16.Ethics Guide Mental Capacity

8/4/2019 16.Ethics Guide Mental Capacity

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Medical research involving adults who cannot consent

MRCETHICS GUIDE 2007


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1. Introduction

2. Ethical principles

2.1 General principles

2.2 Specicprinciples

2.3 Risksandbenets

3. Key concepts

3.1 Capacity/competence

3.2 Consent

3.2.1 Givingconsentonbehalfofanadultwholackscapacity

3.2.2 Lossofcapacityduringthecourseoftheresearch

4. Legal requirements for research

4.1 Legislationrelevanttomedicalresearch

4.2 Requirementsforresearch

4.2.1 Clinicaltrials(allofUK)

4.2.2 Otherresearch(EnglandandWales)

4.2.3 Otherresearch(Scotland)

4.2.4 Otherresearch(NorthernIreland)

4.3 Requirementsforresearchinemergencysituations

4.3.1 Clinicaltrialsinemergencysituations(allofUK) 4.3.2 Otherresearchinemergencysituations(EnglandandWales)

4.3.3 Otherresearchinemergencysituations(Scotland)

4.3.4 DataProtectionAct1998andresearchinemergency

situations(allofUK)

Contents


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Medical research involving

adults who cannot consent 2007

Medicalresearchinvolvingadultswholackmentalcapacitytoconsentcanleadto

innovationsinhealthcarethatcansubstantiallyimprovetheirhealthandqualityoflife

andthatofotherswithsimilarconditions.Itisthereforeimportantthattheseadultsare

giventheopportunitytoparticipateinsuchresearch.Toexcludethemfromanyresearch

wouldbediscriminatoryandwoulddiminishtheirabilitytoparticipateasfullyaspossible

insociety.Itwouldalsopreventresearchersmakingprogressintheunderstandingof

manydisordersthatcanaffectthebrain,andinthecareandtreatmentofthosewho

havesuchdisorders.However,suchresearchrequiresspecialsafeguardstoensurethatthisvulnerablegroupareprotectedwhentheydoparticipateinmedicalresearch.

Thelawrelatingtotheconductofresearchwhenthepotentialparticipantslackcapacity

toconsenthasdevelopedconsiderablyoverthepastyears.Thesechangesprovide

welcomeclaricationofthelegalframeworkwithinwhichsuchresearchcanbecarried

out.SpeciclegislationhasbeenintroducedinScotland1andEnglandandWales2 relating

toadultswithmentalincapacity(orwhomaybecomeincapacitated).InNorthern

Irelandtherecommendationsofareviewofmentalhealthlegislationarecurrently

beingconsidered.Furtherguidanceforthisregionwillbeissuedonceavailable.Otherinstruments,suchastheClinicalTrialsRegulations2004,theHumanTissueAct20043

andtheDataProtectionAct1998,arealsoofrelevancetoresearchinthisarea.

Thisguidanceaimstosetoutthegeneralprinciplesforassessingwhetherindividuals

havethecapacitytoconsenttoparticipationinresearch.Itwillalsodiscussparticipation

inresearchprojectswhensuchcapacityislacking.Theguidancedoesnotdealwith

determiningcapacityinchildren,whichisdiscussedinaseparateMRCpublication4.The

emphasisofthispublicationisonthelegislationrelatingtomentalcapacity,including

explanationofthislegislation.ThegreateremphasisthaninpreviousMRCguidance5on

thelegalrequirementsforsuchresearchreectsthealteredlegalframework.

Itishopedthatthisguidancewillhelpscientiststoensurethatresearchinvolvingpeople

wholackmentalcapacityisconductedinalegallyandethicallyacceptablemanner.It

isalsointendedtogivecondencetoresearchersthatadultswithincapacitycanbe

includedintheirstudiessothat,whenappropriate,theywillmaketheopportunity

available,inaccordancewiththerequiredandrecommendedsafeguardsdescribedhere.

1Adults with Incapacity Act 2000.2Mental Capacity Act 2005.3Medicines for Human Use (Clinical Trials) Regulations 2004. SI 2004 1031 (as amended).4MRC Ethics Guide: Research involving children, 2004.5The Ethical Conduct of Research in the Mentally Incapacitated. MRC 1991.

1. Introduction


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2.1 General principles

Aswithanyresearch,theneedtorespecttheinterestsofanindividualparticipantis

moreimportantthananypotentialbenetsoftheresearchtoothers6,7

.

Allmedicalresearchstudies,includingthoseinvolvingadultswholackmental

capacity,shouldcomplywithacceptedprinciplesofgoodpractice,includingthe

DeclarationofHelsinkiandrelevantEuropeanandUKlegislation.Inaccordance

withsection13oftheDeclaration,theresearchprotocolshouldbesubmitted

toandapprovedbyanindependentresearchethicscommittee(REC).UnderUK

legislationrelatingtoresearchinvolvingadultswholackthecapacitytoconsent,this

RECapprovalisalegalrequirement8.Detailedguidanceonapplyingforapprovalis

availablefromtheNationalResearchEthicsService9.

2.2 Specic principles

Individualsunabletoconsenttoparticipationinaresearchprojectduetoalackof

mentalcapacityareaparticularlyvulnerablegroup.Theirinterestsmustthereforebeprotected.Theyshouldbegiventhesameopportunitiestoparticipateinethically

designedresearchprojectsasthosewhodonotlackcapacitybutmustnotbeput

atunwarrantedrisk.Theirparticipationneedstobeagreedbysomeonewhois

independentofthestudyandwhocanassessthepotentialparticipantsinterestsin

accordancewithcurrentlegislationandguidance.Thispersonmaybearelative,a

careroranindependentrepresentative.

2. Ethical principles

6Declaration of Helsinki, 2000: www.wma.net/e/policy/b3.htm.

7Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of

Biology and Medicine: Convention on Human Rights and Biomedicine Oviedo, 4.IV.1997 Chapter 1 article 2.8Excluding, at present, Northern Ireland.9National Research Ethics Service: www.nres.npsa.nhs.uk/applicants/help/guidance.htm#awi.


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Ifpossible,theproposedstudyshouldalsobediscussedorcommunicatedwiththe

personthemselvesinawayappropriatetotheirunderstanding.Inanemergencysetting,consultationwiththerepresentativeorparticipantmaynotbeimmediately

possiblebutshouldoccurassoonaspractical.(Thereismoreinformationabout

emergencysituationsinsection4.3).

Someonewholacksthementalcapacitytoconsenttotakepartinresearch

shouldnottakepartinastudyifheorshedoesnotseeminagreementwithany

interventionorpartofthestudy,evenifagreementhasbeengivenbyanother

person.Ifthishappens,researchersareexpectedtoinformtheindividuals

independantrepresentativethattheindividualwillnotbetakingpartdespitetherepresentativesagreement,andtellthemthereasonsforthisdecision.

Therisksandbenetsofparticipationinanyresearchmustalwaysbeweighedup

sothatpotentialdirectbenetsoutweighanyrisks.Anypotentialrisksmustbe

minimisedthroughthestudydesign.Ifnodirectbenetisanticipatedtherisksmust

benegligible(seeTable1).

Table 1: Key principles when considering the participation of

adults who lack capacity in research

Theinterestsoftheindividualmustalwaysoutweighthoseofscience

andsociety.

Theresearchmustrelatetoaconditionorimpairmentthataffectsthe

individualorthetreatmentofthiscondition10.

Itmustnotbepossibletoconductequallyeffectiveresearchwithadults

whohavethecapacitytoconsent.

Thepotentialbenetsoftheprojectshouldoutweightherisks:thelevelofacceptableriskdependspartlyonthepossiblebenettotheindividual.

Viewsofthoseclosetotheparticipantshouldalwaysbesought,unlessthisis

notpossibleduetoparticularcircumstances.

Aparticipantwholackscapacityshouldonlybeincludedinastudywhen

therearenoindicationsthatheorsheobjectstothis.

10Under the Mental Capacity Act and Adults with Incapacity (Scotland) Act, this condition or impairment must relate

to the reason for incapacity. Under the Clinical Trials Regulations this is not specied.


