ARRA Pathfinder Opportunity
03.5.10 by Michelle Kienholz
Not quite hiking the Appalachian Trail …
The NIH Director’s ARRA Funded Pathfinder Award to Promote Diversity in the Scientific Workforce (DP4)
LOI: April 5, 2010
Application: May 4, 2010
Total costs for 3-year project may not exceed $2M – up to 5 awards to be made
This new FOA introduces a new research grant program to encourage exceptionally creative individual scientists to develop highly innovative and possibly transforming approaches for promoting diversity within the biomedical research workforce. To be considered highly innovative, the proposed research must reflect ideas substantially different from those already being pursued or it must apply existing research designs in new and innovative ways to unambiguously identify factors that will improve the retention of students, postdocs and faculty from diverse backgrounds. Awardees must commit a major portion (generally 30% or more) of their research effort to activities supported by the Director’s Pathfinder Award and the proposed research must be endorsed by the highest levels of institutional management.
Letters of reference are an important component of the Director’s Pathfinder application. Applicants must arrange to have 3 (and no more than 3) letters of reference submitted on their behalf.
Description of no more than 1 page of the applicant’s single most significant publication or research accomplishment. Applicants should submit one single accomplishment, not a summary of several accomplishments, multiple publications, or background narratives. Publications or other documents will not be accepted.
In 6 pages maximum (Research Strategy upload), describe the applicant’s innovative vision for addressing diversity within the biomedical research workforce, the importance of this problem on an institutional and a national level, and the applicant’s qualifications to engage in groundbreaking research related to workforce diversity. No detailed scientific plan should be provided since the research plan is expected to evolve during the tenure of the grant. The essay should include the following sections in the order given: Science Area, Project description, Evidence of innovativeness, How does the planned research differ from your past or current work, Suitability for Director’s Pathfinder program
References are not required but if included must fit within the 6-page limit. Figures and illustrations may be included but must also fit within the 6-page limit.
Include a biosketch only for the PI. Do not submit biosketches for other senior/key personnel.
Cover Letters should not be included unless related to an application which was corrected during the two day checking period after submission in grant.gov
PO:
Clifton Poodry, PhD
Division of Minority Opportunities in Research, NIGMS
Telephone: (301) 594-3900
Email: poodryc@nigms.nih.gov
Go forth and find the path with the greatest diversity …
Act FAST for 100th Anniversary Edition Offer
03.1.10 by Michelle Kienholz
I love Ron Abeles … from the BSSR Guide to NIH Grants, Issue No. 100, March 1, 2010:
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Issue No. 100, March 1, 2010
ONE-HUNDREDTH ANNIVERSARY ISSUE
To mark the 100th issue of this electronic service,
the first 10 readers to submit an application will receive a R .01 Award.
Submit your name and US postal address to abeles@nih.gov.
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Joint NIH-FDA Leadership Council Announced
02.26.10 by Michelle Kienholz
The NIH and FDA announced “a new collaboration on regulatory and translational science to … help speed the translation of research into medical products and therapies.”
Oh, you know this is going to be good, starting with their description of the two, um, partners in this collaboration:
The initiative involves two interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into treatments; and regulatory science, the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality. Both disciplines are needed to turn biomedical discoveries into products that benefit people.
And, indeed, the NIH is just the partner to make it happen, according to Francis Collins:
“This collaboration … will use the NIH’s breadth of experience as a leader in biomedical sciences, to help make the regulatory review process at the FDA as seamless as possible.”
Hmm. Somehow I missed that improving the FDA’s regulatory review process was a major priority in biomedical research, though clearly the FDA does need help in that department. But wait, there’s more …
As part of the effort, the agencies will establish a Joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues. The Joint Leadership Council [chaired by NIH Director and FDA Commissioner plus 6 members from each agency] will work together to help ensure that regulatory considerations form an integral component of biomedical research planning, and that the latest science is integrated into the regulatory review process.
I have not yet had time to view the entire hour-long videocast of this announcement, so I didn’t hear how much the NIH budget would be increased to absorb this additional effort (which will clearly need more than $6.75M to succeed).
