the plan to create the National Center for Advancing Translational Science is enacted, which NIH Director Francis Collins has said he hopes will be by the beginning of the next fiscal year, in October.

A small group called the NCRR Task Force, working at the behest of NIH's Scientific Management Review Board, issued its final interim recommendations on where NCRR's programs should reside, saying that some programs will go to NCATS, the National Institute of General Medical Sciences, and the Office of the Director, and several will go into a new "Infrastructure Entity" that will not be its own institute.

From its public unveiling at the end of 2010, the plan that Collins has called a "bold step" forward has stoked the ire of critics who see a need for a distinct NCRR. Some parties are troubled by the accelerated process of such a substantial institutional reshuffling. Others are concerned about their funding and programs, and some still think NIH may over-step its mandate to support basic science if it dips its toes too deep into the drug development waters.

Jeremy Berg, Director of the National Institute of General Medical Sciences and the only SMRB member to vote against the plan to create the institute, said this week in an open letter that the process to decide what to do with NCRR has been "rushed," and that it is "particularly troubling" that SMRB has simply not had time to consider the implications of its plans, which require "careful consideration."

Collins admitted that the process has been speedy, and noted during the teleconference yesterday that he wants the new center, announced less than three months ago, to be started in a little more than 200 days. But he disagrees that the process has been overly rushed.

"There has been a lot of discussion about this. No less than four deliberative bodies of external and internal experts have been looking at the various aspects of what this might mean," Collins said.

"Some people have said, 'Gosh, NIH, you're moving awfully fast,'" he said.

"Well, okay, in this instance the motivation for that is the desire to reach out and do something that hasn't really been done before in terms of figuring out how to re-engineer this process of developing therapeutics. Our job here is to try to proceed as quickly as possible down that path," he continued.

Collins also said that in spite of concerns about the "complex" process and its side-effects, the general plan to create NCATS has "received a lot of support and enthusiasm."

Patient advocacy groups such as the Genetic Alliance and the Parkinson's Action Network, Collins pointed out, have "endorsed the importance and the urgency of moving the translational agenda forward and were strongly supportive of what is trying to be done here with NCATS."

Most of the critics do seem to support the general goal behind the new center, but they worry about what will happen to NCRR's programs.

A group of US Senators recently sent a letter to Collins and to Secretary of Health and Human Services Director Kathleen Sebelius asking NIH to handle the reorganization with caution and to protect certain programs in which they are particularly interested.

NIH also has received more than a thousand public comments on its feedback page, a great many of which are from NIH-funded investigators who raise questions about what will happen to NCRR programs that they rely on or use.

NCRR's National Advisory Research Resources Council (NARRC) this week said that the decision to dismantle 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.

NARRC also has a particular bureaucratic beef, arguing that SMRB has bypassed rules under the NIH Reform Act of 2006. The council says that SMBR is supposed to analyze budgetary and operational consequences of proposed changes, to estimate resource needs, to take into account historical funding levels for certain programs, and to analyze how changes could affect the process of research.

To illustrate the rapidity of the process, Berg explained in his letter this week that he was given less than one full day to respond to the sudden proposal that NIGMS take over the more than $200 million Institutional Development Award (IDeA) Program, which is aimed at enhancing the competitiveness of investigators and institutions by supporting faculty development and research infrastructure at institutions in 23 states and Puerto Rico. Running IDeA would include managing and funding the Centers of Biomedical Research Excellence (COBRE) and IDeA Networks of Biomedical Research Excellence (INBRE) programs.

Berg — who announced in December that he plans to leave NIH in the summer of 2011 to take a position as a vice chancellor at the University of Pittsburgh — said he received the proposal in a phone call at the end of the business day earlier this month and was given until the afternoon of the next day to respond.

Berg said that he agreed to take on the program with hesitation.

"I did so, however, with very little comfort that this was a sound decision since I had not had anywhere near an appropriate period of time to familiarize myself with anything other than the rudiments of the program, to consult with NIGMS staff, or to meet with the staff from NCRR who direct the IDeA program," Berg explained.

NCRR is home to a number of important NIH programs, among them the Clinical and Translational Science Awards Program; the Shared Instrumentation Grants program; the Molecular Libraries Program and its Chemical Genomics Center and Molecular Probe Production Centers Network; the Therapeutics for Rare and Neglected Diseases Program; the National Primate Research Centers; and the Biomedical Technology Research Centers, among others.

But the IDeA program may be one of the trickiest to deal with, which became apparent this month when a group of powerful senators representing states with relatively small research budgets questioned NIH's plans specifically on this program. Senators from Vermont, Montana, West Virginia, North Dakota, Nebraska, and other states sent a letter to Collins primarily highlighting the importance of the IDeA program.

The senators said they were concerned about "timing of the reorganization process," and that the "pace of decision-making has not allowed for a thorough analysis of how this reorganization will impact critical programs including IDeA.

"We ask that NIH proceed cautiously as you consider these organizational changes to ensure important programs such as IDeA are located in permanent institutes or centers where they can continue to succeed," the senators urged.

Under the latest NCRR Task Force recommendations, the CTSA program should relocate to the new NCATS institute because the CTSAs "will serve as a test bed for NCATS activities." They advise that the IDeA program should reside at NIGMS, and that the BTRCs should end up either at NIGMS or at the National Institute of Biomedical Imaging and Bioengineering.

Under the plan, the Science Education Partnership Awards program would be moved to Office of the Director, and the Research Centers in Minority Institutions program would be under the National Institute of Minority Health and Health Disparities.

Also under the NCRR Task force plan, the so-called Infrastructure Entity would include the Extramural Construction programs; the Shared and High-end Instrumentation programs; the Non-human Primate Research Resources; Clinical Research Resources; the Research and Animal Facilities Improvement program, and the Comparative Medicine programs, among others.