Last month, the Scientific Management Review Board (SMRB) recommended the creation of a new National Center for the Advancement of Translational Sciences (NCATS). They have also recommended merging programs from NIAAA and NIDA into a new IC focused on addiction research. Pretty powerful stuff from the new kid on the block.
The SMRB was authorized by the Great Zerhouni-era NIH Reform Act of 2006 (signed into law in January 2007), was chartered in Aug 2007, had its membership announced in 2008, and met for the first time in April 2009. According to its charter:
The purpose of the SMRB is to advise the NIH Director and other appropriate agency officials, through reports to the NIH Director, on the use of these organizational authorities and identify the reasons underlying the recommendations.
… Not less than once each 7 years, … the Board will (1) determine whether and to what extent the organizational authorities should be used; and (2) issue a report providing the recommendations of the Board regarding the use of the authorities and the reasons underlying the recommendations.
So the SMRB issues reports. How are they told to discharge this duty, at least with regard to recommended organizational changes?
… the Board will (a) analyze the budgetary and operational consequences of the proposed change(s); (b) take into account historical funding and support for research activities at national research institutes and centers that have been established recently relative to national research institutes and centers that have been in existence for more than two decades; (c) estimate the level of resources needed to implement the proposed changes; (d) assume the proposed changes will be made and make a recommendation for the allocation of the resources of NIH among the national research institutes and national centers; and (e) analyze the consequences for the progress of research in the areas affected by the proposed changes.
In issuing a report on one or more specific contemplated organizational issues, the Board will consult with (1) the heads of national research institutes and national centers whose directors are not members of the Board; (2) other scientific leaders who are officers or employees of NIH and are not members of the Board; (3) advisory councils of the national institutes and national centers; (4) organizations representing the scientific community; and (5) organizations representing patients.
The SMRB has even issued a report on its report-generating process, which itself notes the importance of conducting risk-benefit analyses and examining the broader impacts (not in the NSF sense) of each option for change. So, of course this is how they approached the ginormous responsibility of proposing an entirely new Center.
At the Dec 7 meeting, Collins explained that the TMAT working group was charged to assess only the potential value of a new IC focused on translational medicine – not the potential consequences of creating this new entity. He and Arthur Rubenstein emphasized the need for further deliberation of the potential consequences should a new IC be proposed. Indeed, during the public comment period and in its submitted letter, FASEB urged that the potential consequences be examined before any recommendation be made to establish a new IC (the bureaucratic process of which could in fact delay progress on translational research).
Then what to make of the next agenda item, presciently titled, “The NIH Clinical Center and the Proposed New Center: Opportunities for Partnership” by Director John Gallin. Opportunities for partnership with a Center that had not yet been formally proposed?
Well, not to worry. Just prior to Gallin’s presentation, a motion was introduced that:
- A new translational medicine and therapeutics center be created as recommended in the TMAT Working Group Report;
- The Board endorse and support the NIH’s commitment to undertake a more extensive and detailed analysis through a transparent process to evaluate the impact of the new Center on other relevant extant programs at NIH, including NCRR; and
- The NIH report their findings to the SMRB at its next meeting in approximately 3 months.
With this motion on the table and the clear intention to rapidly approve it, Jeremy Berg quickly asked the obvious question: did the TMAT Working Group consider simply restructuring NCRR to accomplish the desired scientific goals?
Rubenstein indicated that “I think almost by default we did that” and suggested the group quickly came to consensus that a new organization was needed to overcome pharmaceutical company problems and Congressional interest in the CAN. Stephen Katz confirmed the group held no in-depth discussion of such an option. How reassuring.
End of discussion. No one else on the SMRB had any questions or concerns. The motion was brought up for a vote … only Jeremy Berg’s hand went up as opposed (and I got the impression that Augustine almost forgot to ask if there were any “nays”).
In a conference call less than 48 h later, CTSA PI James Heubi (U Cinn) found it “unfortunate” that he, as an NCRR Advisory Council Member, had not been part of the TMAT Working Group discussions. Considering again their charter and operating guidelines, one wonders with which stakeholders the SMRB consulted, if not the likes of NCRR Advisory Council members, particularly one who is also a CTSA PI.
Nonetheless, in his interview with Nature, Collins reports that:
The SMRB took a comprehensive look at the situation and concluded that the scientific opportunities are here now.
A comprehensive look? Based on some global concepts presented in September (where the focus was on the NIAAA-NIDA merger) plus one working group PowerPoint presentation by Rubenstein in late November? How many of you out there were consulted for stakeholder input on such a major (and abrupt) change at the NIH?
(With only 3 months allocated to study potential impacts, you should not delay in registering any comments you have on the new center and/or the fate of NCRR.)
And how much deliberation on the potential consequences can realistically be expected if NCATS is already a ~$650M line item in the FY12 budget?
These questions are important not only for this situation but also for the future operation of the NIH. If such major changes can be implemented so quickly with such little input beyond “working” group members, what else might the SMRB do on behalf of NIH Directors seeking to push through special initiatives?
Of course, if NIDA and NIAAA are merged and NCRR is mothballed (its programs scattered among other ICs), Collins will have an extra slot to fill. Nominations for the next IC anyone?