1. University of Nebraska – Lincoln Office of Research Responsibility Institutional Review Board (IRB) May 11, 2010 Office of Research Responsibility – irb@unl.edu - 402.472.6965

2. Background of UNL’s IRB Categories of Review Review Process & determination of risk Required Information Case Study Questions

3. 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

4. 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

5. 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

6. 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

7. 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?

8. Office of Research Responsibility – irb@unl.edu - 402.472.6965 Case Study A professor in the engineering department has developed a new device for cell phones which can track if the person is texting while driving. She needs people to test the device and has decided to make it a class requirement for students in her class. The students are asked to plug the device into their phone and test it while they are driving around town.

9. 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?

10. 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=ighttp://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.

11. 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

12. Office of Research Responsibility – irb@unl.edu - 402.472.6965 irb@unl.edu 472-6965 – main office number Becky Freeman 472-8127 bfreeman2@unl.edu Contact Information

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