4
8.1.1 thegrantofanewInstitutionalResearchLicence,
8.1.2 therenewalofitsexistingInstitutionalResearchLicence,or
8.1.3 the amendment of the condition of its Institutional Research Licence which describes
theresearchthatitispermittedtocarryoutinaccordancewiththeLicence,
8.2 Inanyapplicationthe
institutionshallberequiredtodemonstratethat‐
8.2.1 it possesses the qualifications, experience and competence ne cessary to carry out the
HumanSubjectsResearchproposedintheapplication,
8.2.2 thereisscientificjustificationforeachoftheresearchactivitiesproposed,and
8.2.3 itwill beabletocomplywiththerequirements
ofthisPolicyandallotherHAADPolicies
applicabletotheresearchactivitiesproposed.
8.3 HAADwillrejectanapplicationiftheinstitutionfailstodemonstratetoitssatisfactionthatthese
criteriaaremet.
8.4 Aninstitutionshallnotmakeanapplicationthatcontainsanystatements,orisaccompaniedby
any
documentsorinformation,whichareincomplete,inaccurate,falseormisleading.
8.5 HAADmayrejectanyapplicationthatisinbreachofrequirements.
9 DutiesofLicensedResearchInstitutions
9.1 ALicensedResearchInstitutionmustcomplywiththeconditionsofitsLicence.
9.2 ALicensed Research Institution must carry out, monitor,
record, control and review all Human
SubjectsResearchinaccordancewithallapplicableHAADPolicies,includinginparticular–
9.2.1 the“PolicyGoverningResearchInvolvingHumanSubjects”(RefPHP/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 ALicensedResearchInstitutionmust–
9.3.1 makeavailabletoHAAD,onrequest,itspolicie sandproceduresrelatingtothecarryin g
out,monitoring,recording,controllingandreviewingofHumanSubjectsResearch,
9.3.2 activelymonitoritscompliancewiththisPolicyandallotherapplicableHAADPolicies,
9.3.3 provide to HAAD,
on request, evidence to establish its compliance with thisPolicy and
allotherapplicableHAADPolicies,
9.3.4 atalltimesmaintainappropriateindemnityinsurancecovering,inrespectofitsHuman
SubjectsResearch–