Let us understand the purpose of the Institutional Review Board, and how it works for the Wisconsin Medical College. The IRB system came into place in 1974. It was a set of rules that the US federal government created, as part of regulations issued in response to problems taking place in some research studies in this country and abroad that involved violation of some basic ethical principles of what should happen when people are involved in research studies.
There are certain regulations about who has to be on an IRB committee, for example, there have to be at least five individuals and they have to all be together so they can talk to each other about it. A mix of men and women, scientists and non-scientists that could be a community member have to be involved to ensure a diversity of disciplines and expertise on the committee. The application process is very rigorous and it involves exquisite detail that the IRB committee reviews and makes suggestions on how it can be done as safely and as high quality as possible. For example, maybe reducing the age range and not having very old people participate would be a way to make it safer.
The guiding principles for the regulations that inform how the IRB goes about doing its business are respect for personal risk, benefit analysis and fairness and justice with regard to respect for persons in terms of informed consent. Making sure that anybody who is participating in a research project is fully informed about everything that is going to be involved in the research and is participating in a voluntary way.
The second principle of looking at risks and benefits requires that the area be tried to discover and be aware of all the risks that might be involved for the participant and do their best to try to minimize those risks. On the issue of fairness of justice, we want to make sure that there is not a segment of the population taking on all the risks and burdens and another segment of the population is getting all of the benefits. We want to make sure there are fairness and justice.
With respect to that issue Medical College of Wisconsin IRB (MCWIRB) is such an active research organization with about 6,000 protocols that approve and oversee. In order to do that we have six IRB committees that meet every week for three hours. In terms of oversight by people outside of MCWIRB that takes place through staff from the Food and Drug Administration from other federal agencies.
This is attached to a nonprofit voluntary accreditation organization that will make a site visit as well. we have three monitors that randomly go to the study teams to check on documentation consent forms to make sure that you’re filling out all the forms correctly. Monitors are part of our human research protection program. Apart from fulfilling the IRB regulations, we ensure that the public are reassured that scientists here at the Wisconsin School of Medicine are working hard with patient safety, privacy rights and well-being in mind for all our research projects.
PRIM&R – https://www.primr.org
IRB FORUM – https://www.irbforum.org/
MCW (Medical College of Wisconsin) IRB – https://www.mcw.edu/departments/human-research-protection-program/irb-committees-and-members
MCWRIB – http://mcwirb.org