When Do You Need an IRB?

IRB or Institutional Review Board is an FDA-approved group that’s responsible for monitoring any biomedical research or study that involves human subjects.

The point is to ensure that the study is done in a manner that doesn’t compromise any human rights. However, does every study involving people require an IRB? When do you need an IRB?

You need an IRB when your study that includes human subjects has research purposes in it, especially if it involves access to private information. 

However, there are some cases where you’d still be gathering data from humans but not require IRB. let’s clear this up a little.

Understanding IRB Involvement

Despite mentioning three reasons above, the main reason to require an IRB is having research or dual purposes. Your project may involve human subjects but still doesn’t require an IRB.

For example, let’s assume that your project involves screening procedures for certain disease(s) for all personnel involved with a certain workplace.

However, you’re not gathering any information or surveying any data from this project for research. You’re just ensuring that everyone in an environment is disease-free.

In that case, your project, despite including human subjects, doesn’t have research purposes in it and thus, doesn’t need an IRB.

When Do You Need An IRB?

To keep things clear, we’ll use the same example mentioned above and make it qualify for an IRB.

Your project would still involve screening procedures for the same disease(s), however, you will be gathering the project data for analysis. This data will involve sensitive information.

For example, you’ll be writing down private information about people like their medical history, current health condition, age…etc.

That’s when you, not only would need an IRB but would also run into legal issues if you don’t get it involved.

Now that we have a basic understanding of IRB and when it’s needed, let’s have a look at some study examples that may or may not require IRB.

Study Examples That Require IRB

  • Dissertations (long academic writings which are based on original research. They are usually parts of graduate or post-graduate degrees).
  • Master’s theses.
  • Studies that involve using information from medical, employment, or student records.
  • Studies that involve interaction or intervention of human subjects like focus groups and surveys.

Study Examples That Don’t Require IRB

  • Studies that involve biographies, as long as the data won’t be used as generalizable knowledge.
  • Collection of data for administrative purposes, like student grades and performance within an educational institution.
  • Collection of data for quality improvement, like sending feedback surveys to customers or students regarding the quality of the service they received.
  • Information regarding training results, providing that you’re not using them for research.

Final Words

To wrap the whole thing up, you’ll need an IRB when you’re gathering sensitive data from human subjects and planning to use them for research purposes. That doesn’t mean that every data gathered from human subjects requires IRB. The study has to have (research) in its purpose to require IRB.