“As part of the interview, Levine explains why the Common Rule defines “research” in reference to design, rather than intent:
In my initial draft of the definition of research, I said research refers to a class of activities intended to do certain things, to develop knowledge. Joe Brady argued that there is no such thing as intent. One of the tenets of behavioral psychology is that the only things that count are what you can observe and measure; Joe insisted that one could not observe intent. He and I had a friendly and collegial, but very forceful argument. I argued that, before you write a protocol, you should know what people intend to do. At the next meeting, Joe brought in reinforcements — Israel Goldiamond, a psychologist from Chicago, to help explain why intent should not be used because you could never measure intent. We compromised on the term, “design.” You can measure the design. You can look at it. It’s written out in a protocol. I said the protocol represents intent, but I lost the argument. I was a pretty good loser. “Design” is not all that bad.”
Also in this the nondefiniton of mental illness in research.