April 2, 2015

Feature Articles

Intellectual Property Considerations for Contracts: Inventions

Opportunities and Resources

In The News

Advice Corner

Choose the Best Opportunity for Funding: Cooperative Agreements & Grants
Reader Questions
- Do I need to request prior approval to reduce effort for everybody on my grant?
- Can I increase my effort on a grant without increasing my salary and thus keep my budget the same?

New Funding Opportunities

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Intellectual Property Considerations for Contracts: Inventions

When it comes to research and development (R&D) contracts and intellectual property (IP), there are a number of issues you should be aware of, such as rights, regulations, and responsibilities.

To help you acquaint—or reacquaint—yourself with the essentials, we'll cover them in this and future issues. We begin with one key type of IP: inventions.

Begin at the Beginning: What Is an Invention?

Before going any further, it's important to know how inventions are officially defined.

According to 35 U.S.C. 201 of the U.S. Patent law as implemented by the Federal Acquisition Regulation (FAR) 52.227-11 Patent Rights-Ownership by the Contractor, an invention is "any invention or discovery that is or may be patentable or otherwise protectable under title 35 of the U.S. Code."

Note: Title 35 of the U.S. Code covers inventions and patents. Chapter 18 of Title 35 is perhaps better known as the Bayh-Dole Act of 1980 (35 U.S.C. Chapter 18 Sec. 200-212) and covers inventions made under federal funding agreements.

It's also important to know about subject inventions, which you may not be familiar with. A subject invention is any invention of the contractor (only the contractor—not a different person) conceived or first actually reduced to practice in the performance of work under a funding agreement.

The government gets a license for itself and may exercise march-in rights in subject inventions. The exercise of march-in rights is very rare. The government wouldn't automatically get the license and march-in rights if the invention was not a subject invention.

For information on march-in rights, see 35 U.S.C. Section 203 of the Bayh-Dole Act and FAR 27.302(f).

Invention Rights

Under the Bayh-Dole Act, businesses (large and small) and nonprofits (including universities) can elect to retain ownership of inventions made under federally funded research and contract programs.

That means contractors have the right to elect and retain title to any invention made under an R&D contract. If a contractor doesn't elect title, then the government can do so.

In some cases, an agency may decide to restrict or eliminate a contractor's right to retain title and will exercise a determination of exceptional circumstances. See FAR 27.303(e).

Check the Solicitation

To learn what invention rights and requirements apply to a particular solicitation, check Part II-Contract Clauses. Depending on the type of contract, it may contain IP-related FAR clauses, for example, FAR 52.227-11 (mentioned above) and FAR 52.227-14, Rights in Data-General.

Invention Protection

If you are awarded a contract and make an invention during the course of it, communicate with staff in your organization'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 organization to discuss patenting your invention and filing a patent application if necessary.*

Your organization typically has the initial right and obligation to patent under the Bayh-Dole Act, as implemented by FAR 52.227-11, but if it chooses not to, you (the inventor with the permission of your employer and the funding federal agency) 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.

*NIAID extramural staff who anticipate filing a patent must complete the

NIAID Extramural Staff Inventorship Division Worksheetand contact their branch chief immediately to discuss and resolve conflicts of interest.

Invention Reporting Requirements

The Bayh-Dole Act requires that all government-funded inventions, from both contracts and grants, 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 contract, and NIH may withhold funds or take other enforcement actions.

To learn what you must do, read our Invention Reporting for Contracts SOP.

Train the Trainers on Global Research Administration

We have exciting news for administrators managing NIAID grant funds at institutions in low- to middle-income countries: Through NIAID's new funding opportunity, you can get advanced training at a U.S. host institution on managing NIH grants and directly learn about complying with various reporting requirements. Then when you return home, you'll be able to train other administrators in turn.

To qualify as the PI, you must be a senior institutional staff member who's responsible for grants administration, such as a grants administrator, business official, or scientist with institutional grants management responsibilities. In addition, the country where your institution is located must be classified as low or middle income on the World Bank's Country and Lending Groups

list. Your institution must already receive NIAID funding when you apply; however, it must have received less than $500,000 total in NIH grant or cooperative agreement support in the last 10 years.

