What is an IRB?

If people are going to be studied in a research endeavor, a committee called an institutional review board (IRB) gets involved. The board places the rights of the participants foremost to assure that the science is sound and ethical and participants are protected. The board looks after the rights, safety and welfare of study participants.

IRBs operate according to government regulations governing human subject research. They review research protocols, assess the appropriateness of any trial and the proposed methodology and ultimately determine if studies can be conducted with human subjects.

There’s no rubber stamp involved. Instead, there’s critical analysis, questions and weighing of risks and benefits. Studies are initially classified as either minimal risk or greater than minimal risk, which determines how the review process proceeds.

The IRB review includes approval of consent forms and human subject recruitment processes and materials. It also reviews proposed modifications to approved studies and becomes involved if unanticipated problems occur that could put human subjects at risk. Since the Well Living Lab studies human subjects in simulated real-world environments, its research must be reviewed and approved by the IRB. The lab utilizes the Mayo Clinic Institutional Review Board as its IRB of record. Like many other institutions involved in research, Mayo Clinic has its own IRB. As one of the nation’s largest research institutions, Mayo’s board oversees thousands of protocols annually.

The Mayo Clinic IRB is comprised of scientific and non-scientific members from inside and outside the organization. Scientific members evaluate the merits of proposed research and together with non-scientific members such as lawyers, ethicists, instructors, engineers and business professionals, also consider non-scientific interests including human rights, welfare and protections. Members typically serve three years and are trained to understand and apply regulations and policies governing human subject research.

As required by law, researchers must successfully complete training in the protection of human research participants before they can conduct human subject research. Well Living Lab staff take this training.

Setting up the structure to allow for human subject research was one of several critical steps conducted as the Well Living Lab was formed. It’s not an easy task to prepare and open a world-class research laboratory, particularly one that explore new frontiers, combining combines health, behavioral, environmental, engineering, building science and computer science. The collaborators, Delos and Mayo Clinic, recognized that buildings and what’s within them play a key role in human health and consequently persevered to make the Well Living Lab a reality.