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NIH Requirements for Scientific Premise

Release Date: June 18, 2018
Category: Scientific Grant Writing
Authors: Sonia M., Ph.D., E.L.S.

In 2016, the NIH introduced new requirements to include information about rigor and reproducibility in research grant proposals. Specifically, proposals must now include information about the scientific premise, scientific rigor, biological variables, and authentication of key biological and/or chemical resources. If you still haven’t figured out how to include these requirements in your proposal, you’re not alone. Below, we provide some help with the scientific premise requirement.

Scientific Premise:

The scientific premise of your proposal is the knowledge upon which you are basing your hypothesis and aims. In a philosophical context, a premise is assumed to be true for the purpose of an argument upon which a conclusion is drawn. In science, however, the validity and accuracy of previous findings cannot necessarily be assumed as true. Instead, you are expected to evaluate the strengths and weaknesses of the evidence you are using as the basis (or premise) of your proposed research. What does this mean exactly? The reviewers want to know that you considered the strengths and weaknesses of the existing literature and/or your own unpublished data when developing your hypothesis.

This critical evaluation of the scientific premise should be included in the Significance section of the proposal. Your Significance section should still include information that describes to the reviewers why your research question(s) are important and the positive benefits of your planned research. For NIH grants, this means that you must emphasize the importance of the question you are asking as it relates to health, such as how your research may elucidate a disease mechanism, lead to new treatments, or prevent health problems. Thus, your Significance section must clearly convey what is currently known, what remains to be discovered, and who will benefit from that discovery.

You must now also include information on the scientific premise of the proposed research in the Significance section. How does this differ from just including background information? You must evaluate the quality of the previous research upon which your proposed research is based. For example, if you are asking if mutations in Protein X affect response to Drug Y, you will need to provide background information regarding why you think there may be a particular link. Is there one case study describing one person carrying a mutation in Protein X who did not respond to treatment with Drug Y? Reviewers will likely consider this rationale for your hypothesis to be weak and not score your proposal. However, if Drug Y has been shown in numerous published reports by multiple different groups to directly target Protein X, your rationale will be much more solid. What if you also know that a retrospective analysis of 1,000 patients’ medical histories found that no patients carrying a mutation in Protein X responded to treatment with Drug Y, but nearly all patients with a wild-type Protein X did respond? If this research was conducted well, with appropriate statistical analyses and sample numbers, the study result would further strengthen your argument. Beyond this simplistic example, consider if the study was properly controlled and if it used a diverse population. If the answers to these questions point to weaknesses, why do you still think you are right, or how will your proposal improve upon or clarify the knowledge? If the answers to these questions indicate strengths, how will you advance knowledge further?

Ultimately, the grant reviewers are specifically asked to evaluate whether you have considered the strengths and weaknesses of the data upon which you are basing your proposed research and to determine if they agree with your conclusion that the previous data is strong. Make their job easy by showing the reviewers that you have considered any weaknesses in previous literature (or in your preliminary results). If some of the data are weak, don’t try to hide that by not mentioning it. If the quality of the data on which you are basing your hypothesis is truly weak, you may be more successful holding off on your application and attempting to improve these data. If just some of the existing data are weak, admit this issue and offer solutions that could address these weaknesses (e.g., perhaps you are waiting on a confirmatory experiment, and you can say so).

Making sure you adequately explain the scientific premise of your work will ensure your proposal is well received by the reviewers and will help provide the best chance of funding success! The BioScience Writers grant reviewers are well versed in NIH rigor and reproducibility requirements. We can review your proposal, pointing out any weaknesses that you may wish to address before submitting your proposal.

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