IRB Application Review IRB Application Review and Approval for and Approval for Researchers from the Researchers from the College of Education: College of Education: Transition from BER to the Transition from BER to the Campus IRBCampus IRB

Ron Banks, Human Subjects Coordinator, IRBrbanks@illinois.edu

© 2012 The Board of Trustees of the University of Illinois

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OVERVIEW

Overview of the transition and what it will Overview of the transition and what it will meanmean

IRB review levels and pathways to approvalIRB review levels and pathways to approval Tips for facilitating approvalTips for facilitating approval Criteria for approval when study isn’t exemptCriteria for approval when study isn’t exempt

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StatisticsStatistics

Approximately 350 COE IRB applications last Approximately 350 COE IRB applications last year (2011-2012)year (2011-2012)– 50 came directly to the campus IRB50 came directly to the campus IRB– Of the remaining 300, 75 came to campus Of the remaining 300, 75 came to campus

after BER review since studies were not after BER review since studies were not exempt or were fundedexempt or were funded

– 225 approved last year at BER (all new 225 approved last year at BER (all new applications will now need to be approved applications will now need to be approved at the campus IRB)at the campus IRB)

Campus IRB approved to hire a new ‘exempt Campus IRB approved to hire a new ‘exempt specialist’specialist’

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Plan for 2012-2013 Academic Year (and beyond) - Campus IRB Responsibilities

New plan:New plan:– All new COE IRB applications - All new COE IRB applications -

submit to campus IRBsubmit to campus IRB– Review and approval of 3 year Review and approval of 3 year

exempt extensionsexempt extensions No change:No change:

– applications already approved at applications already approved at campus + renewals and campus + renewals and amendments for those applicationsamendments for those applications

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Plan for 2012-2013 Academic Year (this year only) BER Responsibilities

Amendments to exempt applications Amendments to exempt applications initially approved at BER less than 3 years initially approved at BER less than 3 years agoago

ConsultationConsultation PresentationsPresentations Related school research work will continue: Related school research work will continue:

OSURR annual updates of school research, OSURR annual updates of school research, background checks, school placements, background checks, school placements, letters of support, Ed Psych Subject Pool, letters of support, Ed Psych Subject Pool, etc.etc.

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Review determinationsReview determinations

Not human subjects researchNot human subjects research ExemptExempt Expedited reviewExpedited review Full boardFull board

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What is a Human Subject?

A living individual about whom A living individual about whom an investigator an investigator obtains data obtains data through intervention or through intervention or interactioninteraction with the individual with the individual

OROR……about whom an investigator about whom an investigator obtains individually identifiable, obtains individually identifiable, private informationprivate information

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What is Research?

A systematic investigation A systematic investigation designed to lead to designed to lead to generalizable knowledgegeneralizable knowledge

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““Not human subjects Not human subjects research” examplesresearch” examples Analysis of de-identified data collected by Analysis of de-identified data collected by

othersothers No intent to contribute to generalizable No intent to contribute to generalizable

knowledge (staff surveys, data collected for knowledge (staff surveys, data collected for internal purposes)internal purposes)

Class research - conducted to educate Class research - conducted to educate students/class purposes onlystudents/class purposes only

No requirement for IRB application if its not No requirement for IRB application if its not human subjects research, check with us human subjects research, check with us first!!!first!!!

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Course projects policy Course projects policy - Campus IRB vs. BER- Campus IRB vs. BER Campus - instructors just assure Campus - instructors just assure

that research fits policy - no that research fits policy - no further involvement from campus further involvement from campus IRBIRB

COE - “coursework projects” COE - “coursework projects” procedure in place for approval procedure in place for approval (practicing teachers doing (practicing teachers doing research in their own classrooms)research in their own classrooms)

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Exempt Applications

Exempt 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.

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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

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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 subject’s responses could reasonably place them at risk of criminal/civil liability or be damaging to their employability, financial standing, or reputation.

