that protection programs can improve the oversight and monitoring of ongoing studies.
Mechanisms should be in place to track protocols and study personnel and provide assurances that data are valid and are collected according to professional standards. These tasks should be accomplished in a way that safeguards participants’ safety, privacy, and confidentiality within the system. Protection measures should be monitored by various means at all levels of oversight—from the government to the research organization to the investigator—to ensure that informed consent has been properly obtained and that all adverse events have been identified and promptly reported by the investigator to the appropriate institutional body, sponsor, and federal agency(ies). In turn, investigators and participants require assurances that the process is being handled responsibly by the protection program, that federal rules are being applied, and that those charged with these responsibilities have been appropriately trained.
Although regulations and guidance are available from both the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) to direct IRBs, investigators, and sponsors in reporting and evaluating adverse events, confusion remains. Moreover, other entities not considered in the federal regulations, such as Data and Safety Monitoring Boards/ Data Monitoring Committees (DSMB/DMCs), are beginning to play an increasingly important role in safety monitoring (DeMets et al., 1999).
In 2001, the National Bioethics Advisory Commission (NBAC) stated that “For the purpose of continuing review, IRBs should focus their attention primarily on research initially determined to involve more than minimal risk” (2001b, p.112). NBAC reasoned that in research involving high or unknown risks, “the first few trials of a new intervention may substantially affect what is known about the risks and potential benefits of that intervention” (2001b, p.112). For minimal risk studies, NBAC stated the following:
Continuing review of such research should not be required because it is unlikely to provide any additional protection to research participants and would merely increase IRB burden. However, because minimal risk research does involve some risk, IRBs may choose to require continuing review when they have concerns. In these cases, other types of monitoring would be more appropriate, such as assessing investigator compliance with the approved protocol or requiring reporting of protocol changes and unanticipated problems. Although such efforts might fail to detect some protocol problems, the resource requirement inherent in conducting continuing reviews for all protocols and the distraction of the IRB’s attention from riskier research do not justify devoting a disproportionate amount of resources to continuing review (2001b, p.112).
This committee concurs with NBAC’s conclusion and thus focuses in