NIAID Funding Newsletter, September 4, 2013

NIAID Funding Newsletter, September 4, 2013

September 4, 2013

Feature Articles

• Step Five: Size Up Your Specific Aims

Opportunities and Resources

• Online Portal Makes Clinical Trial Data Available to Investigators
• Register Now for Grants Policy and Management Training in Argentina

In The News

• Take Note of Notices Affecting Students and Postdocs
• In With the New: Updated Parent Announcements Use Adobe Forms C
• News Briefs
  • Public Comments on AVMA Guidelines for Euthanasia of Animals Now Available
  • Sign Up for the FDA's Fall 2013 Small Business REdI Conference
  • Request for Information (RFI): Big Data

Advice Corner

• Best Way to Get a Speedy Response From Your Grants Management Specialist
• Reader Questions
  • Is travel an allowable expense on an NIH Pathway to Independence Award (K99/R00) application and can the funds allocated for travel be used for research support if travel plans change?
  • Does NIAID usually conduct a reverse site visit at the time of the review?

New Funding Opportunities

• See the list

Step Five: Size Up Your Specific Aims

This article is the fifth in our Ten Steps to a Winning R01 Application series, which we are updating.

Here we show you how to put to the test your draft objectives—Specific Aims—you have planned for your project.
Though we are following the steps shown in Iterative Approach to Application Planning in Step 3: Draft Specific Aims, this step provides 1) an extra check of your aims in light of the study section you identified and 2) advice on presenting your aims if you propose highly innovative research.

Take Aim

Start assessing your Specific Aims by taking a hard look at the significance and innovation of your planned research.

Ask yourself:

• Would my reviewers see my proposed project as tackling an important problem in a significant field?
• Would they view my Specific Aims as capable of opening up new discoveries in my field?
• Would my reviewers regard the work as new and unique?
• Would they view my Specific Aims as likely to exert a significant influence on the research field(s) involved?
• Are my Specific Aims written clearly and are they easy to understand?

You'll want to get outside opinions for a fresh perspective. Don't assume others, including your reviewers, will consider a research area to have the same priority that you do.

Also discuss your draft aims with colleagues who aren’t in your field. If they can understand your project and get excited about it, you have a better chance your reviewers will as well.

It is particularly useful to have your application reviewed by a colleague who has been successful in getting NIH funding, or better yet, has served on an NIH study section.

At this point, you may want to go back to Step 3: Draft Specific Aims, so you can be as certain as possible that the committee will appreciate your research plans.

Oh Innovation, Where Art Thou?

In previous Ten Steps articles, we emphasized the importance of proposing hypothesis-driven research with well-defined and feasible Specific Aims. But where does this leave innovative ideas that are less likely to fit inside "the box"?

Here are a few points to keep in mind:

Hypothesis-driven research does not necessarily constrain paradigm-shifting or "outside-the-box" research, nor does it necessarily mean sticking with the paradigm du jour. Paradigm-shifting and outside-the-box concepts can still lend themselves to focused hypotheses that can help guide the crafting of solid Specific Aims. Such focused hypotheses need not be tied to a broader theory or paradigm; they may simply provide a rationale that can be used to test the strength of the proposed aim or experiment.

Current criteria for scoring applications provide a transparent and fair guide to evaluate large numbers of diverse applications based on the aggregate merit of scientific significance, innovation, and feasibility.

For projects predominantly focused on innovation and outside-the-box research, investigators always have the option to use grant mechanisms, other than R01s, that may better suit their needs [e.g., exploratory/developmental research (R21) grants, NIH Director's Pioneer Award Program (DP1), and NIH Director's New Innovator Award Program (DP2)].

Serendipity is likely to happen just as frequently regardless of the grant mechanism supporting the research. As Einstein said, "Chance favors the prepared mind." NIH strongly encourages investigators to follow up on chance discoveries made in the course of executing R01-supported research programs.

How to Handle Innovation in Your Application

Although innovation is one of the five peer review criteria, many experienced investigators report that it's difficult to succeed in review with so called "high-risk" research.

Heed these words from an investigator who is the PI of an NIH New Innovator Award:

"It's always more difficult to convince people against commonly held beliefs (even though they may not be based on experimental data). Moreover, due to the higher risk of our work, we may also have a higher failure rate," says Sanjay K. Jain, M.D., of Johns Hopkins University School of Medicine and Bloomberg School of Public Health.

As you scrutinize your Specific Aims, make sure your reviewers will view them to be reasonably close to the scientific mainstream.

If your proposal challenges commonly held beliefs, be sure that you include sufficient evidence in your preliminary data to convince the reviewers that these beliefs may not be scientifically valid. If your research is high risk, it is likely to be highly innovative. Your job is to make the reviewers feel confident that the risk is worth taking.

