sábado, 20 de diciembre de 2014

NIAID Funding News, December 17, 2014

NIAID Funding News, December 17, 2014

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Feature Articles
Opportunities and Resources
In The News
Advice Corner
New Funding Opportunities
Header: Feature Articles.

Safeguarding Intellectual Property

Last month's article "Reminder of Invention Implementation Regulations" reminded us it's been a while since we wrote about intellectual property (IP); specifically, protecting it. Because it's an important topic worth revisiting, here's a refresher on points to keep in mind.
Don't Divulge Details Unless…
Before sharing information about IP, including in a grant application, have in place a formal safeguard, such as a copyright, a confidential disclosure agreement, a filed patent application, or an issued patent.
If you don't have a safeguard when applying for a grant, keep your title and abstract free of confidential details. If you're funded, NIH enters those two sections in its RePORTER database, which anyone and everyone can access. This would therefore be a public disclosure.
Also be aware that parts of your funded application can be released, if requested, under the Freedom of Information Act (FOIA). Learn more by reading section Confidentiality of Information in the NIH Grants Policy Statement (GPS).
Another piece of advice: when writing your grant application, ask yourself, "Is it essential to include confidential information so that reviewers can properly evaluate my application?"
If the answer is yes, clearly mark pages containing that information as confidential or proprietary, and work closely with your institution’s technology transfer office to determine the best means of IP protection.
Using a Subaward or Working at a Small Business? Be in "Agreement"
Make sure you have 1) a consortium agreement that covers IP if you're using a subaward or 2) an intellectual property agreement with your collaborators if you're a Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) applicant applying with partners.
You should consider an IP agreement before submitting an application.
For consortium agreements:
  • Be sure the subaward identifies your confidential and proprietary information, and the subawardee agrees to protect it.
  • Include the same patent rights clause used in the prime award, but keep in mind that while you cannot use a subaward as economic leverage to obtain rights to a subawardee's inventions, you may want to negotiate mutually beneficial rights to inventions or data created under the subaward.
Read more about subawards in our Subawards (Consortium Agreements) for Grants SOP.
As for SBIR and STTR applicants, consider doing the following in your IP agreement:
  • Include a license or option to obtain rights for future development and commercialization at a reasonable rate for inventions developed by research institution partners under STTR funding.
  • Describe any inventions or proprietary information your company brings to the partnership so future ownership will not be in doubt.
You should also have an IP agreement with subcontractors that addresses, among other items, what happens to inventions they make. Keep in mind, though, that NIH does not require, review, or enforce such IP agreements.
Copyright Data and Publications
In general, you have the rights to publications and data developed under an NIH grant—including training and fellowship awards—and may copyright them without NIH's approval unless your Notice of Award explicitly says otherwise.
Bear in mind that you and your institution arrange copyright ownership. Your institution may, as grantee, exercise its right of ownership over any work created during your official duties. Note that journals have copyright control over materials you publish with them.
For more information, go to the GPS's 8.2.1 Rights in Data (Publication and Copyrighting).
Invention Protection
If your funded research leads to an invention, communicate with staff in your institution's technology transfer office as soon as possible.
Timing is important, so promptly contact them once you think you have made a patentable discovery and before publicly disclosing such information.
That leaves time for you and your institution to discuss patenting your invention and filing a patent application if necessary.
Your institution typically has the initial right and obligation to patent under the Bayh-Dole Act of 1980 (U.S.C. 18 200-212), but if it chooses not to, you (the inventor) may be allowed to submit a patent application to the United States Patent and Trademark Office(USPTO). Your technology transfer office will be able to guide you through either procedure.
You can start by filing an inexpensive provisional application, but you will need to follow through with a nonprovisional U.S. or international (Patent Cooperation Treaty or "PCT") application within one year of the provisional application's filing date.
For patent-related expenses, see USPTO Fee Information.
Reporting Requirements
The Bayh-Dole Act requires that all government-funded inventions be reported to the awarding federal agency, e.g., NIH.
If you don't comply with reporting requirements, you could lose the right and title to any federally funded inventions made under your grant or contract, and NIH may withhold grant funds or take other enforcement actions.
For a brief summary of required items your institution must provide, go to Invention Reporting Has Four Parts in the Strategy for NIH Funding. Find a more exhaustive list with timeframes at iEdison's Invention Reporting Timeline: At a Glance.
And to learn about invention reporting when your grant ends, read File Your Final Reports at Award End.
Where to Turn With IP and Reporting Questions
Your first point of contact should be staff in your institution's technology transfer office. They can answer questions and also inform you of institution-specific policies and procedures.
For additional assistance on invention and patent reporting compliance and responsibilities, contact the Division of Extramural Inventions and Technology Resources (DEITR) in NIH’s Office of Policy for Extramural Research Administration (OPERA).
Related Links
Header: Opportunities and Resources.

