Quality System Documentation for Research Ethics Clinical Effectiveness Unit Division, PS

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Quality System Documentation forResearch Ethics
Clinical Effectiveness UnitDivision, PS MD
2005
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HA Policy Consideration

• Protect research subjects (HA patients)
• Uphold standard of research conduct among
  employees ( affiliated investigators)
• Manage research-related liabilities
• Ensure service priority

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Research Ethics in HA Past
Infrastructure Progress
1992-1994 1 Ethics Committee at HAHO replaced HSD/DHs EC Universitys IRB/EC (teaching hospitals) Inherited existing practice Mandatory ethical review Compliance with applicable regulatory requirements Declaration of Helsinki
1995- 2001 Set up hospital-based ECs (up to 42 at year 2001) Expanded review capacity to cope with increasing research activities
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A Survey at 2001

• 29 Hospital Ethics Committees
• lt half had operating guideline
• only 2 regularly met to vet application
• lt 1/3 vet indemnity document
• No standard requirement on application dossier
• Rely on EC secretaries to extract information
  from study protocols
• No independent oversight of REC performance

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Research Ethics in HA Present
Infrastructure Progress
2002- 2-tier structure - HA REC (standard setting, compliance oversight, appeal) - Consolidated 42 Hosp ECs to 6 Cluster RECs (ethical review, study oversight) - HA CU, HKU merged their respective RECs in 2002 Segregate standard setting function (HA REC) from execution (Cluster REC) Assure outcome by a Quality System approach using explicit standards procedures to - enforce ethical principles - harmonize practices (HA medical schools) - meet global development - enable compliance oversight
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Importance of Documentation System
Enforceability

• Internalize ethical principles global best
  practices into explicit HA standards
• Provide clear expectations on performance
• Align system process to policy
• Assure consistent, impartial transparent
  processes
• Delineate ethical responsibilities
• Facilitate communication, feedback, training
  compliance oversight

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Documentation sustains Enforceability
Document generation Engage (empower) operators to review current practice system Internalize knowledge accepted practices into institution rules
Validation Ensure alignment to policy achievability
Approval Assign authority ( necessary system support)
Standardized record forms Provide audit trails on control critical events
Dissemination, training Inform equip relevant personnel
Document control Ensure right (update) information
Document maintenance Ensure continual suitability
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Importance of Documentation System

• Internalize ethical principles global best
  practices into explicit HA standards
• Provide clear expectations on performance
• Align system process to policy
• Assure consistent, impartial transparent
  processes
• Delineate ethical responsibilities
• Facilitate communication, feedback, training
  compliance oversight

Procedural justice
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Documentation promotes Procedural Justice

• Consistent, impartial transparent procedures
  are the best guarantee for fair outcomes to
  gain trust
• Justice must be seen to be done
• Standard of documentation must allow evaluation
  of the conduct of review the quality of the
  decision reached
• In audit, not documented not done
• In dispute, intention is judged (inferred)
  objectively

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Importance of Documentation System

• Internalize ethical principles global best
  practices into explicit HA standards
• Provide clear expectations on performance
• Align system process to policy
• Assure consistent, impartial transparent
  processes
• Delineate ethical responsibilities
• Facilitate communication, feedback, training
  compliance oversight

Sharing ethical responsibilities
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Sharing Ethical Responsibilities
Sponsors
Dept of Health
Medical Council
Global references

• IDMC
• Site audit

Research Organizations
CUHK, HKU
Hospital Authority
HAs jurisdiction

• Policy Standards
• Compliance oversight
• Training
• Appeal (REC decision)

Medical Faculty
HA REC
Policy requirements on research Study Site
Administration
Study Site Administration

• Investigator privilege
• Study site facilities
• Clinical trial agreement
• Indemnity agreement
• Risk Mx, insurance
• Handle complaints malpractice

Teaching hospitals
Non-teaching hospitals
University facilities
CU / HKU REC
Cluster REC

• Gate keeping
• Ethical review
• Study oversight
• AE oversight
• Progress reports

Investigators
Investigators
Research subjects
Research subjects
HA patients
Non-HA patients
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Importance of Documentation System

• Internalize ethical principles global best
  practices into explicit HA standards
• Provide clear expectations on performance
• Align system process to policy
• Assure consistent, impartial transparent
  processes
• Delineate ethical responsibilities
• Facilitate communication, feedback, training
  compliance oversight

Compliance oversight CQI
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Documentation enables Compliance Oversight

• RECs performance is subject to monitoring
• Annual inspection
• Review REC operating procedures against HA
  standards requirements
• Random checking of records for compliance to HA
  standards REC operating procedures
• Interview staff on practices
• Continuous improvement corrective actions,
  revising standards, refresher training

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HA delivers research ethics through
by adopting a Quality System approach
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Corresponding to the parties involved, there are
3 Guiding Documents
a number of forms
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Documents accommodate Different Obligations
Audience Perspectives
REC / IRB

1. Study oversight requires prompt SAE reporting to
   REC
2. Review all SAE reports
3. Alert HA REC if SAE demands study termination

Investigators
1. Study has measure for early detection Mx of
possible adverse outcome
2. Inform participants affected ( their
clinicians if indicated) report to sponsors,
REC, HA Legal Services Regulatory Agency (if
required by law)
e.g. on handling SAE
3. Update participants ( consent form) if the
SAE is relevant to subjects willingness to
participate
Study Sites

1. Ensure investigator competence
2. Administrative oversight legal support

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1. REC Guide (internalizing best practices)
Local standards practices

• Established by Cluster REC
• Guides operation
• Enables audit

Cluster REC Standard Operating Procedure Forms

• Established by HA REC
• HA-wide Standards
• Guiding document for Cluster REC
• Enables audit
• Basis for harmonizing with CU HKU

ICH GCP (E6) Other references, e.g. FDA IRB Guide
HA Guide for Cluster REC
International requirements practices
Applicable regulations Professional Code
Conduct HA policy
Declaration of Helsinki
Local requirements
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2. Study Site Guide

• Institutes engaging in clinical research are
  obliged to
• Support REC
• Control research privilege investigator
  qualification, policy in granting access right to
  non-employees
• Verify adequate facility resource support for
  study no undue influence on service
• Undertake formal dealings with sponsor indemnity
  agreement, clinical trial agreement
• Manage risk insurance, policy on collaboration
  with non-affiliated study sites
• Handle complaint misconduct

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3. Investigators Code of Practice

• Has prime responsibility in protecting research
  subjects be answerable to the institution.
  Investigator should
• qualify scientifically, i.e. proficient in the
  area of study
• understand willing to comply with regulatory,
  professional institutional requirements on
  research
• declare conflict of interest
• abide by REC decisions
• PI has overall responsibility in technical,
  administrative fiscal management of study

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Document Internalization within Organization
HA level Cluster Level Hospital level
REC Guide
Investigators COP
Study Site Guide
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