هــﻴﺌـــــﺔ اﻟﺼﺤﺔ Health Authority

1



HealthAuthority–AbuDhabi

ﺔﺤﺼﻟا ﺔـــــﺌﻴــه- ﻲﺒﻇﻮﺑأ

HAADExternalPolicies



Title:

LicensingRequirementsforInstitutionalHuman

SubjectsResearch

ReferenceNumber:PHP/PHR/R02

IssueDate: February2010

NextReviewDate: February2012



CHAPTERI.INTRODUCTION



1 Purpose

1.1 ThisPolicyprovidesforthelicensingofinstitutionsengagedinHumanSubjectsResearchinthe

EmirateofAbuDhabi.

2 Background

2.1 The Health Authority Abu Dhabi (HAAD) is responsible for regulating all aspects of  Human

SubjectsResearchinthe EmirateofAbuDhabi.

2.2 HAAD

hasestablishedagovernanceframeworktoensurethatHumanSubjectsResearchis–

2.2.1 designedandconductedinaccordancewiththelaws and regulationsoftheEmirate of

AbuDhabi,

2.2.2 consistentwith HAADPoliciesandStandards,and

2.2.3 subjecttoethicalreviewandmonitoring.

2.3 The licensing of Human

Subjects Research is the principal means by which HAAD fulfils its

regulatoryoversightandassuresthateffectivecomplianceisachieved.

3 Scope

3.1 ThisPolicysetsouttherequirementsforinstitutionstoobtainandcomplywiththeconditionsof 

alicencetoengageinandconductHumanSubjectsResearch.

3.2 This

PolicyappliesinadditiontootherHAADpoliciesandstandardsrelatingtopublichealth,and

iswithoutprejudiceto therequirementsof allotherFederal and AbuDhabi lawsapplicab le to

theactivityofHumanSubjectsResearch.

4 RelatedPolicies

4.1 ThefollowingHAADPoliciesarecloselyrelatedtothis

one–

2

4.1.1 “PolicyGoverningResearchInvolvingHumanSubjects”(RefPHP/PHR/R03).

4.1.2 “AbuDhabiHealthResearchCouncil”(RefPHP/PHR/R01).

5 InterestedParties

5.1 This Policy is of relevance to all individuals and institutions involved or wishing to engage in

HumanSubjectsResearchintheEmirateofAbuDhabi.

3

CHAPTERII.LICENSING



6 TheLicensingRequirement

6.1 NoinstitutionmaycarryoutanyHumanSubjectsResearchunless–

6.1.1 itholdsanInstitutionalResearchLicencegrantedbyHAAD,and

6.1.2 theHumanSubjectsResearchcarriedoutbyitis withinthedescriptionofresearchth at

itispermittedtocarryoutin

accordancewiththeLicence.

7 TheInstitutionalResearchLicence

7.1 AnInstitutionalResearchLicence–

7.1.1 willcontainaconditiondescribingtheHumanSubjectsResearchthatispermittedtobe

carriedoutinaccordancewiththeLicence,and

7.1.2 maycontainotherconditionswhich‐

(a) imposerestrictionsonthecarrying

outofHumanSubjectsResearch,

(b) requirethatresearchto becarriedoutinaspecifiedmanner,or

reviewed.

7.2 HAADmaymakeanInstitutionalResearchLicencesubje cttoconditionsatthetimeatwhichitis

granted.

7.3

HAADmayaddto,removeoramendthe conditions of an InstitutionalResearchLicenceatany

timeafterithasbeengranted.

7.4 Each InstitutionalResearchLicenceshall haveeffect foraperiodoftwoyearsfromthedateof

itsgrant.

7.5 Attheend ofthisperiod,an

InstitutionalResearchLicenceshallexpire,andshallceasetobeof

anyeffect,unlessHAADdeterminesthatitistoberenewed.

7.6 AnInstitutionalResearchLicencethatisrenewedshallhaveeffectforafurthertwoyearperiod,

attheendofwhichitshallexpireunlessHAADdeterminesthat

itisagaintoberenewed.

7.7 ThereisnolimittothenumberoftimesalicencemayberenewedbyHAAD.

8 LicenceApplications

8.1 ByfollowingtheapplicationproceduresdescribedinAppendixA,aninstitutionmayapplyfor–

4

8.1.1 thegrantofanewInstitutionalResearchLicence,

8.1.2 therenewalofitsexistingInstitutionalResearchLicence,or

8.1.3 the amendment of the condition of its Institutional Research Licence which describes

theresearchthatitispermittedtocarryoutinaccordancewiththeLicence,

8.2 Inanyapplicationthe

institutionshallberequiredtodemonstratethat‐

8.2.1 it possesses the qualifications, experience and competence ne cessary to carry out the

HumanSubjectsResearchproposedintheapplication,

8.2.2 thereisscientificjustificationforeachoftheresearchactivitiesproposed,and

8.2.3 itwill beabletocomplywiththerequirements

ofthisPolicyandallotherHAADPolicies

applicabletotheresearchactivitiesproposed.

8.3 HAADwillrejectanapplicationiftheinstitutionfailstodemonstratetoitssatisfactionthatthese

criteriaaremet.

8.4 Aninstitutionshallnotmakeanapplicationthatcontainsanystatements,orisaccompaniedby

any

documentsorinformation,whichareincomplete,inaccurate,falseormisleading.

8.5 HAADmayrejectanyapplicationthatisinbreachofrequirements.

9 DutiesofLicensedResearchInstitutions

9.1 ALicensedResearchInstitutionmustcomplywiththeconditionsofitsLicence.

9.2 ALicensed Research Institution must carry out, monitor,

record, control and review all Human

SubjectsResearchinaccordancewithallapplicableHAADPolicies,includinginparticular–

9.2.1 the“PolicyGoverningResearchInvolvingHumanSubjects”(RefPHP/PHR/R03),

9.2.2 Policies and standards relevant to document retention and information management;

“Medical Record / Health Information Retention and Disposal Policy” (R ef 

PPR/HCP/0009/07) .

