December 4, 2013Feature Articles
- Hats Off to Our NIAID Review and Committee Volunteers
- News Briefs
- Register and Report Results on ClinicalTrials.gov
- Reader Questions
Ten Steps to a Winning R01 Application series, which we are updating.
Top-notch expertise lies at the heart of your project's feasibility, so expect your reviewers to scrutinize your team's credentials closely.
For an R01 application to succeed in peer review, you must convince reviewers that your team is able to complete your proposed research. You’ll need to convince them to be your advocates, so develop your application with a strategy to get their support.
Here we take you further into the project design, focusing on people, while working within the iterative framework you've been relying on to plan effectively.
Make the Pieces FitMost projects rely on various types of expertise to carry out the different parts of the research.
For each experiment, you'll need to figure out the know-how required and make sure you can secure it. You may want to consider bringing in expert co-investigators, consultants, or even another PI (using a multiple PI project approach; read more below at Up for a Multiple PI Application?).
To get there, go through the Iterative Approach to Application Planning.
As you design your Specific Aims and experiments, you'll assess the expertise needed, while making sure you stay within your targeted budget.
Though we don't delve into budget planning until Step 9, you will need to consider money when you plan for personnel, typically your biggest expense.
In these times of tight budgets, many investigators feel their best bet is a modular budget (up to $250,000 in annual direct costs). This is no longer necessarily the case, and applicants should construct a budget that is appropriate for the proposed aims and objectives.
In a typical scenario, you can figure personnel will come in at about 80 percent of your budget, and equipment and supplies at around 20 percent.
Once you have determined who they are, your institution can give you the salary levels for each type of worker. Then you can calculate costs based on their level of effort (which you will also need for your application's Budget Justification).
In the application, you will specify all key personnel (including collaborators and consultants) by name (or "to be determined") and justify their roles and effort to be contributed to the project. Note that postdocs, students, and technical staff are not generally considered senior/key personnel.
The Art of CollaborationThe technical staff you hire may work on your grant full-time.
Others, especially senior-level collaborators, will sometimes be willing to work part-time on your project for "credit" (e.g., the ability to be associated with a cutting-edge project, their own scientific curiosity, the potential of authorship on future publications), rather than be paid a part of their salary.
It's often a good idea to expand your pool of expertise by recruiting expert consultants and collaborators, especially those who are known and respected in the field. You’ll want to secure collaborators to complement, and not overlap with, your expertise and experience.
If you are a new investigator, adding these highly experienced people to your team will not only fill gaps in your expertise and training, but also help build your reviewers' trust in your future success.
But while collaborations are common, there are some drawbacks.
For one, you will not have absolute control over the execution of that part of the research, for example, the timing of your collaborators' actions. Or something may come up and they may back out at the last minute.
Another issue—which you should decide on at the outset—is the ownership and access to data as well as the order of authors on future publications. Your collaborators will want to use the data they generate for their grant too and may see themselves as the lead. Note that collaborators differ from consultants:
- Consultants usually provide professional advice or services that fill small gaps, for example, supplying software. They often receive a set fee rather than salary support from your grant.
- Collaborators play an active role in the research. A grant may pay part of their salary through a subaward or consortium agreement.
Here are some questions to consider:
- Is the collaborator in your institution?
- If not, what inter-institutional agreements may be necessary?
- You might want to look at multiple PI agreements as an example.
- What intellectual property and data sharing plan arrangements do you need to make?
- What are the expectations for authorship and coauthorship on publications?
Up for a Multiple PI Application?The single PI model does not always work best for multidisciplinary, collaborative research. Another way to enhance expertise is to consider a multiple PI application, which can be very useful for research that needs a team science approach.
Team science can bring complementary and integrated expertise to a project and be a powerful strategy for success. Learn more about the pros and cons of working on a team by going to our Team Science page, linked below.
Note that the multiple PI option is usually appropriate only if you are in different fields and could not complete the research without the other person.
Think carefully before you decide to go this route, especially if you are a new investigator since multiple PI applications have big consequences for you:
- If your application includes an established PI, it won't qualify for the new investigator payline. You'll qualify for it only if all PIs are new.
- Once the multiple PI application is funded, you'll lose your new PI status, i.e., you'll no longer be able to apply as a new investigator.
- You must have time to devote to the project and be at the stage where you can assume duties as a PI. This is not a mentored career development award. The established investigator(s) listed as PIs on your application must also intend to devote the time and effort at the level of the PI.
- It's important that new investigators establish their own "scientific identity," which can be more difficult in a multiple PI situation.
- It can be more challenging to write a multiple PI application because it is more complex. It can be harder to manage too.
- You are more locked into the research you proposed when another person is involved than you are when you are on your own. (Read more on that topic in What Is a Grant? linked below.)
If you are proposing multidisciplinary research, either on your own or as part of a multiple PI project, think about the expertise on the review panel. Be clear about why the inclusion of a multidisciplinary approach can accomplish more, and have a higher impact, than if this approach was not used.
For more information on finding a study section that has the best fit with your proposed project, read Step 4: Identify a Study Section, linked below.
Not yet ready for an R01? Explore other ways of participating on a grant besides being a PI that will allow you to demonstrate leadership capabilities, e.g., leading a subproject within a larger project. Read more in Not Ready for Independent Support?, below.
Strategy for NIH Funding
- Part 1. Qualify for NIH Funding
- Part 2. Pick and Design a Project
- What is a Grant? in Getting a Grant for Innovative Research
- Step 4: Identify a Study Section
Sample Applications and Summary Statements—find examples of outstanding funded applications
- For NIAID reviewers, see our latest list at Thank You Members of NIAID Peer Review Groups and Advisory Committees.
- For Center for Scientific Review reviewers, see CSR Study Section Roster Index.
- For Council, go to Biographical Sketches of NIAID Council Members.
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 email@example.com and accept our apologies.
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."
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.
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.
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
- 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.
- If you have questions for ClinicalTrials.gov staff, email firstname.lastname@example.org (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.
Feel free to send us a question at email@example.com. 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.
- RFA-AI-14-002, International Collaborations in Infectious Diseases Research (U19)
- RFA-AI-14-001, International Collaborations in Infectious Diseases Research (U01)
- RFP-NIAID-DMID-NIHAI2013180, Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases