irb application review and approval for researchers from the college of education: transition from...
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IRB Application Review and Approval for Researchers from the College of Education: Transition from BER to the Campus IRBRon Banks, Human Subjects Coordinator, IRBrbanks@illinois.edu
2012 The Board of Trustees of the University of Illinois
September 19 and 25, 2012*OVERVIEWOverview of the transition and what it will meanIRB review levels and pathways to approvalTips for facilitating approvalCriteria for approval when study isnt exempt
September 19 and 25, 2012*StatisticsApproximately 350 COE IRB applications last year (2011-2012)50 came directly to the campus IRBOf the remaining 300, 75 came to campus after BER review since studies were not exempt or were funded225 approved last year at BER (all new applications will now need to be approved at the campus IRB)Campus IRB approved to hire a new exempt specialist
September 19 and 25, 2012*Plan for 2012-2013 Academic Year (and beyond) - Campus IRB ResponsibilitiesNew plan:All new COE IRB applications - submit to campus IRBReview and approval of 3 year exempt extensionsNo change:applications already approved at campus + renewals and amendments for those applications
September 19 and 25, 2012*Plan for 2012-2013 Academic Year (this year only) BER ResponsibilitiesAmendments to exempt applications initially approved at BER less than 3 years agoConsultationPresentationsRelated school research work will continue: OSURR annual updates of school research, background checks, school placements, letters of support, Ed Psych Subject Pool, etc.
September 19 and 25, 2012*Review determinationsNot human subjects researchExemptExpedited reviewFull board
September 19 and 25, 2012*What is a Human Subject? A living individual about whom an investigator obtains data through intervention or interaction with the individualORabout whom an investigator obtains individually identifiable, private information
September 19 and 25, 2012*What is Research? A systematic investigation designed to lead to generalizable knowledge
September 19 and 25, 2012*Not human subjects research examplesAnalysis of de-identified data collected by othersNo intent to contribute to generalizable knowledge (staff surveys, data collected for internal purposes)Class research - conducted to educate students/class purposes onlyNo requirement for IRB application if its not human subjects research, check with us first!!!
September 19 and 25, 2012* Course projects policy - Campus IRB vs. BERCampus - instructors just assure that research fits policy - no further involvement from campus IRBCOE - coursework projects procedure in place for approval (practicing teachers doing research in their own classrooms)
September 19 and 25, 2012*Exempt ApplicationsExempt research: Exempt means exempt from the federal regulations and formal board member review. However UIUC essentially adheres to these regulations for all studies, but with more flexibility and a shorter application available.
All exempt studies must be designated no more than minimal risk and fit one of the allowable exemption categories as per the federal regulations.
September 19 and 25, 2012*Exempt Research (category 1 for educational research)
Research conducted in commonly accepted educational settings involving normal educational practices including research on determining the effectiveness of instructional strategies or on the effectiveness of or the comparison among instructional techniques, curricula or classroom management strategies
September 19 and 25, 2012*Exempt Research (category 2 for surveys/interviews)Research that only involve surveys, interviews, and/or observations UNLESS:
1) There is some personal identification collected with the responses (even if just a subject number, if the researcher has a data key with subject number tied to name) AND 2) Disclosure of the human subjects responses could reasonably place them at risk of criminal/civil liability or be damaging to their employability, financial standing, or reputation.
