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December 4, 2013

Feature Articles

In The News

Advice Corner

New Funding Opportunities

Header: Feature Articles. 

Step Seven to a Winning Application: Build Your Team

We moved the contents of this article into Ten Steps to a Winning R01 Application. As part of the Strategy for NIH Funding, the ten steps give you a path to funding success if you're applying for an R01.

Header: Other News. 

Hats Off to Our NIAID Review and Committee Volunteers

Big thanks go out to all the volunteers who served on NIAID peer review committees, our advisory Council, or other such group in FY 2013.

If you are an experienced investigator, please consider volunteering to join an NIAID peer review group.

Your generosity would help us identify and fund the best science—plus, your participation can give you valuable insights into the review process for your future applications. Learn more at How to Volunteer for a Review Committee.

Since you can click the Thank You list headers to sort by organization, you could see if any of your colleagues volunteered. Perhaps they can give a firsthand report of what the experience was like.

If you are on our Thank You list and spot any issues with how we listed you, email corrections to deaweb@niaid.nih.gov and accept our apologies.

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News Briefs

Coming Up: Deadline for Annual Reports to OLAW. You have until January 31, 2014, to submit your annual report to NIH's Office of Laboratory Animal Welfare (OLAW). To see what your report should include and how to submit it, read the November 25, 2013, Guide notice.

Changes in Key Dates for HIV-Related FOA. Take note if you're planning to apply for the funding opportunity announcement (FOA) on Pilot Clinical Trials to Eliminate the Latent HIV Reservoir (U01). NIAID pushed back key dates, including the application deadline to July 15, 2014. For others, read the November 25, 2013, Guide notice. We wrote about this FOA in our November 20, 2013, article "HIV Researchers: Funding Opportunities for You."

Header: Advice Corner.

Register and Report Results on ClinicalTrials.gov

This message goes out to PIs conducting Phase II, III, and IV clinical trials, as well as phase 0 and I clinical trials and other clinical research:

Register your trial and post your study results on ClinicalTrials.gov.

For some clinical trials this is mandatory, but we encourage it for all clinical research studies. Can't think of how it would benefit you? Check out the ways it can help you and other groups at Why Should I Register and Submit Results?

When Is Registration and Reporting Mandatory?

It's mandatory for all "applicable clinical trials," defined as:

  • Phase II, III, and IV clinical trials with interventions involving drugs, biologics, or medical devices that meet both of the criteria below:
    • Initiated or ongoing as of September 27, 2007.
    • Not completed before December 26, 2007.

However, you can submit information for clinical research even if your work doesn't fit those criteria.

Deadlines to Remember

Keep in mind important deadlines:

  • Not later than 21 days after enrollment of the first participant—register your trial to be compliant with the Food and Drug Administration Amendments Act (FDAAA).
  • Not later than 12 months after the primary endpoint or outcome—post your results. See Delayed Submission of Results for other exceptions.

Before You Use ClinicalTrials.gov

If you're not familiar with ClinicalTrials.gov, get a lay of the land by reading the following pages:

  • Glossary of Common Site Terms—lists and defines important terms that map to responsibilities and submissions requirements. Here are some of the terms with which you should become familiar:
    • Applicable Clinical Trials
    • Responsible Party
    • Sponsor
    • ClinicalTrials.gov Registration
    • Study Start Date
    • Results Posting
    • Primary Completion Date
    • Study Completion Date
  • Frequently Asked Questions—allows you to come up to speed efficiently in facts, requirements, and process.
  • About the Results Database—describes the results you will submit.

Also know whom to contact with questions:

  • If you have questions for ClinicalTrials.gov staff, email register@clinicaltrials.gov (you can use that email for questions that don't relate to registration).
  • If you have questions for the NIAID division or center that funds your study, contact your program officer, project officer, medical monitor, or project manager.

ClinicalTrials.gov was established as part of the FDAAA. To learn more, go to What NIH Grantees Need to Know About FDAAA.

Header: 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.

"What constitutes research misconduct?"—anonymous reader

Federal policy defines research misconduct as "fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results." See the Definition of Research Misconduct from the HHS Office of Research Integrity.

The law also says misconduct must be an intentional or reckless departure from "accepted practices of the relevant research community."

For more information on research misconduct, go to NIH's Research Integrity portal. To read about NIAID's processes, see our Bars to Grant Awards—Research Misconduct and Allegations of Research Misconduct SOPs.

"I am drafting a budget for a subaward on an R21 application. Are there any limitations on how much a subaward can receive?"—anonymous reader

As long as you play a substantive role in the research, your subaward may receive as much money as you'd like it to within the R21 budget limitations in the funding opportunity announcement. For more information, read our Subawards (Consortium Agreements) for Grants SOP.

Header: New Funding Opportunities. 

See other announcements at NIAID Funding Opportunities List.

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Last Updated December 04, 2013

Last Reviewed December 04, 2013