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September 29, 2010

Feature Articles

Opportunities and Resources

Other News

Advice Corner

New Funding Opportunities

Feature Articles

News Flash graphicNews Flash: HIV/AIDS Clinical Trials Networks on Meeting Docket

Learn about plans for the next clinical trial networks at a town hall meeting.

Come one, come all to a town hall meeting on NIAID's HIV/AIDS Clinical Trials Networks. You'll have an opportunity to learn about plans for the next generation of HIV/AIDS CTNs, including how they'll be structured from 2013 to 2020.

Institute staff and their NIH partners will discuss expanding the networks' scope and other topics, such as:

  • NIAID's clinical research priorities for HIV/AIDS: prevention, therapeutics, and vaccines.
  • Treatment and prevention of other infectious diseases—namely tuberculosis and hepatitis—that affect people who have or are at risk for HIV infection.
  • The upcoming application process.

If you'd like to attend on Tuesday, October 26 in Arlington, VA, you can sign up and submit questions at Registration.

For those unable to make the meeting, watch for a video on the NIAID Web site that will be posted at a later date. You may also find more information and provide comments at blog.AIDS.gov. The Institute has blog posts on various aspects of the Networks' restructuring and welcomes your feedback.

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Can You Bypass Policy Speed Bumps?

This is the ninth article in our New Investigator Series.

Until now, we discussed what it takes to get independent support and key decisions and actions for planning your application. Here we delve into requirements for research that involves hot-button policy areas you should try to avoid.

Research topics that involve human subjects, vertebrate animals, rDNA, and the like invoke a host of policies and procedures that can put speed bumps in your application's path.

Summary

  • Vertebrate animals and rDNA are examples of topics that involve policies and procedures that make applying more complex.
  • Even if you want to take a detour, you may find yourself entering one of these areas.
  • See if you can use an alternate route and still accomplish your goals.
  • Start preparing your "just-in-time" information so it will be ready when we ask and will not delay your award.
  • Talk to your program officer and grants management specialist early on to learn NIH's expectations.

As a new investigator applying for funding, it's generally a good idea to err on the side of simplicity: propose a highly focused project and steer clear of complex policy areas.

Research topics that involve human subjects, vertebrate animals, select agents, rDNA, and the like invoke a host of policies and procedures that can put speed bumps and traffic lights in your application's path.

Even if you want to bypass these areas, you may find yourself entering one. For example, you can bump up against human subjects research even if you're not working with patients, or your microbe of interest may wend its way to the government's select agent list and be subject to the USA Patriot Act.

If that happens, see if you can take a different route. We aren't suggesting that you neglect regulations and policies—you always want to adhere to the highest of standards of conduct. But as a new investigator, you should do your best to keep it as simple as possible.

If you cannot, you'll need plan B: map out the additional application sections to complete, steps to take before you apply, items to submit before we make the award, and reporting requirements after you get your grant.

And you'll need to understand the timing of these extra steps you must take to avoid a delay in getting your award.

The table below gives you a highly simplified overview of additional requirements for the main hot-button policy areas that affect NIH applications and grants.

Policy
Hurdles and Alternatives
Human subjects—includes research on identifiable, private information

Hurdles

In your application, complete extra documentation on the protection of human subjects, data and safety monitoring, and the inclusion of women, children, and minorities.

Before award have your application certified by an institutional review board (or an independent ethics committee for foreign applications), and send documentation of training in human subjects protection and possibly other items.

During the grant, get annual recertification of IRB or IEC approval (as well as any time you change the protocol) and complete reporting requirements.

For a clinical trial, you will have many additional requirements and special NIAID processes to undertake.

Detours

Use nonidentifiable data or specimens.

Vertebrate animals

Hurdles

In your application, address the five points in the Vertebrate Animals Section of the Research Plan.

If you're at a domestic institution, before award get institutional animal care and use committee (IACUC) approval of your animal use protocol.

During the award, get your certification of IACUC approval reapproved every three years.

Detours

Use nonvertebrate animals or plan in vitro studies.

Select agents

Hurdles

Comply with many regulations for access, security, biosafety, restricted experiments, incident response, training, transfer, and others.

For domestic institutions, get certified by CDC or the USDA's Animal and Plant Health Inspection Service, depending on the agent (foreign institutions follow different rules).

Read the Select Agent Awards SOP for details and visit our Biodefense and Select Agents portal for more information.

