Opportunities and Resources
- Work Toward a Preventive HIV Vaccine With HIVRAD
- HCV Funding Opportunity: Take Two
- Recent FDA Licensure Demonstrates NIAID’s Impact
In The News
- NIH Business System Downtime May Affect You
- Reminder: New Biosketch Format Required Soon
- Help NIH Optimize Research Funding
- News Briefs
- Act Sooner Than Later to Resolve a Bar to Award
- Reader Questions
- I am listed as key personnel on an R01, working on the project through a subaward. My institution considers me the PI of the subaward. Does this affect my new investigator status?
- When NIH reissues a funding opportunity announcement, is the pool of applicants limited to awardees who are currently funded?
New Funding Opportunities
If last month's article "Intellectual Property Considerations for Contracts: Inventions" piqued your interest, this one might do the same. It provides a brief overview of another type of IP: data.
First, An Important Note
Data rights is a complex topic with aspects too numerous for us to cover here.
Therefore, if you want to learn more about the topic, we strongly recommend that you read the relevant parts of the Federal Acquisition Regulation (FAR), especially FAR Subpart 27.4, which sets out policies and procedures regarding rights in data and copyrights and acquisition of data, as well as the referenced clauses beginning at FAR 52.227-14.
We also suggest that you contact your contracting officer if you have questions.
Here are a few points to consider.
First, check your contract (or solicitation if a contract has yet to be awarded) for two key pieces of information: 1) what if any data are to be delivered and 2) the rights you have to the data as the contractor. Every contract should have a "rights in data" clause that specifies the respective rights of the contractor and the government in the development or delivery of data.
Generally, contracts will include FAR 52.227-14, which provides the basic foundation for data rights and is suitable for most contracts. While it gives the government unlimited rights in data first produced or actually delivered under the contract, it does not give specifics of what is to be delivered. Again, that must be specified in the contract. Go to FAR 27.406 and 27.409 for more information.
Keep in mind that FAR 52.227 has various clauses, including for example, the Special Works clause that states a contractor can be required to copyright data and assign it to the government. This is often used in contracts for computer software development. See FAR 52.227-17 and 27.409(e). Sometimes a contract with tasks having different data requirements will contain more than one data rights clause.
As for copyrighting, under FAR 52.227-14, contractors can assert copyright—without NIH's approval—in scientific and technical articles based on or containing data first produced in the performance of a contract and published in academic, technical, or professional journals; symposia proceedings; or similar works. Note that journals generally require copyright control over materials they publish.
We Repeat . . .
To conclude, we reiterate:
- Check your contract to get specifics on required data deliverables and your rights to that data.
- For complete details on data rights, read the relevant FAR clauses.
- Talk to your contracting officer if you have questions.
If you're ready to address important questions in AIDS prophylactic vaccine research, consider applying for funds through the HIV Vaccine Research and Design (HIVRAD) Program. The next deadline is July 15, 2015, but because program project (P01) applications can be complex, we encourage you to begin the application process early.
For decades, this multi-component, multi-disciplinary funding opportunity has been the mainstay of supporting collaborative AIDS vaccine research.
When considering topics, you might plan to include extensive modeling of vaccine concepts in nonhuman primates, investigate the properties of transmitted-founder viruses, or examine new epitopes described by recent antibody discoveries.
For a list of additional possible topics and more information on this opportunity, see the March 31, 2015, Guide notice. The notice also includes a background overview of recent scientific advances in this field.
Note that clinical studies involving human subjects or research focused solely on therapeutic vaccines are not appropriate for this opportunity.
If you saw the reissued NIH Guide announcement for Hepatitis C Cooperative Research Centers: Immunity to HCV Infection (U19) and thought you had an episode of déjà vu, you did.
We reissued the funding opportunity announcement (FOA) to correct an administrative error. The scope remains the same, and both new and renewal applications are allowed.
We first covered this FOA in "Check Out FOA for Hepatitis C Cooperative Research Centers" from our November 5, 2014, issue.
The application deadline is now June 24, 2015.
You may know that last month the FDA approved filgrastim (trade name Neupogen®) to treat exposure to myelosuppressive doses of radiation by facilitating recovery of bone marrow cells. You may not know, however, that NIAID’s Radiation and Nuclear Countermeasures Program (RNCP) within the Division of Allergy, Immunology, and Transplantation contributed significantly to the approval by funding and developing the animals model and studies that demonstrated filgrastim’s efficacy.
With FDA's involvement, the road from NIAID's initial planning and funding to licensure took 10 years. Ultimately, the drug was approved under the FDA Animal Rule, which allows findings from animal studies to support FDA approval when it is not feasible or ethical to conduct efficacy trials in humans.
