Beyond the policies summarized above, both NIH and FDA have established additional policies and procedures for monitoring the safety of participants in clinical research. As discussed below, one set of policies relates generally to the reporting of adverse events, and another involves the creation of committees to monitor data on such events in certain clinical trials.

An earlier IOM report included a constructive recommendation that “[f]ederal oversight agencies should harmonize their safety monitoring guidance for research organizations, including the development of standard practices for reporting adverse events” (IOM, 2003a, p. 148). The report also recommended that NIH provide additional guidance about the elements that should be included in data and safety monitoring plans for clinical trials and that NIH-funded clinical trials be monitored “with the same rigor and scrutiny as trials carried out” for products subject to FDA approval (IOM, 2003a, p. 151). Further, “any monitoring report for studies under a [research ethics review] board’s purview [should] be shared with that board” (p. 145). This recommendation extended to reports for studies that a sponsor ended without seeking FDA approval of a drug or other product. This committee supports these recommendations.

The summary below focuses on the identification of unexpected and serious research-related problems and the monitoring of participant safety during clinical trials. Because most clinical trials are relatively limited in duration and in the size and diversity of study populations (e.g., by age, severity of illness, and diagnosis), they may fail to identify adverse events that are relatively uncommon, that are late effects that do not emerge for years after an intervention, or that occur as a result of long-term use of a drug or other intervention.3 For example, genetic studies, particularly those


As one response to concerns about patient or consumer safety problems that arise after drugs, devices, and other medical products have been approved for marketing, FDA has created various programs and procedures—under the rubric of postmarketing surveillance—that attempt to identify such problems. Surveillance may take several forms, including mandatory reporting of serious adverse events by manufacturers and health care providers, voluntary reporting by consumers and professionals, patient registries, surveys, and ad hoc investigations (e.g., laboratory or epidemiologic investigations). In addition, FDA may require further clinical studies as a condition of marketing approval. These studies—like other clinical research—require IRB review. In general, the postmarketing surveillance tools are limited in their ability to detect problems that arise after marketing begins. Also, the FDA requirements only cover FDA-regulated products and do not apply to certain kinds of surgical procedures or behavioral interventions. Reporting and analysis of adverse events are also important elements of voluntary efforts to improve the quality and safety of patient care (see, e.g.,

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