However, this new emphasis on regulatory science does explain the latest unusual RFA issued from the Office of the Director (supported with $6M from the NIH Common Fund and $650K from the FDA), Advancing Regulatory Science through Novel Research and Science-Based Technologies (U01), which offers up to $675K in direct costs per year for 2010, 2011, and 2012. The RFA describes 5 broad areas of research to be supported … by 2-3 awards.
More big applied science, one hopes not at the expense of the most basic biomedical research needed to fill the translational pipeline with science to “shape into treatments.”
Reviews of New NIH Review System
02.23.10 by Michelle Kienholz
Thanks to Jef Akst at The Scientist for his post earlier today entitled NIH Reviewers Praise New Rules (& SaG for the alert). Thanks too to those who in turn have commentend on the piece. I tend to agree with both sets of contributors – the 3 grant reviewers in the main article and the various commenters who have come along since.
Recognizing the learning curve associated with adopting a new system and inherent challenges in assessing significance and impact, reviewers felt that “changes to the reviewing guidelines have actually increased the validity and utility of the reviews.” Specifically:
For example, in the new system scoring is limited to whole numbers (1 through 9), whereas before, a reviewer could give a proposal a priority score anywhere from 1 to 5 in increments of tenths. But such a fine scale was counterproductive, Wiley noted. “[Y]ou cannot possibly discriminate grants on that kind of level,” he said, adding that the process was effectively “a crapshoot after you pick the top 25%.”
Another benefit of the new system is that reviewers are now required to justify their scores by listing strengths and weaknesses for each subcriterion…
Other changes to the review process specifically aim to cut down on the amount of time the process takes. … The template now provided by the NIH gives bullet points where reviewers are to write a couple of sentences summarizing the strengths and weakness of each category, limiting them to just half a page.
Finally, rather than reviewing the grant proposals in random order, the study section starts with the highest scored applications (based on preliminary scores) and works their way down the list. In addition to cutting the total number of grants the study section will review orally — low-ranked applications with no chance of getting funded won’t even be discussed — it also helps the reviewers to “recalibrate” their scores, Wiley said, by providing an excellent standard against which the others can be judged. “It was a very clever idea,” he said. “I found this has been very, very helpful.”
Of course, those fast, easy, bulleted comments are not without their shortcomings, as many commenters noted (e.g.):
The comments are vague and provide little meaningful guideline for improvement. Of course, that is not the primary goal-to be helpful. I think this is mainly a mechanism to more efficiently winnow down the stack of applications in this time of tight paylines.
The new format makes the critique more diffuclt to decipher and the applicant will have a hard time to get a handle on how to revise the application to get a better score.
Plus a reflection on the preliminary score-driven discussion order:
The new review order is truely a clever idea that helps to calibrate the scores and make the whole process more consistent. I delibrately avoid the wording “fairer” because I also see the downside of this new order. The more contentious and contraversial applications are more likely being discussed near the lunch breaks or late in the day and people tend to get really tired by that point. The debate on those contraversial grants may not be as vigorous as it used to be.
I dunno. Looking at summary statements coming out of this brave new world, I’m pretty happy with the way things are going, vague bullets and all. I especially like the ability (or perhaps increased tendency) of reviewers to comment directly on the advisability of resubmission. And I’m happy with the way SROs are preparing the Resume & Summary of Discussion paragraphs as well. I like the short applications. I like the reviews. The paylines, not so much.
Cures Acceleration Network Resurfaces
02.4.10 by Michelle Kienholz
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.
FY11 Budget Take 1
02.2.10 by Michelle Kienholz
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.
FIC ARRA RFA for Global Human Subjects Research Oversight
01.29.10 by Michelle Kienholz
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
RFAs from ARRA & NCMHD
01.15.10 by Michelle Kienholz
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
RFAs from ARRA & NCMHD
01.15.10 by Michelle Kienholz
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
US Biomedical Research Funding Trends
01.12.10 by Michelle Kienholz
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.