In addition to obtaining FDA approval, RNCP's work with filgrastim has resulted in two other important outcomes:
- It has set a precedent for licensure of radiation and nuclear medical countermeasures under the FDA Animal Rule pathway, which should allow for faster and more focused plans for approval in the future.
- It has improved our ability to collaborate with the FDA and better understand its emphasis on human safety. For instance, we've seen that candidates already proven effective for other indications are likely to be approved more quickly, having already demonstrated human safety.
RNCP is currently evaluating and developing more than 150 other candidate medical countermeasures, all in various stages of development. If you're interested in getting funding through the Program, the best approach is to contact a program officer and ask about grant, contract, small business, and consortium opportunities. Be aware that most RNCP funding opportunities are carried out through radiation nuclear countermeasure-specific solicitations. Investigator-initiated applications in this scientific area are rare. To touch base with RNCP, contact Dr. Carmen Rios.
And find out more about the science behind filgrastim by reading FDA Approves Radiation Medical Countermeasure and NIH-Funded Research Leads to Approval of Drug for Acute Radiation Injury.
If your award is scheduled to be issued in late May or early June, it will likely be delayed.
From May 19 to June 3, 2015, NIH accounting and business systems will shut down for software upgrades. Once the upgrades are complete, each institute (NIAID included) will need one or two weeks to resynchronize with the NIH systems and work through a backlog of extramural research activities.
During the downtime, NIAID will not be able to:
- Issue new or revised Notices of Award.
- Establish or change employer identification numbers (EINs).
- Process fellowship activations (although xTrain will remain available for submissions).
- Process no-cost extensions (although eRA Commons will remain available for submissions).
- Process Federal Financial Reports (FFRs).
You will still be able to draw down funds on existing awards through the Payment Management System.
The anticipated delay in making awards will not change the terms and conditions of any future or existing awards. You will still be able to incur preaward obligations and expenditures up to 90 days before the budget period start date at your institution’s own risk, as detailed in our article “If Preaward Spending Is Okay With Your Institution, It's Okay With Us.”
The eRA system will undergo its own downtime for a software upgrade on May 23, 2015, so on that day you will not be able to make submissions to eRA Commons or submit new applications through ASSIST.
Submission and review of new applications through Grants.gov will not otherwise be impacted.
For full details on the planned downtimes, read the April 9, 2015, Guide notice.
Don't forget that the new biographical sketch format is required for grant applications with due dates on or after May 25, 2015. If your biographical sketch doesn't fit the requirement, you risk NIH's rejecting your application as noncompliant, as emphasized in the April 15, 2015, Guide notice.
We recommend that you use SciENcv to prepare your biographical sketch because it includes features designed to simplify the process. For a demonstration, see the YouTube video SciENcv: Science Experts Network Curriculum Vitae.
The new format is designed to capture your five most significant contributions to science. Within each of those five descriptions, you may list up to four relevant peer-reviewed publications. We wrote about this in the December 17, 2014, article "New Format for Biographical Sketches."
In the current fiscal environment, in which many excellent research applications are not funded and talented investigators struggle to maintain their laboratories, NIH seeks to create a stronger foundation for future researchers by optimizing its funding policies.
Help us by responding to a request for information (RFI) that solicits strategies to maximize the productivity and creativity of a broad and diverse biomedical research workforce.
Specifically, the RFI invites feedback about:
- Key issues that currently limit the impact of NIH’s funding for biomedical research and challenge the sustainability of the biomedical research enterprise.
- Ideas about adjusting current funding policies to ensure both continued impact and sustainability of the NIH-supported research enterprise.
- Ideas for new policies, strategies, and other approaches that would increase the impact and sustainability of NIH-funded biomedical research.
For example, you may think that NIH funds are used inefficiently when one principal investigator oversees many grants. Your idea might then be that NIH should introduce a minimum research effort requirement for PIs on a given grant, which would limit the number of awards one PI could have.
Perhaps you would prefer that NIH fund applications on a sliding scale, where instead of funding an application fully or not at all, most applications would be funded somewhere in the middle, with better scoring applications being funded at a higher percentage of their proposed costs.
You might believe that the best way for NIH to stretch its research funding across more awards and to more investigators is to set a lower salary cap, which could free up funds to be redistributed elsewhere.
Or maybe you think that all three of those ideas are ill-conceived and wish to defend the status quo or offer an alternative strategy.
Regardless, we want to know what you think.
