Archive for January, 2010

FIC ARRA RFA for Global Human Subjects Research Oversight

This one just has Fogarty ( and its typical pittance for budget) plus NIAID, NIDA, & NIMH.

Program to Enhance NIH-supported Global Health Research Involving Human Subjects (S07)
LOI Receipt Date: February 22, 2010
Application Receipt Date: March 22, 2010

FOA invites applications from US institutions for one year of support for resources & activities that will strengthen oversight of NIH-supported human subjects research conducted collaboratively with institutions in low- to middle-income countries.

Direct costs may not exceed $50,000 for a one-year project period … NO F&A (indirect) COSTS ALLOWED … 12-13 awards anticipated.

12-p Research Strategy narrative

Applications will be supported to develop collaborative processes and training as well as jointly used tools and systems to address the specific needs and capabilities for improved review and monitoring of protocols for NIH-supported research conducted at a developing country institution. The grants will provide one year of support for an applicant US IRB to collaborate with a developing country counterpart IRB that reviews some of the same NIH research protocols to do any of the following:

  • Develop sustainable electronic systems, procedures and communication methods to facilitate collaboration on review and monitoring of protocols sent to both IRBs;
  • Increase administrative, scientific, socio-cultural and ethical competencies of IRB members and staff related to research reviewed by both IRBs through joint workshops, short-term exchange and training activities;
  • Create sustainable international research ethics training resources for global health researchers at both institutions to improve research protocols and practices involving human subjects in the collaborating developing country.

Scientific/Research Contact:
Barbara Sina, PhD
Telephone: (301) 402-9467
Email (preferred): sinab@mail.nih.gov

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Fogarty ARRA Opp

with buy-in from NIBIB, NIDA, NIMH, and NINR …

Recovery Act Limited Competition: Framework Programs for Global Health Signature Innovations Initiative (R24)

LOI Receipt Date: February 22, 2010
Application Due Date: March 22, 2010

Direct costs for 1-year project period cannot exceed $250,000 for single applicants or $400,000 for consortia; 6-10 awards anticipated

This FOA seeks applications from US institutions and their partners to enhance the infrastructure and opportunities at the participating institutions for training postdoctoral investigators to carry out innovative, multidisciplinary research in Global Health. The initiative emphasizes hands on, problem solving, and collaborative approaches and may require the development of new training models and new partnerships within and beyond the university community. In addition, all proposals should address the intent of the ARRA to preserve and create jobs, promote economic recovery in the United States, accelerate the pace of scientific discovery, and spur technological advances in science and health.

Scientific/Research Contact:

Flora Katz, PhD
Telephone: (301) 402-9591
Email (preferred): katzf@mail.nih.gov

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AHRQ ARRA Funding Opps Continue

Yet more big-budget ARRA largesse from AHRQ …

Enhanced Registries for Quality Improvement and Comparative Effectiveness Research (R01)

Application Due Date: March 29, 2010

Total costs of $2-4M per year (yes, million per year) for up to 3 years – total budget cannot exceed $12M
PI must devote a minimum of 20% effort
30-p research narrative

The goal of the FOA is to enhance the electronic clinical capability of an existing registry for two purposes: 1) create and analyze valid data for comparative effectiveness research, and 2) enhance the ability to monitor and advance quality improvement of clinical care. The applicant will clarify the limitations of the existing registry, specify which limitations will be addressed by the proposal, and how the enhanced registry can rapidly and comprehensively address issues aimed at improving quality of care and the comparative effectiveness of clinical interventions. A secondary goal of this FOA is to address issues relevant to the scalability and sustainability of registries that improve quality of care and that can conduct comparative effectiveness research.

Scalable Distributed Research Networks for Comparative Effectiveness Research (R01)

Application Due Date: March 10, 2010

Total costs for a 3-year project cannot exceed $8.31M
PI must devote a minimum of 20% effort
30-p research narrative

The goal of this FOA is to enhance the capability and capacity of electronic health networks designed for distributed research to conduct prospective, comparative effectiveness research on outcomes of clinical interventions. The clinical interventions include, but are not limited to, diagnostics, therapeutics (drugs and biologics), medical devices, behavioral interventions, and surgical procedures used in clinical care.