You'll also need to find a U.S. institution to serve as your host. To qualify as a host, it must have received more than $5 million in total NIH research grant or cooperative agreement support in each of the last 10 years.

Your application's budget is limited to no more than $100,000 for 18 months in direct costs. Indirect costs for foreign grantees are limited to 8 percent. Only one application is allowed from each institution.

The first application due date is July 15, 2015. We encourage you to send a letter of intent 30 days before your targeted due date. Read the March 4, 2015, Guide notice for details, as well as Questions and Answers for PAR-15-131, Global Infectious Disease Research Administration Development Award for Low- and Middle-Income Country Institutions (G11).

Funding for HIV/AIDS Research in Older Adults

Could your grant accommodate research on HIV/AIDS in aging adults?

If so, apply for an administrative supplement of up to $100,000 for one year of additional funding to conduct pilot studies, gather preliminary data for a future R01 application, or investigate novel concepts within your field of research.

Your new project qualifies for a supplement under the following conditions:

Studies HIV infection, HIV-associated conditions, HIV treatment, or biobehavioral or social factors associated with HIV/AIDS in older adults or in the context of aging.
Did not appear in your original grant application.
Does not constitute a change in the scope of your current project.

Administrative supplements allow you to add additional studies within the scope of your parent project only.
Any change in the direction of your parent project would constitute a change in scope.

Does not involve new foreign components (e.g., collaborators and sites). However, you can add domestic components and keep whatever foreign components you already have.

If you do qualify, speak to your program officer about whether your idea fits this funding opportunity.

NIAID accepts applications on any topic within our mission but as a rule we do not supplement career development (K) awards, training (T) grants, or grants in their first or last years or during no-cost extensions.

For details and application instructions, read the March 12, 2015, Guide announcement.

Applications are due May 15, 2015.

Related Links

Journal of Acquired Immune Deficiency Syndromes, HIV and Aging: State of Knowledge and Areas of Critical Need for Research
Centers for Disease Control and Prevention, HIV Among Older Americans
What Constitutes a Change in Scope? in the Strategy for NIH Funding
Get a Speedy Response From Your Program Officer

Help Biomedical Data Repositories Make the Most of Their Data

NIH is looking to fund projects that can improve interoperability among NIH-funded biomedical data repositories.

Your project could receive up to $300,000 for one year of funding under an administrative supplement to an existing grant.

You can apply two ways:

If you're a PI at an NIH-funded biomedical data repository that has a budget of more than $500,000 in direct costs each year, respond to the funding opportunity announcement linked below.
If you're not a PI at an NIH-funded biomedical data repository that has a budget of more than $500,000 in direct costs each year, find somebody who is. Though only the PI at an NIH-funded biomedical data repository may apply, you can receive some funding as a collaborator.

Where can you find a potential collaborator?

Peruse this list of NIH Data Sharing Repositories. While some of those repositories do not qualify for this funding opportunity, and the list is by no means exhaustive, it's a good place to start.

For details, application instructions, and eligibility requirements, read the March 18, 2015, Guide announcement. Keep in mind that your project must create long-term, sustainable benefits even after funding ends.

Application deadline is April 20, 2015.

This opportunity comes out of the 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.

Learn more at NIH Big Data to Knowledge (BD2K).

Focus on Costs in FOAs

When reading a funding opportunity announcement (FOA), you may be particularly interested in the budget information. Here are a couple of points you should keep in mind:

Some FOAs may limit awards based on direct costs per award, or rarely, total costs per award.
Many FOAs cite the total funds set aside for the initiative and the number of anticipated awards to be made.

It's a good idea to look for these details so you can use the figures to plan your budget and get a general idea of how competitive funding may be (e.g., if the FOA's scientific topic is broad or popular but the expected number of awards is few, then competition could be intense).

Updated Inclusion Format Required for Progress Reports

Take note if you are conducting clinical research studies and are preparing to submit a Research Performance Progress Report (RPPR).

