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September 18, 2013

Feature Articles

Opportunities and Resources

In The News

Advice Corner

New Funding Opportunities

Header: Feature Articles. 

Go Beyond Basic Research With New NIH Clinical Research Initiative

Do you believe your discoveries will improve patient outcomes?

A new NIH initiative should help answer this question, and in doing so, open new pathways for large-scale research studies in clinical settings.

Read below for background and information about how you can request funding.

Transition Into the World of Clinical Research

NIH's Health Care System (HCS) Collaboratory, a Common Fund program, supports demonstration projects that test whether basic biomedical discoveries hold up when implemented in a "real world" setting through our health care system.

NIH has always placed a priority on basic research. These demonstration projects are designed to demonstrate how those basic research investments can improve health care practices, explore new ways of conducting research in clinical settings, and provide a framework for partnerships between basic researchers and health practitioners.

As part of that effort, the HCS Collaboratory is looking to measure outcomes for a variety of clinical practices as delivered by health care delivery organizations like hospitals and clinics.

For example, one demonstration project explored whether intensified antibacterial bathing reduces hospital-acquired infections.

That project included a cluster randomized two-arm clinical trial with rigorous controls, no on-site investigators, and significant monitoring to assess the value of chlorhexidine bathing and MRSA decolonization in reducing hospital-associated infections in non-critical care units.

For more about that project, look up Project Information for Decreasing Bioburden to Reduce Healthcare-Associated Infections and Readmissions in NIH's RePORTER database.

For more about the HCS Collaboratory program, go to NIH Collaboratory.

New RFA Focuses on Multiple Chronic Conditions

If you have an idea for your own demonstration project, check out a new opportunity to test interventions for patients with multiple—preferably three or more—chronic conditions.

Though the preference is for three, you can apply for projects that investigate care for adults with two chronic conditions if you can provide a specific justification for the study that describes critical gaps in knowledge about managing the proposed conditions. For studies focused on pediatric patients, two or more conditions is the minimum.

Demonstration projects have to:

  • Ask an important question that will likely lead to partnerships with health care delivery organizations.
  • Propose a simple intervention that does not require a complex structure for implementation.
  • Incorporate rigorous controls in your trial design. Preferably, cluster randomization.
  • Employ simple approaches to monitor and assess outcomes.
  • Use electronic health records as much as possible.

You'll have to partner with multiple health care delivery organizations and get letters of commitment to the project from them before you apply. At least two health care delivery organizations are required. These organizations will provide the infrastructure, patients, and staff, while you and your team will provide trial expertise, design, coordination, and analysis.

Your project must have a consolidated or centralized institutional review board, regardless of how many institutions are involved in the research.

Funding comes in two phases:

  • Phase I: One-year feasibility study.
  • Phase II: Four-year implementation, contingent upon meeting milestones for the feasibility study.

Demonstration projects receive up to $500,000 for the feasibility study, then $1 million each year to support implementation.

Since this RFA is a cooperative agreement, you should expect to work closely with your program officer and take direction from NIH.

Foreign applicants may not apply, and all sites must be located in the U.S. or its territories.

For details, application instructions, and a list of potential research questions and research areas, read the August 7, 2013, Guide notice. The deadline for applications is December 2, 2013.

Header: Opportunities and Resources.

HIV Researchers: Funding Opportunities for You

These two new R01 funding opportunity announcements (FOAs) may pique the interest of investigators studying HIV. Though they have different goals, each includes an intervention component.

Note: Both FOAs have three receipt dates, the first of which is January 7, 2014.

Propose Prevention Packages

MP3 III may have you thinking of a music player, but it's in fact the shortened name of this FOA: Methods for Prevention Packages Program III.

Submit an application if you can assemble a multidisciplinary research team and meet these two objectives:

  • Devise optimal HIV prevention packages for specific populations.
    • Your chosen population may be a specific high-risk group, e.g., Native Americans in the U.S. or men who have sex with men in high-incidence settings.
    • We strongly encourage studying populations that are most affected by the epidemic in a given setting. For example, adolescents (< 16 years old) in Sub-Saharan Africa.
  • Perform feasibility and acceptability studies to show that a prevention package (a group of prevention interventions implemented in tandem in the same population) is acceptable to the target population and the proposed study design is appropriate and feasible.

Proposed prevention packages must include both biomedical and behavioral interventions and interventions to optimize adherence and minimize disinhibition (risk compensation). The biomedical intervention would ideally be one where efficacy is known so that these data can be considered in your mathematical model, a required application component.

See the August 8, 2013, Guide notice for additional information.

Be in the (i)Know

What does our second FOA seek? Its title sums it up: Increased Knowledge and Innovative Strategies to Reduce HIV Incidence—iKnow Projects.

To expand just a bit, it's looking for investigators to develop novel strategies that can better identify people who are in high-risk populations and unaware that they are infected with HIV and link them to HIV testing, treatment, and prevention interventions.

Research areas of interest include:

  • Interventions to increase screening and testing for people unaware of their HIV infection, including those with acute HIV infection.
  • Mathematical modeling of strategies to reduce HIV incidence in these populations.
  • Clinical studies to determine feasibility and acceptability (up to Phase IIA) of novel interventions in these populations.

