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

• Collection and storage of research data

• Management of biosecurity and biosafety, and storage of biological materials of human and animal origin

Last Modified: Thu, 13 Mar 2025 23:52:45 SAST