Ethics in Health Research

By
Mulusew Andualem (BSc, MPH):
A research consultant and Research advisor

February 2015

Mulusew Andualem: College of Medicine & Health Sciences,

Bahir Dar University, Ethiopia

Overview of lecture
1. Introduction
2. Principles of Ethics in Health Research
3. Ethics Codes, guidelines and
regulations

Mulusew Andualem: College of Medicine & Health Sciences,

Bahir Dar University, Ethiopia

References
1. RichardA.CashandTracyL.Rabin.OverviewofEthicalIssuesinCollectingDatain
Developingcountries,withSpecialReferencetoLongitudinalDesigns.Leveraging
LongitudinalDatainDevelopingCountries:ReportofaWorkshop2002.
2. BonnieSteinbock,AlexJohnLondon,JohnD.Arras.EthicalissuesinModern
Medicine,2008.ISBN:0073407356/9780073407357
3. HirotsuguAiga.Bombardingpeoplewithquestions:areconsiderationofsurveyethics.Bull
WorldHealthOrgan2007;85:823.
4. ZulfiqarAhamedBhutta.EthicsininternationalhealthResearch:aperspectivefromthe
developingworld.BullWorldHealthOrgan2002;80:114-120.
5. EthiopianScienceandTechnologyCommissioninCollaborationwiththeEthiopianPublic
HealthAssociationandRegionalStateHealthBureaus.HealthResearchEthicsTraining
Module4,AddisAbabaEthiopia2005.
6. EthiopianScienceandTechnologyCommission.NationalHealthSciencesandTechnology
council.HealthDepartment.NationalHealthResearchEthicsReviewGuideline.4 thEdition
Revised,AddisAbabaEthiopia2005
7. EthicalPrinciplesandGuidelinesfortheprotectionofhumansubjectsofresearch.The
BelmontReport.TheNationalCommissionfortheProtectionofHunanSubjectsof
BiomedicalandBehavioralResearch1979
Mulusew Andualem; College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

1.Introduction

Therearewideinequalitiesinburdenofdiseaseandhealth
outcomesbetweenthedevelopedanddeveloping
countries
Healthresearchplaysapivotalroleinaddressingthese
inequitiesinhealthandhumandevelopment,buttoachieve
theseobjectivestheresearchmustbebasedonsound
scientificandethicalprinciples

Mulusew Andualem; College of Medicine & Health Sciences,

Bahir Dar University, Ethiopia

What is Research?
Asystematiccollection,analysisandinterpretationof
datatosolveaproblem
Systematicinvestigationdesignedtoproduce
generalizableknowledge
Canbeappliedtootherpopulations
Publishedanddisseminated
Mulusew Andualem: College of Medicine & Health
Sciences, Bahir Dar University, Ethiopia

What is Research?
Researchhascontributedimmenselytohumanprogress
andtothedevelopmentofmodernsociety
Scientificknowledgegeneratedthroughresearchis
powerfultoolforsolvingchallengeshumanity
FoodsecuritytodiseasessuchasAIDS,
pollutiontotheproliferationofweapons

Recentadvancesininformationtechnology,geneticsand
biotechnologyholdextraordinaryprospectsforindividual
well-beingandhumankindasawhole
Mulusew Andualem: College of Medicine & Health Sciences, Bahir
Dar University, Ethiopia

What is Research?
Indevelopedcountriesresearch:
Searchfornewknowledge
Advancementoftheoreticalformulations
Developmentofnewinventionsandinnovation

Indevelopingcountriesresearchperceived
Luxury
doneonlywhenacountrybecomesmoredevelopedand
hasextraresources
Manyoftheworldsmostseriousproblemshaveaimpacton
developingcountries,suchasinsub-SaharanAfrica
Mulusew Andualem: College of Medicine & Health Sciences, Bahir
Dar University, Ethiopia

Ethics and Science

The paradox:
Tobeethical,theinvestigatormusttreathis/her
subjectsasautonomouspersons,possessedoffreewill
andanimpressivesetofmoralrights
Tobeprofessional,theinvestigatormusttreathis/her
subjectsasscientificobjects,subjecttothelawsof
natureandtheimpersonalrulesofcauseandeffect.