Program contact for questions related to either RFA: Amy Lindinha, EnhancedRegistrygrants@ahrq.hhs.gov

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RFAs from ARRA & NCMHD

First, yet another specialized ARRA funding opportunity, and then an unusual NCMHD R21 opportunity for Innovative Faith-Based Approaches to Health Disparities Research. For the ARRA K12ish FOA, NCI, NCRR, NCCAM, NIA, NIAAA, NIAID, NIAMS, NIDA, NIDCR, NIDDK, NIMH, NINDS, NINR, and, interestingly, NLM are on board.

Institutional Comparative Effectiveness Research Mentored Career Development Award (KM1)

Application Due Date: March 25, 2010

The mentored career development approach will permit research-intensive institutions to develop an interdisciplinary environment catering to the needs of diverse populations of scholars including (but not limited to) those with backgrounds in medicine, pediatrics, surgery, dentistry, nursing, allied health, pharmacology, health care administration and management, clinical research design, epidemiology, biostatistics, biomedical informatics, economics, quality improvement, modeling systems, ethics, behavioral science, engineering, and law. Scholars supported through this program could include recent doctoral graduates who are entering the research workforce as well as established investigators who are seeking to extend their expertise or experience in CER in a mentored environment.

Total costs cannot exceed $2,500,000 for the 3-year project period; 8-10 awards are anticipated

The narrative cannot exceed 25 p in addressing: Background; Program Plan; Recruitment and Retention to Enhance Diversity; and Plan for Instruction in the Responsible Conduct of Research. Please see RFA for appropriate program contact.

Innovative Faith-Based Approaches to Health Disparities Research (R21)

LOI Receipt Date: February 9, 2010
Application Due Date: March 17, 2010

Standard R21 budget ($275k-2y)/narrative length (6 p) – up to 8 awards are anticipated

NCMHD intends to cultivate empirical, formative, evaluative and transdisciplinary intervention research on faith-motivated initiatives, concepts and theories that have played an important role in addressing health disparities. The focus on exploratory, evaluative and/or intervention research will allow studies to assess the impact of faith-based initiatives and programs in health disparity populations; formulate hypotheses about the role and unique characteristics of faith communities in addressing health disparities; design targeted interventions; and track the efficacy of community and faith-based or faith-motivated programs that result from a participatory approach to research in the community.

Scientific/Research Contacts:

Irene Dankwa-Mullan, MD MPH
Acting Director, Office of Innovation and Program Coordination, NCMHD
Telephone: (301) 402-1366
Email: dankwamullani@mail.nih.gov

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US Biomedical Research Funding Trends

Very briefly, since I need to get to bed for eye surgery tomorrow (this morning, actually), JAMA today published a report on the Funding of US Biomedical Research, 2003-2008. Bottom line: we’re not imagining declines on every front.

The results as summarized in the abstract:

Biomedical research funding increased from $75.5 billion in 2003 to $101.1 billion in 2007. In 2008, funding from the National Institutes of Health and industry totaled $88.8 billion. In 2007, funding from these sources, adjusted for inflation, was $90.2 billion. Adjusted for inflation, funding from 2003 to 2007 increased by 14%, for a compound annual growth rate of 3.4%. By comparison, funding from 1994 to 2003 increased at an annual rate of 7.8% (P < .001). In 2007, industry (58%) was the largest funder, followed by the federal government (33%). Modest increase in funding was not accompanied by an increase in approvals for drugs or devices. In 2007, the United States spent an estimated 4.5% of its total health expenditures on biomedical research and 0.1% on health services research.

After a decade of doubling, the rate of increase in biomedical research funding slowed from 2003 to 2007, and after adjustment for inflation, the absolute level of funding from the National Institutes of Health and industry appears to have decreased by 2% in 2008.

Industry may still be the biggest funder of biomedical research in the US, but separately, although focused on COI issues, Nature Biotechnology flagged a report citing declining industry support for academic researchers.

The JAMA authors (Dorsey et al.) begin their comments by observing that:

While the decrease has occurred at a time of intense economic instability and financial upheaval in the world’s financial markets, the rate diminished even before the events of 2007-2008. Funding from the NIH and industry, which includes pharmaceutical, biotechnology, and medical device firms, slowed from 2003 to 2007 and, after adjusting for inflation, has decreased in 2008.