You must update inclusion data records using the Cumulative Inclusion Enrollment Report format, even if there was no new enrollment in the past year. Trying to submit your RPPR without doing the update will result in an error.

Why the need for this update? As part of the transition to the Inclusion Management System (IMS), NIH migrated inclusion enrollment data from the previous system but couldn't automatically transfer these data into the cumulative inclusion enrollment reporting format.

No longer do you attach a form; you update enrollment data in IMS. Learn how to avoid an error and get full details in the March 12, 2015, Guide notice.

News Briefs

ASSIST Expands to R01s, U01s, and Career Development Activity Codes. Beginning in late April, optional use of Application Submission System and Interface for Submission Tracking (ASSIST) will become available for research project grant (R01), cooperative agreement (U01), and most career development (K) activity codes. See Target Timeline for Single-Project ASSIST Support for additional details.

Data Sharing and Invention Reminders for Grant Applicants and Awardees. NIH grant applicants must follow the NIH Genomic Data Sharing Policy, as summarized in the March 20, 2015, Guide notice. Also, NIH grantees and contractors are reminded to submit invention disclosures and their related forms through iEdison—NIH will not accept submissions submitted by fax, mail, or delivery. Read the March 17, 2015, Guide notice to learn more.

Revised Edition of PHS Laboratory Animal Policy Posted Online. The Public Health Service Policy on Humane Care and Use of Laboratory Animals now reflects all changes made since the 2002 reprint. The March 17, 2015, Guide notice provides a summary of the update.

Choose the Best Opportunity for Funding: Cooperative Agreements & Grants

You have numerous options for submitting your research ideas for NIH funding. For grants and cooperative agreements, you can choose to submit applications in response to the following types of funding opportunity announcements:

Program announcement (PA)
Request for applications (RFA)

PAs identify broad areas of increased priority or emphasis in a specific area of science. PAs are usually accepted on standard receipt dates and reviewed by standing study sections.

There are several types of PAs:

Parent PA: a PA that permits investigator-initiated research. Parent PAs do not define the type of research to be proposed, are submitted on standard due dates, have multiple receipt dates, and are reviewed by standing study sections.
Institute-specific PA: identifies areas of increased priority and/or emphasis. Applications are submitted on standard due dates, have multiple receipt dates, and are reviewed by standing study sections.
PAR: a PA with special receipt, referral and/or review considerations. Identifies areas of increased priority and/or emphasis. A PAR may or may not have set-aside funds.
PAS: a PA that includes set-aside funds. Applications submitted under a PAS may be reviewed by standing study sections.

RFAs solicit grant or cooperative agreement applications in a well-defined scientific area to accomplish specific program objectives. Typically, the scientific area has been identified as being research that would not likely be supported by standing study sections (e.g., screening or descriptive type of studies) or is an up-and-coming area of research.

RFAs have more stringent criteria than PAs, including a more narrowly defined research area and scope, typically a single receipt date, and review by a scientific review group that is convened specifically for the RFA.

While there is no overarching rule to determine which you should apply to, there are several factors to consider when making your decision.

Seek Advice and Stay Informed

The first step in determining the best fit for your proposed research is to speak with a program officer.

For RFAs and PAs, reach out to the program officer listed as the scientific/research contact. Also, you should speak with your current program officer if you already have NIAID-funded research, or use Finding People to locate the appropriate staff for your area of interest.

Council concepts are often the impetus behind PAs as well as RFAs, so staying abreast of NIAID’s research priorities can give you a jumpstart on your competition.

Timing

Your own schedule and availability can greatly impact your readiness to apply for funding, so you should be aware of an opportunity’s submission due dates and your institution’s internal deadlines.

Requests for applications

RFAs usually have only one receipt date, so you must move quickly when you find an RFA that interests you. Make sure to check Concepts: Potential Opportunities (linked below) to get an idea of the type of research initiatives that will be issued in the future. This can assist in the planning of your RFA submission.

