Monitoring for Safety and Compliance

Before beginning any project, researchers should have a plan to monitor their data for subject safety and compliance with the research protocol. Monitoring plans should be tailored to the risk level and complexity of the research.

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What is the Requirement?

45 CFR 46.111 (a) (6): “When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.”

How Do I Comply With the Requirement?

Initial Review Application

On the Monitoring for Safety and Compliance page you will be asked how this research will be monitored for safety?

  • Medical Monitor
  • Data Safety Monitoring Committee
  • Not Applicable/Minimal Risk
  • Other

You will also be asked to describe your monitoring plan. If the research protocol includes a detailed monitoring plan, simply reference the location of the information in the protocol.  Subject safety monitoring plans should reflect the risk profile of the research. For minimal risk research, informal monitoring may be adequate. Greater than minimal risk research requires a formal monitoring plan. For clinical trials initiated by a research sponsor, the sponsor often includes the monitoring plan in the research protocol. For investigator-initiated studies, the researcher will need to establish an independent monitor or monitoring committee to regularly review research data for subject safety. When monitoring subject safety, the discovery of new risk information must be reported to the IRB within 5 business days.

UC Davis Research Integrity and Compliance conducts both random and for cause audits for research compliance. The research team maintains responsibility for ensuring the research is conducted according to the IRB-approved protocol. Any time the research team fails to comply with the requirements of an applicable law, regulation, or institutional policy pertaining to the protection of human subjects, and/or with the requirements or determinations of an IRB, it should be reported to the IRB as an allegation of non-compliance.  Researchers should have a plan to avoid non-compliance and ensure the research is being conducted in accordance with the protocol.  Allegations of non-compliance must be reported to the IRB within 10 business days.

Ethical Considerations

The IRB will consider the following:

  • Is there a detailed and documented plan in place to monitor the safety of the research participant according to the risk level of the research?
  • Will the investigator have enough information to notify the IRB of any:
    • Changes to risk information
    • Unanticipated problems involving risks to subjects or others;
    • Allegations of non-compliance

    Definitions

    Data and Safety Monitoring Plan (DSMP) is a written description of the procedures for reviewing accumulated data in an ongoing research protocol to ensure the safety of research participants, validity, and scientific merit of the study protocol.

    Data and Safety Monitoring Board (DSMB) is a formal committee of experts who review accumulating data from one or more ongoing clinical trials

    Medical Monitor is an individual expert who reviews accumulating data from one or more ongoing clinical trials

    Non-Compliance means failure to comply with the requirements of an applicable law, regulation, or institutional policy pertaining to the protection of human subjects, and/or with the requirements or determinations of an IRB.

    Unanticipated Problem Involving Risks to Subjects or Others (UPIRSO) is an incident, experience, or outcome that meets all of the following criteria:

    • Unexpected (in terms of nature, severity or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and the characteristics of the subject population being studied;
    • Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
    • Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized, even if no harm has actually occurred.

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