Revising and Resubmitting NIH Proposals Guide

Inside this 75-page guide you will find expert guidance for:

• NIH Rules for Resubmitting: Are You Including All of These?
• NIH Policy Change on Resubmitting Applications
• What’s the Difference Between an A1 Resubmission and a New A0 Submission?
• Understanding Reviewer Scores and Comments
• Second Opinions: Who Should Be Involved Throughout the Process of Creating
  Your NIH Proposal?
• Appealing a Review: Do You Have Enough Evidence to Support Your Case?
• Application Submission Tactics: Getting it Right the First Time
• Strategies to Address Common Problems for Significance, Innovation and Approach
  
• Revising Your Proposal for Resubmission: Taking the Time to Do It Right
• Your Revised Proposal´s Required Introduction: What It Needs to Say and Do
• Not Following the Reviewer’s Advice? How to Justify Your Decision
• Budget Changes: Take Advantage of this Opportunity to Clarify Your Spending Goals
• Writing Clarity Matters: Follow These Pointers to Convey a Strong Message
• Plus much more!

>>Click here to view the entire table of contents.

Limited-Time Offer Until Aug. 11th:

And now you can order your Revising and Resubmitting NIH Proposals Guide,
2nd Edition in PDF format for only $179! (a $299 value). Print version only $30 more.

Order your guide today in PDF or print, and receive a complimentary MP4 of the 60-minute, On-Demand Webinar entitled “Revising and Resubmitting an NIH Grant: Deciding Between A1 and A0,” (a $197 value, yours free!).

Upon ordering this manual you will automatically receive a PDF (digital) copy.
If you order a print version, please allow 7-10 days for delivery (US and Canada only).
Delivery times for other countries will vary based on your location and cannot
be controlled by us. You will also receive a PDF version when ordering print.

  Regarding Print version shipping costs:
Shipping and Handling to the US and Canada: FREE
Shipping and Handling to the all other International countries: $50.

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Section 1: NIH Rules for Resubmitting

As with any other aspect of NIH, it is important to read the initial RFA or program announcement you applied under carefully to see if there are any special rules regarding resubmissions. It is also helpful to talk with your program officer about resubmissions before making a decision. NIH has several websites with general advice on resubmissions, and many institutes have their own guidelines. Various institutes and centers run blogs and listservs which provide advice on working with the NIH and feature aspects of grants submissions. Researchers are encouraged to review these materials as part of their decision making regarding whether to resubmit a proposal that has been turned down as an A1.

NIH Policy Change on Resubmitting Applications

The NIH still allows only one resubmission of an unfunded application, which must be submitted within 37 months of the new (A0) application. If the resubmission is not funded, the previous policy stated that the application had to substantially differ in both content and scope in order to be eligible for submission as a new application. However, for all application due dates after April 16, 2014, if your resubmission application (A1) was unsuccessful at receiving funding, you may now submit the same idea as a new (A0) application for the next appropriate new application due date. This change in resubmission policy applies to applications submitted to all grant and cooperative agreement funding opportunities that allow resubmissions, including all fellowship, training, and career development awards.

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Section 2: Understanding Reviewer Scores and Comments

Once a grant is submitted to NIH, it goes to the Division of Receipt and Referral at the Center for Scientific Review, where it is reviewed for completeness and assigned to a Scientific Review Group (SRG) for peer review. Most grants go to centralized SRGs that serve all institutes, handling all proposals in a particular set of topics or approaches. The reviewers on these panels are recruited by the Scientific Review Officers (SRO) for their expertise. The roster of review panel members are published in the Federal Register by NIH, typically 15 days prior to the meeting and an applicant can request that a reviewer with a conflict of interest in a particular proposal not be assigned to review that proposal.

These requests are confidentially handled by the SRO and not passed on to reviewers, so applicants are encouraged to make their concerns clear. However, as one investigator interviewed for this guide noted, reviewers who do not like your work could talk to other reviewers and influence your grant’s outcomes even if they do not review it. That said, reviewers do sign a legally binding document which affirms that they will maintain confidentiality. These issues will be discussed later under the section ‘Appeals’.

PARs, RFAs or very specific proposals such as, an R24 mechanism or training and center grants, may be reviewed by a special review panel assembled for that purpose. In this case, the program officers will suggest reviewers based on the topics of the proposals and the program announcement. The SRO will take these suggestions under advisement when assembling the review panel.

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Section 3: Appeals

In cases where there is or appears to be a clear flaw in the peer review process for a particular proposal, it may be possible to appeal a review. Allowable grounds for an appeal include evidence of: bias, conflict of interest, lack of appropriate expertise within the Scientific Review Group, or factual error(s) made by one or more reviewers that could have altered the outcome of the review substantially. Appeals should only be considered if the applicant can provide evidence to support their case. The goal of the appeal is to have the proposal reviewed again either with different reviewers or a different scientific review group.

NIH’s policy on appeals was released in April 2011 and it applies to any proposal submitted after January 2011. The Institutes and Centers can create deadlines for appeals, but those deadlines must allow 30 days after review so that the comments and summaries are available to investigators. Appeals only should be considered after thoroughly reviewing the comments.

