P.Mean: Can prisons randomly assign prisoners without their consent? (created 2011-05-31). News: Sign up for "The Monthly Mean," the newsletter that dares to call itself average, www.pmean.com/news.

Someone raised an interesting question about randomization and informed consent in a prison setting. Suppose a prison had three treatment programs and it assigned prisoners to those programs randomly. Officials at the prison ask prisoners if they want their data included as part of a research project and they can consent or refuse this aspect of the research. But the prisoners cannot refuse the assignment to treatment programs. Is the coerced treatment assignment part of the research, he asks.

Well, of course, the answer is yes. How patients are assigned to treatments is always part of the research. Any IRB submission needs to note this process because it impacts on scientific validity as well as individual autonomy.

It's an intriguing question because you have to ask, is this a randomized study. In a randomized study, the treatment assignment is under the control of the researchers. Are the same people who do the random assignment the ones who do the research? Or is the research done by outsiders who have the pleasant benefit of getting nicely balanced groups through the randomization of others.

I think you have to discern intent here. Did the prison randomize because they had limited resources and they wanted to allocate those limited resources in a fair and impartial fashion? Is it sort of like a lottery where a few fortunate winners get the fancy new program? Or did they randomly allocate because they knew that they wanted to evaluate the treatments sometime in the future.

Regardless of intent, prisons are free to assign treatments however they see fit. It's a prison, after all. They do lots of coercive things in prison.

But the prison can't claim that the randomization process is off limits and not subject to discussion by the IRB. The question is whether there are sufficient safeguards in place by allowing prisoners to opt out of data collection without also allowing them to opt out of treatment assignment. That's a tough call, but I for one would be much more tolerant if the randomization was designed as a lottery intended to insure fair and impartial allocation of scarce resources.

The IRB can't tell the prison not to randomly assign patients or not to collect data on those patients. But it can withhold approval of the research study if it feels adequate safeguards are not in place. This would effectively make it impossible for the officials at the prison from preparing a research publication based on that data.

This work is licensed under a Creative Commons Attribution 3.0 United States License. This page was written by Steve Simon and was last modified on 2011-01-01. Need more information? I have a page with general help resources. You can also browse for pages similar to this one at Randomization In Research.