Mulusew Andualem: College of Medicine & Health Sciences,

Bahir Dar University, Ethiopia

Participants of Research
Livingindividualsfromwhomtheresearchermayobtain:
Datathroughinteractionorintervention.
Identifiableprivateinformation

Mulusew Andualem: College of Medicine & Health Sciences,

Bahir Dar University, Ethiopia

What is Informed Consent?

Aformalapproachofinvitingapersontoparticipateina
researchundertaking
Isconsentgivenbyacompetentindividualwho
Hasreceivednecessaryinformation
Adequatelyunderstoodit
Consideredit
Arrivedatadecisionwithoutcoercion,undue
influence,inducementorintimidation

Who precisely is consenting to participation?

Thecommunity,household,orindividuals?
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

10

Informed consent (cont.)

Informedconsentofthesecondparty:
Isitethicalforamaleheadofhouseholdtoconsentforhis
entirefamilytoparticipateinresearch?
Wouldchoosinghouseholdoverindividualconsentexpress
culturalsensitivityorethicaldoublestandards?
IsitethicalforConsentinghusbandforawomen?
Innocaseacompetentadultwomanbeenrolledinresearch
solelyupontheconsentofanotherperson.
But,IRBmayacceptaconsentprocess:
Ifitisimpossibletoconducttheresearchwithoutobtaining
supplementalpermission
Iffailuretoconducttheresearchwoulddenybenefitstowomen
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

11

Informed Consent - elements

Researchdescription
Benefits
Alternative
Confidentiality
Compensation
Voluntaryparticipation
Withdrawal
Contact
Documentationofinformedconsent
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

12

2.Fundamental Principles of Ethics in Health Research

Universallyacceptedprinciplestoguideresearchersin
theirselectionandtreatmentofhumansubjectsare:
1. Respectforpersons
2. Beneficence
3. Justice
Universalregardlessofgeographic,economic,legaland
politicalboundaries
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

13

Respect for Persons

a) Respectforautonomy:respectfortheircapacityforselfdetermination.
b)Protectionofpersonswithimpairedordiminished
autonomy.
Autonomy?=selfdetermination
Diminishedautonomy?=Vulnerablegroups
Soitistheresearchersresponsibilityto
systematicallyassesscapacitytoconsentpriortoand
duringtheresearchactivity.
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

14

Respect for Persons: considerations

Informedconsent
ComprehensiveInformation
AppropriateLanguage
Individualautonomyandlocusofdecisionalauthority

IndividualvsCommunity
Selectivedisclosure
Inducementtoparticipation
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

15

Confidentiality
Personalidentifiers
IDvariables
Communitiesidentifiers
GeocodingandGISdata

Mulusew Andualem: College of Medicine & Health Sciences, Bahir

Dar University, Ethiopia

16

Beneficence
Personsaretreatednotonlybyrespectingtheirdecisionsand
protectingthemfromharm,butalsobymakingeffortsto
securetheirwell-being(physical,mentalandsocialasrelated
tothestudy)
Beneficenceisanobligationandnotjustasactsofkindness
/charity

Protectionofthewell-beingoftheparticipantistheprimary
responsibilityofthestudyteam.
WeighrisksVsbenefits
Physical,mentalandsocialwell-being
Riskreductiontoaminimum
Mulusew Andualem: College of Medicine & Health Sciences,
Protectionofparticipants
Bahir Dar University, Ethiopia

17

Maximizing benefits
Communicationofstudyresults
Provisionofhealthcare
Trainingoflocalhealthstaff
FairBenefitframework

Mulusew Andualem: College of Medicine & Health Sciences,

Bahir Dar University, Ethiopia

18

Minimizing harm
Carefuluseoflocalhealthresourcesandrespectfor
localpriorities
Avoidstigmatization,prejudice,economicloss

Preparelocalresearchstaffforspecialsituations
Proposemeasuresagainsteminentrisksobserved
duringthestudy
Avoidharmfulpublicity

Respectlocalsocialandculturalnorms
Confidentiality
Disclosureofconflictofinterest

Mulusew Andualem: College of Medicine & Health Sciences,

Bahir Dar University, Ethiopia

19

Justice
Distributionofriskandbenefits
Equitablerecruitmentofparticipants
Protectionofvulnerablegroups
Theprincipleofjusticeforbidsplacingonegroupof
peopleatrisksolelyforthebenefitofanother

