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UPDATE: NIH Answers Questions, Concerns on New Translational Sciences Center

This article has been updated to include comments from NARRC members.

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – As they develop plans to create a new translational research institute at the National Institutes of Health, which will strip away some large programs from the National Center for Research Resources and will lead to its demise, NIH officials also are working to decide what will be done with NCRR's remaining parts.

The recently announced plan to create a center to support, foster, and catalyze translational research has stirred concerns among grantees and institutes that receive NCRR support about the future of their funding, their jobs, and the research programs that depend heavily on the center.

Seeking to assuage these worries, a task force working under NIH's Scientific Management Review Board to make plans for the National Center for Advancing Translational Sciences (NCATS) held a series of teleconferences with NCRR stakeholders over the past week, culminating today with a presentation at the National Advisory Research Resources Council meeting.

It became evident soon after the plan to create NCATS was approved last month that NCRR, which received funding of $1.25 billion in 2010, would be broken up and that one of its flagship programs, the Clinical and Translational Science Awards (CTSA) program, would be relocated to the new center.

At the meeting today and in conference calls over the past week, NIH Principal Deputy Director Lawrence Tabak attempted to quell some worries, saying repeatedly that NCRR's programs will be moved, not destroyed, and that their budgets and personnel will move with these programs.

As GenomeWeb Daily News reported last week, a task force led by Tabak has issued a straw model of where the NCRR programs may end up, including several programs that support genomics and proteomics technologies.

Under the mock-up, the Shared Instrumentation Grants and High-End Instrumentation grants programs, the mass spectrometry P41 grants, and the Biomedical Research Technology Centers (BRTCs), will be transferred to the National Institute of General Medical Sciences. NIGMS also will take over the non-primate organism programs, under the proposed plan.

NCATS also is expected to include some of the activities currently operating under the National Human Genome Research Institute, according to a statement released by NIH Director Francis Collins yesterday, although the straw model does not specify which programs could be affected.

Tabak reiterated today that the straw model is "a planning document which we fully expect to change before [we] provide recommendations" to the NIH director. "The whole purpose of putting this up and out into the community was to have something to focus discussion on, rather than just have an unstructured discussion," he added.

In his statement yesterday, Collins said that a recent New York Times article about NCATS contained some "misleading statements" that may have contributed to worries among stakeholders, and he wanted to "set the record straight."

"Those statements suggest that a much larger shakeup of NIH is underway than is actually contemplated," Collins said.

"NCATS is not intended to be a drug company. It is a facilitator of translational research across the NIH and complementary to translational research already being conducted and supported on a large scale in the individual NIH Institutes and Centers," Collins continued.

Collins said that the final budget for the new center is unknown, but he explained that it largely will be "the sum of the imported programs" and that "there are no plans to cannibalize the budgets of other programs" or NIH entities. He said he expects that it will be "an amount much smaller than the several billion dollars currently being spent on translational research by existing Institutes and Centers.

Collins offered that NCATS will "bring several existing efforts together in new ways to enhance the ability of all NIH Institutes and Centers to perform research that leads to the development of drugs, diagnostics, devices, vaccines, and strategies for prevention.

"We are working together to develop important details of these plans and are gathering information from a wide range of internal and external stakeholders," he added.

Under the straw model, the CTSA program, which NCRR has planned to expand to eventually fund 60 centers with up $500 million per year, would move to the NCATS, and the Imaging P41 grants program will be shifted to the National Institute of Biomedical Imaging and Bioengineering

Several of NCRR's programs have yet to be designated permanent homes by the task force, and for the purposes of the straw model they will be housed under an interim infrastructure unit run by the Division of Program Coordination and Strategic Initiatives, Tabak explained today.

These include the Extramural Construction grants; National Primate Research Centers; the Institutional Development Awards program; the Science Education Partnership Awards; and three primate research and resource centers.

