See the Glossary for more terms.
Strategy for NIH Funding
Design a Project · Team Science
Pages of Part 2. Pick and Design a Project
Certain policy areas make applying for a grant much more complex. They include human subjects, vertebrate animals, rDNA, and stem cell research. In addition, NIH has requirements for resource sharing that affects applications that propose to create model organisms or request more than $500,000 in direct costs (for sharing final research data).
Here we summarize application requirements and give you possible approaches to bypass these areas. In case you cannot, we give you many links to additional resources.
If you have not yet planned your project, go to Pick a Research Project in Part 2.
While this document is geared toward the basic research project grant, the R01, much of it is useful for other grants.
(This section has factual information only; for advice on this topic, go to Our Advice below.)
If your research includes any of the following topics listed below, you will have additional documentation to complete for your application.
Even if you want to bypass these areas, you may find yourself entering one. For example, you could be conducting human subjects research even if you're not working with patients, or you may discover that your microbe of interest is on the government's select agent list and subject to the USA Patriot Act.
The table below gives you a highly simplified overview of additional requirements for the main hot-button policy areas that affect NIH applications and grants. Find links at the end of the document.
In your application, complete extra documentation on the protection of human subjects, data and safety monitoring, and the inclusion of women, children, and minorities.
Before award, have your application approved by an institutional review board (or an independent ethics committee for foreign applications), and send documentation of training in human subjects protection and possibly other items.
During the grant, do your annual certification of IRB or IEC approval (as well as any time you change the protocol), and complete reporting requirements.
For a clinical trial, you will have many additional requirements and special NIAID processes to undertake.
Use nonidentifiable data or specimens.
In your application, address the five points in the Vertebrate Animals Section of the Research Plan. Also Check for Limits on Your Planned Animal Species or Source in How to Write an Application Involving Research Animals.
If you're at a domestic institution, get your institutional animal care and use committee (IACUC) approval of your animal use protocol before award.
During the award, do your certification of IACUC approval every three years.
Use nonvertebrate animals or plan in vitro studies. See Consider Alternatives to Using Animals in How to Write an Application Involving Research Animals.
Comply with many regulations for access, security, biosafety, restricted experiments, incident response, training, transfer, and others.
For domestic institutions, get certified by CDC or the USDA's Animal and Plant Health Inspection Service, depending on the agent (foreign institutions follow different rules).
Read the Select Agent Awards SOP, and visit our Biodefense and Select Agents portal for more information.
Use an agent on the Select Agents and Toxins Exclusions list.
By September 24, 2015, your institution must establish the infrastructure to follow the federal Policy on Dual Use Research of Concern (DURC), including establishing a standing Institutional Review Entity (IRE).
The IRE assesses research conducted by the institution, identifies DURC as described in the Policy, and assesses the benefits and risks. If the IRE determines that NIH-funded research has DURC potential, your institution must notify the grants management official or contracting officer listed on the award within 30 days.
Avoid DURC concerns by ensuring that your research does not provide knowledge, information, products, or technologies that could be misused to pose a significant threat with broad consequences.
If your IRE determines that your research has DURC potential, work with NIH to develop an appropriate risk mitigation plan.
Before you apply, NIH may require approval by your institutional biosafety committee, NIH Recombinant DNA Advisory Committee, NIH director, or others.
Follow the NIH Guidelines for Research Involving Recombinant DNA Molecules.
Rules are complex—call the NIH Office of Biotechnology Activities at 301-496-9838 for help.
Find information about exempt experiments in the NIH Guidelines for Research Involving Recombinant DNA Molecules.
You must use an approved cell line. If you want to get yours approved, see our How to Get a Human Embryonic Stem Cell Line Approved.
Go to NIH's Stem Cell Information portal for more information.
Use an approved cell line from the NIH Human Embryonic Stem Cell Registry.
Include a plan to share and distribute model organisms or data or justify why you cannot.
Model organisms—if creating new, genetically modified variants of model organisms
Data sharing—share final research data if requesting $500,000 or more in direct costs in any year.
Data sharing for genome-wide association studies—share final research data at any budget level.
Read more in What Resources Do You Need to Share? in Write the Research Strategy in Part 3.
(This section has advice only; you should also read the factual information above at Just the Facts.)
You can bump up against human subjects research even if you're not working with patients.
Research topics that involve human subjects, vertebrate animals, select agents, rDNA, and the like invoke a host of policies and procedures that can put speed bumps and traffic lights in your application's path.
Even if you want to bypass these areas, you may find yourself entering one. For example, you can bump up against human subjects research even if you're not working with patients, or your microbe of interest may wend its way to the government's select agent list and be subject to the USA Patriot Act.
If that happens, see if you can take a different route. We aren't suggesting that you neglect regulations and policies—you always want to adhere to the highest of standards of conduct. But if you are a new investigator, you should do your best to keep it as simple as possible.
If you cannot, you'll need plan B: map out the additional application sections to complete, steps to take before you apply, items to submit before we make the award, and reporting requirements after you get your grant.
And you'll need to understand the timing of these extra steps you must take to avoid a delay in getting your award.
When planning studies using vertebrate animals, for example, think about whether you could achieve your objectives by using a non-vertebrate species or conducting in vitro research.
Ask yourself if you could avoid these areas and still accomplish your goals.
USDA regulations require you to search the scientific literature for alternatives, and if you do need animals, you'll include the search results in the protocol for your IACUC's approval. Even if you are using only animal tissue, you'll need to complete the vertebrate animal section of your application.
For human subjects, requirements don't apply if you are using unidentified data or specimens for lab research. Regulations define a human subject as a living person about whom an investigator obtains either 1) data through intervening or interacting with the person or 2) identifiable, private information.
In general if you're using coded private information, data, or specimens, your research is considered to be human subjects unless it meets both these conditions:
If you or any of your collaborators can determine a subject's identity or have access to identifiers, the research checks positive for human subjects, and all requirements apply.
This is a very tricky area, so be sure to get help. See the resources listed below, and talk to your IRB before writing your application.
If you are planning a clinical trial, call an NIAID program officer early on. You cannot apply for an investigator-initiated clinical trial without going through a defined process (see our Investigator-Initiated Clinical Trials Resources).
Animals in Research
See the other sections ofPart 2. Pick and Design a Project
Table of Contents for the Strategy
We welcome your comments, questions, or suggestions. Email firstname.lastname@example.org.
Last Updated May 13, 2015
Last Reviewed December 01, 2011