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Documentation and certification

• Maintenance of records
• Continuing Review and Re-Certification Procedures
• Writing, Revising, and Managing Standard Operating Procedures

Research ethics committee activities and processes

• Human Research Ethics Committee
• HREC Meetings
• HREC Review Processes

Protocol violations, adverse events and complaints

• Reporting of unanticipated problems/ incidents/ adverse events
• Procedures for reporting allegations of misconduct/ non-compliance/ unethical research practice
• Consequences for non-compliance, protocol violation or unethical research practice
• Protection of whistle-blowers
• Processes for dealing with complaints, queries and appeals about REC operations and decisions

Ethical principles

• Informed consent
• Anonymity and confidentiality regarding participants
• Research involving vulnerable persons
• Research involving minors
• Gatekeeper consent and gatekeeper waiver
• Ethics waiver
• Data Collection and Storage

Last Modified: Fri, 12 Apr 2024 14:58:44 SAST