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Quality System Documentation for Research Ethics Clinical Effectiveness Unit Division, PS & MD 2005. BACKGROUND HK has no Statute specifically on clinical research Ethical oversight relies on Professional self-discipline Administrative control of academia & healthcare providers. - PowerPoint PPT Presentation
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Quality System Documentation Quality System Documentation
forfor
Research EthicsResearch Ethics
Clinical Effectiveness UnitClinical Effectiveness Unit
Division, PS & MD Division, PS & MD
20052005
BACKGROUNDHK has no Statute specifically on clinical researchEthical oversight relies on– Professional self-discipline– Administrative control of academia &
healthcare providers
HA Policy ConsiderationHA Policy Consideration
Protect research subjects (HA patients)Protect research subjects (HA patients)
Uphold standard of research conduct among Uphold standard of research conduct among employees (& affiliated investigators)employees (& affiliated investigators)
Manage research-related liabilitiesManage research-related liabilities
Ensure service priorityEnsure service priority
Goal: To develop a sound ethical framework for clinical research
Research Ethics in HA: PastResearch Ethics in HA: PastInfrastructureInfrastructure ProgressProgress
1992-1992-19941994
1 Ethics Committee 1 Ethics Committee at HAHO replaced at HAHO replaced HSD/DH’s ECHSD/DH’s EC
University’s IRB/EC University’s IRB/EC (teaching hospitals)(teaching hospitals)
Inherited existing practiceInherited existing practice
Mandatory ethical reviewMandatory ethical review
Compliance with applicable Compliance with applicable regulatory requirements ®ulatory requirements & Declaration of HelsinkiDeclaration of Helsinki
1995- 1995- 20012001
Set up hospital-based Set up hospital-based ECs (up to 42 at year ECs (up to 42 at year 2001)2001)
Expanded review capacity Expanded review capacity to cope with increasing to cope with increasing research activitiesresearch activities
A Survey at 2001A Survey at 2001 29 Hospital Ethics Committees
– < half had operating guideline– only 2 regularly met to vet application– < 1/3 vet indemnity document– No standard requirement on application dossier– Rely on EC secretaries to extract information ely on EC secretaries to extract information
from study protocolsfrom study protocols– No independent oversight of REC performanceNo independent oversight of REC performance
Insufficient enforcement mechanism Performance did not meet ICH-GCP standard,
a prerequisite for international drug trials
Research Ethics in HA: PresentResearch Ethics in HA: PresentInfrastructureInfrastructure ProgressProgress
2002-2002- 2-tier structure2-tier structure - HA REC (standard - HA REC (standard
setting, compliance setting, compliance oversight, appeal)oversight, appeal)
- Consolidated 42 Hosp - Consolidated 42 Hosp ECs to 6 Cluster RECs ECs to 6 Cluster RECs (ethical review, study (ethical review, study oversight)oversight)
- HA & CU, HKU - HA & CU, HKU merged their merged their respective RECs in respective RECs in 20022002
Segregate standard setting Segregate standard setting function function (HA REC)(HA REC) from from execution execution (Cluster REC)(Cluster REC)Assure outcome by a Quality Assure outcome by a Quality System approach using System approach using explicit explicit standards & procedures standards & procedures toto
- enforce ethical principles - enforce ethical principles - harmonize practices (HA & - harmonize practices (HA &
medical schools)medical schools) - meet global development- meet global development - enable compliance oversight- enable compliance oversight
Importance of Documentation SystemImportance of Documentation System
Internalize ethical principles & global best practices Internalize ethical principles & global best practices into explicit “HA standards”into explicit “HA standards”
Provide clear expectations on performanceProvide clear expectations on performance
Align system & process to policyAlign system & process to policy
Assure consistent, impartial & transparent processesAssure consistent, impartial & transparent processes
Delineate ethical responsibilitiesDelineate ethical responsibilities
Facilitate communication, feedback, training & Facilitate communication, feedback, training & compliance oversightcompliance oversight
EnforceabilityEnforceability
Documentation sustains EnforceabilityDocumentation sustains EnforceabilityDocument Document generationgeneration
Engage (empower) operators to review current Engage (empower) operators to review current practice & systempractice & systemInternalize knowledge & accepted practices Internalize knowledge & accepted practices into institution rulesinto institution rules
