ETHICAL CONSIDERATIONS OF RESEARCH INVOLVING CHILDREN IN HUMANITARIAN SETTINGS: EXPERIENCES OF MÉDECINS SANS FRONTIÈRES OPERATIONAL CENTRE BARCELONA (MSF OCBA)

Abstract

There is a traditional assumption that children and
young people constitute a vulnerable population
(Wright 2015). This vulnerability is often related to
the capacity to protect one’s self and to make
decisions. The determinants of a child’s capacity for
self-protection and self-determination/decisionmaking
may differ based on availability of resources
(Lundberg 2007). Thus, a child’s vulnerability could
be magnified in low resource, disaster and
emergency settings. While research involving
children provides age-specific evidence, it should
also meet the requirement of ensuring that
children involved in the research are protected.
We explored specific ethical considerations in
research involving children in settings where MSF
OCBA works.

Full text

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1Executive*Officer,*Médecins*Sans*Frontières*Ethics*Review*Board*;*2*Medical*Director,*Médecins*Sans*Frontières*–*Operational*Centre*Barcelona**
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There*is*a*traditional*assumption*that*children*and*
young* people* constitute* a* vulnerable* population*
(Wright*2015).*This*vulnerability*is*often*related*to*
the* capacity* to* protect* one’s* self* and* to* make*
decisions.*The*determinants*of*a*child’s*capacity*for*
self-protection* and* self-determination/decision-
making*may*differ*based*on*availability*of*resources*
(Lundberg*2007).*Thus,*a*child’s*vulnerability*could*
be* magnified* in* low* resource,* disaster* and*
emergency* settings.* While* research* involving*
children* provides* age-specific* evidence,* it* should*
also* meet* the* requirement* of* ensuring* that*
children*involved*in*the*research*are*protected.*
We* explored* specific* ethical* considerations* in*
research* involving* children* in* settings* where* MSF*
OCBA*works.*
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This* study* involved* assessments* of* research*
protocols* and* ethics* reviews,* utilising* the* MSF*
Ethics* Review* Board* (ERB)* Research* Review*
Framework* (Figure* 1)* and* Beauchamp’s* and*
Childress’*ethics*principles*(Figure*2).*
We* evaluated* protocols* with* children* study*
participants* submitted* by* OCBA* for* ethics* review*
or* advice* or* amendment* to* the* MSF* ERB* from*
2015*to*2018.* We* took* note* of* the* methodology,*
community* engagement* plans,* risks* and*
mitigation,* plans* for* securing* consent* and* assent*
and* the* consent* and* assent* documents,* and*
proposed* processes* for* protection* of*
confidentiality*and*privacy*of*study*participants.*
We* also* retrieved* the* respective* MSF* ERB* ethics*
reviews* of* each* protocol* and* took* note* of* the*
comments*and*suggestions*therein.*
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Out*of*56*protocols*submitted*by*OCBA*to*the*MSF*
ERB,*22*included*children*participants*(Figure*3)*
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Figure'3.'Sifting'of'protocols'submitted'by'OCBA'*
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The* topics* for* research* * were:* nutrition* (n=9);*
health* systems* research* (health* survey,* needs*
assessment,*population*assessment,* etc;*n=8);*and*
dengue,* malaria,* migrants,* pneumonia,*
tuberculosis,*and*sexual*and*reproductive*health.*
Thirteen* protocols* were* planned* to* be* conducted*
in* MSF* catchment* communities* and* nine* were* to*
be* conducted* among* patients* in* MSF* health*
services.*
While* majority* of* the* protocols* included* children*
0-59* months* of* age* (n=13),* five* of* the* protocols*
included* older* children* aged* 15-17* years* and* the*
rest*included*minors*aged*0-14*years*(1),*2*months*
to*12*years*(1),*all*ages*(1)*and*“childbearing*age/
pregnant/lactating*women”*(1).*
The* methodologies* justified* inclusion* of* specific*
age*groups.*
None* of* the* protocols* presented* plans* to* engage*
