All studies submitted to the IRB for review must contain a plan for adequately monitoring the data collected to ensure the safety of subjects [c.f. 45 CFR 46.111(a)(6) and 21 CFR 56.111(a)(6)]. Elements of data safety and monitoring plans may vary depending on potential risks, study complexity and type, but all plans must be suitable for the level of risk to be faced by subjects and to the nature of the research involved. If a study is sponsored by an agency or organization which requires specific data and safety monitoring standards, a copy of these monitoring standards must be attached to the study application and the Principal Investigator must submit to the IRB a plan to meet these standards.
For any study considered by the IRB to involve greater than minimal risk to human subjects, the IRB may require that the data safety and monitoring plan include a Data Safety Monitoring Board (DSMB). In particular, the IRB may (and usually will) require a DSMB for Phase III multi-site clinical trials involving interventions that entail potential risk to the participants.
In determining whether a DSMB is required, the IRB shall consider factors suggesting that a DSMB is needed which include:
- a large study population
- multiple study sites (since it is difficult to recognize unusual problems or patterns of problems when investigators are treating only a fraction of the participants)
- highly toxic therapies or dangerous procedures
- high expected rates of morbidity or mortality in the study population
- high change of early termination of the study especially if there is a reasonable likelihood that the study may be terminated early for reasons of safety, futility or efficacy
DSMB members should be experts in the scientific field of the study who are independent from the study and who may, at the discretion of the IRB, be internal or external to the institution. DSMB members shall have no professional or financial interest in the outcome of the studies they monitor. The DSMB shall function as an independent committee to monitor data throughout the duration of the study to determine if continuation of the study is appropriate scientifically and ethically. Determinations by the DSMB shall be considered as recommendations to the IRB and must be reported by the Principal Investigator to the IRB (through the HSRO) in a timely manner.