Send responses electronically through Request for Information (RFI): Optimizing Funding Policies and Other Strategies to Improve the Impact and Sustainability of Biomedical Research by May 17, 2015.
More Positive Payline News. We have increased the R01 (non-new PIs) payline to the 12 percentile and the R01 (new PIs) payline to the 16 percentile for FY 2015. We've also raised the small grant (R03) and exploratory/developmental grant (R21) paylines to a 30 overall impact/priority score. Finally, we set the institutional NRSA training award (T32) payline at an overall impact/priority score of 20. Go to NIAID Paylines to learn more.
Helpful Resources Available for Inclusion Management, Reproducibility, Peer Review. Watch IMS for Principal Investigatorsfor a demonstration of Using the Inclusion Management System (IMS) when completing a progress report. Check out Rigor and Reproducibility to learn about NIH efforts to ensure that we fund reproducible, robust, and transparent research. Peer reviewers: UseGuidance for Reviewers to track your deadlines, find resources and templates, and complete your review obligations.
NIH Clarifies Racial and Ethnic Categories and Definitions. Whether you are currently managing a grant or plan to apply for one, you ought to know how NIH categorizes race and ethnicity for NIH diversity programs and other reporting purposes. Find out by reading the April 8, 2015, Guide notice.
Summer Dates for Small Business Conferences. The National SBIR/STTR Conference will take place June 15 to 17, 2015, in Washington, DC. Can't make it to Washington? Then attend the SBIR Road Tour, which will stop in Fairmont, West Virginia, on May 14 before heading to the Midwest from July 14 to 17 and then out to the Pacific Northwest from August 18 to 21.
Your overall impact/priority score might be the number on your summary statement that interests you most, but check for another important one: 44, as in a code 44.
That indicates a bar to award, which blocks you from getting funded until you resolve scientific review concerns about the protection of human subjects or animal welfare in your application.
To make sure you get your award, act quickly by addressing the problems and submitting all material that NIAID requests.
You'll send the information to your program officer, who will:
- Check to see that it is complete and an acceptable response to the human subjects or animal concern.
- Forward your response—if he or she finds it adequate—to NIH staff, who will ultimately determine whether you've sufficiently cleared up the concern in question, and if so, will lift your bar.
Note that "lifting the bar" can take weeks, depending on the workload of NIH staff involved. Contact your program officer quickly if you're delayed (or anticipate delays) in getting any information to us.
Don't Wait to Act
Acting sooner rather than later, especially in June, July, and August, could be of great benefit. Here's why.
For animal concerns: no resolution, no award
A bar to award due to an animal concern must be resolved, i.e., NIH must approve your response and lift the bar before we can make an award; there is no recourse. Therefore, not responding adequately or timely to an animal concern could leave your application unfunded.
For human subjects concerns: pending resolution, restricted award
For a bar due to a human subjects concern, it’s possible for NIAID to make an award while waiting for NIH to approve your response and lift the bar. However, we will do so only if we 1) have received all your response materials and 2) deemed the response adequate before forwarding it to NIH.
Ultimately, if NIAID makes an award pending NIH approval of your human subjects concern, the Notice of Award would contain restrictions against the use of some or all of your money.
For more information, see the following SOPs:
Feel free to send us a question at firstname.lastname@example.org. 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.
No. NIH recognizes as program director/principal investigator (PD/PI) only those who are listed as such on the Notice of Award. The same would apply in the case of a multiple PI (MPI) award—only those who are listed as PDs/PIs as part of an MPI application jeopardize losing their new investigator status.
Read Definition of New Investigator to learn more.
Not necessarily. Often, NIH allows both new and renewal applications so that additional investigators may respond to the funding opportunity announcement (FOA).
Check "Application Types Allowed" in Section II of the FOA to be sure.
- RFA-AI-15-025, Hepatitis C Cooperative Research Centers: Immunity to HCV Infection
- RFA-AI-15-019, Innovation for HIV Vaccine Discovery
- RFP-NIAID-DMID-NIHAI2015039, Microbiology and Infectious Diseases Biological Research Repository (MID-BRR)
- RFA-AI-15-020, NIH-PEPFAR Collaboration on Implementation Science for HIV: Towards an AIDS-Free Generation (R01)
- RFA-AI-15-021, NIH-PEPFAR Collaboration on Implementation Science for HIV: Towards an AIDS-Free Generation (R21)
- PAR-15-189, Lasker Clinical Research Scholars Program
- RFA-AI-15-022, Consortia for Innovative AIDS Research in Nonhuman Primates
See other announcements at NIAID Funding Opportunities List.