Are there adequate provisions for data and safety monitoring?
Help for IRB Committee Members: Are there adequate provisions for data and safety monitoring?
| Belmont principle | Beneficence |
| Where to start: initial application | Scientific and Scholarly Rationale section, Questions I, J, K |
| Where to start: continuing review application | Provisions for Monitoring Safety of Participants section, Questions D-H |
| Required IRB determinations | When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects |
| General Considerations |
When appropriate, researchers who design research should incorporate plans to monitor the safety of participants. For example, research where serious harms are expected (such as drug side effects, or behavioral side effects, such as HIV infection during a a behavioral HIV prevention study) should include plans to evaluate whether the character, incidence and severity of harms match those that are expected, and to evaluate unexpected harms. For example, in a behavioral HIV prevention study of the use of condoms, researchers may expect that, despite prevention measures and education, that a certain number of patients may be expected to become infected during the study. Where appropriate, greater than minimal risk studies may include a data and safety monitoring board ("DSMB"), particularly when research is conducted at more than one site. The purpose of a data and safety monitoring board is to monitor safety for large, multi-site clinical trials. DSMBs are usually composed of epidemiologists and statisticians who generally have access to all the data in the study, including unblinded data and all adverse events. Reviewers should look for a description of the DSMB membership and evaluate the qualifications of members, and evaluate how the DSMB will report its findings. |
| Accreditation Element | Element II.3.B. The IRB or EC has and follows written policies and procedures for reviewing the plan for data and safety monitoring, when applicable, and determines that the data and safety monitoring plan provides adequate protection for participants. |
| Regulations | 45 CFR §46.111(a)(6), 21 CFR §56.111(a)(6) |
| Guidance | |
| OHRP Guidebook | OHRP Guidebook, Chapter 3: Basic IRB Review: Observation and Monitoring |