Institutional Review Board (IRB): Research at a Site

 Email us at irb@nu.edu    

 Visit the IRB Office Hours page

You are using a research site if you are planning to use the resources of an organization/school/business to recruit your potential participants and/or collect your data. Examples of using resources include:

• Conducting research activities on the property of an organization/school/business
• Someone at an organization/school/business is distributing your recruitment materials to their staff, students, or customers
• Someone at an organization/school/business is providing you with private contact information for their staff, students, or customers

If your research site does not have an IRB (or IRB equivalent), you will need to obtain written permission from an administrator at the site.

If your research site has an IRB (or IRB equivalent), please refer to the next section.

If you are conducting research at a site that has an IRB/HRPP, you will need to obtain their Federal Wide Assurance (FWA). This information is necessary and you will be asked to enter in the FWA from your site IRB/HRPP in your IRB Application. 

What is a Federal Wide Assurance (FWA)?

A Federal Wide Assurance (FWA) is the documentation of an institution’s commitment to comply with Federal regulations and maintain policies and procedures for the protection of human participants. An institution must have an FWA in order to receive Department of Health & Human Services (DHHS) support for research involving human subjects. This is the principal mechanism for compliance oversight by the Office for Human Research Protections.

How do I locate my site's Federal Wide Assurance (FWA)?

To locate your site IRB/HRPP's FWA, please click on the link below and type in the name of the institution/organization where you are conducting your research:

• Locate your site IRB/HRPP's FWA here

If you are unable to locate the FWA, it is likely that the site does not have an IRB/HRPP.

What does an FWA look like?

The FWA is comprised of numbers and letters. For example, National University's FWA is:

• IRB00013778

Need further guidance? Email the IRB (irb@nu.edu).

If you are planning to use a research site that has its own IRB, Human Research Protection Program (HRPP), or equivalent research office, you should reach out to that office early on to determine if your study will be feasible and to plan your next steps.

You should ask the office the following questions:

• Do you need to submit an application to their office?
• How long does it typically take for that office to review and approve applications?
• Do they have their own consent letter template that they want you to use? Or do they want you to use the NU IRB consent letter template?
• Do they want you to have approval from the NU IRB first, before they will review your application?
• Do they want an Institutional Authorization Agreement with NU?

The answers to these questions will determine what you submit to the NU IRB (review next section).

If you choose to submit an application to an additional IRB (or IRB equivalent), please note that you will be responsible for learning about their process, following all of their instructions and guidance, and contacting them directly if you have questions about their requirements.

Keep in mind that some IRBs (or IRB equivalents) may not review applications frequently, and their review process might take months. You should determine how long it might take to go through their process and decide if you are willing to spend that time. If you decide to go through a lengthy review process with another IRB, you can talk to your chair or advisor about taking a leave of absence.

If you submit to another IRB, you will still submit to the NU IRB as part of the requirement for your degree. What you submit to us will depend on the decisions from the IRB at your research site.

The site IRB doesn't want or need you to go through their application process.

You will submit the site IRB's decision in writing. You will then prepare supplemental documents that follow NU IRB requirements and guidance.

The site IRB does want you to go through their application process, and they will review your application without a determination from the NU IRB.

You will submit a copy of the application and supplemental documents you submitted to the site IRB. You will also submit the site IRB's approval/determination letter.

The site IRB wants you to go through their application process, but they want the NU IRB to review and approve your application first.

You will submit the site IRB's decision in writing. You will then prepare supplemental documents that follow NU IRB requirements and guidance.

The site IRB wants you to use the NU IRB consent letter template.

You will submit a consent letter that follows the NU IRB template and has been reviewed in an NU IRB writing service.