Feature Articles
Opportunities and Resources
- A Solution if You're Struggling With Foreign Clinical Regulations
- NIH Solicitation for Small Business Innovation Research Contract Proposals
- FOAs Focus on Role of the Microbiome in HIV-1 Vaccine Responses
- Collaborative Research Program on Disease Transmission
In The News
- NIH Clarifies Significant Changes to Animal Activities
- A Reminder About Just-in-Time Information
- Just Posted: Sample F31-Diversity Application
- News Briefs
Advice Corner
New Funding Opportunities
September Is National Biosafety Stewardship Month
As part of National Biosafety Stewardship Month, join NIH and other HHS agencies in reinforcing safe practices in biomedical research. Federal labs that conduct research with infectious agents or toxins are reviewing their biosafety and biosecurity policies, training, and practices, and conducting inventories of infectious agents and toxins. We strongly encourage you to do the same.
The terms and conditions of all NIH grant awards require grantees and contractors to adhere to applicable federal, state, and local laws and regulations, in addition to any relevant NIH guidelines.
Your institutional biosafety committees (IBCs) and biological safety officers (BSOs) should have received a letter from NIH instructing them to reexamine biosafety practices, inventory infectious agents and toxins, and refine training and training materials for staff.
We request that you and your institution’s leadership support your IBCs and BSOs in this effort. We all share an interest in ensuring that our research programs are safe and secure.
For more information, read the August 27, 2014, Guide notice and the related NIH Director’s Blog post “Promoting Health, Science, and Public Trust through Laboratory Safety.”
A Solution if You're Struggling With Foreign Clinical Regulations
If you're not steeped in foreign clinical regulations, we have a resource that gives you a proverbial lay of the land.
Use NIAID's online database of country-specific regulatory information on clinical research, written in plain language by experts in the field.
Topic areas covered on the Web site include clinical trial lifecycle, competent authority oversight, ethical review, informed consent, investigational products, specimens, and sponsorship.
To access the database, go to ClinRegs. You can also sign up for GovDelivery Alerts to stay informed when there's a ClinRegs update.
Can ClinRegs Help Me With My Application?
Yes. Consult ClinRegs before you write your application to confirm you will be able to conduct your research and accomplish your Specific Aims under the rules and regulations of your foreign site.
I know where to go if I have questions. Why would I use ClinRegs?
We hope this resource is a time-saver for anyone involved in planning or implementing international clinical research.
ClinRegs consolidates regulatory requirements in one place, with staff dedicated to updating the site as regulations change. The site also provides links to official regulations and other key resources related to international clinical research to facilitate independent analysis.
As you use the site, you can send feedback to the project team using the "Feedback Survey" located on the right side of your browser window when you get to the ClinRegs site.
NIH Solicitation for Small Business Innovation Research Contract Proposals
Small businesses take note: NIH has issued the 2015 Small Business Innovation Research (SBIR) program contract solicitation.
Offerors must be small business concerns, as defined in the August 15, 2014, FedBizOpps.gov solicitation. Each research topic listed in the solicitation specifies the objectives for both Phase I and Phase II projects.
NIAID is particularly interested in:
- Development of novel influenza antivirals.
- Methods of clinical sample preparation for rapid detection of bacterial pathogens.
- Inhaled delivery of Clofazimine, an important anti-tuberculosis drug.
- Simple, inexpensive units for removing cells from small amounts of blood in resource-limited settings.
The receipt date deadline is November 5, 2014, at 4:30 p.m. EST. For full details, read SBIR Program Solicitation PHS 2015-1.
If you have any questions, contact Eileen Webster-Cissel.
FOAs Focus on Role of the Microbiome in HIV-1 Vaccine Responses
NIAID seeks to award R01 and R21 grants to support research that's focused on elucidating the role of the microbiome in shaping the host immune responses to HIV-1 transmission and vaccination in the gastrointestinal and genital mucosa.
Your proposed research should lead to developing new vaccine strategies as well as innovative approaches to enhance mucosal and systemic responses to HIV vaccines. Note that these funding opportunity announcements (FOAs) do not support the human clinical evaluation of vaccines or therapies.