9.3 ALicensedResearchInstitutionmust–

9.3.1 makeavailabletoHAAD,onrequest,itspolicie sandproceduresrelatingtothecarryin g

out,monitoring,recording,controllingandreviewingofHumanSubjectsResearch,

9.3.2 activelymonitoritscompliancewiththisPolicyandallotherapplicableHAADPolicies,

9.3.3 provide to HAAD,

on request, evidence to establish its compliance with thisPolicy and

allotherapplicableHAADPolicies,

9.3.4 atalltimesmaintainappropriateindemnityinsurancecovering,inrespectofitsHuman

SubjectsResearch–

5

(a) alladverseoutcomesforindividualswhoarethesubjectoftheresearch,

(b) allotherpotentialliabilitiesoftheInstitution,

contractedto,theInstitution,

9.3.5 report to HAAD, in advance, any proposal to publish ordisseminate the findings

 of its

HumanSubjectsResearch,

9.3.6 provide to HAAD a copy of any publication that contains, or any other document that

disseminates,thosefindings,

9.3.7 promptlyreporttoHAADanybreachoftheconditionsofitsLicence,ofthisoranyother

HAADPolicy,andofanybreachofits

internalpoliciesandprocedures.

10 TheAbuDhabiHealthResearchCouncil

10.1 HAAD may delegate to the Abu Dhabi Health Research Council any or all  of the functions

ascribedtoHAADinthisPolicy.

10.2 WhereafunctionhasbeendelegatedtotheAbuDhabiHealthResearchCouncil,anyexerciseof



thatfunctionbytheCouncilshallhavethesameeffectasifithadbeenmadebyHAAD.

6

CHAPTERIII.COMPLIANCE,SANCTIONS,COMPLAINTS&APPEALS



11 Compliance

11.1 HAAD will monitor and audit compliance with this policy.All Licensed Research Institutions

mustcomplywiththe[HAADPolicyonLicensingRequirementsandDataManagement].

12 Sanctions

12.1 HAAD may impose sanctions in relation to any breach of this Policy in accordance with the

[HAADPolicyon

Complaints,Grievances,Appeals,SanctionsandSuspensions].

13 Complaints

13.1 ComplaintsontheconductofHumanSubjectsResearchmaybemadetoHAAD byanypersonor

bodywith alegitimate interest in the research, and will be considered by HAADin accordance

withitsComplaintsManagementPolicy(www.haad.ae). 

14 Appeals

14.1 A Licensed Research Institution, or an applicant for an Institutional Research Licence, may

appealagainstanydecisionofHAADtakenunderthisPolicy,andtheappealshallbydealtwith

in accordance with the [HAAD Policy on Complaints, Grievances, Appeals, Sanctions and

Suspensions].



7

CHAPTERIV.GLOSSARYOFTERMS

InthisPolicythefollowingtermsshallhavethemeaningsgiventothembelow–

AbuDhabiHealthResearchCouncil has the same meaning as in the Policy “Abu Dhabi Health

ResearchCouncil”(RefPHP/PHR/R01).

HumanSubjectsResearch means any activity falling within one or more of the following

categories‐

• Studies of a physiological, biochemical, or pathological

process,or of the response to a specific intervention –

whetherphysical,chemicalorpsychological–inhealthy

subjectsorinpatients.

• Controlledtrialsofdiagnostic,preventiveortherapeutic

measures in larger groups of persons, designed to

demonstratea specific generalisable response

 to these

measures against a background of individual biological

variation.

• Studies designed to determine the consequences for

individuals and communities of specific preventive or

therapeuticmeasures.

• Studiesconcerninghumanhealth‐relatedbehaviourina

varietyofcircumstancesandenvironments.

InstitutionalResearchLicence means a licence granted by HAAD

to an institution, in

accordance with the provisions of this Policy, authorising the

institutiontoengageinHumanSubjectsResearch.

Licence meansanInstitutionalResearchLicence.

LicensedResearchInstitution meansanyinstitutionholdinganInstitutionalResearchLicence.

8

APPENDIXA.LICENCEAPPLICATIONS



(1) Applicationsmustbemadeto theMedicalResearchSectionatHAADfor–

(a) thegrantofanewInstitutionalResearchLicence,

(b) therenewalofanexistingInstitutionalResearchLicence,or

(c) theamendmentoftheconditionofaInstitutionalResearchLicencewhichdescribesthe

researchthatis

permittedtobecarriedoutinaccordancewiththeLicence.

(2) The application must be made in the standard form which may be found on HAAD website at

www.haad.ae

.

(3) At any time after receiving the application, HAAD may request such additional information  or

documentsasitconsidersnecessaryforthepurposeofassessingtheapplication.

(4) The institution making the application must provide any additional information or documents

requestedbyHAAD,andmustdosowithinanyperiod

oftimespecifiedintherequest.

(5) HAADmayfromtimetotimesetfeestobepaidbyaninstitutionmakinganappl ication,andthe

currentleveloffeesmaybefoundonHAADwebsiteatwww.haad.ae

.

(6) Theinstitutionmakingtheapplicationmustprovidepaymentoftheappropriatefeeatthesame

timeasitmakestheapplication.

(7) HAAD may from time to time set timeframes for processing applications, and the specified

timeframesmaybefoundontheHAADwebsiteatwww.haad.ae.

(8) An application

 for the renewal of an existing Institutional Research Licence should be made at

least60daysbeforetheLicenceisduetoexpire.