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2.3 Risks and benets

Acceptable level of riskTheextenttowhichthelikelybenetofaresearchprojectaffectstheacceptable

levelofriskhasbeenwidelydiscussed.Thisdebateisreectedinchangestothe

wordingofthestatutesinrelationtotheacceptablelevelofrisk:

Adults with Incapacity (Scotland) Act: Inrelationtothelevelofacceptablerisk,

theScottishActdoesnotdifferentiatebetweenresearchthatmaypotentially

benetparticipantsandthatwhichwillnot.Bothmustimpose,atmost,minimal

foreseeableriskandminimaldiscomfort.

Mental Capacity Act:Ifresearchhasthepotentialtobenetparticipants,the

burdensimposedshouldnotbedisproportionatetothatbenet.Ifthereisnopotentialbenetthentheriskstothepatientshouldbenegligible.TheCodeof

Practiceinterpretsnegligibleasequivalenttominimal.

Clinical Trials Regulations:Thetrialshouldbeexpectedtoofferabenetthat

outweighstherisksofparticipationorinvolvenorisksatall.

Insummary,althoughthesevariousinstrumentsdifferslightlyintheirinterpretation

ofacceptablerisks,itisclearthatanyrisksinvolvedinaresearchprojectshould,at

most,beproportionatetoanyexpecteddirectbenet.Ifnobenetsforparticipants

areanticipated,risksshouldbeataminimalornegligiblelevel.

MinimalriskhasbeendenedbytheCouncilofEurope11 asariskthatwillresult,

atthemost,inaveryslightandtemporarynegativeimpactonthehealthofthe

personconcerned.TheCouncildenesminimalburdenonparticipantsasthat

whereitistobeexpectedthatthediscomfortwillbe,atthemost,temporaryand

veryslightforthepersonconcerned. 12

AssessmentofriskhasbeendescribedinMRCguidancerelatingtomedical

researchinvolvingchildren13,whichdividesriskintominimal,loworhigh.Examples

ofminimalriskproceduresinclude14:

Observingandmeasuring,providedthisisdoneinasensitivewayandwith

respectfortheparticipantsautonomyandprivacy.

Obtainingsamplesinanon-invasivemanner,forexample,urinecollection.

11Additional protocol to the convention on human rights and biomedicine, concerning biomedical research. Council of

Europe at article 17 (2). http://conventions.coe.int/Treaty/en/Treaties/Html/195.htm.12Above article 17 (1).13

MRC Ethics Guide: Medical research involving children 2004.

www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430.14

MRC children guidance adapted from the Royal College of Paediatrics and Child Health. Guidelines for the ethical

conduct of medical research involving children 2002.


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Potential benets of participation

Thestatutesdiscussedheredistinguishbetweenresearchprojectswhichmaydirectlybenetparticipantsandthosewhichwillnot.Thisreectsaprevious

divisionofresearchprojectsintotherapeuticandnon-therapeuticadistinction

whichhasbeenwidelycriticised15.

Estimatingthepotentialfordirectbenetisanimportantpartofweighinguptherisks

andbenetsoftakingpartinaresearchproject.Theremaybeoccasions,however,

whenitisdifculttodeterminethepotentialforbenettotheindividual.Thismay

occur,forexample,ifcliniciansaredividedintheirviewsofaparticulartherapyorare

inequipoisesuchaswhenarandomisedcontrolledtrialisconsideredappropriate.

ItisuptoaRECtodecidewhethertherisksassociatedwitharesearchprojectare

acceptableinrelationtotheexpectedbenets.Acarefulassessmentofthisshould

thereforebeprovidedbytheresearchers.(SeeExampleA).

Example A: assessment of risks and benets

TheBlandfordshireRECwasaskedtoreviewaproposaltostudywhether

electronictaggingwasbenecialtothecareofolderpeoplewithvaryingdegreesofdementiawholivedinresidentialhomes.Thehypothesiswas

thatthetaggingwouldallowtheresidentsmorefreedomwhileminimising

theirriskofgettinglost.Therewassomediscussionaboutwhetherthe

taggingwasaninvasionofprivacywhentheindividualsconcernedwere

unabletoprovideinformedconsent.However,theresultsofanindependent

consultation,commissionedbytheresearchers,ofrelativesandcarers

suggestedthatthebenetstotheresidentswereperceivedtooutweigh

thisconcern.Thetaggingdevicewasverysmallandnotnoticeablewhen

worn.WhentheprojectwasreviewedbytheREC,itwasquestioned

whethertheradiofrequenciesusedconstitutedahealthhazardinthis

agegroup.Adecisiononwhetherthestudymightgoaheadwasdeferred

untiltheresearchersprovidedanupdatedanalysisoftheliteratureon

thisissue,inlightofnewscienticevidence.Thisanalysissuggestedthat

theradiofrequencyriskwassimilartothatofmobiletelephones.TheREC

decidedthatthiswasequivalenttoariskencounteredinnormaldailylife

andapprovedthestudy.

15Royal College of Psychiatrists: www.rcpsych.ac.uk/publications/cr/council/cr82i.pdf3.4.

British Medical Association:www.bma.org.uk/ap.nsf/Content/consenttk2~10.


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3.1 Capacity/competence

Apersonisassumedtohavethementalcapacitytomakeadecisionunlessitis

showntobeabsent.Thisisafundamentalprinciple.Mentalcapacityisconsidered

tobelackingif,inaspeciccircumstance,apersonisunabletomakeadecision

forhimorherselfbecauseofanimpairmentoradisturbanceinthefunctioningof

theirmindorbrain16.Indesigningastudy,researchersshouldconsiderwhetheritis

likelythatsomeorallparticipantscouldlackorcouldlosetheircapacitytoconsent

totakepart.Inthiscasetheinformationprovidedtopotentialparticipantsshould

includeoptionsfortheircontinuedparticipationiftheyshouldlosecapacity.

3. Key concepts

Table 2: Dening incapacity from the adults with Incapacity

(Scotland) Act

Incapablemeansunableto:

act;or

makedecisions;or

communicatedecisions;or

understanddecisions;or

retainthememoryofdecisions

byreasonofmentaldisorderorofinabilitytocommunicatebecauseof

physicaldisability.

Itshouldbenotedthat:

Capacityisspecictothematterinquestionandsoapersoncouldhavemental

capacityinrelationtosomemattersbutnottoothers.

Capacitycanalsovaryintime,forexample,inapatientwhoistemporarily

unconsciousorwhohassufferedarelapseintheirpsychiatriccondition.

Capacityispresentifthepersononlyhasadifcultywithcommunicationthat

canbeovercomewithhumanormechanicalassistance.

16Section 2 Mental Capacity Act 2005: A person lacks capacity in relation to a matter if at the material time he is

unable to make a decision for himself in relation to the matter because of an impairment of or a disturbance in

the functioning of the mind or brain.


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10

Assessment of mental capacity

TheMentalCapacityAct(MCA)2005anditsassociatedCodeofPractice

17

setoutcriteriaforassessmentofmentalcapacity.Theybuilduponprinciplespreviously

usedinthecourts18 andsetoutbybodiessuchastheGeneralMedicalCouncil19

andtheBritishMedicalAssociation20.Assessmentofmentalcapacityisdescribed

intheMCAasatwo-stageprocess.First,thepersonmustbeshowntohavean

impairmentordisturbanceofbrainfunctioningand,second,itmustbeshownthat

thisrendersthemunabletomakeaparticulardecision.

Ingeneral,researchersmustaskpotentialparticipantsforconsenttotakepart

inastudy21

.Indoingsotheymustconsiderwhetherthepersonapproachedhasthecapacitytomakethisjudgement.Insomecasestheresearchermayhavethe

necessaryexpertisetomakethisdecision,butoftentheywillneedtoseekan

opinionfromtheclinicalteamcaringforthepotentialparticipant.Thereareseveral

factorstobeconsideredwhendecidingwhetherapersonlacksthementalcapacity

toprovideconsenttoparticipateinresearch.TheseareoutlinedinTable3.

