introduction case study problem solving wrap up

IntroductionCasestudy

ProblemsolvingWrapup

MatthewHunt– McGillUniversityDonal O’Mathuna – DublinCityUniLisaSchwartz– McMasterUniversity

Typesofresearchbeingdoneduringorafterdisasters

CatherineM.Tansey,RenaudBoulanger,JohnPringle,Anushree Davé,MatthewHunt(2017)Mappinghealth-related

disasterresearchinlow-and-

middle-incomecountries:a

scopingreview

Unpublished

Multiplemethods

Arangeofpopulations

Arangeofconditions

Challengingsettings

• Clinicaltrialsinpublichealthemergencies

• Nestedqualitativestudies

• Observationalstudies• Secondaryanalysisof

fielddata

Realitiesofresearchindisaster

• Speed

• Precarioussettings&vulnerablepopulations

• Accesstoresources

• Impactofdisasteronmeetinglocalrequirements- partners

• Impactofresearchontheaims&workofEMTs

• Secondaryuseoffielddataforresearch

• Methodologicalhierarchydrivingwhatresearchwillbedone

• Knowledgetranslationandknowledgemobilazation

Tworesources

• MatthewHunt,CatherineM.Tansey,JamesAnderson,RenaudF.Boulanger,LisaEckenwiler,JohnPringle,LisaSchwartz(2016)TheChallengeofTimely,ResponsiveandRigorousEthicsReviewofDisasterResearch:ViewsofResearchEthicsCommitteeMembersPlos One

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0157142

• Dónal O'Mathúna (2015)Researchethicsinthecontextofhumanitarianemergencies.Jrl ofEvidenceBasedMedicine

http://onlinelibrary.wiley.com/doi/10.1111/jebm.12136/full

ResearchEthicsinDisastersandPublicHealthEmergencies

MatthewHunt,LisaSchwartz

andDónalO’Mathúna

SchoolofNursing&HumanSciences

DublinCityUniversity,Ireland

AdjunctAssistantProfessorof

EmergencyMedicine,TheOhioStateUniversity

Director,Center forDisasterand

HumanitarianEthics(www.ge2p2.org/new-blog/)donal.omathuna@dcu.ie

http://disasterbioethics.eu

DefinitionDisaster:‘Aseriousdisruptionofthefunctioningofacommunityorasocietyatanyscaleduetohazardouseventsinteractingwithconditionsofexposure,vulnerabilityandcapacity,leadingtooneormoreofthefollowing:human,material,economicandenvironmentallossesandimpacts.’Effectmayexceedlocalcapacityrequiringexternalassistance.UNOfficeforDisasterRiskReduction(UNISDR):https://www.unisdr.org/we/inform/terminology

Frequency

Impact

Responding• “Wedon’treallyknowwhich

interventionsaremosteffectivein

reducingrisk,savinglivesand

rebuildinglivelihoodsafter

crises…Itisextremelydifficultforpractitionerstoaccessinformationaboutgoodpracticeinordertoimprovetheirowneffectiveness,becauseinformationisscatteredandisnotavailableinaconsistentformat”(DFID,2012,p.5)

http://www.alnap.org/resource/9823.aspx

• “muchoftheexistingoperationalresearchrelatedtoemergenciesanddisasterslacksconsistency,isofpoorreliabilityandvalidityandisoflimiteduseforestablishingbaselines,definingstandards,makingcomparisonsortrackingtrends”(p.46).– UNISDR.HyogoFrameworkforAction2005-2015,Mid-TermReview

2011.

PhotographcourtesyofJohanVonSchreeb

• “Thefailuretogenerateanduseevidenceinpolicyandresponsemakeshumanitarianactionlesseffective,lessethicalandlessaccountable”(ALNAP,2014,p.5).

• Itis“unethicaltodeliverinterventionsthatare,atbestnotproven,areineffectiveor,worsestill,doactualharm”(DFID,2012,p.11).

http://www.alnap.org/resource/10441

• “Manypractitionersconsiderresearchindisastersettingstobeunethical.Inadditiontobeingperceivedastakingawayresourcesfromhumanitarianaid,thereareconcernsthatresearchcanbeanimpositiononthosealreadysuffering,andthatitdoesnotimmediatelyhelpthosebeingstudied”(DFID,2012,p.11).

PhotographcourtesyofPretesh Kiran

Example:SurgeryinHaiti(2010)• Widelydivergentamputationratesbetweensurgical

teams(from1%to45%ofproceduresconducted).• Recordsoftennotkept.• Allegationsof“disastertourism”.• Ledtoretrospectivestudies,quantitativeandqualitative.• WHOminimumstandards(2013),ICRC/WHO/AOFManual(2016):

https://icrc.aoeducation.org

O’MathúnaDP,VonSchreeb J.UNISDRScientificandTechnical

AdvisoryGroupCaseStudies– 2015.http://bit.ly/1z9NVgl

Photo:JohanVonSchreeb

DualImperative

Evidence Ethics

O’MathúnaDP.“Thedualimperativeindisasterresearchethics”,intheSAGEHandbookofQualitativeResearchEthics,eds.RonIphofen andMartinTolich (inpress)

ResearchEthicsFrameworks

• CouncilforInternationalOrganizationsofMedicalSciences(CIOMS),InternationalEthicalGuidelinesforHealth-relatedResearchInvolvingHumans,Guideline20:ResearchinDisastersandDiseaseOutbreaks (2016):http://www.cioms.ch/

• R2HCEthicalFramework(2014):www.elrha.org/R2HC/research/other-research/ethics-review/(revisedversionto belaunchedin2017)

• MédecinsSansFrontières(MSF)EthicsReviewBoard(2013):http://fieldresearch.msf.org/msf/handle/10144/305288

• WorkingGrouponDisasterResearchandEthics(2011):https://globalhealthtrials.tghn.org/articles/draft-statementguidelines-disaster-research/

BenchmarksofEthicalResearch1. Collaborativepartnership2. Socialvalue3. Scientificvalidity4. Fairselectionofstudypopulation5. Favorable risk-benefitratio6. Independentreview7. Informedconsent8. Respectforrecruitedparticipantsandstudycommunities

• EmanuelEJ,Wendler D,&GradyC.Whatmakesclinicalresearchethicalindevelopingcountries?Thebenchmarksofethicalresearch.JournalofInfectiousDiseases2004;189(5):930-937.