Oof. The accompanying JAMA editorial by Thomas Boat notes the obvious:

The data … make a strong case for more consistent, coordinated, data-driven, and sustainable decisions regarding biomedical research funding.

Boat also points out that institutions are not making up the difference in hard money:

… all-source (extramural) funding of biomedical research increased 14% during 2003-2007, while total research expenditures by colleges and universities expanded at half that rate (7.4%). These rates suggest that intramural [institutional] funding of research in academic settings fell behind in the mid 2000s, a situation that does not bode well for the vibrancy of academic research programs.

Amen Brother Thomas.

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Yet Another ARRA CER FOA

This big-budgeted FOA comes right from the top – the Office of the Secretary of Health & Human Services (NIH’s CSR is handling the review):

ARRA OS: Recovery Act 2009: Accelerating Adoption of Comparative Effectiveness Research Results by Providers and Patients (R18)

Application Due Date: March 11, 2010
$300K to $3M per award (no more than $1M in total costs per year for up to 3 years); 5-10 awards anticipated; 12-p Research Strategy – special abstract instructions plus only 10 pubs on 2-p Biosketch and only 1 p of literature cited

This FOA invites grant applications from organizations that propose to develop and test strategies to improve the adoption of existing CER information and incorporate these findings into practice in both the public and private sector. Activities for this funding opportunity may include the following:

  • Development and implementation of evidence-informed, innovative interventions to increase adoption of CER by providers and translate this evidence into practice (e.g. within a health care network).
  • Development and implementation of evidence-informed, innovative interventions to increase adoption of CER evidence by patients and consumers within a health care network and measure behavior change.
  • Development and testing of incentives and mechanisms for translation and adoption of CER evidence into practice. Examples could include use of economic or other incentives or disincentives, addition of electronic health record (EHR) functions for this purpose, or other innovative approaches.
  • Application or comparison of strategies or tools (e.g. QI program, electronic tool) to implement translation and adoption activities targeting providers within a health care network or organization. Novel strategies or tools for comparison are encouraged.
  • Application or comparison of strategies or tools to implement translation and adoption activities targeting patients within a health care network or organization.
  • Collection of evidence on adoption strategies in practice settings targeting providers and/or patients. Analysis of this evidence should demonstrate which strategies were successful and why, as well as which strategies are successful under which circumstances.
  • Collection and analysis of evidence on the cost-effectiveness of adoption strategies and the system-wide implementation of same.

Scientific/Research Contact:

Patrick Conway, MD, MSc.
Office of the Assistant Secretary for Planning and Evaluation
Office of the Secretary, US DHHS
Phone: 202-690-7858
Email: Patrick.conway@hhs.gov

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FY10 ARRA Supplements

An NIH Notice reminds the scientific community that some limited opportunities for Administrative and/or Summer Research Experience ARRA supplements remain open.

NCIAdministrative (Jan 22, only to specific U10 & U01 programs)

NIAID – Administrative & Summer Research Experience

NIAMSSummer Research Experience

NIEHSAdministrative & Summer Research Experience

NIMHAdministrative

NINRAdministrative & Summer Research Experience (March 19 for both)

NLMAdministrative (Feb 15) & Summer Research Experience (April 1)

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NIH FY10 Fiscal Policies

The NIH gave notice of the FY10 Fiscal Policy for Grant Awards now that its $31B budget (2.3% increase over FY09) is in place. It’s not entirely business as usual.

The goal is to fund 9,200 new and competing RPGs (average cost 2% higher than that in FY09) and at least 1,650 new investigators.

For FY10, only a 2% (vs 3%) inflation allowance will be permitted for non-competing (Type 5) awards. However, this policy does not apply to projects supported by ARRA or to Ks, Fs, Ts, or SBIR/STTRs. NRSAs (Fs, Ts) will receive a 1% increase in stipend levels.

The NIH Director’s Innovator Awards (i.e., Junior Pioneer or DP2) will continue with funding from the Common Fund, and K99s will be implemented as in previous years.

However, the NIH Directors Bridge Award (R56) will be suspended in FY10, though ICs will be permitted to use their own appropriated funds for this purpose (i.e., provide limited support to maintain projects just outside the payline).