We anticipate that studies will require multidisciplinary research in metagenomics, immunology, microbiology, HIV virology, and host genetics. Since the FOAs' research objectives are quite complex, we strongly encourage you to discuss the scope of your proposed project with Dr. Que Dang or Dr. Angela Malaspina, the opportunities' scientific/research contacts.
For complete details, including research areas of interest, read the August 11, 2014, R01 and R21 Guide notices.
For both FOAs, the first of three annual due dates is January 7, 2015.
Collaborative Research Program on Disease Transmission
Expertise in a range of disciplines is needed to uncover the transmission dynamics of zoonotic infectious diseases. TheEcology and Evolution of Infectious Diseases (EEID) Initiative supports multidisciplinary research teams studying how infectious disease agents reach humans and other hosts.
A new joint NSF-NIH grant opportunity will fund projects that are organized around an overarching conceptual framework that leads to a model based on mathematical equations, computational simulations, geospatial algorithms, and statistical models.
Research areas of particular interest include:
- The role of social influences on the susceptibility of individuals or populations.
- Complex interactions between pathogenic and nonpathogenic organisms and their mutual hosts.
- The role of medical, agricultural, or environmental practices on pathogen emergence and transmission.
- Emergence of pathogens from nonpathogenic populations.
- Host switching.
- Evolutionary dynamics in an ecological context such as disease control interventions and drug resistance.
The most competitive proposals will develop a collaborative team that draws from multiple disciplines: modelers, bioinformaticians, genomics researchers, social scientists, economists, epidemiologists, entomologists, parasitologists, microbiologists, bacteriologists, virologists, pathologists, or veterinarians.
As the purpose of this funding opportunity is multidisciplinary research, a proposed investigation will be considered nonresponsive if it focuses solely on:
- Genetic patterns of evolutionary change.
- Human diseases (without considering the broader ecological context).
- Within-host biological processes.
- Vector species ecology.
- Pathogenic organism identification (e.g., metagenomic surveys to identify the pathogenic organism).
Also, unlike previous solicitations within this program, projects focusing on marine systems are no longer accepted, with limited exceptions for aquaculture systems.
Contact NIH or NSF program officials before submitting an application.
Read the August 19, 2014, Guide notice and the National Science Foundation EEID Program Solicitation for more information.
NIH Clarifies Significant Changes to Animal Activities
Your institution's Institutional Animal Care and Use Committee (IACUC) and veterinarian will want to take a close look at NIH's new guidance on significant changes to animal activities.
NIH specifies that changes that could have a negative impact on animal welfare are considered significant, and therefore must be approved by the IACUC. Some activities that may not directly affect animal welfare are also considered significant.
Find examples and full details in the August 26, 2014, Guide notice, also posted by the Office of Laboratory Animal Welfare (OLAW) at Significant Changes to Animal Activities.
In its updated Frequently Asked Questions, OLAW also suggests checking out the Special Seminar, Guidance on Significant Changes to Animal Activities.
A Reminder About Just-in-Time Information
You may have recently received an invitation to submit just-in-time (JIT) information. Be aware, NIH sends this notification automatically to the business office of any applicant who receives an overall impact/priority score of 40 or better.
Only applicants who score near or within the NIAID Paylines should submit JIT information. If there is no payline published for the current fiscal year, use the previous fiscal year's payline as a guide until one is published. You might also be asked directly by NIAID staff to submit JIT information. Receiving a request for JIT information does not guarantee that your proposal will be funded.
For further instruction, read Respond to Pre-Award Requests (“Just-in-Time”).
Just Posted: Sample F31-Diversity Application
When writing a grant application, there's nothing quite as helpful as reading one from a person who's been funded. That's why if you're planning on applying for an NRSA Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research, you'll be happy to hear that we now have an F31-Diversity Sample Application and Summary Statement on our Sample Applications & More page.
With this sample, you can see how the investigator covered all required sections—such as the Research Training Plan and responsible conduct of research—and how the reviewers evaluated it.
We thank the PI who graciously agreed to let us post this exceptional application online, and hope that future applicants find it useful.
