introduction case study problem solving wrap up
TRANSCRIPT
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Unpublished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/)[email protected]
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([email protected]).• 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