Once a protocol is approved and the research has begun, the safety of human subjects must be monitored on an ongoing basis in accordance with the data and safety monitoring plan. All adverse events must be reported, and protocols that place subjects at excessive risk must be modified or terminated. Ongoing external review of approved protocols, through post approval monitoring or auditing by the IRB, study sponsor, or regulatory agencies, ensures that the risk associated with participation remains in a reasonable relationship to the benefits. The links at right provide additional information on these topics:
- Identifying and Reporting Adverse and Unexpected Events
- Renewal of Approval for Protocols, Monitoring, and Postapproval Auditing of Research Protocols
- Terminating a Study Because of Safety Concerns, Demonstrated Effectiveness of Intervention, or Futility of Continuing