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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 can’t be identified

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Examples of “Exempt” Applications (College of Education)

Project NEURON (Novel Education Project NEURON (Novel Education for Understanding Research On for Understanding Research On Neuroscience)Neuroscience)

Special Education Teachers' Beliefs Special Education Teachers' Beliefs About Inclusion in School ClubsAbout Inclusion in School Clubs

Creating an Accessible Block Creating an Accessible Block Alternative for the Fourth and Alternative for the Fourth and Eighth Grade NAEP Mathematics Eighth Grade NAEP Mathematics Assessments Assessments

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Pathway to Approval – Exempt Research Complete an Application for Exemption Complete the required training Respond to IRB Office comments quickly Determination will be made at the IRB Office Approval is good for three years Informal process to approve modifications

that don’t change exempt status (research amendments)

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““Expedited” ReviewExpedited” Review

research must be ‘no more than minimal risk’research must be ‘no more than minimal risk’ There are nine categories of expedited research There are nine categories of expedited research

including:including:

Research on individual or group characteristics or Research on individual or group characteristics or behavior, including, but not limited to, research on behavior, including, but not limited to, research on perception, cognition, motivation, identity, perception, cognition, motivation, identity, language, language, communicationcommunication,, cultural beliefs or practices, and cultural beliefs or practices, and social behavior, or research employing survey, social behavior, or research employing survey, interview, oral history, focus group, program interview, oral history, focus group, program evaluation, human factors evaluation, or quality evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in assurance methodologies. (NOTE: Some research in this category may also qualify as exempt)this category may also qualify as exempt)

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Examples of expedited applications (College of Education)

UIUC Teen Talk 2: Interpreting the Aftermath of Hurricane Katrina Among Diverse Groups of Adolescents

Relating EDA, Occupational Therapy, and Behavior

Cultural Accessibility and Relevance of Mindfulness Training among African American Women

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Pathway to Approval – – Expedited reviewExpedited review Complete the pre-review process with IRB

Office Staff (submit on IRB-1) Complete the required training Application sent to designated IRB Member(s) The IRB member may approve as is, require

changes prior to approval, or send to the full board

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Full Board ReviewFull Board Review

IRB applications that require full board review IRB applications that require full board review are thought to involve potentially higher levels are thought to involve potentially higher levels of risk to subjects, including those applications of risk to subjects, including those applications coded as being ‘more than minimal risk’coded as being ‘more than minimal risk’

Research involving the study of illegal activity, Research involving the study of illegal activity, drug and alcohol studies, X ray studies, drug and alcohol studies, X ray studies, research involving prisoners, or that involves research involving prisoners, or that involves maximal exercise require full board review, maximal exercise require full board review, also studies involving vulnerable populations also studies involving vulnerable populations or that focus on very sensitive topics or that focus on very sensitive topics

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Examples of UIUC studies requiring full Examples of UIUC studies requiring full board review (from COE and others)board review (from COE and others)

– Risk and Resilience Factors for Risk and Resilience Factors for Emotional, Behavioral, and Academic Emotional, Behavioral, and Academic Outcomes among Homeless Students Outcomes among Homeless Students

– Mothers and Babies in Prison? Mothers and Babies in Prison? Longitudinal Effects of the Decatur Longitudinal Effects of the Decatur Moms and Babies Program Moms and Babies Program

– Middle School Bullying and Sexual Middle School Bullying and Sexual Violence: Measurement Issues and Violence: Measurement Issues and Etiological ModelsEtiological Models

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Pathway to Approval - Full BoardFull Board

Submit the complete IRB 1 form Respond promptly to the pre-review

conducted by the office staff Complete the required training The IRB reviews applications at their monthly

meeting The IRB may vote to approve, defer, or

disapprove. Often a protocol may be approved pending satisfactory resolution of relatively minor issues.

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Facilitating IRB Facilitating IRB approval: Practical approval: Practical suggestionssuggestions 10 Tips and suggestions for how 10 Tips and suggestions for how

to decrease time from submission to decrease time from submission to approvalto approval

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Facilitating IRB approval Tip #3

RPI ROLE: careful review of IRB application by RPI ROLE: careful review of IRB application by RPI (Responsible Project Investigator) prior to RPI (Responsible Project Investigator) prior to submission for applications completed by submission for applications completed by students!students!– Carefully review consent and assent letters, insure Carefully review consent and assent letters, insure

all procedures are mentioned, etc.all procedures are mentioned, etc.– Check for literacy level, grammar, typos on the Check for literacy level, grammar, typos on the

consent or assent lettersconsent or assent letters– Check for missing materials, recruitment materials, Check for missing materials, recruitment materials,

measures, etc. measures, etc. – Check to make sure research plans are presented Check to make sure research plans are presented

consistently.consistently.