A separate notice bumps up the FY10 salary cap to $199,700, and another lists the legislative mandates in the FY10 appropriations omnibus bill (e.g., no disseminating false data, no forgetting to acknowledge federal funding, no using federal funds for lobbying, distributing sterile needles, abortions [specified exceptions], human embryo research, promoting legalization of controlled substances, or contracts to contractors who have not paid all their taxes).

Oh, and you get 5 (vs 2) days to correct your electronic applications during the entire Cycle 1 submission period (Jan 25-May 7, 2010).

Remember too that this is the last calendar year to submit any grandfathered A2 applications (no A2s will be accepted after Jan 7, 2011).

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Latest from OppNet – ARRA & Otherwise

Four competitive revision (supplement) opportunities from OppNet, each of which must propose new research objectives and aims outside of the scope of the parent award (see notices for details & application instructions). For each opportunity, direct costs cannot exceed $150,000 for a maximum of 1 y project period. 20-30 awards are anticipated in response to the first 3 (ARRA-funded) notices, 5-10 awards in response to the last (non-ARRA) notice listed in this post. Letters of intent are all sent to:

William N. Elwood, Ph.D.
Office of Behavioral and Social Sciences Research
Office of the Director, NIH
31 Center Drive, Suite B1-C19 (MSC 2027)
Bethesda, MD 20892-2027
Telephone: 301-402-0116
Fax: 301-402-1150
Email: william.elwood@nih.hhs.gov

Recovery Act Funds for Competitive Revision Applications (R01, R03, R15, R21, R21/R33, and R37)
LOI Receipt Date: January 18, 2010
Application Due Date: March 2, 2010 (or maybe February 17, 2010 … conflicting dates in the notice)

Recovery Act Funds for Competitive Revision Applications (R01, R03, R15, R21, R21/R33, and R37) for HIV/AIDS-related Research
LOI Receipt Date: February 16, 2010
Application Due Date: March 25, 2010 (or maybe March 15, 2010)

Recovery Act Funds for Competitive Revision Applications for SBIR/STTR Grants (R43/R44 and R41/R42)
LOI Receipt Date: February 16, 2010
Application Due Date: March 25, 2010 (or maybe March 15, 2010)

HIV/AIDS Funds for Competitive Revision Applications (R01, R03, R15, R21, R21/R33, R37) for HIV/AIDS-related Research
LOI Receipt Date: April 7, 2010
Application Due Date: May 7, 2010

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ARRA Mentored Mid/Senior-Career Development RFA

Yet another unique offering with ARRA funds … this one a little less extravagant:

NIH Basic Behavioral and Social Science Opportunity Network (OppNet) Short-term Mentored Career Development Awards in the Basic Behavioral and Social Sciences for Mid-career and Senior Investigators (K18)

Letters of Intent Receipt Date: January 20, 2010.
Application Due Date: February 18, 2010

Two categories of candidates are targeted: (a) biomedical or clinical researchers with little experience in basic behavioral and social sciences research (b-BSSR) who seek training with a well established b-BSSR investigator in order to explore the introduction of b-BSSR into their research programs; and (b) investigators in the basic or applied behavioral and social sciences who wish to build new components or domains of basic-BSSR into their research programs.

Candidates must identify one or more mentors with extensive research experience in an appropriate domain or discipline, who are well-qualified and willing to sponsor the short term research career development experience. It is expected that the proposed career development plan will represent a novel extension of the research of the candidate. In most cases, the candidate and the proposed host laboratory/research program will not have any previous research collaborations, but candidates may propose such arrangements with justification as to why this program will facilitate career development that could not be achieved solely through a research grant mechanism.

  • Funding may be requested for between 3-12 months.
  • Budget proposals are limited to $50,000 per year for research support. These funds may be used to cover the cost of tuition, technical support, personnel consultant fees for mentor, travel and housing at a host institution, but not living expenses.
  • All candidates must devote a minimum of 25% but no greater than 50% of full-time professional effort. The total salary provided by the award will be prorated based on a full-time, 12-month staff appointment and the support period requested, up to the maximum legislated salary level.
  • This program will provide up to $20,000 in direct costs for research development support to cover career enhancement training experiences, such as tuition and fees for short-term courses, consultant fees, travel to scientific meetings, and research related costs, primarily supplies and technical services. The award will also provide fringe benefits on the calculated base salary at the established institutional rate.

Program officers for this trans-NIH initiative are listed by participating IC.

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