Ifaresearcherorclinicianisuncertainastowhetherapersonhasthemental

capacitytoconsenttoparticipationinresearchordoesnothavetheskillstoassess

this,anindependentassessmentshouldbecarriedout.Ifdoubtremainsorthere

aredifferencesofopinion,forexample,betweenclinicalstaffandrelativesorcarers,

acourtcouldmakearulingonthis.However,itisunlikelythatsuchstepswouldbe

taken:ifsuchuncertaintyexistsitmaybebetternottoincludethepatientinthe

study.Ontheotherhand,whenanadultdoeshavetheabilitytomakeadecision

ortoindicatewillingnesstoparticipateinastudyforwhichtheyareeligible,

thiswillingnessshouldberespectedasfarasispracticalinaccordancewithlegal

requirements.SeeExampleB(page12).

17

MCA Code of Practice issued on 23 April 2007: www.dh.gov.uk/mentalcapacityact.18Re C adult: refusal of medical treatment [1994] 1 All ER 819.19

General Medical Council: Consent atwww.gmc-uk.org/guidance/library/consent.asp.20Assessment of mental capacity: BMA/Law Society Guidance. 2nd ed 2004.

21MCA Code of Practice section 11.7 summarises these for England.

22MRC Code of Practice at 11.4.


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11

Table 3: How to decide whether an individual lacks the mental

capacity to consent to research participation (based on MCA

Code of Practice)

Researchersshouldassumecapacityispresentunlessitisshowntobeabsent.22

Capacityisabsentif,atthetimeofdecisionmaking:

Thepersoninquestionhasimpairedfunctioningoftheirmindorbrain.

Thisimpairmentmakesthepersonunabletodecidewhethertoparticipate

inthisparticularresearch.

Apersonisdeemedunabletodecidewhethertotakepartinresearchif

theycannot23:

Understand theinformationrelevanttothedecision(informationshould

begiveninawaythatisappropriatetotheparticularperson,thismight

includeuseofsimpliedinformationsheets,picturesorsignlanguage).

Retainthatinformationforlongenoughtomakethedecision(thismaybe

forarelativelyshorttime,butstilllongenoughtoenabledecisionmaking

tooccur).

Use orweigh thatinformationaspartoftheprocessofmakingthedecision(theyneedtounderstandtheconsequencesofeachoptionandof

notmakingthedecision).

Communicatetheirdecision(whetherbytalking,usingsignlanguageor

anyothermeans).

22MCA Code of Practice at 11.4.

23Section 3 MCA 2005.


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12

Example B: assessment of capacity

MrBhadtakenearlyretirementfromhiscareerasheadteacherofalargeschoolfollowingthediagnosisofPicksdisease.Hisconditionmeantthathe

hadproblemswithlanguage.Heoftenmisunderstoodwhatwassaidtohim

andhehadtroubleputtingsentencestogether.Thismadehimanxiousand

frustrated.However,hismemoryremainedintact.Theresearcherswanted

totracktheprogressofthisformofdiseasetoassesswhetherthere

werebenetsfromtreatmentwithanewantidepressant.Intheirethics

applicationtheyhadstatedthattheywouldonly include adults with capacity

to consentinthisinitialstudy.InseekingconsentfromMrB,itwasnecessary

toexplainthatthetreatmentmightalleviatetheanxietyhewasfeeling,butcouldnotfundamentallyalterthecourseofthedisease.

However,whentalkingtoMrBtheresearchersfoundthatwhilehereadily

retainedtheinformationpresentedtohim,hedidnotseemto understand

thathewouldbeaparticipantinaresearchstudyorthatthetreatment

wouldbeforsymptomsonly.Theconsultantneurologistleadingthestudy

decidedthatitwouldbemoreappropriateforMrBtobetreatedby

hisclinicalteamratherthantakingpartinaresearchstudy,pendingthe

outcomeofstudiesinparticipantswithlessadvancedPicksdiseasewhodid

havethecapacitytoconsent.

TheprincipalinvestigatordecidedthatMrBlackedcapacitytomake

thisdecision.

Theprotocolsubmittedtotheresearchethicscommittee(REC)wasfor

inclusionofadultswhohadcapacitytoconsentonly.

MrBcouldbesuitableforadifferentresearchstudy.Ascapacityisdecision

specic,hiscapacitytomakeadecisioninrelationtoafuturestudywould

needtobereassessed.

Ifhelackedcapacityinrelationtomakingadecisiontoparticipatein

anotherstudy,hisparticipationwouldbesubjecttothestepsoftherelevant

legislationbeingfollowed.

3.2 Consent

Whenseekingconsent,researchersshouldconsiderhowtopresentthe

informationaboutthestudytoeachindividualwithrespecttotheirlifestyle,interests,needs,religiousbeliefsandpriorities 24.Ifsomeoneisunabletoprovide

consentforthemselvesduetoalackofmentalcapacity,thenextsteptoconsideris

24General Medical Council guidance


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Example C: materials for consent

Ateamofresearcherswascarryingoutaseriesofstudiescomparingthe

benetsofdifferenttypesofphysiotherapyforpeoplewithseriousphysical

restrictionsfollowingaseverestroke.Theybeganwiththeassumptionthat

allpotentialrecruitswouldhavethecapacitytoconsent.Therststepwastotalkwitheachpersontoestablishtheirmentalcapacity,irrespectiveofphysical

disability,usingpicturecardstohelpshowwhattheinterventioninvolved.

AmongthosetheyapproachedwasMrsC,whowasonlyabletocommunicate

bynoddingherheadslightlyandthroughherfacialexpression.Sheseemed

abletounderstandthatthephysiotherapywouldbenetherandtoindicate

thatshewouldlikeit.Tocheckthatshecouldretaintheinformationtheygave

her,theresearchersreturnedtodiscusstheprojectonaseparateoccasion

andsherespondedinthesameway.Theresearchersdeterminedthatshehad

capacityanddiscussedthiswithherGPwhoagreed.Thereasonsforbelievingshehadcapacityweredocumentedinthestudyrecords.

MrsCsdaughterwashermaincarer.Usingthesamemethodstheresearcher

obtainedMrsCsagreementtodiscussthestudywithherdaughter.

3.2.1 Giving consent on behalf of an adult who lacks capacity

Therearevaryinginterpretationsofthemeaningofconsentbyothersforanadult

whocannotgivetheirownconsenttoparticipateinaresearchstudy.Thelaws

andregulationsrelatingtomedicalresearchinvolvingadultswholackcapacityto

consentdonotusethebestintereststest.Insteadtheysetoutthenecessary

criteriafortheresearchtobelegalandallowforvaryingdegreesofconsentby

others.InrelationtoallclinicaltrialsthroughouttheUK(andalltypesofmedical

researchinScotland),consenttotheparticipationofanadultlackingcapacityis

givenbythelegalrepresentativeorrelativeoftheparticipant(thehierarchyforthis

isdescribedfurtherbelow).TheClinicalTrials(CT)Regulationsdescribedbelow

specifythatthisconsentbyalegalrepresentativerepresentsthepresumedwillof

theparticipant25.ForresearchoutsideScotlandnotcoveredbytheCTRegulations,

thepersonconsultedgivesagreementratherthanconsent(seeTable4).

25Medicines for Human Use (Clinical Trial) Regulations SI 2004 no.103sch 3 part 5 (12).

whetherthelegalrequirementsandsafeguardscanbemetiftheyareincluded

withouttheirownconsent(forexample,undersection30oftheMCA).Alternativelytheresearchersshouldconsidernotincludingthepersoninquestion

intheresearch.