If you propose to conduct research in the U.S., we encourage you to study members of populations that have a higher proportion of people undiagnosed with HIV-1 than the national average as defined by the CDC.

For complete details on the opportunity, including other studies that would be appropriate, read the August 8, 2013, Guide notice.

Header: Other News. 

News Briefs

New for U.S. Grantees in FY 2014: PMS Subaccounts. Starting with new and noncompeting FY 2014 grants, your institution will receive funds through grant subaccounts in the Payment Management System (PMS). You will draw funds from a PMS subaccount dedicated solely to your grant.  For more information and special instructions for carryover of funds, read the September 3, 2013, Guide notice.

Added Requirements for Hurricane Sandy Awards. NIH will provide increased monitoring for all Hurricane Sandy recovery awards, including special terms and conditions to ensure compliance with the Disaster Relief Appropriations Act. Individual awards may also include additional Terms and Conditions in the Notice of Award. For more information and specific requirements, read the August 28, 2013, Guide notice.

ImmPort Releases Research Data. New data from six clinical studies or trials and updates to seven additional studies are now available through ImmPort, bringing the total number of shared studies on the site to 60. Research areas include predictive influenza biomarkers, antibody responses to pH1N1 and oral immunotherapy for childhood allergies. Read more about ImmPort in our July 3, 2013, article "'ImmPort' Yourself Over to New Immunology Data."

Watch NIH's Data Catalog Workshop. NIH recently held a two-day workshop to discuss a forthcoming NIH Data Catalog. Watch the workshop in two installments: Day 1, August 21, 2013 and Day 2, August 22, 2013. For upcoming events, visit BD2K Workshops and note that while NIH broadcasts all workshops, attendance is invitation-only.

Header: Advice Corner.

How Appealing Is an Appeal?

If you're thinking about appealing peer review results, consider our advice.

You may appeal if you have evidence of bias, lack of appropriate expertise, reviewer errors of a factual nature, reviewer conflicts of interest, or other flaws in the peer review process that would have had a significant impact on your application's final overall impact score.

Remember: differences in scientific opinion are NOT a basis for a successful appeal. If you disagree with a reviewer's comment, make sure this is not simply a difference of opinion.

Check With a Program Officer

Before contemplating an appeal, discuss your concerns with your program officer. He or she may have insights into reviewer comments and perspective on whether NIH conducted a proper review. Specifically, a program officer might be able to help you distinguish differences of scientific opinion from other issues and to advise on the likelihood of a recommendation of re-review from Council.

After talking to your program officer, you may find it better to revise and resubmit or create a new application.

If you still want to proceed with an appeal, understand the consequences.

Make Sure the Timing Works for You

Ask yourself: how long are you willing to wait for NIH to complete the appeals process?

First, you have to wait for our advisory Council to review your appeal.

If Council agrees with your appeal, we send it to the Center for Scientific Review (CSR) along with Council’s recommendations. If CSR accepts your appeal, your original application goes back for another peer review, which can take several additional months.

Finally, your re-reviewed application goes through our funding process, which adds even more time.

In the meantime you cannot resubmit; if you do, we'll have to withdraw your resubmission because NIH does not allow two versions of the same application at the same time.

If you plan to proceed with your appeal, start the process soon after you receive your summary statement. To be considered for the next Council round, the appeal should be submitted by your authorized organizational representative before Council meets; preferably by at least four weeks.

Keep Your Expectations Realistic

Expect one of two results:

  • Best case: re-review of your application by the same, or more commonly a different, study section. You may not edit or revise, and your application could score worse than it did during the first review. In any event, you have no guarantee of funding.
  • Worst case: failure of your appeal. The review outcome stands and you must resubmit, create a new application, or repurpose the application.

Ultimately your fate rests outside of NIAID. CSR has the final authority to grant or deny re-review—with no possibility of further appeal. Note that this advice applies to investigator-initiated grant applications that have been reviewed by CSR study sections. In most cases, the review of solicited applications (e.g., RFAs, PARs) cannot be appealed.

Have Good Reasons

An appeal may be the right strategy if you have a solid justification and you're confident you'll get a better score on re-review.

However, we find many applicants appeal because they disagree with a reviewer's evaluation of their project's merit—a matter of scientific opinion, not grounds for appeal under NIH's rules.

For examples of reasons to appeal and instructions on how to appeal, read our Appeals of Scientific Review of Grant Applications SOP.

Related Links

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.

"If NIAID doesn't fund my application, might another NIH institute fund it? "—anonymous reader

You can ask your program officer to identify another institute or center (IC) that might be interested in your project. Your program officer may then work with a program officer in the other IC to change your application's primary institute assignment.

For such an option to be considered, your project's scientific focus must be within the mission of the other IC.

Keep in mind that other institutes don’t often accept these types of requests. As an alternative, next time you apply, think about requesting a secondary institute assignment in your cover letter. Financial management plans vary among ICs. An application that is not fundable in one IC might be in another.  

"Does NIAID have samples of successful grant applications?"—anonymous reader

We post examples of exceptional funded applications at Samples and Examples under Sample Applications and Summary Statements.

Header: New Funding Opportunities. 

See other announcements at NIAID Funding Opportunities List.

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Last Updated September 18, 2013

Last Reviewed September 18, 2013