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Section 4: Strategies to Address Common Problems

After reviewing the comments and talking with your program officer, you decide that you want to revise and resubmit your proposal. How can you address problems raised by the review committee? Remember that you need to address all criticisms raised. If you do not agree with the reviews or want to change the project as reviewers suggest, you need to address and respond to the points the reviewers raise. While each proposal is unique, and your major goal is to respond to your reviewer’s comments, some strategies have proven effective with common problems in NIH proposals.

A classic study of NIH research grants published by Allen in the November 1960 issue of Science (Volume 132) found the following major reasons that proposals were turned down:

• Problem (58 percent)
• Approach (73 percent)
• Investigator (55 percent)
• Other (16 percent) (institutional issues, budget problems, not following directions, insufficient time, sloppy presentation)

While the approach is often a key part of the proposal, people involved in the review process now note that significance and impact are increasingly important reasons that a proposal is turned down. The investigator may have a good idea, but if it doesn’t move the science forward in a substantial way, present an innovation in current practice, or have the potential of making a clinical advance, it may not receive funding. Investigators need to not only be clear about their project, but connect their research to its impact on the field. If the project itself may have limited impact, but is an important step that will lead to future breakthroughs, it is critical that the knowledge gap the proposed project aims to fill needs to be spelled out clearly in the application.

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Section 5: Revising Your Proposal for Resubmission

Once you make the decision to revise the proposal, for a resubmission (A1) or as a new proposal (A0) under the current policy for resubmission, you will need to take a number of steps to prepare your revised proposal. Many of these steps occur before you begin writing. If the reviewers had concerns with your significance or impact, you may need to do additional research or talk with others to identify potential concrete clinical outcomes or changes in care that could come out of your project. You will need to seek concrete examples, so take the time to find all of the appropriate literature or identify where changes in clinical practice or care could come out of your project.

You may want to add an additional outcome that involves translating your work into practice, which could involve identifying a partner to try that translational product out. If the reviewers have questions about the investigator or team that can’t be resolved by more carefully describing expertise, previous partnership experience, or a role on the project, you may need to seek additional collaborators.

Before moving toward revising, you will need to identify these additional personnel and negotiate their level of participation in the grant. This may involve discussions with administrators and other institutions. If you need to collect more pilot data, you will need to find the resources to expand your pilot and complete that research. You will also need to identify potential places to publish the pilot data, write those publications, submit them, and wait for responses. If the problem involves pilot data, be prepared to wait a year or more before you can submit.

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About the Author —
Dr. Jo Anne Schneider

Dr. Jo Anne Schneider is currently an Associate Research Professor in Anthropology at George Washington University. She served as an American Association for the Advancement of Science (AAAS) Science and Technology Policy Fellow at NIH working with National Cancer Institute to translate research into practice (2003-2005). Dr. Schneider is an urban anthropologist focusing on the role of government, non-profits, and communities in intergroup relations, opportunity structures for marginalized populations (immigrants, refugees, people of color, people with disabilities, low income families), and social welfare and health policy creation and implementation. Her work consistently involves working with government, local institutions, community members and policy makers to develop applied research projects and translate research into policy and programs. She has an international reputation for developing interdisciplinary projects. Her most recent work focuses on the role of social capital in marginalized communities and the dynamics between government, nonprofits, and communities in implementing social welfare and health policy.

Contributing Author —
John W. Ludlow, Ph.D

Dr. Ludlow began his academic faculty career at the University of Rochester (NY) in 1991, with appointments in the department of biochemistry at the medical school and the university’s cancer research center. During this time he maintained an independently funded research laboratory training graduate students and post doctoral fellows in the area of tumor suppressor gene expression, protein structure, and function. Funding for his laboratory came from a variety of sources, including the NIH, the American Cancer Society, and private foundations. Dr. Ludlow began working in the commercial biotechnology sector in 2000, developing and managing research and preclinical programs for cell therapy and tissue engineered products, where he has continued to compete in, and advise on, multiple NIH award programs.

Researchers who:

• Need assistance reworking their proposals to make them more competitive
• Need to strengthen the Approach Section because 80% of the Impact score comes from here
• Are unsure how to effectively target their applications
• Are unfamiliar with the review process and scoring system
• Need to strengthen their communications with funding agencies
• Have a hard time assessing whether the grant has a chance for funding even with the revision
• Have achieved a low success rate

Limited-Time Offer Until Aug. 11th:

And now you can order your Revising and Resubmitting NIH Proposals Guide,
2nd Edition in PDF format for only $179! (a $299 value). Print version only $30 more.

Order your guide today in PDF or print, and receive a complimentary MP4 of the 60-minute, On-Demand Webinar entitled “Revising and Resubmitting an NIH Grant: Deciding Between A1 and A0,” (a $197 value, yours free!).

Upon ordering this manual you will automatically receive a PDF (digital) copy.
If you order a print version, please allow 7-10 days for delivery (US and Canada only).
Delivery times for other countries will vary based on your location and cannot
be controlled by us. You will also receive a PDF version when ordering print.

  Regarding Print version shipping costs:
Shipping and Handling to the US and Canada: FREE
Shipping and Handling to the all other International countries: $50.

Limited-time offer.