HSP Module 6: Monitoring Research Data, Auditing Protocols and Reporting Adverse Events


The safety of human subjects participating in research is of paramount importance. Investigators must minimize risks to subjects by developing an appropriate research design (plan and procedures), establishing inclusion and exclusion criteria, and actively soliciting information from subjects about adverse events during the course of the study. All approved protocols must contain specific procedures that monitor the safety of subjects throughout the study. An important element of these procedures is the ongoing monitoring of research data to detect any adverse effects of the research on subjects. Depending on the nature of the research study (e.g., its size, number of sites involved, and the severity and duration of potential adverse events), this function may be conducted by the investigator, the research sponsor, or a formal data and safety monitoring committee (DSMC), or board (DSMB). In addition to monitoring adverse events, studies that utilize DSMC/DSMBs often monitor efficacy data and occasionally monitor data acquisition. When monitoring efficacy, DSMC/DSMBs may find that a research protocol will not accomplish its stated objectives (e.g., that it is not trending to a scientifically sound result or that it has reached its objectives with fewer subjects than expected). Ongoing monitoring and collection of data on adverse effects protects subjects by ensuring that studies subjecting participants to unexpected or unacceptable levels of harm are detected early and that the protocols are modified as necessary or terminated. Human subjects are also protected from potential harm when protocols unlikely to result in generalizable knowledge are terminated. Early detection of an effective intervention, procedure, drug, or test device allows the benefit of the new knowledge to be disseminated sooner.

When an adverse effect is observed in a subject due to participation in research, it may be classified as an unexpected or an anticipated adverse event and it will also be graded as either a nonserious or a serious event. These terms are defined later in this module forsocial-behavioral and biomedical research. It is the responsibility of investigators to carefully observe their subjects for signs of adverse events (serious and nonserious), especially those adverse events that were not anticipated during the protocol design. These events are all evaluated by the investigator to determine if they may be the result of trial participation, and are reported as defined in the protocol. Knowledgeable and conscientious safety monitoring by investigators and their study team is essential for protecting study subjects.