AHRQ Institutional NRSA Postdoctoral Comparative Effectiveness Development Training Award (T32)

Letter of Intent Receipt Date: December 15, 2009
Application Receipt Date: January 20, 2010

The purpose of this program is to support the postdoctoral training of health services and clinical researchers who have made a commitment to focus their research on the generation, translation, and dissemination of new scientific evidence and analytical tools in comparative effectiveness. The award will provide two years of supervised study and research for two cohorts of clinical and research doctorates, with one cohort initiating training in the first year of the grant and the second initiating training in the second year of the grant.

Total project period costs cannot exceed $900,000; 3-year project period; 5-7 awards anticipated; 20-page Research Training Program Plan

AHRQ Mentored Clinical Scientists Comparative Effectiveness Development Award (K12)

Letters of Intent Receipt Date: December 24, 2009
Application Receipt Date: January 20, 2010

The purpose of this program is to support the career development of health services and clinical researchers who have made a commitment to focus their research on the generation, translation, and dissemination of new scientific evidence and analytical tools in comparative effectiveness. The award will provide 3 years of supervised study and research for one cohort of clinical and research doctorates.

Annual total costs cannot exceed $850,000; 3-year project period; Total project period costs cannot exceed $2.55 million; 5-7 awards anticipated; 25-page research plan

Program Officer (for both RFAs):

Shelley Benjamin
Office of Extramural Research, Education and Priority Populations
Division of Research Education, AHRQTelephone: (301) 427-1528
E-mail: shelley.benjamin@ahrq.hhs.gov

Take a gander at the budget levels, particularly on the U13 … that will be one heck of a comparative effectiveness shindig.

ARRA-AHRQ Recovery Act 2009 Limited Competition: PROSPECT Studies: Building New Clinical Infrastructure for Comparative Effectiveness Research (R01)

The total costs for a grant awarded under this FOA are expected to range from $1.5 million to $3 million total costs per year. Total costs may not exceed $3 million annually. The duration of the project may not exceed 3 years. The grantee is required to accelerate the work where and when feasible. A maximum of 5 awards will be made. 25-page narrative.

The primary purpose of the PROSPECT (Prospective Outcome Systems using Patient-specific Electronic data to Compare Tests and therapies) Studies will be to advance the quality, depth and scale of the electronic data collection infrastructure as a basis for comparative effectiveness research. The projects will substantially enhance the nation’s ability and capacity to systematically collect prospective data that will inform comparative effectiveness research on diagnostics, therapeutics, devices, behavioral interventions, and procedures used in clinical care, especially in populations typically under-represented in randomized control clinical trials or that have limited access to healthcare, or both, such as patients with multiple co-morbidities, extremes of age, and minorities.

ARRA-AHRQ Recovery Act 2009 Limited Competition: Electronic Data Methods (EDM) Forum for Comparative Effectiveness Research (U13)

The total costs are $4 million over a maximum of 3 years; AHRQ anticipates making one award. 20-page narrative.

The Electronic Data Methods (EDM) forum will convene investigators who are conducting PROSPECT studies on comparative effectiveness of clinical interventions used in priority conditions and populations, other experts in clinical registries, distributed research methods, health information technology and outcomes research, practicing clinicians, representatives from relevant organizations, and other stakeholders as needed. The EDM forum, through a series of meetings and workshops, will identify the challenges to conducting comparative effectiveness research using electronic data, including but not limited to scientific, technical, organizational, clinical, legal, and ethical issues, and challenges related to compliance with HIPAA. The EDM forum will propose realistic solutions to such challenges, or outline a research agenda and/or discussion that will advance resolution of the issues identified by the forum.

For both FOAs:

LOI receipt date: December 18, 2009
Application receipt date: January 20, 2010

Scientific/Research Contact:
Amy Lindinha
Center for Outcomes and Evidence, AHRQ
Telephone: (301) 427-1600
E-mail address: PROSPECTgrants@ahrq.hhs.gov

This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application (includes the preliminary application and letter of intent phases of the program), by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist. This restriction applies unless:

• the communication is purely logistical;
• the communication is made at a widely attended gathering;
• the communication is to or from a Federal agency official and another Federal Government employee;
• the communication is to or from a Federal agency official and an elected chief executive of a state, local or tribal government, or to or from a Federal agency official and the Presiding Officer or Majority Leader in each chamber of a state legislature; or
• the communication is initiated by the Federal agency official.