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Facilitating IRB approval Tip #4

Informed 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 do

– Flexibility on assent letters use kid-friendly language to explain:

what children are being asked to do that its voluntary, they don’t have to do it just because

their parents say its OK how long it will take

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Facilitating IRB approval Tip #5

Use lay language on the application and related materials

Describe the purpose of the study, research objectives and value of the research using non-technical language - don’t just copy/paste from funding proposal!

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Facilitating IRB approval Tip #6

Permission checkboxes for Permission checkboxes for audio/video/photographsaudio/video/photographs– IRB can’t approve language where participants IRB can’t approve language where participants

give up legal rightsgive up legal rights– get permission for audio recording, video get permission for audio recording, video

recording in checkbox format, or stress in letter recording in checkbox format, or stress in letter allowing audio/video is required (also mention in allowing audio/video is required (also mention in final consent statement)final consent statement)

– suggest separate checkboxes for dissemination suggest separate checkboxes for dissemination (permission to video, permission to disseminate (permission to video, permission to disseminate video clips) - but that is up to you!video clips) - but that is up to you!

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Facilitating IRB approval Tip #7

For K12 school research, review For K12 school research, review information found in IRB web site:information found in IRB web site:

Key Points - Waivers of Parent Permission in Key Points - Waivers of Parent Permission in School ResearchSchool Research

Guidance for Obtaining Informed Consent in Guidance for Obtaining Informed Consent in School ResearchSchool Research

When necessary use informed consent When necessary use informed consent waiver forms - guidance available waiver forms - guidance available from BER or IRBfrom BER or IRB

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Facilitating IRB approval Tip #9

Respond quickly to pre-reviewRespond quickly to pre-review Anticipated time framesAnticipated time frames

Exempt 2-3 weeks from submission to Exempt 2-3 weeks from submission to approval)approval)

Expedited - one monthExpedited - one month Full board - follow deadline dateFull board - follow deadline date

if pre-review issue doesn’t lead to if pre-review issue doesn’t lead to revisions explain whyrevisions explain why

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Facilitating IRB approval #10

Submit applications as early as Submit applications as early as possible in relation to when you possible in relation to when you would like to start the research would like to start the research activitiesactivities

Patience and positive attitude Patience and positive attitude help!!help!!

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Seven Criteria for Approval Seven Criteria for Approval (expedited and full board (expedited and full board approvals)approvals)

Risks to subjects are minimized.Risks to subjects are minimized.

Risks to subjects are reasonable Risks to subjects are reasonable in relation to anticipated benefits in relation to anticipated benefits and the importance of the and the importance of the knowledge that may reasonably knowledge that may reasonably be expected to result. be expected to result.

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Seven Criteria for Seven Criteria for Approval cont’dApproval cont’d

Selection of subjects is equitable.Selection of subjects is equitable.

Informed consent will be sought Informed consent will be sought from each prospective subject.from each prospective subject.

Informed consent will be Informed consent will be appropriately documented. appropriately documented.

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Seven Criteria for Seven Criteria for Approval cont’dApproval cont’d

The research plan makes The research plan makes adequate provision for monitoring adequate provision for monitoring the data collected.the data collected.

Adequate provisions to protect Adequate provisions to protect

the privacy of subjects and to the privacy of subjects and to maintain the confidentiality of maintain the confidentiality of data.data.

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Assistance AvailableAssistance Available

Tip sheets online with examplesTip sheets online with examples Phone: 333-2670Phone: 333-2670 Email: irb@illinois.eduEmail: irb@illinois.edu Schedule appointments with IRB Schedule appointments with IRB

staff + BER staff in 2012-2013!!staff + BER staff in 2012-2013!!