So the research you propose should be new and unique and able to push forward the frontier of knowledge just ahead, starting from what's known, as the Expanding the Frontiers of Knowledge graphic illustrates:

When you write your application, you'll put the information about your project's importance and innovation in the Significance and Innovation sections.

Never forget that reviewers also look at the feasibility of the proposed research. Novelty alone will not help you if the proposed studies are not feasible given the available time, funds, and resources to do the work.

Get an idea of how investigators who wrote outstanding applications balanced these complexities by viewing our Sample Applications and Summary Statements, and read more advice on the pages linked below.

Related Links

Strategy for NIH Funding

• Design a Project in Part 2. Pick and Design a Project
• Investigate Committees and Members in Know Your Audience in Part 3. Write Your Application

Find publications

NLM Databases, Resources & APIs

Find funded projects, experts in your field, their publications and grants, and study sections that reviewed their applications

NIH RePORTER

Online Portal Makes Clinical Trial Data Available to Investigators

TrialShare is a new online portal, developed by the Immune Tolerance Network (ITN) to share its clinical trial data in an open and transparent manner.

ITN, an international clinical research consortium sponsored by NIAID, is dedicated to the clinical evaluation of novel, tolerance-inducing therapies for autoimmune diseases; asthma and allergic diseases; and rejection of transplanted organs, tissues, and cells.

The TrialShare portal provides public access to the underlying raw data and statistical analysis from ITN clinical trials as well as data analysis tools to enable investigators to reanalyze the information and develop new hypotheses. Currently, TrialShare houses data from eight ITN clinical studies.

TrialShare also provides a catalogue of ITN’s bio-repository samples, which investigators may request to perform follow-up experiments.

Earlier this year, the TrialShare research Web portal was recognized with an honorable mention in Best Practices by Bio-IT World.

The TrialShare portal is open to the public and creating an account is free. Visit the ITN TrialShare Web site for more information.

Register Now for Regional Grants Policy and Management Training in Argentina

Join NIAID staff in Buenos Aires, Argentina, September 23 to 25, for a Grants Policy and Management Training Workshop.

This three-day event is designed for principal investigators, business officials, budget coordinators, and others involved in grant administration. The focus will be on post-award management problems that are frequently encountered by foreign grantee institutions.

Sessions will cover information on grant and funding policies and resources for managing awards. You will also have the option to attend various mini-workshops on topics that may be of specific interest to you.

For information on registration and to see the agenda, go to Upcoming NIH Grants Policy and Management Training Workshops.

Take Note of Notices Affecting Students and Postdocs

At the recommendation of the NIH Advisory Committee to the Director's Biomedical Workforce Task Force, NIH is implementing two measures regarding students and postdocs that become effective in October 2014. For those who'd like to start preparing, here's a brief overview.

NIH Encourages Grantees to Develop Development Plans

To help graduate students and postdocs achieve their career goals, NIH expects grantees to take two actions:

1. Develop and implement institutional policies requiring Individual Development Plans (IDPs) for every graduate student and postdoc supported by any NIH grant.
2. Starting October 1, 2014, report IDP use in progress reports, no matter the type of NIH grant that's used for support.
   • NIH encourages institutions with IDP policies already in place and using the Research Performance Progress Report (RPPR) to start reporting IDPs after October 18, 2013.

Find additional details in the July 23, 2013, Guide notice and NIH's July 23, 2013, Extramural Nexus article.

Students With Commons IDs Will Be Common Soon

Postdocs working on NIH grants are no longer the only ones who need an eRA Commons account. That requirement now extends to graduate and undergraduate students who participate in NIH-supported projects for at least one person month of full-time work.

NIH is phasing in this new policy to give people time to register in the Commons and create a profile. Here's the implementation plan:

• Phase I, already in progress—as of August 15, graduate and undergraduate students can establish their Commons accounts.
• Phase II, starting October 18, 2013—the following take place:
  • Revised instructions and forms for the PHS 2590 Non-Competing Continuation Progress Report and Research Performance Progress Report (RPPR) become available.
  • Both the PHS 2950 and RPPR will prompt for graduate and undergraduate students' Commons IDs. Though IDs won't yet be required, the RPPR will generate a warning for students who have not established one.
  • Students—and postdocs—creating a Commons profile will be required to provide details such as birth date, disabilities, citizenship, and gender, race, and ethnicity.
    • Note: people may choose to answer "I Do Not Wish to Provide" for questions on gender, disabilities, race, and ethnicity.
• Phase III, starting October 1, 2014—Commons IDs are required. NIH will not accept RPPRs or PHS 2590s that do not have this information.

For more information, read the August 2, 2013, Guide notice and Extramural Nexus article.