The NIH issued a notice summarizing the changes to the application packages for submissions on or after January 25, 2010. Most important is this reminder for those planning electronic submissions (i.e., most of you):

Applicants MUST return to the FUNDING OPPORTUNITY ANNOUNCEMENT (FOA), or the reissued Parent Announcement, to download the new application forms for due dates on or after January 25, 2010.

The sample biosketch in the PHS 398 form list is always convenient to have on hand though. The PHS 398 (paper submission) page includes instructions and forms, while you’ll of course find the instructions only for SF 424 electronic submissions (Adobe Forms B).

Have fun.

Yes, OptNet is indeed short for Opportunity Network, which, according to the NIH news release, will be supported in its first year with $10M in ARRA funds. Hmm. Don’t spend it all in one place.

To further explain, this is the Basic Behavioral and Social Science Opportunity Network, which will fund studies of

mechanisms and processes that influence behavior at the individual, group, community and population level. Research results lead to new approaches for reducing risky behaviors and improving the adoption of healthy practices.

… Twenty-four ICs and five programs within the Office of the Director will integrate existing NIH efforts, target research challenges best met collectively and collaborate on new research initiatives in complementary scientific areas. OppNet will also develop a plan for focused multi-year programs across ICs to advance priority topics within b-BSSR [basic behavioral and social sciences research].

… OppNet expects to release these first funding opportunity announcements by December 2009. Starting in Fiscal Year 2011, OppNet will be supported through NIH’s pool of common funds shared among the ICs.

Jeremy Berg (NIGMS) and Richard Hodes (NIA) are driving the bus, with plenty of help from their friends (“a steering committee of IC Directors and with facilitation from the Office of Behavioral and Social Sciences Research”). Watch the OBSSR Website for updates on OppNet as it unfolds.

NIBIB has released the RFA for Phase II (Implementation) of its Quantum Grant Program - aka Medical Moonshots.

Letter of intent due December 22, application receipt date on January 22, 2010 (just misses the Jan 25 transition to enhanced shorter applications, so these use a 25-p research narrative … “typewritten” paper submission no less).

The goal is to achieve a profound (quantum) impact on the prevention, diagnosis, or treatment of a major disease or national public health problem through the development and implementation of biomedical technologies.

Total costs (i.e., direct plus indirect/F&A costs) for any single year (5-y project period) may not exceed $3M. NIBIB expects most applicants to request $1-3M in total annual costs.

Before you get too excited, only 1-3 awards will be made.

NIBIB made 5 awards in the Phase I competition “on stem cell therapies for diabetes and stroke, nanoparticles to help eliminate brain tumors, development of an implantable device to replace kidney dialysis, and a microchip to capture circulating tumor cells for clinical and research purposes” — but anyone can apply for Phase II funding so long as their research plan “demonstrates the potential for a quantum advance by the end of Phase II via substantial pre-clinical data or a first clinical implementation.”

How much of an advance? NIBIB envisions that the “technology being developed would overcome a major, present-day disease or national public health problem (i.e., leading categories of disease burden, high-mortality/morbidity diseases affecting more than 100,000 individuals annually, technologies that revolutionize over 200,000 procedures annually), or change the paradigm of prevention, diagnosis, treatment in the practice of medicine.” In 5 years. I guess $3M a year will do that for you. I can’t wait to read the way cool announcements in NIH Research Matters.

What I want to know is where NIBIB finds reviewers with the vision needed to foresee a paradigm shift and quantum advance in the practice of medicine within the next 5 years … and whether these reviewers are available to take a look at my 401K portfolio.

Lots more detail in the RFA. Happy reading.

Of interest to a select audience … one application per parent grant but no limit on the number of applications from a given institution. The big “have” institutions will have lots of these big core center awards and will no doubt get in line for an extra $1.2M+ for each of these facilities, complements of ARRA.

Today’s notice of Administrative Supplements to Support Core Consolidation provides up to $500,000 in equipment, up to $500,000 for alteration and renovation, and/or up to $200,000 (DC) for other costs such as personnel and supplies. The NIH plans to spend ~$15 million of ARRA funds by September 30, 2010 to support requests submitted in response to this notice. Participating ICs include NCRR (G12 plus all P and U awards), NCI (only Cancer Center Support P30s are eligible), NIAID (only CFAR P30s are eligible), NIAMS (only P30s are eligible), NIDDK (only P30s & P60s are eligible), NIEHS (only P30s are eligible), and NIDA (“particularly interested in consolidation that results in synergistic enhancement of existing research capabilities, while continuing current services”).