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1

Table 4

Type of

study

Clinicaltrialin

England,Walesand

NorthernIreland

Clinicaltrialin

Scotland

Researchwhichisnotaclinicaltrial

(EnglandandWales)

Researchwhichis

notaclinicaltrial

(Scotland)

Who should

be asked

Legalrepresentative:

1. Relative or person

independent of trial and

providing care or

2. Doctor primarilyresponsible for adults

treatment, or another

independent person

nominated by

healthcare provider

Legalrepresentative:

1. Guardian or welfare

attorney authorised to take

decisions re research or

2. Nearest relative or

3. Doctor primarily

responsible for adults

treatment, or another

independent person

nominated by

healthcare provider

Carerorconsultee1. Unpaid person with an

interest in the welfare of

the potential participant or

2. Person who is

independent of project

1. Guardian or welfare

attorney authorised to

take decisions about the

research or

2. Nearest relative

What

should they

be asked

Presumedwill

ofparticipant

Presumedwill

ofparticipant

Opiniononviewsand

feelingsof

participant

Theirconsent

What is

given?

Informed

consent

Informed

consent

Adviceastowhether

participant

woulddeclineto

takepartifheor

shehadcapacity

Consent

Note: Emergency recruitment to research projects has separate requirements which are summarised in section 4.3.


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1

3.2.2 Loss of capacity during the course of the research

(SeeseparateguidancefortransitionalarrangementsforstudiesalreadyunderwayinEnglandandWaleson1October2007.)

1. Clinical Trials Regulations:

Inaclinicaltrial(asdenedbytheCTRegulationsseemoredetailsinsection

4.1),consentfromanadulttoparticipateinatrialremainsvalidafterlossof

capacity,providingthetrialisnotsignicantlyaltered.Itisgoodpracticeinsucha

casetoconsultwithcarersandtakenoteofanysignsofobjectionordistressfrom

theparticipant.Theinvestigatorshouldconsiderwithdrawingaparticipantifany

objectionsareraised.

2. Mental Capacity Act:

1.Whereitisknownthataparticipanthaslostcapacityfollowingagreement

totakepartinastudyandfurtherconsentisrequiredfromallparticipants,for

exampleforfurtherbloodsamplecollection,researchersshouldcomplywiththe

requirementsoftheMCA.

2.Forparticipantswhogaveconsentbefore31March2008totakepartina

studythatbeganbeforeOctober2007,therearespecicregulationsunderthe

MCAdetailingthestepstobetakenifaparticipantissubsequentlyknownto

havelostcapacity26.

3.Forparticipantsandstudiesthatdonotfallunderguidancefortheabovedates,

theMCAdoesnotspecifywhatstepsshouldbetakenifcapacityislostfollowing

consenttoparticipateinastudy.Ifnofurtherinterventionsarerequiredinthestudy

andresearcherswishtokeepusingdataortissues,itisopentointerpretationas

towhetherfurtherconsentisrequired.CurrentguidancefromtheDepartmentof

Health,England(DH)andtheWelshAssemblyGovernmentisthatinthissituation

properlyinformedandexpressedconsent27givenpriortolossofcapacitycanbe

reliedupon.Intheabsenceofsuchconsent,DHandWelshAssemblyGovernment

guidancesaysthattherequirementsoftheMCAmustbefullled.Thisincludes

obtainingagreementfromapersonalorprofessionalconsulteeforcontinueduseof

dataortissuesinthestudy,aswellasobtainingRECapprovalforthis.

26Please see separate guidance from the MRC on these transitional arrangements.

27Mental Capacity Act and consent for research, Department of Health (England) and Welsh AssemblyGovernment 2007.


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1

Ifanindividualhasmadeadecisiontoparticipateinresearchandsubsequentlyloses

capacity,itisexpectedthatthisconsentwouldberespectedinmostcircumstancesandsouseofsamplesordatacouldcontinue.Proceduresshouldbeinplaceinany

studytoensurethat,wherenecessary,participantscanwithdraworbewithdrawn

fromthestudyatanytime.Iftheparticipantlosescapacity,arequestbya

representativeforwithdrawalfromastudyshouldbeconsideredcarefullytoensure

thatitreectsthewishesofaparticipantbeforelossofcapacity,theircurrent

situationandanypotentialbenetsorharmthatcouldarisefromcontinued

participationintheresearchstudy.

Whendesigningstudies,researchersshouldconsidertheriskofparticipantslosingcapacityduringthecourseofastudyand,whereappropriate,shoulddiscussthis

possibilitywiththem.Theconsentformshouldincludeanoptiontoconsentto

remaininthestudyintheeventofincapacity.Thisconsentwouldnotbeabsolute,

ascontinuedparticipationwilldependuponindividualcircumstances.

Theparticipantmaycontinuetoreceiveatreatmentreceivedduringtheresearchif

withdrawalwouldcreateasignicantrisktotheirhealth.

3. Adults with Incapacity (Scotland) Act:

TheActdoesnotrefertolossofcapacityduringaresearchstudy.Itwillbeupto

researchersandtheRECtodecidewhetherproceduresneedtobeinplacefor

suchaneventuality.TheMRCadvisesthattheprinciplesdescribedaboveshouldbe

followedwhenconsideringexistingconsentandthepotentialforwithdrawalfrom

astudy.

4. Human Tissue Act 2004:

TheActanditsassociatedregulations28statethatstorageanduseofhumantissue

forresearchmustbedoneinaccordancewiththeprovisionsoftheMCA,unless

theadultconsentedbeforelosingcapacity.InNorthernIrelandapprovalisrequired

fromanRECtostoreandusetissuefromadultswholackcapacitytoconsent.

ExampleDillustratessomeoftheissuesthatmayarisewhenapersonloses

capacityduringthecourseofresearch.

28Human Tissue Act 2004 (Persons who lack capacity to consent) Regulations 2006 at 3c and d and Human Tissue

Act 2004 at s6.


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Example D: consent for new samples in long-term study

MrDhadenrolledinalong-term,REC-approved,populationstudyofpeopleatriskofdementia20yearspreviously.Awareofthedevastatingeffectsof

thedisease,hewantedtohelpndoutmoreaboutittohelpexpandthe

optionsforfuturetreatmentandcare.MrDwentontodevelopAlzheimers

inhislate60sandwasnowinanadvancedstageofdementia.Whensigning

upforthestudy,hehadgivenconsenttore-assessmentatyearlyintervals

throughouthislifeandindicatedthathewouldwishthistocontinueinthe

eventthathelostcapacity.Healsoconsentedtocontinueduseofhisdatain

thestudyintheeventthathelostcapacityorwaswithdrawnfromthestudy.

Thismeantthattheresearcherswereabletocontinuetomonitorhim.

Foralongtime,hehadseemedperfectlyhappywiththisarrangement

andthiswasconrmedwhentheresearcherscheckedannuallywithhis

carers.Howeverwhenanimportantnewtestbecameavailablethatwould

involvetakingfurtherbloodsamplesfromtheentirestudypopulationit

becamenecessarytoaskeachparticipantfortheirspecicconsenttothe

alterationinsamplingpractice.Althoughtheresearcherswouldhaveliked

tokeepMrDinthestudy,hewasnolongerabletoconsentforhimself

andhispriorwisheswereunknown.Furthermore,hiscarersinformedthe

researchersthathehadrecentlybeenhospitalisedwithaninfectionandhad

subsequentlydevelopedamarkedfearofneedles.

TheresearchersagreedwiththefamilythatMrDshouldnotbeincludedin

thenextroundofsamplingastheoutcomeoftheresearchwouldnotbeof

anydirectbenettohisownhealth.Inaddition,hispresentconditionmeant

thathemayhavefoundthetakingofbloodsamplesdistressing:thiswas

deemedanunacceptablerisk.

However,thefamilyagreedthatthedataandsamplesalreadycollected

couldcontinuetobeusedinthestudy,inaccordancewithMrDs

previouslyexpressedwishes.


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4.1 Legislation relevant to medical research

ThelawintheUKnowmakesadistinctionbetweentwotypesofresearchinvolving

people.Theseare(i)clinicaltrialsofmedicinalproductsand(ii)otherresearch

involvingpeople.Inrelationtocapacity,thesestudiesaregovernedbythree

separatepiecesoflegislation.Clinicaltrialsofmedicinalproductsaregovernedby

theMedicinesforHumanUse(ClinicalTrials)Regulations2004(CTRegulations)

whileotherresearchisgovernedbytheAdultsWithIncapacity(Scotland)Act2000

(AWIS)ortheMentalCapacityAct2005(MCA).TheCTRegulationsimplementa

EuropeanDirectiveandapplytoalloftheUK.TheAWISappliesonlytoScotland

andtheMCAappliesonlytoEnglandandWales.