September 19 and 25, 2012*Exempt Research (category 4 for analysis of existing data)Analysis of existing data for a different purpose than originally intended, if data can be recorded in such a manner that participants cant be identified
September 19 and 25, 2012*Examples of Exempt Applications (College of Education)Project NEURON (Novel Education for Understanding Research On Neuroscience)Special Education Teachers' Beliefs About Inclusion in School ClubsCreating an Accessible Block Alternative for the Fourth and Eighth Grade NAEP Mathematics Assessments
September 19 and 25, 2012*Pathway to Approval Exempt ResearchComplete an Application for Exemption Complete the required trainingRespond to IRB Office comments quicklyDetermination will be made at the IRB OfficeApproval is good for three yearsInformal process to approve modifications that dont change exempt status (research amendments)
September 19 and 25, 2012*Expedited Reviewresearch must be no more than minimal riskThere are nine categories of expedited research including: Research on individual or group characteristics or behavior, including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may also qualify as exempt)
September 19 and 25, 2012*Examples of expedited applications (College of Education)UIUC Teen Talk 2: Interpreting the Aftermath of Hurricane Katrina Among Diverse Groups of AdolescentsRelating EDA, Occupational Therapy, and BehaviorCultural Accessibility and Relevance of Mindfulness Training among African American Women
September 19 and 25, 2012*Pathway to Approval Expedited reviewComplete the pre-review process with IRB Office Staff (submit on IRB-1)Complete the required trainingApplication sent to designated IRB Member(s)The IRB member may approve as is, require changes prior to approval, or send to the full board
September 19 and 25, 2012*Full Board ReviewIRB applications that require full board review are thought to involve potentially higher levels of risk to subjects, including those applications coded as being more than minimal risk Research involving the study of illegal activity, drug and alcohol studies, X ray studies, research involving prisoners, or that involves maximal exercise require full board review, also studies involving vulnerable populations or that focus on very sensitive topics
September 19 and 25, 2012*Examples of UIUC studies requiring full board review (from COE and others)Risk and Resilience Factors for Emotional, Behavioral, and Academic Outcomes among Homeless Students Mothers and Babies in Prison? Longitudinal Effects of the Decatur Moms and Babies Program Middle School Bullying and Sexual Violence: Measurement Issues and Etiological Models
September 19 and 25, 2012*Pathway to Approval - Full Board
Submit the complete IRB 1 formRespond promptly to the pre-review conducted by the office staffComplete the required trainingThe IRB reviews applications at their monthly meetingThe IRB may vote to approve, defer, or disapprove. Often a protocol may be approved pending satisfactory resolution of relatively minor issues.
September 19 and 25, 2012*Facilitating IRB approval: Practical suggestions10 Tips and suggestions for how to decrease time from submission to approval
September 19 and 25, 2012*Facilitating IRB approval Tip #1Supply everything that can be submitted at initial submission:IRB-1 Application or Application for ExemptionConsent letters, assent letters, parental consent letters.Informed consent related waiver forms when requiredRecruitment materials (if any)Measures (interview protocols, questionnaires, etc.)Screening tools (if any)Required attachments (if any), such as the Research Equipment form for eye tracking studies.
September 19 and 25, 2012*Facilitating IRB approval Tip #2Be CONSISTENT in your application across the application, consent letters, measures:
confidentiality issues often not presented consistently, stressing confidential throughout until consent which has casual mention that all data is confidential unless you tell us otherwiseSimple things, duration/payment mismatch of application vs. the consent/assent lettersNot all research activities mentioned on consent lettersExclusion criteria not mentioned on the recruitment flyers
September 19 and 25, 2012*Facilitating IRB approval Tip #3RPI ROLE: careful review of IRB application by RPI (Responsible Project Investigator) prior to submission for applications completed by students!Carefully review consent and assent letters, insure all procedures are mentioned, etc.Check for literacy level, grammar, typos on the consent or assent lettersCheck for missing materials, recruitment materials, measures, etc. Check to make sure research plans are presented consistently.
September 19 and 25, 2012*Facilitating IRB approval Tip #4Informed consent and assent process and letters Check literacy levels on consent and assent letters, many letters meant for general population are written at college level.Adequately describe the CONSENT/ASSENT PROCESS, how its insured that the research participants understand what they are agreeing to doFlexibility on assent letters use kid-friendly language to explain:what children are being asked to do that its voluntary, they dont have to do it just because their parents say its OKhow long it will take