The Notice provides full application details. Applications are due January 13, 2010.

Well, they haven’t spent all the ARRA funds yet, as evidenced by the latest FOA to be released:

Building Sustainable Community-Linked Infrastructure to Enable Health Science Research (RC4)
LOI: November 12, 2009
Application: December 11, 2009

NCI, NEI, NHLBI, NHGRI, NIA, NIAAA, NIAMS, NIBIB, NICHD, NIDCR, NIDDK, NIDA, NIEHS, NIMH, NINR, NLM, NCMHD, OWHR, and NCRR are all on board. The NIH plans to fund 30 of these awards, which provide up to a total of $1M for a 3-year period ($1M total for all 3 years, not per year).

Applications are invited from US institutions/organizations proposing to develop or expand needed infrastructures that will fundamentally transform collaboration and communication between academic health centers and local communities. … This RFA is not intended to fund research or evaluation projects, clinical trials, or public health campaigns. …

In this community research infrastructure program, NIH establishes the role of Community Research Associate (CRA), who will be a community representative and serve as a primary liaison facilitating communication and collaboration between the academic health center and the local community. Applicants must identify at least one CRA and include a biosketch. It must be demonstrated and documented in some manner that the CRA can represent the community’s needs and will.

Illustrative examples of potential community-linked infrastructure projects include, but are not limited to:

• Collaborations that develop community organizations’ infrastructure for developing tools and skills for building research portfolios.
• Collaborations that establish or expand community-based infrastructure (i.e. core facilities, equipment, personnel) for collaborative clinical and translational research addressing health disparities in medically underserved areas, including health promotion, disease prevention research and dissemination.
• Collaborations that develop or expand telehealth networks linking academic health centers and health care providers in rural and other medically underserved areas by leveraging existing telehealth and related programs (e.g., HRSA, IHS, USDA and other agencies’ resources) to increase community capacity for clinical and translational research.

One page for specific aims, followed by a 12-page narrative organized as:

Background/Preliminary Studies: State the broad goals of the project and describe how the project may result in research and development innovations that could effectively be linked to long-term improvements and growth in the research enterprise, public health and health care delivery. Include a description of the proposed research-CBO partnership including its history (if any) of prior research collaborations.

Opportunity and Potential Impact: What is the research opportunity, scientific knowledge gap or technology that will be addressed? How broad is the potential impact in science and/or health? Which community(ies) will be affected? What is (are) the size(s) of the community(ies)? Will the potential impact be major?

Approach: How will you attempt to explore or solve the stated research infrastructure problem? How will your rationale and/or approach overcome existing challenges or barriers in the field? If you propose to improve existing approaches to community wellness or to develop new approaches, which needs are being addressed? Which elements of your approach are transformative and have the potential to ensure equity, future capacity and sustainability of your partnership? Provide enough information for reviewers to determine what you are proposing to do, but do not include a detailed science plan.

Timeline, Milestones, Expected Measurable Outcomes and Deliverables: Provide a timeline for the proposed research indicating points where intermediate objectives will be assessed, the measurable outcomes that will be evaluated to assess progress, and the timing and process that will be used to reach decisions regarding the course and direction of the continuing research effort. Possible alternative paths that may be followed at critical junctures in the project plan should be described and indicated on the timeline.

Long Term Sustainability Plan: Applications must include a plan that describes how the infrastructure and services expect to be maintained and supported beyond the initial NIH funded period. The plan should include potential sources of support other than NIH. The level of institutional support and commitment and organizational structure should also be included.

One page for literature cited, 2-page biosketches (up to 10 publications), no supplemental material. Specific contacts are listed for each of the participating ICs.

It’s a bit sad that my first reaction was to cringe when I received this NAS news release excitedly touting the National New Biology Initiative,

a new multiagency, multiyear, and multidisciplinary initiative to capitalize on the extraordinary advances recently made in biology and to accelerate new breakthroughs that could solve some of society’s most pressing problems — particularly in the areas of food, environment, energy, and health. …

The committee used the term “new biology” to describe an approach to research where physicists, chemists, computer scientists, engineers, mathematicians, and other scientists are integrated into the field of biology to create the type of research community that can tackle society’s big problems. “‘The new biologist’ is not a scientist who knows a little bit about all disciplines, but a scientist with deep knowledge in one discipline and a ‘working fluency’ in several,” the report says. To be sure, biologists are already working successfully in many instances with other scientists and engineers. But for collaborations to take advantage of advances in imaging, high-throughput technologies, computational science and technology, and others, a major new initiative is needed, the committee concluded.

