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IRB Process - Towson University

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IRB Process
Effective January 19th, 2018
Institutional Review Board
What is an IRB?What is its job?What are its guiding Principles?Belmont Report (i.e., Respect for Persons, Beneficence, Justice)Code of Federal Regulations, Title 45 – Public Welfare, Part 46 Protection of Human Participants (akaThe Common Rule)USM Policies and Procedures, Section III and Section IV
IRBProcessStep 1
Determine Whether Your Study RequiresIRBReview
What is Human Subjects’ Research?
IRBProcessStep 2
Ensure All Study Personnel Have Completed HumanSubjects’ Protections Training
Human Subjects’ Protections Training
CITI PROGRAMComplete allmodulesShould take severalhoursScore at least 80%Print out and submit copy of CompletionCertificate
New UserClick onRegisterto set up a free accountClick onAffiliate with Another Institution; follow instructionsUnder Towson University Courses, Click onAdd a CourseQuestion 1: Responsible Conduct of Research – optionalQuestion 2:SkipQuestion 3: Faculty/Staff SelectSocial & Behavioral ResearchORBiomedical ResearchStudents Students Conducting No More than Minimal Risk ResearchQuestion 4:Not at this time, thank youHitSubmit
NOTE: Studies will not be submitted for review UNTIL evidence of Human Subjects’ Protection Training has been providedby ALLstudy personnel involved in data collection or analysis
IRBProcess Step 3
Determine LevelofReview
Minimal Risk
As defined in 45CFR46.102.j,minimal risk . . .…means that the probability and magnitude ofharm or discomfort, anticipated in the research are not greater in and of themselves than those risks ordinarilyencountered in daily lifeor during the performance ofroutine physical or psychological tests.
TU Review Categories
Accelerated Review
Full BoardReview
Continuing Review?
Progress Report every 3 years
Annually via Standard Review,Unless…*
…(a) you intend to modify the study procedures or consent document; (b) a participant complains about the research or there is an adverse event; (c) there is a protocol violation/deviation; and/or (d) new findings indicate that the study risks, or the risk/benefit ratio, havechange
Review Categories
IRB Process Step4
The Successful IRB Application
Provides detail about:Study rationale as well as aims or hypothesesAnticipated benefitsInclusion/Exclusion criteriaRecruitment planHow informed consent will be obtained
Provides detail about:Study procedures (i.e., in chronological order, what will subjects be asked to do)Measures to be usedAnticipated risks and plans for mitigating or managing risksIf applicable, a statement that there are no foreseeable risks
The Successful IRB Application
Provides detail about:How confidentiality or anonymity will be assuredHow data will be stored to ensure security and who has access to dataIf/when/how data will be destroyedIf/how subjects will be compensated
Informed Consent/Assent**Includes all required elements (use TU Consent/Assent template)8thgrade reading level (adults)Appropriate reading level (children/adolescents)Sufficient detail so that participants understand risks and what is expected of them** If data are anonymous, use an information sheet
The Successful IRB Application
At minimum, attach the following:Informed consent form or information sheetMeasures (or detailed description of questions, if proprietary), interview questionsHuman Subjects’ Protections Training certificationIf student PI, Faculty Advisor signature
If appropriate also attach:Informed assent formRecruitment materials, including:Content of e-mails or lettersScripts for verbal recruitmentFliersContent of ads and where they will be placedLinks to relevant websites
IRB Process Step 5
Revising Your Application BasedonReviewer Comments
Revising your Application
Address ALL reviewer concernsSubmit a cover letter with the reviewer’s comments and your response/revisionIf you disagree with a suggested revision In your response, provide a detailed explanation for why you disagree with the comment; be advised the reviewer may still require the revision if the rationale is not convincingSubmit a revised protocol AND consent formUse track changes, highlighting, or different colored font for revisionsDO NOT BEGIN DATA COLLECTION UNTIL APPROVAL FOR THE STUDY HAS BEEN GRANTED!!Once approved, you will receive notification from the IRB office – you may begin data collection!
IRB Process Step6
Amending Your ApplicationAfter Approval
Amending Applications
All substantive changes to consent forms or protocols MUST be reviewed and approved by the IRBIf not sure if change is substantive, askSubmitE-mail describing the change and its rationaleProtocol with track changes, highlighting, or different colored fontConsent form with track changes, highlighting, or different colored fontInclude: new questionnaires; recruitment materials,etcNOTE: You may not implement protocol changes until the IRB has approved the amendment
Some Final Thoughts
What to doif. . .I want to include17-year-oldcollege studentsI want to pay participantsI want to use datapanelsSomeone complains about the researchA participant experiences an adverse eventThere is a protocol deviation/violation
NOTE: Formore detailed information on all of these topics, see thePrincipal Investigator’s Instruction Manualwhich is available on the IRBwebsite





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IRB Process - Towson University