University of Nebraska – LincolnOffice of Research Responsibility

Institutional Review Board (IRB)

May 11, 2010

Office of Research Responsibility – irb@unl.edu - 402.472.6965

Office of Research Responsibility – irb@unl.edu - 402.472.6965

• Background of UNL’s IRB

• Categories of Review

• Review Process & determination of risk

• Required Information

• Case Study

• Questions

Office of Research Responsibility – irb@unl.edu - 402.472.6965

Background of UNL’s IRB

• Established in 1992

• 1 IRB reviews all projects at UNL

• Mostly a Social/Behavioral research campus

• 1079 current approved projects

Office of Research Responsibility – irb@unl.edu - 402.472.6965

Categories of Review

• Exempt: less than minimal risk

• Expedited: minimal risk (risks encountered in everyday life)

• Full Board: greater than minimal risks

Office of Research Responsibility – irb@unl.edu - 402.472.6965

Review Process

• Exempt – reviewed by 1 person in the office

• Expedited – reviewed by 1 person on the IRB

• Full Board – reviewed by the convened IRB

Office of Research Responsibility – irb@unl.edu - 402.472.6965

Required Information

• Complete protocol application• Funding applications• Recruitment documents (flyers, letters,

emails, scripts, etc)• Informed consent and assent forms• Surveys, questionnaires, etc• Approval letters

Office of Research Responsibility – irb@unl.edu - 402.472.6965

Factors Considered in Risk Assessment

• Who are the participants?

• What will participants be doing?

• Are responses identifiable?

• How will results be reported?

• Who has access to the raw data?

Office of Research Responsibility – irb@unl.edu - 402.472.6965

Case Study

A professor in the engineering department hasdeveloped a new device for cell phones which cantrack if the person is texting while driving. Sheneeds people to test the device and has decided tomake it a class requirement for students in herclass. The students are asked to plug the deviceinto their phone and test it while they are drivingaround town.

Office of Research Responsibility – irb@unl.edu - 402.472.6965

• How would this change if the study were to be done in a simulated environment?

• How about if she recruits from another professor’s class and is conducted in a simulated environment?

Office of Research Responsibility – irb@unl.edu - 402.472.6965

Case Study

• Havasupai Indians• http://www.nytimes.com/2010/04/22/us/22dna.ht

ml?partner=rss&emc=rss&src=ig• Diabetes Research with Arizona State University• Researchers at ASU used the DNA for further

research which questions the tribes’ ancestry. Tribe sued the University.

Office of Research Responsibility – irb@unl.edu - 402.472.6965

• http://nugrant.unl.edu

• http://research.unl.edu/orr/index.shtml

• http://www.citiprogram.org

Important Websites

Office of Research Responsibility – irb@unl.edu - 402.472.6965

• irb@unl.edu

• 472-6965 – main office number

• Becky Freeman472-8127bfreeman2@unl.edu

Contact Information

Office of Research Responsibility – irb@unl.edu - 402.472.6965

Questions