The national new biology initiative should have a timeline of at least 10 years and funding in addition to current research budgets, and it should be an interagency effort to reflect the interdisciplinary approach to research, the committee emphasized. The report also underscores the importance of making information technologies a priority in the initiative given that information is the “fundamental currency” of the new biology. …

The report says that by targeting society’s major challenges, the initiative would provide an opportunity to attract students who want to solve real-world problems to scientific fields. The initiative will need to devote resources to interdisciplinary education to support the training of new biologists, the report adds.

You can, as usual, read the report — A New Biology for the 21st Century: Ensuring the United States Leads the Coming Biology Revolution – online for free and download the prepublication PDF.

You can also view a PowerPoint presentation by the co-chairs of the Committee on a New Biology for the 21st Century, Thomas Connelly of the DuPont Company and Phillip A. Sharp from MIT, where you’ll learn that the Initiative’s goals are to “Propel science to a new level” and “Provide solutions to pressing societal problems” and become inspired by the sense of tension and excitement the slides generate:

• A moment of unique opportunity — Current research has brought biology to an inflection point
• An opportunity for New Biology with impact at an unprecendented scale
• New Biology could affect urgent problems
• Mission: sustainable local food production
• Mission: halt and reverse ecosystem damage
• Mission: sustainable alternative to fossil fuels
• Mission: individualized health surveillance and care
• One biology: same science supports all four missions

Wow. So nice to know that “New Biology” is on the case. Wonder what the rest of us have been mucking about doing all these years … in the meantime, possibly yet another grant-writing gimmick to work into my repertoire if they do manage to carve out a mega interagency budget to solve the world’s ills.

UPDATE: As discussed here, the official NIH notice is out about policies governing the shorter page length and modified format for grant applications submitted on and after Jan 25, 2010.

We’ve been told the R01 will drop to 12 pages, with other mechanisms possibly set at half that length. The narrative will be restructured to align with review criteria (significance, innovation, approach), so you’d best stop thinking in terms of the time-honored foursome of every NIH research narrative (i.e., Specific Aims, Background & Significance, Preliminary Studies, Research Design & Methods). Since there is no clear review criteria for preliminary data/progress reports, these may be folded into the Approach portion of the narrative as appropriate.

The recent notice about Changes to the eSNAP PHS 2590 probably foreshadows what’s coming down the pike with regard to biosketches for future NIH submissions:

Another change associated with the peer review initiative is the addition of a Personal Statement to the biographical sketch. The statement is for the senior/key personnel to address why their experience and qualifications make them particularly well-suited for their role on the project. Instructions for the biographical sketch also encourage applicants to limit the list of publications to no more than 15.

This covers the “Investigators” review criteria, and a better description (versus rote facilities, equipment, other resources, et al. boilerplate) of the scientific environment for the specific work to be conducted will no doubt be in order.

Let’s see .. new scoring system, new review process/summary statement format, new application format, shorter page limits, even less preliminary data and methodological detail, condensed biosketches. I’m sure reviewers can’t wait … and CSR must be about to explode. Or implode.

Also of interest for FY10 are some ESI policy changes at NHLBI … and perhaps other ICs:

The special payline policy for non-ESI will be phased out in FY 2010. In addition, ESI applications on which all named principal investigators are ESI investigators that are >5 but <=10 percentile points above the regular R01 payline may undergo an expedited review to resolve comments in the summary statement.

How about some opportunity for rebuttal for anyone within a few percentile points of the “payline” (whatever that is for most ICs)?

A brief observation. This morning, the Washington Post sent out a news alert that “Obama promises more than 600,000 stimulus jobs” this summer. As if we needed another reminder as to a key review criteria for applications for ARRA funding.

Perhaps this would be a good time to remind you that in the NSF Dear Colleage letter that appeared and then disappeared and then reappeared, the Science of Science & Innovation Policy (SciSIP) Program is accepting 2-5 page proposals for RAPID funding that address the outcome of ARRA, such as:

• What was the contribution of the science investment to the creation and retention of jobs?
• What was the contribution of the science investment to science and technology industries?
• What scientific or technological advances were achieved?
• What was the impact on the scientific workforce?

In keeping with the Presidential focus on openness and transparency in government, proposals might also examine and evaluate different approaches to building appropriate platforms for tracking and assessing science investments across the federal government as well as ways to visually convey the information to policy makers and the American public.

Edward Tufte, your country needs you.