Strategy for NIH Funding

Design a Project   ·   Team Science

Will Your Application Involve Policy Areas With Special Requirements?

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.

Table of Contents

• Just the Facts
• Our Advice
  • Is There a Detour?

Just the Facts

(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.

Policy	Hurdles and Alternatives
Human subjects—includes research on identifiable, private information	Hurdles 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. Detours Use nonidentifiable data or specimens.
Vertebrate animals	Hurdles 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. Detours Use nonvertebrate animals or plan in vitro studies. See Consider Alternatives to Using Animals in How to Write an Application Involving Research Animals.
Select agents	Hurdles 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. Detours Use an agent on the Select Agents Exclusions list.
rDNA	Hurdles 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. Detours Find information about exempt experiments in the NIH Guidelines for Research Involving Recombinant DNA Molecules.
Human embryonic stem cells	Hurdles 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. Detours Use an approved cell line from the NIH Human Embryonic Stem Cell Registry.
Resource sharing	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. You will also need our approval before submitting any investigator-initiated application requesting that level of funding. For details, see the Big Grants SOP. Data sharing for genome-wide association studies—share final research data at any budget level. Include a data sharing plan in the application for a study of variation across the entire human genome to identify genetic associations with observable traits or the presence or absence of a disease or condition. You'll need institutional review board approval for this plan. Read more in What Resources Do You Need to Share? in Write the Research Strategy in Part 3.

Our Advice

(This section has advice only; you should also read the factual information above at Just the Facts.)

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.

Is There a Detour?

Ask yourself if you could avoid these areas and still accomplish your goals.

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.

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:

• You are not collecting samples by interacting or intervening with living people.
• None of the investigators listed in the application can identify the subjects (e.g., identity is blocked by a written agreement).

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).

More Resources

Human Subjects

• To decide whether your research involves human subjects, see:
  • Are You Conducting Human Subjects Research? in the NIAID Human Subjects Application and Grant Handbook
  • SF 424 Application Guide
• NIAID resources—go to the NIAID Human Subjects Resources portal
• NIH resources
  • FAQs From Applicants Human Subjects Research
  • FAQs About Research Using Human Specimens, Cell Lines, or Data
  • Inclusion of Women and Minorities as Participants in Research Involving Human Subjects—Policy Implementation Page
  • Research Involving Human Subjects
• HHS Office for Human Research Protections
  • File a New Federalwide Assurance
  • Human Research questions and answers
  • International Compilation of Human Subjects Research Protections—to use, scroll down and choose a country
  • Special Protections for Children as Research Subjects

Animals in Research

• Office of Laboratory Animal Welfare
  • Guide for the Care and Use of Laboratory Animals
  • PHS Policy on Humane Care and Use of Laboratory Animals
  • Domestic Institutions with a PHS Approved Animal Welfare Assurance or Foreign Institutions with a PHS Approved Animal Welfare Assurance
• NIAID resources—go to the Animals in Research portal
  • How to Write an Application Involving Research Animals
  • Vertebrate Animals in Research questions and answers

Select Agents

• NIAID resources—go to the Biodefense and Select Agents portal for SOPs, terms of award, and more
• National Select Agent Registry
  • HHS AND USDA Select Agents and Toxins
  • Select Agents Exclusions list

rDNA

• NIH Guidelines for Research Involving Recombinant DNA Molecules—Section III describes six categories of experiments covered by the Guidelines
• NIH Office of Biotechnology Activities

Stem Cells

• NIAID's How to Get a Human Embryonic Stem Cell Line Approved
• NIH's Stem Cell Information portal

Sharing Policies

• Data Sharing for Grants: Final Research Data SOP and Data Sharing for Grants: Genome-Wide Association Studies (GWAS) SOP
• Sharing Model Organisms SOP

Strategy for NIH Funding

Design a Project   ·   Team Science

See the other sections of
Part 2. Pick and Design a Project

Table of Contents for the Strategy

We welcome your comments, questions, or suggestions. Email deaweb@niaid.nih.gov.