AMDA Foundation - IRB Assessment and Management of QI Projects

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IRB Assessment and Management of QI Projects

Vol XXXVI, Oct '08

In his session, “IRB Assessment and Management of QI Projects,” Ed Davidson, PharmD, MPH, a researcher, IRB member, and editor of The Consultant Pharmacist, will help participants understand how to work effectively with IRBs on QI projects. “The government has defined clearly what human subject research is. It can be difficult for people to make that determination in relation to QI,” he notes, adding that the result is studies that violate human subject rights and get the researchers in trouble.

IRBs employ trained people who can help make this determination and help investigators put together study protocols and processes that protect patients and the researchers alike. “The IRB doesn’t want investigators or institution to violate federal law. Instead, we want to help them do safe, productive studies. We actually have a subcommittee that meets for 1-2 hours before the IRB meetings to review QI projects, including those from physicians in the community,” Dr. Davidson says. “By going through this process and walking through the paperwork, the IRB can make decisions about issues such as whether you can waive the need for informed consent,” he notes. He adds that there are Web-based tools such as a “series of decision charts that individuals can go through and answer questions to help determine if they’re doing human subjects research.”

Essentially, this all comes down to evaluating the level of risk for patients. This risk, says Dr. Davidson, isn’t limited to physical risk. It also includes issues such as risk of privacy violations or stigmatization. The definition of “minimal risk” means that the probability and magnitude of harm and discomfort are not greater than those encountered in routine life.

Attend Dr. Davidson’s session at the Research Network Conference (Saturday at 8:30 am) to learn more about IRBs and QI projects.