Detours

Use an agent on the Select Agents Exclusions list.

rDNA

Hurdles

Before you apply, NIH may require approval by your institutional biosafety committee, NIH Recombinant DNA Advisory Committee, NIH director, or others.

Follow the NIH Guidelines for Research Involving Recombinant DNA Molecules.

Rules are complex—call the NIH Office of Biotechnology Activities at 301-496-9838 for help.

Detours

See Exempt Experiments in the NIH Guidelines for Research Involving Recombinant DNA Molecules.

Stem cells

Due to recent legal changes, this area is in flux. Call your program officer for advice and go to NIH's Stem Cell Information portal for information.

Resource sharing

Include a plan to share and distribute model organisms or data or justify why you cannot.

  • Model organisms— if creating new, genetically modified variants of model organisms
  • Data sharing— share final research data if requesting $500,000 or more in direct costs in any year.
    • You will also need to get NIAID approval before submitting any investigator-initiated application requesting that level of funding or higher. For details, see the Big Grants SOP.
  • Data sharing for genome-wide association studies—share final research data at any budget level.
    • Include a data sharing plan in the application for a study of variation across the entire human genome to identify genetic associations with observable traits or the presence or absence of a disease or condition.
    • You'll need institutional review board certification for this plan.

Is There a Detour?

Ask yourself if you could avoid these areas and still accomplish your goals.

When planning studies using vertebrate animals, for example, think about whether you could achieve your objectives by using a non-vertebrate species or conducting in vitro research.

USDA regulations require you to search the scientific literature for alternatives, and if you do need animals, you'll include the search results in the protocol for your IACUC's approval. Even if you are using only animal tissue, you'll need to complete the vertebrate animal section of your application (see our first reader question below).

For human subjects, requirements don't apply if you are using unidentified data or specimens for lab research. Regulations define a human subject as a living person about whom an investigator obtains either 1) data through intervening or interacting with the person or 2) identifiable, private information.

In general if you're using coded private information, data, or specimens, your research is considered to be human subjects unless it meets both these conditions:

  • You are not collecting samples by interacting or intervening with living people.
  • None of the investigators listed in the application can identify the subjects (e.g., identity is blocked by a written agreement).
If you or any of your collaborators can determine a subject's identity or have access to identifiers, the research checks positive for human subjects, and all requirements apply.

This is a very tricky area, so be sure to get help. See the resources listed below, and talk to your IRB before writing your application.

If you are planning a clinical trial, call an NIAID program officer early on. You cannot apply for an investigator-initiated clinical trial without going through a defined process (see our Investigator-Initiated Clinical Trials Resources).

Put the Pedal to the Metal for Just-In-Time

For applications that have a reasonable chance of being funded, we request some information just-in-time, in other words, you send information to us when we request it, after initial peer review.

We request just-in-time documentation for any of the following items relevant to your research that you did not include in your application:

  • Human subjects
    • Assurance number.
    • Certification of institutional review board approval of Research Plan.
    • Letter to document training in the protection of human subjects.
  • Animals
    • Animal welfare assurance number.
    • Certification of institutional animal care and use committee approval.

Just-in-time doesn't really save you time. Even though you must wait for our request before you can submit, start preparing your submission early—if you have any chance of funding—so you don't risk a delay for your award. Talk to your program officer for advice about funding.

Until we are satisfied that your application meets all requirements, we will not make the award. Before we do, your grants management specialist goes through a checklist of items to make sure your application complies with all NIH policies that affect it.

In addition to the documentation mentioned above, he or she looks at such items as our preapproval of an application over $500,000, compliance with any special requirements in a request for applications, and research overlap with another funded grant.

If your research will be in any of the high-profile policy areas we've discussed, talk to your grants management specialist early on to learn NIH's expectations.

One more point to keep in mind: a just-in-time request is not a guarantee that we will fund your grant—read more in our article in this issue "Stay on Top of Just-in-Time Information."

Learn more about these and other areas in the links below. For detailed information, read the SF 424 R&R Application Guide and your funding opportunity announcement. And be sure to talk to your business office to find out about your institution's own requirements.

Related Links

Human Subjects

Animals in Research

Select Agents

rDNA

Stem Cells

Sharing Policies

Opportunities and Resources

Find Resources for Infectious Disease Research

Choose from approximately 15,000 authenticated, quality-assured, unique products ready for distribution.

