Understanding IRB Office of Research Integrity

Transcription

1 Understanding IRB Office f Research Integrity

2 Federal Definitins Research: A systematic investigatin, including research develpment, testing and evaluatin, designed t develp r cntribute t generalizable knwledge. Human Subjects: A living individual abut whm an investigatr cnducting research btains Data cllected thrugh interventin r interactin with the individual Identifiable private infrmatin is cllected Federalwide Assurance (FWA): a legal agreement between an institutin and Department f Health and Human Services, that allws fr the cnduct f DHHS-supprted r funded research

3 What is the Institutinal Review Bard? Primary missin: Respnsible fr prtecting the rights and welfare f research participants Cmpsed f experienced/active researchers Tasked with reviewing and apprving all human subjects research befre recruiting r data cllectin begins Respnsible fr determining what is (r is nt) research

4 The IRB is NOT Respnsible fr prtecting the researchers r the institutin, thugh if we all d ur jbs right, then all are prtected The research plice Able t make assumptins abut what PI s want t d r are ding A grup f bureaucrats fcusing nly n technicalities

5 IRB Submissin Steps Cmplete the Cllabrative Institute Training Initiative (CITI) Register with IRBNet Uplad All Study Dcuments Submit Prject Review Prcess Begins

6 ORI/IRB Review Prcess PI Submits Prject n IRBNet ORI Receives Prject and Pre-Review (ORI may cntact PI if any questins r revisins are needed prir t IRB review) IRB Designated Reviewer fr Initial Review and Review Determinatin (IRB Designated Reviewer may cntact PI if any questins r revisins are needed) IRB Review

7 10 Areas f Assessing Risk 1. Target Ppulatin Wh are they and what are their characteristics? 2. Infrmatin What infrmatin des the researcher want? 3. Harms What are the ptential harms t participants? 4. Pssibility and Prbability Can it reasnably happen? What are the chances? 5. Severity Hw bad culd it ptentially get?

8 10 Areas f Assessing Risk 6. Duratin Hw lng can it last? 7. Csts What are the pssible cnsequences t this persn? 8. Benefits What des the persn get ut f this? 9. Avidance Can risks and harms be avided? 10. Mitigatin If nt, hw can they be limited r reduced?

9 Federal Definitin f Minimal Risk Prbability and magnitude f harm is nt greater in and f itself than that rdinarily encuntered in daily life r during the perfrmance f rutine physical r psychlgical examinatins r tests.

10 Categries f IRB Review 1. Exempt Review Minimal risk study Des nt invlve identifiable sensitive infrmatin r prtected ppulatins Reviewed n a rlling basis 2. Expedited Review Middle level f review (case by case) Minimal risk study May invlve a prtected ppulatin grup and/r sensitive infrmatin Review is cnducted by an IRB Subcmmittee (weekly/bi-weekly) 3. Full Bard Review Greater than minimal risk studies Invlves prtected ppulatins and identifiable, sensitive infrmatin Review is cnducted by the Full IRB Cmmittee (mnthly)

11 IRB Bard Actins Apprval Letter frm IRBNet is sent stating that yur prject has been apprved. Yur fficial letter is lcated r IRBNet. Deferred Letter Revisins Required frm IRBNet is sent stating that the IRB requires crrectins r needs mre infrmatin befre study can be apprved Nt Apprved Letter

12 Additinal Infrmatin

13 Internet Research Widely used, especially fr survey research There is n expectatin f privacy n the internet! Typically cannt get a signature n IC frm Usually unable t screen fr minrs, prtected ppulatins, etc. Many PI s d nt understand (r use) IT security technlgy/measures If using a scial netwrking site, check their researcher/privacy plicies!

14 Scial Media in Research Grwing trend in Scial and Behaviral Research Knw what plicies are fr each scial media site yu are cnsidering Facebk Twitter Ggle Many thers

15 Internatinal Research Limited cnsistency between US and Internatinal laws Nt every cuntry has an IRB r IRB-like prcess Cultural, plitical, r ecnmic cnditins that culd increase risk t participants must be cnsidered Language and literacy barriers must be cnsidered by the PI and the IRB Cnsent frms must be available in English and native language IRB can alter/waive cnsent prcess t cnfrm t established cultural nrms, literacy levels, etc. In many cases, it is nt pssible t expedite internatinal prtcls

16 Cmmn Pitfalls Viewing the IRB prcess as a rubber stamp Shtgun apprach asking fr everything, but actually needing very little Inadequate data security measures Infrmed cnsent t technical r written at a high reading level Incmplete study design Assumptins as t what peple knw: EXPLAIN, EXPLAIN, EXPLAIN Failure t keep the target ppulatin in mind

17 Sme Helpful Suggestins If yu dn t need it, dn t ask. Use data grupings when pssible. Write in easy t read language. Cnsider hw yu wuld feel r what yu wuld want t knw as the subject Once apprved, d nt make changes t yur prtcl withut IRB apprval When in dubt, cntact the ORI

18 Keep in Mind Mst federal funders nw require IRB review and apprval befre grants are awarded r funds are released Many jurnals require IRB apprval befre any research is published Yu can never guarantee abslute cnfidentiality If yur prtcl expires, yu will need t start the prcess ver Take the IRB prcess seriusly. The gvernment and yur funders d.

19 Questins?

20 Thank yu fr yur time! If yu have any questins, please feel free t cntact us! Office f Research Integrity TC Chris Mangelli, Directr, ORI cmmangelli@bsu.edu Jhn Mulcahy, Assciate Directr, ORI jmulcahy@bsu.edu Jennifer Weaver, Research Integrity Administratr jmweaver@bsu.edu Dr. Bryan Byers, IRB Chair bbyers@bsu.edu