BioCoder #3

DIYbio and Human Subjects Research

Michael Scroggins

In what follows, I am going to float a thought balloon: DIYbio laboratories should think through their relationships with Title 45 Code of Federal Regulations Part 46, informally known as the “Common Rule”, which establishes the existence of institutional review boards (IRBs) for research involving human subjects. I think there are two related reasons for doing so.

First, DIYbio is quickly pushing into research involving human subjects. The GETit Project and the Immunity Project point to medical clinical research as an emerging direction for DIYbio research, and certainly there are others in the planning stage. This is not surprising, given that biology is an unusually broad discipline and DIYbio is more than just an amateur version of synthetic biology, even though it is often portrayed as such.

But medical and clinical research is a field with a long and complicated history that warrants caution. Scientists have experimented on themselves and those close to them since time immemorial. Jonas Salk, for instance, first tested his polio vaccine on himself, then on his family, then on children at the Watson Home for Crippled Children in Sewickley, PA, then on residents of Sewickley, and then on a few traveling friends and family members. Beginning with his own body, Salk’s vaccine spread outward in an ever-expanding circle.

In contrast to Salk’s success, Stubbins Ffirth, an 18th-century medical apprentice, was convinced that yellow fever ...