PMean: Informed consent in a study without human subjects

Steve Simon


Dear Professor Mean,

Do you need an informed consent form if you are not conducting research on human subjects?

Dear Reader,

Well, you don’t normally give informed consent forms to laboratory mice.They chew up the forms and eat them.

Let’s just make sure that you understand what “human subjects research” is. According to the U.S. Code of Federal Regulations, a human subject is someone from whom you obtain data from interaction or intervention or from whom you get identifiable private information. See guidance from hhs.

Research that does not involve human subjects is normally exempt from IRB review. You might want to talk to someone on your IRB if there is any potential ambiguity. It’s often worthwhile to get a written assurance of exempt status from your IRB before you start your research.

It’s also worth noting that some types of human subjects research can apply for a waiver of informed consent. For details, see the HHS Informed Consent FAQ.

You can find an earlier version of this page on my blog.