This is the second in a series of articles highlighting resources for researchers from NIAID's Division of Microbiology and Infectious Diseases (DMID).

When you're looking for organisms and reagents to move your research forward, don't forget to check the Microbiology and Infectious Diseases Biological Resources Repository.

Choose from approximately 15,000 authenticated, quality-assured, unique products ready for distribution. You can get materials at no charge; you just pay shipping and handling fees.

You don't need an NIAID grant, but you do have to be PI or research director at an institution that has facilities and safety programs appropriate for the product you want.

When you register with the repository, provide the information necessary to confirm you're equipped to handle the materials. After your registration is processed—it takes no more than a few days—you can start shopping from an online catalog.

For links to the catalog and information on eligibility, assurances, user requirements, a program contact, and the application and approval process, visit Microbiology and Infectious Diseases Biological Resources Repository.

Related Links

Other News

News Briefs

NCMHD Becomes an Institute. On September 13, 2010, the National Center on Minority Health and Health Disparities (NCMHD) moved up to institute status, becoming the National Institute on Minority Health and Health Disparities. NIAID has a strategic plan on health disparities; we will pursue future collaborations with NIH's newest institute. Read more in NIH Announces Institute on Minority Health and Health Disparities.

New Scoring for Investigator-Initiated P01 Cores. NIAID review groups are assigning overall impact scores from 1 to 9 for program project (P01) cores. Previously, cores were given a rating of acceptable or unacceptable. The overall program, each project, and each core now get their own overall impact score. We'll let you know later how we will score cores for solicited P01s.

NIH Restricts Submission of Late Application Materials. The time has arrived for strict limits for post-submission application materials. NIH has curbed the type of information you are allowed to submit late to mainly administrative items. See our June 23, 2010, article "Stricter Rules for Late Application Materials Are on Their Way" and the July 23, 2010, Guide notice.

Advice Corner

Stay on Top of Just-in-Time Information

How important is it that your just-in-time information be accurate and up to date? So important that NIH issued a Guide notice earlier this month to drive the point home.

As you may know, if your application falls within the range of possible funding, you'll be asked to submit items such as other support and certifications related to human subjects and vertebrate animals.

The ball then falls in your court to not only provide this information expeditiously but also to ensure that it is correct and current up to the time of award.

Your institutional business official can submit updated information electronically as often as needed through the just-in-time feature of the eRA Commons. For further details, including what items to send just-in-time, see Related Links below.

Keep in mind that a just-in-time notification has no implications for funding. NIH automatically sends it to people whose R01 applications score below a certain percentile—a number that has no relation to our funding payline.

If your application does score above the payline, follow your program officer's advice. In most cases, you should start preparing your submission early to avoid a possible delay in getting the grant.

Related Links

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Reader Questions

Feel free to send us a question at deaweb@niaid.nih.gov. After responding to you, we may include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.

"If I will use animal tissue from a company and not the animals, do I need to include a vertebrate animal section in the application and a protocol number?"—Dr. Joshua W. Brownlee, Department of Pediatrics and Communicable Diseases, University of Michigan Health System

Yes, you must include a vertebrate animal section and include your collaborator's protocol number. For general information about vertebrate animals, visit our Animals in Research portal.

"Can I apply for SBIR and SHIFT funding for the same project at the same time?"—an anonymous reader

No, NIH can accept only one application for the same project, so you have to pick one announcement. If your application does not succeed, you can choose to revise and either resubmit to the same opportunity or try for the other one. Learn more about SHIFT at SHIFT Connector: Bringing Business Jobs to Academic Investigators.

"Do you have any sample applications with the shorter Research Strategy to share yet?"—several readers

(Editor's note: After this issue was published, we posted Sample R01 Applications and Summary Statements at Samples and Examples.)

It's still too soon, but we're almost there. We don't expect applicants to give us permission to use their applications as samples before they are funded and the research is underway. We'll start making some FY 2011 awards this month.

While we do have older applications at Samples and Examples, use them with great care since they have the outdated Research Plan format.

As soon as is feasible, we'll start making inquiries toward getting new samples and will let you know as soon as they are on the site.

Funding Opportunity Links

See these and older announcements at NIAID Funding Opportunities List.

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Last Updated February 09, 2012

Last Reviewed November 23, 2010