Scope

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Document Development forResearch Ethics
Clinical Effectiveness UnitDivision, PS MD
2005
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Important Policy Considerations

• Protection of human research subjects
• Comply with Declaration of Helsinki, ICH-GCP,
  international best practices local regulations
• Mandatory ethical review, approval monitoring
  by a recognized REC/ IRB
• Management of research-related liabilities
• Basic competence of investigators facilities
• Should not compete with service needs

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Development Past Present
1992- HA Ethics Committee replaced HSD/DHs Ethics Committee
1995- Evolved a 2-tier mechanism Central HA Ethics Committee (on policy) Hospital Ethics Committees (on operation) 40 Hospital-ECs at 2001, lt half had operating guidelines, lt one-third reviewed indemnity arrangement, only 2 regularly met to vet applications
2002- Consolidated hospital ECs into Cluster-RECs Merging with corresponding REC/ IRB of CU HKUs medical faculties HA-REC to establish standards, guidelines harmonize research ethics development in HA
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Reason for change

• Ensure HKs participation in drug trials by
  complying with ICH-GCP
• Address system weakness
• Variation in standards
• Few REC met to vet
• Documents not user-friendly may be inadequate
• Process relied heavily on REC secretaries
• Insufficient support to most RECs
• Lack of training
• To consolidate resource, expertise harmonize
  practices

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Progress
Revamp HA REC 2Q 02
Establish SOP supporting forms for Cluster REC 1Q 03
Consolidate hospital ECs into Cluster RECs 3-4Q 02
Merging with the University REC/IRBs 3-4Q 02
REC training 4Q 02 - 1Q 03
Develop database Mx software for Cluster REC 4Q 04
Establish a central database on Clinical Research 4Q 04
Establish Study Site Guide Investigators COP 4Q 04
Investigator training refreshing training on REC 1Q 05 -
Develop on-line submission of application 3-4Q 05
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Why ?
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Provides Anchorage

• Align structure, process output requirements to
  policy
• Delineate responsibility / accountability of
  relevant parties personnel
• Convert knowledge accepted practices to
  institution rules
• Guide specific tasks
• Describe expectation on performance (competence)
• Basis for training audit

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In-process Metrics for CQI
Benefits
Documentation steps
Document generation maintenance
Validation
Approval
Dissemination, training
Design record forms
Engage (empower) practitioners to (regularly) review current practice ( system)
Ensure practicability ( align to policy)
Assign authority ( system support)
Communicate to ( equip) practitioners
Control critical events (QA, provide audit trail)
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Ensures Applicability

• Internalizing convert knowledge accepted
  practices into institution rules (deliberation to
  adapt into local context)
• From generic to specific requirements
• Customize with system, expertise resources
  (practical consideration)
• Tailor requirement to audiences perspectives
  (drafting skill for technical communication)
• Approval assign authority to document

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Assures Right Information

• To preclude use of obsolete documents, documents
  are
• uniquely identified
• filed in a readily accessible source
• distributed to concerned personnel workplaces
  (consider web-based technology)
• Obsolete document for archive is clearly denoted
• Scheduled review to ensure continual validity

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3 Pillars Protecting Research Subjects
REC / IRB
Protection of Human Research Subjects
Investigators (research team)
They have related but different roles
responsibilities, thus require correspondingly
different guiding documents
Study Site Authority (hospital/ HA, University)
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Document Should Accommodate Audiences Perspective
REC / IRB

1. Require PI to report SAE to REC
2. Review SAE reports
3. Notify HA REC if SAE demands study termination
   (Alert/Recall)

Investigators
1. Institute measures for early detection Mx of
possible adverse outcomes

• 2. Report SAE to
• Participants ( their clinicians if indicated)
• Sponsors REC (in accordance with ICH-GCP)
• Legal Services Section of HAHO (if there is
  potential claim legal implication)
• Regulatory agency (if required by law)

e.g. on handling SAE
3. Update participants if the SAE may be relevant
to their willingness to continue participate in
study
Study Sites

• Ensure all SAEs with potential claim legal
  implication are reported to Legal Services
  Section of HAHO
• Ensure investigator competence

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1. REC / IRB Guide (internalizing good practices)
Local requirements practices
Cluster REC Standard Operating Procedure Forms

• Established by Cluster REC
• Guides operation
• Enables audit

• Established by HA REC
• HA-wide Standards
• Framework for SOP Form development in clusters

ICH GCP (E6) Other references, e.g. FDA IRB Guide
HA Guide for Cluster REC
International requirements practices
Local regulation HA policy
Declaration of Helsinki
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2. Investigators Code of Practice

• Investigators have the primary responsibility for
  protecting the rights welfare of human research
  subjects. They must comply with all applicable
  provisions, such as
• Ethical responsibility
• Right of participants
• Consent to research
• Regulatory requirements, professional standard,
  institutional policies procedures
• Relationship with external sponsor
• Interaction with REC study site administration
• Handling potential conflict of interest

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3. HA Study Site Guide

• All institutions involved in clinical research
  have a responsibility to protect research
  participants
• Explicit policy procedures on human protection
  in research
• Sufficient facilities competent investigators
• Formal vetting approval procedure
• Study monitoring, esp. record management, SAE
  handling, complaint management, procedure to deal
  with incompetence misconduct
• Training, risk management
• Interfaces with REC HAHO

Administrative procedures may be handled
differently from one institution to another
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Level of Document Internalization
HA level Cluster Level Hospital level
REC/IRB Guide
Investigators COP
Study Site Guide