News Briefs
New $500,000 Challenge in Single Cell Analysis. The NIH Single Cell Analysis Program's "Follow That Cell" Challenge seeks novel, robust methods of individual cell analysis that can detect and assess changes in cell behavior and function over time. To learn more, read About the “Follow that Cell” Challenge.
Collecting Input on Data-Related Standards Resource. NIH is considering creating an NIH Standards Information Resource (NSIR) and wants your input about potential NSIR content and strategy. Read the August 27, 2014, Guide notice for the full request for information. Responses are due by September 30, 2014.
Updated Forms for Some Administrative Supplements. Research Supplements to Promote Diversity in Health-Related Research and Research Supplements to Promote Reentry into Biomedical and Behavioral Research Careers will now use version 'C' grant application forms. For details, read the August 11, 2014, Guide notice.
See What's New About Our Renewal Advice
We now have new advice and options for approaching your renewal application. Read Apply for a Renewal.
When NIH changed its submission policy to allow you to submit an unsuccessful application as a new application without making substantial changes to the scientific direction or scope, we updated our Research Funding Web site but held off on our renewal information until we had some time to observe and reflect on the implications of the policy change.
How Does the Change in NIH Policy Affect Renewals?
NIH's policy change shouldn't affect your decision whether to renew or not, but it does change your options and gives you an opportunity to get funded under a new application if your renewal doesn't succeed.
Learn more about the policy change in the April 22, 2014, Guide notice and our April 17, 2014, article "Big News on Application Submission Policy."
Why Would I Try for a Renewal if I Can Now Simply Submit a New Application?
Renewals offer some advantages over new applications.
Successful renewals reflect well on how you're perceived as a researcher. Being able to continually renew your grant, especially in this era of tight budgets, shows you can build and sustain a productive research program.
And, reviewers will consider your productivity as an indication of your chances of success as you continue your research.
That said, we encourage you to make the best decision for your situation and the science you propose.
Renewals come with limitations—for example, some funding opportunity announcements don't allow them, and R01 renewals come with budget caps that can limit your science. The budget for the first year of your renewing grant should not be more than 20 percent higher than the last year of your current grant.
A renewal is also a poor option if you haven't made a lot of progress during your previous project period, or you’ve made a discovery that you think is potentially more important but would move the research in a new direction.
Get more advice in Apply for a Renewal.
Related Links
- June 19, 2014, article "Check Out Web Updates Due to the New Submission Policy"
- Apply for a Renewal
- Renewal Funding SOP
Feel free to send us a question at deaweb@niaid.nih.gov. After responding to you, we may ask your permission to include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.
"Are organizations in the United Kingdom eligible for NIH funding? If so, are there any special restrictions?"—Claire Ellis, Demuris Ltd.
Each funding opportunity announcement (FOA) specifies whether or not foreign organizations are allowed to apply. Every applicant must meet all the FOA requirements. For more information, read Determine Eligibility for NIAID Grants.
If your organization is awarded a grant, it must—as a grantee—be able to interface and register electronically within our Electronic Research Administration (eRA) systems, as well as complete registrations (e.g., System for Award Management (SAM), Grants.gov) pre-award and maintain them post-award.
"For a renewal application, should I use my original Specific Aims or write new Specific Aims?"—anonymous reader
Your renewal should have new Specific Aims, given the expectation that most of your original aims have been achieved. Peer reviewers will take into account what you have accomplished when assessing the merits of your renewal application.
Also, a renewal should clearly link back to your previous grant's Specific Aims, showing progress without duplicating the aims of the previous grant. It's important to show that you successfully conducted relevant research, got results, and then will use those results to pursue the next set of experiments.
We suggest reading Apply for a Renewal.
- BAA-NIAID-DAIDS-NIHAI2014014, Staged Vaccine Development
- PAR-14-341, NIAID Career Transition Award
- RFP-NIAID-DAIT-NIHAI2014005, Radiation and Nuclear Medical Countermeasure (MCM) Product Development Support Services
- PAR-14-329, Limited Competition: Strategic Timing of Antiretroviral Treatment (START)
- PA-14-328, Administrative Supplements for U.S.-Brazil Biomedical Collaborative Research
See other announcements at NIAID Funding Opportunities List.