The IRB must ensure, to the extent possible, the safety of research subjects including that subjects do not incur undue risk and that the risks versus benefits are continually reassessed throughout the study period. In order to make this evaluation, the IRB must consider the Data Safety Monitoring Plan proposed for the study. The types of monitoring are anticipated based on the nature, size, and complexity of the study.
Data and safety monitoring is required for all types of studies and there are minimum standards for all human research conducted and/or overseen by ISMMS.
1. Minimum Standards for Data Safety Monitoring Plans (for projects that entail minimal risk to subjects)
The following minimum requirements apply to all projects, including retrospective reviews of medical records, use of tissue samples, and many minimal risk studies, such as observational and survey research. Because these minimum requirements apply to all studies within a project, a specific written Data Safety Monitoring Plan (DSMP) will not usually be required for projects that do not pose greater than minimal risk to subjects. PPHS may alter the required level of monitoring if appropriate.
For all projects, the principal investigator must have a plan to assure that data integrity will be maintained during data collection, storage, and analysis. All research projects must adhere to ISMMS’ recommendations on the storage of research data. Loss of data containing identifiable information is reportable to the IRB within five business days.
Any problems concerning the consent process, and any subject complaints should be monitored by the investigator who should file reports of such problems at least annually. The discretion of the protocol director will guide the need to report these problems immediately or more frequently in accordance with the Requirements for the submission of Reportable New Information.
Typically, the principal investigator is the monitoring entity for the minimum DSMP. When a principal investigator is not a faculty member, the supervising faculty member must be responsible for the data and safety monitoring aspect of the protocol.
2. Data Safety Monitoring Plans for projects that entail potential greater than minimal risk to subjects
We follow NIH Policy and FDA Guidance on Data and Safety Monitoring, including when a Data Safety Monitoring Board (DSMB) is required.
Please refer to the following information when proposing a Data and Safety Monitoring Plan. In addition, when a Data Safety Monitoring Board (DSMB) is required the IRB requires the submission of the Charter for review.