What the New NIH Guidelines for Appendices Means for You

The NIH Application Guide has been updated again, this time to introduce two changes to submission guidelines (effective on and after 25 January 2017). The first (NOT-OD-16-129) further restricts what may be included in the application’s appendix, while the second (NOT-OD-16-130) simplifies and consolidates guidelines for post-submission materials. This post reviews the appendix guidelines. The new post-submission materials guidelines will be discussed in a later post.

As of 25 January 2017, unless the instructions for the specific funding opportunity announcement (FOA) to which you are responding indicate otherwise, appendices will be limited to:

• blank surveys, questionnaires, data collection instruments, and informed consent/assent forms for all applications;
• clinical trial protocols and the investigator’s brochure from an IND (Investigational New Drug) for applications proposing clinical trials.

The new appendix guidelines are simply a further step in a sustained effort by the NIH to refine the application process. Back in the day, researchers threw everything they couldn’t fit in the proposal, usually papers and manuscripts, into the appendix in an effort to circumvent page limits. It could get sloppy, and, as a result, the ideas in these papers and manuscripts often were not well articulated in the proposal itself. In the past few years as part of the effort to refine the application process, the NIH and other agencies have restricted and more clearly defined what may be included in an application’s appendix. The penalty for ignoring these restrictions—withdrawal of the application from the review process—generally assures they are followed. Additionally, for those FOAs that allow for more materials to be included in the appendix, it was important to note that reviewers were not under an obligation to review materials included in the appendix. As a result, the strategic grant writer has already been writing proposals as if the new guidelines were already in place.

How to Strategically Respond to the New Limits

Just as airlines’ increasingly stringent limits on checked baggage and carry-on bags have forced travelers to pack less overall and be more strategic about what they do pack, page and appendix limits force applicants to be more strategic in how they present and package their ideas for reviewers. For strategic grant writers, the new limits will have little or no impact, because they already take care to assure that important information is written into the body of the proposal, not left to its own devices in the appendix. But for many who still rely on the appendix for whatever reason, this latest step in the refinement of the guidelines defining the application appendix will force the evolution of their approaches to the grant application.

Well-conceived plans are usually the easiest to articulate and present concisely, and so my rule of thumb when advising researchers is that if they are having trouble with the page and appendix limits, it’s likely less a problem with the verbiage and more likely a problem with the plan itself. The clunky parts of the proposal probably correspond to a clunky part of the research design, so work on the design itself before investing a lot of time trying to rework the proposal verbiage. If you find the logic and design are sound, review your literature review to assure it is complete and fully supports your logic. Sometimes researchers will spend a lot of time and space trying to extend the logic of their literature review to support their ideas, rather than appropriately expanding the literature review. The footprint of your literature review should correspond to that of your proposed research.

So How Do I Include Those Things That I Used to Throw Into the Appendix?

Papers and manuscripts, the usual items inappropriately chucked into an appendix, are not included in the list of approved appendix materials. So how do you include this information in your application? Of course, if the information is appropriate and important, it should appear in the proposal itself and have appropriate citations. This neatly addresses the issue of any peer-reviewed publications you are tempted to attach as an appendix. Also, publications and other appropriate materials can now be included in the NIH Biosketch by linking to your online bibliography. However, remember that reviewers are under no obligation to follow that link and review the body of your work, which is why, again, if the information is important it should be in the proposal. Manuscripts are a different matter, of course, and this is why researchers need to engage in strategic planning of their research, which involves consciously tending to their publication schedule in light of their funding application schedule.

As always, closely read the instructions for the FOA to which you are responding—those instructions supersede the general guidelines. Good luck!