Institutional Review Board Institutional Review Board (IRB)(IRB)

What’s New? What’s New?

Rebecca Pliske Rebecca Pliske

Chair, Dominican University Chair, Dominican University IRBIRB

September 2, 2005September 2, 2005

Institutional Review Board Institutional Review Board (IRB)(IRB)

In 2002, DU established an IRBIn 2002, DU established an IRB To review projects that involve collecting To review projects that involve collecting

information from people, or analyzing information from people, or analyzing existing records obtained from living human existing records obtained from living human beingsbeings

Dominican UniversityDominican University IRBIRB GuidelinesGuidelines describe the review process fordescribe the review process for Systematic research projects conducted to Systematic research projects conducted to

increase general knowledge about a topicincrease general knowledge about a topic Classroom projects that involve the collection Classroom projects that involve the collection

of information from people outside of the of information from people outside of the classroomclassroom

How to Obtain IRB ApprovalHow to Obtain IRB Approval

Forms and other IRB materials available Forms and other IRB materials available on the intranet on the intranet http://http://domin.dom.edu/irb.htmdomin.dom.edu/irb.htm

Different forms and review processes Different forms and review processes for:for:1) Class projects—submit to IRB rep from 1) Class projects—submit to IRB rep from

your schoolyour school

2) Systematic research projects—submit to 2) Systematic research projects—submit to Office of Sponsored ResearchOffice of Sponsored Research

Changes 2005-2006Changes 2005-2006

New IRB Administrator New IRB Administrator IRB Professional Development IRB Professional Development

Training OpportunityTraining Opportunity IRB Alternate Representatives for IRB Alternate Representatives for

the Schoolsthe Schools

IRB AdministratorIRB Administrator

Dr. Kathleen MullaneyDr. Kathleen Mullaney Newly appointed Director of Sponsored ResearchNewly appointed Director of Sponsored Research Will also serve as the IRB AdministratorWill also serve as the IRB Administrator Dr. Rebecca Pliske will continue to serve as IRB Dr. Rebecca Pliske will continue to serve as IRB

ChairChair All systematic research project applications All systematic research project applications

will be submitted to the Office of Sponsored will be submitted to the Office of Sponsored Research, rather than the Office of the Research, rather than the Office of the Provost or to Dr. PliskeProvost or to Dr. Pliske

IRB AdministratorIRB Administrator

Dr. Mullaney will be doing the initial Dr. Mullaney will be doing the initial processing of the systematic research processing of the systematic research applicationsapplications Checking for completenessChecking for completeness Determining which applications are exempt from Determining which applications are exempt from

Full IRB ReviewFull IRB Review In the near future, she will also be In the near future, she will also be

contacting all PIs to inquire about previously contacting all PIs to inquire about previously approved projectsapproved projects Final Reports?Final Reports? Renewal Applications?Renewal Applications?

IRB Professional Development IRB Professional Development Training OpportunityTraining Opportunity

On-line IRB training for researchers On-line IRB training for researchers offered at offered at www.citiprogram.orgwww.citiprogram.org

You can log in from any computer You can log in from any computer connected to the webconnected to the web Create your own username and passwordCreate your own username and password Complete the training over as many Complete the training over as many

sessions as you likesessions as you like Total time: 2-4 hoursTotal time: 2-4 hours

IRB Professional Development IRB Professional Development Training OpportunityTraining Opportunity

You earn a Training Certificate when you You earn a Training Certificate when you complete the 7 required modules and 2 (of complete the 7 required modules and 2 (of 10) optional modules10) optional modules

There is a short quiz for each module, There is a short quiz for each module, which you can take as many times as which you can take as many times as necessary in order to earn a passing score necessary in order to earn a passing score (80% correct)(80% correct)

The IRB Administrator will be informed The IRB Administrator will be informed when you have completed the coursewhen you have completed the course

Why are We Offering IRB Why are We Offering IRB Training?Training?

IRB members need it!IRB members need it! Other universities (e.g., UIC) have Other universities (e.g., UIC) have

been forced by the DHHS OHRP to been forced by the DHHS OHRP to require training for all researchersrequire training for all researchers

Great learning opportunity for both Great learning opportunity for both graduate students (GSSW, SOE) and graduate students (GSSW, SOE) and undergraduates (psychology, undergraduates (psychology, sociology)sociology)

Who Has to Complete the Who Has to Complete the Training?Training?

