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Monitoring Research (page 1 of 2)

Research by its very nature is a trip into the unknown for the subjects as well as for the entire investigator team. While the IRB has some monitoring responsibilities, it is not constituted so as to visit sites, examine data, interact with subjects, or make decisions as to the nature of an adverse event. In fact, IRBs function largely on trust; trust that the investigators will carry out the study according to protocol, trust that the data will be collected carefully, trust that the interests of the subjects will be primary and supercede those of the research, and trust that the investigators' conflicts of interest will not interfere with or bias the study. Research catastrophes have led to the conclusion that trust is not enough. Several kinds of research monitoring have evolved to deal with these issues.

  1. Clinical Trial Monitors:
    Sponsored clinical trials have monitors who make sure that the primary data are collected and recorded properly. They meet periodically with research coordinators and review their study records. They ensure that the reporting of adverse events is complete. This very useful auditing function serves to promote Good Clinical Practices and to enhance the compulsive collection of data. It is required by the FDA, which does not like to review incomplete studies. These monitors do not relate to the subjects.

  2. Data and Safety Monitoring Boards (DSMBs):
    In 1998 the NIH wrote policies for Data and Safety Monitoring Boards for studies supported by its Institutes and Centers. The report can be found at: http://grants.nih.gov/grants/guide/notice-files/not98-084.html

    Key elements are replicated here but the entire policy is brief.

    It is the policy of the NIH that each Institute and Center (IC) should have a system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all NIH-supported or conducted clinical trials. The establishment of the data safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. The data and safety monitoring functions and oversight of such activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB).

    Although there are potential benefits to be derived from participation in clinical research, the IRBs and the NIH must ensure, to the extent possible, the safety of study participants and that they do not incur undue risk and that the risks versus benefits are continually reassessed throughout the study period.

    All clinical trials require monitoring -- Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III); etc.

    Monitoring should be commensurate with risks -- The method and degree of monitoring needed is related to the degree of risk involved. A monitoring committee is usually required to determine safe and effective conduct and to recommend conclusion of the trial when significant benefits or risks have developed or the trial is unlikely to be concluded successfully. Risk associated with participation in research must be minimized to the extent practical.

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Chapter 5
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