Toensurethatresearchisconductedlawfullyresearchersmustrstdetermine

intowhichcategorytheirproposedresearchfalls.Itisimportanttonotethatthe

legaldenitionofaclinicaltrial(i.e.astudywhichfallsundertheCTRegulations)

istightlydened,whereasinwiderusagethetermcansometimesrefertoother

typesofstudy.SeeExampleE.

1.Clinicaltrialsofmedicinalproducts:TheseareregulatedbytheCTRegulations

anddenedasinterventionalinvestigationsorstudiesundertakentoascertainthe

efcacyorsafetyofamedicinalproductinhumansubjects29.TheCTRegulations

containrequirementsthatapplyifadultswholackcapacityaretobeincluded

insuchresearch.Furtherguidanceontheregulationofclinicaltrialsandhowto

determineifastudyfallsintothiscategoryisavailableatwww.ct-toolkit.ac.uk.

TheMedicinesandHealthcareproductsRegulatoryAgency(MHRA)canprovide

adviceonanindividualbasisaboutwhetheraproposedtrialiscoveredbytheCTRegulations.Inaddition,analgorithmtohelpdecidewhetherresearchisaclinical

trialofamedicinalproductisavailableathttp://ec.europa.eu/enterprise/

pharmaceuticals/pharmacos/docs/doc2006/04_2006/clinical_trial_

qa_april_2006.pdf.

4. Legal requirements for research

29Medicinal products are dened by the MHRA as substances or combinations of substances which either prevent

or treat disease in human beings or are administered to human beings with a view to making a medical diagnosis

or to restore, correct or modify physiological functions in humans.

A clinical trial is dened by the MHRA the as an investigation in human subjects which is intended to discover

or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products,

identify any adverse reactions or study the absorption, distribution, metabolism and excretion, with the object of

ascertaining the safety and/or efcacy of those products. This denition includes pharmacokinetic studies.

www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=723.


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30MCA Code pf Practice at 11.6.

31AWIS 2000 at 51(3).

Example E: clinical trial governed by the MCA or CT Regulations

ResearchersinanEnglishteachinghospitalaimtocomparetwodifferentneurosurgicaltechniquesfortreatingseveresub-arachnoidhaemorrhage.

Manyofthepotentialparticipantswilllackcapacitytoconsentduetothe

effectsofthehaemorrhage.

This will not be a clinical trial of a medicinal product and so would fall under

the MCA.

Thesameunitalsowishestoperformastudycomparingtheeffectsofa

newanti-brinolyticdrugonoutcomeaftersub-arachnoidhaemorrhage.

This research is a clinical trial of a medicinal product.

2.AllotherintrusiveresearchinEnglandandWalesinvolvingadultswholackmental

capacitytoconsentfallsundertheMCA,whichcontainsspecicrequirementsforthe

conductofsuchresearch.Intrusiveresearchinthiscontextisdescribedasthatwhere:

ifapersontakingparthadcapacity,theresearcherwouldneedtogetconsentto

involvethem30.ItspecicallyexcludesresearchthatfallsundertheCTRegulations.

3.ResearchinScotlandisgovernedbytheAWIS.Thiscontainsrequirementsforsurgical,medical,nursing,dentalorpsychologicalresearch31.TheActgivesspecic

requirementswhicharebroadlysimilartotheMCAbuthavesomedifferencesin

theirdetail.Section4.2.3belowsummarisesthepositioninScotland.

4.Table5summarisesthelegislationrelevanttoresearchinvolvingpeoplein

differentpartsoftheUK.


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32Of relevance, section (45) of the Human Tissue Act relating to DNA analysis also applies in Scotland. For further

guidance on the use of human tissue in research, please refer to separate MRC publications.33

At the time of publication in October 2007, a draft Bill amending this Act was being prepared.

yesIsthisaclinicaltrial? 4.2.1

no

no

IstheresearchinScotland?

Section4.2.2

yes4.2.3

Table 5: Summary of relevant legislation

EnglandandWales Scotland NorthernIreland

TheMedicinesforHuman

Use(ClinicalTrials)Regula-

tions2004(CTRegulations) yes yes yes

AdultsWithIncapacity

(Scotland)2000(AWIS) no yes no

MentalCapacityAct2005

(MCA) yes no underreview

HumanTissueAct2004 yes mostly yes

no32

HumanTissue(Scotland)

Act2006 no yes no

DataProtectionAct1998 yes yes yes

HumanFertilisationand

EmbryologyAct199033 yes yes yes

4.2. Requirements for research

Thissectionsummarisestherequirementsofthedifferentlawsandregulationsthat

applytoresearchinvolvingadultswholackcapacitytoconsent.Initalicsarepoints

ofgoodpracticethatareadditionaltothelegalrequirements.Inordertoreferto

thecorrectsection,thekeyquestionsare:


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4.2.1 Clinical trials (all of the UK)

ClinicaltrialsthatfallundertheCTRegulationsaredenedabove(section4.1):InordertocomplywiththeCTRegulations,atrialmustbeapprovedbyarecognised

researchethicscommittee(REC)andlicensedbytheMHRA.Allclinicaltrialsmust

complywiththeGoodClinicalPractice(GCP)guidelinesissuedbytheInternational

ConferenceonHarmonisation.Inrelationtoadultswholackmentalcapacityto

consent,theGCPguidelineshavespecicrequirementsthatmustbemet.Theseare

summarisedhere.Pleasenotethatthereareseparaterequirementsforresearchin

emergencysituations,whichisdiscussedinsection4.3.

Trial designAclinicaltrialmustrelatedirectlytoalife-threateningordebilitatingclinical

conditionfromwhichapotentialparticipantsuffers.(Notethatthisdiffersfrom

therequirementsforothertypesofresearch,whichmustberelevanttothe

conditionorimpairmentcausingthelossofcapacity.)SeeExampleF.

Example F: clinical trials that relate directly to a

participants condition

1.Researchershavedesignedatrialstudyingadultswithheadinjuryandimpairedconsciousness.Theywishtoassesstheeffectsofa48-hour

infusionofcorticosteroidsonsurvivalandneurologicaldisability.

This trial relates directly to the cause of the impaired consciousness in this group

of patients.

2.Atrialisunderwaycomparingtheefcacyoftwodifferentdietaryplanson

bloodglucosecontrolinlate-onsetdiabetes.MrsFhasadvanceddementia

anddiabetes.Herfamilyhavereadaboutthetrialandrequestthatshebe

included.TheresearchersconsulttheRECastowhethertheycouldapprove

anamendmenttotheprotocoltoallowincapacitatedadultstobeincluded.

In this case the study (which is not a clinical trial of a medicinal product) does not

relate to the cause of the impairment of Mrs Fs capacity which is dementia.

It would therefore not be possible for the REC to approve this amendment.

However, if it were a clinical trial comparing oral and subcutaneous insulin Mrs Fs

participation could be approved. This is because the study would then be a clinical

trial of a medicinal product and would relate directly to a condition diabetes

from which Mrs F suffers.


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Theremustbegroundstoexpectthatadministeringthemedicinalproductto

betestedinthetrialwillproduceabenettotheparticipantthatoutweighstherisks(orwillresultinnoriskatall).

Theclinicaltrialisessentialtovalidatedataobtained:

inotherclinicaltrialsinvolvingparticipantswhoareabletogiveinformed

consent,or

byotherresearchmethods.

Noincentivesornancialinducementsmaybegiventoaparticipantortheirlegal

representative,exceptprovisionforcompensationintheeventofinjuryorloss34

.

Consent by legal representative

Consentbyalegalrepresentativeisrequiredifconsenttoparticipatewasnot

givenpriortothelossofcapacity.

Iftheproposedstudyparticipantrefusedconsenttoparticipatebeforethelossof

capacity,heorshecannotbeincludedinthetrial.

