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November 24, 2010

Articles

Reader Questions

New Funding Opportunities

Is Your Research “Human Subjects”? The Answer May Surprise You

Don’t get caught behind bars to award. Just because you aren’t working directly with patients, don’t assume you aren’t doing human subjects research.

A number of factors play into whether NIH will classify your work as human subjects research.

Reviewers and NIH make judgments based on the information you provide in the application. Your application will suffer if your call is different from NIH’s because it will lack the required human subjects information. That would cause NIH to slap on a code 44 for human subjects, which can affect your score and delay funding.

Avoiding a Code 44

First critical item to keep in mind: don’t make a human subjects determination on your own.

Before writing your application, always ask your institutional review board (IRB) if your proposed research classifies as human subjects. You probably don’t have time to wade through all the policies, so let your IRB guide you through the process.

The second critical point is that while your IRB will help you determine whether your work falls under the rubric of human subjects research, it won’t tell you what information to include in your application.

And that’s what can trip you up.

Tips for Filling Out Your Application

Keep the following on your radar:

  • NIH takes the protection of human subjects very seriously, so assume it will take the toughest stance on this sensitive topic.
    • In your application, show why your research is—or isn’t—human subjects.
    • In some instances, simply checking the “No” box for human subjects involvement doesn’t cut it—you must describe the reasons.
      • For example, if you’re working with samples and data of human subjects origin and want to consider your research not human subjects, you will need to give clear reasons why.
      • The links at the end of this article can help you make this distinction.
  • You may have more than one research activity in your application. Assess each activity independently to determine whether it’s:
    • Human subjects research.
    • Exempt human subjects research. Note: Very few NIAID applications fall under this category.
    • Research that does not involve human subjects.
    • To learn the distinction among these three categories, see Related Links below.
  • Intent doesn’t matter: “I don’t intend to ask for private information, therefore it’s not human subjects” is irrelevant if you could get access to the information.
  • Incomplete information for research involving specimens and data is often the trigger point for a code 44.
    • Even if you feel strongly that your proposed studies using human data or biological specimens are not human subjects research, you still need to justify that assertion.
      • Check first with your IRB to be sure its members agree; then carefully make your case in your application.
      • See Related Links bullets three and four below as well as the “Instructions for Preparing the Section on Protection of Human Subjects” in the PHS 398 instructions or SF 424 Grant Application Guide.
    • It’s not enough just to consider the PI’s access and role in the research. You need to describe scenarios starting with:
      • Source of the data and specimens.
      • Role of the provider of the data and specimens.
      • Roles of the recipient investigators.
      • Specimens or data you will obtain.
      • Statement whether the coded private information or biological specimens can be linked to living people.
    • Be careful not to go too far the other way. If, at the end of the day, you and your IRB have determined your research is not human subjects, avoid raising a red flag for your reviewers by providing so much information that you imply you have access to more data than you actually do.

Related Links

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ImmGen Offers Mouse Immune Data, iPhone App

Not only can you find microarray data of the mouse immune system at the Immunological Genome Project (ImmGen), but now you can get an ImmGen iPhone App to put the information at your fingertips.

The App lets you search for GeneSymbols or other aliases and see gene expression levels in different lineages of mouse immune cells. You can also get a barcode view for all lineages or detailed histograms for single lineages.

ImmGen is an NIAID-sponsored database that offers gene expression profiles and genetic regulatory networks for many cell populations in the innate and adaptive immune systems.

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SHIFT Your Plans to Business

Have you considered moving from academia into the realm of product development at a small business? Then check out SHIFT Award: Small Businesses Helping Investigators to Fuel the Translation of Scientific Discoveries, a funding opportunity that opened in March.

To help you make the move, use our SHIFT Connector: Bringing Business Jobs to Academic Investigators, which can help investigators and businesses link up. It’s open to all, regardless of scientific area or institute.

We’ve posted a long list of businesses hoping to recruit a scientist at SHIFT Connector: Businesses. And you can find networking opportunities through one of the organizations listed at SHIFT Connector: Networking.

Just recently we added our first investigator on SHIFT Connector: Academic Investigators. Researchers: consider following this person’s lead and send us your information. Businesses have told us they’re eager to see more candidates. You can use an anonymous email address if you’d like.

For more on SHIFT, see our introductory article from March 17, 2010, “Looking to SHIFT Your Career to Business?

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What’s Next for Our New Investigator Series

For now, we’re taking a break. We’ll publish our next article in the New Investigator Series — writing your Research Plan — in January.

Meanwhile, we’re focusing on posting some outstanding funded applications for you. Since no single strategy can work for everyone, we are striving for multiple examples that use different approaches to the Research Plan.

