Regulations

In light of the comments on my last post, I thought I'd post some of my thoughts about regulations. I have said most of this in the many presentations I've given on the regulations, but I thought I'd repeat them for this blog.

First of all, none of this (meaning human research protections) should be about complying with regulations. Now, I'm not saying you don't have to comply with the regulations. As a former fed, I'd be the last person to say that. You do have to comply with the regulations. But, that shouldn't be the primary focus of human research protections programs. The primary focus should be on doing it right because it is the right thing to do. Researchers have a moral and ethical responsibility to the subjects of their research and all research activities need an independent, objective review to help ensure that the research is done ethically. The primary focus of both the researchers and the IRBs should be on the ethics (along with the appropriate documentation to maintain accountablity). The good news is that, if researchers and IRBs focus on the ethics, they are most of the way there to complying with the regulations, since the regulations were designed to implement the ethical principles. The rest is just "dotting the i's and crossing the t's".

The second point I want to make is that the regulations are the floor, not the ceiling. The regulations establish minimum standards that must be followed with regard to human subjects research. Institutions are fee and should decide for themselves what the appropriate standards are for research conducted under their auspices, as long as those standards at least comply with the regulations.

Finally, as I said in my comment to Zach in the last post, I do not think that institutions should base their human subjects research policies on complying with the regulations. They should base their policies on how the institution has decided to fulfill its responsibility to the subjects because it's the right thing to do. In doing so, of course, the institution must commit to complying with all relevant federal, state, and local laws and regulations. In addition, I think that the decision making that goes into developing and adopting these policies should be an open and transparent process that includes input from all the stake holders (including investigators). In this way, no one at the institution can say, "Who are you to say I have to do this?"

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.