IRB Process and Submission. Office of Research Integrity

Transcription

1 IRB Prcess and Submissin 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 Hw t Submit a Research Prtcl

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

7 CITI Training First time: Register and affiliate yurself with Ball State If yu have taken CITI Training at anther university, yu are nt required t take the training. Just lg in and affiliate with Ball State. PI, Faculty Advisr, and all research team members must cmplete either the: Scial and Behaviral Research-Basic/Refresher Curse; r Bimedical Research-Basic/Refresher Curse Respnsible Cnduct f Research (RCR) Take this curse nly if the research is federally funded r required by a granting agency, federal fficial, r BSU. This Certificatin is gd fr three years.

8 Register Uplad IRB Dcuments IRBNet Principal Investigatr E-Signature Faculty Advisr E-Signature (fr Student PI s nly) Submissin IRBNet Guides available n ORI Website ( t/irbnetguidancepages.aspx)

9 IRB Dcuments Human Subjects Research Applicatin and Narrative Frm Infrmed Cnsent Study Dcuments Letters f Supprt Additinal Supprt Dcuments

10 Human Subjects Research Applicatin and Narrative Frm Cmbines the applicatin and prtcl infrmatin int ne frm Study prtcl is nt required

11 Types f Sensitive Infrmatin Sexual attitudes, preferences, r practices Use f alchl, drugs, r ther addictive prducts Infrmatin pertaining t illegal cnduct Infrmatin that, if released, culd reasnably damage an individuals financial standing, emplyability, r reputatin within the cmmunity Health and medical infrmatin cntained in a medical recrd, chart, r insurance file (HIPAA) Psychlgical, psychiatric, r mental health infrmatin abut a specific individual Student s academic recrds infrmatin (FERPA) Genetic Infrmatin

12 Prtected Ppulatins Children/Minrs (under age 18) Prisners Pregnant wmen (invlved in sme types f research) Peple with diminished capacity t give cnsent Mentally r physically challenged individuals Cntact the Office f Research Integrity fr mre infrmatin regarding Prtected Ppulatins.

13 Infrmed Cnsent IC is ne f yur mst imprtant dcuments! Infrmed Cnsent prcess is always required. Cnsent is always active, never passive. Written t the participant (nt in 3 rd persn) Blanket r pen-ended IC is nt allwed. Cannt waive r defer liability f harms t participants IC frm shuld be crafted t the specific study. Readability must be at either: The 6-8 th grade reading level; r At target audience s reading level (i.e., 4 th grade fr 4 th graders)

14 Elements f Infrmed Cnsent 1. Study Title 2. Study Purpse and Ratinale 3. Inclusin/Exclusin Criteria Including age range f participants 4. Participatin Prcedures and Duratin Include a detailed explanatin 5. Audi r Vide Recrdings (if applicable) 6. Disclsure f Alternative Prcedures Prcedure fr thse that d nt wish t participate 7. Data Cnfidentiality r Annymity 8. Strage f Data This includes data retentin as well

15 Elements f Infrmed Cnsent 9. Risks r discmfrts 10. Wh t cntact, shuld yu experience any negative effects frm participating in this study Cunseling r medical services 11. Benefits Only state direct benefits t the participant, nt incentives 12. Vluntary Participatin Statement This is MANDATORY and has t be stated CLEARLY. 13. IRB Cntact Infrmatin 14. Cnsenting/Signatry Area 15. Principal Investigatr/Faculty Advisr Cntact Infrmatin

16 Parental Cnsent/ Child Assent If yu plan t use any children/minrs (<18 years ld) yu are required t have Parental Cnsent and Child Assent Parental Cnsent has the same infrmatin as an adult cnsent, but stating fr their child Child Assent is a separate dcument Child Assent must be written age-apprpriately Children 5-17 shuld assent Children yunger than 5 may have verbal cnsent, but a script must be written. Cntact the ORI fr questins regarding Parental Cnsent and Child Assent.

17 Study Dcuments Interview questins Surveys and Questinnaires Advertisements (Recruitment Scripts) Debriefings (if needed) Media Permissin Frms (if media will be used in the research publicatins r cnferences) Letter f Supprt/Permissin

18 Letters f Supprt Letters f Supprt/Permissin are letters frm schls r rganizatins permitting research t be dne at that lcatin They need t indicate in these letters that they are aware yu are there fr RESEARCH purpses in additin t any ther reasn yu may be there! Letters must be n the schl/rganizatinal letterhead s will NOT be accepted. Letters must be signed by the schl/rganizatin s directr, manager, principal, r superintendent. Letters must be upladed n IRBNet prir t IRB review (nt after)

19 Other Supprt Dcuments FERPA Permissin Dcuments Fr educatinal recrds HIPAA Permissin Dcuments Fr health/medical recrds Any ther required supprt dcuments

20 Hw Will My Study Be Reviewed?

21 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

22 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?

23 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?

24 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.

25 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)

26 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

27 IRB Mdificatins If there are ANY changes t yur research study, yu are required t submit a Mdificatin Request n IRBNet fr all apprved studies Changes f study title Changes f PI/Faculty Advisr Add/Delete Key Persnnel Change in number f participants Prcedural changes Mdificatin Request Submissin Dcuments Mdificatin Frm Revised Highlighted Dcuments Adding Persnnel (CITI Training) PI/Faculty Advisr E-Signature n IRBNet

28 IRB Annual Cntinuing Review Expedited r Full Bard Prjects Only Exempt Apprvals are nt required t submit Expedited and Full Bard Prjects are apprved fr ONE year frm the last apprval date PI will receive alerts apprximately 90, 60, and 30 days prir t expiratin date If the expiratin date passes, the prject will be clsed and PI will need t re-submit as a new study Cntinuing Review Submissin Dcuments Annual Cntinuing Review Frm PI/Faculty Advisr E-Signature n IRBNet

29 Study Clsure Final Reprt (Expedited r Full Bard) Exempt studies are nt required t submit Adverse Events All apprved studies Serius Adverse Events (SAEs) All apprved studies

30 Adverse Events (AEs) Adverse Event = unexpected r unanticipated prblem related r pssibly related t participatin in the research AE may result frm prtcl deviatins, participant r persnnel minr injury, lst r stlen data, lss f multiple persnnel, higher than expected participants withdraw rate, abnrmal results, etc. AEs must be submitted t the ORI within 5 business days AE Frms are lcated n the ORI website r n IRBNet Library Manager

31 Serius Adverse Events (SAEs) Serius Adverse Events = serius event that was unexpected r unanticipated during the research study SEAs must be reprted t the ORI within 24 hurs f the event Examples f SAEs include: Death Hspitalizatins Permanent damages Suspicius findings Birth defects/cngenital anmaly Overdse f drugs Adverse pregnancy Lss r stlen identifiable infrmatin/recrds

32 Additinal Infrmatin

33 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!

34 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

35 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

36 Submissin Ntes Explain in enugh detail what yur study is abut. D nt assume what the bard might knw. Spell ut acrnyms. Sync up the narrative and infrmed cnsent. Include infrmatin n data security, privacy, cnfidentiality, data retentin perids,and data destructin. Explain exactly hw yu plan n carrying ut each f these prcesses in detail. When in dubt, explain hw and why. Remember Parental Cnsent AND Child Assent Please d nt cpy and paste frm ne dcument t anther. Check spelling and grammar!

37 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

38 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

39 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.

40 Questins?

41 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