ValidationValidation Ensure alignment to policy & achievabilityEnsure alignment to policy & achievabilityApprovalApproval Assign authority (& necessary system support)Assign authority (& necessary system support)Standardized Standardized record formsrecord forms
Provide audit trails on control critical eventsProvide audit trails on control critical events
Dissemination, Dissemination, trainingtraining
Inform & equip relevant personnelInform & equip relevant personnel
Document Document controlcontrol
Ensure right (update) informationEnsure right (update) information
Document Document maintenancemaintenance
Ensure continual suitabilityEnsure continual suitability
Importance of Documentation SystemImportance of Documentation System
Internalize ethical principles & global best practices Internalize ethical principles & global best practices into explicit “HA standards”into explicit “HA standards”
Provide clear expectations on performanceProvide clear expectations on performance
Align system & process to policyAlign system & process to policy
Assure consistent, impartial & transparent processesAssure consistent, impartial & transparent processes
Delineate ethical responsibilitiesDelineate ethical responsibilities
Facilitate communication, feedback, training & Facilitate communication, feedback, training & compliance oversightcompliance oversight
Procedural justiceProcedural justice
Documentation promotes Procedural JusticeDocumentation promotes Procedural Justice
Consistent, impartial & transparent procedures are Consistent, impartial & transparent procedures are the best guarantee for fair outcomes & to gain trustthe best guarantee for fair outcomes & to gain trustJustice must be seen to be doneJustice must be seen to be doneStandard of documentation Standard of documentation must allow evaluation of must allow evaluation of the conduct of review & the quality of the decision the conduct of review & the quality of the decision reachedreached– In audit, In audit, not documented ≡ not donenot documented ≡ not done– In dispute, intention is judged (inferred) objectivelyIn dispute, intention is judged (inferred) objectively
必須有目共睹必須有目共睹
Practice point: Corrections made in document must be crossed out (still see through), initialled & dated
Importance of Documentation SystemImportance of Documentation System
Internalize ethical principles & global best practices Internalize ethical principles & global best practices into explicit “HA standards”into explicit “HA standards”
Provide clear expectations on performanceProvide clear expectations on performance
Align system & process to policyAlign system & process to policy
Assure consistent, impartial & transparent processesAssure consistent, impartial & transparent processes
Delineate ethical responsibilitiesDelineate ethical responsibilities
Facilitate communication, feedback, training & Facilitate communication, feedback, training & compliance oversightcompliance oversight
Sharing ethical responsibilitiesSharing ethical responsibilities
CUHK, HKUMedical Faculty
Hospital Authority
Study Site Administration
Teaching hospitalsNon-teachinghospitals
Sharing Ethical ResponsibilitiesSharing Ethical ResponsibilitiesSponsors
Cluster REC
Investigators
Research subjects
• Policy & Standards• Compliance oversight• Training• Appeal (REC decision)
Dept of Health Medical Council Global references
University facilities
Research OrganizationsResearch Organizations
HApatients
Non-HApatients
Research subjects
Investigators
HA REC
• Investigator privilege• Study site facilities• Clinical trial
agreement• Indemnity agreement• Risk Mx, insurance• Handle complaints &
malpractice
Policy & requirements on researchStudy Site
Administration
CU / HKU REC
• Gate keeping• Ethical review• Study oversight• AE oversight• Progress reports
HA’sHA’s jurisdictionjurisdiction
• IDMC• Site audit
Importance of Documentation SystemImportance of Documentation System
Internalize ethical principles & global best practices Internalize ethical principles & global best practices into explicit “HA standards”into explicit “HA standards”
Provide clear expectations on performanceProvide clear expectations on performance
Align system & process to policyAlign system & process to policy
Assure consistent, impartial & transparent processesAssure consistent, impartial & transparent processes
Delineate ethical responsibilitiesDelineate ethical responsibilities
Facilitate communication, feedback, training & Facilitate communication, feedback, training & compliance oversightcompliance oversightCompliance oversight & CQICompliance oversight & CQI
Documentation enables Compliance OversightDocumentation enables Compliance Oversight
