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Safety monitoring

Robert Hood

08/27/2008 03:06 pm

Help for researchers: Safety monitoring

Safety Monitoring Plans

Information and Examples

General considerations Investigators should incorporate plans to monitor the data for the safety of participants when appropriate. For research not greater than minimal risk, data and safety monitoring is not usually needed to protect participants.
  • For research that presents greater than minimal risks, monitoring plans are needed. In general, investigators should describe who will conduct the monitoring, what will be assessed, and the criteria used to assess the data to assure the ongoing safety of research participants.
  • Monitoring applies to all studies where the risks are greater than minimal, not just biomedical studies. For example, in a social and behavioral study of depression, monitoring might include ongoing assessment of suicidal thoughts, or other psychological assessment. Even in a study involving data analysis, if the potential violations of confidentiality present greater than minimal risks, then safety monitoring would involve assessment of the adequacy of protections for confidentiality. For example, if a principal investigator is working with a team of other investigators and study staff, the investigator might monitor study personnel to make sure they change passwords on a regular basis, or that they use encryption consistently, or that they follow protocols for transporting data.
  • There is considerable flexibility in how monitoring may be conducted. Monitoring can be conducted by the investigator, by a sponsor (pharmaceutical company), data monitoring committee, or another investigator. Investigators should understand that options include:
    • monitoring at a specific point in time
    • monitoring after a certain number of participants have been recruited
    • monitoring upon recognition of harms
  • When a data safety monitoring committee is responsible for monitoring the research, the investigator should describe how often it meets, how information will be reported, and qualifications of the members.
Investigators should report results of monitoring at continuing review.
  • For example, investigators might report at continuing review that a pharmaceutical company monitor visited the site and had no negative findings.
  • Investigators should report activities of any data safety monitoring committees at continuing review. IRBs conducting continuing review of research may rely on a current statement from the DSMB or sponsor indicating that it has reviewed study-wide adverse events, interim findings, and any recent literature that may be relevant to the research, in lieu of requiring that this information be submitted directly to the IRB by the safety monitoring committee.
Required Determinations by the IRB A regulatory criterion for approval of research is that when appropriate, the research plan makes adequate provisions for monitoring the data to ensure the safety of participants.
Accreditation Element
  • Element II.4.B: The Research Review Unit reviews the plan for data and safety monitoring in research protocols, when applicable, and determines that the plan provides adequate protection for participants.48
  • Element III.2.D: The Investigator designs and carries out research studies with adequate data and safety monitoring during the research, when appropriate.
DOH policies Including but not limited to:
Regulations 45 CFR §46.111(a)(6), 21 CFR §56.111(a)(6)
Guidance  
References Evaluation Instrument for Accreditation, Association for Accreditation of Human Research Protection Program

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