At last we are funding the shorter FY 2011 applications that can serve as examples. If you were recently awarded a grant, you may hear from us and we hope you will agree to participate.

If you’re new to the series, you may want to use this downtime to catch up and read the important advice in the earlier articles.

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Coming to Terms With New Terms of Award

For recent grants, you’ll get a Notice of Award with new terms and conditions that mean new requirements for you to comply with. You’ll need to understand these — and all — terms and conditions so you don’t unknowingly violate them.

In a nutshell, these are the main new items. See the Related Links section for more information.

The Federal Funding Accountability and Transparency Act mandates that, for federal awards, grantees report information about subawards and executive compensation and make sure subawards have a DUNS number.

Subaward Reporting

Beginning with new awards issued after October 1, 2010, institutions must provide data for subawards worth more than $25,000 over the course of the grant to the Federal Subaward Reporting System. Reports are due by the end of the month following the month in which the obligation was made. For example, obligation: October 29, report due: November 30.

Awards to the following are excluded from this requirement: 1) individuals, 2) other federal agencies, and 3) grantee institutions that have less than $300,000 in gross income for the previous tax year.

DUNS for Subawards

Subawardee institutions must have a DUNS number before they can receive a subaward. If you are applying as the PI, be sure to tell your potential subawardees about this requirement.

Executive Compensation

Depending on their size, structure, tax status, and amount of federal funding, some institutions have to report the total compensation of their five most highly-compensated executives for themselves and any subawardees receiving $25,000 or more over the course of the grant.

Reports are due by the end of the month following the month in which the obligation was made. Until further notice, this term applies only to new awards issued after October 1, 2010.

Questions?

If you have questions regarding these or other terms, contact the grants management specialist listed on your Notice of Award.

Related Links

Articles

News Flash!News Flash: New Interim NIAID Paylines

Check out the latest interim NIAID Paylines (overall impact scores):

  • Small grants (R03)—24
  • Academic Research Enhancement Awards (AREA) (R15)—24
  • Exploratory/developmental grants (R21)—24
  • SBIR, Small Business Innovation Research (R43 and R44)—27
  • STTR, Small Business Technology Transfer grants (R41 and R42)—29

We already told you about our interim paylines for R01s at the 8 percentile for non-new investigators and 12 percentile for new investigators.

As happens every fiscal year, we are using interim paylines to fund very high-quality applications before we establish our true paylines. To get Email Alerts for final paylines, choose that category at Email Alerts Subscription Center.

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Learn More About Research Integrity

This is your one stop for all needs regarding research integrity.

Check out NIH's new Research Integrity Web site, now open to the public. NIH has high expectations for investigators and staff to comply with research integrity rules and regulations.

You will find a variety of helpful tools on this site. Not exactly sure what research integrity is? Clueless about what process to follow if you suspect research integrity misconduct? This site provides links to pages that give step-by-step instructions on how to handle any relevant situation.

For more information and additional useful links, visit the Research Integrity Web site.

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Fellowships Get On Board With xTrain

For fellowships, using xTrain will be a requirement rather than an option starting January 1.

You may now submit termination forms through the xTrain module of the eRA Commons. But you must still mail in postdoctoral activation notices and payback agreements.

Starting January 1, 2011, using xTrain becomes a requirement rather than an option. For details, see the following:

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News Brief

NIH Revises Application Instructions. NIH updated the application instructions to reflect recent policy changes and other clarifications. All the policy changes should be familiar to you from previous Guide notices. For a summary of the updates and links, see the November 19, 2010, Guide notice.

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.

"Could I speak with a program officer in person about my research? I'll be visiting the Bethesda area near NIH soon."—an anonymous reader

The primary responsibility of program officers is to meet and advise researchers like yourself, but touch base with him or her to make arrangements and find out where to go. To find a program officer in your area of science, go to these pages:

Note that most of NIAID's program officers are not stationed on NIH's Bethesda campus, though their offices are nearby.

"Can a small business award application have a foreign PI?"—an anonymous reader

Yes, if all of the following are true:

  • PI has primary employment (more than half) with the small business at the time of award and for the duration of the project.
  • PI has either citizenship or a visa allowing work in the U.S.
  • PI receives a salary and pays taxes here (note: for STTR, the PI need not receive any salary from the grant).
  • All work is conducted in the U.S.
Read more in the Eligibility section of the parent announcements, SBIR Eligibility and STTR Eligibility.

For more information, visit our Small Business Awards portal.

Funding Opportunity Links

See these and older announcements at NIAID Funding Opportunities List.

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Last Updated October 06, 2011

Last Reviewed November 24, 2010