Exploring Novel Therapeutics for Fighting Bacterial Infections

Infectious bacteria are developing resistance to the current arsenal of antibiotics at an alarming rate. To help combat this trend, NIAID will fund research on nontraditional treatment modalities for bacterial infections using an R21/R33 Phased Innovation Award.
Your innovative approach can qualify for funding if it meets several key requirements.
First, your research must target bacterial pathogens listed as either “Urgent Threats” or “Serious Threats” in CDC’s report Antibiotic Resistance Threats in the United States, 2013. Note that applications focused on drug-resistant Mycobacterium tuberculosis face additional limitations, which are listed in the funding opportunity announcement (FOA).
Second, your research must center on nontraditional therapeutic approaches, meaning approaches using a mechanism of action that differs from traditional small-molecule bactericidal and bacteriostatic agents that would not be likely to promote development of resistance to existing antibodies. Examples of nontraditional approaches include:
  • Therapeutic bacteria
  • Bacteriophages
  • Bacteriocins
  • Antivirulence strategies or therapeutics that target nonessential bacterial virulence factors
  • Adjunctive combination therapies
  • Therapeutic vaccines
The FOA includes descriptions and examples of each approach.
Third, your application must not propose to develop:
  • Antiviral, antifungal, or antiparasitic agents.
  • Traditional antibacterial compounds (small molecules that bind single, previously identified bacterial targets whose mechanism of action involves inhibiting essential bacterial pathways such as cell wall, nucleic acid, or protein synthesis).
  • Membrane-active small molecules.
  • Antibody-based agents.
  • Antibacterial agents that modify, disrupt, or inhibit host targets or processes.
  • Agents that target Mycobacterium species other than strategies to develop or evaluate therapeutic vaccines or immune potentiators.
  • Combination therapies based solely on existing antibiotics.
Nor can your application propose a clinical trial, although you may discuss clinical development strategies within an overall project.
Your application must clearly be divided into the R21 and R33 phases. To do so, describe clearly defined, quantitative Transition Milestones that can be used to mark the transition from the R21 phase to the R33 phase. NIAID will use these markers to assess progress during the first phase and preparedness to move to the second phase. For more about phased innovation awards, see ourR21/R33 Phased Innovation Award SOP.
Support for the R21 is limited to $275,000 in direct costs over a two-year period, with a maximum of $200,000 in direct costs allowed in any single year. The R33 award phase is limited to $300,000 in annual direct costs for up to three years. NIAID expects approximately 50 percent of funded R21 awards to transition to R33 awards.
Letters of intent are due by January 23, 2015. The application deadline is February 23, 2015. For more information, including additional examples of nontraditional therapeutic types, read the November 14, 2014, Guide notice.
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Get Funding to Develop Big Data Educational Resources

Apply for a two-year grant worth up to $50,000 each year to develop an educational resource related to creating, managing, and sharing biomedical big data.
You can do so under one of two funding opportunity announcements (FOAs) from NIH's Big Data to Knowledge (BD2K) program, NIH's effort to develop new approaches, standards, methods, tools, software, and competencies to improve your use of data sets and databases that are too large or complex for conventional biomedical research approaches.
For the first FOA, you'd create a Massive Open Online Course (MOOC) for librarians, information specialists, and anybody else who trains graduate students, research staff, and administrators on how to find, classify, and access resources and training related to big data. This MOOC should also be useful for anybody who wants self-instruction.
For the second FOA, you'd produce curriculum modules that librarians and information specialists can use to teach graduate students and researchers about sharing, annotating, and curating big data.
Get details and ideas of potential topics in the November 26, 2014, MOOC and Educational Resources Guide announcements.
Contact Dr. Valerie Florance at bd2k_training@mail.nih.gov for advice on your application and answers to any questions you may have. Deadline is March 17, 2015, for both opportunities.
Related Links
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More Chances for Innovative Research on HIV Reservoirs

