1. Institutional Review Board (IRB) What’s New? Rebecca Pliske Chair, Dominican University IRB September 2, 2005

2. Institutional Review Board (IRB) In 2002, DU established an IRB In 2002, DU established an IRB To review projects that involve collecting information from people, or analyzing existing records obtained from living human beings To review projects that involve collecting information from people, or analyzing existing records obtained from living human beings Dominican University IRB Guidelines describe the review process for Dominican University IRB Guidelines describe the review process for Systematic research projects conducted to increase general knowledge about a topic Systematic research projects conducted to increase general knowledge about a topic Classroom projects that involve the collection of information from people outside of the classroom Classroom projects that involve the collection of information from people outside of the classroom

3. How to Obtain IRB Approval Forms and other IRB materials available on the intranet http://domin.dom.edu/irb.htm Forms and other IRB materials available on the intranet http://domin.dom.edu/irb.htm http://domin.dom.edu/irb.htm Different forms and review processes for: Different forms and review processes for: 1) Class projects—submit to IRB rep from your school 2) Systematic research projects—submit to Office of Sponsored Research

4. Changes 2005-2006 New IRB Administrator New IRB Administrator IRB Professional Development Training Opportunity IRB Professional Development Training Opportunity IRB Alternate Representatives for the Schools IRB Alternate Representatives for the Schools

5. IRB Administrator Dr. Kathleen Mullaney Dr. Kathleen Mullaney Newly appointed Director of Sponsored Research Newly appointed Director of Sponsored Research Will also serve as the IRB Administrator Will also serve as the IRB Administrator Dr. Rebecca Pliske will continue to serve as IRB Chair Dr. Rebecca Pliske will continue to serve as IRB Chair All systematic research project applications will be submitted to the Office of Sponsored Research, rather than the Office of the Provost or to Dr. Pliske All systematic research project applications will be submitted to the Office of Sponsored Research, rather than the Office of the Provost or to Dr. Pliske

6. IRB Administrator Dr. Mullaney will be doing the initial processing of the systematic research applications Dr. Mullaney will be doing the initial processing of the systematic research applications Checking for completeness Checking for completeness Determining which applications are exempt from Full IRB Review Determining which applications are exempt from Full IRB Review In the near future, she will also be contacting all PIs to inquire about previously approved projects In the near future, she will also be contacting all PIs to inquire about previously approved projects Final Reports? Final Reports? Renewal Applications? Renewal Applications?

7. IRB Professional Development Training Opportunity On-line IRB training for researchers offered at www.citiprogram.org On-line IRB training for researchers offered at www.citiprogram.orgwww.citiprogram.org You can log in from any computer connected to the web You can log in from any computer connected to the web Create your own username and password Create your own username and password Complete the training over as many sessions as you like Complete the training over as many sessions as you like Total time: 2-4 hours Total time: 2-4 hours

8. IRB Professional Development Training Opportunity You earn a Training Certificate when you complete the 7 required modules and 2 (of 10) optional modules You earn a Training Certificate when you complete the 7 required modules and 2 (of 10) optional modules There is a short quiz for each module, which you can take as many times as necessary in order to earn a passing score (80% correct) There is a short quiz for each module, which you can take as many times as necessary in order to earn a passing score (80% correct) The IRB Administrator will be informed when you have completed the course The IRB Administrator will be informed when you have completed the course

9. Why are We Offering IRB Training? IRB members need it! IRB members need it! Other universities (e.g., UIC) have been forced by the DHHS OHRP to require training for all researchers Other universities (e.g., UIC) have been forced by the DHHS OHRP to require training for all researchers Great learning opportunity for both graduate students (GSSW, SOE) and undergraduates (psychology, sociology) Great learning opportunity for both graduate students (GSSW, SOE) and undergraduates (psychology, sociology)

10. Who Has to Complete the Training? 2005-2006 Academic Year 2005-2006 Academic Year IRB members and alternates must complete 16 modules IRB members and alternates must complete 16 modules Principal Investigators, as required by the IRB when their research projects involves more than minimal risk Principal Investigators, as required by the IRB when their research projects involves more than minimal risk In the future ??? In the future ??? Maybe all Principal Investigators prior to submitting an IRB application? Maybe all Principal Investigators prior to submitting an IRB application? Note: you can have your students take this course (for free!) Note: you can have your students take this course (for free!)

