Emerging SACHRP Issues
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Emerging SACHRP Issues
K. Lynn Cates, MDAssistant Chief Research & Development OfficerDirector, PRIDEOffice of Research & DevelopmentDepartment of Veterans AffairsOctober 17, 2005
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SACHRP• Secretary’s Advisory Committee on Human
Research Protection, HHS*
• Purpose• To provide expert advice &
recommendations to the Secretary of HHS & the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects.
*Authority: 42 U.S.C. 217a, section 222, PHS Act
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Emerging SACHRP Issues
• Federal Adverse Events Taskforce (FAET)
• IRB Workshop
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Federal Adverse Event Taskforce
• Charge• Propose specific means for promoting
harmonized and streamlined federal requirements for reporting, analyzing, and communicating adverse events in clinical research.
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Federal Adverse Event Taskforce• Member Agencies
• AHRQ• CDC• DoD• FDA• OHRP• NIH• VA
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Federal Adverse Events Taskforce
• Objectives1. Common terms & definitions2. Common AE report forms3. Common workflow patterns4. Communications
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1. Common Terms & Definitions
• Reduce variability in language• e.g., “unanticipated problem” vs. “adverse
event” or “unanticipated” vs. “unexpected”
• Align federal agencies’ policies & guidance
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2. Common AE Report Forms
• Basal Adverse Event Report (BAER)• Develop a baseline set of core information
adopted by all agencies
• Address individual agency needs by adding extra fields
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3. Common Workflow Patterns
• Develop a best practices blue print for reporting, analyzing, and applying AE data
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AE Reporting in Multi-Center Clinical Trials: Trans-Federal Guidance
• Clarify regulatory requirements for reporting and reviewing adverse events from multi-center trials
• Outline criteria for when AE reports should be forwarded to other sites
• Work with industry and academia
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4. Communication
• Effective communication• Enhance subjects’ safety• Further scientific knowledge• Earn public trust
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FAET Focus Groups
• Examine current practices at the local level• What safety information does an IRB receive
and when?• How is the safety information analyzed?• How and to whom is it communicated?
• Identify Problem Areas• Does government contribute?
• Define what needs to be done
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VA Local Management of Adverse Events:Mission
• Ensure that local management of unanticipated problems in research, including adverse events, assures maximal protection for VA research participants, and complies fully with all laws, regulations, and standards.
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VA Local Management of Adverse Events:Charge
• Identifying/Reporting• What should be reported?• When should it be reported?• Where should it be reported?
• Monitoring• Who monitors?• What is monitored?• What trends/patterns require further
action?
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VA Local Management of Adverse Events:Charge
• Research v. Patient Safety• Corrective Action
• Who takes action?• What are appropriate actions?• When does it become research
misconduct?
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Alternatives to Current IRBs
• IRB Workshop
• VA Central IRB
• “What is Research?” Panel
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IRB Workshop
• Steering Group• OHRP• NIH• AAMC• ASCO• VA
• November 17-18, 2005, Washington, DC
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IRB Workshop
• Invitational, exploratory meeting
• Diverse perspectives• IRBs• Academic and community-based investigators• Attorneys• Patients• Ethicists• Industry officials• Senior university and medical school research
administrators
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IRB Workshop Topics
• Institutional responsibilities
• Ways to reduce burdens (especially for multi-site trials)
• Costs and other barriers
• The federal policy framework relevant to new IRB arrangements
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IRB Workshop: Follow-on Activities
• Report for SACHRP on• The suitability of alternative models of
IRB review for different research contexts
• Strategies to address barriers
• Public meeting
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VA Central IRB
• Review multi-site VA studies
• Assure quality by ensuring appropriate representation (scientific, ethical, “community”)
• Enhance efficiency
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VA Central IRB:Timeline
Fall 2005• Implementation strategies Policies & procedures• Begin recruitment process for IRB Administrator• Site visits to NCI CIRB, Western & Chesapeake
Winter 2005-6• IRB Chair and field input
Summer & Fall 2006• Training – local accountability
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Alternatives to Current IRB System“What is Research?” Panel
• Responsibilities• Review multi-site projects to determine
whether or not they are “research”• Develop guidance for the field on “What
is Research?” (vs. Quality)
• High level representatives from ORD, ORO, Ethics, Patient Services, Quality