There is still time to apply for funding through the Targeting Persistent HIV Reservoirs initiative, as NIAID has reissued the funding opportunity announcement (FOA) for the TaPHIR R21/R33 Phased Innovation Award.
Through this FOA, NIAID will continue to fund high-risk, technology-driven research that contributes to targeting and eradicating HIV provirus residing in resting CD4+ memory T cells. We are particularly interested in projects that:
  • Develop methods for isolating, quantifying, and characterizing rare reservoir cells.
  • Identify markers of latency or specific reactivators of HIV gene expression to enable targeting of reservoir cells.
  • Test strategies to eliminate or inactivate reservoir cells.
As we told you in our February article “Thanks to Changes, Your Research May Now Fit an HIV Reservoir FOA,” the scope of the FOA has expanded slightly from its original form. For example, you can now propose basic research into the cellular and molecular mechanisms of HIV latency and persistence.
For the phased innovation award, you should propose a project period of no more than five years, with the exploratory (R21) phase limited to two years and the proof-of-concept study (R33) phase limited to three. Your application should clearly delineate the R21 and R33 phases using milestones, charts, and timelines. Keep in mind that this FOA will not support clinical trials.
For the R21, limit your budget to $275,000 in direct costs over a two-year period, with a maximum of $200,000 for any single year. For the R33 award phase, your budget cannot exceed $300,000 in annual direct costs. We expect that about 50 percent of funded R21 awards will transition to R33 awards.
The number of awards will be commensurate with the number of high-quality applications received. TaPHIR aligns with the priorities listed in the press release "NIH announces plan to increase funding toward a cure for HIV/AIDS."
Note that there will be a single annual receipt date, April 7, each year from 2015 to 2017. For complete details, read the November 20, 2014, Guide notice.
Header: Other News.

New Format for Biographical Sketches

Highlight your contributions to science in a new way with NIH's updated biographical sketch format. You can start voluntarily using it right away. However, starting with due dates on or after May 25, 2015, you must use the new format.
Check out the new format and instructions at SF 424 (R&R) Forms and Applications. For fellowship applications, note that there are special versions of the form pages and instructions for pre- and postdocs.
With the new approach, you get up to five pages instead of four. You can describe up to five of your most significant contributions, along with the historical background that framed your research. You can also outline the central findings of your prior work and the influence of those findings. For more on the changes, read the December 5, 2014, Guide notice. Also see Frequently Asked Questions: Biosketches.
As noted on the Web pages above, the Science Experts Network (SciENcv) will support the new biosketch format soon. SciENcv can build your biosketch for you in a PDF format used by several federal agencies. If you haven't tried it before, give it a shot.
As we mentioned in our June issue, NIH has been piloting a new biosketch format for months. For survey results from pilot participants, as well as background on the change, read Implementing the Modified NIH Biosketch Format in the Rock Talk blog.

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News Briefs

Chance to Comment on Use of Single IRBs for Multisite Research. NIH is soliciting feedback on a draft policy that would require multisite studies to use a single institutional review board (IRB), with some exceptions. By eliminating duplication of effort, the policy will improve IRB efficiency without jeopardizing efficacy. Read the December 3, 2014, Guide notice for full details on the draft policy. Email your comments to the Office of Clinical Research and Bioethics Policy before the January 29, 2015, deadline.
Clarification From OLAW on Shared Animal Welfare Concerns. NIH's Office of Laboratory Animal Welfare (OLAW) requires institutions to self-report serious or continuing noncompliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. OLAW shares self-reports of serious animal welfare concerns with U.S. Department of Agriculture Animal and Plant Health Inspection Service. APHIS will cite institutions that do not adequately address incidents of noncompliance following the criteria listed in the December 1, 2014, Guide notice.
Style Requirement Lifted for Resubmission Applications. NIH no longer requires resubmission applications (A1 applications) to identify changes from the previous version using bracketing, indenting, or a change of typography, as announced in the December 4, 2014, Guide notice. However, your Introduction must still describe how you've changed your application for resubmission.
Header: Advice Corner.