InEngland,WalesandNorthernIrelandthelegalrepresentativeis:

Apersonindependentofthetrial,whobyvirtueoftheirrelationshipwiththe

potentialstudyparticipantissuitabletoactastheirlegalrepresentativeforthe

purposesofthattrial,andwhoisavailableandwillingtosoactforthosepurposes.

Or if there is no such person:

Apersonindependentofthetrial,whoisthedoctorprimarilyresponsiblefor

themedicaltreatmentprovidedtothatadult.

Orapersonnominatedbytherelevanthealthcareprovider.

InScotlandthelegalrepresentativeis:

Theguardianorwelfareattorney(thisisapersonappointedtodealwith

mattersofpersonalwelfarebyanindividualpriortohisorherlossofcapacity).

Or, if one has not been appointed:

Thenearestrelative.

34MRC policy is that, as in other research, payment of legit imate expenses of participants or representatives directly

related to participation in the trial is generally considered acceptable.


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Or, if that person is not available:

Thedoctorresponsibleforthemedicaltreatmentofthepatientiftheyareindependentofthestudy,orapersonnominatedbythehealthcareprovider.

Thelegalrepresentativeshouldhaveaninterviewwithamemberoftheinvestigating

team,duringwhichthefollowingshouldbediscussedormadeavailabletothem:

Objectives,risksandinconveniencesofthetrialandtheconditionsunderwhich

itistobecarriedout.

Contactdetailsforfurtherinformation.

Theirrighttowithdrawtheparticipantfromthetrialatanytimewithoutdetriment.

Aftersuchdiscussions,thelegalrepresentativemaygivetheirinformedconsentfor

thepersontoparticipateintheclinicaltrial.Inrelationtoclinicaltrials,thisconsent

istakenbytheCTRegulationstorepresentthepresumedwilloftheparticipant.

Views of the participant

Thepotentialparticipantshouldreceiveinformationaboutthetrialanditsrisks

andbenetsaccordingtohisorhercapacitytounderstandthisinformation.

Ifthepersoninquestioniscapableofassessingtheinformationreferredtoabove

andforminganopinionaboutit,thenanexplicitwishtorefuseparticipationorto

withdrawfromtheclinicaltrialatanytimemustbegivenseriousconsideration

bytheinvestigator.

Althoughthelawrequiresonlyconsideration,itisgoodpracticetocomplywith

anysuchrequest.Theonlyexceptionwouldbeifnotparticipatingorwithdrawing

fromthetrialwouldbedetrimentaltotheparticipantshealth.Inthissituation,

researchersshouldalsoconsiderwhethertheobjectionisshort-termorrelating

tofactorsthatcouldbealtered,suchastheresearchenvironment.Researchers

shoulddiscussadecisiontokeepaparticipantinastudyinthissituationwiththe

clinicalteamcaringfortheparticipantandwiththeirlegalrepresentative.

4.2.2 Other research (England and Wales)

IntheUKexcludingScotland,intrusiveresearchthatdoesnotinvolveaclinicaltrial

isgovernedbytheMCA,whichhasspecicrequirementsforsuchresearch(see

Table6).


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Requirements of the MCA

TherequirementsofthisActarediscussedinitsaccompanyingCodeofPractice 35.

InordertocomplywiththeMCA,thefollowingrequirementsmustbemet

byresearchers:

1.RECapproval(byarecognisedcommittee).

2.Consultingrelatives/carers/others.

3.Safeguardstoprotectparticipants.

1. Ethical approval for the project or study

ThereareseveralquestionssetoutintheMCAthatmustbeconsideredbefore

ethicalapprovalcanbegranted.Researchersshouldensurethattheyaddress

theseintheirapplicationforRECapproval.TheRECmustberecognisedbythe

DepartmentofHealth(England)ortheWelshMinistersforthepurposeofapproving

researchthatfallsundertheAct.Atthetimeofpublication,allsuchcommitteesare

partoftheNationalHealthServiceRECsystemfurtherguidanceonrecognised

committeescanbeobtainedfromtheNationalResearchEthicsService(NRES)36.

Is the research study related to the impairing condition or its treatment?Asdiscussedinsection3.1,anadultdeemedtolackcapacitytoconsenttotakepart

inaresearchstudymusthaveimpairedordisturbedfunctioningoftheirmindor

brain.Tobeapproved,theproposedresearchmust be connected with a condition which

may cause, contribute to or result from this impairment of function of the mind or brain or

its treatment.Thismeansthatparticipationcannotbeapprovediftheconditionbeing

investigatedbythestudyiscompletelyunrelatedtothereasonformentalincapacity.

Thelinkbetweenthestudyandthereasonforthepotentialparticipantslackof

capacityshouldbeexplainedintheapplicationforethicalapproval.

35MRC policy is that, as in other research, payment of legit imate expenses of participants or representatives directly

related to participation in the trial is generally considered acceptable.36

National Research Ethics Service: www.nres.npsa.nhs.uk.

Table 6: When does the Mental Capacity Act 2005 apply?

Itappliesto:

Intrusiveresearch,thatis,anyresearchprojectthatwouldrequireconsent

fromadultswhohavecapacityasamatteroflaw.

Butdoesnotapplyto:

ResearchthatfallsundertheCTRegulations(seesection4.1).

ResearchcarriedoutinScotland(seesection4.2.3)orNorthernIreland

(seesection4.2.4).


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Example G: studies where it is not necessary to include

adults who lack capacity to consent

Researcherswishtoassesschangesinbloodlevelsofimmunefactors

followinginsertionofaninvasivemonitoringdeviceintoanartery.The

teamarebasedinintensivecareandsotheyareseekingRECapprovaltoincludeinthestudyunconsciouspatientsintheintensivecareunitwhowill

frequentlyrequiresuchvenousaccess.However,thescientistsconsiderthat

thesepatientswillnotbeabletoconsenttotakepartinthestudy.They

thereforedecidetoinsteadenrolpatientswhorequiretheplacementof

suchlinesbeforeelectivesurgeryandfromwhomconsentcouldbesought.

This study is related to treatment for the condition causing the impairment of

capacity, but it could be done as effectively in patients who are able to consent

to participation.

37MCA Code of Practice 2005 at 11.14.

Does the study have the potential to benet the participant?

Ifso,thentheexpectedburdenoftakingpartintheresearchshouldbe

proportionatetothepossiblebenets.Researchersshouldconsiderwhatwillbe

requiredofparticipants,includinganypossiblediscomfort,restrictionofmobility

oruseoftheirdataortissue.Thisshouldbeweighedagainstthepotentialforthe

studytobeofdirectbenettothosetakingpart.Potentialbenetsarediscussed

furtherintheMCACodeofPractice37.

Is there unlikely to be any benet to the participant?

Ifso,theresearchmustfullallofthefollowingobjectives:

Itmustbeinvestigatingthecause,treatmentorcareofpeoplewithsimilar

conditions.

Therisksoftheprojectmustbenegligible(seethediscussioninsection2.2on

levelsofrisks).

Theprojectmustnotsignicantlyinterferewithfreedomofactionorprivacy.

Theprojectmustnotbeundulyinvasiveorrestrictive.

Could the study be done involving only adults with capacity to consent?

Researchersshouldenrolparticipantswholackthecapacitytoconsenttotakepartonlyifthereisreasontobelievethatthestudycouldnotbedoneaseffectivelyifit

involvedonlyadultswhocouldgiveconsent.ThisisillustratedinExampleGbelow.


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TheMCACodeofPracticestatesthatactionswillnotusuallybeclassedasunduly

invasiveiftheydonotgobeyondtheexperienceofdailylife,aroutinemedicalexaminationorapsychologicalexamination38.

2. Consulting carers or others

TheMCAstipulatesthatbeforeanydecisionistakentoinvolveaparticularpersonin

researchwithRECapproval,researchersmustidentifyaconsulteewhoiswillingtobe

consultedaboutthepersonsparticipation.Therearetwopossibletypesofconsultee:

1.Ifavailable,theresearchersmustconsultapersonalconsultee.Thisissomeone

whocaresforthepotentialparticipantorisinterestedinhisorherwelfareother

thaninaprofessionalcapacityorbecausetheyarepaidtodoso.Theresearchermusttakereasonablestepstoidentifysuchaperson.

