02.4.10 by Michelle Kienholz
Cures Acceleration Network Resurfaces
As I noted last spring, NIH Stimulus Patron Arlen Specter introduced the concept of the Cures Acceleration Network (CAN) as part of the NIH Reauthorization Bill of 2009. Last year, this intiative was to be housed outside the NIH (and DHHS), governed by Presidential appointees, and launched at an initial budget of $1B per program area to pay out $15M grant awards.
Nature Medicine now reports on Specter’s slipping the CAN into health care reform legislation with a $500M price tag (but no appropriated funds) and operating within the NIH. Some of the details are the same otherwise.
The network would be overseen by the NIH director, with advice from a board of 24 experts drawn from academia, venture capital firms, government agencies and disease advocacy groups. It would disburse individual grants of up to $15 million per year to speed potential therapies from bench to bedside. Awardees with access to private funds would be required to match every three government dollars with one private dollar. Key to CAN’s functioning would be early and close coordination with the Food and Drug Administration to ensure that a drug’s development meets regulatory requirements.
Still no word on who appoints the 24-member expert board … and no guarantee that Congress will up the NIH appropriation by $500M to absorb CAN. And, of course, no guarantee that Specter’s amendment will survive the conference committee process in its current form (though this initiative would be popular and his now Democratic vote is critical) … or that the legislation itself will survive in any form.
02.2.10 by Michelle Kienholz
Findings of Misconduct in Science
Notice is hereby given that on January 7, 2010, the DHHS Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the misconduct in science findings of ORI in the following case:
James Gary Linn, PhD, former Professor, School of Nursing, Tennessee State University (TSU) committed misconduct in science and research misconduct in research supported by S06GM008092 and G12RR03033. Specifically, ORI found:
- The Respondent knowingly and intentionally falsified and/ or fabricated the data and results of a study in which he purportedly tested the effects of an intervention to reduce sexual risk behaviors in high risk, impaired populations of homeless men with mental illness by reporting false values for variables in Tables 2-5 of Cellular and Molecular Biology 49(7):1167-1175, 2003. In that published article, he falsified the values in Tables 2-5 by altering the values that he had obtained from another author’s manuscript.
- The Respondent provided a CD ROM disc to TSU’s Institutional Research Investigation Committee (RIC) that he claimed contained files supporting his analyses for the article in question but that contained fabricated and/or falsified data.
- The Respondent submitted falsified summary data to the TSU RIC during the TSU investigation and to ORI.
ORI issued a charge letter enumerating the above findings of misconduct in science and proposing HHS administrative actions. Dr. Linn subsequently requested a hearing before an Administrative Law Judge of the Departmental Appeals Board to dispute these findings. However, on November 30, 2009, Dr. Linn withdrew his request for a hearing. On December 18, 2009, the Judge accepted Dr. Linn’s withdrawal and dismissed his request for a hearing.
For 3 years, beginning January 7, 2010, Dr. Linn is debarred from any contracting or subcontracting with any agency of the US Government and from eligibility or involvement in nonprocurement programs and from serving in any advisory capacity to PHS.
02.2.10 by Michelle Kienholz
FY11 Budget Take 1
Quick post with some links to nice Science Insider overviews of Obama’s budget request for the NIH ($32.1B, with 3% increase from FY10) and NSF ($7.4B, with 8% increase from FY10). The NIH news sounds good until you get to:
The pot of money for new and competing extramural grants will fall 0.3% to roughly $4 billion, and the number of these grants will drop by 199 to 9052. And demand for grants could soar because of the many scientists who received temporary, 2-year funding through the $8.2 billion for extramural research that NIH received in the Recovery Act.
Indeed, Collins expects success rates—the chances that a submitted application will be funded—to slide in 2011.
The Chronicle of Higher Education has a great table showing the increase from FY10 to FY11 for individual ICs at the NIH and Directorates at NSF (keep scrolling down past the DoEd listings to “In Other Federal Agencies”). Nature likewise has a summary of who got what (including more detail on NSF).
You can also check out the 114-p Budget in Brief for a summary of all HHS budget components.
Maybe Congress will pass appropriation bills by this time next year … or maybe not.
01.29.10 by Michelle Kienholz
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
01.26.10 by Michelle Kienholz
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
01.22.10 by Michelle Kienholz
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
01.15.10 by Michelle Kienholz
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
01.15.10 by Michelle Kienholz
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
01.12.10 by Michelle Kienholz
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.
01.11.10 by Michelle Kienholz
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