11. DU IRB 2005-2006 Current Voting Members Judy Beto, Alternate Chairperson, Rosary College Judy Beto, Alternate Chairperson, Rosary College Hugh McElwain, Rosary College Hugh McElwain, Rosary College Charles Stoops, Graduate School of Social Work Charles Stoops, Graduate School of Social Work Dan Condon, School of Business Dan Condon, School of Business Dennis Kirchen, School of Education Dennis Kirchen, School of Education Kanti Srikantaiah, Graduate School of Library and Information Science Kanti Srikantaiah, Graduate School of Library and Information Science Dr. Roger Dominowski, Retired UIC prof, serves as our outside member Dr. Roger Dominowski, Retired UIC prof, serves as our outside member

12. DU IRB 2005-2006 Alternate Members Kelly Burns, Rosary College Kelly Burns, Rosary College Elizabeth Talbot, Graduate School of Social Work Elizabeth Talbot, Graduate School of Social Work Peter Alonzi, School of Business Peter Alonzi, School of Business Christine Kelly, School of Education Christine Kelly, School of Education TBD, Graduate School of Library and Information Science TBD, Graduate School of Library and Information Science

13. Future IRB Meeting Dates 2005-2006  Monday, Sep 26  Thursday, Oct 27  Monday, Nov 28  Tuesday, Jan 10  Monday, Feb 27  Thursday, March 30  Monday, April 24

14. Questions?

15. Review DU IRB policy One of the most frequently asked questions I receive is “What type of review do I need for this project?” One of the most frequently asked questions I receive is “What type of review do I need for this project?” Class projects— your students are collecting data from humans for an assigned project Class projects— your students are collecting data from humans for an assigned project Systematic research— you are collecting data from humans for a presentation or publication Systematic research— you are collecting data from humans for a presentation or publication So what’s so confusing? So what’s so confusing?

16. Case 1 Professor Smith decides to try peer-tutoring in her statistics class this fall. She plans to give her students questionnaires at the end of the semester to see if they liked the peer-tutoring. If it turns out they liked this teaching method, she plans to write up the results of the questionnaires and submit an article to the Teaching in Psychology journal. Does she need to submit her plan for IRB review? If so, what type of review (Systematic Research or Classroom Project)?

17. Answer for Case 1 Because she intends to publish these results, this is an example of Scholarship of Teaching research which is a type of Systematic Research. Because she intends to publish these results, this is an example of Scholarship of Teaching research which is a type of Systematic Research. If she uses a procedure that “blinds” her as to which students choose to participate AND has the students complete informed consent forms AND uses an anonymous questionnaire, this would qualify as Exempt from Full Review. If she uses a procedure that “blinds” her as to which students choose to participate AND has the students complete informed consent forms AND uses an anonymous questionnaire, this would qualify as Exempt from Full Review. However, if she had no intent to publish the results of the questionnaire, this would not even have to be submitted to the IRB—it would be a course evaluation for internal organizational purposes only. However, if she had no intent to publish the results of the questionnaire, this would not even have to be submitted to the IRB—it would be a course evaluation for internal organizational purposes only.

18. Case 2 Professor Jones is teaching a developmental psychology course and assigns a class project in which his students will interview children about their favorite TV shows. Does this project require IRB review? If so, what type of review (Systematic Research or Classroom Project)?

19. Answer for Case 2 This is a trick question!! This is a trick question!! Although this is a classroom project, because it involves interviews with minor children it would have to go to the full board. Although this is a classroom project, because it involves interviews with minor children it would have to go to the full board. If the project involved interviews with adults (age 18 or over) this would be processed as a Class Project. If the project involved interviews with adults (age 18 or over) this would be processed as a Class Project.

20. Case 3 Dr. Wilson is planning to go on a mission trip sponsored by her church. She will be working in an orphanage in Guatemala where she plans to conduct unstructured interviews with the recovering drug addicts who work there. She is doubtful that this will lead to a journal article, but she hopes to share her findings with others by giving talks at other churches and at a professional conference. Does she need to get IRB approval for this project? Dr. Wilson is planning to go on a mission trip sponsored by her church. She will be working in an orphanage in Guatemala where she plans to conduct unstructured interviews with the recovering drug addicts who work there. She is doubtful that this will lead to a journal article, but she hopes to share her findings with others by giving talks at other churches and at a professional conference. Does she need to get IRB approval for this project?

21. Answer for Case 3 YES, if she plans to ask multiple individuals the same questions and plans to share the knowledge gained with other people, this constitutes systematic research. YES, if she plans to ask multiple individuals the same questions and plans to share the knowledge gained with other people, this constitutes systematic research. Remember: just because you are conducting your research outside of the US, that does not exempt you from IRB review! Remember: just because you are conducting your research outside of the US, that does not exempt you from IRB review!

22. Questions?