Mulusew Andualem: College of Medicine & Health Sciences, Bahir

Dar University, Ethiopia

20

Justice: considerations
Equityinselectionofsubjects
Exclusionsmustbejustifiable:itisunjustto
deprivegroupsofpersonsthebenefitofresearch
Ensureaccesstothebenefitsoftheresearchtothe
researchcommunity,particularlywhennosuperioror
equivalentapproachestotherapyareavailable.
Institutionalization:Sustainability
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

21

Justice(cont.)
Overcrowdingofresearchproject
Overcrowdedcommunity:Communityfatigue
A survey, again? You are the third survey team who
visited us during these couple of months. I am fed
up with ...
Mayresultinduplicationofefforts
Overaccumulationofanalyzeddata

Mulusew Andualem: College of Medicine & Health Sciences,

Bahir Dar University, Ethiopia

22

Group work and Presentation

Mulusew Andualem: College of Medicine & Health Sciences,

Bahir Dar University, Ethiopia

23

3.Ethics Codes, guidelines and regulations

Nurembergcode
DeclarationofHelsinki
Belmontreport
Commonrule
CIOMS
InternationalconferenceonHarmonization
NationalBioethicsAdvisoryCommittee

Mulusew Andualem: College of Medicine & Health Sciences,

Bahir Dar University, Ethiopia

24

Changing International Guidelines

1947, the Nuremberg Code
1964, The Declaration of Helsinki (World Medical
Association) revisedin1975,1983,1989,1996,2000,
2002
1991, International Guidelines for Ethical Review of
EpidemiologicalStudies[CouncilforInternational
OrganizationsofMedicalSciences(CIOMS)]
1993,InternationalEthicalGuidelinesforBiomedicalResearch
InvolvingHumanSubjects(CIOMS)revisedin2002
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

25

Nuremberg Code
Emphasizedon:
Informedconsent
Qualifiedresearchers
Appropriatedesign
Weighriskagainstbenefit
Freetostopatanytime
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

26

Helsinki Declaration
Emphasizedon:
Wellbeingofsubjecttakesprecedenceoverinterestsofscience
andsociety
Consentinwriting
Limiteduseofplacebo
Greateraccesstobenefit
Usecautionifparticipantisindependentrelationshipto
researcher
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

27

Common Rule
ApprovedbyEthicscommittee
Writteninformedconsentanddocumentation
Equitablerecruitmentofparticipants
Specialprotectionofvulnerablegroups
Continuingreviewofapprovedresearch
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

28

CIOMS (Council for International Organization of

medical Science) guidelines

Emphasison:
Informedconsent
Protectionofvulnerablegroups
Distributionsofburdensandbenefits
RoleofEthicscommittee
Researchindevelopingcountries
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

29

Common to all
Fundamentalprinciples:respect,Beneficenceand
justice.
Researchisaprivilegenotaright
Wellbeingofparticipantisparamount

Mulusew Andualem: College of Medicine & Health Sciences,

Bahir Dar University, Ethiopia

30

Some Reasons for Frequent Revisions

HIV/AIDSpandemic;large-scaletrialsofvaccineand
treatmentdrugs
Rapidadvancesinmedicineandbiotechnology
Changingresearchpracticessuchasmultinationalfield
trials.
Experimentationinvolvingvulnerablepopulationgroups
Involvementofpopulationsindevelopingcountriesin
humanexperimentation
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

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Source: Addis continental institute of public health, Ethiopia.

Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

32

Researchers Responsibilities
Protectionofhumanparticipants
Conductresearchaccordingtoprotocol
CompliancewithEthicsCommitteerequirements
Poststudy:longterminterestofparticipants

Mulusew Andualem: College of Medicine & Health Sciences, Bahir

Dar University, Ethiopia

33

Sponsors Responsibility
Ensureappropriatereview,approvalandsupervision
Monitorresearch
Selectqualifiedresearchers
Providepoliciesandprocedures
Complywithlocalethicalrequirements
Ensurelocalrelevanceofresearch
Provideresearchintegrity
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia

34

Respect for persons, Beneficence and

Justice

Mulusew Andualem: College of Medicine & Health Sciences,

Bahir Dar University, Ethiopia

35

k
n
a
h
T

!
u
yo

Mulusew Andualem: College of Medicine & Health Sciences,

Bahir Dar University, Ethiopia

36