• O’MathúnaDP.Researchethicsinthecontextofhumanitarianemergencies.JournalofEvidence-BasedMedicine 2015;8(1):31-5.[openaccess]

• WADEMWebinar:O’MathúnaDP.DisasterResearch Ethics:DevelopingEvidenceEthically.2017.https://wadem.org/resources/webinar/

Casestudy• Divide intosmallgroups.• Identifyonepersontotakenoteson thepageprovidedandreport

backattheendtothewholeroom.• Eachgroupwillbeassignedone phaseoftheresearchtodiscuss.• Readoverthecasestudyprovided.• Usethe(DRAFT)R2HCEthicsFramework2.0

toguideyourdiscussionofthe3questions.• Keeptrackofthetime!• Pleaseprovideyourfeedbackonthecasestudy

sheetorbyemail(donal.omathuna@dcu.ie).• Wewouldalsolikefeedbackontheusefulness

(orotherwise)ofthedraftEthicsFramework.

PhotographcourtesyofJohanVonSchreeb

BeyondCodesandGuidelines

• “thevirtuousresearcher”– ‘afocusontheinternalethical

motivationofindividualinvestigators,notonlytherulesandregulationsthatexternallymotivateinvestigatorstowardcompliance’(p.32)

https://bioethicsarchive.georgetown.edu/pcsbi/node/558.html

• Researchersandresearchteamsneedtodeveloptheskillsto:– identifyethicalissues,– reflectonethicalissues,– reachethicaldecisionsthatcanbedefended.

• AND,becomevirtuousresearcherswiththehigheststandardsofpersonalandresearchintegrity.

• Trainingandassessmentischallenging.• Whenresearchersaretemptedinsomelessthanethicaldirection,

alltheymayhaveistheirconscienceandtheirvirtues.– O’MathúnaDP.“Thedualimperativeindisasterresearchethics”,in

theSAGEHandbookofQualitativeResearchEthics,eds.RonIphofenandMartinTolich (inpress).

Furtherresources

n Ahandoutwithvariousresourcesisavailablehere.

n O’MathúnaDP,GordijnB,andClarke,M.DisasterBioethics:NormativeIssues

whenNothingisNormal (Springer,2014).n https://humanitarianhealthethics.netn http://DisasterBioethics.eun https://BioethicsIreland.ie/disasters

ThankYou!

Researchethicsoversightindisastersandpublic

healthemergencies

April26,2017

DisasterResearchEthicsStudyTeam

LisaEckenwiler

MatthewHunt

LisaSchwartz

JamesAnderson

RenaudBoulanger

CathyTansey

AnantBhan

AnushreeDavé

JohnPringle

Disasterresearchethicsproject

Interviewswith

researchers

Systematicmappingofdisasterresearch

InterviewswithRECmembers

REC: Research Ethics Committee

1

2

3

"to be nimble and responsive to the needs of the field, and still deliver high quality reviews, [in] a timely manner.”

(Respondent affiliated with the REC of an international organization)

What attributes characterize a research

ethics committee (REC) that is well suited to

review crisis research?

• Timeliness

• Responsiveness

• Rigorousness

3 key characteristics of effective ethics review :

Timely Review

Procedures are calibrated so that

specific research protocols, based on

the degree of temporal urgency, are

reviewed promptly and are not unduly

delayed.

“wearesensitivetothatinthesenseoftryingtospeedup

theprotocol’sprocessofreview…becauseweunderstand

thatsomebodyneedstoactrapidly.”

REC chair

Responsive Review

Sufficient awareness of and appreciation

for the realities of conducting research in

a disaster, and access to knowledge

about the locale where the disaster has

occurred.

“itisverydifficultto,whilewearereviewing,

tounderstandthesituationwithinthatarea”

Respondent from a country where a disaster

occurred in a remote region

Rigorous Review

Provision of due scrutiny to ensure

that reviews provide sufficient

protections for individuals and

communities participating in

research, while ensuring

independence of the review

process.

• May need to resist “the pressure of urgency” to ensure due level of ethical

scrutiny

• May need to resist “the pressure of politics” to ensure independence of the

review process, e.g. a REC sought to

“maintain their independence” and “to not politicize the committee.”

Rigorous Review

Whatnext?

• Furtherresearch• Askyourethicsboardwhattheyaredoingtohelp• Developpoliciesforenablingethicalresearchinyourorganization• Enablelocalcapacitydevelopmentinresearch,ethicsreview• Beopen,honest,self-critical:whowillbenefit?Whocouldbeharmed?• Visithhe &COSTaction DisasterEthics websites– cases,toolkit,blogs• JoinHumEthNet communityofpractice• Follow@HumEthNet,@DisasterBioethics,#WADEMethics• JohanvonShreeb – followupwithplanningmeetings