©  2018 Health Media Lab, Inc.





Does Your Study Need an IRB Review?

Generally speaking, if you have human subjects in your study, you will need IRB approval of the protocols for their protection prior to conducting your research.

Specifically, if you are about to conduct research involving human subjects that will obtain:

you will need IRB approval of all human subjects’ protection protocols before your study begins.

Moreover, if any of your subjects are children or minors (most countries consider subjects less than 18 years to be minors, and NIH considers any subject less than 21 years to be a minor), you should certainly obtain IRB approval.

IRB review assures compliance with Federal regulation (45 CFR part 46) essential to conducting human research, and protects both your subjects’ rights and your institution’s ethical and legal responsibilities. IRB approval may also enhance funding opportunities by promoting the reputation of your organization’s research quality. Compliance with regulatory and ethical responsibilities work together to build a quality research program.  IRB approval is vital for maintaining effective and efficient human research protection program based on considered ethical and legal decisions.

Regarding IRB Exemption

There are exemptions described in the Federal Code 45CFR46.101(b)(2).  Examples of studies that potentially do not need IRB review include:

However, most funding agencies still require IRB authorization.  Even if you feel your study qualifies for an exemption, it is advisable to have IRB approval, even if just an expedited IRB. For more on the principles and details of human subject protection rules, call us or visit DHHS Regulations.

If you are unsure whether your project needs IRB approval, please contact us and we will help with your decision.

It’s usually best for us to talk before you submit a request for IRB review, so please give us a call or an email anytime.