Notice Number: NOT-AR-15-010

Key Dates
Release Date: February 10, 2015
Response Date: New Date April 27, 2015 per issuance of NOT-AR-15-017. (Original Date: March 27, 2015)

Related Announcements
March 24, 2015 - Notice of Extension of the Response Date for NOT-AR-15-010. See Notice NOT-AR-15-017.

Issued by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

The purpose of this RFI is to solicit input from the community that will inform the NIAMS about critical aspects related to the structure and function of future core centers in support of clinical research within the mission of the NIAMS.

Background

In fulfilling its mission to support research and research training, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) employs a number of support mechanisms. These include various types of research projects; career development programs, institutional training grants, and individual training fellowships; and a number of center grant mechanisms. The center grants are interrelated to, and interdependent upon, all of the other support mechanisms. NIAMS Centers offer a vehicle for integrative investigation in NIAMS mission areas ripe for such an approach.

NIAMS periodically reviews the programs it funds to ensure that taxpayer dollars are used efficiently to promote the best possible science. In so doing, the Institute seeks input provided by the scientific community toward the optimal development and use of publicly funded programs and resources. NIAMS recently undertook an evaluation of its Centers program to ascertain whether the current configuration of Centers meets the needs of the NIAMS scientific community, given the rapid evolution of biomedicine.

Recently, NIAMS formed a Centers Evaluation Working Group (CEWG) to advise the Institute as to how the Centers program could be more responsive to current research needs and opportunities. The CEWG concluded that NIAMS should allow flexibility and dynamism in the design, structure, and conduct of its Centers, to accommodate the variable needs of NIAMS research areas that differ with respect to investigator community, resource availability, and knowledge depth and breadth.

The CEWG recommended that future Centers should address a set of common goals. These include promoting interdisciplinary basic, clinical, and health services research; facilitating the sharing of important resources and promoting their visibility; preserving methodological excellence; and fostering training of future generations of researchers. The CEWG believed that adhering to these goals will transform NIAMS Centers and allow the scientific community to assemble integrated, synergistic groups of investigators who will drive innovation and technical advancement toward improving health in all NIAMS mission areas.

Core Resources for Clinical Research
The NIAMS Multidisciplinary Clinical Research Centers (MCRC) were established in 2001 to promote clinical, epidemiological, and health services research. Each MCRC consists of a Methodology Core and separate research projects. The MCRC have been successful in fostering the use of advanced methodologies to design clinical studies and perform statistical analyses in NIAMS mission areas, resulting in ground-breaking clinical research. Indeed, the areas of study supported by MCRC are now thriving and in less need of a direct stimulus. Furthermore, despite the ongoing importance of these areas of research, more recently the connectivity between MCRC Methodology Cores and research projects has been variable. NIAMS has perceived a problem in applications for MCRC funding in the dissociation in quality between proposed Methodology Cores and research projects, at least as judged by peer review.

The CEWG observed that Methodology Cores continue to play an important role in fostering clinical research and collaborations. A critical mass of methodologists, working alongside subject-matter experts, can uniquely create a culture of research that enhances rigor, promotes creativity and discovery, and fosters training. Methodology Cores create an environment of sophisticated study design and analysis for the investigation of NIAMS-related diseases, and they also play an important role as the glue that binds together collaborative groups of clinical and epidemiological researchers within an institution. The CEWG concluded that with the support of the Methodology Core and Pilot & Feasibility projects, investigators would be able to develop successful clinical research applications for independent funding.

The CEWG encouraged the NIAMS to preserve investigators flexibility in the design of Centers that include Methodology Cores to best accommodate the needs and opportunities of their respective institutions.

Based on these recommendations, the NIAMS is now re-designing its program for support of Core Centers for Clinical Research.

Information Requested

Through this Request for Information (RFI), NIAMS invites researchers in academia and industry, members of scientific or professional organizations, and other interested members of the public to provide comments from their perspective on core centers for clinical research in arthritis, musculoskeletal and skin diseases.

We also welcome input that includes, but is not limited to, the following topics:

• Input on key structural components of future core centers for clinical research (CCCR)
• Suggestions as to how CCCR generally should be defined, and the types of flexibility in the structure or functions of the cores that could improve efficiencies and enhance the use of most advanced and rigorous approaches to clinical research
• Input on whether CCCR individually should have a defined focus or a broad mission to support different clinical research needs, and whether they should serve as local, regional or national resources
• Approaches to integrate new, innovative and emerging scientific methodologies into advanced clinical methodology cores
• Suggestions for avenues for integration and complementarity of functions among cores at different institutions
• Approaches to integrate the functions of the centers with CTSAs
• Approaches to build a dynamic set of pilot and feasibility (P&F) projects within the new clinical core center
• Approaches to building a network of centers that can take on an emerging, public health question and provide critical data and analysis to inform future research and policy.

How to Submit a Response

Responses to this RFI must be submitted electronically by email to the following address: [email protected]. Responses will be accepted until March 27, 2015.

Responses to this RFI are voluntary. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response.

This request is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States Government. The NIAMS or the NIH will not make any awards based on responses to this RFI, nor will the NIAMS or the NIH otherwise pay for the preparation of any information submitted or for the Government's use of such information.

The NIAMS will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Inquiries

Please direct all inquiries to:

Justine Buschman, M.S.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-496-4811
Email: [email protected]