2005-2006 Academic Year2005-2006 Academic Year IRB members and alternates must complete 16 IRB members and alternates must complete 16

modulesmodules Principal Investigators, as required by the IRB Principal Investigators, as required by the IRB

when their research projects involves more when their research projects involves more than minimal riskthan minimal risk

In the future ???In the future ??? Maybe all Principal Investigators prior to Maybe all Principal Investigators prior to

submitting an IRB application?submitting an IRB application? Note: you can have your students take this Note: you can have your students take this

course (for free!)course (for free!)

DU IRB 2005-2006 DU IRB 2005-2006 Current Voting MembersCurrent Voting Members

Judy Beto, Alternate Chairperson, Rosary CollegeJudy Beto, Alternate Chairperson, Rosary College Hugh McElwain, Rosary CollegeHugh McElwain, Rosary College Charles Stoops, Graduate School of Social WorkCharles Stoops, Graduate School of Social Work Dan Condon, School of BusinessDan Condon, School of Business Dennis Kirchen, School of EducationDennis Kirchen, School of Education Kanti Srikantaiah, Graduate School of Library Kanti Srikantaiah, Graduate School of Library

and Information Scienceand Information Science Dr. Roger Dominowski, Retired UIC prof, serves Dr. Roger Dominowski, Retired UIC prof, serves

as our outside memberas our outside member

DU IRB 2005-2006 DU IRB 2005-2006 Alternate MembersAlternate Members

Kelly Burns, Rosary CollegeKelly Burns, Rosary College Elizabeth Talbot, Graduate School of Elizabeth Talbot, Graduate School of

Social WorkSocial Work Peter Alonzi, School of BusinessPeter Alonzi, School of Business Christine Kelly, School of EducationChristine Kelly, School of Education TBD, Graduate School of Library and TBD, Graduate School of Library and

Information ScienceInformation Science

Future IRB Meeting DatesFuture IRB Meeting Dates 2005-2006 2005-2006

Monday, Sep 26Monday, Sep 26 Thursday, Oct 27Thursday, Oct 27 Monday, Nov 28Monday, Nov 28 Tuesday, Jan 10Tuesday, Jan 10 Monday, Feb 27Monday, Feb 27 Thursday, March 30Thursday, March 30 Monday, April 24Monday, April 24

Questions?Questions?

Review DU IRB policyReview DU IRB policy

One of the most frequently asked One of the most frequently asked questions I receive is “What type of questions I receive is “What type of review do I need for this project?”review do I need for this project?” Class projects— Class projects— your studentsyour students are collecting are collecting

data from humans for an assigned projectdata from humans for an assigned project Systematic research— Systematic research— youyou are collecting are collecting

data from humans for a presentation or data from humans for a presentation or publicationpublication

So what’s so confusing? So what’s so confusing?

Case 1Case 1Professor Smith decides to try peer-tutoring in Professor Smith decides to try peer-tutoring in

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

Answer for Case 1Answer for Case 1 Because she intends to publish these Because she intends to publish these

results, this is an example of Scholarship of results, this is an example of Scholarship of Teaching research which is a type of Teaching research which is a type of Systematic Research. Systematic Research.

If she uses a procedure that “blinds” her as If she uses a procedure that “blinds” her as to which students choose to participate to which students choose to participate AND has the students complete informed AND has the students complete informed consent forms AND uses an anonymous consent forms AND uses an anonymous questionnaire, this would qualify as Exempt questionnaire, this would qualify as Exempt from Full Review. from Full Review.

However, if she had no intent to publish the However, if she had no intent to publish the results of the questionnaire, this would not results of the questionnaire, this would not even have to be submitted to the IRB—it even have to be submitted to the IRB—it would be a course evaluation for internal would be a course evaluation for internal organizational purposes only.organizational purposes only.

Case 2Case 2

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

Answer for Case 2Answer for Case 2

This is a trick question!! This is a trick question!! Although this is a classroom project, Although this is a classroom project,

because it involves interviews with because it involves interviews with minor children it would have to go to minor children it would have to go to the full board. the full board.

If the project involved interviews with If the project involved interviews with adults (age 18 or over) this would be adults (age 18 or over) this would be processed as a Class Project.processed as a Class Project.

Case 3Case 3

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

Answer for Case 3Answer for Case 3

YES, if she plans to ask multiple individuals YES, if she plans to ask multiple individuals the same questions and plans to share the the same questions and plans to share the knowledge gained with other people, this knowledge gained with other people, this constitutes systematic research. constitutes systematic research.

Remember: just because you are Remember: just because you are conducting your research outside of the conducting your research outside of the US, that does not exempt you from IRB US, that does not exempt you from IRB review!review!

Questions?Questions?