Transcript HIC Human Research Subjects Protection

The QA/QI Process
Human Research
Subjects Protection
Human Investigation
Committee
Tracy Rightmer, JD, CIP
Compliance Manager
HIC Human Research Subjects Protection
Compliance Program
Goals – Strengthen and Facilitate:
– Safeguards for the rights and welfare of human
research subjects
– Responsible conduct of research involving
human research subjects
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Current HIC Compliance Program
Assurance of Compliance to the “Federal
Policy” (Yale/DHHS) (Federal Wide
Assurance or FWA) and to Ethical
Principles (Belmont Report)
Compliance after HIC approval
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Two Critical Program Processes
•
Quality Assurance
•
Quality Improvement
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Quality Assurance
•
Assess Compliance (regulatory, policy,
approved protocol, etc.)
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Resolve/correct problems and
discrepancies
•
Verify Compliance
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Quality Improvement
•
Provide insight to where systems and
processes are ineffective
•
Collaborative with PI and study staff
•
More creative and educative process
• Change or add
processes/procedures/guidance, etc.
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QA/QI Stages
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Introduction/Scheduling
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PI/Investigator Interviews
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Staff Interview
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Review of Regulatory Binder (all
vital study documents -- protocol,
consents, HIC correspondence, sponsor
correspondence, SAE/AE reports,
Investigator’s Brochure, etc.)
•
Review of Subject Study Records
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QA/QI Stages
•
Draft Findings Report
•
Release of Findings Report
•
Tracking of Corrective
Actions/Plans, if applicable
•
Closure
(
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What Does the Auditor Want to See?
• Documentation that you are following
your approved protocol
• Proper use of consent forms
• Following inclusion/exclusion criteria
• Following study procedures
• Experimental drug/device accountability
• Following Data and Safety Monitoring
Plan (DSMP)
• Following AE collection, reporting, data
review
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Can You Prepare Ahead of Time?
• Complete the self-assessment checklist
• Create a list of all participants in your
study
• Review each consent form & make sure
it’s the correct version & has been
signed/dated properly by the subject
• If you find a problem with a consent,
make a note in the study file and fix the
problem as soon as possible (notify HIC)
• Make sure you have all HIC
correspondence in the Regulatory File
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Authorities and References
• 45 CFR 46, Protection of Human Subjects
• 21 CFR 50, Protection of Human Subjects
• 21 CFR 56, Institutional Review Boards
• 21 CFR 11, Electronic Records
• 21 CFR 54, Financial Disclosure by
Clinical Investigators
• Applicable DHHS Office of Human
Research Protection policy, guidance, and
directives (including OHRP Guidebook for
Human Subject Protections)
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Authorities and References
• 21 CFR 312, Investigational New Drug
Application
• 21 CFR 812, Investigational Device
Exemptions
• The Belmont Report, Ethical Principles and
Guidelines for the Protection of Human
Subjects in Research, National Commission
for the Protection of Human Subjects of
Biomedical and Behavioral Research-, April
1979
• Applicable National Institutes of Health
policy, guidance, and directives
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Authorities and References
• HIC policy, procedures, and guidelines
• Yale University policy, procedures, and
guidelines
• Connecticut State Statutes & Directives
•Yale University Federal Wide Assurance
#FWA00002571
• Specific grant/contractual requirements
(as applicable)
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