IRB Issues Compliance Quality and Consent A Faculty Members Perspective Considerations and Suggestions for Navigating the Consent Process Shayne B Piasta Assistant Professor Department of Teaching and Learning ID: 357150
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EHE Office of Research Workshop 10/13/15IRB Issues: Compliance, Quality, and Consent
A Faculty Member’s Perspective: Considerations and Suggestions for Navigating the Consent Process
Shayne B. Piasta
Assistant Professor, Department of Teaching and Learning
Faculty Associate, Crane Center for Early Childhood Research and PolicySlide2
My lensIRB is responsible for “ensur[ing] that research is designed and conducted in an ethical manner that protects the rights, dignity, welfare, and privacy of research subjects”I am responsible for protecting participants involved in my research studies and IRB complianceI am responsible for advocating for my research and my research team, in successfully addressing research goals and deliverables
(esp for funded projects)Slide3
IRB’s role is to SUPPORT researchers in protecting human subjectsKnowledge, planning, communication, ‘negotiation’ is keyParticularly for complex projectsSlide4
My research: Context and populationsSlide5
ProcessGetting educators/administrators on boardMOU/consentGetting parents on boardConsentGetting children on boardAssent (“required whenever the child is capable of providing assent, based on the age, maturity, condition, and psychological/emotional state of the child.”)
Across all - Clear, consistent communication is essentialBoth with stakeholders/participants AND in how you communicate your plan to IRBSlide6
Schools as research sites“Approved Research Performance Sites” Include/add non-approved sites to IRBRequires formal agreement (MOU)Slide7
Educators/administrators as key research personnel, participants, or neitherImportant implications for IRB protocol, CITI training, etc.!Depends on involvement, esp recruitment and consentSlide8
Educators as key personnel
Educators as means of accessSlide9
Educators as distributors/collectors of consent formsShould NOT have bearing on consent response (i.e., not recruitment or coercion)No explanation of consent from educators – simply distributorCollect in a way that minimizes coercion and maintains privacyCentrally-located drop boxSelf-addressed, stamped envelopesConsent forms collected regardless of responseSlide10
Increasing consent ratesMake personal contact and provide ways for ongoing communicationTeacher lunch, staff meetingsParent nights, dropoff/pickupMultiple contact attempts (without being overbearing)Teacher/school letterIncentivesCarefully attend to consent form language and lengthSlide11
Consent form (and other communications)Keep it simple and briefSlide12
Consent form (and other communications)Keep it simple and briefPlan for full project duration (and beyond)Consider your audience8th grade readabilityMinimize technical terms/legalese
Need to read orally or translate?Language is important!Clearly state benefits and obligationsAdhere to/include any requirements stipulated by IRBhttp://orrp.osu.edu/irb/investigator-guidance/consent/ Slide13
Waiver or alteration of informed consentOnly in compelling circumstances under very specific criteriaResearch on public benefit or service programs with cooperation of state/federal governmentResearch that involves minimal risk and could not practically be carried out without waiver/alterationResearch to study conditions in children when parent permission is not a reasonable requirement to protect the child subjectsSlide14
Minor providing consent for both child and self
Classroom observationsSlide15
Additional suggestionsBe informed about IRB policies/regulationsBe your own biggest advocate with respect to balancing responsibilities as a researcherPick your battlesBe open and creative in solutionsSeek permission, not forgivenessCommunicate with IRB staff and use them as supportsSlide16
Additional suggestionsRemember that IRB staff and IRB members may not conduct field-based/educational researchStructure your IRB proposal/protocol to make your research plan as clear as possibleTry to head off any potential pitfallsBe courteous, professional, and responsive
Piasta.1@osu.edu