Tabak said that the "fundamental principle" the task force is operating on will be to keep NCRR staff with the programs that they are working on already, while "recognizing that some people multitask" and work in more than one area.

"I'd like to emphasize that all NCRR staff will have positions; they may not be the same job but they will have comparable positions," he added.

The NCRR task force will make its recommendations by February 23. A preliminary NCATS working group will make recommendations to the NIH Director by March, and the proposed staff changes are set to take effect at the beginning of Fiscal Year 2012, which begins in October 2011.

During its outreach to stakeholders through today's meeting, conference calls, and a public comment web page (which has received more than 1,100 comments), NIH has heard a large number of questions about the proposed center.

One central question asked of Tabak today is why NCRR must be dissolved in order to create the NCATS center. He explained that once the decision was made to move the CTSA program to NCATS, what remained at NCRR was a mixture of some relatively unrelated programs.

"You ask yourself the question: 'If given the opportunity with a blank sheet of paper would you recreate the adjacencies that exist absent the CTSA within the NCRR program? Given the opportunity to have a blank sheet of paper, to place technology development programs in structural biology in adjacency to the program that is responsible for the so-called Chimp Haven?' I wouldn't. That just doesn't make scientific sense to me," he said.

National Advisory Research Resources Council member Mark Lively told GenomeWeb Daily News after the meeting ended that he disagreed with Tabak's 'blank sheet' view of NCRR's programs, and that he was "looking at it all from the wrong direction."

"In fact, NCRR evolved from the need to have a place to put infrastructure and research resource programs together. Those by definition will disparate, they'll be different. They are going to be animal resources, and not just primates, they have the zebrafish, mice, and rats," said Lively, who is director of Wake Forest University's Protein Analysis, DNA Synthesis, and DNA Sequence Analysis Core labs.

Tabak is "trying to say it's an illogical patchwork quilt," he added. "Instead, it's a collection of resources that benefit the extramural funding effort of the other $25 or $27 billion that NIH puts out on the street every year … The point is, we're providing resources in a way that's not tied to the mission" of any one NIH institute.

Some NARRC members also had questions about the timing of the process that took place in the decision to create NCATS, in particular why the stakeholder and public outreach efforts came after the decision to create the center and dissolve NCRR was already made. Similarly, another council member suggested that it was unusual to not have a plan already in place when making a large decision such as the elimination of an institute and creation of another. And another council member questioned the fast-track nature of the planned timeline — to have NCRR dissolved and parts of the new center in motion by October of this year.

These concerns surrounding timing, process, and speed of the NCATS efforts are understandable to Lively.

"The question that we keep asking them is: 'Why does it have to happen so rapidly?,' and, 'Why was there so much, at least initially, so much secrecy or lack of information?'" said Lively. "I think we're all concerned about the process, and we really haven't gotten any significant answers … that explain why they did things this way," he continued.

Lively guesses that the reason NIH leadership is moving so swiftly on the program is self-evident in Collins' remarks about the value of a translational research center, and not that NIH leadership is operating on a hidden agenda.

"I think they're hurrying it because Dr. Collins wants it to happen and he wants it to happen very rapidly. We are just concerned that they pushed too rapidly and that sufficient attention hasn't been given to details," he said.

Tabak did not offer details in answering those questions, but said simply that NCATS "represents one of [Collins'] high priorities."

"He believes that this is crucially important, and when you have something that is this important, you move forward," Tabak said, without providing further details on the timeline of the decisions.

One of those who asked Tabak about the SMRB's process and planning of the NCATS and its ramifications on NCRR was NARRC member Mark Pauly.

"I did not feel that I got a convincing answer to my question about why NCRR was abolished before plans were put in place about what would replace it," Pauly, a professor of Health Care Management at the Wharton School of the University of Pennsylvania, told GWDN in an e-mail the day after the meeting.

"The [straw model] presented hardly constitutes a finished plan or even a thought-through plan for finishing, based on my experience in looking at substantial reorganizations such as this. Homework has not been done," he said.

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