The Mission of the IRB
What is the mission of the IRB? If you ask most IRB members, the almost universal response will be that the mission is to protect human subjects. In my opinion, that is the wrong response. Seeing this as the mission of the IRB creates a "good guy/bad guy" mentality. It implies that research is a bad thing from which people need to be protected. Researchers are like Dr. Frankenstein and we are the villagers storming his castle with flaming torches to protect the public. In reality, research is a good thing. If we did not believe in the societal value of research, we would not be involved in the research enterprise. And, although there are a few "bad apples", the vast majority of researchers are good, well-intentioned people who would not dream of intentionally harming their subjects. In addition, this protectionist mission creates a mindset in IRB members where they look at each protocol thinking, "What are we going to find wrong with this one?"
Rather, the real mission of the IRB is to facilitate ethical research. As I said, research is a good thing and any unnecessary burdens or delays imposed on research has a social cost. That is not to say that IRBs should cut corners or be "rubber stamps". Research must be held to a high ethical (and regulatory) standard. But, IRBs should be focused on trying to help researchers do it right rather than catching them doing it wrong. IRB members should be thinking, "How can we help this good research go forward ethically?"
How can IRBs do this? For one thing, IRBs should keep in mind that every requirement that an IRB imposes on a researcher has a cost, either in time, paperwork, delay or even money. In the spirit of the Belmont principle of beneficence, IRB members should ask whether the benefits of imposing a requirement justify the cost to the investigator. Secondly, IRBs should work with investigators to explore options that meet the ethical and regulatory requirements without unduly interfering with the research. The IRB review process should be a dialog between the IRB and the investigators, with the common goal of the best research that meets the highest ethical standards.
posted by Jeffrey Cohen @ 6/08/2007 07:49:00 AM
2 comments
2 Comments:
For better or worse, the "almost universal response" you condemn is, in fact, federal law (42 USC 289):
"The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall prescribe) a board (to be known as an 'Institutional Review Board') to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research."
I agree that this is "the wrong response." Can I count on your help to lobby for a better law?
Zach
Zach,
Although you are right about the federal law, I am more concerned about how institutions and IRB members perceive their role. The regs influence this, of course, but that should not determine how the IRBs view their role. Although institutions and IRB must comply with the requirements of the regulations, their mission should not be based on the regulations, but on the moral and ethical responsiblity that researchers owe their research subjects. I have been arguing for many years that institutions should not base their human subjects research policies on the regulations. Rather, they should have human subjects research policies because it is the right thing to do. As long as the requirements in the regulations are complied with, institutions decide what the mission of the IRB is, not Washington.
With regard to the law, I'm not very concerned with changing it because hardly anyone even knows it exists, let alone reads it. The regulations are more relevant, but, as you know, I think those work fine for reviewing social research as long as IRBs know how to use them.
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