Befuddled by a FOA? Scientific Contact Can Clear Up Confusion, Questions

We often advise that before you apply for a grant, you should carefully read your chosen funding opportunity announcement (FOA). But let's say you've read the FOA and still have questions or need clarification about its research-related aspects. What then?
Get in touch with the NIAID scientific/research contact listed in Section VII. Agency Contacts of the FOA. That staff member can further explain the FOA's scope, talk to you about your proposed submission, clear up any points you're not sure of, and more.
Also, if you are eyeing a FOA but aren't certain about whether that particular activity code (e.g., R01, R03) is right for you, the scientific contact listed in the FOA can help. For more on this, go to Choose the Grant in the Strategy for NIH Funding.
Keep in mind that you must be in touch with the scientific contact to get preapproval before you apply for some types of grant applications, e.g., big grants and conference grants.
Don’t wait until the last minute before an application deadline to make your request. In some cases, the scientific contact will need to refer it to the program officer who would be assigned your application.
Speaking of FOAs . . .
If you see a discrepancy between an NIH funding opportunity announcement and any other reference, go with information in the FOA.
The instructions in published FOAs in the NIH Guide always supersede the instructions in the SF 424, PHS 398, and parent program announcements for an activity code. Be sure to check the FOA for any exceptions (e.g., page limits). The FOA is also your official source for submission deadlines.
Header: Reader Questions.
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.
"Will my grant application be assigned to and reviewed at NIAID since it is HIV/AIDS-related?"—anonymous reader
Not necessarily. NIH's Center for Scientific Review (CSR) will not automatically assign your application to NIAID, as most institutes and centers (ICs) receive HIV/AIDS-related funding and have HIV/AIDS-related areas within their mission. If you are submitting an investigator-initiated application (i.e., applications in response to Parent Announcements), then CSR will assign the application to the IC that is the best match for the overall scientific objectives. In some cases, NIAID may also be assigned as the secondary IC.
Before you submit a grant application, check the funding opportunity announcement (FOA) text to see whether NIAID is participating and whether your proposed topic fits our areas of interest. If areas of interest aren’t listed by IC, discuss your proposed idea with the scientific/research contacts listed in the FOA.
The peer review contact listed in the FOA will indicate where your application will be reviewed, as we told you in a previous reader question How can I tell if my application will be reviewed by NIAID or CSR?
Pay special attention to mentored K awards (K01, K08, K23, or K25) since those applications have FOA requirements that vary by IC. The locus of review also depends on where the application is assigned. Ks assigned to NIAID are reviewed in NIAID by theAIDS Research Review Committee. Check with a program officer or the scientific contacts in the FOA to be sure.
Instead of leaving your assignment completely to chance, request an IC and study section in your cover letter. For instructions, readRequesting an Institute and Study Section in the Strategy for NIH Funding. While you are not guaranteed to have your application assigned to your requested IC and study section, cover letter requests speed up the referral and assignment process and often lead to the desired assignment.
“How should I address reviewers' comments in my resubmission application, given the single-page limit for the Introduction?”anonymous reader
You should address reviewers' concerns in both the Introduction and Research Strategy (or elsewhere if the reviewers had concerns). Many applicants use the Introduction to explain how their resubmission responds to the issues and criticism raised in the original application's summary statement and then address individual comments throughout the Research Strategy.
While we recommend addressing comments one-by-one in the Introduction, that may not always be possible due to the one-page limit. Fortunately our recommendation is not an NIH requirement. If you're cramped for space, don't drop important details in favor of making space to address reviewer comments. Learn more by reading How to Resubmit in the Strategy for NIH Funding.
Remember, responding to criticism usually means altering your approach to account for reviewer concerns rather than arguing that the criticism is misguided. Don't waste space insisting that you were right all along.
For advice that’s specific to your application’s critiques and how you might address them within the one-page limit, talk to your program officer.
Header: New Funding Opportunities.
See other announcements at NIAID Funding Opportunities List.

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