Program announcements

Most PAs have multiple receipt dates, so you have more flexibility. You should be mindful of the timing of your submission, taking into consideration that often an application submitted the first time will not receive a fundable score and will need to be resubmitted. Check the specific PA for submission dates, which often follow NIH's Standard Due Dates. PAs are often active for up to three years. Keep in mind a PAR may have special receipt dates and one, two, or three receipt dates a year.

Funding

Our procedures vary for funding applications in response to RFAs versus those in response to PAs.

Requests for applications

RFAs carry stricter budget limits than most investigator-initiated PAs (an exception being program announcements with specific set-aside funds). Also, RFAs are usually limited to one activity code and have limits on the total amount of funds available and the number of awards.

A program officer can discuss with you whether your idea meets the requirements of the RFA.

Program announcements

Applications submitted under a parent PA are funded if they meet the payline. The payline is a percentile- or score-based cutoff, and every year NIAID establishes a payline for each activity code (e.g., R01, R21). New investigators are given a slightly higher payline than established investigators for R01s. RFAs do not have a differential payline based on new investigator status.

NIAID also allows program officers to nominate meritorious applications for selective pay and R56-Bridge awards, which creates additional flexibility for investigator-initiated applications to be funded beyond the payline.

Budgets for investigator-initiated applications are typically modular, which have maximum budget limits. For investigator-initiated applications with direct costs of $500,000 or more in any year of the grant, make sure to request prior approval and follow our Big Grants SOP.

We also fund applications to institute-specific PAs according to the activity code’s payline. There are exceptions, such as a PAS or PAR with set-aside funds, where set-aside funds enable us more flexibility in choosing which applications to fund. Be sure to read through the PA for details on funding procedures before applying.

Expertise

The specificity of research NIAID calls for in RFAs and PAs varies. Thus, your expertise may determine whether you should pursue funding through a given RFA or PA.

Requests for applications

While you may depart from the track of your previous research to match the requirements of an RFA, you must demonstrate the necessary expertise to carry out your proposed research.

Collaborations are key—ideally you will have established collaborations before proposing new research in response to the RFA. If this is not possible, you should choose a collaborator who is an expert in the field and ensure that the plans for data exchange are adequately detailed in the application.

Larger RFA programs (e.g., U19, UM1) may require that you have the necessary research infrastructure, like core facilities, which can affect your readiness to apply. They may also allow you to propose service cores, which typically provide standardized tools and reagents to support the program. When proposing a service core, make sure that you adhere to the requirements as outlined in the RFA.

Program announcements

For an investigator-initiated application in response to a parent PA, you have leeway to generate your own ideas and center your research within your own interests and expertise. However, you will have to convince peer reviewers that your topic can make an impact worthy of NIH's investment.

As with RFAs, NIAID uses institute-specific PAs to encourage studies in promising or under-researched scientific areas. For PARs and PASs, NIAID gives broad guidelines, which allow you greater flexibility to determine the direction of your research, although not as much freedom as when applying for a parent PA.

In all cases, talking with a program officer can help you decide whether your proposed research meets the necessary requirements, and can help you identify funding opportunities that match your expertise and research goals.

Related Resources

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.

"Do I need to request prior approval to reduce effort for everybody on my grant?"—anonymous reader

No. At NIAID, we require prior approval for significant (25 percent) changes in effort for only the following people:

Principal investigator
Personnel listed by name or job title in Section IV of the Notice of Award (the “AI Special Terms and Conditions” section)

Also, on multiproject or program project grants, NIAID requires prior approval for project and core leaders, though these people would not normally be listed in Section IV.

Your institution may determine other people are “key personnel” that we do not.

“Can I increase my effort on a grant without increasing my salary and thus keep my budget the same?”—anonymous reader

Yes, but we expect you to budget for salary at a level that matches your level of effort, up to the salary cap.

Keep in mind that if increasing your effort will alter the scope of your research, you need NIAID's permission for the change in scope.

Read Putting Effort Into Your Application and Grant and What Constitutes a Change in Scope? in the Strategy for NIH Funding to learn more.