Research and Graduate Studies @ KU

KU Human Subjects Committee
reaches applications milestone

Anyone in Lawrence who’s conducted research involving people the past 15 years knows David Hann, coordinator of the Human Subjects Committee in the Office of Research and Graduate Studies.  The committee, or Institutional Review Board (IRB), is charged with ensuring integrity in this very sensitive area of research.

Since its origins in 1966, the IRB has processed more than 17,000 applications for the approval of research protocols.  IRB approval is required whenever a faculty member or student conducts research with human subjects.  This is true regardless of the origin of the research and whether or not it's funded externally.

The 17,000 figure is a milestone for Hann, who begins phased retirement this year.  He’s probably been involved in half of those applications and has worked with 66 IRB members over the years, including 18 from outside the university.

"Historically, there was little outside oversight of human subjects research," Hann said.  "This was true everywhere.  The kind of formal protocols we use today did not exist." 

The risks associated with that approach became obvious in the 1970s, when the 40-year U.S. Public Health Service "Tuskegee Study" was exposed as the most infamous research scandal in the nation’s history.

"The IRB at KU and other universities ensures that kind of tragedy won’t happen again," Hann said.  "We operate under a federal statute and federal regulations.  Our goal is to find out what researchers want to do and advise them on how best to carry out their plans.  It’s not our mission to thwart research.  It is our mission to make sure human subjects research is carried out appropriately, ethically and lawfully."

All principal investigators on research grants take a tutorial on human subjects research.  Hann also meets with classes at KU to explain the protocols. 

"In the beginning, the message was 'Do this and you get into trouble,'" Hann said.  "Now we focus on facilitating research that adheres to standards required by the government and endorsed by responsible research professionals nationwide."

Hann said the IRB can expedite or waive approval when there’s minimal risk.  Examples include interviews and surveys, moderate physical activity or the use of attached but non-invasive devices.  IRB chair John Colombo, professor and graduate director in the department of psychology and interim director of the Schiefelbusch Institute for Life Span Studies, works closely with Hann to determine whether the proposed research qualifies for such action.

The IRB meets monthly to review proposals that require more discussion.  Examples include proposals that involve vulnerable populations, such as minor children outside the classroom or convicted prisoners.  Some expedited projects must still undergo further review by the locale where the research is to be conducted.

 "Research involving indigenous nations subjects at Haskell Indian Nations University or on tribal lands would most likely require full board review by the IRB or tribal council," Hann said.  "Also, school districts and corrections facilities typically require review by their own committees before allowing research to proceed."

 "The IRB is not my office," Hann said.  "In addition to the staff, it includes about 30 KU faculty and graduate students, plus community members from the Lawrence Unified School District, Community Corrections and physicians.  They make the decisions my staff and I implement.  My measure of success is whether I’ve made sure the interests of the subjects, the researchers, the IRB and the university have been taken care of.  The vast majority of human subjects research is intended to help humanity.  I assist researchers in doing that."

In 2006, more than 700 new applications were submitted to the IRB.  About 600 received expedited consideration, and 100 received full board review.  Currently, the IRB has an oversight role in more than 1,300 active projects.

Growth in research at Lawrence has meant growth in the IRB’s work load, Hann said.  In addition, federal HIPAA standards protecting the privacy of personal health information were adopted in 1996 and require extra documentation.  Hann is assisted by Mary Denning, associate coordinator, and Sharon Anthony, assistant coordinator.  They are part of KU’s Office of Research Integrity, directed by Bill Sharp.

After retiring in 2009, Hann, who has a degree in public administration, plans to pursue his avocation: researching and writing about little-known aspects of Kansas history.

More information about the IRB, including forms, tutorials and a handbook, is available at http://www.rcr.ku.edu/hscl/.