2.Ifapersonalconsulteeisnotavailable,theresearchermustconsultanominated

consultee.Thispersonmusthavenoconnectionwiththeproject.Researchers

mustincludeintheprotocolsubmittedtotheRECthearrangementsfor

identifyingandconsultingwiththisperson.Inemergencycircumstances,a

consulteedoesnotneedtobeconsultedpriortoenrolmentinthestudy.The

conditionsunderwhichthiscanhappenareclearlydenedseesection4.3.

Difcultyinndingapersonal consulteemayariseifthepersonmostappropriate

tobeconsultedisapaidcarer.Thiscouldoccur,forexample,ifthepotential

participanthadnorelativesoronlydistantrelatives.TheMCAspecicallyrequires

thatthepersonconsultedisnotpaidforthecareheorsheprovidestothe

potentialparticipant.Theconsulteemayholdpowerofattorney39forthepatient

orbeacourt-appointeddeputy,solongasthisisinapersonal(notprofessionalor

paid)capacityforinstance,aparticipantssolicitorwouldbeexcludedfrombeing

apersonalconsultee.

TheMRCrecommendsthatitisgoodpracticetoinvolveanypaidcarerswhoare

closetotheparticipantinthedecision-makingprocessevenifthedecisionhasto

betakenbyanindependentnominee.

Itisimportantthatpersonalnomineesappreciatethatthisisavoluntaryroleand

thattheyarenotunderanypressuretoagreetollthispositioniftheydonotwish

todoso.Thisshouldbemadeclearbytheresearchers.

38MCA Code of Practice at 11.19.

39The MCA 2005 allows an adult to assign power of attorney to another person prior to loss of capacity; the power

assigned may extend to nancial affairs and/or personal welfare.


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40Department of Health (England): www.dh.gov.uk.

41Welsh Assembly Government: www.word-wales.gov.uk/index.htm.

Table 7: Consultees: information requirements

Theconsulteeshouldbegiventhefollowinginformationaboutthestudy:

Whytheyarebeingapproached.

Theroleofaconsultee.

Explanationthatactingasaconsulteeiscompletelyvoluntary.

Detailsofthestudy(aswouldbegiventoaparticipantwithcapacity).

Theconsulteeshouldprovidethefollowinginformation:

Adviceonwhethertheparticipantshouldtakepartinthestudy.

What,intheiropinion,theparticipantsviewsandfeelingswouldhavebeen

ontakingpartintheprojecthadtheyretainedcapacity.

Iftheconsulteeadvisesthatthepersoninquestionwouldnothavewantedtotake

partintheproject,thatpersonmustnotberecruited.Similarly,theparticipant

mustbewithdrawnfromtheprojectifatanytimetheconsulteeisoftheopinion

thattheparticipantwouldnothavewishedtocontinue.Anexceptioncanbemade

iftheparticipantisreceivingtreatmentaspartoftheprojectandtheresearcher

hasreasonablegroundstothinkthatwithdrawalofthistreatmentwouldcausea

signicantrisktotheirhealth.Toapplythisexception,theresearcherneedstogive

goodreasonsforthetreatmenttocontinue.Discussionwiththemedicalteamand

therepresentativeofthepatientwillbeessential.

Regarding a nominated consultee,theMCACodeofPracticehasawide

interpretationofwhatconnectedtotheprojectmeans.Itcouldexcludeanyoneconnectedwiththeactualproject,membersoftheresearchteamoranyonewitha

widerconnection,forinstancepeoplewithadirectlinktothefundingbodyorthe

ethicscommitteethatapprovedtheproject.Furtherguidanceisavailablefromthe

DepartmentofHealth(England)40andtheWelshAssemblyGovernment41astohow

thispersonshouldbechosen.

Inpractice,apersonshouldbeidentiedwhocanunderstandtheprojectandtakeaview,

asdescribedinTable7,ontheintendedparticipation.Thismaybe,forexample,another

clinicianorhealthcareworkerintheunitwheretheresearchisbeingundertaken(whoisnotconnectedwiththeresearchproject).Itneednotberestrictedtoonepersonfor

eachprojectbutmaybemoreappropriatetohaveseveralpeopleavailabletogiveadvice.

Researchersshouldsetoutintheprotocolandethicalapprovalapplicationwhothey

proposetoconsultinthiscategoryintheeventthatasuitablecarerisnotavailable.


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3. Safeguards to protect the interests of patients

Onceaparticipantisenrolledinastudy,severalmeasuresmustbetakentoensureprotectionoftheparticipantsinterests:

Nothingshouldbedonewhichtheparticipantseemstoobjectto(unlessitisto

protectthemfromharm).

Nothingshouldbedonewhichwouldbecontrarytoanadvancedirectiveor

anyotherstatementbytheparticipant. This only applies if the researcher is aware

of such an expression of wishes. Researchers should nd out from relatives and carers

what the participants views were on relevant issues prior to loss of capacity. They should

specically ask whether any relevant advance directives or expressions of wish are

available and, if so, keep a record of them.Theinterestsoftheparticipantmustalwaysoutweighthoseofscienceandsociety.

Theresearchermustwithdrawtheparticipantifanyoftheconditionsforhisor

herinclusionintheresearchprojectnolongerapply.

Theparticipantshouldbewithdrawnfromthestudyifheorshegivesanyindication

ofnotwantingtocontinuetotakepart(unlesstheprojectinvolvestreatmentandit

isconsideredthatcontinuationofthisisinthepatientsbestinterests).

Research involving human tissue samples

Research(outsideScotland)usinghumantissuemustcomplywiththeHuman

TissueAct2004.Thisgenerallyrequiresconsentfortheuseoftissueforresearch,

subjecttocertainexemptions.Thelawallowsadultswithoutcapacitytobeincluded

insuchresearch,providingthattheresearchisconductedinaccordancewiththe

CTRegulationsorMCAasdiscussedinsection4.1.

4.2.3 Other research (Scotland)

InScotland,researchthatdoesnotfallundertheCTRegulationsisgoverned

bytheAdultswithIncapacity(Scotland)Act2000(AWIS).TheActregulatesthe

involvementofincapacitatedadultsinresearch 42.Ithassimilarrequirementstothe

MCAbuthassomedifferences.Itsrequirementsaresetoutinfullbelow.Inorder

tocomplywiththeAWIS,thefollowingconditionsmustbemet:

1. Nature of the research

Itmustnotbepossibletocarryoutresearchofasimilarnatureonanadult

whohascapacitytoconsent,andtheresearchmustbeintothecauses,diagnosis,

treatmentorcareoftheadultsincapacity;ortheeffectofanytreatmentorcare

givenduringhisincapacitytotheadultwhichrelatestothatincapacity.

42Adults With Incapacity (Scotland) Act 2000 section 51.


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2. Risks of the research

Participationentailsnoforeseeablerisk,oronlyaminimalforeseeableriskandimposesnodiscomfort,oronlyminimaldiscomfort,ontheadult.

3. Benets of the research

Theresearchmusteitherbeofrealanddirectbenettotheparticipantor,wherethe

researchisnotlikelytoproducerealanddirectbenet,itcanbecarriedoutifitwill

contributesignicantlytoscienticunderstandingoftheadultsincapacityandthus

willbenettheparticipantdirectly,orbenetotherpeoplewiththesameincapacity.

4. ConsentConsentmustbeobtainedfromanyguardianorwelfareattorneywhohasthe

powertoconsenttotheadultsparticipationinresearchor,wherethereisnosuch

guardianorwelfareattorney,fromtheadultsnearestrelative.Inadditionthepotential

participantmustnotindicateunwillingnessorobjectiontoparticipationintheresearch.

5. Ethical committee review

AllresearchmustbeapprovedbytheRECstatedundertheAWISregulations.At

thetimeofpublication,thiscommitteewastheScotlandAREC.TheNRESCentral

AllocationSystemcandirectapplicationsappropriately.