REC’s performance is subject to monitoringREC’s performance is subject to monitoringAnnual inspectionAnnual inspection– Review REC operating procedures against HA Review REC operating procedures against HA
standards & requirementsstandards & requirements– Random checking of records for compliance to Random checking of records for compliance to
HA standards & REC operating proceduresHA standards & REC operating procedures– Interview staff on practicesInterview staff on practicesContinuous improvement: corrective actions, Continuous improvement: corrective actions, revising standards, refresher trainingrevising standards, refresher training
by adopting a Quality System approachby adopting a Quality System approach
HA delivers research ethics throughHA delivers research ethics through
Research Research SubjectSubjectProtectionProtection
InvestigatorsInvestigators
HospitalHospital(Study Sites(Study Sites))
AdministrationAdministration
HA RECHA RECCluster RECsCluster RECs
Corresponding to the Corresponding to the parties involved, there are parties involved, there are
3 Guiding Documents3 Guiding Documents
& a number of forms& a number of forms
Documents accommodate Different Documents accommodate Different Obligations & Audience PerspectivesObligations & Audience Perspectives
e.g. on e.g. on handling handling SAESAE
1. Ensure investigator competence2. Administrative oversight & legal
support
1. Study oversight requires prompt SAE reporting to REC
2. Review all SAE reports3. Alert HA REC if SAE demands
study termination
REC / IRBREC / IRB
Study SitesStudy Sites
1. Study has measure for early detection& Mx of possible adverse outcome
InvestigatorsInvestigators
2. Inform participants affected (& their clinicians if indicated) & report to sponsors, REC, HA Legal Services & Regulatory Agency (if required by law)
3. Update participants (& consent form) if the SAE is relevant to subjects’ willingness to participate
1. 1. REC Guide (internalizing best practices)REC Guide (internalizing best practices)
HA Guide forCluster REC
Established by HA REC:Established by HA REC:• HA-wide StandardsHA-wide Standards• Guiding document for Cluster Guiding document for Cluster
RECREC• Enables auditEnables audit• Basis for harmonizing with CU Basis for harmonizing with CU
& HKU& HKU
ICH GCP (E6)Other references,e.g. FDA IRB Guide
InternationalInternationalrequirementsrequirements& practices& practices
Applicable regulationsProfessional Code & Conduct
HA policy
Cluster REC Standard OperatingProcedure & Forms
Established by Cluster REC:Established by Cluster REC:• Guides operationGuides operation• Enables auditEnables audit
Local standards & practicesLocal standards & practices
Declaration of Helsinki
Local requirementsLocal requirements
2. Study Site Guide2. Study Site Guide
Institutes engaging in clinical research are obliged to: Institutes engaging in clinical research are obliged to: – Support RECSupport REC– Control research privilege: investigator qualification, Control research privilege: investigator qualification, policy in gpolicy in granting access right to non-employeesranting access right to non-employees
– Verify adequate facility & resource support for study Verify adequate facility & resource support for study & no undue influence on service& no undue influence on service
– Undertake formal dealings with sponsor: indemnity Undertake formal dealings with sponsor: indemnity agreement, clinical trial agreementagreement, clinical trial agreement
– Manage risk: insurance, policy on collaboration with Manage risk: insurance, policy on collaboration with non-affiliated study sitesnon-affiliated study sites
– HandleHandle complaint complaint & misconduct& misconduct
3. Investigator’s Code of Practice3. Investigator’s Code of Practice
Has prime responsibility in protecting research subjects Has prime responsibility in protecting research subjects & be answerable to the institution. Investigator should:& be answerable to the institution. Investigator should:– qualify scientifically, i.e. proficient in the area of studyqualify scientifically, i.e. proficient in the area of study– understand & willing to comply with regulatory, understand & willing to comply with regulatory,
professional & institutional requirements on researchprofessional & institutional requirements on research– declare conflict of interest declare conflict of interest – abide by REC decisionsabide by REC decisions
PI has overall responsibilityPI has overall responsibility in in technical, administrativetechnical, administrative && fiscal management of fiscal management of studystudy
Document Internalization within OrganizationDocument Internalization within Organization
HA level Cluster Level Hospital level
REC Guide + + –
Investigator’s COP + – –
Study Site Guide + ± ±