In With the New: Updated Parent Announcements Use Adobe Forms C

Use the newly reissued parent announcements for your R01, R03, and R21 applications due on or after September 25. This new version uses the Adobe Forms C grant application packages, so if you had been working on an application using the old forms, you’ll need to copy your information into the new forms instead.
See the parent opportunities here:

• PA-13-302, Research Project Grant (Parent R01)
• PA-13-303, Exploratory/Developmental Research Grant (Parent R21)
• PA-13-304, Small Research Grant (Parent R03)

Beginning September 25, you’ll need to use the new forms for AIDS applications and continuous submission as well (see links above). In the meantime, for AIDS applications for the September 7 due date (which rolls forward to September 9), continue to use PA-11-260, PA-11-261, and PA-11-262.

For more on transition dates, see our earlier article “You Should "C" Which SF 424 Forms to Use.” NIH highlighted this shift in a July 26, 2013, Guide notice.

News Briefs

Public Comments on AVMA Guidelines for Euthanasia of Animals Now Available. Public Health Service (PHS) awardee institutions take note: NIH received 12 comments from the public about the updated American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals: 2013 Edition. Tthe NIH Office of Laboratory Animal Welfare has submitted all comments to the AVMA Panel on Euthanasia for consideration. For more information, including the link to view the comments, see the July 22, 2013, Guide notice.

Sign Up for the FDA's Fall 2013 Small Business REdI Conference. If you are planning to attend NIAID's SBIR workshop on September 27, 2013, in Washington, D.C., you may also be interested in attending the Food and Drug Administration's Small Business Regulatory Education for Industry (REdI) Conference. This conference will be held September 25 and 26 in Bethesda, MD and is free to attend. See the Fall 2013 REdI Conference Web page for more information.

Request for Information (RFI): Big Data. Respond to NIH's RFI on methods to improve data compression/reduction, data visualization, data provenance, and data wrangling. For details, read the August 8, 2013, Guide notice. Comments are due this Friday, September 6. Also read the August 21, 2013, article "Big Data: Web Site, Workshop, Funding Opportunity."

Best Way to Get a Speedy Response From Your Grants Management Specialist

If you have a grant, you have a grants management specialist to help you with administrative elements of your award: negotiation, reporting, budgeting, and management.

Whether you work with this person directly or your institution's business office takes the lead, when you need to get in touch, follow these steps to get a timely and thorough response:

• Contact your grants management specialist (listed in eRA Commons) if you know you're approved for an award or you’re already managing your grant. Otherwise, a program officer is probably your best bet.
• If contacting your grants management specialist is the right move, start with an email. In your email, do the following:
  • Provide your grant or application number.
  • Clearly explain why you are getting in touch and describe what you want.
  • Provide any other contact numbers and email addresses you have.
  • State how urgent the matter is, or give a time or date by which you need a response.
  • Copy your program officer.

Grants management specialists typically respond by the end of the next business day. However, from July to September their workloads get substantially heavier, so it may take two business days to get back to you. If you can afford to wait, please do.

If your issue is urgent or you do not get a reply within two business days, take these steps to escalate your request:

• Follow up with a call to the grants management specialist.
• If you still don't hear back, contact the most appropriate branch chief; find his or her name at Grants Management Program Contacts.
• If the branch chief doesn't reply in two business days, contact the Grants Management Program Chief, Mary Kirker.

For a graphic illustrating this process, go to Get a Speedy Response From Your Grants Management Specialist.

When would I contact my grants management specialist instead of my program officer?

Here's a rule of thumb:

• Talk to your grants management specialist about budgets, paperwork, and NIH policies. Read When to Contact an NIAID Grants Management Specialist.
• Talk to your program officer about scientific issues, your chances of getting funded, or changes in your application or funded research. Read When to Contact an NIAID Program Officer.

How do I know who my grants management specialist is and how to contact him or her?

Find his or her name and contact information in your funding opportunity announcement before applying, and in the eRA Commons after you apply or during the award. Keep in mind this can change during the life of the award, so check the Commons for the current person for that grant year.

You may also check NIAID's Grants Management Program Contacts.

Learn more in Communicating With NIAID—How to Get Help.

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.

"Is travel an allowable expense on an NIH Pathway to Independence Award (K99/R00) application and can the funds allocated for travel be used for research support if travel plans change?"—Margo Gladys, Aaron Diamond AIDS Research Center

Travel is an allowable expense, and yes, you may reallocate funds if travel plans change.

For more information, see Pathway to Independence Awards (K99/R00) SOP.

"Does NIAID usually conduct a reverse site visit at the time of the review?"—anonymous reader

No. However, this is sometimes a consideration for large, complex awards. If a site visit is necessary, your program officer will make arrangements with you and send a letter that includes a list of participants and an agenda.

See the Site Visits, Grantee SOP for more information.

• RFA-AI-13-036, Inner City Asthma Consortium

See other announcements at NIAID Funding Opportunities List.