Theethicscommitteeisrequiredtoconsider43:

Objectives,design,methodology,statisticalconsiderationsandorganisationof

theresearch.

Relevanceoftheresearchandstudydesign.

Justicationofpredictablerisksandinconveniencesweighedagainstthe

anticipatedbenetsforresearchparticipantsandfutureparticipants.

Suitabilityoftheleadresearcher.

Adequacyofthewritteninformationandproceduresforobtainingconsent.

Arrangementsforrecruitmentofparticipants.

43The Adults With Incapacity (Ethics Committee) (Scotland) Regulations 2002 No. 190.


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4.2.4 Other research (Northern Ireland)

AsatOctober2007,therecommendationsfromareviewofmentalhealthlegislationinNorthernIrelandwerebeingconsidered.Furtherguidancerelatingto

thisregionwillbeissuedonceavailable.Atpresent,thereisnospeciclegislation

applicabletoresearchinvolvingadultswholackcapacity.Allresearchmustbe

approvedbyanethicscommitteeandmustcomplywithcommonlawprinciples.

4.3 Requirements for research in emergency situations

Specicallowanceismadeforresearchinemergencysituationswhenitmaynot

bepossibletoconsultasrequiredbythevariouslaws.Theseallowancesapply

toresearchwhichfullstheotherrequirementsoftherelevantlegislationbutwhereitisnotpossibletoobtaintheconsentoragreementofaconsulteebefore

participationinaclinicaltrialorotherstudybegins.Thisexceptioncanonlybe

relieduponuntilitispossibletoconsultorseekconsentinthenormalmanner.

4.3.1 Clinical trials in emergency situations (all of UK)

TheCTRegulationswereamendedin2006 44 toallowpatientstoberecruitedinto

trialsinemergencysituations.Thisisnowpossibleif:

Treatmentisbeinggivenorisabouttobegiventoapersonwholackscapacity and

Duetothenatureoftheclinicaltrialandtheparticularcircumstances,itis

necessarytotakeactionforthepurposesofthetrialbut

Itisnotpracticaltomeettheconditionsrequiredforconsultationand

Theethicsreviewcommitteehasapprovedtheprocedureforsuchrecruitment.

Whendesigningsuchastudyresearchersshouldconsiderthearrangementsthat

willbemade.IntheinformationprovidedtotheRECitshouldbeexplainedwhyit

isnecessarytoincludeparticipantsinthetrialbeforeconsentcanbesoughtfroma

legalrepresentative.Theresearchersshouldalsodocumentwhatstepswillbetaken

toobtainappropriateconsentonceaparticipanthasbeenrecruitedandhowthey

willaddressrefusalofsuchconsent.Twoexamples(HandI)areprovidedbelow.

44The Medicines for Human Use (Clinical Trials) Amendment (no.2) Regulations 2006. SI 2006 No. 2984.


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Examples of clinical trials requiring immediate recruitment

H.Alargemultinationalstudyisexaminingtheeffectivenessofpre-hospitalthrombolysisforcardiacarrest

45.Thetrialinvolvesrecruitmentof

participantsbeforetheyarriveathospital.Thetrialincludesonlypatients

whohavesufferedacardiacarrestandsonoparticipantsareableto

giveconsenttoinclusion.

I.Amulticentreclinicaltrialisbeingsetuptocomparetheeffectiveness

oftwoantiepilepticdrugsinpregnantwomenwitheclampsia.Many

ofthesepatientswillbetemporarilyunabletoconsentduetotheir

medicalcondition.Theymaybeunaccompaniedwhentheyarriveat

hospitaland/orhaveaneclamptict.Whendesigningtheprotocol,theresearchersaddressedthevariouspossibilitiesforobtainingconsent.

Thisincludeddiscussingthetrialwithwomenatparticularriskof

eclampsiaandobtainingconsentpriortotheconditionoccurring.Careful

communicationwasimportant,asitcanbedifculttoidentifywhich

womenmayactuallydevelopeclampsiatheresearchersdidnotwishto

unnecessarilyalarmwomenwhowouldnotthenrequiretherapy.They

alsoconsideredhowconsentwouldbeobtainedifawomanwasenrolled

inthestudybeforeshehadconsented,anddecidedthatthiscouldbe

througharelativebeforethewomanregainedcapacity,orfromthe

participantherselfwhensheregainedcapacity.

45European Journal of Clinical Investigation. 2005 May;35(5):315-23.

4.3.2 Other research in emergency situations (England and Wales)

TheMCAallowspatientstoberecruitedintoresearchstudiesinanemergency

withoutconsultationwitharelativeorcarer.However,recruitmentinanemergency

canonlyoccuriftreatmentneedstobegiventothepatientasamatterofurgency

andenrolmentintotheresearchalsohastobedoneasamatterofurgency.If

thereisnottimetoconsult,asdescribedinsection4.2,theresearchershouldhave

agreementfromaregistereddoctorwhoisindependentoftheproject.Ifthisisalso

impractical,recruitmentintothestudymayoccurifitisdoneinaccordancewitha

protocolalreadyagreedbyanethicscommittee.SeeExampleJ.


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Example J: Research in an emergency situation

Aresearchstudyisproposedtoexaminethechangesincertaininammatorymarkersinacutetraumapatientswhoareunconsciouson

admissiontohospital.Thestudyinvolvestakinginitialbloodandurine

samplesonadmissiontointensivecareandregularsamplesthereafter.

Whensuchpatientsareadmittedtherewilloftennotbearelative

immediatelyavailablewithwhomtodiscussthestudy.Thesampleswould

betakenfromintravenouslinesinsertedtomanagethepatientsclinical

condition.Intheprotocoltheresearchersproposethat,whereavailable,

aconsultantanaesthetistunconnectedwiththestudywillbeconsulted

aboutinclusionofeachpatient.Wherethisisnotpossible,forinstanceatnightsorweekends,thepatientswillbeenrolledintothestudyandbaseline

andfurtherbloodtestsanddatacollected.However,assoonasarelative

orunpaidcarerisavailabletheywillbeconsultedaboutthecontinued

participationofthepatientinthestudy.Ifandwhenthepatientregains

consciousnesstheresearchprojectwillbefullyexplainedandtheywillbe

abletochoosewhethertheirdatashouldremaininthestudycohort.The

approvedthisprotocol.

4.3.4 Other research in emergency situations (Scotland)

Atthistimethereisnoprovisionforrecruitmentintonon-clinicalresearchinan

emergencywithouttheconsultativestepsdescribedinsection4.3.Thismeansthat

suchresearchcannotbelawfullycarriedoutinScotlandatpresent.Ifresearchers

believethatthismayaffectastudytheyareconsidering,theyshouldseekfurther

advicefromtheMRCortheScotlandAREC.

4.3.5 Data Protection Act 1998 and research in emergency

situations (all of UK)

Ithasbeenestablished46 thatdatamaybeprocessedforresearchinemergency

situationsinvolvingincapacitatedadultsprovidinginformationaboutthisworkis

giventothemonrecoveryofcapacity.Atthispointtheymayrefusetoparticipatein

theresearch,includingrefusaltoallowfurtherprocessingofdataalreadycollected.

Thismakestheuseofdataforresearchpurposesinthissituationacceptablein

relationtotheDataProtectionAct.Anyresearchmustalwaysalsocomplywithany

otherlegalrequirementssuchastheMCA,AWISorCTRegulations.

46Time to get our Acts together. Reid CL and Menon DK. BMJ: 355; 415.


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AWIS AdultswithIncapacity(Scotland)Act2000

CT RegulationsMedicinesforHumanUse(ClinicalTrials)Regulations2004

HTA HumanTissueAuthority

HTAct HumanTissueAct2004

ICH GCP InternationalConferenceonHarmonisation:Good

ClinicalPracticeMCA MentalCapacityAct2005

MHRA MedicinesandHealthcareproductsRegulatoryAgency

NRES NationalResearchEthicsService(formerlyCOREC)

REC ResearchEthicsCommittee

Glossary


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16.Ethics Guide Mental Capacity

Documents

Transcript of 16.Ethics Guide Mental Capacity