The following research history trivia quiz should get us thinking both about just how long research has been going on, and why maintaining certain ethical standards is important.
Q. Where would you look to find a description of the earliest known activity that might be described as research involving one or more human subjects?
- Published descriptions of the Tuskegee experiment
- Contemporary accounts of Edward Jenner’s smallpox vaccination testing
- The Old Testament’s description of trying different kinds of diets
Yes, you guessed it — research is mentioned as far back as the Old Testament. Daniel 1:12-16 describes examining the effects of a particular diet, using an intervention and a control group:
“Please test your servants for ten days: Give us nothing but vegetables to eat and water to drink. Then compare our appearance with that of the young men who eat the royal food, and treat your servants in accordance with what you see.”
So he agreed to this and tested them for ten days. At the end of the ten days they looked healthier and better nourished than any of the young men who ate the royal food. So the guard took away their choice food and the wine they were to drink and gave them vegetables instead.”
The three “research” examples listed above do have at least two traits in common. First, they all predate the IRB era by a very long time, as the Common Rule describing how IRBs are to function wasn’t adopted until 1991. Second, they all have what might be called very significant ethical shortcomings that would never, ever get by an IRB (or an IRB previewer) doing their job correctly today. In fact, it looks as though these experiments fail just about all of the criteria for approval listed at 45 CFR 46.111 and in IRB Policy 7.1. We encourage you think about these experiments and try to identify how, exactly, they fail the criteria for approval.