The IRB's Monitoring Function: Four Concepts of Monitoring

Abstract

Since Institutional Review Boards (IRBs) were introduced, concerns about institutional accountability, consumer rights, and conflicts of interests among institutional committees, the institutions, and the public have all increased. These concerns are reflected today in increased pressures on IRBs to diversify their membership, to submit to external audit of their activity, and to assume more functions. While monitoring is a term that is increasingly used to describe new IRB functions, it is used imprecisely and to refer to a range of possible activities. is acknowledged to have some meaning in the area of continuing review. It is also often discussed in terms of police-like duties and surveillance. Some proposed regulations refer to of solicitation of assent. The 1974 DHEW proposed regulation described the duties of the consent committees that were to be set up by using words such as oversee, monitor, and intervene. More recently the proposed FDA regulations on IRBs combine continuing review with assurances of compliance. IRBs are quickly developing a highly specialized jargon. Monitoring is a word that is being used in that new jargon without careful consideration given to its meaning. The word monitoring should be eliminated from the regulations and replaced with four more concrete and precise concepts. Each of these concepts can then be debated on its own merits without being confused with the other three. Some may be accepted and others rejected without tossing out all of altogether. The four concepts are (1) continuing review; (2) review of the consent process: (3) review for adherence to an approved protocol; and (4) review to identify unapproved activities.