children*in*the*research,*where*feasible.*
Majority* of* the* health* service-based* protocols*
(n=7)* presented* risks* related* to* clinical* care* while*
the* community-based* protocols* were* said* to* pose*
no*to*minimal*risks*to*study*participants.*
Where* assent* should* already* be* secured,* no*
assenting*process*and*assent*forms*were*submitted*
in*two*protocols.*Contents*of*the*assent*form*were*
not* in* harmony* with* the* information* contained* in*
the* consent* form* for* parents/guardians* in* one*
protocol.*
In* the* nine* protocols* where* assent* should* be*
secured,* the* ERB* gave* feedbacks* to* simplify* the*
information*provided*to* the* child*to*ensure*better*
understanding*and/or*look*into*any*means*to*make*
the* assenting* process* less* daunting* (e.g.,* use* of*
pictographs,*verbal*rather*than*written*assent,*etc.)**
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In* planning* for* research* involving* children,*
their* limited* capacity* for* self-protection* and*
self-determination*which*are*magnified*in*low*
resource,* disaster* and* emergency* settings,*
should* be* carefully* considered.* A* deeper*
reflection* on* the* children’s* capacities* (and*
other* inputs)* could* be* done* if* they* are*
involved* in* the* community* engagement*
processes.*
For* OCBA* research* involving* children* in* low*
resource,* disaster* and* emergency* settings,*
most* of* the* issues* we* identified* revolve*
around* the* principle* of* autonomy,* either*
directly* or* resulting* from/to* issues* regarding*
the*other*principles.**
A* careful* reflection* of* risks* secondary* to* the*
research,* and* any* mitigating* actions* is*
recommended* to* be* included* in* the*
documents*in*a*way*these*can*be*explained*to*
the*children*participating*in*the*research**
The*risk* of*therapeutic*misconception*should*
always* be* taken* into* account.* Research,*
especially*but*not*limited*to*those*conducted*
by* care* providers/humanitarian*
organizations,*in*this* group* in*these*contexts*
may*be*viewed*by*parents*and/or*the*child*as*
beneficial* to* his/her* (and/or* their* family’s)*
current*or*future*access*to*services*and*could*
greatly*influence*their*decisions.**
While* the* minimum* age* for* assent* is* based*
either* on* context-specific* age* thresholds/
local* regulations* or* the* World* Health*
Organization’s* recommended* age* of* 7* years,*
personalisation*of*assent*may*also*be*utilised*
depending*on*the*capacity*of*a*child*to*make*
decisions.*
Where* assent* is* secured,* efforts* must* be*
exerted* to* provide* full* information* and* to*
support* the* autonomous* decision-making*
capacity*of*a*child,*ensuring*that:*information*
is*provided*in*the*most*optimal*way*for*better*
understanding;* the* child’s* right* to* decide* is*
respected;* and* safeguards* for* the* protection*
of*the*interests*of*the*child*are*in*place.**
The* role* of* parents/guardians* in* decision-
making*in* a*child’s*research*participation*vis-
à-vis* local* regulations* needs* careful*
consideration;* this* may* include,* among*
others,* who* can* give* consent* for* the* child’s*
participation*in*lieu*of*the*parent/guardian.**
It* should* also* be* noted* that* diverging*
interests* (researchers* versus* parents* versus*
child)* and* diverging* decisions* (parent* versus*
child)* are* possible* eventualities* that* would*
require*attention.*
Re-assent*and*re-consent*of*children*research*
participants*are*issues*which*were*not*tackled*
in*the*protocols*and*in*the*reviews;*these*may*
need* to* be* looked* into* especially* in*
longitudinal*research*and*research*with*plans*
for* biobanking* and/or* long-term* storage* of*
identifiable*data.*
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Figure'1:'MSF'ERB'Research'Ethics'Review'Template'
Figure'2:'Beauchamp’s'&'Childress'principles'of'ethics'
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We*thank*the*members*of*the*MSF*ERB,*the*Medical*Directors*of*the*different*Operational*Centres*and*the*
International*Medical*Coordinator*for*their*contributions.*